DRONTAL ALLWORMER FOR LARGE 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)

01-07-2013

Active ingredient:

PYRANTEL AS PYRANTEL EMBONATE; PRAZIQUANTEL; FEBANTEL

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

praziquantel(175mg/Tb)+pyrantel as pamoate(174.4mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

PYRANTEL AS PYRANTEL EMBONATE ANTHELMINTIC Active 174.4 mg/Tb; PRAZIQUANTEL ANTHELMINTIC Active 175.0 mg/Tb; FEBANTEL CARBAMATE Active 875.0 mg/Tb

Units in package:

2 tablets; 25 tablets; 70 tablets

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: DOG: [GIARDIA SPP., HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - BUNOSTOMUM SPP., HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - LACTATING: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - BUNOSTOMUM SPP., HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - PREGNANT: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - BUNOSTOMUM SPP., HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - PUPPY: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - BUNOSTOMUM SPP., HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; For the control of all gastrointestinal worms: roundworm, hookworm, whipworm and tapeworm in dogs, puppies, pregnant and lactating bitches, and to control the shedding of oocysts of the protozoan Giardia sp in dogs.DOES NOT CONTROL HEARTWORM. TO BE USED BY, OR UNDER THE DIRECTION OF, A REGISTERED VETERINARY SURGEON ONLY.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Drontal
Allwormer
FOR LARGE DOGS
Drontal
Allwormer
FOR LARGE DOGS
FOR ANIMAL TREATMENT ONLY
®
®
7 0 TA B L E T S
®
®
Drontal
Allwormer
FOR LARGE DOGS
®
®
Drontal
Allwormer
FOR LARGE DOGS
®
®
For the control of all gastrointestinal worms:
roundworm, hookworm, whipworm and tapeworm
in dogs, puppies, pregnant and lactating bitches,
and to control the shedding of oocysts
of the protozoan _Giardia_ sp. in dogs.
For the control of all gastrointestinal worms:
roundworm, hookworm, whipworm and tapeworm
in dogs, puppies, pregnant and lactating bitches,
and to control the shedding of oocysts
of the protozoan _Giardia_ sp. in dogs.
Each tablet contains
175 MG PRAZIQUANTEL
174.4 MG PYRANTEL AS PYRANTEL EMBONATE
875 MG FEBANTEL
TO BE USED BY, OR UNDER THE DIRECTION OF,
A REGISTERED VETERINARY SURGEON ONLY.
DRONTAL is recommended for the control of all gastrointestinal worms
in dogs
including:
Roundworm _ Toxocara canis, Toxascaris leonina._
Hookworm
_Ancylostoma caninum, Ancylostoma braziliense_ (This hookworm is
usually restricted to tropical areas in Australia), _Ancylostoma_
_ _
_ceylanicum, Uncinaria stenocephala._
Whipworm
_Trichuris vulpis._
Tapeworm
_Echinococcus granulosus_ (hydatid tapeworm), _Dipylidium caninum_
(common fl ea tapeworm), _Taenia spp., Taenia ovis, T. pisiformis, T._
_ _
_hydatigena._
and to control the shedding of oocysts of the protozoan _Giardia_ sp.
in dogs.Does not
control heartworm _(Dirofi laria immitis)_.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
DOSAGE: 1 tablet per 35kg bodyweight. (Administer this dose once for
worms, and for 3
consecutive days for Giardia). IF WORM PROBLEMS PERSIST, CONSULT A
VETERINARIAN.
DISPOSAL: Dispose of empty container and packaging by wrapping in
paper and putting
in garbage.
WARRANTY: Bayer Australia Limited (BAL) warrants that this product is
of merchantable
quality and fi t for it’s intended purpose indicated on this label.
Notwithstanding anything
else contained on this label, BAL’s liability is limited to
replacing thi

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET

A18187/04/AUS

DRONTAL ALLWORMER FOR LARGE DOGS

SECTION 1 – IDENTIFICATION, CONTACTS

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free

CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
TELEPHONE NUMBER: (02) 9391-6000

Product Name
DRONTAL ALLWORMER FOR LARGE DOGS

Product Use
All purpose intestinal wormer for large dogs.

Other Names
Praziquantel, Pyrantel embonate, Febantel

Creation Date
20
th
May 2003

Revision Date
24 June 2013 (SDS is current for 5 years after this date)

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
HAZARDOUS SUBSTANCE
NON-DANGEROUS GOODS
Risk Phrases
Harmful if swallowed. May cause sensitisation by inhalation and
skin
contact.
Safety Phrases
None
RISK

&

SAFETY

PHRASES

ARE

NOT

REQUIRED

ON

PACKAGES

INTENDED

FOR

END

USERS.

APPROPRIATE

SAFETY

DIRECTIONS

AND

FIRST

AID

STATEMENTS

ARE

SHOWN

ON

THE

PRODUCT

LABEL.

A18187/04/AUS DRONTAL ALLWORMER FOR LARGE DOGS
PAGE 2 OF 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Praziquantel*
55268-74-1
7.6%
(175 mg/tab)
Pyrantel embonate**
22204-24-6
21.8%
(504 mg/tab)
Febantel***
58306-30-2
37.9%
(875 mg/tab)
Other ingredients determined not to be hazardous
-
32.7%
(756 mg/tab)
*Praziquantel
is 2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4H-pyrazino (2,1-a)
isoquinolin-4-one.
**Pyrantel embonate is E)1,4,5,6-tetrahydro-1-methyl-2- (E)-2-(2-thienyl)-vinyl -
pyrimidine-4,4'-methylenebis(3-hydroxy-2-naphthoate).
***Febantel is N-(2-methoxyacetamide-4-phenylthio)-N'N''-bis-methoxycarbonyl-guanidine.

SECTION 4�

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