Idarubicin hydrochloride injection 20 mg in 20 mL (1)

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

idarubicin hydrochloride, Quantity: 1 mg/mL

Disponible depuis:

Pfizer (Perth) Pty Ltd

forme pharmaceutique:

Injection, solution

Composition:

Excipient Ingredients: glycerol; hydrochloric acid; water for injections

Mode d'administration:

Intravenous Infusion

Unités en paquet:

1 x 20 mL

Type d'ordonnance:

(S1) This Schedule is intentionally blank

indications thérapeutiques:

CANADA Idarubicin alone or in combination with other anticancer drugs are used in the treatment of: ? Acute non-lymphocytic leukaemia as a first line treatment in adults ? Acute lymphocytic leukaemia as a second line in adults and children FRANCE ZAVEDOS solution for infusion is indicated for the treatment of acute myeloid leukemia. ZAVEDOS solution for infusion is indicated for the treatment of acute lymphoblastic leukemia in relapse. GERMANY Adults Zavedos is indicated for use in combination with other cytostatics (such as cytabarine) for the treatment (remission induction and consolidation) of adult patients with acute myeloid leukaemia (AML, ANLL) who have not received any previous treatment. Children and adolescents Zavedos, in combination with cytarabine, is indicated for first-line remission induction treatment of children with blood cancer, called acute myeloid leukaemia (AML), who have not received any previous treatment. NETHERLANDS Adults Acute Myeloblastic Leukaemia (AML): for remission induction as first line treatment or for remission induction in relapsed or refractory patients. Acute Lymphoblastic Leukaemia (ALL): second line treatment. Children Acute Myeloblastic Leukaemia (AML): for remission induction as first line treatment, in combination with cytarabine. Acute Lymphoblastic Leukaemia (ALL): second line treatment. SWITZERLAND Acute myeloid leukaemia in combination with other cytostatics. Acute lymphatic leukaemia as reserve medication in combination with other cytostatics.

Descriptif du produit:

Visual Identification: Plastic vials containing a red-orange, clear, mobile solution practically free of visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Listed (Export Only)

Date de l'autorisation:

2019-03-18