Oralject P-BUTAZONE* PASTE ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES

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1 Draft Label: ORALJECT P-BUTAZONE * PASTE Page 1 of 13 (AUS/NZ) 30 ml syringe label Date Drafted : MAIN PANEL PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Oralject P-BUTAZONE* PASTE ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES Active constituent: Each 5 ml contains PHENYLBUTAZONE 1g Info pest Verified 30 ml INDICATIONS: As an aid in the treatment of musculo-skeletal conditions, and soft tissue swellings in horses where anti-inflammatory, antipyretic and analgesic activity would be beneficial. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: For best results, give paste 30 minutes prior to feeding. DOSAGE: Horses: 450 kg 10 ml (2 g PBZ) twice on first day as a loading dose, then 5 ml (1g PBZ) twice daily for 4 days, then 5 ml (1 g PBZ) daily or every alternate day as required. Ponies: 225 kg 5 ml (1 g PBZ) daily for 4 days, then 2.5 ml (½ g PBZ) daily, or every alternate day as required. ADMINISTRATION: Remove cap from nozzle. Turn ring to required dose setting which should be on the left of the ring. Insert nozzle into horse's empty mouth. Direct towards back of tongue, and depress plunger to deposit paste. Lift horse's chin and hold mouth closed for a few seconds to ensure that full dose is swallowed. Replace cap on nozzle. MEAT WITHHOLDING PERIOD: NOT TO BE USED in horses intended for human consumption. NRA 38761/1299- STORAGE: Store below 30 o C (room temperature). (B) EXP: Vetsearch International logo) Freecall Customer Service Line: VETSEARCH INTERNATIONAL PTY. LIMITED 6 LENTON PLACE, NORTH ROCKS, N.S.W. 2151, AUSTRALIA Prescription Animal Remedy (P.A.R) Class I for use only following a veterinary consultation. Licensed under the Animal Remedies Act 1967 No LICENSED TO: BOMAC LABORATORIES LTD WIRI STATION ROAD, MANUKAU CITY, AUCKLAND, NEW ZEALAND *Trademark

2 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 2 of 13 (AUS/NZ) 30 ml carton Date Drafted : MAIN PANEL PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Oralject P-BUTAZONE* PASTE (graphic) ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES Active constituent: Each 5 ml contains PHENYLBUTAZONE 1 g As an aid in the treatment of musculo-skeletal conditions and soft tissue swellings in horses. Vetsearch International (logo) 30 ml

3 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 3 of 13 (AUS/NZ) l30 ml carton SIDE PANEL 1 INDICATIONS: As an aid in the treatment of musculo-skeletal conditions, and soft tissue swellings in horses where anti-inflammatory, antipyretic and analgesic activity would be beneficial. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. DIRECTIONS FOR USE: For best results, give paste 30 minutes prior to feeding. DOSAGE: Horses: 450 kg 10 ml (2 g PBZ) twice on first day as a loading dose, then 5 ml (1 g PBZ) twice daily for 4 days, then 5 ml (1 g PBZ) daily or every alternate day as required. Ponies: 225 kg 5 ml (1 g PBZ) daily for 4 days, then 2.5 ml (½ g PBZ) daily, or every alternate day as required. RX. (Name of Horse) Administer ml daily for.day(s) Then...mL daily for.days (s) Then...mL as required Veterinarian

4 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 4 of 13 (AUS/NZ) 30 ml carton Date Drafted : SIDE PANEL 2 ADMINISTRATION: Remove cap from nozzle. Turn ring to required dose setting which should be on the left of the ring. Insert nozzle into horse s empty mouth. Direct towards back of tongue, and depress plunger to deposit paste. Lift horse s chin and hold mouth closed for a few seconds to ensure that full dose is swallowed. Replace cap on nozzle. MEAT WITHHOLDING PERIOD: NOT TO BE USED in horses intended for human consumption. VETSEARCH INTERNATIONAL PTY. LIMITED 6 LENTON PLACE, NORTH ROCKS, N.S.W. 2151, AUSTRALIA Freecall Customer Service Line: NRA 38761/1299 Dispose of empty syringe by wrapping in paper and placing in garbage. New print number Prescription Animal Remedy (P.A.R) Class I for use only following a veterinary consultation. Licensed under the Animal Remedies Act 1967 No Licensed to: BOMAC LABORATORIES LTD WIRI STATION ROAD, MANUKAU CITY, AUCKLAND, NEW ZEALAND STORAGE: Store below 30 o C (room temperature). (B) Exp: (graphic)

5 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 5 of 13 (AUS/NZ) 30 ml carton Date Drafted : BACK PANEL PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Oralject P-BUTAZONE* PASTE (graphic) ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES Active constituent: Each 5 ml contains PHENYLBUTAZONE 1 g As an aid in the treatment of musculo-skeletal conditions and soft tissue swellings in horses. Vetsearch International (logo) 30 ml

6 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 6 of 13 (AUS/NZ) 30mL carton Date Drafted: END FLAPS Oralject P-BUTAZONE* PASTE Vetsearch International (logo) BARCODE

