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CLINDAMYCIN 150MG/ML SOLUTION FOR INJECTION

Active substance(s): CLINDAMYCIN PHOSPHATE / CLINDAMYCIN PHOSPHATE / CLINDAMYCIN PHOSPHATE

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PATIENT INFORMATION LEAFLET

2895
14.12.16[3]

Dalacin® C 300mg/2ml Sterile Solution
(clindamycin phosphate)
Your medicine is available using the above names but will be referred to
as Dalacin C Solution throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Dalacin C Solution is and what it is used for
2. Before you are given Dalacin C Solution
3. How Dalacin C Solution is given to you
4. Possible side effects
5. How to store Dalacin C Solution
6. Further Information

Adults/Elderly
The recommended dose of Dalacin C Solution is 600 to 2700 mg
clindamycin per day in two to four equal doses, depending on the severity
of your infection. Higher doses than this (up to 4800 mg daily) may be
given by your doctor for very severe infections.

Please tell your doctor if you are taking or have recently taken any other
medicines including medicines obtained without a prescription.

Normally Dalacin C is only given to patients in hospital. The medical staff
will be keeping a close eye on you during your treatment. If you need to
have more than one course of treatment with clindamycin, your doctor
may want to check that the clindamycin is not having any effect on the
way your kidneys and liver are working.

Pregnancy
If you are pregnant or think you might be pregnant you should contact
your doctor before being given Dalacin C Solution.

1. What Dalacin C Solution is and what it is used for
Dalacin C Solution is a sterile solution for injection into a vein
(intravenously) or into a muscle (intramuscularly). The solution contains
clindamycin phosphate which is an antibiotic used in the treatment of
serious bacterial infections.
2. Before you are given Dalacin C Solution
Do not use If you are allergic (hypersensitive) to clindamycin, lincomycin
or to any of the other ingredients in this medicine.
Take special care with Dalacin C Solution
Before you are given this medicine make sure that your doctor knows if
you:
 have diarrhoea or usually get diarrhoea when you take antibiotics or
have ever suffered from problems with your stomach or intestines
(bowel disease). If you develop severe or prolonged or bloody diarrhoea
during or after using Dalacin C Solution tell your doctor immediately
since it may be necessary to interrupt the treatment. This may be a sign
of bowel inflammation (pseudomembranous colitis) which can occur
following treatment with antibiotics.
 you suffer from problems with your kidneys or liver.
 you suffer from asthma, eczema or hayfever. Dalacin C does not get
into the brain and is therefore not suitable for treating serious infections
in and around the brain. Your doctor may need to give you another
antibiotic if you have these infections.

INFORMATION LEAFLET FOR HEALTHCARE PROFESSIONAL

Dalacin® C 300mg/2ml Sterile Solution
(clindamycin phosphate)
150mg/ml
For further information consult the Summary of Product Characteristics.
Qualitative and quantitative composition
Each ml contains 150mg clindamycin (as phosphate).Also contains benzyl
alcohol, disodium edetate, sodium hydroxide and water for injection.
Directions for use
Parenteral (I.M. or IV. administration). Dalacin C Phosphate must be
diluted prior to IV. administration and should be infused over at least
10-60 minutes.
Parenteral (I.M. or IV. administration)
Adults including the elderly:
Serious infections: 600-1200 mg/day in 2, 3 or 4 equal doses.
More severe infections: 1200-2700 mg/day in 2, 3 or 4 equal doses.
Single I.M. injections of greater than 600 mg are not recommended nor is
administration of more than 1.2 g in a single one-hour infusion.
Children (over 1 month of age):
Serious infections: 15-25 mg/kg/day in three or four equal doses.
More severe infections: 25-40 mg/kg/day in three or four equal doses.
In severe infections it is recommended that children be given no less than
300 mg/day regardless of body weight.
The concentration of clindamycin in diluent for infusion should not exceed
18 mg per mL and INFUSION RATES SHOULD NOT EXCEED 30 mg
PER MINUTE.
The usual infusion rates are as follows:
Dose

Taking other medicines
Some medicines can affect the way Dalacin C Solution works, or
Dalacin C itself can reduce the effectiveness of other medicines taken at
the same time. These include:
 erythromycin (an antibiotic).
 muscle relaxants used during operations
 oral contraceptive pills. You should use extra contraception such as
condoms whilst receiving Dalacin C and for seven days after receiving
Dalacin C.
 warfarin or similar medicines - used to thin the blood. You may be more
likely to have a bleed. Your doctor may need to take regular blood tests
to check how well your blood can clot.

Diluent

Time

300mg

50mL

10 min

600mg

50mL

20 min

900mg

50-100mL

30 min

1200mg

100mL

40 min

Indications
The management of serious infections due to organisms susceptible to
this anti-infective.
Contra-indication etc.
Contra-indications:
Dalacin C Phosphate is contra-indicated in patients previously found to be
sensitive to clindamycin, lincomycin or to any components of the
formulation particularly benzyl alcohol.

