PRASCEND 1MG TABLETS FOR HORSES

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredjent attiv:

PERGOLIDE MESYLATE

Disponibbli minn:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (Isem Internazzjonali):

pergolide as mesylate(1mg/Tb)

Għamla farmaċewtika:

ORAL TABLET

Kompożizzjoni:

PERGOLIDE MESYLATE AMINO Active 1.0 mg/Tb

Unitajiet fil-pakkett:

100Tablets; 160Tablets; 60 Tablets

Klassi:

VM - Veterinary Medicine

Żona terapewtika:

ENDOCRINE SYSTEM

Sommarju tal-prodott:

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.

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2023-07-01

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

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: [phone] (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: [phone] (OFFICE HOURS)
LEVEL 1, 78 WATERLOO RD
FAX: [phone]
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

Folja tad-Dejta dwar is-Sigurtà

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