DALACIN C clindamycin 600 mg/4 mL (as phosphate) injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clindamycin phosphate, Quantity: 0 QS (Equivalent: clindamycin, Qty 150 mg/mL)

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Clindamycin phosphate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; benzyl alcohol; sodium hydroxide; disodium edetate; hydrochloric acid

Administration route:

Intravenous, Intramuscular

Units in package:

4mL x 10

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 20 JUNE 2005 : DALACIN C Phosphate is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. DALACIN C Phosphate is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin - allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. Anaerobes - Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection, all when given in conjunction with an antibiotic of appropriate gram

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-04-11

Patient Information leaflet

DALACIN
® C INJECTION
_Clindamycin phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dalacin C Injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Dalacin
C Injection against the benefits this
medicine is expected to have for you.
Dalacin C Injection should only be
given to you by a health professional.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DALACIN C
INJECTION IS USED FOR
Dalacin C Injection is an antibiotic. It
is used to treat infections in different
parts of the body caused by bacteria.
This medicine works by killing or
stopping the growth of bacteria
causing your infection.
It will not work against viral
infections such as colds or flu.
Dalacin C Injection is recommended
for patients who are allergic to
penicillin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DALACIN C
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
Dalacin C Injection for another
reason.
This medicine is available only with
a doctor's prescription.
Dalacin C Injection is not addictive.
BEFORE YOU ARE GIVEN
DALACIN C INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DALACIN C
INJECTION IF YOU HAVE AN ALLERGY TO:
•
clindamycin or lincomycin
•
any of the other ingredients listed
at the end of this leaflet (see
'Product Description').
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF THE EXPIRY DATE PRINTED
ON THE PACK HAS PASSED OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is damaged, return
it to your p

Summary of Product characteristics

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Supersedes: pfpdacpi10221
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
-
DALACIN
® C (CLINDAMYCIN PHOSPHATE) INJECTION
1. NAME OF THE MEDICINE
Clindamycin phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of DALACIN C contains clindamycin phosphate equivalent to
150 mg clindamycin
base; 9.45 mg benzyl alcohol; 0.5 mg disodium edetate; and Water for
Injections q.s. When
necessary, pH is adjusted with sodium hydroxide and/or hydrochloric
acid.
Clindamycin is a semi-synthetic antibiotic produced by a
7(S)-chloro-substitution of the
7(R)-hydroxyl group of the parent compound lincomycin.
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Solution for Injection.
DALACIN C (clindamycin phosphate injection) is a sterile solution of a
water soluble ester of
clindamycin and phosphoric acid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DALACIN C is indicated in the treatment of serious infections caused
by susceptible anaerobic
bacteria.
DALACIN C is also indicated in the treatment of serious infections due
to susceptible strains
of streptococci, pneumococci and staphylococci.
Its use should be reserved for penicillin-allergic patients or other
patients for whom, in the
judgement of the physician, a penicillin is inappropriate.
ANAEROBES
Serious respiratory tract infections such as empyema, anaerobic
pneumonitis and lung abscess;
serious skin and skin structure infections; septicaemia;
intra-abdominal infections such as
peritonitis and intra-abdominal abscess (typically resulting from
anaerobic organisms resident
in the normal gastrointestinal tract) and infections of the female
pelvis and genital tract such as
endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis
and post-surgical vaginal
cuff infection, all when given in conjunction with an antibiotic of
appropriate gram-negative
aerobic spectrum.
Version: pfpdacpi11021
Supersedes: pfpdacpi10221
Page 2 of 16
STREPTOCOCCI
Serious respiratory tract infections; serious skin