DEPOSEL Slow Release Selenium Injection for Cattle and Sheep

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1 Date of change: 21 October 2004 Page: 1 of 9 Carton (front panel). POISON KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY DEPOSEL Slow Release Selenium Injection for Cattle and Sheep Active ingredient: Selenium 50 mg/ml (as barium selenate) For the prevention and treatment of selenium deficiency in sheep and cattle. Provides an elevation in blood selenium status of sheep for up to 24 months. Provides an elevation in blood selenium status of cattle for up to 12 months ml [200 ml, 500 ml, 1 L]

2 Date of change: 21 October 2004 Page: 2 of 9 Carton (Rear panel) DEPOSEL Slow Release Selenium Injection for Cattle and Sheep DIRECTIONS FOR USE Restraint: DO NOT USE in lactating sheep where milk or milk products may be used for human consumption. Contraindications. This product is contraindicated for use by intra-muscular injection. This may cause a serious reaction. To ensure that this does not occur, administer the product only by subcutaneous injection high on the neck behind the ear. About a week after injection, a lesion may have formed at the injection site. Such lesions usually diminish over time, but may last up to 3 months or longer. To avoid potential toxicity, this product is contraindicated for use in flocks or herds being treated with additional selenium sources (selenised vaccine, pellets, fertiliser, oral drench or other injectable products) or grazing pasture known to be high in selenium or where selenium accumulating plants are known to occur. Precautions Only use in flocks or herds which are selenium deficient. Determine selenium status of the flock or herd prior to treatment. If in doubt as to the selenium status of the animals, consult your veterinarian or State Agricultural Authority. DO NOT exceed stated dose or frequency as there is no specific antidote. Take care when handling weak or pregnant animals to avoid unnecessary stress. During the early part of pregnancy, accurate dosing is important and particular care should be taken to avoid overdosing. Read EXPORT TRADE ADVICE before using this product Dosage and administration 1 ml per 50 kg bodyweight, equivalent to 1 mg selenium per kg, by subcutaneous injection high on the neck behind the ear. Raise the skin into a tent and insert needle parallel to the body, ensuring injection is placed UNDER THE SKIN and not into the muscle. Refer to graphic on the side of the carton. To achieve correct injection, it is recommended that cattle are packed tightly into a race with access gained from the side. Attempting correct injection with the animal in a cattle crush is discouraged due to the difficulty and danger in accessing the neck area and correctly delivering the injection. The following table is intended as a guide: Lambs at weaning 0.5 ml Adult sheep 1 ml Cattle Dose (ml) Weight 50 to 100 kg 0.2 ml/10 kg bodyweight kg kg kg kg kg 10 >500 kg 2 ml/100 kg bodyweght When treating a large number of animals, a suitable multiple dose injector must be used. Shake pack well before use to ensure re-suspension of contents. Do not leave product in gun.

3 Date of change: 21 October 2004 Page: 3 of 9 The frequency of dosing should be related to the severity of the deficiencies. Product will last for up to 24 months in sheep and up to 12 months in cattle. Check selenium status of animals before retreating. Consult your animal health adviser for advice specific to your flock or herd. Caution: Avoid Carcass Damage 1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus. 2. Maintain cleanliness at all times. 3. Keep needles sharp and clean. Replace frequently. 4. Use shortest needle possible, certainly not exceeding 15 mm. 5. Avoid injection of animals during wet weather or under dusty conditions as far as possible. 6. This product must be injected only under the skin. 7. Inject high on the neck behind the ear. 8. DO NOT administer by intramuscular injection WITHHOLDING PERIODS MEAT: NIL MILK (Cattle): NIL. (Sheep): DO NOT USE in lactating animals where milk or milk products may be used for human consumption. EXPORT TRADE ADVICE - TREATED STOCK Export Slaughter Interval (ESI): Not required when DEPOSEL is used as directed (subcutaneous injection), as visible injection site deposits are trimmed from the carcass at slaughter. Note: Some export markets employ x-ray screening technology which will detect radio-opaque substances such as barium selenate. Incorrect application of DEPOSEL could result in injection site residues not being trimmed at slaughter leading to detection and a potential risk to meat export. Carton (side panel 1) FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre (Ph: ). If skin contact occurs, remove contaminated clothing and wash skin thoroughly. Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety Data Sheet. For a copy phone Disposal Dispose of empty containers and packaging by wrapping in paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labeled sharps container. Storage Store below 25 C (air conditioning) in original container, tightly closed, away from foodstuffs. Following withdrawal of the first dose, use remainder of the product within 28 days. 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. NOVARTIS CUSTOMER ASSISTANCE TOLL FREE from anywhere in Australia 8:30 am to 5:30 pm EST Monday to Friday.

