DBL® Leucovorin Calcium

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Calcium folinate 10.5 mg/mL (4% overage);  ;  

Tilgjengelig fra:

Pfizer New Zealand Limited

INN (International Name):

Calcium folinate 10.5 mg/mL (4% overage)

Dosering :

50 mg/5mL

Legemiddelform:

Solution for injection

Sammensetning:

Active: Calcium folinate 10.5 mg/mL (4% overage)     Excipient: Sodium chloride Water for injection

Enheter i pakken:

Vial, glass, 1x5ml, 5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

GMT Fine Chemicals SA

Indikasjoner:

Calcium Leucovorin has shown good results in the treatment of certain megaloblastic anaemias resulting from folic acid deficiency. This mainly occurs in infants, during pregnancy, in malabsorption syndromes, liver diseases, sprue and malnutrition. It is not more effective than folic acid for these conditions. Calcium Leucovorin also has shown good results in reducing the toxicity and circumventing the effect of folic acid antagonists, if therapeutically desired. Use in combination with 5-fluorouracil in the treatment of advanced colorectal carcinoma.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, 5ml - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisasjon dato:

1982-07-29

Preparatomtale

Version: pfdleuca10522
Supercedes: pfdleuca11021
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Leucovorin Calcium 15 mg Tablet.
DBL™ Leucovorin Calcium 15 mg/2 mL, 50 mg/5 mL or 300 mg/30 mL
Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DBL Leucovorin Calcium Tablet contains 15 mg folinic acid (as
calcium folinate
hydrate).
Each 2 mL ampoule of DBL Leucovorin Calcium Solution for Injection
contains 7.5 mg/mL
folinic acid (as calcium folinate).
Each 5 mL vial of DBL Leucovorin Calcium Solution for Injection
contains 10 mg/mL folinic
acid (as calcium folinate).
Each 30 mL vial of DBL Leucovorin Calcium Solution for Injection
contains 10 mg/mL folinic
acid/mL (as calcium folinate).
EXCIPIENTS WITH KNOWN EFFECT:
SOLUTION FOR INJECTION
Each 2 mL ampoule of DBL Leucovorin Calcium Injection contains 8.1
mg/mL of sodium
chloride.
Each vial of DBL Leucovorin Calcium Injection 50 mg/5 mL and 300 mg/30
mL contains 8.5
mg/mL of sodium chloride.
TABLETS
Each DBL Leucovorin Calcium Tablet contains 141.4 mg of lactose
monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
TABLETS
DBL Leucovorin Calcium tablets are light yellow, round, flat, scored,
uncoated tablet,
engraved with CF.
.
SOLUTION FOR INJECTION
DBL
™
Leucovorin Calcium Injection is a sterile, clear, straw to pale yellow
coloured solution,
free from visible particulate matter.
Version: pfdleuca10522
Supercedes: pfdleuca11021
Page 2 of 13
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Leucovorin Calcium has shown good results in the treatment of
certain megaloblastic
anaemias resulting from folic acid deficiency. This mainly occurs in
infants, during pregnancy,
in malabsorption syndromes, liver diseases, sprue and malnutrition. It
is not more effective
than folic acid for these conditions.
DBL
Leucovorin
Calcium
also
has
shown
good
results
in
reducing
the
toxicity
and
circumventing the effect of folic acid antagonists, if therapeutically
desired.
Use in combination