Irinotecan hydrochloride Injection 100 mg in 5 mL (11)

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Disponible depuis:

Pfizer (Perth) Pty Ltd

forme pharmaceutique:

Injection, concentrated

Composition:

Excipient Ingredients: sorbitol; water for injections; lactic acid

Mode d'administration:

Intravenous

Unités en paquet:

1 X 5 mL

Type d'ordonnance:

(S1) This Schedule is intentionally blank

indications thérapeutiques:

Irinotecan is indicated for single-agent or combination treatment of patients with: ? Metastatic carcinoma of the colon or rectum that has recurred or progressed following 5-flurouracil (5-FU) ? based therapy. ? Previously untreated metastatic carcinoma of the colon or rectum. ? Non-small cell lung cancer. ? Small cell lung cancer. ? Cervical cancer. ? Ovarian cancer. ? Inoperable or recurrent gastric cancer. ? Esophageal cancer. Irinotecan in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) ? expressing, KRAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease after failure of irinotecan including cytotoxic therapy. Irinotecan in combination with 5-FU, folinic acid (FA) and bevacizumab is indicated for first line treatment of patients with metastatic carcinoma of the colon or rectum. Irinotecan in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma. Irinotecan is indicated for single-agent treatment of patients with: ? Inoperable or recurrent breast cancer. ? Squamous cell carcinoma of skin. ? Malignant melanoma. ? Malignant lymphoma. ? Pancreatic cancer. ? Glioma.

Descriptif du produit:

Visual Identification: Clear, light yellow solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Listed (Export Only)

Date de l'autorisation:

2019-09-03