Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Vancomycin
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
VANCOCIN CP CMI - 230310 Page 1 of 3 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vancocin CP powder for injection. It does not contain all the available information and does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT VANCOCIN CP IS USED FOR Vancocin CP contains the active vancomycin (as vancomycin hydrochloride). Vancocin CP is an antibiotic used to treat serious infections caused by bacteria (germs). These infections may occur in different parts of the body. Vancocin CP can also be used orally to treat serious infections involving the bowel. Vancocin CP works by killing the bacteria causing the infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VANCOCIN CP HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Vancocin CP for another reason. This medicine is only available with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN IT _ YOU SHOULD NOT BE GIVEN VANCOCIN CP IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • any medicines containing vancomycin hydrochloride • the inactive ingredient, disodium edetate. Signs of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the Read the complete document
PRODUCT INFORMATION VIALS VANCOCIN CP (Sterile Vancomycin Hydrochloride) Intravenous NAME OF THE MEDICINE VANCOCIN CP (vancomycin hydrochloride) has the chemical formula C 66 H 75 Cl 2 N 9 O 24 .HCl. The formula weight is 1449; 500 mg of the base is equivalent to 0.35 mmol. The CAS number is 1404-93-9. The following structure of vancomycin hydrochloride has been confirmed by X-ray diffraction: [http://www.pharmacopoeia.co.uk/bp2009/ixbin/bp.cgi?a=imagezoom&file=bp2009_v2_08_01_monographs_medicinal_and_pharmaceutical_substances/large/vancomycinhydrochloride_1_2009_60_cs.png] DESCRIPTION Vancocin CP (Sterile Vancomycin Hydrochloride), Intravenous, is a chromatographically purified tricyclic glycopeptide antibiotic derived from _Amycolatopsis orientalis _(formerly _Nocardia orientalis_) which is bactericidal against many gram-positive bacteria. It should be administered intravenously in dilute solution (_see_ DOSAGE AND ADMINISTRATION). VANCOCIN CP powder for injection vial - Product Information Page 1 of 14 VANCOCIN CP powder for injection vial - Product Information Page 2 of 14 Vancocin CP is available as sterile vials containing vancomycin equivalent to either 500 mg (500,000 IU) or 1 g (1,000,000 IU) of vancomycin activity. It is an off-white lyophilised plug. When reconstituted in water, it is a clear solution with a pH range of 2.8 to 4.5. Disodium edetate has been added during processing. Sodium hydroxide and/or hydrochloric acid may be used during manufacture for pH adjustment. CLINICAL PHARMACOLOGY Vancocin CP is poorly absorbed after oral administration; it is given intravenously for therapy of systemic infections. Intramuscular injection is painful. In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximatel Read the complete document