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MANDATORY DRUG INFORMATION 1 NAME AND ADRESS OF MARKETING AUTHORIZATION HOLDER B.Braun Melsungen AG 34209 Melsungen, Germany 2. NAME OF THE MEDICINAL PRODUCT Gelofusine 40 mg/ml Solution for Infusion (Other names: Gelafundin 4%, Physiogel) 3. QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml of solution contain: Gelatine polysuccinate (=modified fluid gelatin) 40.0 g Sodium chloride 7.01g Electrolyte concentrations: Sodium 154 mmol/l Chloride 120 mmol/l 4. THERAPEUTIC INDICATIONS Colloidal plasma volume substitute for: • Prophylaxis and treatment of imminent or manifest relative or absolute hypovolemia and shock • Prophylaxis and treatment of hypotension (e.g. during induction of epidural or spinal aneaesthesia) • Procedures involving extracorporal circulation (e.g. heart-lung machine) • Acute normovolaemic haemodilution 5. CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients • Hypervolaemia • Hyperhydration 6. UNDESIRABLE EFFECTS Definition of frequency terms: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Immune systems disorders Rare: Anaphylactoid reactions (all grades) Very rare: Severe anaphylactoid reactions Cardiac disorders Very rare: Tachycardia Vascular disorders Very rare: Hypotension Respiratory, thoracic and mediastinal disorders Very rare: Respiratory difficulties MANDATORY DRUG INFORMATION Skin and subcutaneous tissue disorders Rare: Allergic skin reactions General disorders and administration site conditions Uncommon: Mild Transient mild rise of body temperature Very rare: Fever, chills 7. NOTE Prescription only. Not all products are registered and approved for sale in all countries or regions. Indications of use may also vary by country and region. Please contact your country representative for product availability and information. 8. DATE OF LATEST UPDATE 01/2012