CLINDAMYK clindamycin (as hydrochloride) 150 mg capsule blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

clindamycin hydrochloride, Quantity: 162.87 mg

Предлага се от:

Arrotex Pharmaceuticals Pty Ltd

INN (Международно Name):

clindamycin hydrochloride

Лекарствена форма:

Capsule, hard

Композиция:

Excipient Ingredients: Gelatin; titanium dioxide; lactose monohydrate; purified talc; magnesium stearate; maize starch; Shellac; iron oxide black

Начин на приложение:

Oral

Броя в опаковка:

100 capsules, 24 capsules

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin capsules are 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. 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. Pneumococci Serious respiratory tract infections. Adjunctive Therapy In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

Каталог на резюме:

Visual Identification: A hard gelatin capsule, size 1 white/white containing white crystalline powder, with marking "CLIN 150"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2014-08-22

Листовка

CLINDAMYK
1
CLINDAMYK
_contains the active ingredient (clindamycin hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLINDAMYK
capsules.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking CLINDAMYK
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CLINDAMYK
CAPSULES IS USED FOR
CLINDAMYK is an antibiotic. It is
used to treat infections in different
parts of the body caused by bacteria.
CLINDAMYK works by killing or
stopping the growth of the bacteria
causing your infection.
CLINDAMYK will not work against
viral infections such as colds or flu.
CLINDAMYK is recommended for
patients who are allergic to penicillin
or patients for whom penicillin is not
suitable.
Your doctor may have prescribed
CLINDAMYK for another reason.
Ask your doctor if you have any
questions about why CLINDAMYK
has been prescribed for you.
This medicine is available only with
a doctor's prescription.
CLINDAMYK is not addictive.
BEFORE YOU TAKE
CLINDAMYK CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CLINDAMYK
CAPSULES:
IF YOU HAVE AN ALLERGY TO:
•
clindamycin or lincomycin
•
lactose or 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
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 you take it after the expiry date, it
may have no effect at all, or worse,
an entirely unexpected effect.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION
CLINDAMYK
(Clindamycin hydrochloride) capsules
1
NAME OF THE MEDICINE
Clindamycin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
:
Clindamycin hydrochloride, equivalent to 150 mg of clindamycin.
Clindamycin hydrochloride is white or almost white, crystalline
powder,
very soluble in water, slightly soluble in ethanol (96 per cent).
Clindamycin is methyl 7-chloro-6,7,8-trideoxy-6-[(2
_S,_
4
_R_
)-1-methyl-4-propylpyrrolidine-2-
carboxamido]-1-thio-α-L-
_threo_
-D-
_galacto_
-octapyranoside (CAS 18323-44-9). It is a semi- synthetic
antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl
group of the parent compound
lincomycin.
EXCIPIENT(S) WITH KNOWN EFFECT:
Lactose monohydrate
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CLINDAMYK
Capsules 150mg
:
The capsules consist of a white cap and white body imprinted with
‘Clin
150’ in black printing ink.
4
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Clindamycin hydrochloride capsules are indicated in the treatment of
serious infections caused by
susceptible anaerobic bacteria.
Clindamycin capsules are 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.
STREPTOCOCCI
Serious respiratory tract infections; serious skin and skin structure