Leucovorine Sandoz 10 mg/ml, oplossing voor injectie

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

CALCIUMFOLINAAT, GEHYDRATEERD SAMENSTELLING overeenkomend met ; ; FOLINEZUUR

Available from:

Sandoz B.V.

ATC code:

V03AF03

INN (International Name):

CALCIUMFOLINAAT, HYDRATED COMPOSITION corresponding to ; ; folinic acid

Pharmaceutical form:

Oplossing voor injectie

Composition:

NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Administration route:

Intraveneus gebruik

Therapeutic area:

Calcium Folinate

Product summary:

Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Authorization date:

2017-02-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEUCOVORINE SANDOZ 10 MG/ML, OPLOSSING VOOR INJECTIE
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you are given [nationally completed name]
3.
How you are given [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR_ _
[Nationally completed name] is a solution containing the active
ingredient folinic acid in form of
calcium folinate, which is one of a group of medicines called
detoxifying agents.
[Nationally completed name] is used to reduce the side effects of
certain anticancer drugs or if too
much has been given in adults and children. [Nationally completed
name] works by acting against
drugs that work against folic acid such as methotrexate. This is
called "Calcium Folinate Rescue".
[Nationally completed name] may also be used in combination with
5-fluorouracil (another
anticancer drug).
Calcium Folinate Injection is also used to reduce the side effects of
other medicines (a
group of medicines called folic acid antagonists). Examples of folic
acid antagonists
are:

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY COMPLETED NAME]
YOU SHOULD NOT BE GIVEN [NATIONALLY COMPLETED NAME] IF YOU:
-
are allergic to calcium folin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Leucovorine Sandoz 10 mg/ml, oplossing voor injectie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution for injection/infusion contains 10 mg of folinic
acid provided as calcium folinate
hydrate.
_ _
Excipient(s) with known effect
Sodium (3.3 mg/ml)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, yellowish solution, practically free from turbidity and foreign
matter with pH of 7.0 - 8.6 and
osmolarity of 275 mOsm.
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
Posology
_Calcium Folinate Rescue in methotrexate therapy: _
Refer to the applied intermediate- or high-dose methotrexate protocol
for posology and method of
administration of calcium folinate. The methotrexate protocol will
dictate the dosage regimen of
Calcium Folinate Rescue because it depends heavily on the posology and
method of the intermediate-
or high-dose methotrexate administration.
The following guidelines may serve as an illustration of regimens used
in adults, elderly and children:
Calcium folinate rescue has to be performed by parenteral
administration in patients with
malabsorption syndromes or other gastrointestinal disorders where
enteral absorption is not assured.
Dosages above 25-50 mg should be given parenterally due to saturable
enteral absorption of calcium
folinate.
_ _
Calcium Folinate Rescue is necessary when methotrexate is given at
doses exceeding 500 mg/m
2
body
surface and has to be considered with doses of 100 mg – 500 mg/m
2
body surface.
Dosage and duration of use of Calcium folinate primarily depend on