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CLINDAMYCIN 150MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CLINDAMYCIN PHOSPHATE

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• you are given Clindamycin Injection
for a long time;
• your baby is given Clindamycin
Injection.
If you have problems with your liver and
kidneys your dose may be reduced.

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you forget
Injection

Clindamycin 150mg/ml solution
for injection or infusion
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or nurse.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• 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
nurse.
In this leaflet:
1. What Clindamycin Injection is and
what it is used for
2. Before you use Clindamycin Injection
3. How to use Clindamycin Injection
4. Possible side effects
5. How to store Clindamycin Injection
6. Further information

1.What Clindamycin
Injection is and what it is
used for
Clindamycin 150mg/ml solution for
injection or infusion (called Clindamycin
Injection in the rest of this leaflet)
belongs to a group of medicines called
antibiotics. Antibiotics are used to treat
infections. Clindamycin injection is used
to kill certain serious bacterial infections.
You will usually be in hospital when you
receive this medicine.

Do not use Clindamycin Injection
• if you are allergic (hypersensitive) to
clindamycin or lincomycin (another
antibiotic) or any of the other ingredients
of Clindamycin Injection (see section 6);
• if you have meningitis.
Tell your doctor or nurse if any of the
following apply to you:
• if you have colitis (severe stomach
cramps,
diarrhoea).
Clindamycin
Injection may not be suitable for you;
• if you have ever had problems with
your stomach or bowels;
• if you have any allergies such as
hayfever, asthma or eczema;
• if you have problems with your
kidneys;
• if you have problems with your liver.
Using other medicines
Make sure your doctor knows if you are
taking any medicine listed here:
• erythromycin an antibiotic used to
treat infection: Clindamycin Injection
and erythromycin may not work as
well when they are used together.
• contraceptive pill: the pill may not
work and may not prevent pregnancy.
Use additional contraception, such as a
condom, while receiving Clindamycin
Injection and for 7 days after your last
dose of Clindamycin Injection.

Clindamycin

If you have too much Clindamycin
Injection

• warfarin or other similar medicines
used to thin the blood: you may bleed
more than usual when taking these
medicines together with Clindamycin
Injection. Your doctor may need to
perform regular blood tests to check
how well your blood clots.
If you are in hospital to have an
operation or a hospital procedure tell
your doctor you are taking Clindamycin
Injection. Clindamycin Injection may
increase the effect of certain medicines
(such as those given to help your
muscles relax).

If you think you have been given too
much Clindamycin Injection tell a
doctor or a nurse.
If you have any further questions on the
use of this product, ask your doctor or
nurse.

4. Possible side effects
Like all medicines, Clindamycin Injection
can cause side effects, although not
everybody gets them.

Tell your doctor or nurse if you are
taking or have recently taken any other
medicines,
including
medicines
obtained without a prescription.

If you have any of the following side
effects while taking your medicine tell
your doctor immediately. If you are not
in hospital YOU MUST go straight away.
These side effects are rare but very
serious.

Pregnancy and breast-feeding
• If you are pregnant, thinking of getting
pregnant, or are breast-feeding, ask
your doctor or nurse for advice before
they give you Clindamycin Injection.

• Severe allergic reaction which may
include a red and lumpy skin rash,
difficulty breathing, swelling of face,
mouth, lips or eyelids, unexplained
high temperature (fever) and feeling
faint. If the swelling affects your throat
and makes breathing and swallowing
difficult, go to hospital straight away.
• Symptoms of colitis such as severe
diarrhoea, severe stomach and
abdominal cramps, blood in the
faeces. This may occur many months
after your treatment has been
finished.
• Severe skin reaction for example,
pinky-red spots or blotches with clear
or violet coloured centres.
• Heart attack if your injection is given
too quickly.

Important information about some of the
other ingredients in Clindamycin Injection
• Your medicine contains sodium (salt).
This medicinal product contains
0.286mMol (or 6.57mg) sodium per ml
of solution (prior to dilution). To be
taken into consideration by patients
on a controlled sodium diet.

