AFILARIA SR-12 INJECTION Once-a-year Heartworm Preventative for Dogs

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:

MOXIDECTIN

Available from:

FATRO S.P.A.

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MOXIDECTIN ANTHELMINTIC Active 100.0 mg/g

Units in package:

10 mL; 20 mL; 50 mL

Class:

VM - Veterinary Medicine

Therapeutic area:

PARASITICIDES

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [HEARTWORM - PREVENTION OF, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

                                AFILARIA SR-12 INJECTION Once-a-year Heartworm Preventative for Dogs
92818/136737
Product Name:
APVMA Approval No:
Label Name:
AFILARIA SR-12 INJECTION Once-a-year Heartworm Preventative for Dogs
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
[Moxidectin Microspheres Vial]
MOXIDECTIN 100 mg/g
[Vehicle Vial]
HYPROMELLOSE 25 mg/mL
[Carton & leaflet]
MOXIDECTIN 100 mg/g (Microspheres vial)
HYPROMELLOSE 25 mg/mL (Vehicle vial)
The reconstituted suspension contains MOXIDECTIN 10 mg/mL and
HYPROMELLOSE 22
mg/mL when suspended according to directions.
Claims:
For 12 months prevention of heartworm (Dirofilaria immitis) disease in
dogs.
For control of larval and adult infections of canine hookworms
(Ancylostomum caninum and
Uncinaria stenocephala) at the time of treatment and for up to 4
months after treatment.
Control of canine hookworms (Ancylostoma caninum and Uncinaria
stenocephala),
including adult and the L4 larval stages at the time of treatment and
to provide persistent
control of re-infection by these two species of hookworm for up to
four months.
Moxidectin is a macrocyclic lactone of the milbemycin class.
Suspected clinical cases of resistance to anthelmintics should be
investigated using
appropriate tests.
Net Contents:
[Moxidectin Microspheres Vial]
Contains 0.9 [1.8, 4.5] g
Not to be sold separately.
[Sterile Vehicle Vial]
Contains at least 9 [17, 44] mL
[Carton] RLP APPROVED
Contents:
1 vial containing 0.9 [1.8, 4.5] g Moxidectin microspheres (Moxidectin
100 mg/g), plus
1 vial containing at least 9 [17, 44] mL sterile vehicle,
1 adapter for reconstitution and withdrawal [1 syringe and 1 needle].
SMALL [MEDIUM, LARGE]
It is illegal to sell AFILARIA SR-12 Injection Microspheres and
AFILARIA SR-12 Injection
Sterile Vehicle separately.
[Leaflet]
Each SMALL pack of AFILARIA SR-12 contains:
• 1 vial containing 0.9 g AFILARIA SR-12 Moxidectin microspheres
(Moxidectin 100 mg/g),
• 1 vial containing at least 9 mL AFILARIA SR-12 sterile 
                                
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