Folinic Acid (as Calcium Folinate) Solution for Injection 10mg/ml (5mL)

Kraj: Malta

Język: angielski

Źródło: Malta Medicines Authority

Składnik aktywny:

CALCIUM FOLINATE

Dostępny od:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

Kod ATC:

V03AF03

INN (International Nazwa):

CALCIUM FOLINATE 10 mg/ml

Forma farmaceutyczna:

SOLUTION FOR INJECTION

Skład:

CALCIUM FOLINATE 10 mg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

ALL OTHER THERAPEUTIC PRODUCTS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2006-12-27

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLINIC ACID (AS CALCIUM FOLINATE) 10 MG/ML SOLUTION FOR INJECTION
CALCIUM FOLINATE HYDRATE
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, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Folinic acid Solution for Injection is and what it is used for
2. What you need to know before you use Folinic acid Solution for
Injection
3. How to use Folinic acid Solution for Injection
4. Possible side effects
5. How to store Folinic acid Solution for Injection
6. Contents of the pack and other information
1.
WHAT FOLINIC ACID SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Folinic acid is one of the B group of vitamins.
Folinic acid Solution for Injection is used to reduce the side effects
of other medicines (a
group of medicines called folic acid antagonists). Examples of folic
acid antagonists are:
• methotrexate (a medicine often used to treat cancer)
• trimetrexate (an antibiotic and anti-cancer medicine)
• trimethoprim (an antibiotic)
• pyrimethamine (a medicine often used to treat malaria)
It may also be used to treat an overdose of these medicines.
Folinic acid Solution for Injection may also be used to increase the
effectiveness of the anti-
cancer medicine fluorouracil.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FOLINIC ACID SOLUTION FOR
INJECTION
FOLINIC ACID SOLUTION FOR INJECTION MUST NOT BE INJECTED INTRATHECALLY
(INTO THE SPINE).
DO NOT USE FOLINIC ACID SOLUTION FOR INJECTION
•

Charakterystyka produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Folinic Acid (as Calcium Folinate) 10 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 5 ml, 10 ml or 30 ml solution contains 10 mg/ml of
folinic acid provided as calcium
folinate hydrate.
Each 1 mg of folinic acid is equivalent to 1.08 mg of calcium folinate
hydrate.
Excipients with known effect:
Folinic Acid 50 mg/5 ml solution for injection contains 16.74 mg of
sodium in each 5 ml vial.
Folinic Acid 100 mg/10 ml solution for injection
contains 33.5 mg of sodium in each 10 ml vial.
Folinic Acid 300 mg/30 ml solution for injection
contains 100.5 mg of sodium in each 30 ml vial.
For the full list of excipients, see section 6.1
_. _
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear, straw to pale yellow solution free of particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium folinate is indicated
a)
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”;
b)
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
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the dosage regimen of calcium folinate rescue. Therefore, it is best
to refer to the