Vinblastine 10mg/10ml solution for injection vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Vinblastine sulfate

Tilgjengelig fra:

Pfizer Ltd

ATC-kode:

L01CA01

INN (International Name):

Vinblastine sulfate

Dosering :

1mg/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 08010400; GTIN: 5015997702252

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
VINBLASTINE SULPHATE 1 MG/ML INJECTION
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 or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Vinblastine Sulphate Injection is and what it is used for
2.
What you need to know before you use Vinblastine Sulphate Injection
3.
How to use Vinblastine Sulphate Injection
4.
Possible side effects
5.
How to store Vinblastine Sulphate Injection
6.
Contents of the pack and other information
1. WHAT VINBLASTINE SULPHATE INJECTIONS IS AND WHAT IT IS USED FOR
Vinblastine
sulphate
is
an
anti-cancer
medicine.
Treatment
with
an
anti-cancer
medicine is sometimes called cancer chemotherapy.
Vinblastine Sulphate Injection is sometimes used in the treatment of
cancers of the
lymph nodes, spleen, bone marrow, testicles, placenta, kidney and
breast. It may be
given alone or in combination with other anti-cancer medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINBLASTINE SULPHATE INJECTION
VINBLASTINE SULPHATE INJECTION MUST NEVER BE INJECTED INTRATHECALLY
(INTO THE
SPINE).
DO NOT USE VINBLASTINE SULPHATE INJECTION:
•
if you are allergic to vinblastine or to any of the other ingredients
of this
medicine (listed in section 6).
•
if you have a bacterial infection which is not under control
•
if your blood tests show that you do not have enough white blood cells
to fight
infection
Tell your doctor if any of the above applies to you before this
medicine is used.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Vinblastine Sulphate
Injection
•
if you are an elderly patient in poor health or with skin sores
•
if you have liver disease, including inflammation of the liver
(hepatitis) or
yellowing of your skin

Preparatomtale

OBJECT 1
VINBLASTINE SULPHATE 1 MG/ML INJECTION
Summary of Product Characteristics Updated 16-Aug-2016 | Hospira UK
Ltd
1. Name of the medicinal product
Vinblastine Sulphate 1 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml contains 1.0 mg of vinblastine sulphate.
Each 10 ml presentation contains 10 mg of vinblastine sulphate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
A clear, colourless sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Vinblastine sulphate is a cytotoxic drug that arrests cell growth at
the metaphase. Its actions are more
pronounced on the rapidly dividing cell than on the normal cell. It
appears to act, like vincristine, by
binding to the microtubular proteins of the mitotic spindle,
preventing polymerisation.
Information available at present suggests that vinblastine sulphate
may be useful, either alone or in
combination with other oncolytic drugs, for the treatment of:
Hodgkin's disease; non-Hodgkin's
lymphoma; carcinoma of the breast; methotrexate-resistant
choriocarcinoma; renal cell carcinoma;
testicular teratoma and seminoma; histiocytosis X. Other neoplasms
occasionally show a marked response
to vinblastine sulphate, but less frequently than the more susceptible
conditions listed above.
4.2 Posology and method of administration
METHOD OF ADMINISTRATION
The solution may be injected either directly into the vein or into the
injection site of a running intravenous
infusion. Injection of vinblastine sulphate may be completed in about
one minute.
FOR INTRAVENOUS USE ONLY.
FATAL IF GIVEN BY OTHER ROUTES (see Warnings)
IN CASE OF MISTAKEN ADMINISTRATION BY INTRATHECAL ROUTE, SEE SECTION
4.4.
Syringes containing this product should be overlabelled with the
intrathecal warning label provided -
'FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'.
POSOLOGY
The recommended dose for adults, the elderly and children is 6 mg/m
2
, usually administered no more
frequently than once every seven days. For