Etopophos 100mg powder for solution for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Etoposide phosphate

Tilgængelig fra:

Neon Healthcare Ltd

ATC-kode:

L01CB01

INN (International Name):

Etoposide phosphate

Dosering:

100mg

Lægemiddelform:

Powder for solution for injection

Indgivelsesvej:

Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 08010400; GTIN: 5012712002192

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETOPOPHOS
™
100 MG POWDER FOR SOLUTION FOR INJECTION
Etoposide phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
-
This medicine has been prescribed for you only. 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
ETOPOPHOS
is and what it is used for
2.
What you need to know before you are given
ETOPOPHOS
3.
How you will be given
ETOPOPHOS
4.
Possible Side Effects
5.
How to store
ETOPOPHOS
6.
Contents of the pack and other information
1.
WHAT ETOPOPHOS IS AND WHAT IT IS USED FOR
The name of your medicine is ETOPOPHOS.
Each vial contains etoposide phosphate equivalent to etoposide 100 mg
as the active ingredient.
Etoposide phosphate belongs to a group of medicines called cytostatics
which are used in the treatment of
cancer.
ETOPOPHOS is used to in the treatment of certain types of cancer in
adults:
-
testicular cancer
-
small cell lung cancer
-
cancer of the blood (acute myeloid leukaemia)
-
tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s
lymphoma)
-
reproductive system cancers (gestational trophoblastic neoplasia and
ovarian cancer)
ETOPOPHOS is used in the treatment of certain types of cancers in
children:
-
cancer of the blood (acute myeloid leukaemia)
-
tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s
lymphoma)
The exact reason why you have been prescribed ETOPOPHOS is best
discussed with your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOPHOS
DO NOT RECEIVE ETOPOPHOS:
-
If you are allergic to etoposide or any of the other ingredients of
this medicine (listed in section 6).
-
If y

Produktets egenskaber

OBJECT 1
ETOPOPHOS 100MG POWDER FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 23-Oct-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
ETOPOPHOS 100mg Powder for Solution for Injection
2. Qualitative and quantitative composition
Each vial contains 113.6 mg etoposide phosphate equivalent to 100 mg
etoposide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection.
White to off-white dry powder.
4. Clinical particulars
4.1 Therapeutic indications
TESTICULAR CANCER
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of first line, recurrent or refractory testicular cancer in adults.
SMALL CELL LUNG CANCER
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of small-cell lung cancer in adults.
HODGKIN'S LYMPHOMA
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of Hodgkin's lymphoma in adult and paediatric patients.
NON-HODGKIN'S LYMPHOMA
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of non-Hodgkin's lymphoma in adult and paediatric patients.
ACUTE MYELOID LEUKAEMIA
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of acute myeloid leukaemia in adult and paediatric patients.
GESTATIONAL TROPHOBLASTIC NEOPLASIA
ETOPOPHOS is indicated for first line and second line therapy in
combination with other approved
chemotherapeutic agents for the treatment of high risk gestational
trophoblastic neoplasia in adults.
OVARIAN CANCER
ETOPOPHOS is indicated in combination with other approved
chemotherapeutic agents for the treatment
of non-epithelial ovarian cancer in adults.
ETOPOPHOS is indicated for the treatment of
platinum-resistant/refractory epithelial ovarian cancer in
adults.
4.2 Posology and method of administration
ETOPOPHOS should only be administered and monitored u