FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats

Transcription

1 Date of change: 12 February 2004 Page: 1 of 12 Bottle, front panel READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats Active Constituent: 100 g/l TRICLABENDAZOLE For the treatment of susceptible Early Immature, Immature and Mature liver fluke (Fasciola hepatica) in sheep, cattle and goats. 0.8 L / 2.2 L / 5 L / 10 L / 15 L / 20 L

2 Date of change: 12 February 2004 Page: 2 of 12 Bottle, Back panel (0.8 L, 2.2 L, 5 L only) FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats READ INSTRUCTION LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE Restraint: DO NOT USE in lactating animals where milk or milk products may be used for human consumption. SHAKE WELL BEFORE USE ORAL DOSE RATE: SHEEP AND GOATS 1 ml per 10 kg BW CATTLE 6 ml per 50 kg BW Precaution: In areas where Black Disease is known to occur, adequate vaccination procedures are advised. WITHHOLDING PERIODS MEAT - 21 DAYS EXPORT SLAUGHTER INTERVALS: 63 days (sheep) 56 days (cattle) MILK - DO NOT USE IN LACTATING ANIMALS WHERE MILK OR MILK PRODUCTS MAY BE USED FOR HUMAN CONSUMPTION. See leaflet for full withholding period instructions. Protection of Livestock, Wildlife and Others Dangerous to fish. DO NOT contaminate dams, rivers or streams with the drench or used container. SAFETY DIRECTIONS Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after use. FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre (Ph: ). Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety Data Sheet. For a copy phone (1800) Disposal: Triple rinse containers before disposal and dispose of rinsate in a disposal pit away from desirable plants and their roots, and watercourses. On-site disposal of undiluted chemicals is unacceptable. Destroy empty containers by breaking, crushing, puncturing or shredding them where applicable. Dispose of the containers at a local authority landfill that does not burn its refuse. If there is no local authority landfill readily available in your area, bury the containers at a depth of 500 mm or more at a licensed/approved disposal site. In some States wastes can only be buried at a licensed landfill. DO NOT burn empty containers or product. Storage: Store below 30 o C (Room Temperature) in original container, tightly closed, in a cool dry place. Keep out of reach of children.

3 Date of change: 12 February 2004 Page: 3 of 12 (BW) kg Oral Dose (ml) Number of doses per pack Sheep and 0.8 L 2.2 L 5 L goats Up to ml/5 kg liveweight 11 to Over 75 1 ml/10 kg liveweight Treatment of sheep for liver fluke, roundworm, lungworm and tapeworm To treat sheep for roundworm, lungworm and tapeworm in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole) according to the instructions below. Treatment of sheep for roundworm, lungworm and tapeworm and control of selenium deficiency To treat sheep for roundworm, lungworm, tapeworm and control selenium deficiencies in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Plus Selenium Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole, 1 g/l selenium) according to the instructions below. Shake container of each product before mixing. Into an appropriately labeled plastic container, mix equal volumes of FASINEX 100 and COMBI drench (or COMBI Plus Selenium drench). Prepare only enough mixture for the required numbers of sheep to be treated (refer to table below). Use mixture within 7 days of preparing. Always remix thoroughly when using a previously prepared mixture and discard any mixtures older than 7 days. Dosage and administration Give 2 ml FASINEX 100/COMBI drench (or FASINEX/COMBI Plus Selenium drench) for every 10 kg bodyweight. Drench sheep orally, using an appropriate drench gun. FASINEX 100/COMBI drench mixture and FASINEX 100/COMBI Plus Selenium drench mixture kg Liver fluke, Roundworm Lungworm Tapeworm ml Liver fluke, Roundworm Lungworm Tapeworm + Selenium ml 11 to , , , , No. of sheep treated per 10 L of mixture

4 Date of change: 12 February 2004 Page: 4 of 12 Sheep in excess of 75 kg bodyweight should be dosed at 2 ml/10 kg bodyweight. PRECAUTIONS To avoid levamisole toxicity, exercise care in handling weak, pregnant and young animals to avoid unnecessary stress. Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching with a mixture. Recommended dose should not be exceeded except under veterinary supervision. DO NOT treat stressed or dehydrated sheep. (BW) kg Oral Dose (ml) Number of doses per pack Cattle 0.8 L 2.2 L 5 L Up to ml/10 kg liveweight Over ml/50 kg liveweight WARRANTY AND EXCLUSION OF LIABILITY This product is warranted fit for the purposes specifically recommended by Novartis Animal Health Australasia Pty Limited when used strictly as directed on this label. All other warranties and obligations or liabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that exclusion is permitted by law. APVMA Approval No /1002 Registered trademark of Novartis AG, Basel, Switzerland NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED A.C.N Waterloo Road NORTH RYDE NSW 2113 NOVARTIS CUSTOMER ASSISTANCE TOLL FREE from anywhere in Australia 8:30 am to 5:30 pm E.S.T. Monday to Friday. Batch Number Expiry Date