3. How to use Clindamycin
Injection
You will usually be in hospital when you
are given Clindamycin Injection.
You will be given Clindamycin Injection
by a doctor or nurse as an injection into
your muscle, or infusion into a vein (using
a drip). The injection or infusion will take
10-60 minutes.

Other side effects which may occur
-

Adults and the elderly
• The usual dose is 600-1200mg
clindamycin per day. This will be given
in 2, 3 or 4 equal doses over a 24-hour
period.
• If you have a very severe infection
your doctor may increase your dose
to a maximum of 2700mg per day.
This will be given in 2, 3 or 4 equal
doses over a 24-hour period.

-

Doses up to 4800mg per day have been
given in life-threatening cases.

nausea (feeling sick)
vomiting
stomach pain
itchy or sore vagina; discharge from
the vagina
skin rash or itching or blistering of the
skin
jaundice (where your skin and whites
of the eyes appear yellow)
low blood pressure (you may feel faint
or dizzy on standing)
changes in your blood which may
make you bruise or bleed more easily
and make you feel more likely to get
an infection

Effects which may occur at the site of
injection
• itching
• pain
• abscesses
• swollen and painful veins.

Children (over 1 month old)
• The dose for children is based on your
child’s body weight.
• The doctor will decide how much to
give your child.
• The usual dose is 15 to 25mg per kg of
body weight. This will be given in 3 or 4
equal doses over a 24-hour period.
• If your child has a very severe infection
your doctor may increase the dose to
at least 300mg. The dose is not related
to the weight of your child. This will be
given in 3 or 4 equal doses over a
24-hour period.

If you need a blood test tell your doctor
you are taking Clindamycin Injection
because it may affect the results.

5. How to store
Clindamycin Injection
Keep out of the sight and reach of
children.
Do not store above 25°C.
Keep ampoules in outer carton.
Do not use after the expiry date stated
on the carton and ampoule. The expiry
date refers to the last day of the month.
Do not refrigerate or freeze.
Once your doctor or nurse has opened
the ampoule it should be used
immediately. Any remaining Clindamycin
Injection must be thrown away by the
doctor or nurse.
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 Injection contains
- The active substance is clindamycin
phosphate. Each ml contains 150mg
clindamycin.
- The other ingredients are sodium
edetate, sodium hydroxide and water
for injections.
What Clindamycin solution for injection
looks like and contents of the pack
Clindamycin Injection is a clear solution
in a glass ampoule containing 2ml or 4ml
of the solution for injection. This product
is available in cartons containing 1 x 2ml,
1 x 4ml, 5 x 2ml or 5 x 4 ml ampoules.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital
House, 1st Floor, 85 King William Street,
London EC4N 7BL, UK.
Tel: 01283 495 280
Fax: 01283 495 290
Email:
medinfo@focuspharma.co.uk
Manufacturer
Vianex SA, 12th Km Athens Lamia
National Road, Metamorfosi, Athens,
Greece
For any information about this medicinal
product, please contact the Marketing
Authorisation Holder, details provided
above.

For information in large print,
audio CD or Braille please
telephone +44 (0)1283 495 280
or email
medinfo@focuspharma.co.uk.
This leaflet was last revised in 06/2015.

See section 2 of this leaflet for side
effects that may be caused by sodium,
one of the ingredients in your medicine
(‘Important information about some of
the
ingredients
in
Clindamycin
Injection’).

Your doctor will test your blood and
check that your liver and kidneys are
working properly if:
continued overleaf

Technical Leaflet for healthcare professionals
CLINDAMYCIN 150mg/ml SOLUTION FOR INJECTION OR INFUSION

Treatment for infections caused by beta
haemolytic streptococci should be continued for
at least 10 days to guard against subsequent
rheumatic fever or glomerulonephritis.

