MEKINIST trametinib (as dimethyl sulfoxide) 0.05 mg/mL powder for oral solution bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

trametinib dimethyl sulfoxide, Quantity: 0.0564 mg/mL (Equivalent: trametinib, Qty 0.05 mg/mL)

Disponible depuis:

Novartis Pharmaceuticals Australia Pty Ltd

forme pharmaceutique:

Solution, powder for

Composition:

Excipient Ingredients: sulfobutyl betadex sodium; sucralose; citric acid monohydrate; dibasic sodium phosphate; potassium sorbate; methyl hydroxybenzoate; Flavour

Mode d'administration:

Oral

Unités en paquet:

1

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Unresectable or metastatic melanoma,MEKINIST in combination with dabrafenib is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.,MEKINIST as a monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is intolerance to BRAF inhibitors or BRAF inhibitors cannot be used.,MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on BRAF inhibitor therapy (see section 5.1 Clinical Trials).,Adjuvant treatment of melanoma,MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.,Anaplastic thyroid cancer (ATC),MEKINIST in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.,Non-small cell lung cancer (NSCLC),MEKINIST in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.,Low-grade glioma,Mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 5.1 Clinical studies).,High-grade glioma,Mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 Clinical studies).

Descriptif du produit:

Visual Identification: white or almost white powder; Container Type: Bottle; Container Material: Glass Type III Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Registered