Calcium Folinate Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Calcium folinate pentahydrate 12.71 mg/mL equivalent to 10 mg/mL folinic acid

Available from:

Novartis New Zealand Ltd

INN (International Name):

Calcium folinate pentahydrate 12.71 mg/mL (equivalent to 10 mg/mL folinic acid)

Dosage:

10 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Calcium folinate pentahydrate 12.71 mg/mL equivalent to 10 mg/mL folinic acid Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 5 x 5mL amp pack, 25 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck & Cie

Therapeutic indications:

· As rescue therapy to reduce toxicity following high-dose methotrexate therapy. · 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 · Overdosage of methotrexate and in impaired methotrexate elimination · Reducing the toxicity and circumventing the effect of folic acid antagonists

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 5mL amp pack - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 10mL vial in single vial packs - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 30mL vial in single vial packs - 30 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 100mL vial in single vial packs - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2004-07-26

Patient Information leaflet

Calcium Folinate Ebewe
Calcium Folinate Ebewe_CMI_v2_Dec 2014
Page 1 of 3
CALCIUM FOLINATE EBEWE
CONSUMER MEDICINE INFORMATION LEAFLET
_Calcium Folinate Ebewe _
_(calcium folinate) _
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Calcium Folinate
Ebewe. 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 taking Calcium
Folinate Ebewe 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.
You may need to read it again.
WHAT CALCIUM FOLINATE
EBEWE IS USED FOR
Calcium Folinate Ebewe contains
calcium folinate. 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 reduce the toxic side
effects of some medications such
as methotrexate.
Calcium Folinate Ebewe may be
used for the management of other
conditions that are not mentioned
above. Your doctor will be able to
tell you about the specific condition
for which you have been prescribed
Calcium Folinate Ebewe.
_ _
Calcium Folinate Ebewe is not
addictive
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU
.
BEFORE YOU ARE GIVEN
CALCIUM FOLINATE
EBEWE
_When you must not be given _
_it _
_ _
YOU MUST NOT BE GIVEN CALCIUM
FOLINATE EBEWE IF YOU HAVE OR
HAVE HAD AN ALLERGY TO CALCIUM
FOLINATE EBEWE, FOLIC ACID, OR ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction to
Calcium Folinate Ebewe may
include:

shortness of breath,
wheezing or difficulty
breathing
�

Summary of Product characteristics

CALCIUM FOLINATE EBEWE DATA SHEET
Page 1 of 6
NAME OF THE MEDICINE
Calcium folinate injection
Composition_ _
_ACTIVE:_ Calcium folinate (equivalent to 10 mg folinic acid per mL)
_INACTIVE:_ Sodium chloride (7.7mg/mL), qs Water for Injections.
Preservative free.
The structural formula of calcium folinate is:
Molecular formula: C
20
H
21
CaN
7
O
7
CAS: 1492-18-8
DESCRIPTION
Calcium folinate is a white or light yellow, amorphous or crystalline
powder, sparingly
soluble in water and practically insoluble in acetone and ethanol.
Calcium folinate potency
is usually expressed in terms of equivalent units of folinic acid.
PHARMACOLOGY
Folinic acid is the formyl derivative of tetrahydrofolic acid (THF)
which is a metabolite and
active form of folic acid. It is effective in the treatment of
megaloblastic anaemia caused by
folic
acid
deficiency
and
is
a
potent
antidote
for
both
the
haematopoietic
and
reticuloendothelial toxic effects of folic acid antagonists, e.g.
methotrexate, pyrimethamine,
trimethoprim. In some cancers, folinic acid enters and 'rescues'
normal cells, in preference
to tumour cells, from the toxic effects of folic acid antagonists, due
to a difference in
membrane transport mechanism. This principle is applied in high dose
methotrexate
therapy with 'folinic acid rescue'.
_PHARMACOKINETICS _
Following administration, calcium folinate enters the body’s pool of
reduced folates. Peak
levels of total reduced folates are reached on average 10 minutes and
52 minutes
following intravenous and intramuscular administration, respectively.
It has been reported
that peak plasma levels of folinic acid are achieved 10 minutes and 28
minutes after
intravenous and intramuscular administration, respectively. Calcium
folinate is rapidly
converted in vivo to 5-methyl tetrahydrofolate (5-methyl-THF), the
active metabolite. 5-
methyl-THF becomes the major circulating form of the drug. Peak levels
of 5-methyl-THF
are observed at 1.3 and 2.8 hours following intravenous and
intramuscular administration.
(anhydrous calcium salt)