Country: Australia
Bahasa: Inggeris
Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)
PERGOLIDE MESYLATE
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
pergolide as mesylate(1mg/Tb)
ORAL TABLET
PERGOLIDE MESYLATE AMINO Active 1.0 mg/Tb
100Tablets; 160Tablets; 60 Tablets
VM - Veterinary Medicine
ENDOCRINE SYSTEM
Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT (HORSES): DO NOT USE in horses that may be used for h uman consumption.; Host/pest details: HORSE: [CUSHINGS DISEASE]; PONY: [CUSHINGS DISEASE]; Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT (HORSES): DO NOT USE in horses that may be used for human consumption.; Host/pest details: HORSE: [CUSHINGS DISEASE]; PONY: [CUSHINGS DISEASE]; For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing's Disease) in horses and ponies.DO not use in horses that may be used for human consumption. This product is contraindicated in horses with known hypersensitivity to pergolide mesylate or other ergot derivatives.
Registered
2023-07-01
PRASCEND 1MG TABLETS FOR HORSES 69335/134850 Prod uct Name: Product No: Label Name: PRASCEND 1MG TABLETS FOR HORSES Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY READ SAFETY DIRECTIONS BEFORE OPENING OR USING Constituent Statements: 1 mg/tablet PER GOLIDE MESYLATE Claims: For the control of clinical signs associated with Pituitary Pars lntermedia Dysfunction (PPID) (Equine Cushing's Disease) in horses and ponies. Net Contents: 60 Tablets 100 Tablets 160 Tablets Directions for Use: Restraints: DO NOT USE in horses that may be used for human consumption. Contraindications: This product is contraindicated in horses with known hypersensitivity to pergolide mesylate or other ergot derivatives. Precautions: Use with caution in breeding animals and pregnant or lactating mares. Safe use in these groups has not been established and the pharmacological action of pergolide mesylate suggests that it may interfere with reproductive functions such as lactation. Use with caution in horses less than 2 years of age. Side Effects: Prascend is well tolerated in horses. Potential adverse reactions in horses include sweating, inappetence, transient anorexia and lethargy, mild central nervous system signs (e.g. mild depression and mild ataxia), diarrhoea and colic. These signs are RLP APPROVED usually mild and transient in nature. If signs of dose intolerance develop, treatment should be stopped for 2 to 3 days and reinstated at one-half of the previous dose. The total daily dose may then be titrated back up to the desired clinical effect by 0.5 mg increments every 2 to 4 weeks. Dosage and Administration: The product should be administered orally, once daily. The tablet can be administered whole in a treat. To facilitate administration, the required daily dose can be placed in a small amount of water and/or mixed with molasses or other sweetener and agitated until dissolved. In this case, the dissolved tablets should be administered with a syringe. The whole amount should be admini Baca dokumen lengkap
PRODUCT NAME: PRASCEND® 1MG TABLETS FOR HORSES PAGE: 1 OF 5 THIS VERSION ISSUED: OCTOBER, 2014 SAFETY DATA SHEET Issued by: Boehringer Ingelheim Pty Limited Phone: +61 (2) 8875-8634 (office hours) POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800 764 766 IN NEW ZEALAND) SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER BOEHRINGER INGELHEIM PTY LIMITED PHONE: +61 (2) 8875-8634 (OFFICE HOURS) LEVEL 1, 78 WATERLOO RD FAX: +61 (2) 8875-8715 NORTH RYDE, NSW 2113 CHEMICAL NATURE: Synthetic ergot derivative, a potent dopamine receptor agonist. TRADE NAME: PRASCEND ® 1MG TABLETS FOR HORSES OTHER NAMES: Pergolide Mesylate Tablets. PRODUCT USE: For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction, PPID (Equine Cushing’s Disease) in horses and ponies. CREATION DATE: OCTOBER, 2014 THIS VERSION ISSUED: OCTOBER, 2014 and is valid for 5 years from this date. SECTION 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE This product is classified as: Xn, Harmful. Hazardous according to the criteria of SWA. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. RISK PHRASES: R22. Harmful if swallowed. SAFETY PHRASES: S20, S22, S36, S24/25. When using, do not eat or drink. Do not breathe dust. Wear suitable protective clothing. Avoid contact with skin and eyes. SUSMP CLASSIFICATION: S4 ADG CLASSIFICATION: None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. UN NUMBER: None allocated GHS SIGNAL WORD: WARNING HAZARD STATEMENT: H302: Harmful if swallowed. H335: May cause eye, skin and respiratory irritation. Can cause nervous system, reproductive, heart and hormonal effects. PREVENTION P102: Keep out of reach of children. P262: Do not get in eyes, on skin, or on clothing. P264: Wash contacted areas thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P280: Wear protective gloves, protective clothing and eye or face protection Baca dokumen lengkap
DATE: 09.10.2014 MATERIAL NUMBER: 40020859-08/14 PRODUCT: Prascend 1 mg 60 tablets COUNTRY: Australia / New Zealand DIMENSIONS: 125 x 85 x 40 mm SCALE: 1 : 1 8pt NUMBER OF COLOURS: 3 Black T Pantone 204 C Pantone 287 C COLOUR CODES: BOEHRINGER INGELHEIM VETMEDICA GMBH 2 For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease) in horses and ponies. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. DIRECTIONS FOR USE RESTRAINT: DO NOT USE IN HORSES THAT MAY BE USED FOR HUMAN CONSUMPTION. CONTRAINDICATIONS THIS PRODUCT IS CONTRAINDICATED IN HORSES WITH KNOWN HYPERSENSITIVITY TO PERGOLIDE MESYLATE OR OTHER ERGOT DERIVATIVES. DOSAGE AND ADMINISTRATION For oral use. Read the enclosed leaflet before using this product. SAFETY DIRECTIONS HARMFUL IF SWALLOWED. WASH HANDS AFTER USE. FIRST AID If poisoning occurs contact a doctor or Poisons Information Centre. _Phone Australia 131126 _ DISPOSAL Dispose of empty container by wrapping with paper and putting in garbage. STORAGE Store below 25°C (Air conditioning). AUSTRALIA Boehringer Ingelheim Pty Limited Animal Health Division 78 Waterloo Road North Ryde NSW 2113 APVMA 69335/60522 Prascend® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH – used under license. Batch No.: Expiry: GTIN: (01)09310717400866 ABCD 40020859-08/14 1 MG TABLETS FOR HORSES ACTIVE CONSTITUENT: 1.0 mg pergolide (as pergolide mesylate) 60 TABLETS ® PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY READ SAFETY DIRECTIONS BEFORE OPENING OR USING 1 MG TABLETS FOR HORSES ACTIVE CONSTITUENT: 1.0 mg pergolide (as pergolide mesylate) 60 TABLETS ® For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease) in horses and ponies. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. DIRECTIONS FOR USE RESTRAINT: DO NOT USE IN HORSES THAT MAY BE USED FOR HUMAN CONSUMPTION. CONTRAINDICATIONS THIS PRODUCT IS CONTRAINDICATED IN HORS Baca dokumen lengkap