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DALACIN C PHOSPHATE STERILE SOLUTION

Active substance(s): CLINDAMYCIN

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PHYSICIAN LEAFLET

Dalacin® C Phosphate Sterile Solution
RECTO

clindamycin phosphate

PAA052884
577

PHYSICIAN LEAFLET

For further information consult the Summary of Product Characteristics.

Qualitative and quantitative composition

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin, benzyl
alcohol 9.45 mg/ml, disodium edetate and sterilised water for injections.

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
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.
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.
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
continued overleaf...

PATIENT INFORMATION LEAFLET

Dalacin C Phosphate
®

Sterile Solution 150 mg/ml
clindamycin phosphate

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
your 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

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

Process Black

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.

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

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

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

continued overleaf...

VERSO

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; super-infection 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 Dalacin C Phosphate 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).
Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K
antagonists.
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 this product 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.
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.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.

Manufacturer

Pharmacia NV/SA, Rijksweg 12, B-2870 Puurs, Belgium.
Date of preparation: 07/2014
Ref: DA 14_0

mixed with a sugar or saline (salt) solution before use
and given using a drip.
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 is given too fast it
could rarely cause a heart attack.

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.

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.
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.
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

Process Black

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)
• Effects on your genital area: inflammation of the
vagina
• Injection site reactions: swelling, redness,
irritation, pain and boil (abscess) formation around
site of injection.
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.

5. How to store Dalacin C Solution
• Keep out of the reach and sight 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.
• This medicine will not be stored above 25ºC.
• This medicine will not be refrigerated or frozen.

6. Further information
What Dalacin C Solution contains
The active substance is clindamycin phosphate. Each
ml of solution contains clindamycin phosphate
equivalent to 150 mg of clindamycin.
The other ingredients are benzyl alcohol, disodium
edetate and sterilised water for injections

What Dalacin C Solution looks like and
contents of the pack
Dalacin C Solution is a clear, colourless solution. It is
supplied in glass ampoules containing either 2 ml or
4 ml of solution. Each ampoule is packed in a
cardboard carton with a leaflet.

Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, UK.

Manufacturer:
Pharmacia NV/SA, Rijksweg 12, B -2870, Puurs,
Belgium.

Company Contact address:
If you have any comments on the way this leaflet is
written, please contact Medical Information at Pfizer
Limited in Walton Oaks, Tadworth, Surrey.
Tel: 01304 616161.
This leaflet was last revised in 07/2014
Ref: DA 14_0

PAA052884

Expand view ⇕

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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