ABIPLATIN TEVA

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

CISPLATIN

Beschikbaar vanaf:

ABIC MARKETING LTD, ISRAEL

ATC-code:

L01XA01

farmaceutische vorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samenstelling:

CISPLATIN 1 MG/ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

Therapeutische categorie:

CISPLATIN

Therapeutisch gebied:

CISPLATIN

therapeutische indicaties:

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.

Autorisatie datum:

2014-08-31

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
ABIPLATIN TEVA
CONCENTRATE FOR SOLUTION FOR INFUSION
FOR I.V. INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Abiplatin Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abiplatin Teva 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 Teva 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 Teva concentrate for solution for infusion does not
contain any antimicrobial preservative, and is intended for
single-dose administration only.
In patients with renal dysfunction or bone marrow depressi