Vincristine 1mg/1ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vincristine sulfate

Available from:

Pfizer Ltd

ATC code:

L01CA02

INN (International Name):

Vincristine sulfate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010400; GTIN: 5015997707158

Patient Information leaflet

Page 1 of 7
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 thi

Summary of Product characteristics

OBJECT 1
VINCRISTINE SULPHATE 1 MG/ML INJECTION
Summary of Product Characteristics Updated 17-Mar-2017 | Hospira UK
Ltd
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 5ml presentation contains 5 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.
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.
Vincrist