BAY-O-PET DRONTAL ALLWORMER FOR SMALL DOGS AND PUPPIES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

DOG - PUPPY | DOG - SMALL OR TOY | DOG - SMALL | DOG - TOY

Therapeutic area:

PARASITICIDES

Therapeutic indications:

HOOKWORM | HOOKWORM - ANCYLOSTOMA CANINUM | HOOKWORM - ANCYLOSTOMA CEYLANICUM | HOOKWORM - UNCINARIA STENOCEPHALA | HYDATID TAPEWORM | ROUNDWORM - TOXASCARIS LEONINA | ROUNDWORM - TOXOCARA CANIS | TAPEWORM | TAPEWORM - DIPYLIDIUM CANINUM | TAPEWORM - TAENIA PISIFORMIS | TAPEWORM - TAENIA SPP. | WHIPWORM - TRICHURIS VULPIS | ANCYLOSTOMA BRAZILIENSE | ANCYLOSTOMA CANINUM | ASCARID | DIPYLIDIUM CANINUM | HUMAN INTESTINAL ROUNDWORM | TAENIA HYDATIGENA | TAENIA OVIS | TAENIA PISIFORMIS | TAENIA SPP. | UNCINARIA STENOCEPHALA

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: DOG - PUPPY: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - SMALL OR TOY: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG - PUPPY: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; DOG - SMALL OR TOY: [HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, HYDATID TAPEWORM, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, TAPEWORM, TAPEWORM - DIPYLIDIUM CANINUM, TAPEWORM - TAENIA PISIFORMIS, TAPEWORM - TAENIA SPP., WHIPWORM - TRICHURIS VULPIS]; Controls all 12 gastrointestinal worms and the shedding of Giardia oocysts.Does not control heartworm in dogs

Authorization status:

Stopped

Authorization date:

2022-07-01

Patient Information leaflet

LABEL - FRONT PANEL
Issue Date: 5/4/2011
Page: 1 of 5
_The information above this line is not included in the label _
FOR ANIMAL TREATMENT ONLY
BAY-O-PET
®
DRONTAL
®
ALLWORMER
®
FOR SMALL DOGS AND PUPPIES
Each tablet contains:
15 mg PRAZIQUANTEL, 14.9 mg PYRANTEL as the EMBONATE, 75 mg FEBANTEL
Controls all 12 Gastrointestinal Worms and the shedding of Giardia
oocysts
_ (dog photo) _
DOES NOT CONTROL HEARTWORM IN DOGS
One tablet treats 3 kg
4 TABLETS RLP APPROVED
Info
PEST


Verified
LABEL – INNER PANELS
Issue Date: 5/4/2011
Page: 2 of 5
_The information above this line is not included in the label _
BAY-O-PET
®
DRONTAL
®
ALLWORMER
®
FOR SMALL DOGS AND PUPPIES
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 flea 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 in dogs
DIRECTIONS FOR USE
Fasting prior to dosing is not necessary. IT IS ESSENTIAL TO WEIGH
DOGS BEFORE
TREATMENT.
For intestinal worms - DRONTAL is given as a single dose by mouth.
See Dosing Recommendations below
DOSAGE
Bodyweight
Tablets
TO REMOVE TABLET PUNCH
THROUGH FROM FRONT
500 g – 1.5kg
½
1.6 – 3 kg
1
TAMPER EVIDENT PACK
3.1 – 6 kg
2
6.1 – 9 kg
3
IF WORM PROBLEMS PERSIST, CONSULT A VETERINARIAN.
For Giardia infection - Administer the above dosage for three
consecutive days. DRONTAL should
ONLY
be used when a
_Giardia_
sp. infection has been diagnosed by a veterinarian.
HYDATID TAPEWORM
A single dose of DRONTAL is all that is required. Dogs in hydatid
areas should be treated every 6
weeks to ensure that newly acquired hydatid tapew

Summary of Product characteristics

PAGE 1 OF  6

SAFETY DATA SHEET 

     A18051/09/AUS  

BAY-O-PET 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: [phone]  

Product Name 
BAY-O-PET 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 2103 (SDS is current for 5 years from 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.

A18051/09/AUS 
BAY-O-PET 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) 
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

Safety Data Sheet

HYDATID TAPEWORM
A single dose of DRONTAL is all that is
required. Dogs in hydatid areas should be
treated every 6 weeks to ensure that newly
acquired hydatid tapeworms are expelled
before reaching maturity.
DOGS SHOULD NOT BE FED, OR ALLOWED TO FEED
ON, OFFAL FROM ANY SPECIES. DOGS IN HYDATID
AREAS SHOULD BE TREATED EVERY 6 WEEKS.
It is important to ensure that the dog does not
acquire offal in order to break the life cycle of
the hydatid tapeworm. It should be noted that
hydatid tapeworm poses a severe risk to
human health by transmission to humans from
infected dogs.
HOOKWORMS & ROUNDWORMS
J
Dogs & Puppies: TREAT AT 2, 4, 8 AND
12 WEEKS and then every month until
six months of age; THEREAFTER EVERY
3 MONTHS or on veterinary advice.
J
Pregnant Bitches: TREAT AT MATING,
THEN 10 DAYS BEFORE WHELPING, at
2 and 4 weeks after whelping, THEN
EVERY 3 MONTHS.
WHIPWORMS
TREAT EVERY 6 TO 8 WEEKS AFTER 3 MONTHS OF AGE.
TAPEWORMS
TREAT EVERY 3 MONTHS except in hydatid
tapeworm areas where every 6 weeks is
recommended, or on veterinary advice.
_Dipylidium caninum_ tapeworms are
transmitted by fleas. Control of this tapeworm
will require effective control of the local flea
population. Worms, if present, may not appear
in the droppings at all, or may not appear for
up to 48hrs after treatment.
GIARDIA
This protozoan parasite is found commonly in
dogs and may be the cause of diarrhoea,
particularly in pups. It is more common
amongst dogs living in multi-dog households
and kennels. _Giardia_ also occurs in humans
and has historically been considered a
potential zoonosis, however recent studies
suggest that host-specific species may exist.
Control of _Giardia_ is difficult because the
oocysts are resistant and long-lived in the
environment. Diagnosis of suspected _Giardia _
infection should be confirmed by a veterinary
surgeon. Some evidence indicates that
bathing and a move to a non-contaminated
environment in conjunction with treatment
will improve overall control.
COMPATIBILITY
DRONTAL Chewable may be combined
with other trea