Dalacin C Phosphate 150 mg/ml Concentrate for solution for injection/infusion (2ml vial)

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

CLINDAMYCIN

Dostupné z:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC kód:

J01FF01

INN (Medzinárodný Name):

CLINDAMYCIN 150 mg/ml

Forma lieku:

CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION

Zloženie:

CLINDAMYCIN 150 mg/ml

Typ predpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2005-10-31

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DALACIN
®
C PHOSPHATE 150 MG/ML
CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
clindamycin (as clindamycin phosphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Dalacin C Solution is and what it is used for
2.
What you need to know before you are use Dalacin C Solution
3.
How to use Dalacin C Solution
4.
Possible side effects
5.
How to store Dalacin C Solution
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE DALACIN C SOLUTION
DO NOT USE DALACIN C SOLUTION:

If you are allergic to clindamycin, another antibiotic called
lincomycin or to any of the
other ingredients of this medicine (listed in section 6).

If you are experiencing diarrhoea or suffer from intestinal
inflammatory disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Dalacin C Solution if
you have any of the
following conditions:

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 diarrhoea
during or after using Dalacin C Solution TELL YOUR DOCTOR IMMEDIATELY
since it will be
necessary to stop treatment. This may be a sign of bowel inflammation
(_pseudomembranous colitis_) which can occur following treatment with
antibiotic

Súhrn charakteristických

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0057284
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dalacin C Phosphate 150 mg/ml Concentrate for solution for
injection/infusion, 2 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 150
mg clindamycin,
giving 300 mg clindamycin per ampoule.
Excipients with known effect
Each ml of solution contains 9 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion.
Clear colourless sterile solution with a pH of 5.5-7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the management of serious infections due to organisms susceptible
to this anti-infective.
Clindamycin does not penetrate the blood/brain barrier in
therapeutically effective quantities.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Parenteral (IM or IV administration).
Dalacin C Phosphate
MUST
be diluted prior to IV administration and should be infused slowly
and should be infused over at least 10-60 minutes (see ‘
DILUTION FOR IV USE AND IV INFUSION
RATES
’ at the end of the section).
Dalacin C Phosphate IM administration should be used undiluted.
_Adult: _
The usual daily adult dosage of Dalacin C Phosphate for infections of
the intra-abdominal
area, female pelvis, and other complicated or serious infections is
1800-2700 mg given in
2,
3,
or
4
equal
doses.
Less
complicated
infections
due
to
more
susceptible
microorganisms may respond to lower doses such as 1200-1800 mg/day
administered in
3 or 4 equal doses. Doses of up to 4800 mg daily have been used
successfully.
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Single IM injections of greater than 600 mg are not recommended nor is
administration of
more than 1.2 g in a single one-hour infusion.
Alternatively, the drug may be administered in the form of a single
rapid infusion of the first
dose followed by continuous IV infusion.
_ _
_Paediatric population _
Clindamycin should be dosed based on total body weight regardless o