5 Date of change: 12 February 2004 Page: 5 of 12 Bottle, Back panel (10 L, 15 L and 20 L packs only) FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats DIRECTIONS FOR USE Restraint: DO NOT USE in lactating animals where milk or milk products may be used for human consumption. SHAKE WELL BEFORE USE ORAL DOSE RATE: SHEEP AND GOATS 1 ml per 10 kg BW CATTLE 6 ml per 50 kg BW (BW) kg Oral Dose (ml) Number of doses per pack Sheep and 10 L 15 L 20 L goats Up to ml/5 kg liveweight 11 to Over 75 1 ml/10 kg liveweight Treatment of sheep for liver fluke, roundworm, lungworm and tapeworm To treat sheep for roundworm, lungworm and tapeworm in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole) according to the instructions below. Treatment of sheep for roundworm, lungworm and tapeworm and control of selenium deficiency To treat sheep for roundworm, lungworm, tapeworm and control selenium deficiencies in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Plus Selenium Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole, 1 g/l selenium) according to the instructions below. Shake container of each product before mixing. Into an appropriately labeled plastic container, mix equal volumes of FASINEX 100 and COMBI drench (or COMBI Plus Selenium drench). Prepare only enough mixture for the required numbers of sheep to be treated (refer to table below). Use mixture within 7 days of preparing. Always remix thoroughly when using a previously prepared mixture and discard any mixtures older than 7 days. Dosage and administration Give 2 ml FASINEX 100/COMBI drench (or FASINEX/COMBI Plus Selenium drench) for every 10 kg bodyweight. Drench sheep orally, using an appropriate drench gun.

6 Date of change: 12 February 2004 Page: 6 of 12 FASINEX 100/COMBI drench mixture and FASINEX 100/COMBI Plus Selenium drench mixture kg Liver fluke, Roundworm Lungworm Tapeworm ml Liver fluke, Roundworm Lungworm Tapeworm, + Selenium ml 11 to , , , , , , ,330 No. of sheep treated per 20 L of mixture Sheep in excess of 75 kg bodyweight should be dosed at 2 ml/10 kg bodyweight. PRECAUTIONS To avoid levamisole toxicity, exercise care in handling weak, pregnant and young animals to avoid unnecessary stress. Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching with a mixture. Recommended dose should not be exceeded except under veterinary supervision. DO NOT treat stressed or dehydrated sheep. (BW) kg Oral Dose (ml) Number of doses per pack Cattle 10 L 15 L 20 L Up to ml/10 kg liveweight Over ml/50 kg liveweight Precaution: In areas where Black Disease is known to occur, adequate vaccination procedures are advised. General Instructions FASINEX 100 is a ready to use, free flowing aqueous suspension for the treatment and control of acute and chronic fascioliasis of sheep, cattle and goats. FASINEX 100 contains triclabendazole, a member of the benzimidazole family of drenches. It is effective against sensitive strains of Fasciola hepatica (liver fluke). Resistance may develop to any drench. FASINEX 100 when used at the recommended rate of 10 mg triclabendazole/kg for sheep, i.e. 1 ml FASINEX 100 per 10 kg bodyweight and 12 mg/kg for cattle, i.e. 6 ml per 50 kg bodyweight, is highly

