Regulin Implant for Improved Reproductive Performance in Sheep and Goats

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MELATONIN

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

melatonin(18mg/Imp)

Pharmaceutical form:

PARENTERAL IMPLANT, DEVICE

Composition:

MELATONIN HORMONE Active 18.0 mg/Im

Units in package:

2x25 Impls

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

SHEEP EWE (FEMALE) | FEMALE SHEEP | OVINE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

IMPROVE REPRODUCTIVE PERFORMANCE | STIMULATE OVULATION | PROMOTE OVULATION | SUPEROVULATION

Product summary:

Poison schedule: 0; Withholding period: Sheep: Meat:Zero (0) days Milk: Zero ( 0) days Angora Goats: Meat:Zero (0) day s EXPORT SLAUGHTER INTERVAL (ESI): An E SI has not been established for this pro duct. Note—observing the meat withholdin g period may not be sufficient to mitiga te potential risks to export trade. Trad e advice should be sought from Ceva Anim al Health on [phone] before usin g this product.; Host/pest details: ANGORA GOAT: [IMPROVED JOINING PERFORMANCE IN ANGORA GOATS]; GOAT BUCK (MALE): [IMPROVED JOINING PERFORMANCE IN BUCKS, INCREASED SEMEN PRODUCTION]; GOAT DOE (FEMALE): [INCREASE OVULATION RATE, STIMULATE OVULATION]; SHEEP EWE (FEMALE): [IMPROVED JOINING PERFORMANCE IN SHEEP, INCREASE OVULATION RATE, STIMULATE OVULATION]; SHEEP RAM (MALE): [IMPROVED JOINING PERFORMANCE IN SHEEP, INCREASED SEMEN PRODUCTION IN RAMS ]; Poison schedule: 0; Withholding period: WITHOLDING PERIODS: MEAT: Nil Milk:NI L EXPORT SLAUGHTER INTERVAL (ESI): ESI not required.; Host/pest details: SHEEP EWE (FEMALE): [IMPROVED JOINING PERFORMANCE IN SHEEP, INCREASE OVULATION RATE, STIMULATE OVULATION]; SHEEP RAM (MALE): [IMPROVED JOINING PERFORMANCE IN SHEEP, INCREASED SEMEN PRODUCTION IN RAMS ]; For improved joining performance and increased ovulation rates in sheep.Contraindicated for use in reproductively immature or pregnant animals. Contraindicated to treat ewes to be joined in Autumn that cannot be joined in 30-40 days from treatment.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX 2
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Australian Pesticides and
Veterinary '\'ledicincs Authority
+
RLP
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
D
New Product (include all applicable RLPs)
OR
0
Variation (highlight instructions that are being varied). Approval
no.
of label being varied:
38233/1109
Signal
heading:
Product name:
KEEP OUT OF REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
REGULIN
For
improved
joining
performance
and
increased
ovulation
rates in sheep
' Active constituent/s:
Each implant contains 18mg melatonin
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
i
Contraindications:
I
'
I Precaut1ons·
Side
effects:
Dosage
&
administration:
General directions:
For improved joining performance and increased ovulation rates
in
sheep
2 x
25
implants
Directions for Use
•
Contraindicated for use
in
reproductively immature animals or pregnant animals.
•
It
is
contraindicated
to
treat ewes
to
be
joined
in
Autumn that cannot
be
joined
in
30-40 days from treatment.
Administer one implant
to
each ewe
30
to
40
days before joining rams with the ewes.
Method
of
administration
Use
by
subcutaneous implantation only
Use the Regulin implanter
to
place one implant beneath the skin (subcutaneously)
near the base
of
the ear.
•
Sterilise needles by boiling before use.
Avoid
the
use
of
strong disinfectants.
Keep needles sharp and clean: replace frequently.
•
Maintain cleanliness
at
all
times.
The product
is
recommended for use
in
Merinos. Comebacks. Polwarths. Corriedales
and Merino First Crosses joined
in
Spring and early Summer (October, November or
December) for
lambing
in
Autumn
(March,
April
or
May).
Use
of
Regulin
is
not
recommended
in
any months earlier than September.
In
principle Regulin treatment
will also be effective
in
British breed ewes such as Border Leicester, Romney and
other carpet wool breeds. However, the treatment time may differ from
that above.
and
no recommendation
is
made
at
this

Summary of Product characteristics

PRODUCT NAME: REGULIN FOR IMPROVED JOINING PERFORMANCE & INCREASED
OVULATION RATES IN SHEEP
PAGE: 1 OF 4
THIS VERSION ISSUED: APRIL, 2013
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
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
CEVA ANIMAL HEALTH PTY LTD
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD
FAX: [phone]
GLENORIE, NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
subcutaneous hormone implant for use in sheep.
TRADE NAME:
REGULIN FOR IMPROVED JOINING PERFORMANCE & INCREASED
OVULATION RATES IN SHEEP
APVMA CODE:
38233
PRODUCT USE:
For improved joining performance and increased ovulation rates in
sheep.
CREATION DATE:
NOVEMBER, 2009
THIS VERSION ISSUED:
APRIL, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
EMERGENCY OVERVIE