4 Date of change: 21 October 2004 Page: 4 of 9 APVMA Approval No.: 57793/1L/1104 (1 L carton) APVMA Approval No.: 57793/500ML/1104 (500 ml carton) Registered trademark of Novartis AG, Basel, Switzerland Carton (side panel 2) DEPOSEL Slow Release Selenium Injection for Cattle and Sheep [Diagram showing correct injection technique] Batch Number Expiry Date Bar Code Novartis Animal Health Australasia Pty Limited ACN Waterloo Road, North Ryde NSW 2113 Carton (top flap) DEPOSEL Slow Release Selenium Injection for Cattle and Sheep

5 Date of change: 21 October 2004 Page: 5 of 9

6 Date of change: 21 October 2004 Page: 6 of 9 Zip seal label (front panel) same for all pack sizes POISON KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY DEPOSEL Slow Release Selenium Injection for Cattle and Sheep Active ingredient: Selenium 50 mg/ml (as barium selenate) For the prevention and treatment of selenium deficiency in sheep and cattle. Provides an elevation in blood selenium status of sheep for up to 24 months. Provides an elevation in blood selenium status of cattle for up to 12 months. 100 ml [200 ml, 500 ml, 1 L]

7 Date of change: 21 October 2004 Page: 7 of 9 Zip seal label (back label is in the form of a fold out 10 page booklet) applies to all pack sizes DEPOSEL Slow Release Selenium Injection for Cattle and Sheep IMPORTANT: READ THE ATTACHED BOOKLET BEFORE USE Storage Store below 25 C (air conditioning) in original container, tightly closed, away from foodstuffs. Following withdrawal of the first dose, use remainder of the product within 28 days. Batch Number Expiry Date APVMA Approval No.: 57793/1L/1104 APVMA Approval No.: 57793/500ML/1104 DIRECTIONS FOR USE Restraint DO NOT USE in lactating sheep where milk or milk products may be used for human consumption. Contraindications. This product is contraindicated for use by intra-muscular injection. This may cause a serious reaction. To ensure that this does not occur, administer the product only by subcutaneous injection high on the neck behind the ear. About a week after injection, a lesion may have formed at the injection site. Such lesions usually diminish over time, but may last up to 3 months or longer. To avoid potential toxicity, this product is contraindicated for use in flocks or herds being treated with additional selenium sources (selenised vaccine, pellets, fertiliser, oral drench or other injectable products) or grazing pasture known to be high in selenium or where selenium accumulating plants are known to occur. Precautions Only use in flocks or herds which are selenium deficient. Determine selenium status of the flock or herd prior to treatment. If in doubt as to the selenium status of the animals, consult your veterinarian or State Agricultural Authority. DO NOT exceed stated dose or frequency as there is no specific antidote. Take care when handling weak or pregnant animals to avoid unnecessary stress. During the early part of pregnancy, accurate dosing is important and particular care should be taken to avoid overdosing. Read EXPORT TRADE ADVICE before using this product Dosage and administration 1 ml per 50 kg bodyweight, equivalent to 1 mg selenium per kg, by subcutaneous injection high on the neck behind the ear. Raise the skin into a tent and insert needle parallel to the body, ensuring injection is placed UNDER THE SKIN and not into the muscle. Refer to graphic on the side of the carton. To achieve correct injection, it is recommended that cattle are packed tightly into a race with access gained from the side. Attempting correct injection with the animal in a cattle crush is discouraged due to the difficulty and danger in accessing the neck area and correctly delivering the injection. The following table is intended as a guide: Lambs at weaning 0.5 ml Adult sheep 1 ml

8 Date of change: 21 October 2004 Page: 8 of 9 Cattle Dose (ml) weight 50 to 100 kg 0.2 ml/10 kg bodyweight kg kg kg kg kg 10 >500 kg 2 ml/100 kg bodyweght When treating a large number of animals, a suitable multiple dose injector must be used. Shake pack well before use to ensure re-suspension of contents. Do not leave product in gun. The frequency of dosing should be related to the severity of the deficiencies. Product will last for up to 24 months in sheep and up to 12 months in cattle. Check selenium status of animals before retreating. Consult your animal health adviser for advice specific to your flock or herd. Caution: Avoid Carcass Damage 1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus. 2. Maintain cleanliness at all times. 3. Keep needles sharp and clean, replace frequently. 4. Use shortest needle possible, certainly not exceeding 15 mm. 5. Avoid injection of animals during wet weather or under dusty conditions as far as possible. 6. This product must be injected only under the skin. 7. Inject high on the neck behind the ear. 8. DO NOT administer by intramuscular injection WITHHOLDING PERIODS MEAT: NIL MILK (Cattle): NIL. (Sheep): DO NOT USE in lactating animals where milk or milk products may be used for human consumption. EXPORT TRADE ADVICE - TREATED STOCK Export Slaughter Interval (ESI): Not required when DEPOSEL is used as directed (subcutaneous injection), as visible injection site deposits are trimmed from the carcass at slaughter. Note: Some export markets employ x-ray screening technology which will detect radio-opaque substances such as barium selenate. Incorrect application of DEPOSEL could result in injection site residues not being trimmed at slaughter leading to detection and a potential risk to meat export. FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre (Ph: ). If skin contact occurs, remove contaminated clothing and wash skin thoroughly. Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety Data Sheet. For a copy phone Disposal Dispose of empty containers and packaging by wrapping in paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labeled sharps container. Storage Store below 25 C (air conditioning) in original container, tightly closed, away from foodstuffs. Following withdrawal of the first dose, use remainder of the product within 28 days.

9 Date of change: 21 October 2004 Page: 9 of 9 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. NOVARTIS CUSTOMER ASSISTANCE TOLL FREE from anywhere in Australia 8:30 am to 5:30 pm EST Monday to Friday. Registered trademark of Novartis AG, Basel, Switzerland BARCODE

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