מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
heparin sodium, Quantity: 2000 IU/L
Baxter Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; citric acid monohydrate; dibasic sodium phosphate dodecahydrate
Intravenous
1000mL x 12
(S4) Prescription Only Medicine
INDICATIONS AS AT 11 JULY 2003: Heparin Sodium in 0.9% Sodium Chloride Intravenous Infusion is indicated as an anticoagulant in extracorporeal circulation, dialysis procedures, and as an aid in the maintenance of catheter patency.
Visual Identification: Clear solution; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-30
________________________________________________________________________________ Heparin CMI Page 1 of 3 HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION Consumer Medicine Information WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about the HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INTRAVENOUS (IV) INFUSION. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you using Heparin Sodium in 0.9% Sodium Chloride IV Infusion against the benefit they expect it will have for you. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about having this medicine, ask your doctor or pharmacist. WHAT HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE IV INFUSION IS USED FOR This medicine is used to prevent the blood clotting when blood is removed from the body, for example during dialysis. It is also useful to ensure that catheters do not become blocked. Your doctor may have prescribed Heparin Sodium in 0.9% Sodium Chloride IV Infusion for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. BEFORE YOU ARE GIVEN HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INFUSION _ _ _THE HEPARIN SODIUM IN 0.9% _ _SODIUM CHLORIDE INFUSION _ _MUST NOT BE GIVEN TO YOU IF: _ • you have an allergy to any ingredient listed at the end of this leaflet; • you have had an allergic reaction to heparin or pork products. Some of the symptoms of an allergic reaction may include skin rash, peeling of the skin and swelling of the face, lips or tongue, causing difficulty swallowing or shortness of breath; • you have a bleeding disease or a problem with your blood vessels; • you have low blood platelet count, or are bleeding or bruising more easily than normal; • the expiry date printed on the pack has passed. _YOU SHOULD TELL YOUR DOCTOR IF _ _YOU: _ • have had a reaction to heparin in the past • have heart problems or high blood pressure; • have liver disease; • hav קרא את המסמך השלם
BAXTER HEPARIN SODIUM in 0.9% SODIUM CHLORIDE Intravenous Infusion Version 2.0 1 of 13 AUSTRALIAN PRODUCT INFORMATION – BAXTER HEPARIN SODIUM (HEPARIN SODIUM) IN 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Heparin sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baxter Heparin Sodium in 0.9% Sodium Chloride Intravenous (IV) Infusion is a sterile, nonpyrogenic solution of heparin sodium standardised for use as an anticoagulant in 0.9% Sodium Chloride IV Infusion buffered with 0.4 mg citric acid monohydrate and 5.8 mg dibasic sodium phosphate dodecahydrate (Na 2 HPO 4 .12H 2 O) per mL to pH range of 5.5 – 8.0. It is supplied in single dose VIAFLEX plastic bag containers for intravenous administration. Heparin is a heterogenous mixture of variably sulfated polysaccharide chains composed of repeating units of disaccharides, _D_ -glucosamine and _L_ -iduronic acid or _D_ -glucosamine and _D_ - glucuronic acids. It is extracted from porcine intestinal mucosa. Upon complete hydrolysis, it yields a mixture of _D_ -glucosamine, _D_ -glucuronic acid, _L_ -iduronic acid, acetic acid and sulphuric acid. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α- _D_ -glucose 6-sulfate, (3) β- _D_ -glucuronic acid, (4) 2- acetamido-2-deoxy-α- _D_ -glucose, and (5) α- _L_ -iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Clear solution for intravenous infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Baxter Heparin Sodium in 0.9% Sodium Chloride Intravenous IV Infusion is indicated as an קרא את המסמך השלם