Idarubicin Hydrochloride Injection 5 mg in 5 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: hydrochloric acid; water for injections; glycerol

Mode d'administration:

Intravenous Infusion

Unités en paquet:

1 X 5 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 in adult patients. ? Acute lymphocytic leukaemia as a second line in adults and children. THAILAND Zavedos is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents. CHILE ? Acute non-lymphocytic leukemia (ANLL); also called acute myelogenous leukemia (AML) in children and adults for remission induction as first-line therapy or for remission induction in relapsed or refractory patients. ? Acute lymphocytic leukemia (ALL) as second-line treatment in adults and children. DENMARK Acute leukaemias. Paediatric population Zavedos, combined with cytarabine, for first-line therapy in children with acute myeloid leukaemia (AML). FRANCE ? Acute myeloblastic leukaemia. ? Idarubicin, in combination with cytarabine is indicated for first-line remission induction treatment in children with acute myeloid leukaemia (AML) who have not undergone previous treatment. ? Acute lymphoblastic leukaemia in relapsed patients. FINLAND Adults For remission induction in acute myeloid leukemia as primary therapy, or for remission induction in relapsed or refractory patients. Children Idarubicin, in combination with cytarabin, is indicated for the first remission induction-line treatment of previously untreated children with acute myeloid leukemia (AML). Zavedos solution for injection may be used in combination therapy with other cytotoxic agents. INDIA Adults Acute myeloid leukemia (AML): for the induction of the remission both as first line therapy and for remission induction in relapsed or refractory patients. Acute lymphocytic leukemia (ALL): second-line treatment. Children Acute lymphocytic leukaemia (ALL): second line therapy. ICELAND Acute myelogenous leukemia (AML). Paediatric population Zavedos, combined with cytarabine, for first-line therapy in children with acute myeloid leukaemia (AML). NETHERLANDS Adults Acute Myeloid Leukaemia (AML): for remission induction as first line treatment or for remission induction in relapse or refractory patients. Acute Lymphoblastic Leukaemia (ALL): second line treatment. PORTUGAL Adults Acute non-lymphocytic leukaemia, as a first line treatment for induction of remission, or for induction of remission in patients with relapsed or refractory occurrence of the disease. Acute lymphocytic leukaemia, as a second line treatment. Children Acute non-lymphocytic leukaemia, in combination with cytarabine, as a first line treatment for induction of remission. Acute lymphocytic leukaemia, as a second line treatment. UNITED KINGDOM Adults For the treatment of acute myeloid leukaemia (AML), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Paediatric population For first line treatment of acute myeloid-leukaemia (AML), in combination with cytarabine, for remission induction. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents. IRELAND Adults For the treatment of acute myeloid leukaemia (AML), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Paediatric population For first line treatment of acute myeloid-leukaemia (AML), in combination with cytarabine, for remission induction. For second line treatment of relapsed acute lymphoblastic leukaemia (ALL). Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents POLAND Adults: - Acute non-lymphocytic leukemia [ANLL, also referred to as acute myelogenous leukemia (AML)] for remission induction as first-line therapy or for remission induction in relapsed or refractory patients. - Acute lymphocytic leukemia (ALL) as second line treatment. Children: - Acute myeloid leukemia (AML) in combination with cytarabine, as first line therapy for remission induction. - Acute lymphocytic leukemia (ALL) as second line treatment.

Descriptif du produit:

Visual Identification: Plastic vials containing a red-orange, clear, mobile solution and practically free from 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