Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
clindamycin phosphate, Quantity: 0 QS (Equivalent: clindamycin, Qty 150 mg/mL)
Pfizer Australia Pty Ltd
Clindamycin phosphate
Injection, solution
Excipient Ingredients: water for injections; benzyl alcohol; sodium hydroxide; disodium edetate; hydrochloric acid
Intravenous, Intramuscular
4mL x 10
Medicine Registered
(S4) Prescription Only Medicine
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
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
Registered
1994-04-11
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 Leggi il documento completo
Version: pfpdacpi11021 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 Leggi il documento completo