Prescribing Information

For full Prescribing Information, refer to the Professional Information Leaflet.

S4 ABITIG^® (250 mg Tablets). Reg no.: 51/21.12/0508. Each tablet contains 250 mg abiraterone acetate. Contains sugar: lactose monohydrate 164,75 mg per tablet. Contains sodium: 4,6 mg sodium per tablet — 18,4 mg sodium per daily dose.

S4 BOTIGEN^® 3,5 (Powder for Solution for Injection). Reg no.: 51/26/0163. Each vial contains 3,5 mg bortezomib (as a mannitol boronic ester). After reconstitution, 1 mL of solution for subcutaneous injection contains 2,5 mg bortezomib. After reconstitution, 1 mL of solution for intravenous injection contains 1 mg bortezomib. Contains sugar: 35 mg mannitol per vial.

S4 CAXETA^® 150 mg and 500 mg (Film-coated tablets). Reg. No: 47/26/1287 and 47/26/1288. Each film-coated tablet contains 150 mg and 500 mg capecitabine respectively. Contains sugar: lactose anhydrous 29,526 mg and 143,408 mg per tablet respectively.

S4 DOXOLIP (Concentrate for infusion). Reg. No.: 43/26/0018. Each vial contains 2 mg/1 mL doxorubicin hydrochloride in a pegylated liposomal formulation and delivers 10 mL (20 mg) in a concentrate for infusion for single intravenous use. Contains sugar: sucrose 100,00 mg/mL.

S4 GEMTAZ^® 1 g (Lyophilised Powder for Injection). Reg no.: 41/26/0933. Each vial contains gemcitabine hydrochloride equivalent to 1 g of gemcitabine (40 mg/mL). Contains sugar alcohol: 1 000 mg mannitol per vial.

RT-GEL Medical device: Class A. RT GEL (Non-sticky, soft opaque gel). Composition: Dimethicone, Cyclopentasiloxane, Polysilicone-11, Cyclomethicone, Stearyl alcohol, Polysorbate 80, Isohexadecane, Ammonium polyacryloyldimethyl taurate, Jojoba oil, Polysorbate 20, C12-15 Alkane, Dimethicone Crosspolymer, Stearoxytrimethylsilane, Tocopherol acetate.

S4 SUNMATIN^® 100 mg and 400 mg (Film-coated tablet). Reg no.: 44/26/0886 and 44/26/0887. Each film-coated tablet contains imatinib mesilate equivalent to 100 mg and 400 mg imatinib, respectively. Contains sugar: mannitol 100 mg and 400 mg per film-coated tablet, respectively.

S4 ZOBONE (Powder for solution for infusion). Reg no.: 42/34/0664. Each vial contains 4 mg zoledronic acid (as zoledronic acid monohydrate). Contains sugar alcohol: 220 mg mannitol per vial.

Applicant: Ranbaxy Pharmaceuticals (Pty) Ltd., a Sun Pharma company. Reg. No. 1993/003111/07. 14 Lautre Road, Stormill Ext.1, Roodepoort, 1724. Tel: +27 11 495 0100. www.sunpharma.com.

[ONCOLOGY/MAY26/DG/SM]