LEUCOVORIN TEVA TABLETS

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

CALCIUM FOLINATE

Disponible desde:

TEVA ISRAEL LTD

Código ATC:

V03AF

formulario farmacéutico:

TABLETS

Composición:

CALCIUM FOLINATE 16.2 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapéutico:

DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT

indicaciones terapéuticas:

Counteracts the action of folic acid antagonists. Improves blood picture in megaloblastic anemias due to folate deficiency.

Fecha de autorización:

2023-03-31

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
LEUCOVORIN TEVA TABLETS
Composition:
Each tablet contains:
Calcium folinate 16.2 mg (equivalent to 15 mg
folinic acid(
For information on inactive and allergenic ingredients
in the preparation, see section 2 “Important
information about some of the ingredients of the
medicine” and section 6 “Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment
of your ailment. Do not pass it on to others. It may
harm them even if it seems to you that their medical
condition is similar.
1. WHAT IS THIS MEDICINE INTENDED
FOR?
Leucovorin belongs to a group of medicines called
antidotes. Antidotes prevent damage caused by
other substances.
Leucovorin Teva Tablets is used:
• to improve anemia conditions caused by folic acid
deficiency
• to reduce the harmful effects of certain anti-cancer
medicines, that are folic acid antagonists
THERAPEUTIC GROUP:
Formylic derivative of tetrahydrofolic acid – a
metabolite of folic acid.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredient
or to any of the other ingredients contained in the
medicine.
• You are suffering from anemia due to a vitamin
B
12
deficiency (malignant anemia or certain types
of megaloblastic anemia(.
Consult a doctor or pharmacist if you need further
information.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH THE MEDICINE, TELL THE
DOCTOR IF:
You are being treated with methotrexate. Leucovorin
Teva Tablets should only be used after treatment with
methotrexate.
DRUG INTERACTIONS
IF YOU ARE TAKING, OR IF YOU HAVE RECENTLY TAKEN,
OTHER MEDICINES, INCLUDING NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPLEMENTS,

Ficha técnica

Leucovorin Teva Tablets 15mg SPC
Notification 06/2022 N.A
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Leucovorin Teva Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Calcium folinate 16.2mg (equivalent to 15mg folinic acid)
Excipient with known effect: Lactose 194.3 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
A standard convex tablet, almost white to cream with slight speckling.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To diminish the toxicity and counteract the action of folic acid
antagonists such as
methotrexate in cytotoxic therapy. Known as leucovorin rescue.
Amelioration of the blood picture in some megaloblastic anaemias due
to folate
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Calcium Folinate Rescue_
:
_Adults and Children_
: In general up to 120mg in divided doses over 12 - 24 hours
by intramuscular injection, bolus intravenous injection, or
intravenous infusion in
0.9% w/v sodium chloride solution followed by 12 - 15mg
intramuscularly or
15mg orally, every six hours for the next 48 hours.
Leucovorin Teva should not be given simultaneously with methotrexate
as it may
reduce or suppress its anti-neoplastic activity. It is recommended
that
administration should commence within the first 24 hours following
methotrexate.
In overdose situations or when the half-life of methotrexate is
increased (e.g.
renal function impairment or pleural or peritoneal effusions) it is
important that
Leucovorin Teva be given until the blood concentration of methotrexate
declines
to non-toxic concentrations. In these cases, doses of Leucovorin Teva
equal to or
greater than those of methotrexate should be given.
Leucovorin Teva Tablets 15mg SPC
Notification 06/2022 N.A
_Folinate deficiency: _
Adults:
_ _
15mg (one tablet) per day
_. _
Children up to 12 years: 0.25mg/kg/day
.
4.3 CONTRAINDICATIONS
Hypersensitivity to the preparation or active substance or to any of
the
excipient listed in sectio