7 Date of change: 12 February 2004 Page: 7 of 12 effective against susceptible early immature fluke as well as immature and adult fluke, and has a high safety margin. Ask your local veterinary practitioner or animal health adviser for recommended parasite management practices for your area to reduce development of resistance. It is advisable that a drench resistance test be conducted before any drench is used. WITHHOLDING PERIODS MEAT - DO NOT USE less than 21 days before slaughter for human consumption. EXPORT SLAUGHTER INTERVALS: 63 days (sheep) 56 days (cattle) MILK - DO NOT USE in lactating animals where milk or milk products may be used for human consumption. DO NOT USE less than 21 days before calving, lambing or kidding in cows, ewes or does where milk and milk products from treated animals may be used for human consumption. Where FASINEX 100 is accidentally given within this period or should any cows, ewes or does calve, lamb or kid earlier than 21 days after treatment, milk will contain residues. This milk must not be used for human consumption, or supplied for processing for at least 21 days following treatment. Calves fed this milk should not be slaughtered for human consumption within 10 days. Lambs or kids fed this milk should not be slaughtered for human consumption within 7 days. Protection of Livestock, Wildlife and Others Dangerous to fish. DO NOT contaminate dams, rivers or streams with the drench or used container. SAFETY DIRECTIONS Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after use. FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre (Ph: ). Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety Data Sheet. For a copy phone (1800) Disposal: Triple rinse containers before disposal and dispose of rinsate in a disposal pit away from desirable plants and their roots, and watercourses. On-site disposal of undiluted chemicals is unacceptable. Destroy empty containers by breaking, crushing, puncturing or shredding them where applicable. Dispose of the containers at a local authority landfill that does not burn its refuse. If there is no local authority landfill readily available in your area, bury the containers at a depth of 500 mm or more at a licensed/approved disposal site. In some States wastes can only be buried at a licensed landfill. DO NOT burn empty containers or product. Storage: Store below 30 o C (Room Temperature) in original container, tightly closed, in a cool dry place. Keep out of reach of children. WARRANTY AND EXCLUSION OF LIABILITY This product is warranted fit for the purposes specifically recommended by Novartis Animal Health Australasia Pty Limited when used strictly as directed on this label. All other warranties and obligations or liabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that exclusion is permitted by law. APVMA Approval No /1002 Registered trademark of Novartis AG, Basel, Switzerland

8 Date of change: 12 February 2004 Page: 8 of 12 NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED A.C.N Waterloo Road NORTH RYDE 2113 NOVARTIS CUSTOMER ASSISTANCE TOLL FREE from anywhere in Australia 8:30 am to 5:30 pm E.S.T. Monday to Friday. Batch Number Expiry Date

9 Date of change: 12 February 2004 Page: 9 of 12 Leaflet (0.8 L, 2.2 L, 5 L only; 10 L, 15 L and 20 L packs do not have a leaflet) READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY Complete directions for use inside - Read before using FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats Active Constituent: 100 g/l TRICLABENDAZOLE For the treatment of susceptible Early Immature, Immature and Mature liver fluke (Fasciola hepatica) in sheep, cattle and goats. General Instructions: SHAKE WELL BEFORE USE Precaution: In areas where Black Disease is known to occur, adequate vaccination procedures are advised. FASINEX 100 is a ready to use, free flowing aqueous suspension for the treatment and control of acute and chronic fascioliasis of sheep, cattle and goats. FASINEX 100 contains triclabendazole, a member of the benzimidazole family of drenches. It is effective against sensitive strains of Fasciola hepatica (liver fluke). Resistance may develop to any drench. FASINEX 100 when used at the recommended rate of 10 mg triclabendazole/kg for sheep, i.e. 1 ml FASINEX 100 per 10 kg bodyweight and 12 mg/kg for cattle, i.e. 6 ml per 50 kg bodyweight, is highly effective against susceptible early immature fluke as well as immature and adult fluke, and has a high safety margin. Ask your local veterinary practitioner or animal health adviser for recommended parasite management practices for your area to reduce development of resistance. It is advisable that a drench resistance test be conducted before any drench is used. WITHHOLDING PERIODS MEAT - DO NOT USE less than 21 days before slaughter for human consumption. EXPORT SLAUGHTER INTERVALS: 63 days (sheep) 56 days (cattle) MILK - DO NOT USE in lactating animals where milk or milk products may be used for human consumption. DO NOT USE less than 21 days before calving, lambing or kidding in cows, ewes or does where milk and milk products from treated animals may be used for human consumption. Where FASINEX 100 is accidentally given within this period or should any cows, ewes or does calve, lamb or kid earlier than 21 days after treatment, milk will contain residues. This milk must not be used for human consumption, or supplied for processing for at least 21 days following treatment. Calves fed this milk should not be slaughtered for human consumption within 10 days. Lambs or kids fed this milk should not be slaughtered for human consumption within 7 days.

10 Date of change: 12 February 2004 Page: 10 of 12 SAFETY DIRECTIONS Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after use. FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre (Ph: ). Disposal: Triple rinse containers before disposal and dispose of rinsate in a disposal pit away from desirable plants and their roots, and watercourses. On-site disposal of undiluted chemicals is unacceptable. Destroy empty containers by breaking, crushing, puncturing or shredding them where applicable. Dispose of the containers at a local authority landfill that does not burn its refuse. If there is no local authority landfill readily available in your area, bury the containers at a depth of 500 mm or more at a licensed/approved disposal site. In some States wastes can only be buried at a licensed landfill. DO NOT burn empty containers or product. Storage: Store below 30 o C (Room Temperature) in original container, tightly closed, in a cool dry place. Keep out of reach of children. Protection of Livestock, Wildlife and Others Dangerous to fish. DO NOT contaminate dams, rivers or streams with the drench or used container. Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety Data Sheet. For a copy phone WARRANTY AND EXCLUSION OF LIABILITY This product is warranted fit for the purposes specifically recommended by Novartis Animal Health Australasia Pty Limited when used strictly as directed in this leaflet. All other warranties and obligations or liabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that exclusion is permitted by law. APVMA Approval No /1002 Registered trademark of Novartis AG, Basel, Switzerland. Novartis Animal Health Australasia Pty Limited, ACN , 54 Waterloo Road, North Ryde 2113 NOVARTIS CUSTOMER ASSISTANCE TOLL FREE from anywhere in Australia 8:30 am to 5:30 pm E.S.T. Monday to Friday.