Breast-feeding
Tell your doctor if you will be breast-feeding while you are taking
Dalacin C as the active substance in this medicine may be passed into
breast milk. Your doctor will decide if Dalacin C is appropriate for you.
Although it is not likely that a nursing infant will take in very much of the
active substance from the milk it drinks, if your baby gets bloodstained
diarrhoea or shows any signs of illness, tell your doctor at once. You
should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with
Dalacin C Solution.
Important information about some of the ingredients of Dalacin C
Solution
Dalacin C Solution contains benzyl alcohol (9.45mg/ml as preservative)
and must not be given to premature babies or babies less than one
month old. It may cause allergy and toxic reactions and has caused
serious side effects in the brain, heart, blood, and breathing rate in
children, which have been fatal in some cases.
3. How Dalacin C Solution is given to you
Your doctor will give you your medicine as an injection into your vein
(intravenous) or your muscle (intramuscular). If it is given into a vein, it is
always mixed with a sugar or saline (salt) solution before use and given
using a drip.

Children
The recommended dosage for children (over 1 month of age) is 15 to 40
mg of clindamycin per kg bodyweight each day in three or four equal
doses. Higher doses of up to 300 mg per day (regardless of body weight)
may be given by your doctor for very severe infections until a full response
to treatment is observed.

Long term use can also make you more likely to get other infections that
do not respond to Dalacin C treatment.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Tell your doctor immediately if you develop:
 severe, persistent or bloody diarrhoea (which may be associated with
stomach pain or fever). This is an uncommon side effect which may
occur during or after completing treatment with antibiotics and can be a
sign of serious bowel inflammation
 signs of a severe allergic reaction such as sudden wheeziness, difficulty
in breathing, swelling of eyelids, face or lips, rash or itching (especially
affecting the whole body)
 blistering and peeling of large areas of skin, fever, cough, feeling unwell
and swelling of the gums, tongue or lips
 yellowing of the skin and whites of the eyes (jaundice).
Other possible side effects may include:

 Effects on your nervous system: impaired sense of taste
 Effects on your skin: reddening of the skin, skin rash, itching (hives)
 Effects on your stomach and intestines: throat ulcers, sore throat,
feeling sick, being sick, stomach pain and diarrhoea

 Effects on your blood system: reduced numbers of blood cells
 Effects on your liver: poor liver function
 Effects on your heart: low blood pressure (feeling light headed, dizzy
or faint), rarely heart attack (if given too fast)

When giving you Dalacin C, your doctor will ensure that the concentration
of clindamycin does not exceed 18 mg per ml and the rate it is given to
you does not exceed 30 mg per minute. If Dalacin C is given too fast it
could rarely cause a heart attack.

 Effects on your genital area: inflammation of the vagina
 Injection site reactions: swelling, redness, irritation, pain and boil

Warnings:
This product contains benzyl alcohol (9.45mg/ml as preservative).
Intravenous administration of the preservative benzyl alcohol has been
associated with serious adverse events, and death in paediatric patients
including neonates characterized by central nervous system depression,
metabolic acidosis, gasping respirations, cardio-vascular failure and
haematological anomalies (“gasping syndrome”). Although normal
therapeutic doses of this product ordinarily deliver amounts of benzyl
alcohol that are substantially lower than those reported in association
with the “gasping syndrome”, the minimum amount of benzyl alcohol at
which toxicity may occur is not known. Use only if it is necessary and if
there are no alternatives possible. If given in high volumes, should be
used with caution and preferably for short term treatment in subjects with
liver or kidney impairment because of the risk of accumulation and toxicity
(metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).
Premature and low-birth weight infants may be more likely to develop
toxicity.
Benzyl Alcohol containing products should not be used in pre-term or
full-term neonates unless strictly necessary.
Benzyl alcohol can cross the placenta and clindamycin should only be
used during pregnancy if clearly needed.

Coagulation tests, therefore, should be frequently monitored in patients
treated with vitamin K antagonists.

Dalacin C Phosphate should only be used in the treatment of serious
infections. In considering the use of the product, the practitioner should
bear in mind the type of infection and the potential hazard of the
diarrhoea which may develop, since cases of colitis have been reported
during, or even two or three weeks following, the administration of
clindamycin.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium
difficile) is the principal direct cause of antibiotic-associated colitis.
These studies also indicate that this toxigenic clostridium is usually
sensitive in-vitro to vancomycin. The disease is likely to follow a more
severe course in older patients, or patients who are debilitated.
Diagnosis is usually made by the recognition of the clinical symptoms,
but can be substantiated by endoscopic demonstration of
pseudomembranous colitis. The presence of the disease may be further
confirmed by culture of the stool for C. difficile on selective media and
assay of the stool specimen for the toxin(s) of C. difficile.
The appearance of marked diarrhoea should be regarded as an
indication that the product should be discontinued immediately.
Clostridium difficile associated diarrhoea (CDAD) has been reported to
occur over 2 months after the administration of antibacterial agents.
Precautions:
History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms.
Periodic liver and kidney function tests should be carried out during
prolonged therapy. Such monitoring is also recommended in neonates
and infants. Safety and appropriate dosage in infants less than one
month old have not been established.

(abscess) formation around site of injection.

