Gazette APVMA 8, 2 August 2005 page 11

NOTICE OF REGISTRATION OF AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following products, with effect from the dates shown.

VETERINARY CHEMICAL PRODUCTS

1. RESTRICTED PRODUCT:

“No Entries.”

2. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS:

“No Entries.”

3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Frusemide Injection Diuretic - Saluretic
Active Constituent/s: 50 mg/mL frusemide
Applicant Name: Phoenix Scientific Inc
Summary of Use: A loop diuretic and saluretic for the treatment and management of ascites, oedema, heart disease, and hypercalcaemia in dogs, cats, horses and cattle.
Date of Registration: 4 July 2005
Label Approval No: 58737/50mL/0505, 58737/100mL/0505

Product Name: RWR Calm-P Oily Injection
Active Constituent/s: 100 mg/mL hydroxy progesterone hexanoate
Applicant Name: RWR Veterinary Products Pty Ltd
Applicant ACN: 088 423 018
Summary of Use: A long-acting hydroxyprogesterone hexanoate injection for use in horses.
Date of Registration: 4 July 2005
Label Approval No: 59590/10ML/0405, 59590/50ML/0405

Product Name: Selcote Ultra Selenium Trace Element Pasture Treatment
Active Constituent/s: 10 g/kg selenium as sodium and barium selenate
Applicant Name: Crop Care Australasia Pty Ltd
Applicant ACN: 061 362 347
Summary of Use: For the treatment of selenium deficient soils every two years to protect against selenium deficiency in sheep, cattle, goats, horses and deer.
Date of Registration: 5 July 2005
Label Approval No: 59405/25KG/0105

Product Name: Allzyme PT
Active Constituent/s: xylanase (1,4-B-D-Xylan xylohydrolase) – Min. 600 XU/g derived from Aspergillus niger
Applicant Name: Alltech Biotechnology Pty Limited
Applicant ACN: 075 560 584
Summary of Use: A naturally occurring enzyme supplement for increasing the digestibilty of wheat, wheat by products, triticale or rye used in starter diets for poultry broilers and turkey poults.
Date of Registration: 5 July 2005
Label Approval No: 59090/25/0305

Product Name: Rovabio Excel AP
Active Constituent/s: 185 g/kg endo-1,3(4)-β-glucanase (2000 u/g [AGL]) and endo-1,4-β-xylanase (1400 u/g [AXC])
Applicant Name: Adisseo Australia Pty Limited
Applicant ACN: 098 527 247
Summary of Use: An enzyme mix to increase digestibility of pig and poultry feeds.
Date of Registration: 6 July 2005
Label Approval No: 59256/25/0505

Product Name: Abamectin Baymec LV Oral Drench for Sheep and Lambs
Active Constituent/s: 2 g/L abamectin
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For treatment and control of abamectin sensitive strains of internal parasites (including benzimidazole, levamisole and morantel resistant strains) of sheep itch mite and nasal bot on sheep.
Date of Registration: 6 July 2005
Label Approval No: 59094/2.2L/1004, 59094/4.4L/1004

Product Name: Drontal Allwormer Chewable for Large Dogs
Active Constituent/s: Each chew contains 174.4 mg pyrantel as pyrantel embonate, 175 mg praziquantel, 875 mg febantel
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of gastrointestinal worms and to control the shedding of oocycts of Giardia sp in large dogs.
Date of Registration: 6 July 2005
Label Approval No: 59290/50/0605

Product Name: Allzyme BG
Active Constituent/s: 650 BGU/g beta-glucanase (1,3-(1,3:1,4)-β-D-glucan 3(4)-glucanhydrolase) derived from Trichoderma viride
Applicant Name: Alltech Biotechnology Pty Limited
Applicant ACN: 075 560 584
Summary of Use: An enzyme supplement for increasing the digestibility of poultry and pig feeds.
Date of Registration: 6 July 2005
Label Approval No: 59255/25/0305

Product Name: Drontal Allwormer Chewable for Dogs
Active Constituent/s: Each chew contains 49.8 mg pyrantel as pyrantel embonate, 50 mg praziquantel, 250 mg febantel
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of gastrointestinal worms and to control the shedding of oocycts of Giardia sp in dogs.
Date of Registration: 6 July 2005
Label Approval No: 59291/80/0605

