Erwinase

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Asparaginase 10000 [iU]

Commercializzato da:

New Zealand Medical & Scientific Ltd

INN (Nome Internazionale):

Asparaginase 10000 IU

Dosaggio:

10000 IU

Forma farmaceutica:

Powder for injection

Composizione:

Active: Asparaginase 10000 [iU] Excipient: Glucose monohydrate Sodium chloride Water for injection

Confezione:

Vial, glass, single dose, 20 x 1ml, 20 mL

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Public Health England (PHE)

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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)

Data dell'autorizzazione:

1991-01-30

Scheda tecnica

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.
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