8. Due to possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (alpha-Gal), the risk of sensitization and consequent anaphylactic reaction to gelatin- containing solutions could be highly increased in patients with history of allergy to red meat (mammal meat) and offal and/or tested positive for anti-alpha-Gal IgE antibodies.
3) In case of an allergic reaction, the infusion must be stopped immediately and appropriate treatment given. g. patients with right or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oligo- or anuria.
• with severely impaired renal function • with severe hypernatraemia • with severe hyperchloraemia • having oedema with water/salt retention • with major blood coagulation disorders • of advanced age (elderly patients) as those are more prone to develop disorders such as cardiac or renal insufficiency Clinical monitoring should include regular checks of serum electrolyte concentrations, acid-base balance and water balance, in particular in patients with hypernatraemia, hyperchloraemia or impairment of renal function.
Gelofusine contains supraphysiological concentrations of sodium (154 mmol/L) and chloride (120 mmol/L). g. signs of tetany, paraesthesia); then specific corrective measures should be taken. Influence on haemodilution and blood coagulation The haemodynamic, haematological and coagulation system should be monitored.
During compensation of severe blood losses by infusions of large amounts of Gelofusine, haematocrit and electrolytes must be monitored. The haematocrit should not decrease below 25%. In elderly or critically ill patients it should not fall below 30%.
Likewise in those situations the dilution effect on coagulation factors should be observed, especially in patients with existing disorders of haemostasis. 2, “Maximum dose”. Paediatric population There is insufficient experience with the use of Gelofusine in children.
Therefore, Gelofusine should only be administered to these patients if the expected benefits clearly outweigh potential risks. 2). Influence on laboratory tests Laboratory blood tests (blood group or irregular antibodies) are possible after Gelofusine infusions.
Nevertheless it is recommended to draw blood samples before the infusion of Gelofusine in order to avoid hampered interpretation of results. g. the biuret method. g. corticosteroids, non-steroidal anti- inflammatory agents) as concomitant administration may lead to oedema.
6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of Gelofusine in pregnant women. 3). Due to the limited data available and the possibility of severe anaphylactic/anaphylactoid reactions, with consecutive foetal and neonatal distress due to maternal hypotension, the use of modified fluid gelatin solutions during pregnancy should be restricted to emergency situations.
Breast-feeding There are no or limited data regarding the excretion of succinylated gelatine in mother’s milk, but because of its high molecular weight it is not expected that the milk will contain relevant amounts. Sodium and chloride are normal constituents of the human body and of food.
No significant increase in the content of these electrolytes in mother’s milk is expected following the use of Gelofusine. Fertility There are no data on the effect of Gelofusine on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that Gelofusine will affect fertility.
7 Effects on ability to drive and use machines Gelofusine has no or negligible influence on the ability to drive and use machines. 8 Undesirable effects Undesirable effects are listed according to their frequencies as follows: 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: (cannot be estimated from the available data) Summary of the safety profile Adverse drug reactions can occur during and after the use of Gelofusine.
4, notably for hypersensitivity to galactose-α-1,3-galactose (alpha- Gal) and allergy to red meat and offal). 4) Cardiac disorders Very rare: Tachycardia Vascular disorders Very rare: Hypotension General disorders and administration site conditions Very rare: Fever, chills Gastro intestinal disorders Unknown: Nausea, vomiting, abdominal pain Investigations Unknown: Oxygen saturation decreased Blood and lymphatic system disorders Very common: Decreased haematocrit and reduced concentration of plasma proteins Common (depending on the administered dose): Relatively large doses of Gelofusine result in dilution of coagulation factors and can therefore affect blood coagulation.
Prothrombin time can be […]