Calcium Folinate Solution for Inj/Inf 10mg/ml (100ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM FOLINATE

Available from:

Fresenius Kabi Deutschland GmbH Else-Kroener Strasse 1, Bad Homburg v.d.H. 61352, Germany

ATC code:

V03AF03

INN (International Name):

CALCIUM FOLINATE 10.8 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

CALCIUM FOLINATE 10.8 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2016-02-26

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIUM FOLINATE 10 MG/ML, SOLUTION FOR INJECTION OR INFUSION
Folinic acid
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 Calcium Folinate is and what it is used for
2.
What you need to know before you take Calcium Folinate
3.
How to take Calcium Folinate
4.
Possible side effects
5.
How to store Calcium Folinate
6.
Contents of the pack and other information
1.
WHAT CALCIUM FOLINATE IS AND WHAT IT IS USED FOR
Calcium Folinate 10 mg/ml, Solution for Injection or Infusion contains
calcium folinate, 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.
Calcium Folinate 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 Calcium Folinate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM FOLINATE
DO NOT TAKE CALCIUM FOLINATE
-
if you are allergic to calcium folinate 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 Calcium Folinate together with certain
anticancer drugs if you are pregnant
or breast-feeding (your doctor will know which thes

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcium Folinate 10 mg/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%
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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 may serve as an illustration for a calcium
folinate rescue