Pfizer (Australia) CYTARABINE 500mg/25mL injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

cytarabine, Quantity: 500 mg

Saadav alates:

Pfizer Australia Pty Ltd

Ravimvorm:

Injection, solution

Koostis:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride

Manustamisviis:

Intravenous, Subcutaneous

Ühikuid pakis:

25mL x 1

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

INDICATIONS AS AT 24 OCTOBER 2001: Cytarabine is indicated primarily for: Induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. It has also been found to be useful in the treatment of other leukaemias such as acute lymphocytic leukaemia, chronic myelocytic leukaemia (blast phase). Cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combined therapy. Children with non-Hodgkin's lymphoma have benefited from a combination drug program (LSA212) that includes cytarabine. Remissions induced by cytarabine not followed by maintenance treatment have been brief. Maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity. Cytarabine has been used intrathecally in meningeal leukaemia. Focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Toote kokkuvõte:

Visual Identification: Clear, colourless to almost pale-yellow aqueous solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 18 Months; Container Temperature: Store between 15-25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1994-12-20

Toote omadused

Version: pfpcytai10320
Supersedes: pfpcytai11117
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
CYTARABINE
(CYTARABINE
20
MG/ML,
100
MG/ML) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Cytarabine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cytarabine
Injection
is
a
sterile,
isotonic,
preservative-free
solution
containing
either
Cytarabine BP 20mg/mL with Sodium Chloride BP 6.8mg/mL in Water for
Injections BP or
Cytarabine BP 100mg/mL in Water for Injections BP.
3.
PHARMACEUTICAL FORM
Cytarabine Injection is a clear, colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cytarabine is indicated primarily for:
•
Induction and maintenance of remission in acute myelocytic leukaemia
of both adults
and children.
It has also been found to be useful in the treatment of other
leukaemias such as:
•
Acute lymphocytic leukaemia
•
Chronic myelocytic leukaemia (blast phase).
Cytarabine may be used alone or in combination with other
antineoplastic agents, the best
results are often obtained with combination therapy.
Children with non-Hodgkin’s lymphoma have benefited from a
combination drug program
(LSA2L2) that includes cytarabine.
Remissions induced by cytarabine not followed by maintenance treatment
have been brief.
Maintenance therapy has extended these and provided useful and
comfortable remissions with
relatively little toxicity.
Cytarabine has been used intrathecally in meningeal leukaemia. Focal
leukaemic involvement
of the central nervous system may not respond to intrathecal
cytarabine and may better be
treated with radiotherapy.
Version: pfpcytai10320
Supersedes: pfpcytai11117
Page 2 of 16
4.2 DOSE AND METHOD OF ADMINISTRATION
Cytarabine may be administered by intravenous injection or infusion,
or subcutaneously. It
has been administered intrathecally as a special application.
Thrombophlebitis has occurred at the site of drug injection or
infusion in some patients, and
rarely patients have noted pain and inflammation at subcutaneous
injection sites. In most
instances, howeve