Topotecan 4mg powder for solution for infusion vials

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Topotecan hydrochloride

Beschikbaar vanaf:

Accord Healthcare Ltd

ATC-code:

L01XX17

INN (Algemene Internationale Benaming):

Topotecan hydrochloride

Dosering:

4mg

farmaceutische vorm:

Powder for solution for infusion

Toedieningsweg:

Intravenous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 08010500

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN 4 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Topotecan
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 further questions, ask your doctor, pharmacist or nurse.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
sign of illness are the same as yours
-
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.
IN THIS LEAFLET:
1. What Topotecan for Infusion is and what it is used for
2. Before you use Topotecan for Infusion
3. How to take Topotecan for Infusion
4. Possible side effects
5. How to store Topotecan for Infusion
6. Further information
1. WHAT TOPOTECAN FOR INFUSION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘
Topotecan 4 mg Powder for concentrate for solution for Infusion’ but
in the rest of the
leaflet it will be called “Topotecan for Infusion”.
WHAT TOPOTECAN FOR INFUSION IS:
Topotecan for Infusion
helps to destroy tumours. A doctor or a nurse will give you the
medicine as an infusion into a
vein (a drip) in hospital.
WHAT TOPOTECAN FOR INFUSION IS USED FOR:
Topotecan for Infusion is used to treat:
-
ovarian cancer or small cell lung cancer that has come back after
chemotherapy
-
advanced cervical cancer if surgery or radiotherapy treatment is not
possible. When treating cervical cancer,
Topotecan for Infusion is combined with another drug called cisplatin.
Your doctor will decide with you whether
Topotecan for Infusion therapy is better than further treatment with
your initial chemotherapy.
2. BEFORE YOU USE TOPOTECAN FOR INFUSION
YOU SHOULD NOT RECEIVE TOPOTECAN FOR INFUSION:
-
if you are allergic
(hypersensitive) to topotecan or any of the other ingredients of
Topotecan for Infusion
(listed
in section 6).
-
if you are breast feeding
-
if your blood cell counts are too low. Your doc

Productkenmerken

OBJECT 1
TOPOTECAN 4 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 15-Apr-2015 | Accord
Healthcare Limited
1. Name of the medicinal product
Topotecan 4 mg Powder for Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Each vial contains Topotecan Hydrochloride equivalent to 4 mg
Topotecan
Each ml of reconstituted solution contains 1 mg Topotecan
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
A Yellow powder.
4. Clinical particulars
4.1 Therapeutic indications
Topotecan monotherapy is indicated for the treatment of:
• patients with metastatic carcinoma of the ovary after failure of
first-line or subsequent therapy.
• patients with relapsed small cell lung cancer [SCLC] for whom
re-treatment with the first- line regimen
is not considered appropriate (see section 5.1).
Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the cervix recurrent
after radiotherapy and for patients with Stage IVB disease. Patients
with prior exposure to cisplatin
require a sustained treatment free interval to justify treatment with
the combination (see section 5.1).
4.2 Posology and method of administration
Method of administration
The use of topotecan should be confined to units specialised in the
administration of cytotoxic
chemotherapy and should only be administered under the supervision of
a physician experienced in the
use of chemotherapy (see section 6.6).
Topotecan must be reconstituted and further diluted before use (see
section 6.6).
Posology
When used in combination with cisplatin, the full prescribing
information for cisplatin should be
consulted.
Prior to administration of the first course of topotecan, patients
must have a baseline neutrophil count of
≥1.5 x 10
9
/l, and a platelet count of ≥100 x 10
9
/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if
necessary).
_OVARIAN AND SMALL CELL LUNG CARCINOMA_
_INITIAL DOSE _
The re