7 print number Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 7 of ml and 1 Litre label Date Drafted : MAIN PANEL PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Oralject P-BUTAZONE* PASTE ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES Active constituent: Each 5 ml contains PHENYLBUTAZONE 1 g As an aid in the treatment of musculo-skeletal conditions and soft tissue swellings in horses. Vetsearch International (logo) 230 ml [1 Litre]

8 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 8 of ml and 1 Litre label Date Drafted : SIDE PANEL 1 INDICATIONS: As an aid in the treatment of musculo-skeletal conditions, and soft tissue swellings in horses where anti-inflammatory, antipyretic and analgesic activity would be beneficial. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. DIRECTIONS FOR USE: For best results, give paste 30 minutes prior to feeding. DOSAGE: Horses: 450 kg 10 ml (2 g PBZ) twice on first day as a loading dose, then 5 ml (1 g PBZ) twice daily for 4 days, then 5 ml (1 g PBZ) daily or every alternate day as required. Ponies: 225 kg 5 ml (1 g PBZ) daily for 4 days, then 2.5 ml (½ g PBZ) daily, or every alternate day as required. Administration: Stir contents before use. Withdraw required dose with syringe. Invert to expel air. Adjust to dose. Insert into side of horse's empty mouth. Direct to back of tongue and depress plunger to deposit paste. Lift horse's chin and hold mouth closed for a few seconds to ensure that full dose is swallowed. Reseal container after use. MEAT WITHHOLDING PERIOD: NOT TO BE USED in horses intended for human consumption. print number

9 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 9 of ml label Date Drafted : SIDE PANEL 2 (barcode) Vetsearch International (logo) VETSEARCH INTERNATIONAL PTY. LIMITED 6 LENTON PLACE, NORTH ROCKS, N.S.W. 2151, AUSTRALIA Freecall Customer Service Line: Dispose of empty container by wrapping in paper and placing in garbage. Store below 30 o C (room temperature). NRA 38761/1299 (B) Exp: *Trademark

10 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 10 of 13 1 Litre label Date Drafted : SIDE PANEL 2 (barcode) Vetsearch International (logo) VETSEARCH INTERNATIONAL PTY. LIMITED 6 LENTON PLACE, NORTH ROCKS, N.S.W. 2151, AUSTRALIA Freecall Customer Service Line: Recycle clean container. Store below 30 o C (room temperature). NRA 38761/1299 (B) Exp: *Trademark

11 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 11 of 13 (AUS/NZ) Date Drafted : PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Oralject P-BUTAZONE* PASTE ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES Active constituent: Each 5 ml contains PHENYLBUTAZONE 1 g Oralject P-BUTAZONE* paste a palatable oral paste formulation which provides a convenient and accurate oral dosage form of the widely used anti-inflammatory drug, Phenylbutazone BP. As an aid in the treatment of musculo-skeletal conditions and soft tissue swellings in horses, where antiinflammatory, anti-pyretic and analgesic activity would be beneficial. DIRECTIONS FOR USE: For oral administration only Do not administer to horses with a history of cardiac, hepatic or renal dysfunction, or when gastro-intestinal tract ulceration, or blood dyscrasias, are present or suspected. Discontinue therapy if signs of lethargy, colic, diarrhoea, inappetence, oral ulceration or vascular disorders, resulting in ventral oedema, occur during treatment. Studies have indicated that foals and pony breeds have reduced tolerance and greater risk of toxicity than the horse. (1,2) It is therefore important to adhere to the recommended dose rates for ponies. Therapy in ponies should be discontinued if no response is obtained after 4 to 5 days of treatment. For best results, give paste 30 minutes prior to feeding. DOSAGE: Horses: 450 kg 10 ml (2 g PBZ) twice on first day as a loading dose (8,8 mg/kg/day), then 5 ml (1g PBZ) twice daily for 4 days, then 5 ml (1 g PBZ) daily or every alternate day to maintain symptomatic relief (2.2 mg/kg/day). Ponies: 225 kg 5 ml (1 g PBZ or 4.4 mg/kg/day) daily for 4 days, then 2.5 ml (½ g PBZ or 2.2 mg/kg/day) daily, or every alternate day to maintain symptomatic relief. Operation of Dial-a-Dose 30 ml Syringe Remove cap from nozzle. Turn ring to required dose setting which should be on the left of the ring. Insert nozzle into horse s empty mouth. Direct towards back of tongue, and depress plunger to deposit paste. Lift horse s chin and hold mouth closed for a few seconds to ensure that full dose is swallowed. Replace cap on nozzle.

