País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Asparaginase 10000 [iU]
New Zealand Medical & Scientific Ltd
Asparaginase 10000 IU
10000 IU
Powder for injection
Active: Asparaginase 10000 [iU] Excipient: Glucose monohydrate Sodium chloride Water for injection
Vial, glass, single dose, 20 x 1ml, 20 mL
Prescription
Prescription
Public Health England (PHE)
Erwinase is used in combination with other anti-neoplastic agents to treat acute lymphoblastic leukaemia. It may also be used in other neoplastic conditions where depletion of asparagines might be expected to have a useful effect. Patients receiving treatment with L-asparaginase from Escherichia coli, and who develop hypersensitivity to that enzyme may be able to continue treatment with Erwinase as the enzymes are immunologically distinct.
Package - Contents - Shelf Life: Vial, glass, single dose, 5 x 1ml - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1991-01-30
NEW ZEALAND DATASHEET 1. PRODUCT NAME Erwinase ® 10,000 Units/vial, Lyophilisate for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Crisantaspase (Asparaginase from Erwinia chrysanthemi; Erwinia L-asparaginase), 10,000 Units/vial. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for solution for injection. White lyophilised powder in a vial. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Erwinase is used in combination with other anti-neoplastic agents to treat acute lymphoblastic leukaemia. It may also be used in other neoplastic conditions where depletion of asparagines might be expected to have a useful effect. Patients receiving treatment with L-asparaginase from Escherichia coli, and who develop hypersensitivity to that enzyme may be able to continue treatment with Erwinase as the enzymes are immunologically distinct. 4.2 Dose and method of administration For all patients the usual dose is 6,000 Units/m 2 body surface area (200 Units/kg of body weight), three times a week for three weeks. Therapy may be further intensified according to protocol. Reference to current Medical Research Council protocols on leukaemia therapy should be made for information on dose, route and frequency of treatment. Method of administration Erwinase solution can be given by intravenous injection or by intramuscular or subcutaneous injection. 4.3 Contraindications Previous allergic reaction to Erwinia asparaginase. Previous episode of acute pancreatitis related to L-asparaginase therapy. Breast-feeding (see section 4.6). 4.4 Special warnings and precautions for use Warnings: Anaphylactic reactions have been observed after the use of Erwinase. Facilities should be made available for management of an anaphylactic reaction, should it occur, during administration. Careful observation is required on re-exposure to L-asparaginase after any time interval (e.g. between induction and consolidation), which may increase the risk of anaphylactic reactions occurring. Posterior Reversi Leer el documento completo