READYSERVE ALTRENOGEST INJECTION FOR HORSES

Država: Australija

Jezik: engleski

Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Kupi sada

Uputa o lijeku Uputa o lijeku (PIL)
25-02-2019
Svojstava lijeka Svojstava lijeka (SPC)
25-02-2019

Aktivni sastojci:

ALTRENOGEST

Dostupno od:

CEVA ANIMAL HEALTH PTY LTD

INN (International ime):

ALTRENOGEST

Farmaceutski oblik:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sastav:

ALTRENOGEST STEROID-PROGESTIN Active 50.0 mg/ml

Jedinice u paketu:

30mL

Razred:

VM - Veterinary Medicine

Područje terapije:

ENDOCRINE SYSTEM

Proizvod sažetak:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE in horses that may be used for huma n consumption.; Host/pest details: HORSE MARE (FEMALE): [EQUINE OESTRUS CYCLE, MAINTAIN PREGNANCY]; Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT WITHHOLDING PERIOD: DO NOT USE IN HORSES THAT MAY BE USED FOR HUMAN CONSUMPTION.; Host/pest details: HORSE MARE (FEMALE): [EQUINE OESTRUS CYCLE]; HORSE MARE (FEMALE) - [EQUINE OESTRUS CYCLE]

Status autorizacije:

Registered

Datum autorizacije:

2023-07-01

Uputa o lijeku

                                Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR
ANIMAL TREATMENT ONLY
Active constituent/s:
50 mg/ml altrenogest
Statement of
claims:
For the suppression of oestrus in normally cycling mares.
Net contents:
30 mL
Directions for Use
Heading:
DIRECTIONS FOR USE
Restraints:
DO NOT USE in horses that may be used for human consumption
Contraindications:
This product is contraindicated for use in stallions or geldings.
T h i s
p r o d u c t
i s
c o n t r a i n d i c a t e d
f o r
u s e
i n
m a r e s
w i t h
a
p r e v i o u s
o r
current
history
of
uterine
inflammation
(i.e.
acute,
subacute
or
chronic
e n d o m e t r i t i s ) ,
a s
p r o g e s t a g e n s
m a y
e x a c e r b a t e
e x i s t i n g
l o w - g r a d e
uterine inflammation into a
fulminating uterine infection.
Precautions:
There is evidence that when progestagens are administered to rats
during the
embryonic stage of pregnancy at doses higher than the recommended
equine dose,
foetal abnormalities (specifically masculinization of female
genitalia) can result.
Side effects:
Dosage &
administration:
Use the contents of the vial within 3 months of initial broaching and
discard any
unused portion.
3 mL per 500 kg bodyweight by intramuscular injection once every 5-7
days as
required to suppress signs of oestrus.
Efficacy studies were performed on Thoroughbred horses with an average
weight of
500 kg using a dose of 3 mL per horse every 7 days. The dose rate
should be
extrapolated according to bodyweight if treating lighter or heavier
horses (for
example, ponies or heavy horses).
Product Name:
APVMA Approval Number:
READYSERVE ALTRENOGEST INJECTION FOR HORSES
69854/116027 RLP APPROVED
General directions:
Actions:
Altrenogest acts similarly to the natural hormone progesterone by
suppressing the
normal
sexual
cycle
and
preventing
signs
of
heat
and
ovulation.
Mares
return
to
heat
and
release
natural
hormones
again
once
treatment
stops.
T r e a t m e n t
w i t h
a l t r e n o g e s t
m a k e s
i
                                
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Svojstava lijeka

                                PRODUCT NAME: READYSERVE ALTRENOGEST INJECTION FOR
HORSES
PAGE: 1 OF 6
THIS VERSION ISSUED: AUGUST, 2016
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: 02 9652 7000 (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
CEVA ANIMAL HEALTH PTY LTD
PHONE: 02 9652 7000 (OFFICE HOURS)
11 MOORES RD
FAX: 02 9652 7001
GLENORIE NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Altrenogest, an Endocrine agent (hormone) in propylene glycol
solution.
TRADE NAME:
READYSERVE ALTRENOGEST INJECTION FOR HORSES
PRODUCT USE:
For the suppression of oestrus in normally cycling mares.
CREATION DATE:
MARCH, 2016
THIS VERSION ISSUED:
AUGUST, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
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.
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
Flammable liquids Category 4
Skin Sensitisation Category 1
Reproductive Toxicity Category 2
HAZARD STATEMENT:
H227: Combustible liquid.
H317: May cause an allergic skin reaction.
H361: Suspected of damaging fertility or the unborn child.
PREVENTION
P102: Keep out of reach of children.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and
understood.
P210: Keep away from heat, sparks, open flames and hot surfaces. - No
smoking.
P261: Avoid breathing fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P272: Contaminated work clothing should not be allowed out of the
workplace.
P281: Use personal protective equipment as req
                                
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