DRONTAL WORMING SUSPENSION FOR PUPPIES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

30-11-2023

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

PYRANTEL EMBONATE; FEBANTEL

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

febantel(15mg/mL)+pyrantel as pamoate(5mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

PYRANTEL EMBONATE ANTHELMINTIC Active 14.4 mg/ml; FEBANTEL CARBAMATE Active 15.0 mg/ml

Units in package:

25mL; 30mL; 50mL

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:

Product summary:

Poison schedule: 0; Withholding period: ; Host/pest details: DOG - PUPPY: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, WHIPWORM - TRICHURIS VULPIS]; DOG - SMALL OR TOY: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 0; Withholding period: WHP:N/A; Host/pest details: DOG - PUPPY: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, WHIPWORM - TRICHURIS VULPIS]; DOG - SMALL OR TOY: [HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, WHIPWORM - TRICHURIS VULPIS]; For the control of roundworms, hookworms and whipworms in puppies and small dogs.Does not control tapeworms or heartworm.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DRONTAL WORMING SUSPENSION FOR PUPPIES
48642/141167
Product Name:
APVMA Approval No:
Label Name:
DRONTAL WORMING SUSPENSION FOR PUPPIES
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
15 mg/mL FEBANTEL
14.4 mg/mL PYRANTEL EMBONATE (equivalent to 5mg PYRANTEL base)
Claims:
For the control of roundworms, hookworms and whipworms in puppies and
small dogs.
Drontal Puppy Suspension contains pyrantel embonate a
tetrahydropyrimidine
anthelminthic and febantel is a pro-benzimidazole belonging to the
class of benzimidazoles.
Drontal Suspension is recommended for the control of gastrointestinal
worms in puppies
and small dogs including:
Roundworms -
Toxocara canis
,
Toxascaris leonina
Hookworm -
Ancylostoma caninum
,
A. braziliense
(this hookworm is usually restricted to
tropical areas of Australia),
A. ceylanicum
and
Uncinaria stenocephala
.
Whipworm -
Trichuris vulpis
.
Does not control heartworm in dogs.
Does not control hydatid tapeworms (
Echinococcus granulous
).
If worm problems persist consult a veterinarian.
Net Contents:
25 mL
30 mL
50 mL
Directions for Use:
Restraints:
Contraindications:
This product is not formulated for cats and is not recommended for
this use.
Precautions: RLP APPROVED
Side Effects:
In very rare cases mild transient digestive tract disorders (e.g.
vomiting, diarrhoea) may
occur after treatment.
Dosage and
Administration:
SHAKE WELL BEFORE USE.
Give as a single dose by mouth using the enclosed dosing syringe.
Fasting prior to dosing
is NOT necessary. It is essential to weigh dogs before treatment.
Dosage: 1 mL/kg bodyweight. This corresponds to 15 mg/kg febantel and
14.4 mg/kg
pyrantel embonate.
Hookworms and Roundworms
Puppies and small dogs: Treat at 2, 4, 6, 8, 10 and 12 weeks of age
and then every month
until six months of age thereafter every 3 months or on veterinary
advice. Use Drontal
Tablets for larger dogs where appropriate and based on dog’s size.
Whipworms
Treat every 6 to 8 weeks after 3 months of age.
Dogs can become reinfested with worms and treatment should

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET


  A18148/07/AUS

DRONTAL WORMING SUSPENSION FOR 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 WORMING SUSPENSION FOR PUPPIES

Product Use
Worming suspension for puppies and small dogs.

Other Names
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. Irritating to eyes and skin. 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.

A18148/07/AUS DRONTAL WORMING SUSPENSION FOR PUPPIES
PAGE 2 OF 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Pyrantel embonate*
22204-24-6
1.44%
Febantel**
58306-30-2
1.5%
Dioctylsodium sulfosuccinate
577-11-7
0.04%
Citric acid
77-92-9
0.15%
Other ingredients determined not to be hazardous
-
10 - <30%
Water
-
>60%
*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 – FIRST AID MEASURES
Label Regulated First
Aid Stateme

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