Calcium Folinate Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Calcium folinate pentahydrate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrate, equivalent to 10 mg/mL folinic acid)

Available from:

Sandoz New Zealand Limited

INN (International Name):

Calcium folinate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrtae, equivalent to 10 mg/mL folinic acid)

Dosage:

1000 mg/100mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Calcium folinate pentahydrate 10.8 mg/mL (as 12.71 mg/mL of calcium folinate pentahydrate, equivalent to 10 mg/mL folinic acid) Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection

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: Vial, glass, - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2016-08-04

Patient Information leaflet

Calcium Folinate Sandoz
Calcium Folinate Sandoz _CMI_v4_Mar_2023
Page 1 of 3
CALCIUM FOLINATE SANDOZ
CONSUMER MEDICINE INFORMATION LEAFLET
_Calcium Folinate Sandoz _
_folinic acid (as calcium folinate) _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Calcium Folinate
Sandoz. 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 Sandoz 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
SANDOZ IS USED FOR
Calcium Folinate Sandoz contains
folinic acid (as 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 Sandoz 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 Sandoz.
_ _
Calcium Folinate Sandoz 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
SANDOZ
_When you must not be given _
_it _
_ _
YOU MUST NOT BE GIVEN CALCIUM
FOLINATE SANDOZ IF YOU HAVE OR
HAVE HAD AN ALLERGY TO CALCIUM
FOLINATE SANDOZ, FOLIC ACID, OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction to
Calcium Folinate Sandoz may
include:
•
shortness of b

Summary of Product characteristics

230320-calcium folinate sandoz-ds
Page 1 of 11
NEW ZEALAND DATA SHEET
CALCIUM FOLINATE SANDOZ (FOLINIC ACID) 10 MG/ML
1.
PRODUCT NAME
Calcium Folinate Sandoz 10 mg/mL; concentrate for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Calcium Folinate Sandoz, concentrate for injection contains
10 mg folinic acid (as
calcium folinate 10.8 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate for injection
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC 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.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSE IS EXPRESSED IN UNITS OF MG OF FOLINIC ACID.
(
_as Calcium folinate potency is usually _
_expressed in terms of equivalent units of folinic acid._
)
Calcium Folinate Sandoz may be administered by the intramuscular or
intravenous route.
Calcium Folinate Sandoz should not be administered intrathecally.
When required for intravenous infusion, folinic acid may be diluted
with either glucose 5%
intravenous infusion or sodium chloride 0.9% intravenous infusion to
give a final concentration
of 0.05 to 0.4 mg/mL. Further diluted solutions of folinic acid in
glucose 5% intravenous
infusion and sodium chloride 0.9% intravenous infusion are stable for
24 hours when stored
between 2ºC to 8ºC. To avoid microbial contamination hazards,
infusion should be commenced
as soon as practicable after preparation.
In the treatment of accidental overdose of folic acid antagonists e.g.
methotrexate, folinic acid
should be given as soon as possibl