VINBLASTINE SULFATE 1 Mg/Ml Solution for Inj/Inf

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

VINBLASTINE SULFATE

Διαθέσιμο από:

Hospira UK Limited

Φαρμακολογική κατηγορία (ATC):

L01CA01

INN (Διεθνής Όνομα):

VINBLASTINE SULFATE

Δοσολογία:

1 Mg/Ml

Φαρμακοτεχνική μορφή:

Solution for Inj/Inf

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Vinca alkaloids and analogues

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1990-10-15

Φύλλο οδηγιών χρήσης

0004120-MC03
Black:
COMPONENT SPECIFICATION
Item number:
0004120-MC03
Request number:
PAR-2016-0004120
Country:
Ireland
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118 x 570 mm (20 panels)
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REQUESTER
PACKAGE LEAFLET: 
INFORMATION FOR THE USER
VINBLASTINE SULFATE 1 MG/ML SOLUTION FOR INJECTION OR INFUSION
Vinblastine Sulfate
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 Vinblastine Sulfate is and what it is used for
2.  Before you use Vinblastine Sulfate
3.  How to use Vinblastine Sulfate
4.  Possible side effects
5.  How to store Vinblastine Sulfate
6.  Contents of the pack and other information
1.  WHAT VINBLASTINE SULFATE IS AND WHAT IT IS USED FOR
Vinblastine Sulfate is an a

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vinblastine Sulfate 1mg/ml Solution for Injection or Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1.0 mg of Vinblastine Sulfate.
Each 10ml vial contains 10 mg of Vinblastine Sulfate.
Excipient(s) with known effect: Each 10ml vial contains approximately
35mg (1.5mmol) sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
A clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vinblastine Sulfate is used either alone or in combination with other
neoplastic agents, in the treatment of Hodgkin's
Disease (Stages III and IV); lymphocytic lymphoma (nodular and
diffuse, poorly and well differentiated); histiocytic
lymphoma; advanced stages of mycosis fungoides; advanced carcinoma of
the testis; Kaposi's sarcoma and Letterer-
Siwe disease (histocytosis X).
Vinblastine Sulfate may be used in the treatment of choriocarcinoma
resistant to other
chemotherapeutic agents; carcinoma of the breast, unresponsive to
appropriate endocrine surgery and hormonal
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IN CASE OF MISTAKEN ADMINISTRATION BY THE INTRATHECAL ROUTE, SEE
SECTION 4.4.
It is recommended to infuse Vinblastine Sulfate over 5 to 10 minutes
after dilution in Sodium Chloride 0.9% to a final
volume of 50 ml to 100 ml with a final concentration between 0.04 and
0.4mg/ml.
Alternatively, Vinblastine Sulfate may be injected directly into a
vein over about one minute.
Syringes containing this product should be overlabelled with the
warning label provided:
'FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'. DOSAGE
Vinblastine sulfate is given intravenously at weekly intervals
according to the needs of the patient.
Therapy is initiated
by a single intravenous dose in accordance with the following dosage
table, and white blood cell counts should be
made to determine the sensitivity of the patient to vinblastine.
FOR INTRAVENOUS USE ONLY.
FA