PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

pemetrexed disodium, Quantity: 1102.9 mg (Equivalent: pemetrexed, Qty 1000 mg)

Dostopno od:

Accord Healthcare Pty Ltd

INN (mednarodno ime):

pemetrexed disodium

Farmacevtska oblika:

Injection, powder for

Sestava:

Excipient Ingredients: mannitol; sodium hydroxide; hydrochloric acid

Pot uporabe:

Intravenous

Enote v paketu:

1 vial per carton

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell lung Cancer,Pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,Pemetrexed as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Povzetek izdelek:

Visual Identification: A white to either light yellow or greenish yellow lyophilized solid in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2015-05-28