Pregnancy and lactation:
Safety of use in pregnancy has not been established. Exercise caution
when prescribing to nursing mothers.
Benzyl alcohol can cross the placenta (see Warnings).
Undesirable effects:
Side effects include nausea, vomiting, cramps, abdominal pain, diarrhoea,
hypersensitivity reaction such as Stevens Johnson syndrome, liver
dysfunction and jaundice, blood dyscrasia, pruritus, vaginitis, dermatitis,
cardiopulmonary arrest and hypotension (following too rapid an
administration) and local reactions at the site of injection.
The appearance of marked diarrhoea should be regarded as an indication
that this drug should be discontinued immediately.
Overdose:
In cases of overdosage no specific treatment is indicated. The serum
biological half-life of lincomycin is 2.4 hours. Clindamycin cannot readily
be removed from the blood by dialysis or peritoneal dialysis.
If an allergic adverse reaction occurs, therapy should be with the usual
emergency treatments, including corticosteroids, adrenaline and
antihistamines.
Handling and Storage requirements
Do not store above 25°C.
Do not refrigerate or freeze.
This product is for single dose only.
Any unused solution should be discarded.
Dilution and Compatibility:
In-vitro compatibility studies monitored for 24 hours at room temperature
using a concentration no greater than 6 mg/ml have demonstrated no
inactivation or physical incompatibility with the use of Dalacin C
Phosphate in IV solutions containing sodium chloride, glucose or
potassium usually used clinically.
Dalacin C Phosphate has been shown to be physically and chemically
compatible for at least 24 hours in dextrose 5% water and sodium chloride
injection solutions containing the following antibiotics in usually
administered concentrations: amikacin sulphate, aztreonam, cefamondole
nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium,
ceftazidime sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin
sulphate, piperacillin, tobramycin and ciprofloxacin.
The compatibility and duration of stability of drug admixtures will vary
depending upon concentration and other conditions.

The dosage of Dalacin C Phosphate may require reduction in patients
with renal or hepatic impairment due to prolongation of the serum
half-life.

Incompatibilities:
Solutions of clindamycin salts have a low pH and incompatibilities may
reasonably be expected with alkaline preparations or drugs unstable at
low pH. Incompatibility has been reported with: ampicillin sodium,
aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium,
diphenylhydantoin, idarubicin hydrochloride, magnesium sulphate,
phenytoin sodium and ranitidine hydrochloride.

Interactions:
Use with caution in patients receiving neuromuscular blocking agents.
Do not use concurrently with erythromycin.

Parallel Import Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.

Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding, have been reported
in patients treated with clindamycin in combination with a vitamin K
antagonist (e.g. warfarin, acenocoumarol and fluindione).

Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 14.12.16[3]

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Dalacin C Solution
 Keep out of the sight and reach of children.
 Dalacin C Solution will not be used after the expiry date which is stated
on the carton. The expiry date refers to the last day of that month.
 Do not store above 25°C.
 Do not refrigerate or freeze.
 If the solution shows any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Dalacin C Solution contains
The active substance is clindamycin phosphate.
Each ml contains 150mg clindamycin (as phosphate).
The other ingredients are: benzyl alcohol, disodium edetate, sodium
hydroxide and water for injection.
What Dalacin C Solution looks like and contents of the pack
Transparent, glass ampoule containing 2ml or 4ml of clear, colourless,
sterile, aqueous solution, packed in cardboard carton.
Dalacin C Solution is available in pack sizes of 1 x 2ml, 5 x 2ml, 1 x 4ml
and 5 x 4ml glass ampoules.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2895

Leaflet revision and issue date (Ref.) 14.12.16[3]
Dalacin C is a trademark of Pharmacia & Upjohn Company LLC.

PATIENT INFORMATION LEAFLET

2895
14.12.16[3]

Dalacin® C 600mg/4ml Sterile Solution
(clindamycin phosphate)
Your medicine is available using the above names but will be referred to
as Dalacin C Solution throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Dalacin C Solution is and what it is used for
2. Before you are given Dalacin C Solution
3. How Dalacin C Solution is given to you
4. Possible side effects
5. How to store Dalacin C Solution
6. Further Information

Adults/Elderly
The recommended dose of Dalacin C Solution is 600 to 2700 mg
clindamycin per day in two to four equal doses, depending on the severity
of your infection. Higher doses than this (up to 4800 mg daily) may be
given by your doctor for very severe infections.

Please tell your doctor if you are taking or have recently taken any other
medicines including medicines obtained without a prescription.

Normally Dalacin C is only given to patients in hospital. The medical staff
will be keeping a close eye on you during your treatment. If you need to
have more than one course of treatment with clindamycin, your doctor
may want to check that the clindamycin is not having any effect on the
way your kidneys and liver are working.

Pregnancy
If you are pregnant or think you might be pregnant you should contact
your doctor before being given Dalacin C Solution.

