HEARTGARD 30 PLUS (IVERMECTIN/PYRANTEL) CHEWABLES EACH CHEWABLE CONTAINS 136UG IVERMECTIN AND 114MG PYRANTEL (AS EMBONATE SALT)

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Preparatomtale Preparatomtale (SPC)
19-06-2017

Aktiv ingrediens:

IVERMECTIN; PYRANTEL EMBONATE

Tilgjengelig fra:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

ivermectin(136ug/Ch)+pyrantel as pamoate(114mg/Ch)

Legemiddelform:

ORAL BOLUS, CHEWABLE

Sammensetning:

IVERMECTIN ANTHELMINTIC Active 136.0 ug/Tb; PYRANTEL EMBONATE ANTHELMINTIC Active 114.0 mg/Tb

Enheter i pakken:

1 Chew; 12 Chews; 3 Chews; 6 Chews

Klasse:

VM - Veterinary Medicine

Produsert av:

MERIAL AUSTRALIA

Terapeutisk gruppe:

DOG | BITCH | CASTRATE | PUPPY

Terapeutisk område:

PARASITICIDES

Indikasjoner:

HEARTWORM | HOOKWORM - ANCYLOSTOMA CEYLANICUM | HOOKWORM - BUNOSTOMUM SPP. | ROUNDWORM - ASCARIDIA GALLI

Produkt oppsummering:

Poison schedule: 5; Withholding period: WHP: N/A; Host/pest details: DOG: [HEARTWORM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - BUNOSTOMUM SPP., ROUNDWORM - ASCARIDIA GALLI]; For use in dogs where both heartworm prevention and monthly treatment for control of roundworms and hookworms is necessary. For dogs 12-22 kg.Do not use in puppies under 6 weeks of age. All dogs should be tested by a veterinarian before heartworm prevention is initiated.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

                                For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
MERIAL AUSTRALIA PTY LTD
PRODUCT NAME:
HEARTGARD 30 PLUS (IVERMECTIN/PYRANTEL) CHEWABLES EACH
CHEWABLE CONTAINS 136UG IVERMECTIN AND 114MG PYRANTEL (AS
EMBONATE SALT)
ELABEL APPLICATION NO:
DC12-57403735E104
APVMA APPROVAL NO:
39540/100436
PRODUCT NO:
39540
VERSION NO:
8.0
APPLICATION STARTED:
2014-Sep-11 09:53:02
VERSION CREATED:
2015-Feb-02 15:02:41
STARTED BY:
Carolyn Conacher
PRINTED:
2015-Feb-06 15:01:58
LABEL NAME:
HEARTGARD 30 PLUS (IVERMECTIN/PYRANTEL) CHEWABLES EACH CHEWABLE
CONTAINS 136UG IVERMECTIN AND 114MG PYRANTEL (AS EMBONATE SALT)
SIGNAL HEADINGS:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
Each Chewable contains 136 ug IVERMECTIN and 114mg PYRANTEL (as
embonate salt)
CLAIMS:
For use in dogs where both heartworm prevention and monthly treatment
for control of
roundworms and hookworms is necessary.
• Heartworm prevention
• Controls roundworms and hookworms
• Monthly dose
• Real beef chewable for dogs
For DOGS 12-22kg
INDICATIONS
HEARTGARD-30 Plus prevents heartworm disease in dogs by eliminating
heartworm
larvae (Dirofilaria immitis) that infected the dog in the month (30
days) before treatment.
HEARTGARD-30 Plus also controls heartworm infections acquired in the
previous 4
months provided monthly treatment is continued for at least 12 months.
For the treatment and control of roundworms (Toxocara canis and
Toxascaris leonina)
and hookworms (Ancylostoma caninum, A. braziliense, A. ceylanicum and
Uncinaria
stenocephala).
Your veterinarian can advise if there is a need for monthly treatment
of roundworms and
hookworms with HEARTGARD-30 Plus in pups and adult dogs.
NET CONTENTS:
1 Chewable/3 Chewables/6 Chewables/12 Chewables
Illegal to sell chewables separately. RLP APPROVED
For Official Use Only
DIRECTIONS FOR USE:
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
PRECAUTIONS:
As macrocyclic lactones may have some effects against adult
heartwo
                                
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Preparatomtale

                                MATERIAL SAFETY DATA SHEET
HEARTGARD 30 PLUS CHEWABLES FOR DOGS
Version 4
Issue Date: 23 August, 2011
Page 1 of 5
SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product description:
Blue pack:
beef chewables for dogs up to 11kg:
68µg ivermectin/57 mg pyrantel embonate per chewable
Green pack:
beef chewables for dogs 12 to 22kg:
136µg ivermectin/114 mg pyrantel embonate per chewable
Brown pack:
beef chewables for dogs 23 to 45kg:
272µg ivermectin/227 mg pyrantel embonate per chewable
Recommended use:
For use in dogs for heartworm prevention and monthly treatment and
control
of roundworms and hookworms. Prevents heartworm disease by
eliminating heartworm larvae that infected the dog in the month before
treatment and controls heartworm infections acquired in the previous 4
months if monthly treatment is continued for at least 12 months.
Supplier name:
Merial Australia Pty Ltd
Address:
Building D, 12-24 Talavera Road
Macquarie Park NSW 2113
Telephone number (toll-free):
1800 808 691
All hours emergency phone number - Poisons Information Centre 131126
anywhere in Australia
SECTION 2
HAZARDS IDENTIFICATION
CLASSIFIED AS HAZARDOUS according to the National Occupational Health
and Safety Commission’s Approved
Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)].
APPROVED CRITERIA: CLASSIFICATION:
HARMFUL Xn
NOT CLASSIFIED AS DANGEROUS GOODS ACCORDING TO THE ADG CODE.
Risk phrase(s) (Hazard):
HARMFUL IF SWALLOWED (R22)
Safety phrase(s)):
KEEP OUT OF THE REACH OF CHILDREN (S2)
(Precautionary statements)
KEEP AWAY FROM FOOD AND DRINK (S13)
DO NOT EMPTY INTO DRAINS (S29)
IF SWALLOWED, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW
THE CONTAINER OR LABEL (S46)
SUSDP CLASSIFICATION - POISONS SCHEDULE: 5
ADG CODE CLASSIFICATION: Not classified
UN No.
None
LOCAL EFFECTS OF PRODUCT:
Acute:
SWALLOWED:
Poisonous if swallowed. Symptoms following over-exposure to the
ivermectin ingredient may include: drowsiness, nausea, vomiting,
tachycardia, somnolence, blood pressure variations, slow breathing,
dilation
of pupils
                                
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