Product Name: Rovabio Excel LC2
Active Constituent/s: 134.4 g/L endo-1,3(4)-ß-glucanase (1000 u/mL [AGL]) and endo-1,4- ß –xylanase (700 u/mL [AXC])
Applicant Name: Adisseo Australia Pty Limited
Applicant ACN: 098 527 247
Summary of Use: Stockfeed enzyme to increase the digestibility of diets for poultry and pigs.
Date of Registration: 6 July 2005
Label Approval No: 58043/200L/0505, 58043/1000L/0505

Product Name: Panacur Equine Guard
Active Constituent/s: 100 g/L fenbendazole
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: For the treatment and control of small strongyle larvae (encysted inhibited third stage and encysted mucosal third and fourth stage) as well as immature and mature large strongyles, immature and mature benzimidazole-susceptible small strongyles, ascarids and pinworms in horses.
Date of Registration: 6 July 2005
Label Approval No: 58459/225ML/0604

Product Name: Ichonex by Aquasonic
Active Constituent/s: 0.60 mg/mL malachite green, 0.50 mg/mL copper as copper (II) sulfate
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: An ornamental aquarium antiseptic for the treatment of freshwater fish.
Date of Registration: 7 July 2005
Label Approval No: 57896/100mL/0704, 57896/250mL/0704, 57896/1L/0704

Product Name: Equis Shoo Fly Insecticidal Spray and Wash Concentrate for Horses
Active Constituent/s: 40 g/L permethrin (25:75::cis:trans)
Applicant Name: Mavlab Pty. Ltd.
Applicant ACN: 009 708 187
Summary of Use: For the control of pyrethroid sensitive flies: buffalo fly (Haematobia irritans exigua), stable fly (Stomoxys calcitrans) and biting insects (Culicoides spp.) on horses. An aid in the treatment of Queensland itch on horses.
Date of Registration: 7 July 2005
Label Approval No: 59243/125/0305, 59243/500/0305, 59243/5L/0305, 59243/20L/0305

Product Name: Value Plus Neutral-X Mild Diuretic and Urinary Buffer for Horses and Greyhounds
Active Constituent/s: 285 g/L sodium acid citrate
Applicant Name: C M Laboratories Pty Ltd
Applicant ACN: 098 897 637
Summary of Use: An oral solution for use in greyhounds and horses to aid in the prevention and treatment of muscle cramping and acidosis.
Date of Registration: 11 July 2005
Label Approval No: 59841/1L/0505, 59841/5L/0505, 59841/20L/0505

Product Name: Virbac Maxi-Trans Oral Rehydration Therapy
Active Constituent/s: 900 g/kg glucose, 20 g/kg potassium chloride, 40 g/kg sodium bicarbonate,
40 g/kg sodium chloride
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: Oral rehydration therapy for
cattle at risk of dehydration.
Date of Registration: 12 July 2005
Label Approval No: 59652/8KG/0405, 59652/25KG/0405

4.VARIATIONS

Product Name: Magik Spray-On Sheep Blowfly and Lice Treatment
Applicant Name: Novartis Animal Health Australasia Pty. Limited
Applicant ACN: 076 745 198
Summary of Variation: Approval of variation of claim to include treatment of unshorn lambs up to three months of age.
Date of Variation: 21 June 2005
Label Approval No: 58306/5L/0505, 58306/20L/0505, 58306/20L5L/0505

Product Name: Fasimec Cattle Pour-On Flukicide and Broad Spectrum Anthelmintic
Applicant Name: Ancare Australia Pty Limited
Applicant ACN: 076 252 241
Summary of Variation: Addition of 15L pack size to be used as anthelminthic pour-on for cattle.
Date of Variation: 30 June 2005
Label Approval No: 58971/15L/0205

Product Name: Vitapet Broad Spectrum All Wormer for Cats and Kittens
Applicant Name: Masterpet Australia Pty Limited
Applicant ACN: 000 333 353
Summary of Variation: Correction to product name from VITAPET SUPER ALL WORMER FOR CATS AND KITTENS to VITAPET BROAD SPECTRUM ALL WORMER FOR CATS AND KITTENS.
Date of Variation: 8 July 2005
Label Approval No: 58504/4/0904, 58504/6/0904

Product Name: Elanco AF0375 Surmax 100 Avilamycin Premix
Applicant Name: Elanco Animal Health A Div Of Eli Lilly Australia Pty Ltd
Applicant ACN: 000 233 992
Summary of Variation: Approval of extension of use of the product to aid in the prevention of necrotic enteritis due to Clostridium perfringens in broiler chickens.
Date of Variation: 11 July 2005
Label Approval No: 49376/25kg/0305

5.. RESTRICTED PRODUCT VARIATION

“No Entries.”