1. What Dalacin C Solution is and what it is used for
Dalacin C Solution is a sterile solution for injection into a vein
(intravenously) or into a muscle (intramuscularly). The solution contains
clindamycin phosphate which is an antibiotic used in the treatment of
serious bacterial infections.
2. Before you are given Dalacin C Solution
Do not use If you are allergic (hypersensitive) to clindamycin, lincomycin
or to any of the other ingredients in this medicine.
Take special care with Dalacin C Solution
Before you are given this medicine make sure that your doctor knows if
you:
 have diarrhoea or usually get diarrhoea when you take antibiotics or
have ever suffered from problems with your stomach or intestines
(bowel disease). If you develop severe or prolonged or bloody diarrhoea
during or after using Dalacin C Solution tell your doctor immediately
since it may be necessary to interrupt the treatment. This may be a sign
of bowel inflammation (pseudomembranous colitis) which can occur
following treatment with antibiotics.
 you suffer from problems with your kidneys or liver.
 you suffer from asthma, eczema or hayfever. Dalacin C does not get
into the brain and is therefore not suitable for treating serious infections
in and around the brain. Your doctor may need to give you another
antibiotic if you have these infections.

INFORMATION LEAFLET FOR HEALTHCARE PROFESSIONAL

Dalacin® C 600mg/4ml Sterile Solution
(clindamycin phosphate)
150mg/ml
For further information consult the Summary of Product Characteristics.
Qualitative and quantitative composition
Each ml contains 150mg clindamycin (as phosphate).Also contains benzyl
alcohol, disodium edetate, sodium hydroxide and water for injection.
Directions for use
Parenteral (I.M. or IV. administration). Dalacin C Phosphate must be
diluted prior to IV. administration and should be infused over at least
10-60 minutes.
Parenteral (I.M. or IV. administration)
Adults including the elderly:
Serious infections: 600-1200 mg/day in 2, 3 or 4 equal doses.
More severe infections: 1200-2700 mg/day in 2, 3 or 4 equal doses.
Single I.M. injections of greater than 600 mg are not recommended nor is
administration of more than 1.2 g in a single one-hour infusion.
Children (over 1 month of age):
Serious infections: 15-25 mg/kg/day in three or four equal doses.
More severe infections: 25-40 mg/kg/day in three or four equal doses.
In severe infections it is recommended that children be given no less than
300 mg/day regardless of body weight.
The concentration of clindamycin in diluent for infusion should not exceed
18 mg per mL and INFUSION RATES SHOULD NOT EXCEED 30 mg
PER MINUTE.
The usual infusion rates are as follows:
Dose

Taking other medicines
Some medicines can affect the way Dalacin C Solution works, or
Dalacin C itself can reduce the effectiveness of other medicines taken at
the same time. These include:
 erythromycin (an antibiotic).
 muscle relaxants used during operations
 oral contraceptive pills. You should use extra contraception such as
condoms whilst receiving Dalacin C and for seven days after receiving
Dalacin C.
 warfarin or similar medicines - used to thin the blood. You may be more
likely to have a bleed. Your doctor may need to take regular blood tests
to check how well your blood can clot.

Diluent

Time

300mg

50mL

10 min

600mg

50mL

20 min

900mg

50-100mL

30 min

1200mg

100mL

40 min

Indications
The management of serious infections due to organisms susceptible to
this anti-infective.
Contra-indication etc.
Contra-indications:
Dalacin C Phosphate is contra-indicated in patients previously found to be
sensitive to clindamycin, lincomycin or to any components of the
formulation particularly benzyl alcohol.

Breast-feeding
Tell your doctor if you will be breast-feeding while you are taking
Dalacin C as the active substance in this medicine may be passed into
breast milk. Your doctor will decide if Dalacin C is appropriate for you.
Although it is not likely that a nursing infant will take in very much of the
active substance from the milk it drinks, if your baby gets bloodstained
diarrhoea or shows any signs of illness, tell your doctor at once. You
should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with
Dalacin C Solution.
Important information about some of the ingredients of Dalacin C
Solution
Dalacin C Solution contains benzyl alcohol (9.45mg/ml as preservative)
and must not be given to premature babies or babies less than one
month old. It may cause allergy and toxic reactions and has caused
serious side effects in the brain, heart, blood, and breathing rate in
children, which have been fatal in some cases.
3. How Dalacin C Solution is given to you
Your doctor will give you your medicine as an injection into your vein
(intravenous) or your muscle (intramuscular). If it is given into a vein, it is
always mixed with a sugar or saline (salt) solution before use and given
using a drip.

Children
The recommended dosage for children (over 1 month of age) is 15 to 40
mg of clindamycin per kg bodyweight each day in three or four equal
doses. Higher doses of up to 300 mg per day (regardless of body weight)
may be given by your doctor for very severe infections until a full response
to treatment is observed.

