ADVICE SUMMARY
PRODUCT APPLICATION
Product name:
Applicant:
Product number:
Application number:
PROHEART SR-12 INJECTION ONCE-A-YEAR HEARTWORM PREVENTATIVE FOR DOGS
FORT DODGE AUSTRALIA PTY LIMITED
51805
36168
Purpose of Application and Description of Use:
Active Constituent(s):
Variation of the label approval to include additional technical safety claims.
MOXIDECTIN MICROSPHERES
Regulatory Decision:
To grant the application subject to the following conditions:
Standard Conditions of Registration/Approval
1. Label must contain an Expiry Date and Batch Number (Vet only)
For full conditions, refer to http://www.apvma.gov.au/data_protection/adv_summaries.shtml.
36168
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ADVICE
External Efficacy Reviewer
This submission included one published reference to support that growth assumptions were reasonable and that all breed categories of dogs, inclusive of large
and giant breeds, were represented in the efficacy trial; one trial that investigated prophylactic efficacy against Dirofilaria immitis in puppies 12 weeks old; and
five safety studies. Trial design, experimental conditions, analysis of trial data and trial validation were adequate. The Australian registered formulation was
used in the safety trials, but not in the efficacy trial. Arguments justifying the use of the US registered formulation were acceptable.
In the efficacy trial 12-week old puppies were treated with the US-registered formulation then infected 180 days later with third stage larvae of Dirofilaria
immitis subcutaneously. After a further 169-189 days the puppies were euthanised and examined for the presence of adult heartworms. The level of efficacy
achieved is acceptable and is consistent with the approved claim for prevention of heartworm disease, as well as the WAAVP Guidelines for Evaluating the
Efficacy of Anthelmintics for Dogs and Cats. The trial results together with the published reference and arguments support a claim for heartworm prophylaxis
for Proheart SR-12 Injection that includes first treatment of puppies at 3 months of age, followed by a second dose 6 months later then annual treatment
thereafter.
Five safety studies were conducted to support that Proheart SR-12 Injection is safe for use in breeding animals, including pregnant and lactating bitches, and
breeding male dogs; heartworm positive dogs; ivermectin-sensitive collies; and 12-week old puppies.
One study explored the reproductive safety in female beagle dogs that were treated with Proheart SR-12 Injection at 3X the recommended label dose during
pre-mating, mating, mid-gestation and lactation. The product had no adverse effects on females, their breeding behaviour or reproductive capacity, or on their
offspring, when administered at various stages of the reproductive cycle.
A second reproductive study investigated the effect of Proheart SR-12 Injection on total sperm per ejaculate, total normal sperm per ejaculate, total progressive
motility, and total progressive motile sperm per ejaculate of intact male beagle dogs. At 3X the recommended dose rate, Proheart SR-12 Injection had no
observed effect on the males or on seminal quality.
A third study examined the safety of Proheart SR-12 Injection when adult dogs were implanted with adult heartworms and had high levels of circulating
microfilariae. Treatment at 61days post-implantation with 3X the label dose of the product showed no adverse reactions or health effects.
In a fourth study, ivermectin-sensitive collies were treated with Proheart SR-12 Injection at 1X, 3X and 5X the label dose. The dogs were observed once prior
to treatment and then at regular intervals up to 24 hours post-treatment for ivermectin-like signs of clinical toxicosis. None of the treated dogs showed signs of
adverse reactions.
36168
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Twelve-week old puppies in a fifth trial were treated with Proheart SR-12 Injection at either 1X and 3X the label dose. The pups were observed for adverse
reactions up to 21 days post-treatment. No clinically apparent adverse effects were observed during the observation period.
Data from these safety studies justify the additional safety claims.
Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
144
S
K. Heaney
6017
S
147
S
A.J Hawthorne, D
Booles, P.A Nugent,
G Gettinby and J
Wilkinson
R. Dino Rulli
148
S
R. Dino Rulli
149
S
R. Dino Rulli
150
S
R. M. Cleale
146
S
M. Holm-Martin
Title
Date
Data Type
Authorising
Party
The Six Month Prophylactic Activity Against
Dirofilaria immitis Infection of ProHeart« 6
(Moxidectin Canine SR Injectable)
Administered to 12 Week Old Puppies
Body-Weight Changes During Growth in
Puppies of Different Breeds
20 Oct
2004
Efficacy and Safety
Efficacy
Applicant
2004
Efficacy and Safety
Efficacy
Public
A Reproductive Study of ProHeart 12
(Moxidectin Canine Sustained Release
Injectable) in Female Beagle Dogs
Effect of ProHeart 12 (Moxidectin Canine
Sustained Release Injectable) on the Seminal
Quality in Male Beagles
Clinical Observations Following the
Administration of ProHeart 12 (Moxidectin
Canine Sustained Release Injectable) Given at
3X to Dogs with Implanted Adult Heartworm
(Dirofilaria immitis) Infections in Georgia
Clinical Observations from the Administration
of ProHeart 12 (Moxidectin Canine Sustained
Release Injectable) to Ivermectin-Sensitive Dogs
Safety Overdose Study of Moxidectin 10%
Sustained Release Injectable in Dogs at 12
Weeks of Age
1 Dec
03
Efficacy and Safety
Target Animal Safety
Studies
Applicant
7 Jan
2004
Efficacy and Safety
Target Animal Safety
Studies
Applicant
12 Feb
2004
Efficacy and Safety
Target Animal Safety
Studies
Applicant
30 Sep
2003
Efficacy and Safety
Target Animal Safety
Studies
Applicant
26 Apr
2001
Efficacy and Safety
Target Animal Safety
Studies
Applicant
* S = Data submitted with the application
36168
Data Sub-type
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Inherited
Application
No.
I = Data inherited (that is, referenced) from another application
36168
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