Download MANDATORY DRUG INFORMATION 1 NAME AND

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