Long term use can also make you more likely to get other infections that
do not respond to Dalacin C treatment.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Tell your doctor immediately if you develop:
 severe, persistent or bloody diarrhoea (which may be associated with
stomach pain or fever). This is an uncommon side effect which may
occur during or after completing treatment with antibiotics and can be a
sign of serious bowel inflammation
 signs of a severe allergic reaction such as sudden wheeziness, difficulty
in breathing, swelling of eyelids, face or lips, rash or itching (especially
affecting the whole body)
 blistering and peeling of large areas of skin, fever, cough, feeling unwell
and swelling of the gums, tongue or lips
 yellowing of the skin and whites of the eyes (jaundice).
Other possible side effects may include:

 Effects on your nervous system: impaired sense of taste
 Effects on your skin: reddening of the skin, skin rash, itching (hives)
 Effects on your stomach and intestines: throat ulcers, sore throat,
feeling sick, being sick, stomach pain and diarrhoea

 Effects on your blood system: reduced numbers of blood cells
 Effects on your liver: poor liver function
 Effects on your heart: low blood pressure (feeling light headed, dizzy
or faint), rarely heart attack (if given too fast)

When giving you Dalacin C, your doctor will ensure that the concentration
of clindamycin does not exceed 18 mg per ml and the rate it is given to
you does not exceed 30 mg per minute. If Dalacin C is given too fast it
could rarely cause a heart attack.

 Effects on your genital area: inflammation of the vagina
 Injection site reactions: swelling, redness, irritation, pain and boil

Warnings:
This product contains benzyl alcohol (9.45mg/ml as preservative).
Intravenous administration of the preservative benzyl alcohol has been
associated with serious adverse events, and death in paediatric patients
including neonates characterized by central nervous system depression,
metabolic acidosis, gasping respirations, cardio-vascular failure and
haematological anomalies (“gasping syndrome”). Although normal
therapeutic doses of this product ordinarily deliver amounts of benzyl
alcohol that are substantially lower than those reported in association
with the “gasping syndrome”, the minimum amount of benzyl alcohol at
which toxicity may occur is not known. Use only if it is necessary and if
there are no alternatives possible. If given in high volumes, should be
used with caution and preferably for short term treatment in subjects with
liver or kidney impairment because of the risk of accumulation and toxicity
(metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).
Premature and low-birth weight infants may be more likely to develop
toxicity.
Benzyl Alcohol containing products should not be used in pre-term or
full-term neonates unless strictly necessary.
Benzyl alcohol can cross the placenta and clindamycin should only be
used during pregnancy if clearly needed.

Coagulation tests, therefore, should be frequently monitored in patients
treated with vitamin K antagonists.

Dalacin C Phosphate should only be used in the treatment of serious
infections. In considering the use of the product, the practitioner should
bear in mind the type of infection and the potential hazard of the
diarrhoea which may develop, since cases of colitis have been reported
during, or even two or three weeks following, the administration of
clindamycin.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium
difficile) is the principal direct cause of antibiotic-associated colitis.
These studies also indicate that this toxigenic clostridium is usually
sensitive in-vitro to vancomycin. The disease is likely to follow a more
severe course in older patients, or patients who are debilitated.
Diagnosis is usually made by the recognition of the clinical symptoms,
but can be substantiated by endoscopic demonstration of
pseudomembranous colitis. The presence of the disease may be further
confirmed by culture of the stool for C. difficile on selective media and
assay of the stool specimen for the toxin(s) of C. difficile.
The appearance of marked diarrhoea should be regarded as an
indication that the product should be discontinued immediately.
Clostridium difficile associated diarrhoea (CDAD) has been reported to
occur over 2 months after the administration of antibacterial agents.
Precautions:
History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms.
Periodic liver and kidney function tests should be carried out during
prolonged therapy. Such monitoring is also recommended in neonates
and infants. Safety and appropriate dosage in infants less than one
month old have not been established.

(abscess) formation around site of injection.

Pregnancy and lactation:
Safety of use in pregnancy has not been established. Exercise caution
when prescribing to nursing mothers.
Benzyl alcohol can cross the placenta (see Warnings).
Undesirable effects:
Side effects include nausea, vomiting, cramps, abdominal pain, diarrhoea,
hypersensitivity reaction such as Stevens Johnson syndrome, liver
dysfunction and jaundice, blood dyscrasia, pruritus, vaginitis, dermatitis,
cardiopulmonary arrest and hypotension (following too rapid an
administration) and local reactions at the site of injection.
The appearance of marked diarrhoea should be regarded as an indication
that this drug should be discontinued immediately.
Overdose:
In cases of overdosage no specific treatment is indicated. The serum
biological half-life of lincomycin is 2.4 hours. Clindamycin cannot readily
be removed from the blood by dialysis or peritoneal dialysis.
If an allergic adverse reaction occurs, therapy should be with the usual
emergency treatments, including corticosteroids, adrenaline and
antihistamines.
Handling and Storage requirements
Do not store above 25°C.
Do not refrigerate or freeze.
This product is for single dose only.
Any unused solution should be discarded.
Dilution and Compatibility:
In-vitro compatibility studies monitored for 24 hours at room temperature
using a concentration no greater than 6 mg/ml have demonstrated no
inactivation or physical incompatibility with the use of Dalacin C
Phosphate in IV solutions containing sodium chloride, glucose or
potassium usually used clinically.
Dalacin C Phosphate has been shown to be physically and chemically
compatible for at least 24 hours in dextrose 5% water and sodium chloride
injection solutions containing the following antibiotics in usually
administered concentrations: amikacin sulphate, aztreonam, cefamondole
nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium,
ceftazidime sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin
sulphate, piperacillin, tobramycin and ciprofloxacin.
The compatibility and duration of stability of drug admixtures will vary
depending upon concentration and other conditions.

