Mitomycin for Injection

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Mitomycin 20mg;  

Disponibil de la:

Teva Pharma (New Zealand) Limited

INN (nume internaţional):

Mitomycin 20 mg

Dozare:

20 mg

Forma farmaceutică:

Powder for injection

Compoziție:

Active: Mitomycin 20mg   Excipient: Mannitol

Unități în pachet:

Vial, glass, 50 mL amber, chlorobutyl rubber stopper, aluminium filp off seal, 1 dose unit

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Sicor (Societa Italiana Corticosteroidi) Srl

Indicații terapeutice:

Mitomycin for Injection USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin for Injection USP is not recommended to replace appropriate surgery and/or radiotherapy.

Rezumat produs:

Package - Contents - Shelf Life: Vial, glass, 50 mL amber, chlorobutyl rubber stopper, aluminium filp off seal - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days reconstituted (not refrigerated) stored at or below 25°C

Data de autorizare:

2010-09-13

Caracteristicilor produsului

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Mitomycin, Powder for Injection, 5 mg/vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Mitomycin 5 mg.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection. Blue-violet cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mitomycin for Injection is not recommended as single-agent, primary
therapy. It has been shown to
be useful in the therapy of disseminated adenocarcinoma of the stomach
or pancreas in proven
combinations with other approved chemotherapeutic agents and as
palliative treatment when other
modalities
have
failed.
Mitomycin
is
not
recommended
to
replace
appropriate
surgery
and/or
radiotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose:
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration whenever solution and container permit.
Mitomycin should be given intravenously only, using care to avoid
extravasation of the compound. If
extravasation occurs, cellulitis, ulceration, and slough may result.
Each vial contains either mitomycin 5 mg and mannitol 10 mg. To
administer, add Sterile Water for
Injection, 10 mL. Shake to dissolve. If product does not dissolve
immediately, allow to stand at room
temperature until solution is obtained.
After full haematological recovery (see guide to dosage adjustment)
from any previous chemotherapy,
the following dosage schedule may be used at 6 to 8 week intervals:
20 mg/m
2
intravenously as a single dose via a functioning intravenous catheter.
Because of cumulative myelosuppression, patients should be fully
reevaluated after each course of
mitomycin, and the dose reduced if the patient has experienced any
toxicities. Doses greater than 20
mg/m
2
have not been shown to be more effective, and are more toxic than
lower doses.
The following schedule is suggested as a guide to dosage adjustment:
NADIR AFTER PRIOR DOSE
LEUKOCYTES/MM
3
PLATELETS/MM
3
PERCENTAGE OF PRIOR DOSE TO