11 Date of change: 12 February 2004 Page: 11 of 12 Directions for Use Restraint: DO NOT USE in lactating animals where milk or milk products may be used for human consumption. Parasite Controlled (BW) kg Oral Dose (ml) No. treated per litre Liver Fluke Sheep and goats Up to ml/5 kg liveweight (Fasciola 11 to hepatica) Early Immature, Immature and Mature Over ml/5 kg liveweight Critical Comments 1. FASINEX 100 may be administered to lambs and kids, pregnant or lactating ewes and does or weak or debilitated animals. 2. Vaccination against Black Disease should be maintained. 3. FASINEX 100 does not stain wool. 4. Wash out equipment with water after use. 5. FASINEX 100 can be used at the same time as jetting with Vetrazin or dipping with Topclip dips, or most pour-on lousicides. 6. FASINEX 100 is palatable to sheep and goats. 7. Sheep in excess of 75 kg to be dosed at a rate of 1 ml per 10 kg of bodyweight. A representative sample of animals should be weighed before treatment. Dose rate to be based on heaviest animal (by liveweight) in each group (ewes, wethers, rams, lambs; does, bucks, kids). DO NOT underdose. Treatment of sheep for liver fluke, roundworm, lungworm and tapeworm To treat sheep for roundworm, lungworm and tapeworm in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole) according to the instructions below. Treatment of sheep for roundworm, lungworm and tapeworm and control of selenium deficiency To treat sheep for roundworm, lungworm, tapeworm and control selenium deficiencies in addition to liver fluke, mix FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats and COMBI Plus Selenium Oral Drench for Sheep and Lambs (34 g/l albendazole, 70 g/l levamisole, 1 g/l selenium) according to the instructions below. Shake container of each product before mixing. Into an appropriately labeled plastic container, mix equal volumes of FASINEX 100 and COMBI drench (or COMBI Plus Selenium drench). Prepare only enough mixture for the required numbers of sheep to be treated (refer to table below). Use mixture within 7 days of preparing. Always remix thoroughly when using a previously prepared mixture and discard any mixtures older than 7 days. Dosage and administration Give 2 ml FASINEX 100/COMBI drench (or FASINEX/COMBI Plus Selenium drench) for every 10 kg bodyweight. Drench sheep orally, using an appropriate drench gun.

12 Date of change: 12 February 2004 Page: 12 of 12 FASINEX 100/COMBI drench mixture and FASINEX 100/COMBI Plus Selenium drench mixture kg Liver fluke, Roundworm Lungworm Tapeworm ml Liver fluke, Roundworm Lungworm Tapeworm + Selenium ml 11 to , , , , No. of sheep treated per 10 L of mixture Sheep in excess of 75 kg bodyweight should be dosed at 2 ml/10 kg bodyweight. PRECAUTIONS To avoid levamisole toxicity, exercise care in handling weak, pregnant and young animals to avoid unnecessary stress. Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching with a mixture. Recommended dose should not be exceeded except under veterinary supervision. DO NOT treat stressed or dehydrated sheep. Parasite Controlled (BW) kg Oral Dose (ml) No. treated per litre Liver Fluke Cattle Up to ml/10 kg liveweight (Fasciola hepatica) Early Immature, Immature And Mature Over ml/50 kg liveweight Critical Comments 1. FASINEX 100 may be administered at the same time as animals are treated for lice. 2. FASINEX 100 may be administered to calves, pregnant cows or weak or debilitated animals. 3. Wash out equipment with water after use. 4. FASINEX 100 is palatable to cattle. 5. Cattle in excess of 650 kg should be dosed at 6 ml per 50 kg. A representative sample of animals should be weighed before treatment either with scales or a weighband. Dose rate to be based on heaviest cattle in each group (bulls, cows, steers, calves, etc.). DO NOT underdose. Where there is a larger variation in size within the group, draft into two or more lines based on bodyweight, to avoid excessive overdosing.