Topotecan Accord 1mg/ml concentrate for solution for infusion

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Topotecan (as hydrochloride)

제공처:

Accord Healthcare Ireland Ltd.

ATC 코드:

L01XX; L01XX17

INN (국제 이름):

Topotecan (as hydrochloride)

복용량:

1 milligram(s)/millilitre

약제 형태:

Concentrate for solution for infusion

치료 영역:

Other antineoplastic agents; topotecan

승인 상태:

Marketed

승인 날짜:

2012-05-04

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN ACCORD 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
TOPOTECAN
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 Topotecan Accord is and what it is used for
2.
What you need to know before you are given Topotecan Accord
3.
How to use Topotecan Accord
4.
Possible side effects
5.
How to store Topotecan Accord
6.
Contents of the pack and other information
1.
WHAT TOPOTECAN ACCORD IS AND WHAT IT IS USED FOR
Topotecan Accord helps to destroy tumours. A doctor or a nurse will
give you the medicine as an
infusion into a vein in hospital.
Topotecan Accord 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 Accord is combined with another medicine
called cisplatin.
Your doctor will decide with you whether Topotecan Accord therapy is
better than further treatment
with your initial chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TOPOTECAN ACCORD
YOU SHOULD NOT RECEIVE TOPOTECAN ACCORD:
-
if you are allergic to topotecan or any of the other ingredients of
this medicine (listed in section 6).
-
if you are breast feeding
-
if your blood cell counts are too low. Your doctor will tell you
whether this is the case, based on
the results of your last blood test.
TELL YOUR DOCTOR
if any of these applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before you are given this
medicine:
-
if you have any kidney or liver problems. Your dose of Topotecan
Accord may need to be adjusted.
-
if you are p

제품 특성 요약

Health Products Regulatory Authority
28 June 2023
CRN00DF44
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topotecan Accord 1mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg topotecan
(as hydrochloride).
Each 1 ml vial of concentrate contains 1 mg topotecan (as
hydrochloride)
Each 4 ml vial of concentrate contains 4 mg topotecan (as
hydrochloride)
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear yellow colour solution free from visible foreign particles. pH
in the range of 1.5 to 2.5 and Osmolarity in the range of
approximately 100 to 40 mOsm/Litre
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. Topotecan
should only be administered under the supervision of a physician
experienced in the use of chemotherapy (see section 6.6).
POSOLOGY
When topotecan is 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 109/l and a haemoglobin level of ≥9 g/dl
(