Cisplatin-Asteria Inj. 50mg/50ml solution for i/v injection

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

cisplatin

Beschikbaar vanaf:

Hankook Korus Pharm Co.

ATC-code:

L01XA01

INN (Algemene Internationale Benaming):

cisplatin

Dosering:

1mg/ml

farmaceutische vorm:

solution for i/v injection

Eenheden in pakket:

50ml glass vial

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2017-06-22

Bijsluiter

COMPOSITION
Each vial contains
Active ingredients
Cisplatin
…………………………………………………………..
10mg/20mL
Cisplatin
…………………………………………………………..
50mg/50mL
Inactive ingredients
D-mannitol, sodium chloride, hydrochloride acid, sodium hydroxide,
water for injection
DESCRIPTION
Colorless, clear to pale yellow clear solution in vials.
INDICATIONS & USAGE
Cisplatin forms part of a group of medicines called cytostatics, which
are used in the treatment of cancer. Cisplatin can be used alone but
more commonly Cisplatin is used in combination with other cytostatics.
Cisplatin can destroy cells in your body that may cause certain types
of cancer (tumour of testis, tumour of ovary, tumour of the bladder,
head and neck epithelial tumour, lung cancer and for cervical cancer
in combination with radiotherapy)
ADMINISTRATION & DOSAGE
Cisplatin 1 mg/ml concentrate for solution for infusion is to be
diluted before administration. For instructions on dilution of the
product
before administration.
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.
_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 combination chemotherapy. The dosage directions are
applicable for both adults and children.
For monotherapy, the following two dosage regimens are recommended:
<< Single dose of 50 to 120 mg/m2 body surface every 3 to 4 weeks;
< 15 to 20 mg/m2/day for five days, every 3 to 4 weeks.
If cisplatin is used in combination chemotherapy, the dose of
cisplatin must be reduced. A typical dose is 20 mg/m2 or more once
every 3
to 4 weeks.
For treatment of cervical cancer cisplatin is used in combination with
radiotherapy. A typical dose is 40 mg/m2 weekly for 6 weeks.
Fo

Productkenmerken

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Cisplatin-Asteria Inj. 50mg/50mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/ vial
Use
1
Cisplatin
50mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/vial
Use
1
Sodium Chloride
47 5mg
Inactive
ingredient
2
D-mannitol
50mg
Inactive
ingredient
3
Hydrochloric acid
q.s
Inactive
ingredient
4
Sodium hydroxide
q.s
Inactive
ingredient
5
Water for injection
q.s
Inactive
ingredient
3. PHARMACEUTICAL FORM
Solution for i/v injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cisplatin forms part of a group of medicines called cytostatics, which
are used in the treatment
of cancer. Cisplatin can be used alone but more commonly Cisplatin is
used in combination
with other cytostatics.
Cisplatin can destroy cells in your body that may cause certain types
of cancer (tumour of testis,
tumour of ovary, tumour of the bladder, head and neck epithelial
tumour, lung cancer and for
cervical cancer in combination with radiotherapy)
Summary of Product Characteristics
4.2 Posology and method of administration
Cisplatin 1 mg/ml concentrate for solution for infusion is to be
diluted before administration.
For instructions on dilution of the product before administration.
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.
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 combination
chemotherapy. The dosage
directions are applicable for both adults and children.
For monotherapy, the following two dosage regimens are recommended:
<< Single dose of 50 to 120 mg/m2 body surface every 3 to 4 weeks;
< 15 to 20 mg/m2/day for five days, every 3 to 4 weeks.
If cisplatin is used in combination chemotherapy, the d