DEPOSEL Slow Release Selenium Injection for ... - Agtech.com.au

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 1 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.Carton (front panel).POISONKEEP OUT OF REACH OF CHILDRENFOR ANIMAL TREATMENT ONLYDEPOSEL ® Slow Release SeleniumInjection for Cattle and SheepActive 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]

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 2 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.Carton (Rear panel)DEPOSEL ® Slow Release Selenium Injection for Cattle and SheepDIRECTIONS FOR USERestraint:• DO NOT USE in lactating sheep where milk or milk products may be used for humanconsumption.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 theneck behind the ear. About a week after injection, a lesion may have formed at the injection site. Suchlesions 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 withadditional selenium sources (selenised vaccine, pellets, fertiliser, oral drench or other injectableproducts) or grazing pasture known to be high in selenium or where selenium accumulating plants areknown to occur.Precautions• Only use in flocks or herds which are selenium deficient. Determine selenium status of the flock or herdprior to treatment. If in doubt as to the selenium status of the animals, consult your veterinarian or StateAgricultural 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 partof pregnancy, accurate dosing is important and particular care should be taken to avoid overdosing.Read EXPORT TRADE ADVICE before using this productDosage and administration1 mL per 50 kg bodyweight, equivalent to 1 mg selenium per kg, by subcutaneous injection high on theneck behind the ear. Raise the skin into a “tent” and insert needle parallel to the body, ensuring injection isplaced 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 gainedfrom the side. Attempting correct injection with the animal in a cattle crush is discouraged due to the difficultyand danger in accessing the neck area and correctly delivering the injection.The following table is intended as a guide:Lambs at weaning 0.5 mLAdult sheep1 mLCattleDose (mL)Weight50 to 100 kg 0.2 mL/10 kg bodyweight101 – 150 kg 3151 – 200 kg 4201 – 300 kg 6301 – 400 kg 8401 – 500 kg 10>500 kg 2 mL/100 kg bodyweghtWhen 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.

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 3 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.The frequency of dosing should be related to the severity of the deficiencies. Product will last for up to 24months in sheep and up to 12 months in cattle. Check selenium status of animals before retreating. Consultyour animal health adviser for advice specific to your flock or herd.Caution:Avoid Carcass Damage1. 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 injectionWITHHOLDING PERIODSMEAT: NILMILK (Cattle): NIL.(Sheep): DO NOT USE in lactating animals where milk or milk products may be used forhuman consumption.EXPORT TRADE ADVICE - TREATED STOCKExport 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 substancessuch as barium selenate. Incorrect application of DEPOSEL could result in injection site residues not beingtrimmed at slaughter leading to detection and a potential risk to meat export.Carton (side panel 1)FIRST AIDIf poisoning occurs contact a doctor or Poisons Information Centre (Ph: 131126). If skin contactoccurs, remove contaminated clothing and wash skin thoroughly.Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety DataSheet. For a copy phone 1800 633 768.DisposalDispose 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.StorageStore 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 LIABILITYThis product is warranted fit for the purposes specifically recommended by Novartis Animal HealthAustralasia Pty Limited when used strictly as directed on this label. All other warranties and obligations orliabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that exclusionis permitted by law. NOVARTIS CUSTOMER ASSISTANCE 1800 633 768 TOLL FREE from anywhere in Australia 8:30 amto 5:30 pm EST Monday to Friday.

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 4 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.APVMA Approval No.: 57793/1L/1104 (1 L carton)APVMA Approval No.: 57793/500ML/1104 (500 mL carton)® Registered trademark of Novartis AG, Basel, SwitzerlandCarton (side panel 2)DEPOSEL ®Slow Release SeleniumInjection for Cattle and Sheep[Diagram showing correct injection technique]Batch NumberExpiry DateBar CodeNovartis Animal HealthAustralasia Pty LimitedACN 076 745 19854 Waterloo Road,North Ryde NSW 2113Carton (top flap)DEPOSEL ®Slow Release SeleniumInjection for Cattle and Sheep

