Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Colistimethate sodium
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Medicine Registered
Page 1 of 4 COLISTIN LINK _(KOE-LIS-TI MEE-THATE SO-DI-UM)_ _ _ _ _ _Colistin 150 mg (as colistimethate sodium) Powder for injection _ CONSUMER MEDICINE INFORMATION _ _ _Name _ _Address _ _Address _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Colistin Link. 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 Colistin Link against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT IS COLISTIN LINK USED FOR Colistin Link is used to treat bacterial infections in different parts of the body. This medicine will not work against infections caused by viruses such as colds or the flu. Colistin Link is an antibiotic that belongs to a group of medicines called polymixins. These antibiotics work by killing bacteria causing your infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. Colistin Link is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN COLISTIN LINK _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN COLISTIN LINK IF YOU HAVE AN ALLERGY TO: • any medicine containing the active ingredient colistin. • any of the ingredients listed at the end of this leaflet • any other similar medicines (such as other polymixin antibiotics). Some of the symptoms of an allergic r Perskaitykite visą dokumentą
Page 1 of 7 PRODUCT INFORMATION COLISTIN LINK COLISTIN 150 MG/2 ML (AS COLISTIMETHATE SODIUM) POWDER FOR INJECTION VIAL For Intramuscular and Intravenous use. NAME OF THE MEDICINE Colistimethate sodium for injection, USP Colistin Link contains the sodium salt of colistimethate, a polypeptide antibiotic with an approximate molecular weight of 1750; the empirical formula is C 56 H 106 N 16 Na 6 O 26 S 6 . CAS Number: 8068-28-8 DESCRIPTION Colistin Link is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin per vial) as a white to slightly yellow lyophilized cake containing the equivalent of 4,500,000 IU antibiotic activity. PHARMACOLOGY _MICROBIOLOGY _ Colistimethate sodium has bactericidal activity against the following gram-negative bacilli: Enterobacter, aerogenes, Escherichia coli, Klebsiella pneumonia and Pseudomonas aeruginosa. _HUMAN PHARMACOLOGY _ Typical serum and urine levels following a single 150 mg dose of colistimethate sodium IM of IV in normal adult subjects are shown in Figure 1. Page 2 of 7 Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2-3 hours following either intravenous or intramuscular administration in adults and children including premature infants. Colistimethate sodium is transferred across the placental barrier, and blood levels of about 1 mcg/mL are obtained in the foetus following intravenous administration to the mother. Average urine levels ranged from about 270 mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration and from 200 to about 25 mcg/mL, during a similar period following intramuscular administration. CLINICAL TRIALS Clinically, colistimethate sodium has bee Perskaitykite visą dokumentą