ORCANTAS 20/8.19 trifluridine 20 mg/ tipiracil hydrochloride 9.420 mg (equivalent to tipiracil 8.19 mg) film-coated tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

trifluridine, Quantity: 20 mg; tipiracil hydrochloride, Quantity: 9.42 mg

Verfügbar ab:

Servier Laboratories (Aust) Pty Ltd

INN (Internationale Bezeichnung):

tipiracil hydrochloride,trifluridine

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: lactose monohydrate; macrogol 8000; stearic acid; pregelatinised maize starch; Carnauba Wax; titanium dioxide; iron oxide red; purified talc; hypromellose; Shellac; indigo carmine aluminium lake; iron oxide yellow; magnesium stearate

Verabreichungsweg:

Oral

Einheiten im Paket:

60 film-coated tablets, 20 film-coated tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Colorectal cancer ORCANTAS is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.,Gastric cancer ORCANTAS is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Produktbesonderheiten:

Visual Identification: Pale red, round, biconvex, immediate-release film-coated tablet imprinted with "20" on one side, and "102" and "20 mg" on the other side in grey ink.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2017-05-23