DBL LEUCOVORIN CALCIUM folinic acid 300 mg/30 mL (as calcium folinate) injection vial

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

calcium folinate, Quantity: 324.1 mg (Equivalent: folinic acid, Qty 300 mg)

Fáanlegur frá:

Pfizer Australia Pty Ltd

INN (Alþjóðlegt nafn):

Calcium folinate

Lyfjaform:

Injection

Samsetning:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride

Stjórnsýsluleið:

Intravenous, Intramuscular

Einingar í pakka:

1 x 30 mL

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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 disease, 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.

Vörulýsing:

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

Leyfisstaða:

Registered

Leyfisdagur:

2006-07-10

Upplýsingar fylgiseðill

DBL
TM
LEUCOVORIN CALCIUM
1
DBL
TM
LEUCOVORIN CALCIUM
INJECTION
_ (also called Calcium Folinate or Folinic Acid) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions that you may
have about DBL
TM
Leucovorin
Calcium Injection (leucovorin
calcium). It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being treated with
leucovorin calcium, against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL
TM
LEUCOVORIN CALCIUM IS
USED FOR
DBL
TM
Leucovorin Calcium is
considered to be a supportive
therapy. It is used in two main
situations:
1.
When your body does not have
enough folic acid.
This occurs in conditions such as
megaloblastic anaemia, where the
level of red blood cells and iron
in the blood is too low.
Megaloblastic anaemia can
happen during pregnancy or
infancy, or due to liver disease,
malnutrition, or a reduced ability
to absorb folic acid from the diet.
2.
As an antidote or rescue therapy
to the toxic effects of some
medications such as
methotrexate.
DBL
TM
Leucovorin calcium is not
addictive.
BEFORE YOU ARE GIVEN
DBL
TM LEUCOVORIN
CALCIUM
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN DBL
TM
LEUCOVORIN CALCIUM IF YOU HAVE OR
HAVE HAD AN ALLERGY TO LEUCOVORIN
CALCIUM, FOLIC ACID, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction to
leucovorin calcium may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN DBL
TM
LEUCOVORIN CALCIUM IF YOU HAVE
PERNICIOUS ANAEMIA OR ANY OTHER
MEGALOBLASTIC ANAEMIAS WHICH ARE
DUE TO A LACK OF VITAMIN B12
YOU MUST NOT BE GIVEN DBL
TM
LEU

Vara einkenni

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Supersedes: Version 6.0
Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
[DBL
TM
LEUCOVORIN
CALCIUM
INJECTION
(CALCIUM FOLINATE)]
1.
NAME OF THE MEDICINE
Calcium folinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Leucovorin Calcium Injection presentations, 50 mg/5 mL and 300
mg/30 mL contain
calcium folinate equivalent to 50 mg and 300 mg folinic acid,
respectively.
DBL
™
Leucovorin Calcium Injection vial 50 mg/5 mL contains 10 mg of folinic
acid per mL.
DBL
™
Leucovorin Calcium Injection vial 300 mg/30 mL contains 10 mg of
folinic acid per
mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL™ Leucovorin Calcium Injection is a clear straw-to pale yellow
coloured sterile solution
of folinic acid in water for injection free from visible particular
matter.
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 good results in reducing the toxicity and
circumventing the effect
of folic acid antagonists, if therapeutically desired.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
In the treatment of accidental overdosage of folic acid antagonists,
e.g. methotrexate, DBL™
Leucovorin Calcium should be administered as promptly as possible. As
the time interval
between antifolate administration and DBL™ Leucovorin Calcium rescue
increases, DBL™
Leucovorin Calcium’s effectiveness in counteracting toxicity
diminishes.
Monitoring of serum methotrexate concentration is essential in
determining the optimal dose
and duration of treatment with DBL™ Leucovorin Calcium. Delayed
methotrexate excretion
may be caused by a third space fluid accumulation (i.e. ascites,
pleural effusion), renal
Version: hhpleuvi10120
Superse