The dosage of Dalacin C Phosphate may require reduction in patients
with renal or hepatic impairment due to prolongation of the serum
half-life.

Incompatibilities:
Solutions of clindamycin salts have a low pH and incompatibilities may
reasonably be expected with alkaline preparations or drugs unstable at
low pH. Incompatibility has been reported with: ampicillin sodium,
aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium,
diphenylhydantoin, idarubicin hydrochloride, magnesium sulphate,
phenytoin sodium and ranitidine hydrochloride.

Interactions:
Use with caution in patients receiving neuromuscular blocking agents.
Do not use concurrently with erythromycin.

Parallel Import Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.

Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding, have been reported
in patients treated with clindamycin in combination with a vitamin K
antagonist (e.g. warfarin, acenocoumarol and fluindione).

Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 14.12.16[3]

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Dalacin C Solution
 Keep out of the sight and reach of children.
 Dalacin C Solution will not be used after the expiry date which is stated
on the carton. The expiry date refers to the last day of that month.
 Do not store above 25°C.
 Do not refrigerate or freeze.
 If the solution shows any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Dalacin C Solution contains
The active substance is clindamycin phosphate.
Each ml contains 150mg clindamycin (as phosphate).
The other ingredients are: benzyl alcohol, disodium edetate, sodium
hydroxide and water for injection.
What Dalacin C Solution looks like and contents of the pack
Transparent, glass ampoule containing 2ml or 4ml of clear, colourless,
sterile, aqueous solution, packed in cardboard carton.
Dalacin C Solution is available in pack sizes of 1 x 2ml, 5 x 2ml, 1 x 4ml
and 5 x 4ml glass ampoules.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2895

Leaflet revision and issue date (Ref.) 14.12.16[3]
Dalacin C is a trademark of Pharmacia & Upjohn Company LLC.

PATIENT INFORMATION LEAFLET

2895
14.12.16[3]

Clindamycin 150mg/ml Solution for injection
(clindamycin phosphate)
Your medicine is available using the above names but will be referred to
as Clindamycin Solution throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Clindamycin Solution is and what it is used for
2. Before you are given Clindamycin Solution
3. How Clindamycin Solution is given to you
4. Possible side effects
5. How to store Clindamycin Solution
6. Further information

Adults/Elderly
The recommended dose of Clindamycin Solution is 600 to 2700 mg
clindamycin per day in two to four equal doses, depending on the severity
of your infection. Higher doses than this (up to 4800 mg daily) may be
given by your doctor for very severe infections.

Please tell your doctor if you are taking or have recently taken any other
medicines including medicines obtained without a prescription.

Normally Clindamycin Solution is only given to patients in hospital. The
medical staff will be keeping a close eye on you during your treatment. If
you need to have more than one course of treatment with clindamycin,
your doctor may want to check that the clindamycin is not having any
effect on the way your kidneys and liver are working.

Pregnancy
If you are pregnant or think you might be pregnant you should contact
your doctor before being given Clindamycin Solution.

1. What Clindamycin Solution is and what it is used for
Clindamycin Solution is a sterile solution for injection into a vein
(intravenously) or into a muscle (intramuscularly). The solution contains
clindamycin phosphate which is an antibiotic used in the treatment of
serious bacterial infections.
2. Before you are given Clindamycin Solution
Do not use If you are allergic (hypersensitive) to clindamycin, lincomycin
or to any of the other ingredients in this medicine.
Take special care with Clindamycin Solution
Before you are given this medicine make sure that your doctor knows if
you:
 have diarrhoea or usually get diarrhoea when you take antibiotics or
have ever suffered from problems with your stomach or intestines
(bowel disease). If you develop severe or prolonged or bloody diarrhoea
during or after using Clindamycin Solution tell your doctor
immediately since it may be necessary to interrupt the treatment. This
may be a sign of bowel inflammation (pseudomembranous colitis) which
can occur following treatment with antibiotics.
 you suffer from problems with your kidneys or liver.
 you suffer from asthma, eczema or hayfever. Clindamycin solution does
not get into the brain and is therefore not suitable for treating serious
infections in and around the brain. Your doctor may need to give you
another antibiotic if you have these infections.

INFORMATION LEAFLET FOR HEALTHCARE PROFESSIONAL

Clindamycin 150mg/ml Solution for injection
(clindamycin phosphate)
For further information consult the Summary of Product Characteristics.
Qualitative and quantitative composition
Each ml contains 150mg clindamycin (as phosphate). Also contains
benzyl alcohol, disodium edetate, sodium hydroxide and water for
injection.
Directions for use
Parenteral (I.M. or IV. administration). Clindamycin must be diluted prior
to IV. administration and should be infused over at least 10-60 minutes.
Parenteral (I.M. or IV. administration)
Adults including the elderly:
Serious infections: 600-1200 mg/day in 2, 3 or 4 equal doses.
More severe infections: 1200-2700 mg/day in 2, 3 or 4 equal doses.
Single I.M. injections of greater than 600 mg are not recommended nor is
administration of more than 1.2 g in a single one-hour infusion.
Children (over 1 month of age):
Serious infections: 15-25 mg/kg/day in three or four equal doses.
More severe infections: 25-40 mg/kg/day in three or four equal doses.
In severe infections it is recommended that children be given no less than
300 mg/day regardless of body weight.
The concentration of clindamycin in diluent for infusion should not exceed
18 mg per mL and INFUSION RATES SHOULD NOT EXCEED 30 mg
PER MINUTE.
The usual infusion rates are as follows:
Dose

