Cisplatin 50mg/50ml concentrate for solution for infusion vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Cisplatin

Inapatikana kutoka:

Sandoz Ltd

ATC kanuni:

L01XA01

INN (Jina la Kimataifa):

Cisplatin

Kipimo:

1mg/1ml

Dawa fomu:

Solution for infusion

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 08010500; GTIN: 5015915599049

Tabia za bidhaa

OBJECT 1
CISPLATIN 1MG/ML INJECTION BP
Summary of Product Characteristics Updated 30-Jul-2015 | Sandoz
Limited
1. Name of the medicinal product
Cisplatin 1mg/ml Injection BP
Cisplatin 1 mg/ml Concentrate for solution for infusion
2. Qualitative and quantitative composition
1 ml contains 1 mg cisplatin.
1 vial of 10 ml concentrate for solution for infusion contains 10 mg
cisplatin.
1 vial of 20 ml concentrate for solution for infusion contains 20 mg
cisplatin.
1 vial of 50 ml concentrate for solution for infusion contains 50 mg
cisplatin.
1 vial of 100 ml concentrate for solution for infusion contains 100 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 to yellowish solution.
4. Clinical particulars
4.1 Therapeutic indications
To be used as mono-therapy, or as part of an existing chemotherapy for
advanced or metastatic tumours:
testicular carcinoma (palliative and curative poly-chemotherapy) and
ovary carcinoma (stages III and IV),
and head and neck squamous-cell epithelioma (palliative therapy).
In the treatment of small cell lung carcinoma.
In the treatment of advanced non-small cell lung carcinoma.
4.2 Posology and method of administration
Cisplatin 1mg/ml concentrate for solution for infusion is to be
diluted before use (see section 6.6.).
The diluted solution should be administered only intravenously by
infusion (see below). 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.).
ADULTS AND CHILDREN:
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 and children. For recommendations on the
dosage applicable, based on the
diagnosis and the clinical condition, the current medical literature
s