Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Folinic acid

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

V03AF; V03AF03

INN (International Name):

Folinic acid

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Detoxifying agents for antineoplastic treatment; calcium folinate

Authorization status:

Marketed

Authorization date:

2016-01-22

Patient Information leaflet

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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Folinic acid is and what it is used for
2.
What you need to know before you take Folinic acid
3.
How to take Folinic acid
4.
Possible side effects
5.
How to store Folinic acid
6.
Contents of the pack and other information
1.
WHAT FOLINIC ACID IS AND WHAT IT IS USED FOR
Folinic acid (as calcium folinate) 10 mg/ml solution for injection or
infusion contains Folinic acid, which is one of a group of medicine
called detoxifying agents. It is a calcium salt of folinic acid, which
is
related to the vitamin folic acid.
Folinic acid is used to:
-
reduce the harmful effects and treat overdose of certain
types of anti-cancer medicines for instance methotrexate
and other folic acid antagonists. This is known as “calcium
folinate rescue”.
-
treat cancer in combination with 5-fluorouracil (an anti-cancer
medicine). 5-fluorouracil works better when it is given
together with Folinic acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLINIC ACID
DO NOT TAKE FOLINIC ACID
-
if you are allergic to Folinic acid or any of the other
ingredients of this medicine (listed in section 6).
-
if you suffer from anaemia (not enough red blood cells)
caused by a lack of vitamin B
12
, such as:
•
pernicious anaemia (your immune systems fights your
red blood cells)
•
megaloblastic anaemia (your red blood cells are larger
than normal)
You should not be given Folinic acid together with certain anticancer
drugs if you are pregnant or breastfeeding (your doctor will know
which these are).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nur

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2023
CRN009KDL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folinic acid (as calcium folinate) 10mg/ml solution for injection or
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg of folinic acid provided as calcium folinate.
Each 5, 10, 20, 35, 50, 100 ml vial contains 50, 100, 200, 350, 500
and 1000 mg of folinic acid respectively (provided as calcium
folinate).
Excipient with known effect:
3.14 mg/ml to 3.20 mg/ml (0.14 mmol/ml) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, yellowish solution, free from visible particles.
pH: 6.5 – 8.5
Osmolality: 225-325 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium folinate is indicated
- to diminish the toxicity and counteract the action of folic acid
antagonists such as methotrexate in cytotoxic therapy and
overdose in adults and children. In cytotoxic therapy, this procedure
is commonly known as “Calcium Folinate Rescue”.
- in combination with 5-fluorouracil in cytotoxic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous and intramuscular administration only. In the case of
intravenous administration, no more than 160 mg of
calcium folinate should be injected per minute due to the calcium
content of the solution.
For intravenous infusion, calcium folinate may be diluted with 0.9%
sodium chloride solution or 5%
glucose solution before use. Refer also to sections 6.3 and 6.6.
POSOLOGY:
_Calcium folinate rescue in methotrexate therapy:_
Since the calcium folinate rescue dosage regimen depends heavily on
the posology and method of the intermediate- or
high-dose methotrexate administration, the methotrexate protocol will
dictate the dosage regimen of calcium folinate rescue.
Therefore, it is best to refer to the applied intermediate or high
dose methotrexate protocol for posology and method of
administration of calcium folinate.
The following guidelines