Navelbine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vinorelbine tartrate 13.85 mg/mL equivalent to 10 mg/mL vinorelbine

Available from:

New Zealand Medical & Scientific Ltd

INN (International Name):

Vinorelbine tartrate 13.85 mg/mL (equivalent to 10 mg/mL vinorelbine)

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

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

Units in package:

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

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pierre Fabre Medicament - Plantes et Industrie

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C - Vial, glass, single dose, - 4 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C - Vial, glass, single dose, - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C

Authorization date:

1995-12-22

Patient Information leaflet

Navelbine IV
1
NAVELBINE IV
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY DO I NEED NAVELBINE®IV?
Navelbine IV contains the active ingredient vinorelbine tartrate.
Navelbine IV is used to treat lung cancer and advanced breast
cancer. For more information, see Section 1. Why do I need
Navelbine®IV? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN NAVELBINE®IV?
Do not use if you have ever had an allergic reaction to or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Navelbine IV? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Navelbine IV and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS NAVELBINE IV GIVEN?
•
Navelbine IV is given as a slow infusion (drip) into your veins.
Navelbine IV must only be given by a doctor or nurse.
More instructions can be found in Section 4. How is Navelbine IV
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM GIVEN NAVELBINE IV?
THINGS YOU
SHOULD DO
•
Tell your doctor or nurse immediately if you feel any pain or
discomfort during theinfusion.
•
Keep all appointments with your doctor to check on your progress and
monitor side effects.
•
If you become pregnant while taking Navelbine IV, tell your doctor
immediately.
•
THINGS YOU
SHOULD NOT DO
•
You should not breast-feed while you are being treated with Navelbine
IV.
•
Do not use if you have or have had an infection or high temperature in
the last 2 weeks
•
Do not use if you are currently receiving radiation therapy.
•
Do not use if you have recently had a yellow fever vaccination or plan
to have one.
•
Do not use if

Summary of Product characteristics

Page 1 of 19
NEW ZEALAND DATA SHEET
1
NAVELBINE
® (10 MG/ML SOLUTION FOR INJECTION)
NAVELBINE
®
vinorelbine (as tartrate) 10 mg/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL contains 10 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
NAVELBINE Injection is a clear colourless to pale yellow solution. The
pH of NAVELBINE
Injection is approximately 3.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NAVELBINE Injection 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
ADULTS
Single agent treatment is usually given at 25-30mg/m
2
weekly.
In combination chemotherapy the dose may be the same and frequency of
administration
reduced, i.e. day 1 and 8 or day 1 and 5 every 3 weeks.
NAVELBINE Injection should be administered either by infusion over 6
to 10 minutes after
dilution in 50 mL of a 0.9% sodium chloride solution or by an infusion
over 20 to 30 minutes,
after dilution in 125 mL of normal saline solution. Administration
should always be followed
by at least 250 mL normal saline infusion to flush the vein.
Page 2 of 19
DOSAGE IN PATIENTS WITH HAEMATOLOGICAL TOXICITY
Neutrophil counts should be ≥1000 cells/mm
3
prior to the administration of NAVELBINE
Injection. Adjustments in the dosage of NAVELBINE Injection 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 NAVELBINE (MG/M
2
)

1500
30
1000 TO 1499
15
< 1000
Do not administer**
**Repeat neutrophil count in 1 week. If three consecutive weekly doses
are
held because neutrophil count is <1000 cells/mm
3
, discontinue NAVELBINE
®
.
Note:
For patients who, during treatment with NAVELBINE Injection, have
experienced fever
and/or sepsis while neutropenic or had 2 consecutive weekly dos