DBL LEUCOVORIN CALCIUM folinic acid 50 mg/5 mL (as calcium folinate) injection USP vial (NF)

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

calcium folinate, Quantity: 54 mg (Equivalent: folinic acid, Qty 50 mg)

Tilgængelig fra:

Pfizer Australia Pty Ltd

Lægemiddelform:

Injection, solution

Sammensætning:

Excipient Ingredients: sodium chloride; water for injections

Indgivelsesvej:

Intravenous, Intramuscular

Enheder i pakken:

1 x 5mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Neutralising the immediate toxic effects of folic acid antagonists, eg methotrexate. Treatment of megaloblastic anaemias due to folic acid deficiency, eg in sprue, malnutrition, pregnancy, infancy, liver disease and malabsorption syndromes. Folinic acid rescue, ie using calcium folinate in conjunction with folic acid antagonists, eg methotrexate, to minimise systemic toxicity. INDICATIONS AS AT 13 JAN 05 : 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. Leucovorin Calcium has also shown good results in reducing the toxicity and circumventing the effect of folic acid antagonists, if therapeutically desired.

Produkt oversigt:

Visual Identification: A clear, straw to pale yellow coloured solution, free from visible particulate matter.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1992-10-08

Indlægsseddel

DBL™ LEUCOVORIN CALCIUM
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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 AM I USING DBL LEUCOVORIN CALCIUM?
DBL Leucovirin Calcium Tablet contains the active ingredient calcium
folinate hydrate and DBL Leucovorin Calcium Injection
contains the active ingredient calcium folinate. It is a type of
Vitamin B used to treat some types of anaemia when they occur during
pregnancy and infancy or caused by liver disease, inadequate food
intake or poor food absorption. It may also be used to treat the
toxic effects of some medicines.
For more information, see Section 1. Why am I using DBL Leucovorin
Calcium? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DBL LEUCOVORIN CALCIUM?
Do not use if you have ever had an allergic reaction to calcium
folinate or any of the ingredients listed at the end of the CMI or if
you
have a type of anaemia caused by too little vitamin B12.
Talk to your doctor if you have any other medical conditions, have
problems with your kidneys or have diarrhoea; if you take any
other medicines or are pregnant or plan to become pregnant or are
breastfeeding.
Discuss the need for any restrictions with food and drink with your
doctor.
For more information, see Section 2. What should I know before I use
DBL Leucovorin Calcium? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Leucovorin Calcium and affect
how it works. It is especially important to tell your doctor if
you are taking medicine to treat epilepsy.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DBL LEUCOVORIN CALCIUM?
Your doctor will decide what dose and how long you will receive DBL
Leucovorin Calcium. This depends on the condition you are
being treated for.
More instructions can be found in Section 4. How do I use DBL
Leucovorin Calcium? in the full CMI.
5.

Produktets egenskaber

Version: pfpleutb10422
Supersedes: hhpleuvi10120 & pfpleutb11219
Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
TM
LEUCOVORIN
CALCIUM
(CALCIUM
FOLINATE
HYDRATE)
TABLETS
AND
(CALCIUM FOLINATE) INJECTION
1.
NAME OF THE MEDICINE
Folinic acid (as calcium folinate hydrate) - tablets.
Folinic acid (as calcium folinate) - injections.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS
Each DBL Leucovorin Calcium Tablet contains 15 mg folinic acid (as
calcium folinate
hydrate).
SOLUTION FOR INJECTIONS
Each 2 mL DBL Leucovorin Calcium Injection 15 mg/2 mL contains 15 mg
folinic acid (as
calcium folinate).
Each 5 mL DBL Leucovorin Calcium Injection 50 mg/5 mL contains 50 mg
folinic acid (as
calcium folinate).
Each 30 mL DBL Leucovorin Calcium Injection 300 mg/30 mL contains 300
mg folinic acid
(as calcium folinate).
EXCIPIENTS WITH KNOWN EFFECTS
TABLETS
Contains sugars as lactose. Each DBL Leucovorin Calcium Tablet
contains 141.4 mg of lactose
monohydrate.
SOLUTION FOR INJECTION
DBL Leucovorin Calcium Injection 15 mg/2 mL contains 8.1 mg/mL of
sodium chloride.
DBL Leucovorin Calcium Injection 50 mg/5 mL and 300 mg/30 mL contains
8.5 mg/mL of
sodium chloride.
For the full list of excipients, see Section 6.1 List of excipients.
Version: pfpleutb10422
Supersedes: hhpleuvi10120 & pfpleutb11219
Page 2 of 14
3.
PHARMACEUTICAL FORM
TABLETS
DBL Leucovorin Calcium Tablets are light yellow, round, flat, scored,
uncoated tablets,
engraved with CF.
SOLUTION FOR INJECTION
DBL Leucovorin Calcium Injection is a clear straw-to pale yellow
coloured sterile, isotonic
solution free from visible particular matter. The solution does not
contain a bactericide.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Folinic acid 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.
Folinic acid has also shown g