国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
iron polymaltose, Quantity: 318 mg (Equivalent: iron, Qty 100 mg)
Sigma Company Limited
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid
Intramuscular, Intravenous
5 X 2mL
(S4) Prescription Only Medicine
INDICATIONS AS AT 8 April 2002: For the treatment of iron deficiency anaemia in the following circumstances: * When oral therapy is contraindicated. * When enteric absorption of iron is defective. * When patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical.
Visual Identification: A slightly viscous, dark reddish brown liquid. Free of obvious contamination.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2002-04-22
Page 1 F F E E R R R R O O S S I I G G I I N N J J E E C C T T I I O O N N _(Iron polymaltose injection) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about FERROSIG INJECTION. It does not contain all the available information. It does not take place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of using FERROSIG INJECTION against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS FERROSIG INJECTION? The name of your medicine is FERROSIG Injection. FERROSIG injection is an iron supplement. _It contains iron in a form _ _that can be used by your _ _body _ _to _ _build _ _up _ _iron _ _reserves that are needed for _ _your _ _system _ _to _ _operate _ _properly. _ WHAT IS FERROSIG INJECTION USED FOR? FERROSIG INJECTION is used in cases of iron deficiency (too little iron in the system). FERROSIG INJECTION is used when dosage by mouth is impractical, the anaemia is severe or disturbances in the gastro- intestinal tract make absorption difficult or uncertain. FERROSIG INJECTION is also used for treating iron deficiency states discovered in the third trimester of pregnancy and in circumstances wher e contact between patient and doctor only occurs at irregular intervals. Your doctor however, may have prescribed and used FERROSIG INJECTION for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FERROSIG INJECTION HAS BEEN PRESCRIBED FOR YOU. A doctor's prescription is required for FERROSIG INJECTION. BEFORE YOU ARE GIVEN FERROSIG INJECTION When you must not be given it: Do not use FERROSIG INJECTION if you have ever had an allergic reaction to: 1. FERROSIG INJECTION or other iron preparations. 2. a n y of the other ingredients i n FERROSIG. _You must tell your doctor _ _if_ : 1. YOU HAVE HAD AN ALLERGIC REACTION TO IRON SUPPLEMEN 阅读完整的文件
Page 1 AUSTRALIAN PRODUCT INFORMATION – FERROSIG (IRON POLYMALTOSE) 1 NAME OF THE MEDICINE Iron polymaltose (AAN) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carton of 5 x 2 mL ampoules, with each 2 mL ampoule containing 318 mg iron polymaltose equivalent to 100 mg iron III (50 mg per mL). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM FERROSIG Injection is an aqueous, approximately isotonic solution for intravenous and intramuscular injection. It is a slightly viscous, dark reddish-brown liquid. Free of obvious contamination. FERROSIG Injection contains a macromolecular spherocolloidal complex of iron (III) hydroxide and the carbohydrate polymaltose. Iron polymaltose is also considered to be a _complex of ferric hydroxide and isomaltose_ . Each 2 mL ampoule of FERROSIG Injection contains the equivalent of 100 mg of iron. The aqueous colloidal solution is sterile, pyrogen-free and approximates the pH and tonicity of the tissues. The excipients are water for injections and hydrochloric acid or sodium hydroxide (for pH adjustment). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FERROSIG is indicated for the treatment of iron deficiency anaemia in the following circumstances: • When oral therapy is contraindicated. • When enteric absorption of iron is defective. • When patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical. 4.2 DOSE AND METHOD OF ADMINISTRATION INTRAMUSCULAR USE Technique of injection: THE TECHNIQUE OF INJECTION IS OF CRUCIAL IMPORTANCE. Page 2 FERROSIG INJECTION SHOULD NEVER BE INJECTED INTO THE ARM OR OTHER EXPOSED AREAS. THE WRONG INJECTION TECHNIQUE MAY RESULT IN PAIN AND PERSISTENT DISCOLOURATION OF THE SKIN. The following method of ventro-gluteal injection according to Hochstetter is recommended instead of the nonnal method of injection in the top outer quadrant of the gluteus maxi.mus muscle. a. The length of the needle should be at least 5-6 cm. The lumen of the needle should not be too wide. b. T 阅读完整的文件