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 5 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 6 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.Zip seal label (front panel) same for all pack sizesPOISONKEEP OUT OF REACH OF CHILDRENFOR ANIMAL TREATMENT ONLYDEPOSEL ® Slow Release SeleniumInjection for Cattle and SheepActive 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]

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 7 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.Zip seal label (back label is in the form of a fold out 10 page booklet) applies to all pack sizesDEPOSEL ® Slow Release Selenium Injection for Cattle and SheepIMPORTANT: READ THE ATTACHED BOOKLET BEFORE USEStorageStore 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 NumberExpiry DateAPVMA Approval No.: 57793/1L/1104APVMA Approval No.: 57793/500ML/1104DIRECTIONS FOR USERestraint• DO NOT USE in lactating sheep where milk or milk products may be used for humanconsumption.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 theneck behind the ear. About a week after injection, a lesion may have formed at the injection site. Suchlesions 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 withadditional selenium sources (selenised vaccine, pellets, fertiliser, oral drench or other injectableproducts) or grazing pasture known to be high in selenium or where selenium accumulating plants areknown to occur.Precautions• Only use in flocks or herds which are selenium deficient. Determine selenium status of the flock or herdprior to treatment. If in doubt as to the selenium status of the animals, consult your veterinarian or StateAgricultural 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 partof pregnancy, accurate dosing is important and particular care should be taken to avoid overdosing.Read EXPORT TRADE ADVICE before using this productDosage and administration1 mL per 50 kg bodyweight, equivalent to 1 mg selenium per kg, by subcutaneous injection high on theneck behind the ear. Raise the skin into a “tent” and insert needle parallel to the body, ensuring injection isplaced 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 gainedfrom the side. Attempting correct injection with the animal in a cattle crush is discouraged due to the difficultyand danger in accessing the neck area and correctly delivering the injection.The following table is intended as a guide:Lambs at weaning 0.5 mLAdult sheep1 mL

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 8 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.CattleDose (mL)weight50 to 100 kg 0.2 mL/10 kg bodyweight101 – 150 kg 3150 – 200 kg 4201 – 300 kg 6301 – 400 kg 8401 – 500 kg 10>500 kg 2 mL/100 kg bodyweghtWhen 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 24months in sheep and up to 12 months in cattle. Check selenium status of animals before retreating. Consultyour animal health adviser for advice specific to your flock or herd.Caution: Avoid Carcass Damage1. 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 injectionWITHHOLDING PERIODSMEAT: NILMILK (Cattle): NIL.(Sheep): DO NOT USE in lactating animals where milk or milk products may be used forhuman consumption.EXPORT TRADE ADVICE - TREATED STOCKExport 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 substancessuch as barium selenate. Incorrect application of DEPOSEL could result in injection site residues not beingtrimmed at slaughter leading to detection and a potential risk to meat export.FIRST AIDIf poisoning occurs contact a doctor or Poisons Information Centre (Ph: 131126). If skin contactoccurs, remove contaminated clothing and wash skin thoroughly.Material Safety Data Sheet: If additional hazard information is required refer to the Material Safety DataSheet. For a copy phone 1800 633 768.DisposalDispose of empty containers and packaging by wrapping in paper and putting in garbage. Discarded needlesshould immediately be placed in a designated and appropriately labeled ‘sharps’ container.StorageStore 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.

Product name: DEPOSEL Slow Release Selenium Injection for Cattle and SheepDate of change: 21 October 2004 Page: 9 of 9Todays date: 3 June, 2005Type of label: Carton and primary labelPack sizes: 100 mL, 200 mL, 500 mL, 1 L Version: 9File: Deposel Label_JBOct04.docReason: add export trade advice + other changesText above this line is not included in the actual label.WARRANTY AND EXCLUSION OF LIABILITYThis product is warranted fit for the purposes specifically recommended by Novartis Animal HealthAustralasia Pty Limited when used strictly as directed on this label. All other warranties and obligations orliabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that exclusionis permitted by law. NOVARTIS CUSTOMER ASSISTANCE 1800 633 768 TOLL FREE from anywhere in Australia 8:30 amto 5:30 pm EST Monday to Friday.® Registered trademark of Novartis AG, Basel, SwitzerlandBARCODE