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INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINAL PRODUCTS: Amoxicillin/Clavulanic acid 500/100mg or 1000/200mg Powder for solution for injection/infusion must not be mixed with amino acid solutions, lipid emulsions, blood and glucose solutions.
Amoxicillin/Clavulanic Acid 500/100mg or 1000/200mg Powder for solution for injection/infusion is less stable in infusions containing dextran or bicarbonate. Reconstituted solution should, therefore, not be added to such infusions but may be injected into the drip tubing over a period three to four minutes.
Because of the inactivation of aminoglycosides by amoxicillin, in-vitro mixing should be avoided.
INSTRUCTIONS FOR USE AND HANDLING: The reconstitution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter prior to administration. The solution should only be used if the solution is clear and free from particles. Any unused solution should be discarded.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the injection and infusion solutions should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. For single use only.
600 mg vial: Preparation of intravenous injections: Vials of 500/100mg are diluted with 10ml or up to 20ml of water injections. (See Table 3).
Click on icon to see table/diagram/imagePreparation of intravenous infusions: The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume for solution for infusion: The vial of 500/100mg is first reconstituted with one of the compatible intravenous fluids in its vial. This solution has then to be transferred into a suitable infusion bag which should contain the same compatible fluid as used for reconstitution. Controlled and validated aseptic conditions have to be observed.
Vials of 500/100mg are diluted with 25ml or up to 50ml of water for injection or of the following fluids: Physiological saline, Sodium lactate 167mmol/l, Ringer's solution, Hartmann's solution.
If the product is dissolved in water for injection as specified, this solution may be mixed with the following solvents: Water for injection, Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
1,200 mg vial: Preparation of intravenous injections: Vials of 1000/200mg are diluted with 20 ml of water for injections. (See Table 4.)
Click on icon to see table/diagram/imagePreparation of intravenous infusions: Vials of 1000/200 mg are diluted with 20 ml of water for injections or of the following fluids: Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume for solution for infusion.
The vial of 1000/200mg is first reconstituted with one of the compatible intravenous fluids in its vial. This solution has then to be transferred into a suitable infusion bag which should contain the some compatible fluid as used for reconstitution, with a volume of 50ml or up to 100 ml.
Controlled and validated aseptic conditions have to be observed.
Bottles of 1000/200 mg are diluted with 50 ml of water for injections or of the following fluids: Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
If the product is dissolved in water for injection as specified, this solution may be mixed with the following solvents: Water for injection, Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.
Solutions for intravenous infusion should be administered in full within 60 min of preparation.
After dissolution in water for injection, transient pink color may occur, the solution will become clear again rapidly afterwards.
