ABIPLATIN 1 MGML

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

CISPLATIN

Commercializzato da:

SALOMON,LEVIN & ELSTEIN LTD

Codice ATC:

L01XA01

Forma farmaceutica:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composizione:

CISPLATIN 1 MG/ML

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

Area terapeutica:

CISPLATIN

Indicazioni terapeutiche:

Palliative therapy to be employed either alone, or more commonly in established combination therapy with orher approved chemotherapeutic agents and in patients with metastatic testicular tumor and metastatic ovarian tumor who have alreasy received appropriate surgical and/or radiotherapeutic procedures and in patients with advanced bladder cancer.

Data dell'autorizzazione:

2014-11-30

Scheda tecnica

ABIPLATIN 1 mg/ml MF 11/2019 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
ABIPLATIN 1 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
FOR I.V. INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
ABIPLATIN 1 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abiplatin 1 mg/ml concentrate for solution for infusion contains 1
mg/ml of cisplatin.
Excipient with known effect:
Each ml of solution contains 3.5 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, light yellow solution, essentially free from visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palliative therapy to be employed either alone, or more commonly in
established combination therapy
with other approved chemotherapeutic agents and in patients with
metastatic testicular tumor and
metastatic ovarian tumor who have already received appropriate
surgical
and/or radiotherapeutic
procedures and in patients with advanced bladder cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_General _
Abiplatin 1 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. For administration, any
device containing aluminium that may come in contact with cisplatin
(sets for intravenous infusion,
needles, catheters, syringes) must be avoided (see section 6.2.).
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration, whenever solution and container permit.
The cisplatin dosage depends on the primary disease, the expected
reaction, and on whether cisplatin is
used for monotherapy or as a component of combination chemotherapy.
The dosage directions are
applicable for both adults and children.
Abiplatin concentrate for solution for infusion does not contain any
antimicrobial preservative, and is
intended for single-dose administration only.
ABIPLAT