PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

06-11-2023

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

IVERMECTIN; PRAZIQUANTEL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

ivermectin(19mg/g)+praziquantel(238mg/g)

Pharmaceutical form:

ORAL PASTE

Composition:

IVERMECTIN ANTHELMINTIC Active 19.0 mg/g; PRAZIQUANTEL ANTHELMINTIC Active 238.0 mg/g

Units in package:

120 x 6.3g syringe; 20 x 6.3g syringe; 30 x 6.3g syringe; 6.3g syringe; 60 x 6.3g syringe

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: MEAT WITHHOLDING PERIOD (HORSES) DO NO T USE less than 28 days before slaughte r for human consumption.; Host/pest details: HORSE: [ASCARID - PARASACRIS EQUORIUM, BOTS - GASTEROPHILUS SPP., INTESTINAL THREADWORM - S. WESTERI, LARGE MOUTH STOMACH WORM, LARGE STRONGYLES, LUNGWORM - DICTYOCAULUS ARNFIELDI, PINWORM - OXYURIS EQUI, SMALL STRONGYLES, STOMACH HAIR WORM, TAPEWORM - ADULT/IMMATURE/HEADS/SEGMENTS]; For the treatment and control in horses (300kg -600kg) of ivermectin or praziquantel susceptible tapeworms and roundworms, bots and skin lesions (summer sores) …

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
62378/141760
Product Name:
APVMA Approval
No:
Label Name:
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
238 mg/g PRAZIQUANTEL
19 mg/g IVERMECTIN
Claims:
For the treatment and control in horses (300 kg - 600 kg) of
ivermectin or praziquantel
susceptible tapeworms and roundworms (including arterial larval stages
of Strongylus
vulgaris and benzimidazole resistant small strongyles), bots and skin
lesions (summer
sores) caused by Habronema and Draschia spp, and microfilariae of
Onchocerca spp
(cutaneous onchocerciasis).
INDICATIONS: At the recommended dose level, Promectin Plus LV
Allwormer Paste for
Horses (300 kg - 600 kg) controls the following ivermectin or
praziquantel susceptible
parasites:
Tapeworms: Anoplocephala perfoliata, A. magna, Paranoplocephala
mamillana (adult and
immature, heads and segments).
Large Strongyles: Strongylus vulgaris (adults and arterial larval
stages), S. edentatus
(adults and tissue stages), S. equinus (adults) and Triodontophorus
spp (adults).
Small Strongyles: including benzimidazole resistant strains of
Cyathostomum spp,
Cylicocyclus spp, Cylicostephanus spp, Cylicodontophorus spp,
Gyalocephalus spp.
Pinworms: Oxyuris equi (adult and immature).
Ascarids: Parascaris equorum (adult and immature).
Hairworms: Trichostrongylus axei (adult).
Large Mouth Stomach Worms: Habronema muscae (adult).
Bots: Gasterophilus spp (oral and gastric stages).
Lungworms: Dictyocaulus arnfieldi (adult and immature).
Intestinal Threadworms: Strongyloides westeri (adult).
Promectin Plus LV Allwormer Paste for Horses (300 kg – 600 kg) also
effectively controls
skin lesions caused by Habronema and Draschia spp cutaneous larvae
(summer sores)
and microfilariae of Onchocerca spp (cutaneous onchocerciasis).
All horses should be included in a regular parasite control program,
with particular attention
paid t

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Summary of Product characteristics

PROMECTIN PLUS MINI ALLWORMER PASTE
Page 1 of 7
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
16 FEBRUARY 2016
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
PROMECTIN PLUS MINI ALLWORMER PASTE FOR HORSES
(300 KG – 600 KG)
PROMECTIN PLUS MINI ALLWORMER PASTE FOR FOALS AND
PONIES (150 KG – 300 KG)
PRODUCT CODE:
503750 (6.3 g product for horses)
503755 (3.15 g product for foals and ponies)
RECOMMENDED USE:
Small volume oral paste for the treatment of roundworms and
tapeworms in horses.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
EMAIL:
jenq@jurox.com.au
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS: This product has been assessed according to
GHS and is classified as follows:
GHS CATEGORY
HAZARD CODE
HAZARD STATEMENT
Acute Toxicity (Oral) Category 4
H302
Harmful if swallowed
Skin Sensitizer Category 1
H317
May cause an allergic skin reaction
Lactation Effects
H362
May cause harm to breast-fed children
STOT- SE Category 2
H371
May cause damage to organs
Chronic Aquatic Hazard Category 1
H410
Very toxic to aquatic life with long lasting
effects
SIGNAL WORD: WARNING
GHS PICTOGRAMS:
Health Exclamation Envrionment
Hazard Mark
PROMECTIN PLUS MINI ALLWORMER PASTE
Page 2 of 7
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
PRECAUTIONARY STATEMENTS:
Prevention
P201 Obtain special instructions before use.
P260 Do not breathe vapours.
P263 Avoid contact during pregnancy / while nursing.
P264 Wash hands thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P272 Contaminated work clothing should not be allowed out of the
workplace.
P280 We

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