Cisplatin Ebewe concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cisplatin

Available from:

EBEWE Pharma Ges. m.b.H. Nfg. KG

ATC code:

L01XA01

INN (International Name):

cisplatin

Dosage:

0,5mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

glass vial 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-06-05

Summary of Product characteristics

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PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Cisplatin Ebewe® concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg cisplatin (0.5 mg/ml).
1 vial with 20 ml solution contains 10 mg cisplatin.
1 vial with 50 ml solution contains 25 mg cisplatin.
1 vial with 100 ml solution contains 50 mg cisplatin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The concentrate is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisplatin Ebewe is used in adults, children and adolescents (0-18
years old).
Cisplatin Ebewe is indicated for the treatment of:
- advanced or metastatic testicular cancer
- advanced or metastatic ovarian carcinoma
- advanced or metastatic bladder carcinoma
- advanced or metastatic squamous cell carcinoma of the head and neck
area
- advanced or metastatic non-small cell lung carcinoma
- advanced or metastatic small cell lung carcinoma.
In the treatment of cervical carcinoma, cisplatin is indicated in
combination with
radiotherapy.
Cisplatin can be used as monotherapy and in combination therapy.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CISPLATIN EBEWE 0.5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION IS TO
BE DILUTED
BEFORE administration. For instructions on dilution of the product
before administration
see section 6.6.
The diluted solution should be administered only intravenously by
infusion (see below).
For administration, any device containing aluminium parts that may
come in contact
with cisplatin (sets for intravenous infusion, needles, catheters,
syringes) must be
avoided (see sections 4.4 and 6.2.).
POSOLOGY
ADULTS, CHILDREN AND ADOLESCENTS:
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The cisplatin dosage depends on the primary disease, the expected
reaction, and on
whether cisplatin is used for monotherapy or as a component of a
combination
chemotherapy. The dosage directions are applicable for both adults,
children and
adole