Vincristine Sulphate 1mg/ml Injection (2ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VINCRISTINE SULFATE

Available from:

Hospira UK Limited

ATC code:

L01CA02

INN (International Name):

VINCRISTINE SULFATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

VINCRISTINE SULFATE 1 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2007-05-07

Patient Information leaflet

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.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If any of the side effects gets serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Vincristine Sulphate Injection is and what it is used for
2.
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.
Further 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. 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 is used.
TAKE SPECIAL CARE WITH VINCRISTINE SULPHATE INJECTION

to make sure that this medicine is only given to you through a v

Summary of Product characteristics

Page 1 of 10
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 excipients, see 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 2 of 10
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 sulphate is a