Cosmegen Lyovac 500microgram powder for solution for injection vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Dactinomycin

Fáanlegur frá:

Recordati Rare Diseases UK Ltd

ATC númer:

L01DA01

INN (Alþjóðlegt nafn):

Dactinomycin

Skammtar:

500microgram

Lyfjaform:

Powder for solution for injection

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08010200; GTIN: 3663502000410

Vara einkenni

OBJECT 1
COSMEGEN LYOVAC
Summary of Product Characteristics Updated 30-Apr-2014 | Orphan Europe
(UK) Limited
1. Name of the medicinal product
COSMEGEN
®
LYOVAC* 500 micrograms powder for solution for injection
2. Qualitative and quantitative composition
'Cosmegen' Lyovac is supplied as a yellow-orange, lyophilised powder,
in a vial containing 500
micrograms dactinomycin with 20 mg mannitol E421.
3. Pharmaceutical form
Lyophilised powder for solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
'Cosmegen' is a cytotoxic, antineoplastic antibiotic with
immunosuppressant properties.
'Cosmegen', as part of a combination chemotherapy and/or
multi-modality treatment regimen, is indicated
for the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's
sarcoma, and metastatic
nonseminomatous testicular cancer.
'Cosmegen' is indicated as a single agent, or as part of a combination
chemotherapy regimen, for the
treatment of gestational trophoblastic neoplasia.
'Cosmegen', as a component of regional perfusion in combination with
melphalan, is indicated for the
treatment of locally recurrent or locoregionally metastatic melanoma.
4.2 Posology and method of administration
Toxic reactions due to 'Cosmegen' are frequent and may be severe (see
4.8 'Undesirable effects'), thus
limiting the amount that may be administered in many cases. However,
the severity of toxicity varies
markedly and is only partly dependent on the dosage used.
Posology
_Intravenous use_
The dosage of 'Cosmegen' will vary with the tolerance of the patient,
the size and location of the
neoplasm, and the use of other forms of therapy. It may be necessary
to reduce the usual dosage
suggested below when additional chemotherapy or radiation therapy is
used concurrently or has been
employed previously.
The dosage of 'Cosmegen' is calculated in micrograms. The dose
intensity per-two-week cycle for adults
or children should not exceed 15 micrograms per kg per day or 400-600
micrograms per square meter of
body surface daily, intravenousl