Topotecan 4mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Topotecan hydrochloride

Available from:

Actavis UK Ltd

ATC code:

L01XX17

INN (International Name):

Topotecan hydrochloride

Dosage:

4mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5012617021410

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN ACTAVIS 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
TOPOTECAN ACTAVIS 4 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
topotecan
-
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 Topotecan Actavis is and what it is used for
2.
Before you use Topotecan Actavis
3.
How to use Topotecan Actavis
4.
Possible side effects
5.
How to store Topotecan Actavis
6.
Further information
1.
WHAT TOPOTECAN ACTAVIS IS AND WHAT IT IS USED FOR
Topotecan Actavis helps to kill tumour cells.
Topotecan Actavis is used to treat:
-
small cell lung cancer that has come back after chemotherapy
-
advanced cervical cancer if surgery or radiotherapy is not possible.
In this case Topotecan
Actavis treatment is combined with medicines containing cisplatin.
2.
BEFORE YOU USE TOPOTECAN ACTAVIS
DO NOT USE TOPOTECAN ACTAVIS
-
if you are allergic (hypersensitive) to topotecan or any of the other
ingredients of
Topotecan Actavis (listed in section 6 under ‘What Topotecan Actavis
contains’);
-
if you are breast-feeding. You should stop breast-feeding before
starting treatment with
Topotecan Actavis;
-
if your blood cell counts are too low.
TELL YOU DOCTOR
if you think any of these could apply to you.
TAKE SPECIAL CARE WITH TOPOTECAN ACTAVIS
Tell your doctor:
-
if you have any kidney problems. Your dose of Topotecan Actavis may
need to be adjusted.
Topotecan Actavis is not recommended in case of severe kidney
impairment;
-
if you have liver problems. Topotecan Actavis is not recommended in
case of severe liver
impairment;
-
if you suffer from lung inflammation with signs such as cough, fever
and difficulties in
breathing, see also section 4 “Possible side effects”.
Topotecan Actavis may cause a decr

Summary of Product characteristics

OBJECT 1
TOPOTECAN ACTAVIS 4 MG POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 26-Oct-2011 | Accord-UK Ltd
1. Name of the medicinal product
Topotecan Actavis 4 mg powder for concentrate for solution for
infusion
2. Qualitative and quantitative composition
Each vial contains 4 mg topotecan (as hydrochloride).
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Excipient: Each vial contains 2.07 mg sodium (0.09 mmol).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
Yellow lyophilisate.
4. Clinical particulars
4.1 Therapeutic indications
Topotecan monotherapy is indicated for the treatment of 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, a platelet count of ≥ 100 x 10
9
/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if
necessary).
_SMALL CELL LUNG CARCINOMA_
_Initial dose_
The recommended dose of topotecan is 1.5 mg/m
2
body surface area/day admi