Taking other medicines
Some medicines can affect the way Clindamycin Solution works, or
Clindamycin Solution itself can reduce the effectiveness of other
medicines taken at the same time. These include:
 erythromycin (an antibiotic).
 muscle relaxants used during operations
 oral contraceptive pills. You should use extra contraception such as
condoms whilst receiving Clindamycin Solution and for seven days
after receiving Clindamycin Solution.
 warfarin or similar medicines - used to thin the blood. You may be more
likely to have a bleed. Your doctor may need to take regular blood tests
to check how well your blood can clot

Diluent

Time

300mg

50mL

10 min

600mg

50mL

20 min

900mg

50-100mL

30 min

1200mg

100mL

40 min

Indications
The management of serious infections due to organisms susceptible to
this anti-infective.
Contra-indication etc.
Contra-indications:
Clindamycin is contra-indicated in patients previously found to be sensitive
to clindamycin, lincomycin or to any components of the formulation
particularly benzyl alcohol.

Breast-feeding
Tell your doctor if you will be breast-feeding while you are taking
Clindamycin Solution as the active substance in this medicine may be
passed into breast milk. Your doctor will decide if Clindamycin Solution is
appropriate for you. Although it is not likely that a nursing infant will take
in very much of the active substance from the milk it drinks, if your baby
gets bloodstained diarrhoea or shows any signs of illness, tell your doctor
at once. You should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with
Clindamycin Solution.
Important information about some of the ingredients of Clindamycin
Solution
Clindamycin Solution contains benzyl alcohol (9.45mg/ml as
preservative) and must not be given to premature babies or babies less
than one month old. It may cause allergy and toxic reactions and has
caused serious side effects in the brain, heart, blood, and breathing rate
in children, which have been fatal in some cases.
3. How Clindamycin Solution is given to you
Your doctor will give you your medicine as an injection into your vein
(intravenous) or your muscle (intramuscular). If it is given into a vein, it is
always mixed with a sugar or saline (salt) solution before use and given
using a drip.

Children
The recommended dosage for children (over 1 month of age) is 15 to 40
mg of clindamycin per kg bodyweight each day in three or four equal
doses. Higher doses of up to 300 mg per day (regardless of body weight)
may be given by your doctor for very severe infections until a full response
to treatment is observed.

Long term use can also make you more likely to get other infections that
do not respond to Clindamycin Solution treatment.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Tell your doctor immediately if you develop:
 severe, persistent or bloody diarrhoea (which may be associated with
stomach pain or fever). This is an uncommon side effect which may
occur during or after completing treatment with antibiotics and can be a
sign of serious bowel inflammation
 signs of a severe allergic reaction such as sudden wheeziness, difficulty
in breathing, swelling of eyelids, face or lips, rash or itching (especially
affecting the whole body)
 blistering and peeling of large areas of skin, fever, cough, feeling unwell
and swelling of the gums, tongue or lips
 yellowing of the skin and whites of the eyes (jaundice).
Other possible side effects may include:

 Effects on your nervous system: impaired sense of taste
 Effects on your skin: reddening of the skin, skin rash, itching (hives)
 Effects on your stomach and intestines: throat ulcers, sore throat,
feeling sick, being sick, stomach pain and diarrhoea

 Effects on your blood system: reduced numbers of blood cells
 Effects on your liver: poor liver function
 Effects on your heart: low blood pressure (feeling light headed, dizzy
or faint), rarely heart attack (if given too fast)

When giving you Clindamycin Solution, your doctor will ensure that the
concentration of clindamycin does not exceed 18 mg per ml and the rate
it is given to you does not exceed 30 mg per minute. If Dalacin is given
too fast it could rarely cause a heart attack.

 Effects on your genital area: inflammation of the vagina
 Injection site reactions: swelling, redness, irritation, pain and boil

Warnings:
This product contains benzyl alcohol (9.45mg/ml as preservative).
Intravenous administration of the preservative benzyl alcohol has been
associated with serious adverse events, and death in paediatric patients
including neonates characterized by central nervous system depression,
metabolic acidosis, gasping respirations, cardio-vascular failure and
haematological anomalies (“gasping syndrome”). Although normal
therapeutic doses of this product ordinarily deliver amounts of benzyl
alcohol that are substantially lower than those reported in association
with the “gasping syndrome”, the minimum amount of benzyl alcohol at
which toxicity may occur is not known. Use only if it is necessary and if
there are no alternatives possible. If given in high volumes, should be
used with caution and preferably for short term treatment in subjects with
liver or kidney impairment because of the risk of accumulation and toxicity
(metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).
Premature and low-birth weight infants may be more likely to develop
toxicity.
Benzyl Alcohol containing products should not be used in pre-term or fullterm neonates unless strictly necessary.
Benzyl alcohol can cross the placenta and clindamycin should only be
used during pregnancy if clearly needed.

