Vinblastine Sulfate 1mg/ml Solution for Injection or Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

VINBLASTINE SULFATE

Disponível em:

Pfizer Healthcare Ireland

Código ATC:

L01CA; L01CA01

DCI (Denominação Comum Internacional):

VINBLASTINE SULFATE

Dosagem:

1 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection/infusion

Tipo de prescrição:

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

Área terapêutica:

Vinca alkaloids and analogues; vinblastine

Status de autorização:

Marketed

Data de autorização:

1990-10-15

Folheto informativo - Bula

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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 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, pharmacist, or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vinblastine Sulfate is and what it is used for
2.
What you need to know 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 a vinca alkaloid which is an anti-cancer
medicine. Treatment with an anti-
cancer medicine is sometimes called cancer chemotherapy.
Vinblastine Sulfate is sometimes used in the treatment of cancers of
the lymph nodes, spleen, bone
marrow, testicles, ovaries, skin 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 SULFATE
VINBLASTINE SULFATE MUST NEVER BE INJECTED INTRAMUSCULARLY,
SUBCUTANEOUSLY OR INTRATHECALLY
(INTO THE SPINE). VINBLASTINE SULFATE IS FOR INTRAVENOUS USE ONLY.
DO NOT USE VINBLASTINE SULFATE
•
if you are allergic to vinblastine sulfate or any of the other
ingredients of this medicine (listed
in section 6).
•
if your blood tests show that you do not have enough white blood cells
to fight infection
(unless this is a result of your condition)
•
if you have a bacterial infection which is not under control
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using vinblastine
sulfate
•
if you are an elderly patient in poor health or with skin sores
•
if you have liver disease, inclu

Características técnicas

Health Products Regulatory Authority
13 October 2023
CRN00DT17
Page 1 of 10
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 vinblastine sulfate
Each 10 ml vial contains 10 mg of vinblastine sulfate
Excipient(s) with known effect:
Vinblastine Sulfate 1 mg/ml solution for injection or infusion
contains 35.42 mg sodium in each 10 ml vial.
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
FOR INTRAVENOUS USE ONLY.
FATAL IF GIVEN BY OTHER ROUTES (see section 4.4)
IN CASE OF MISTAKEN ADMINISTRATION BY THE INTRATHECAL ROUTE, SEE
SECTION 4.4.
Posology
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. Dosage should
not be increased after that dose which reduces the white
cell count to approximately 3000 cells/mm
3
.
Adults
mg/m
2
bsa
Children
mg/m
2
bsa
First Dose
3.7
2.5
Second Dose
5.5
3.75
Third Dose
7.4
5.0
Fourth Dose
9.25
6.25
Fifth Dose
11.1
7.5
Dosage increase may