CLINDAMYCIN 150 Mg/Ml Solution for Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN

Available from:

Fannin (UK) Ltd

ATC code:

J01FF01

INN (International Name):

CLINDAMYCIN

Dosage:

150 Mg/Ml

Pharmaceutical form:

Solution for Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Lincosamides

Authorization status:

Authorised

Authorization date:

2011-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Clindamycin 150 mg/ml Solution for Injection or Infusion
Clindamycin phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1. What Clindamycin 150 mg/ml Solution for Injection or Infusion is
and what it is used for
2. Before you take Clindamycin 150 mg/ml Solution for Injection or
Infusion
3. How to take Clindamycin 150 mg/ml Solution for Injection or
Infusion
4. Possible side effects
5. How to store Clindamycin 150 mg/ml Solution for Injection or
Infusion
6. Further information
1. WHAT CLINDAMYCIN 150 MG/ML SOLUTION FOR INJECTION OR INFUSION IS
AND WHAT IT
IS USED FOR
This medicine contains clindamycin phosphate,
which is an antibiotic. It is used to cause infections.
Clindamycin
is
usually
reserved
for the
treatment
of
serious infections, especially
when
other
antibiotics have been unable to clear the infection and when the
infection is caused by bacteria that are
sensitive to clindamycin.
THERAPEUTIC INDICATIONS
Clindamycin is indicated for the treatment of:
-
Intra-abdominal infections
-
Skin and soft tissue infections
-
Respiratory tract infections
-
Pelvic inflammatory disease
2. BEFORE YOU TAKE CLINDAMYCIN 150 MG/ML SOLUTION FOR INJECTION OR
INFUSION
DO NOT TAKE CLINDAMYCIN 150 MG/ML SOLUTION FOR INJECTION OR INFUSION
-
if you are allergic (hypersensitive) to the active substance
(clindamycin) or to one of the
ingredients of Clindamycin 150 mg/ml Solution for Injection or
Infusion.
TAKE SPECIAL CARE WITH CLINDAMYCIN 150 MG/ML SOLUTION FOR INJECTION OR
INFUSION
-
if you have
impaired hepatic (liver) and renal (kidney) functi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clindamycin 150 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 150mg
of clindamycin.
Each 2ml ampoule contains 300mg clindamycin
Each 4ml ampoule contains 600mg clindamycin
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion
Clindamycin 150 mg/ml Solution for injection or Infusion is a clear
colourless solution in a clear ampoule.
pH=5.5 – 7.0
osmolality= 760 – 900 mosm/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clindamycin is indicated for the treatment of following (see section
4.4 and 5.1)
Severe infections caused by anaerobic bacteria including:
•
Intra-abdominal infections
•
Skin and soft tissue infections
•
Infections of the lower respiratory tract such as aspiration
pneumonitis
•
Pelvic inflammatory disease
As needed clindamycin should be administered in conjunction with
another antibacterial
agent
that
is active against
gram negative aerobic bacteria
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Parenteral (IM or IV administration). Clindamycin 150 mg/ml solution
for injection or infusion must be diluted prior to
IV administration and should be infused over at least 10- 60 minutes.
ADULTS
-
Serious infections: 600mg to 1.2g/ day in two, three, or four divided
doses
More severe infections:
1200 to 2700 mg clindamycin in 2-4 equal doses.
In life-threatening infections doses up to 4800 mg/day have been
given.
Single IM injections of greater than 600 mg are not recommended nor is
the administration of more than 1.2g in a
single one-hour infusion.
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