Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron)
100mg/2mL
Solution for injection
Active: Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron) Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Ampoule, glass, 2ml, 5 dose units
Prescription
Prescription
Vifor (International) Inc
For the prevention and 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 · Treating iron deficiency anaemia of prematurity and that occurring in geriatric patients · Treating iron deficiency states discovered in the third trimester of pregnancy · Anaemia resulting from excessive blood loss · Where contact between the doctor and patient occurs at irregular intervals
Package - Contents - Shelf Life: Ampoule, glass, 2ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C
1969-12-31
FERRUM H ® Iron Polymaltose CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about FERRUM H. 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 using FERRUM H 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 FERRUM H IS USED FOR FERRUM H provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency. FERRUM H is used when dosage by mouth is impractical or contraindicated and when disturbances in the gastrointestinal tract make absorption difficult or uncertain. BEFORE YOU ARE GIVEN FERRUM H WHEN YOU MUST NOT BE GIVEN IT DO NOT USE FERRUM H IF: You are known to be sensitive (allergic) to any of the ingredients of FERRUM H Your anaemia is not due to a shortage of iron You have a condition known as haemochromatosis (an excess of iron in the body) You have any medical conditions or health problems including arthritis, bronchial asthma, hepatitis You are in the 1 st trimester of a pregnancy FERRUM H should not be used after the expiry date printed on the label. PAGE 2/5 CONSUMER MEDICINE INFORMATION FERRUM H PIL-YA460/AU/E04 IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN FERRUM H PLEASE TALK TO YOUR DOCTOR. BEFORE YOU ARE GIVEN IT_ _ YOU SHOULD BE AWARE THAT: A blood test should have been carried out to ensure treatment with this medicine is appropriate If you have a history of asthma, eczema or other atopic allergies you are more susceptible to experience allergic reactions YOU MUST TELL YOUR DOCTOR IF: You are pregnant or breastfeeding You or a blood relative have the condition haemochromatosis You have a history of_ _liver disease IF YOU HAVE NOT TOLD YOUR DOCTOR ABOUT ANY O Прочитать полный документ
NEW ZEALAND DATA SHEET 1. FERRUM H SOLUTION FOR INJECTION 100 MG/2ML AMPOULE FERRUM H solution for injection 100 mg/2mL ampoule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iron polymaltose equivalent to iron 100 mg/2 mL. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A slightly viscous, dark reddish brown liquid. Odour faintly malt-like. Each ampoule of FERRUM H 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and 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 • Treating iron deficiency anaemia of prematurity and that occurring in geriatric patients • Treating iron deficiency states discovered in the third trimester of pregnancy • Anaemia resulting from excessive blood loss • Where contact between the doctor and patient occurs at irregular intervals 4.2 DOSE AND METHOD OF ADMINISTRATION INTRAMUSCULAR USE _TECHNIQUE OF INJECTION _ THE TECHNIQUE OF INJECTION IS OF CRUCIAL IMPORTANCE. FERRUM H 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 normal method of injection in the top outer quadrant of the gluteus maximus muscle: 1. The length of the needle should be at least 5-6 cm. The lumen of the needle should not be too wide. 2. The site of injection is determined as follows (see Fig. 1): First point A is found, corresponding to the ventral iliac spine. If the patient lies on the right side, for instance, the middle finger of the left hand is placed on point A. The index finger is extended away fr Прочитать полный документ