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Guardian® SR Injectable
- The first injectable endectocide based on moxidectin for the prevention and treatment of Dirofilaria immitis in dogs, also known as heartworm and to treat the infestations produced by larvae or adult stages of Ancylostomum caninum and Uncinaria stenocephala present at the moment of the dirofilariosis prevention.
- Its unique sustained release Moxidectin formulation in microspheres allows one treatment to last for the whole heartworm season, as opposed to the other available products that require monthly oral administration.
- Moxidectin is a parasiticide active against a wide range of internal and external parasites and it is a second generation macrocyclic lactone of the milbemycin family.
- The product is very safe and can be administered to dogs as young as 12 weeks of age.
Description
| Active Ingredients per 100 g of microsphere: | |
|---|---|
| Moxidectin | 10 mg |
| Excipients: | |
| Glyceryl tristearate q.b a | 100 |
| Vehicle per 100 ml | |
| Sodium chloride | 0,9 g |
When constituted with vehicle (17 ml) the final suspension contains
3.4 mg/moxidectin/ml
Indications
- For the prevention of heartworm (D. immitis).
- For the treatment of larval and adult infections of canine hookworms (Ancylostomum caninum and Uncinaria stenocephala) present at time of prevention of heartworm.
CONTRAINDICATIONS
- Do not use in dogs less than twelve weeks of age.
- Do not administer by IV route.
ADVERSE REACTIONS
In a limited number of cases can be present a slight pain at site of injection, or a mild
transient swelling at the site of injection (2-3 weeks) have been observed.
GUARDIAN® SR Injectable is safe also to ivermectin sensitive dogs
and to animals testing positive for heartworm.
On very rare occasions, hypersensitivity reactions like local (e.g. face, mucosae,
legs, testicle, palpebral, lip) or generalized angioedema, urticaria, pruritus or anaphylaxis
may occur. Also very rare cases of diarrhoea and vomiting and transient ataxia, tremor or
lethargy have been reported.
TARGET SPECIES
Dogs.
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
GUARDIAN® SR Injectable should be administered at dose of 0.17 mg of moxidectin per
kg bodyweight as single dose by subcutaneous injection, i.e. 0,05ml of the final suspension for
injection per kg bodyweight. When administered within one month of the starting activity of
the intermediate host (mosquito) GUARDIAN® SR injectable has shown persistent efficacy over
the seasonal period of risk for heartworm in Europe.
Persistent preventative efficacy of GUARDIAN® SR injectable versus A. caninum and U. stenocephala
has not been determined.
For growing dogs between 12 weeks and 9 months of age the following procedure is indicated:
Administer the full dose of constituted product considering the body weight of the dog at time of
treatment. Do not overdose in anticipation of the pup's expected future weight. Because of the
rapid change in bodyweight expected for puppies of 12 weeks of age, an additional treatment might
be required to insure full protection. Use according to a risk assessment by a responsible veterinarian.
Subsequently seasonal treatment may coincide with the dogs' annual vaccination.
The following table may be used as a guide to dosage:
| Dog b.w. (kg) | Dose volume (ml) |
|---|---|
| 1 | 0.05 |
| 5 | 0.25 |
| 10 | 0.50 |
| 15 | 0.75 |
| 20 | 1.00 |
| 25 | 1.25 |
| 30 | 1.50 |
| 35 | 1.75 |
| 40 | 2.00 |
| 45 | 2.25 |
| 50 | 2.50 |
| 55 | 2.75 |
| 60 | 3.00 |
| 65 | 3.25 |
Dogs over 65 kg receive 0.25 mL for each additional 5 kg body mass.
If a dosage of GUARDIAN® SR injectable is substituting for monthly heartworm preventative treatment,
its first dose should be administered within one month from last treatment.
Each package contains moxidectin 10% microspheres and vehicle vials with needles for air inflow and syringe.
Mixing instructions:
- Withdraw part of sterile vehicle from the vial labelled Vehicle for GUARDIAN® SR Injectable and do not use any other vehicle.
- Insert the vent needle provided in the package into the vial GUARDIAN® SR Injectable moxidectin to facilitate the exit of air and then of the product.
- Gently transfer the sterile vehicle into the microsphere vial, (if added to quickly some of vehicle could come out).
- Once the sterile vehicle has been added, remove the vent and transfer needles from the microsphere vial.
- Shake the microsphere vial thoroughly until an evenly mixed suspension is ready.
- Allow the suspension to stand for at least 10 minutes to allow large air bubbles to dissipate.
- Record the date of mixing on the microsphere vial for shelf life purpose.
- Before every use, gently swirl the mixture to achieve a uniform suspension.
- Administer promptly after filling the syringe. If administration is delayed, gently rock the syringe prior to injection to maintain an even suspension of microsphere and ensure accurate dosing.
- Use an appropriately sized sterile syringe with an 18G or 20G x 1 inch needle for administration. (A 20 gauge needle is recommended for dogs less than 20 kg, and an 18 gauge for those over 20 kg).
WITHDRAWAL PERIOD
Not applicable.
SHELF LIFE
Shelf-life of the veterinary medicinal product as packaged for sale: 36 months
Shelf-life after reconstitution 28 days stored at 2-8°C
SPECIAL STORAGE PRECAUTIONS
Do not freeze.
Do not store above 25°C
Keep the container in the outer carton, do not expose to light.
After the first broaching the product has to be kept at temperature of 2°C-8°C.
SPECIAL WARNINGS
Special precautions for use in animals:
GUARDIAN® SR injectable heartworm prevention should be only used in dogs testing negative for the presence of
heartworm infection. Prior to initiating treatment with GUARDIAN®SR injectable, infected dogs should be
treated to remove adult heartworm and microfilaria. These treatments should be carried out under the responsibility
of the Veterinary Surgeon.
Special precautions to be taken by the person administering the product:
Avoid contact with skin and eyes
Wash hands after use
Take care to avoid self-injection. Seek prompt medical attention in case of accidental self-injection: treat
any specific signs symptomatically.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product
should be disposed of in accordance with local requirements.
OTHER INFORMATION
ATC Vet Code- QP 54 AB02
Nature and composition of immediate packaging
Moxidectin Microsphere vial: Glass vial of 20 ml containing not less than 538 mg of moxidectin microsphere (equal to 59.2 mg of moxidectin).
Vehicle vial: Glass vial of 20 ml containing not less than 17 ml of vehicle.
Syringe and needles.
