DBL™ Vinorelbine Injection Concentrate

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Vinorelbine tartrate 13.85mg equivalent to to 10 mg vinorelbine

Dostępny od:

Pfizer New Zealand Limited

INN (International Nazwa):

Vinorelbine tartrate 13.85 mg (equiv. to 10 mg vinorelbine)

Dawkowanie:

10 mg/mL

Forma farmaceutyczna:

Concentrate for injection

Skład:

Active: Vinorelbine tartrate 13.85mg equivalent to to 10 mg vinorelbine Excipient: Nitrogen Water for injection

Sztuk w opakowaniu:

Vial, glass, single dose, 10mg/1mL, 1 mL

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Eriochem SA

Wskazania:

DBL™ Vinorelbine Injection Concentrate is indicated as a single agent or in combination for 1. the treatment of non small cell lung cancer (NSCLC), and 2. the second line treatment of advanced breast cancer.

Podsumowanie produktu:

Package - Contents - Shelf Life: Vial, glass, single dose, 10mg/1mL - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 50mg/5mL - 5 mL - 24 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data autoryzacji:

2004-10-28

Charakterystyka produktu

Version:pfdvinoi10219
Supersedes: Version 5.0
Page 1 of 15
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Vinorelbine Injection Concentrate
10mg/mL
Concentrate for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Vinorelbine Injection Concentrate contains 10 mg vinorelbine
tartrate equivalent to
10 mg vinorelbine per mL (present as 13.85 mg of vinorelbine
tartrate).
3.
PHARMACEUTICAL FORM
DBL™ Vinorelbine is a concentrate for injection. It is a clear
colourless to pale yellow
solution. The pH of DBL™ Vinorelbine Injection Concentrate is
approximately 3.0 to 4.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL™ Vinorelbine Injection Concentrate is indicated as a single
agent or in combination for
1.
the treatment of non small cell lung cancer (NSCLC), and
2.
the second line treatment of advanced breast cancer
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Single agent treatment is usually given at 25 to 30mg/m
2
weekly.
In combination chemotherapy the dose may be the same and frequency of
administration
reduced, ie: day 1 and 8 or day 1 and 5 every 3 weeks.
DBL™ Vinorelbine Injection Concentrate should be administered either
by slow bolus over 6
to 10 minutes after dilution in 50mL of a normal saline solution or by
a short infusion over 20
to 30 minutes, after dilution in 125mL of normal saline solution.
Administration should
always be followed by at least 250mL normal saline infusion to flush
the vein.
DOSE ADJUSTMENTS
DOSAGE IN PATIENTS WITH HAEMATOLOGICAL TOXICITY
Version:pfdvinoi10219
Supersedes: Version 5.0
Page 2 of 15
Neutrophil counts should be ≥ 1000 cells/mm
3
prior to the administration of Vinorelbine
Injection
Concentrate.
Adjustments
in
the
dosage
of
DBL™
Vinorelbine
Injection
Concentrate should be based on neutrophil counts obtained on the day
of treatment (see Table
1).
TABLE 1
NEUTROPHILS (CELLS/MM
3
) ON DAY OF TREATMENT
DOSE OF VINORELBINE (MG/M
2
)
≥ 1500
30
1000 TO 1499
15
< 1000
Do not administer **
**Repeat neutrophil count in 1 week. If three consecutive week