POPANTEL ALLWORMER TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

OXANTEL EMBONATE; PYRANTEL EMBONATE; PRAZIQUANTEL

Available from:

JUROX PTY LIMITED

INN (International Name):

praziquantel(50mg/Tb)+oxantel embonate(542mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

OXANTEL EMBONATE ANTHELMINTIC Active 542.0 mg/Tb; PYRANTEL EMBONATE ANTHELMINTIC Active 143.0 mg/Tb; PRAZIQUANTEL ANTHELMINTIC Active 50.0 mg/Tb

Units in package:

*4 Tabs; *Blister; @10 Tabs; @Blister; 100 Tabs; 2 Tablets; 4 Tablets; Unit=1 Tab

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WHP: NOT APPLICABLE; Host/pest details: DOG: [FALSE HYDATID TAPEWORM-TAENIA HYDATIGENA, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SHEEP MEASLES TAPEWORM - TAENIA OVIS, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 6; Withholding period: WHP: NOT APPLICABLE; Host/pest details: DOG: [FALSE HYDATID TAPEWORM-TAENIA HYDATIGENA, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SHEEP MEASLES TAPEWORM - TAENIA OVIS, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 6; Withholding period: ; Host/pest details: DOG: [FALSE HYDATID TAPEWORM-TAENIA HYDATIGENA, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SHEEP MEASLES TAPEWORM - TAENIA OVIS, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, WHIPWORM - TRICHURIS VULPIS]; For the control in dogs of: roundworms, whipworms, hookworms and tapeworms, plus the hydatid tapeworm. Does not control heartworm.DOES NOT CONTROL HEARTWORM (Dirofilaria immitis)

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

C80 M5 Y0 K0
ALLWORMER
TABLETS FOR DOGS
For the control in dogs of ROUNDWORMS, WHIPWORMS,
HOOKWORMS, TAPEWORMS,
plus the Hydatid Tapeworm.
DOES NOT CONTROL HEARTWORM _(Dirofilaria immitis)._
2 Tablets
_See reverse for directions and further information_
Each tablet contains:
50 mg PRAZIQUANTEL,
542 mg OXANTEL EMBONATE and
143 mg PYRANTEL EMBONATE
DIRECTIONS FOR USE: IF WORM PROBLEMS PERSIST, CONSULT
YOUR VETERINARY SURGEON.
One tablet per 10kg bodyweight. Dosage should be rounded up
to the nearest quarter tablet.
ROUNDWORMS AND HOOKWORMS.
Treat at 2, 4, 8 and 12 weeks
of age and then every 3 months.
WHIPWORMS.
Treat every 6 to 8 weeks after 3 months of age.
PREGNANT BITCHES.
Treat at mating, before whelping and then
every 3 months.
HYDATID TAPEWORMS.
Dogs in hydatid areas should be treated
every 6 weeks. Dogs should not be fed, or allowed to feed on,
offal from any species.
OTHER TAPEWORMS.
Treat every 3 months, and treat your dog
regularly to control fleas.
FIRST AID. If poisoning occurs, contact a doctor or Poisons
Information Centre, phone Australia 131126.
DISPOSE of empty container by wrapping with paper and
putting in garbage.
APVMA No. 40468/2env/1106
xxxxxx
JUROX PTY LTD.
85 Gardiner Road, Rutherford NSW 2320 AUSTRALIA
INFOLINE 1800 023 312
For the control of ROUNDWORMS _(Toxocara canis, _
_Toxascaris leonina),_ WHIPWORMS _(Trichuris vulpis), _
HOOKWORMS _(Ancylostoma caninum, A. braziliense, _
_Uncinaria stenocephala),_ TAPEWORMS _(Dipylidium _
_caninum, Taenia pisiformis, T. ovis, T. hydatigena),_ PLUS
THE HYDATID TAPEWORM _(Echinococcus granulosus)._
Does not control heartworm.
Magenta indicates knifeline DO NOT PRINT
SIZE INDICATED ON PROOF IS 100% SIZE
82mm wide
112mm high
Envelope
3 colour only printing
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
APVMA FILE: 40468_39702_2 tablet envelope_primary_MPL_V2.pdf
Dimensions: primary pack = 112mm (high) x 82mm (wide)
Scale: 100% on A4
Date: 8 May 2007
Exp:
B
STORE below 30°C
(Room Temperature).
ONE TABLET TREATS 10KG
APPROVED
LABEL
Info

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Summary of Product characteristics

POPANTEL ALLWORMER TABLETS FOR DOGS
Page 1 of 6
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
18 JANUARY 2016
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT IDENTIFIER:
POPANTEL ALLWORMER TABLETS FOR DOGS
POPANTEL ALLWORMER TABLETS FOR LARGE DOGS
PRODUCT CODE:
501000 (10kg 100s); 503645 (10kg 4s x 8); 500995 (40kg 50s)
RECOMMENDED USE:
For the control in dogs of roundworms, whipworms, hookworms,
tapeworms, (including the hydatid tapeworm). Does not control
heartworm.
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
Eye irritation Category 2A
H319
Causes serious eye irritation
SIGNAL WORD: WARNING
GHS PICTOGRAMS:
Exclamation
mark
PRECAUTIONARY STATEMENTS:
Prevention
P280 Wear protective gloves and eye protection.
Response
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
POPANTEL ALLWORMER TABLETS FOR DOGS
Page 2 of 6
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Oxantel embonate (pamoate)
68813-55-8
57%
Pyrantel embonate (pamoate)
22204-24-6
15%
Praziquantel
55268-74-1
5.3%
Ingredients not contributing to the hazards
22.7%
SECTION 4: FIRST AID MEASURES
GENERAL INFORMATION: Consult the National Poisons Centre on 13 1126 or
a doctor immediately in every case
of suspected chemical poisoning. Never give fluids or

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