CILNEM 500MG VIAL

Pack Size

20ml

Dosage

You will not be expected to give yourself CILNEM. It will be given to you by a person who is qualified to do so. Your doctor will decide how much CILNEM you need. This will depend upon your condition and the severity of your infection. Adults and adolescents The usual daily dose is 1 - 2 g administered in 3 - 4 divided doses. If you have kidney problems or if you weigh less than 70 kg, your doctor may lower your dose. Children The usual dose for children and infants (3 months or older) is 15 mg/kg every 6 hours. CILNEM is not recommended in children under 3 months of age and children with kidney problems.

Warnings and Contraindications

Tell your doctor or healthcare provider before CILNEM is given to you, if you have: • allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) • colitis (inflammation of the bowels) or any other gastrointestinal disease • any central nervous system disorders such as localised tremors or epileptic seizures • kidney or urinary problems, including reduced kidney function (CILNEM blood levels increase in patients with reduced kidney function. Central nervous system adverse reactions may occur if the dose is not adjusted to the kidney function) • liver problems. You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will explain this to you. Tell your doctor if you are taking medicines called valproic acid or divalproex sodium (see “Other medicines and CILNEM”). Use in children CILNEM is not recommended in children less than 3 months of age or children with kidney problems.

Composition

Each vial contains 500 mg imipenem (as imipenem monohydrate) and 500 mg cilastatin (as cilastatin sodium salt). The other ingredient is sodium bicarbonate. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 ml vial contains 500 mg imipenem (as imipenem monohydrate) and 500 mg cilastatin (as cilastatin sodium salt). Excipient with known effect: Each vial contains sodium bicarbonate equivalent to approximately 1,6 millimole sodium (approximately 37,6 mg) per vial. Sugar free. Final concentration of the reconstituted solution is 5 mg/ml. Sterile powder for solution for infusion. White to almost white or light (pale) yellow powder.

PI / PIL