GENERAL INFORMATION

THERAPEUTIC INDICATIONS
Clindamycin is indicated for the treatment of
severe infections. Consideration should be
given to official guidance on the appropriate
use of antibacterial agents.
Clindamycin does not penetrate the blood/brain
barrier in therapeutically effective quantities.
POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous or intramuscular infusion only.
Parenteral (I.M. or I.V. administration).
Clindamycin 150mg/ml Solution for Injection
and Infusion must be diluted prior to I.V.
administration and should be infused over at
least 10-60 minutes.
Adults: Serious infections: 600mg-1.2g/day in
two, three or four equal doses.
More severe infections: 1.2-2.7g/day in two,
three or four equal doses.

Single I.M. injections of greater than 600mg are
not recommended nor is administration of more
than 1.2g in a single one-hour infusion.
For more serious infections, these doses may
have to be increased. In life-threatening
situations, doses as high as 4.8g daily have been
given intravenously to adults.
Alternatively, the drug may be administered in
the form of a single rapid infusion of the first dose
followed by continuous I.V. infusion.

The concentration of clindamycin in diluent for
infusion should not exceed 18mg per ml and
INFUSION RATES SHOULD NOT EXCEED 30MG 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
STORAGE AND DISPOSAL OF CLINDAMYCIN
150MG/ML SOLUTION FOR INJECTION OR INFUSION

Children (over 1 month of age): Serious infections:
15-25mg/kg/day in three or four equal doses.
More severe infections: 25-40mg/kg/day in three
or four equal doses. In severe infections it is
recommended that children be given no less
than 300mg/day regardless of body weight.

Unopened product: Do not store above 25°C.
Keep ampoules in outer carton.
Injection:
The product should be used immediately after
opening. Dispose of any remaining solution after
a single use.

Elderly patients: The half-life, volume of
distribution and clearance, and extent of
absorption after administration of clindamycin
phosphate are not altered by increased age.
Analysis of data from clinical studies has not
revealed any age-related increase in toxicity.
Dosage requirements in elderly patients should
not be influenced, therefore, by age alone. See
Precautions for other factors which should be
taken into consideration.

Infusion:
Shelf life
Unopened: 2 years
After dilution: 24 hours
Specific text for preparations for Infusion or
Injection
Chemical and physical in-use stability has
been demonstrated for 24 hours at 25ºC. From a
microbiological point of view, the product should

Special precautions for disposal and other handling
Any unused product or waste material should
be disposed of in accordance with local
requirements. Solution for injection is for single use
only. Any unused product should be discarded.
Infusion: Each ml of solution contains 6.57mg
(0.286mMol) of sodium, prior to dilution.
Clindamycin 150mg/ml Solution for Injection or
Infusion 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, cefoxitin sodium,
ceftazidime sodium, ceftizoxime sodium,
gentamicin sulphate, piperacillin and tobramycin. The compatibility and duration of stability of
drug admixtures will vary depending upon
concentration and other conditions.
10mm

Injection:
Clindamycin 150mg/ml Solution for Injection or Infusion
is for single use only. Any unused content should be
discarded.
Solution for Infusion:
Clindamycin 150mg/ml Solution for Injection or
Infusion can be diluted with solutions for infusion
containing: 0.9% sodium chloride and 5% dextrose.

be used immediately. If not used immediately,
in-use storage times and conditions prior to use
are the responsibility of the user and would
normally be no longer than 24 hours at 2 to 8ºC,
unless reconstitution/dilution (etc) has taken
place in controlled and validated aseptic
conditions. The reconstitution/dilution should be
made under aseptic conditions. The solution
should be inspected visually for particulate
matter and discoloration prior to administration.
The solution should only be used if the solution is
clear and free from particles.

10mm

435 mm

2. Before you use
Clindamycin Injection

use

Clindamycin Injection will be given to
you by a doctor or nurse. If you think you
have missed a dose tell your doctor or
nurse.

Clindamycin phosphate

Read all of this leaflet carefully before
you start using this medicine.

to

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/yellow
card. By reporting side effects you can
help provide more information on the
safety of this medicine.

CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT

tel:
01283 495280

pharmaceuticals ltd

fax:
01283 495290

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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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