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ADEC 205th meeting resolutions, 5-6 August 1999

Australian Drug Evaluation Committee

5 August 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 205th (1999/5) Meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 August 1999) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care, and the Secretary, Department of Health and Aged Care, that the following drugs should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

OROCHOL Recombinant live attenuated oral Vibrio cholerae CVD 103-HgR vaccine
2-10 x 108 colony forming units (CFU) of V. cholerae/dose
CSL Limited
Indications: For active immunisation against disease caused by V. cholerae 01, in travellers to endemic areas who are at high risk of infection, and who are aged two years or older.

CARDIOLITE Technetium Tc-99m Sestamibi kit for preparation of solution for injection
DuPont (Australia) Ltd
Indications: To include use as a diagnostic aid to assist in the evaluation of patients in whom mammography is inconclusive.

ASASANTIN SR Dipyridamole/aspirin sustained release combination capsules 200 mg/25 mg
Boehringer Ingelheim Pty Limited
Indications: For the secondary prevention of ischaemic stroke and transient ischaemic attacks.

SANDOSTATIN LAR Octreotide modified release injection 10 mg, 20 mg and 30 mg vials
Novartis Pharmaceuticals Australia Pty Ltd
Indications: For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment in patients who are adequately controlled on subcutaneous treatment with Sandostation. In acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. For the relief of symptoms associated with functional tumours of the gastroenteropancreatic endocrine system, including carcinoid tumours with features of the carcinoid syndrome, and Vasoactive Intestinal Peptide secreting tumours (VIPomas), in patients who are adequately controlled on subcutaneous treatment with Sandostatin.

RISPERDAL Risperidone tablets 1 mg, 2 mg, 3 mg, 4 mg and 6 mg, and oral solution 1 mg/mL
Janssen-Cilag Pty Ltd
Variation: To include an amended daily dosage regimen for the treatment of schizophrenia and related psychoses, up to a maximum dose of 8 mg daily.

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AROPAX 20/AROPAX 30 Paroxetine hydrochloride tablets 20 mg and 30 mg
SmithKline Beecham (Australia) Pty Ltd
Indications: To include treatment of social anxiety disorder/social phobia.

CAMPTOSAR Irinotecan hydrochloride concentrated solution for injection 40 mg/2 mL and 100 mg/5 mL vials
Pharmacia & Upjohn Pty Limited
Variation: To include an alternative dosage regimen of 300-350 mg/m2 every three weeks for the currently approved indications.

DUROGESIC Fentanyl transdermal patch 2.5 mg, 5.0 mg, 7.5 mg and 10.0 mg
Janssen-Cilag Pty Ltd
Indications: For the management of pain requiring chronic opioid analgesia.

MAXIPIME Cefepime hydrochloride powder for injection 500 mg, 1 G and 2 G vials
Bristol-Myers Squibb Australia Pty Ltd
Indications: To include use in paediatric patients aged from two months to twelve years for the treatment of the following infections when caused by susceptible bacteria: pneumonia; urinary tract infections, both complicated (including pyelonephritis) and uncomplicated; skin and skin structure infections; empiric treatment of febrile neutropenia; and treatment of septicaemia.

ALPHAGAN Brimonidine tartrate eye drops 2 mg/mL
Allergan Australia Pty Ltd
Indications: To include: "Alphagan eye drops are effective in lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension. Alphagan eye drops can be used in the treatment of glaucoma as either monotherapy or in combination with topical beta-blockers."

REBIF Interferon beta-1a (rch) solution for injection 22 µg/0.5 mL and 44 µg/0.5 mL in pre-filled syringes
Serono Australia Pty Ltd
Indications: For the treatment of relapsing-remitting multiple sclerosis and transitional multiple sclerosis.

SPORANOX Itraconazole oral solution 10 mg/mL
Janssen-Cilag Pty Ltd
Indications: To include prophylaxis of fungal infections in neutropenic patients. The recommended dose for this indication is 5 mg/Kg, administered as a twice daily dose, until recovery of the neutrophil count.

REGRANEX Becaplermin gel 100 µg/G in 15 G tube
Janssen-Cilag Pty Ltd
Indications: For the treatment of small neuropathic diabetic foot ulcers (<5 cm2) which have demonstrated adequacy of perfusion (see Clincial Trials).

SYNERCID Quinupristin/dalfopristin powder for injection 150 mg/350 mg vials
Rhone-Poulenc Rorer Australia Pty Ltd
Indications: For the treatment of suspected or proven methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus faecium infections requiring intravenous therapy, where other antibiotics are inappropriate.

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ZOCOR/LIPEX Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Merck Sharp & Dohme (Australia) Pty Limited/AMRAD Pharmaceuticals Pty Ltd
Variation: To include the following statement in the Product Information describing the effect of simvastatin in patients with combined hyperlipidaemia: "In a randomised, double-blind, 3-period crossover study, 130 patients with combined hyperlipidaemia (LDL-C>3.4mmol/L and TG: 7.7-18.1mmol/L) were treated with placebo, ZOCOR 40, and 80 mg/day for 6 weeks. In a dose-dependent manner ZOCOR 40 and 80 mg/day, respectively, decreased mean LDL-C by 29 and 36% (placebo: 2%) and median TG levels by 28 and 33% (placebo: 4%), and increased mean HDL-C by 13 and 16% (placebo: 3%) and apolipoprotein A-1 by 8 and 11% (placebo: 4%)."

IMODIUM ADVANCED Loperamide hydrochloride/simethicone chewable tablets 2 mg/125 mg
Janssen-Cilag Pty Ltd
Indications: For the treatment of acute diarrhoea with associated gas-related abdominal discomfort, in adults and children over 12 years of age.

QVAR Beclomethasone dipropionate CFC free metered dose inhaler 50 µg/actuation and 100 µg/actuation
3M Pharmaceuticals Pty Ltd
Indications: For the prophylactic management of asthma.

IMPLANON Etonogestrel subdermal implant 68 mg
Organon (Australia) Pty Limited
Indications: For use as a contraceptive agent. The implant should be removed and replaced every three years.

TIKOSYN Dofetilide capsules 125 µg, 250 µg and 500 µg
Pfizer Pty Limited
Indications: For the conversion to and maintenance of normal sinus rhythm in patients with persistent symptomatic atrial fibrillation or atrial flutter of more than one week's duration.

RECORMON Epoetin beta powder for injection 1000 U, 2000 U, 5000 U and 10,000 U
Roche Products Pty Limited
Indications: To include the prevention and treatment of anaemia in adult patients with solid tumours who are treated with platinum-based chemotherapy.

FLIXONASE Fluticasone propionate nasal drops 400 µg/unit dose
Glaxo Wellcome Australia Ltd
Indications: For the treatment of mild to moderate nasal polyps.

TICLID Ticlopidine hydrochloride tablets 250 mg
Syntex Australia Pty Limited
Indications: To include use as adjunctive therapy in the prophylaxis of cardiovascular events in coronary artery stenting.

NASONEX/RHINAX/UNICLAR Mometasone furoate monohydrate nasal spray 50 mg/actuation
Schering-Plough Pty Ltd
Indications: To include use in children aged 3-11 years, for the treatment of symptoms associated with seasonal and perennial allergic rhinitis, and the prophylaxis of seasonal allergic rhinitis.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

August 1999

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