CLINDAMYCIN VIATRIS clindamycin (as phosphate) 300 mg/2 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clindamycin phosphate, Quantity: 357 mg (Equivalent: clindamycin, Qty 300 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Clindamycin phosphate

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous

Units in package:

10 x 2 mL vials per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CLINDAMYCIN VIATRIS is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.,CLINDAMYCIN VIATRIS 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.

Product summary:

Visual Identification: Clear, colourless to pale yellow solution free from visible particles, filled in vial with rubber closure and aluminium seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-06-06

Patient Information leaflet

CLINDAMYCIN MYLAN
INJECTION
_Clindamycin phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about clindamycin
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 taking clindamycin
injection against the benefits this
medicine is expected to have for you.
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 CLINDAMYCIN
MYLAN IS USED FOR
Clindamycin is an antibiotic. It is
used to treat infections in different
parts of the body caused by bacteria.
Clindamycin works by killing or
stopping the growth of bacteria
causing your infection.
Clindamycin will not work against
viral infections such as colds or flu.
CLINDAMYCIN MYLAN injection
is recommended for patients who are
allergic to penicillin or patients for
whom, in the judgment of the doctor,
penicillin is inappropriate.
Your doctor may have prescribed
CLINDAMYCIN MYLAN injection
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CLINDAMYCIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
CLINDAMYCIN MYLAN is not
addictive.
BEFORE YOU ARE GIVEN
CLINDAMYCIN
MYLAN INJECTION
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT BE GIVEN
CLINDAMYCIN MYLAN
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')
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing and difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmaci

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CLINDAMYCIN MYLAN
_Clindamycin Phosphate solution for injection _
1
NAME OF THE MEDICINE
Clindamycin phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is clindamycin phosphate.
Each 2 mL solution for injection contains clindamycin phosphate
equivalent to 300 mg clindamycin.
Each 4 mL solution for injection contains clindamycin phosphate
equivalent to 600 mg clindamycin.
The pH of the injection is 5.5 – 7.0. This preparation is
preservative free.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The solution for injection is a sterile clear, colourless to pale
yellow solution free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CLINDAMYCIN MYLAN is indicated in the treatment of serious infections
caused by susceptible
anaerobic bacteria.
CLINDAMYCIN MYLAN 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.
STREPTOCOCCI
Serious respiratory tract infections; serious skin and skin structure
infections; septicaemia.
STAPHYLOCOCCI
Serious
respiratory
tract infections;
serious
skin
and
skin
structure
infections;
septicaemia;
acute
haematogenous osteomyelitis.
CLINDAMYCIN MYLAN �