Eldisine 5mg powder for solution for injection vials

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Vindesine sulfate

थमां उपलब्ध:

Genus Pharmaceuticals Ltd

ए.टी.सी कोड:

L01CA03

INN (इंटरनेशनल नाम):

Vindesine sulfate

डोज़:

5mg

फार्मास्यूटिकल फॉर्म:

Powder for solution for injection

प्रशासन का मार्ग:

Intravenous

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 08010400; GTIN: 5030451002716

सूचना पत्रक

#
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELDISINE *
(Vindesine Sulphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs of illness are the
same as yours.
-
If you get any side-effects talk to your doctor or pharmacist.
This includes any possible side-effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Eldisine is and what it is used for
2. What you need to know before you use Eldisine
3. How to use Eldisine
4. Possible side-effects
5. How to store Eldisine
6. Contents of the pack and other information
1. WHAT ELDISINE IS AND WHAT IT IS USED FOR
Eldisine contains vindesine sulphate. Eldisine is a cytotoxic
medicine. Cytotoxic medicines kill cells which are dividing,
including cancer cells. It is used to treat patients who have a
cancer such as leukaemia, malignant melanoma (a type of skin
cancer) or breast cancer. If your doctor gives you this medicine for
anything else, ask him or her if you have any questions.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELDISINE
DO NOT USE ELDISINE IF YOU:
•
are ALLERGIC to vindesine sulphate or any of the other ingredients
in Eldisine (see section 6 – Contents of the pack and other
information)
•
suffer from any disease affecting the nerves or muscles (such as
Charcot-Marie-Tooth syndrome)
•
have a bacterial infection.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Eldisine if you:
•
are having radiotherapy in the liver area
•
suffer from constipation
•
have liver trouble
OTHER MEDICINES AND ELDISINE
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
•
phenytoin for treating epilepsy
•
mitomycin
PREGNANCY, BREAST-FEEDING AND FERTILITY
Do not use Eldisine if you are pregnant or breast-feeding. If you

उत्पाद विशेषताएं

OBJECT 1
ELDISINE POWDER FOR SOLUTION FOR INJECTION 5MG
Summary of Product Characteristics Updated 26-Nov-2014 | Genus
Pharmaceuticals
1. Name of the medicinal product
Eldisine Powder for Solution for Injection 5.0 mg
2. Qualitative and quantitative composition
Eldisine Powder 5mg contains 5mg vindesine sulphate per 5ml when
reconstituted.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder for Solution for Injection
A clear glass vial containing a lyophilised plug of white crystalline
powder.
4. Clinical particulars
4.1 Therapeutic indications
Eldisine is an anti-neoplastic drug for intravenous use which can be
used alone or in combination with
other oncolytic drugs. Information available at present suggests that
Eldisine as a single agent may be
useful for the treatment of:
• acute lymphoblastic leukaemia of childhood resistant to other
drugs;
• blastic crises of chronic myeloid leukaemia;
• malignant melanoma unresponsive to other forms of therapy;
• advanced carcinoma of the breast, unresponsive to appropriate
endocrine surgery and/or hormonal
therapy.
4.2 Posology and method of administration
This preparation is for intravenous use only. It should be
administered only by individuals experienced in
vindesine administration.
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES
See special warnings in section 4.4 for the treatment of patients
given intrathecal vindesine sulphate
Extreme care must be used in calculating and administering the dose of
vindesine, since overdosage may
have a very serious or fatal outcome.
It is recommended that the drug be administered intravenously in a
single rapid bolus injection at weekly
intervals. The size of the dose is determined by body surface area. In
adults and the elderly, the
recommended starting dose is 3mg/m
2
, and children may be started at 4mg/m
2
. Thereafter, granulocyte
counts should be made prior to each subsequent dose to determine the
patient's sensitivity to the drug.
Provided there is no granulocytopenia or other toxic