VINCRISTINE SULPHATE 1MG/ML SOLUTION FOR INJECTION OR INFUSION

Nchi: Kuprosi

Lugha: Kigiriki

Chanzo: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Viambatanisho vya kazi:

VINCRISTINE SULFATE

Inapatikana kutoka:

PFIZER HELLAS AE (0000003442) 243 MESSOGHION AVENUE, NEO PSYCHIKO, ATHENS, 15451

ATC kanuni:

L01CA02

INN (Jina la Kimataifa):

VINCRISTINE

Kipimo:

1MG/ML

Dawa fomu:

SOLUTION FOR INJECTION OR INFUSION

Tungo:

VINCRISTINE SULFATE (0000207863) 1MG

Njia ya uendeshaji:

INTRAVENOUS USE

Dawa ya aina:

Εθνική Διαδικασία

Eneo la matibabu:

VINCRISTINE

Bidhaa muhtasari:

Νομικό καθεστώς: Με Ιατρική Συνταγή

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
VINCRISTINE SULPHATE 1 MG/ML INJECTION
(1 mg/1 ml and 2 mg/2 ml vials)
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.

If you get any side effects, talk to your doctor. This includes any
possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Vincristine Sulphate Injection is and what it is used for
2.
What you need to know before you use Vincristine Sulphate Injection
3.
How to use Vincristine Sulphate Injection
4.
Possible side effects
5.
How to store Vincristine Sulphate Injection
6.
Contents of the pack and other information
1. WHAT VINCRISTINE SULPHATE INJECTION IS AND WHAT IT IS
USED FOR
Vincristine sulphate is an anti-cancer medicine. Treatment with an
anti-cancer
medicine is sometimes called cancer chemotherapy.
Vincristine Sulphate Injection is used in the treatment of cancers of
the blood (eg.
leukaemia or lymphomas), breast, head and neck or lung. It may be used
to treat
multiple myeloma (a cancer of plasma cells) and it may also be used in
the treatment
of some cancers in children. It may be used in a blood disorder known
as idiopathic
thrombocytopenic purpura (ITP) after other treatments have not been
successful.
Vincristine Sulphate Injection may be given alone or in combination
with other anti-
cancer medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINCRISTINE
SULPHATE INJECTION
VINCRISTINE SULPHATE INJECTION MUST NEVER BE INJECTED INTRATHECALLY
(INTO THE
SPINE).
DO NOT USE VINCRISTINE SULPHATE INJECTION

if you have shown signs of hypersensitivity (severe allergy) to
vincristine or
mannitol in the past

if you have Charcot-Marie-Tooth syndrome (disease which causes
weakness
in the leg muscles)

if you have an infection that is not being treated
Tell your doctor if any of the above applies to you before this
medicine i

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vincristine Sulphate 1 mg/ml Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1.0 mg of vincristine sulphate
Each 1 ml presentation contains 1 mg of vincristine sulphate
Each 2 ml presentation contains 2 mg of vincristine sulphate
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A sterile, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vincristine sulphate is used either alone or in conjunction with other
oncolytic drugs for the
treatment of:
1.
Leukaemias, including acute lymphocytic leukaemia, chronic lymphocytic
leukaemia,
acute myelogenous leukaemia and blastic crisis of chronic myelogenous
leukaemia.
2.
Malignant lymphomas, including Hodgkin's disease and non-Hodgkin's
lymphomas.
3.
Multiple myeloma.
4.
Solid tumours, including breast carcinoma, small cell bronchogenic
carcinoma, head and
neck carcinoma and soft tissue sarcomas.
5.
Paediatric solid tumours, including Ewing's sarcoma, embryonal
rhabdomyosarcoma,
neuroblastoma, Wilms' tumour, retinoblastoma and medulloblastoma.
6.
Idiopathic thrombocytopenic purpura. Patients with true ITP refractory
to splenectomy
and short-term treatment with adrenocortical steroids may respond to
vincristine but the
medicinal product is not recommended as primary treatment of this
disorder.
Recommended weekly doses of vincristine given for 3 to 4 weeks have
produced
permanent remissions in some patients. If patients fail to respond
after 3 to 6 doses, it is
unlikely that there will be any beneficial results with additional
doses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This preparation is for intravenous use only.
It should only be administered by
individuals experienced in vincristine administration.
Page 1 of 11
FOR INTRAVENOUS USE ONLY
FATAL IF GIVEN BY ANY OTHER ROUTE
See Section 4.4 Special warnings and precautions for use for the
treatment of patients given
intrathecal vincristine sulphate.
Vincristine sul