ABIPLATIN TEVA

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

CISPLATIN

から入手可能:

ABIC MARKETING LTD, ISRAEL

ATCコード:

L01XA01

医薬品形態:

CONCENTRATE FOR SOLUTION FOR INFUSION

構図:

CISPLATIN 1 MG/ML

投与経路:

I.V

処方タイプ:

Required

製:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

治療群:

CISPLATIN

治療領域:

CISPLATIN

適応症:

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.

承認日:

2014-08-31

製品の特徴

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