VINCRISTINE TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VINCRISTINE SULFATE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01CA02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

VINCRISTINE SULFATE 1 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS

Therapeutic group:

VINCRISTINE

Therapeutic area:

VINCRISTINE

Therapeutic indications:

Vincristine may be used either as sole agent or in combination therapy in the treatment of acute leukemias. Malignant lymphomas including Hodgkin's disease lymphosarcoma and reticulum cell sarcoma, neuroblastoma, Wilm's tumor, rhabdomyosarcoma.

Authorization date:

2015-02-28

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור ןכדועמ(
/102/50
)
_______ ךיראת
JANUARY 20, 2015
__
תילגנאב רישכת םש
םושירה רפסמו
VINCRISTINE SOLUTION FOR INJECTION
115 51 22790 05
םושירה לעב םש
SALOMON, LEVIN & ELSTEIN LTD. POBOX 3696, PETACH-TIKVA 49133
_
! דבלב תורמחה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRAINDICATIONS
in patients who are hypersensitive to
vincristine sulphate or to one of the
excipients;
in patients who are hypersensitive to active substance or
to any excipient listed in section 6.1 vincristine sulphate
or to one of the excipients;
POSOLOGY, DOSAGE & ADMINISTRATION
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
VINCRISTINE
FOR
INTRAVENOUS
USE
ONLY,
FATAL
IF
GIVEN
BY
OTHER
ROUTES’
Intrathecal
administration
of
vincristine
results
in
fatal
neurotoxicity.
‘
VINCRISTINE FOR INTRAVENOUS USE ONLY,
FATAL IF GIVEN BY OTHER ROUTES’ Intrathecal
administration
of
vincristine
results
in
fatal
neurotoxicity.
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER FORMS OF
INTERACTION
FERTILITY, PREGNANCY AND
LACTATION
ADVERSE EVENTS
_Nervous system disorders _
Not known: Leukoencephalopathy
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance
Any suspected adverse
of the medicinal product.
events should be reported to the Ministry of
Health according to the National Regulation
ne form
by using an onli
(http://forms.gov.il/globaldata/getsequence/ge
tsequence.aspx?formType=AdversEffectMedi
[e-mail]).

Summary of Product characteristics

Vincristine Teva NA 06/2023 Notification
1
Vincristine Teva
Solution for Injection
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vincristine Teva
Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 1 ml contains 1 mg of vincristine sulfate.
Each vial of 2 ml contains 2 mg of vincristine sulfate.
Each vial of 5 ml contains 5 mg of vincristine sulfate.
1 ml of solution contains 1 mg vincristine sulfate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.V. injection.
Clear colourless solution or slightly yellow solution, free of
particles other than gas bubbles.
The pH is 3.5 – 5.5 and osmolality is approximately 600 mOsm/l.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vincristine solution 1mg/ml may be used either as sole agent or in
combination therapy in the
treatment of acute leukaemia.
Malignant lymphomas including Hodgkin’s disease lymphosarcoma and
reticulum cell sarcoma,
neuroblastoma, Wilms' tumour, rhabdomyosarcoma.
4.2
Posology and method of administration
_ _
VINCRISTINE SULFATE SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.
FATAL IF GIVEN BY OTHER ROUTES
See section 4.4 Special warnings and precautions for use.
Posology
Extreme care must be used in calculating and administering the dose to
be injected, because
overdose can have severe and even fatal results. When used as
monotherapy, the dose should be
administered at 1 week intervals. In combination with other
antineoplastic agents, the dosing
frequency depends on the protocol.
The usual dose for adults is 1.4 mg/m² (maximum of 2 mg) once a week.
Children can tolerate a higher dose: 1.5-2.0 mg/m² once per week. For
children weighing 10 kg
or less, the usual starting dose is 0.05 mg/kg once a week.
Vincristine Teva NA 06/2023 Notification
2
Elderly
The normal adult dose is still appropriate in the elderly.
Hepatic impairment
In patients with hepatic impairment or with a direct serum bilirubin
value above 3 mg/100 ml a
reduction of 50% of the dose of vincristi