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ADEC 208th meeting resolutions, 10-11 February 2000

Australian Drug Evaluation Committee

10 February 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 208th (2000/1) meeting of the Australian Drug Evaluation Committee (ADEC) (10-11 February 2000) 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 medicines 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.

NAROPIN Ropivacaine hydrochloride
Solution for injection, 2 mg/mL, 7.5 mg/mL and 10 mg/mL
Astra Pharmaceuticals Pty Ltd
Variation: Extend the indications for Naropin to include: major nerve block, and epidural anaesthesia for caesarean section. Extend the duration of anaesthesia by epidural administration up to 72 hours. Increase the infusion rate and dose for thoracic epidural anaesthesia. Add "top-up" dosage recommendations for analgesia by lumbar epidural administration.

NAROPIN WITH FENTANYL Ropivacaine hydrochloride with fentanyl
Solution for injection, 2 mg/mL/2 m g/mL and 2 mg/mL/4 m g/mL
Astra Pharmaceuticals Pty Ltd
Variation: For the management of post-operative pain by epidural infusion for up to 72 hours.

LIPOBAY Cerivastatin sodium
Tablets 400m g
Bayer Australia Limited
Variation: For use as an adjunct to diet for the treatment of hypercholesterolaemia.

RHINOLAST Azelastine hydrochloride
Nasal Spray 0.1%
Asta Medica Australasia Pty Limited
Indication: For the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children aged five years and older.

OPTISON Octafluoropropane
Suspension for injection, 0.22 mg/mL
Mallinckrodt Australia Pty Ltd
Indication: For use in patients with inconclusive echocardiograms to opacify the left ventricle and improve delineation of the left ventricular endocardial borders.

DOTAREM Gadoteric acid
Injection solution, 279.32 mg/mL
Mallinckrodt Australia Pty Ltd
Indication: For use as a contrast agent to enhance signal intensity in magnetic resonance imaging for intracranial and spinal lesions with an abnormal blood brain barrier or abnormal vascularity, and in whole body imaging.

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XENICAL Orlistat
Capsules, 120 mg
Roche Products Pty Ltd
Indications: For the treatment of obese patients with a body mass index (BMI)³ 30, and overweight patients with a (BMI)³ 27 in the presence of other risk factors, in conjunction with a mildly hypocaloric diet.

VITRAVENE Fomivirsen sodium
Intravitreal injection, 1.65 mg/0.25mL
CIBA Vision Australia Pty Ltd
Indication: For the local treatment of cytomegalovirus retinitis (CMVR) in patients with Acquired Immunodeficiency Syndrome (AIDS) when other treatments have been ineffective or are considered unsuitable.

DYSPORT Clostridium botulinum type-A toxin haemagglutin complex
Intramuscular injection, 500 U
O'Shea and Associates
Indication: For the treatment of spasmodic torticollis.

EFEXOR-XR Venlafaxine hydrochloride
Modified release capsules, 75 mg and 150 mg
Wyeth Australia Pty Limited
Variation: For the treatment of generalised anxiety disorder.

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VALTREX Valaciclovir hydrochloride
Tablets 250 mg, 500 mg and 1000 mg
Glaxo Wellcome Australia Ltd
Variation: For the treatment and prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

PNEUMOVAX 23 Pneumococcal purified capsular polysaccharides
Injection, 25m g/0.5mL
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Amend the indications to include: all individuals over 65 years of age; individuals with asplenia; immunocompromised patients at increased risk of pneumococcal disease; Aboriginal and Torres Strait Islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness; and patients with cerebrospinal fluid leaks. Amend the product information to include statements regarding revaccination and listing patients in whom revaccination is recommended.

TEMODAL Temozolomide
Capsules, 5 mg, 20mg, 100 mg and 250 mg
Schering-Plough Pty Ltd
Variation: To include the treatment of metastatic melanoma.

NORDITROPIN SIMPLEXx Somatropin
Solution for injection, 5 mg, 10 mg and 15 mg in 1.5 mL
Novo Nordisk Pharmaceuticals Pty Ltd
Indication: For the treatment of growth failure in children due to pituitary growth hormone deficiency.

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WINRho SDF Immunoglobulin, anti-D Rho
Freeze-dried human immunoglobulin IgG, 600 IU anti-D (Rho) antibodies/vial
CSL Limited
Indication: For intravenous or intramuscular injection for the prevention of Rh sensitisation in Rho(D)-negative females at or below child bearing age.

AVAXIM Hepatitis A vaccine (inactivated)
160 antigen units/0.5 mL
CSL Limited
Indication: For active immunisation against hepatitis A infection in adults and children two years of age and older.

PROZAC Fluoxetine hydrochloride
Capsules 20 mg, tablets 20 mg and oral solution 20 mg/5mL
Eli Lilly Australia Pty Ltd
Variation: For the treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria(see Product Information).

SAIZEN Somatropin
Powder for injection, 4 IU and 10 IU/vial
Serono Australia Pty Ltd
Variation: For the treatment of growth failure in girls with Turner Syndrome.

PRO-EPANUTIN Fosphenytoin sodium
Solution for injection, 75 mg/mL
Parke-Davis Pty Ltd
Indicaton: For short-term parental administration when other means of phenytoin administration are unavailable, inappropiate or deemed less advantageous. The safety and effectiveness of fosphenytoin in this use has not been systematically evaluated for more then five days. Fosphenytoin can be used for the control of generalised convulsive status epileptus and prevention and treatment of seizures occurring in connection with neurosurgery and/or head trauma. It can be substituted, short-term, for oral phenytoin.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

10 March 2000

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