12 Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 12 of 13 (AUS/NZ) Date Drafted : Dose Withdrawal from 230 ml and 1 Litre Containers Stir contents before use. Insert the syringe nozzle into paste and withdraw the required dose. Invert to expel air. Adjust to dose. Scrape off the excess paste adhering to the outside of the syringe and nozzle onto inner edge of container. Insert nozzle into side of horse s empty mouth. Direct towards back on tongue, and depress plunger to deposit paste. Lift horse s chin and hold mouth closed for a few seconds to ensure that full dose is swallowed. Reseal container after use. Do not administer Oralject P-BUTAZONE Paste in conjunction with other drug therapy, as the risk of drug potentiation may be increased due to the strong blood protein binding capacity of phenylbutazone. Do not administer Oralject P-BUTAZONE Paste within 6 weeks prior to, or following, therapy with coumarin anticoagulants (eg WARFARIN), Significant decreases in total serum protein, albumin, plasma ph, viscosity and magnesium concentration, and increase in albumin: globulin ration have been associated with phenylbutazone therapy in horses. (1,3-6) Regular monitoring of total serum or plasma protein may provide an indication of the need to reduce dose levels or withdraw therapy, where long term continuous therapy is required to provide relief from chronic arthritis and other musculo-skeletal conditions. If a dose level exceeding 8.8 mg/kg/day is contemplated for more than four days in acute conditions, then close observation of clinical signs, and regular monitoring of plasma protein is advised. (7) MEAT WITHHOLDING PERIOD: NOT TO BE USED in horses intended for human consumption. Examples of use of Oralject P-BUTAZONE paste include:- - Acute joint and tendon synovitis, bursitis - Acute sprains of joints and ligaments, sprains of tendons. - Serous arthritis, and in conjunction with antibiotics in infective arthritis. - Control of soft tissue reaction following surgical procedures, including castration. - Control of inflammation following wounds, tissue bruising and abrasions. - As an aid in the relief of pain associated with acute and chronic arthritic conditions. - Anti-inflammatory analgesic therapy in the treatment of acute and chronic laminitis. STORAGE: Store below 30 o C (room temperature). 30 ml syringe replace cap after use. 230 ml bulk pot and 1 Litre pail stir contents before use. Reseal container after use. DISPOSAL: 30 ml syringe and 230 ml bulk pot dispose of empty syringe or bulk pot by wrapping in paper and placing in garbage. 1 Litre pail recycle clean container. NRA 38761/1299 PACK SIZES: 30 ml Dial-a-Dose oral syringe containing 6 x 5 ml (1g) doses. 230 ml Bulk Pot containing 46 x 5 ml (1g doses), with 10 ml oral dosage syringe attached. 1 Litre Pail containing 200 x 5 ml (1 g) doses. PRESENTATION: Pale green paste containing 1 g Phenylbutazone BP per 5 ml in a palatable apple flavoured base. Draft Label: ORALJECT P-BUTAZONE * PASTE Page: 13 of 13

13 (AUS/NZ) Date Drafted: References: 1) Snow, D.H. and Bogan, J.A. (1979) Phenylbutazone toxicity in ponies. Vet.Rec. 105, ) Traub, J.L., Gallina, A.M., Grant, B.D., Reed, S.M., Gavin, P.R., Paulsen, L.M. (1983) Phenylbutazone toxicosis in the foal. Am. J. Vet Res. 44, ) Snow, D.H., Douglas, T.A., Thompson, H., Parkins, J.J. and Holmes, P.H. (1981) Phenylbutazone Toxicosis in Equidae: A biochemical and patho-physiologic study. Am. J. Vet. Res. 42, ) MacAllister, C.G. (1983) Effects of toxic doses of Phenylbutazone in ponies. Am. J. Vet. Res ) MacKay, R.J., French, T.W., Nguyen, H.T. and Mayhew, I.G. (1983) Effects of large doses of phenylbutazone administration to horses. Am. J. Vet.Res. 44, ) Lees, P., Creed, R.F.S., Geering, E.E.L., Gould, P.W., Humphreys, D.J., Maitho, T.E., Michell, A.R. and Taylor, J.B. (1983) Biochemical and haematological effects of phenylbutazone in horses. Equine Vet. J. 15, ) Collins, L.G. and Tyler, D.E. (1984) Phenylbutazone toxicosis in the horse: A clinical study. J.Am.Vet.Med.Ass:184, Copyright 1986 Vetsearch International Pty Ltd *Trademark Vetsearch (logo) INTERNATIONAL VETSEARCH INTERNATIONAL PTY. LIMITED 6 LENTON PLACE, NORTH ROCKS, N.S.W. 2151, AUSTRALIA Freecall Customer Service Line: Prescription Animal Remedy (P.A.R) Class I for use only following a veterinary consultation. Licensed under the Animal Remedies Act 1967 No Licensed to: BOMAC LABORATORIES LTD WIRI STATION ROAD, MANUKAU CITY, AUCKLAND, NEW ZEALAND New print number

Copy in the header and footer will not appear on the final printed label LAB0042 Prepared: 28/02/01 SYRINGE LABEL

Copy in the header and footer will not appear on the final printed label LAB0042 Prepared: 28/02/01 SYRINGE LABEL SYRINGE LABEL PRESCRIPTION ANIMAL REMEDY FOR ANIMAL TREATMENT ONLY VibraVet* 100 PASTE For Cats and Dogs 100 mg/g DOXYCYCLINE as monohydrate Infopest Verified Antibiotic READ LEAFLET BEFORE USE 2.5 g 2.0