DRONTAL ALLWORMER FOR SMALL DOGS & PUPPIES

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(15mg/Tb)+pyrantel as pamoate(14.9mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

PYRANTEL AS PYRANTEL EMBONATE ANTHELMINTIC Active 14.9 mg/Tb; PRAZIQUANTEL ANTHELMINTIC Active 15.0 mg/Tb; FEBANTEL CARBAMATE Active 75.0 mg/Tb

Units in package:

4 tablets; 50 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, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - LACTATING: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - PREGNANT: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - PUPPY: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HYDATID TAPEWORM, 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.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
®
®
5 0 TA B L E T S
FOR SMALL DOGS
AND PUPPIES
Drontal
Allwormer
®
®
FOR SMALL DOGS
AND PUPPIES
Drontal
Allwormer
®
®
FOR SMALL DOGS
AND PUPPIES
Drontal
Allwormer
®
®
FOR SMALL DOGS
AND PUPPIES
FOR ANIMAL TREATMENT ONLY
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
15 MG PRAZIQUANTEL
14.9 MG PYRANTEL AS PYRANTEL EMBONATE
75 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 3kg 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,

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET

A18186/04/AUS

DRONTAL ALLWORMER FOR SMALL DOGS & PUPPIES

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 SMALL DOGS & PUPPIES

Product Use
All purpose intestinal wormer for small dogs and puppies.

Other Names
Praziquantel, Pyrantel embonate, Febantel

Creation Date
25
th
June 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.

A18186/04/AUS DRONTAL ALLWORMER FOR SMALL DOGS & PUPPIES
PAGE 2 OF 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Praziquantel*
55268-74-1
7.6%
(15 mg/tab)
Pyrantel embonate**
22204-24-6
21.8%
(43.2 mg/tab)
Febantel***
58306-30-2
37.9%
(75 mg/tab)
Other ingredients determined not to be hazardous
-
32.7%
(64.8 mg/tab)
*Praziquantel is 2-(cyclohexylcarbonyl)-1,2,3,6,7,llb-hexahydro-4H-pyrazino- 2,1-a
isoquinoline-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).
***Fe

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