Coagulation tests, therefore, should be frequently monitored in patients
treated with vitamin K antagonists.

Clindamycin should only be used in the treatment of serious infections. In
considering the use of the product, the practitioner should bear in mind the
type of infection and the potential hazard of the diarrhoea which may
develop, since cases of colitis have been reported during, or even two or
three weeks following, the administration of clindamycin.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium
difficile) is the principal direct cause of antibiotic-associated colitis.
These studies also indicate that this toxigenic clostridium is usually
sensitive in-vitro to vancomycin. The disease is likely to follow a more
severe course in older patients, or patients who are debilitated.
Diagnosis is usually made by the recognition of the clinical symptoms,
but can be substantiated by endoscopic demonstration of
pseudomembranous colitis. The presence of the disease may be further
confirmed by culture of the stool for C. difficile on selective media and
assay of the stool specimen for the toxin(s) of C. difficile.
The appearance of marked diarrhoea should be regarded as an
indication that the product should be discontinued immediately.
Clostridium difficile associated diarrhoea (CDAD) has been reported to
occur over 2 months after the administration of antibacterial agents.
Precautions:
History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms.
Periodic liver and kidney function tests should be carried out during
prolonged therapy. Such monitoring is also recommended in neonates
and infants. Safety and appropriate dosage in infants less than one
month old have not been established.
The dosage of Clindamycin may require reduction in patients
with renal or hepatic impairment due to prolongation of the serum
half-life.
Interactions:
Use with caution in patients receiving neuromuscular blocking agents.
Do not use concurrently with erythromycin.
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding, have been reported
in patients treated with clindamycin in combination with a vitamin K
antagonist (e.g. warfarin, acenocoumarol and fluindione).

(abscess) formation around site of injection.

Pregnancy and lactation:
Safety of use in pregnancy has not been established. Exercise caution
when prescribing to nursing mothers.
Benzyl alcohol can cross the placenta (see Warnings).
Undesirable effects:
Side effects include nausea, vomiting, cramps, abdominal pain, diarrhoea,
hypersensitivity reaction such as Stevens Johnson syndrome, liver
dysfunction and jaundice, blood dyscrasia, pruritus, vaginitis, dermatitis,
cardiopulmonary arrest and hypotension (following too rapid an
administration) and local reactions at the site of injection.
The appearance of marked diarrhoea should be regarded as an indication
that this drug should be discontinued immediately.
Overdose:
In cases of overdosage no specific treatment is indicated. The serum
biological half-life of lincomycin is 2.4 hours. Clindamycin cannot readily
be removed from the blood by dialysis or peritoneal dialysis.
If an allergic adverse reaction occurs, therapy should be with the usual
emergency treatments, including corticosteroids, adrenaline and
antihistamines.
Handling and Storage requirements
Do not store above 25°C.
Do not refrigerate or freeze.
This product is for single dose only.
Any unused solution should be discarded.
Dilution and Compatibility:
In-vitro compatibility studies monitored for 24 hours at room temperature
using a concentration no greater than 6 mg/ml have demonstrated no
inactivation or physical incompatibility with the use of Clindamycin in IV
solutions containing sodium chloride, glucose or potassium usually used
clinically.
Clindamycin has been shown to be physically and chemically compatible
for at least 24 hours in dextrose 5% water and sodium chloride injection
solutions containing the following antibiotics in usually administered
concentrations: amikacin sulphate, aztreonam, cefamondole nafate,
cephazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime
sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin sulphate,
piperacillin, tobramycin and ciprofloxacin.
The compatibility and duration of stability of drug admixtures will vary
depending upon concentration and other conditions.
Incompatibilities:
Solutions of clindamycin salts have a low pH and incompatibilities may
reasonably be expected with alkaline preparations or drugs unstable at
low pH. Incompatibility has been reported with: ampicillin sodium,
aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium,
diphenylhydantoin, idarubicin hydrochloride, magnesium sulphate,
phenytoin sodium and ranitidine hydrochloride.
Parallel Import Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 14.12.16[3]

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Clindamycin Solution
 Keep out of the sight and reach of children.
 Clindamycin Solution will not be used after the expiry date which is
stated on the carton. The expiry date refers to the last day of that month.
 Do not store above 25°C.
 Do not refrigerate or freeze.
 If the solution shows any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Clindamycin Solution contains
The active substance is clindamycin phosphate.
Each ml contains 150mg clindamycin (as phosphate).
The other ingredients are: benzyl alcohol, disodium edetate, sodium
hydroxide and water for injection.
What Clindamycin Solution looks like and contents of the pack
Transparent, glass ampoule containing 2ml or 4ml of clear, colourless,
sterile, aqueous solution, packed in cardboard carton.
Clindamycin Solution is available in pack sizes of 1 x 2ml, 5 x 2ml, 1 x 4ml
and 5 x 4ml glass ampoules.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870
Puurs, Belgium.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2895

Leaflet revision and issue date (Ref.) 14.12.16[3]

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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