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ADEC 214th meeting resolutions, 8-9 February 2001

Australian Drug Evaluation Committee

8 February 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 214th (2001/1) meeting of the Australian Drug Evaluation Committee (ADEC) (8-9 February 2001) 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.

ACCUPRIL Quinapril hydrochloride
Tablets, 5 mg, 10 mg and 20 mg
Parke Davis Pty Ltd
Variation: Amendment of Product Information.

NAROPIN Ropivacaine hydrochloride
Sterile solution for injection, 2 mg/mL and 5 mg/mL in 10 mL and 20 mL ampoules
AstraZeneca Pty Ltd
Variation: New Indication and patient population to include analgesia (children aged 1-12 years) caudal epidural block, peripheral nerve block for peri- and post-operative pain management.

OP-1 IMPLANT Human osteogenic protein - 1, recombinant
Sterile powder for reconstitution for implantation, 1g per vial
Stryker Australia Pty Ltd
Indication: For the treatment of non-union of long bone fractures secondary to trauma for the purposes of initiating repair by new bone formation.

INTRAGLOBIN F Human immuglobulin normal
Sterile solution for intravenous injection, 50 mg/mL (5% solution) in 10 mL and 20 mL ampoules and 100 mL and 200 mL vials
MDA Pharma
Indication: For replacement therapy in primary immunodeficiency syndromes, myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and congenital AIDS with recurrent infections.

ZOMETA Zoledronic acid
Sterile powder for intravenous injection, 4 mg per vial
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For the treatment of tumour-induced hypercalcaemia.

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SERETIDE INHALER Salmeterol xinfoate/fluticasone propionate
Fixed dose combination, pressurised metered dose inhaler, 25 µg/50 µg, 25 µg/125 µg and 25 µg/250 µg per actuation
Glaxo Wellcome Australia Ltd
Variation: For the regular treatment of asthma, where the use of a combination product is appropriate. This may include patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids and patients who are symptomatic on current inhaled corticosteroid therapy.

FORADILE Eformoterol fumarate dihydrate
Capsules, containing powder for inhalation, 12 µg delivered by Aerolizer
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension ofIndications to include prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD).

CELLCEPT Mycophenolate mofetil
Capsules, 250 mg, tablets, 500 mg and oral suspension, 200 mg/mL
Roche Products Pty Limited
Variation: New Indication and new patient population to include for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

CAMPTOSAR Irinotecan hydrochloride
Sterile solution for intravenous injection, 20 mg/mL, in 2 mL and 5 mL ampoules
Pharmacia Australia Pty Limited
Variation: Extension ofIndications to include use as a component of first-line therapy of metastatic carcinoma of the colon or rectum.

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SOMATULINE LA Lanreotide acetate
Sterile powder for reconstitution for intramuscular injection, 40 mg
Ipsen Pty Limited
Indication: For the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who are dopamine agonist treatment refractory.

MEDROXYHEXAL Medroxyprogesterone acetate
Uncoated tablets, 10 mg
Hexal Australia Pty Ltd
Indication: For use in the treatment of visually-proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful.

  • Secondary amenorrhoea proven not due to pregnancy. In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate.
  • Abnormal uterine bleeding in the absence of organic pathology.
  • Adjunct to oestrogen therapy.

FEMOSTON 1/10 Oestradiol hemihydrate/dydrogesterone
14 tablets of oestradiol 1 mg and dydrogesterone 10 mg
Solvay Pharmaceuticals
Variation: For hormone replacement therapy in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. Prevention of postmenopausal bone mineral density loss in women.

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FEMOSTON-CONTI Oestradiol hemihydrate/dydrogesterone
28 combination tablets of oestradiol 1 mg and dydrogesterone 5 mg
Solvay Pharmaceuticals
Variation: Combination pack for hormone replacement therapy in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. Prevention of postmenopausal bone mineral density loss in women.

AGENERASE Amprenavir
Capsules, 50 mg and 150 mg and oral solution, 15 mg/mL
Glaxo Wellcome Australia Ltd
Indication: For use in combination with other antiretroviral agents for the treatment of protease inhibitor experienced HIV-1 infected adults and children aged four years and older.

PEG-INTRON Peg-interferon alfa-2b
Sterile powder for subcutaneous injection, 50 µg, 80 µg, 100 µg, 120 µg and 150 µg per vial
Schering-Plough Pty Ltd
Indication: For the treatment of chronic hepatitis C, in patients who have received no prior interferon therapy. Patients must be 18 years of age or older and have compensated liver disease. The optimal treatment for chronic hepatitis C is considered to be the administration of interferon alfa-2b with ribavirin.

TRIZIVIR Abacavir/lamivudine/zidovudine
Fixed combination tablets, abacavir sulfate 300 mg, lamivudine 150 mg, zidovudine 300 mg
Glaxo Wellcome Australia Ltd
Indication: For antiretroviral therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents over the age of 12 years. Trizivir should not be administered to adolescents who weigh less than 40 kg because it is a fixed-dose tablet, and the dose cannot be adjusted for this patient population.

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REMINYL Galantamine hydrobromide
Tablets, 4 mg, 8 mg and 12 mg and oral solution 4 mg/mL
Janssen-Cilag Pty Ltd
Indication: For the treatment of mild to moderately severe dementia of the alzheimer type.

CHIROCAINE Levobupivacaine hydrochloride
Sterile solution for injection, 2.5 mg/mL, 5 mg/mL and 7.5 mg/mL in 10 mL ampoules
Abbott Australasia Pty Ltd
Indication: Indicated for the following:

  1. In adults for:
    • surgical anaesthesia:
      • Major: epidural (including for caesarean section), intrathecal, peripheral nerve block.
      • Minor: local infiltration, oral, peribulbar block in ophthalmic surgery.
    • Pain management
      • Continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. For continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine.
  2. Levobupivacaine is indicated in children for:
    • greater than six months of age for infiltration analgesia (ilioinguinal/iliohypogastric blocks); and
  3. After careful consideration of alternative concentrations, the 7.5 mg/mL concentration of levobupivacaine may be considered for those procedures requiring a dense block with low volume. The 7.5 mg/mL concentration should not be considered for obstetric or paediatric use.

TOPAMAX Topiramate
Tablets, 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg and sprinkle capsules, 15 mg, 25 mg and 50 mg
Janssen-Cilag Pty Ltd
Variation: Lower starting dose and slower titration schedule. Titration should begin at 25-50 mg as a single (nightly) or divided dose for one week (or longer) and then increase by 25 to 100 mg/day as divided doses at weekly (or longer) intervals.

ZYPREXA / ZYPREXA ZYDIS Olanzapine
Zyprexa: tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg
Zyprexa Zydis: wafers, 5 mg, 10 mg, 15 mg and 20 mg
Eli Lilly Australia Pty Limited
Variation: Extension ofIndications to include the short-term treatment of acute manic episodes associated with Bipolar I disorder.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

26 February 2001

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