Potactasol 1mg powder for concentrate for solution for infusion vials

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Topotecan hydrochloride

Dostupné s:

Actavis UK Ltd

ATC kód:

L01XX17

INN (Mezinárodní Name):

Topotecan hydrochloride

Dávkování:

1mg

Léková forma:

Powder for solution for infusion

Podání:

Intravenous

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08010500; GTIN: 5012617022448

Informace pro uživatele

Potactasol (Topotecan) All Strengths powder for concentrate for
solution for infusion PIL -
Central Procedure UK & Malta
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions: 130 x 450
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 22.12.14
supplier:
technically app. date: 08.12.105
min pt size: 8 pts
TECHNICAL APPROVAL
AAAH4943
4
22.12.14
R.Paul
11.02.15
R.Paul
Sindan
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 or nurse.
•
If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Potactasol is and what it is used for
2.
What you need to know before you use Potactasol
3.
How to use Potactasol
4.
Possible side effects
5.
How to store Potactasol
6.
Contents of the pack and other information
1.
WHAT POTACTASOL IS AND WHAT IT IS USED FOR
Potactasol contains the active substance topotecan
which helps to kill tumour cells.
Potactasol is used to treat:
•
ovarian cancer or small cell lung cancer that has
come back after chemotherapy
•
advanced cervical cancer if surgery or radiotherapy
is not possible. In this case Potactasol treatment is
combined with medicines containing cisplatin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
POTACTASOL
DO NOT USE POTACTASOL
•
if you are allergic to topotecan or any of the other
ingredients of this medicine (listed in section 6);
•
if you are breast-feeding. You should stop breast-
feeding before starting treatment with Potactasol;
•
if your blood cell counts are too low.
TELL YOU DOCTOR if you think any of these could apply
to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Potactasol:
•
if you have any kidney problems. Your dose of
Potactasol may nee

Charakteristika produktu

OBJECT 1
POTACTASOL 1MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 03-Aug-2015 | Accord-UK Ltd
1. Name of the medicinal product
Potactasol 1 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 1 mg topotecan (as hydrochloride).
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Excipient with known effect:
Each vial contains 0.52 mg (0.0225 mmol) sodium.
For the 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 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
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).
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).
_Ovarian and Small Cell Lung Carcinoma_
_Initial dose_
The recommended dose of topotecan is 1.5 mg/m
2
body surfac