Page 36 - Randlab Global Product Brochure

36 High Performance Endectocide
Joint Therapies
UNDER DEVELOPMENT
Pro-Cardia® 365INJeCtION ONCe-A-yeAR HeARtWORM PReVeNtAtIVe FOR DOGs
For the 12 month prevention of heartworm disease in dogs
ACTIVE CONSTITUENT
Moxidectin 100 mg/g
Moxidectin 10 mg/mL when suspended according to directions
PACK SIZE
10mL, 20mL and 50mL vials
Indications
For the control of larval and adult infections of canine hookworms at the time of treatment and for up to 4 months after treatment.
2. Usingthesterile18Gx1inchneedleandthesterilesyringe provided, withdraw 8 mL of sterile vehicle from the vial labelled Pro-Cardia 365 Injection Sterile Vehicle. (There is more than the required 8 mL of vehicle supplied in the vial).
3. Insert the 25 G x 1⁄2 inch vent needle provided into the vial labelled Pro-Cardia 365 Injection Microspheres to act as a vent.
4. Transfer the sterile vehicle into the microsphere vial using the transfer needle and syringe.
5. Once the sterile vehicle has been added, remove the vent and transfer needles from the microsphere vial. Discard unused vehicle and needles (see disposal directions below). Do not leave the vent needle in the bottle after suspending.
6. Shakethemicrospherevialthoroughlyuntilanevenlymixed suspension is produced (for approximately 30 seconds).
7. Allow the suspension to stand for at least 10 minutes
(preferably 30 minutes) to allow large air bubbles to dissipate.
8. Recordthedateofmixingonthemicrospherevial.
9. Before every use, gently swirl the mixture to achieve a
uniform suspension. The microspheres and sterile vehicle
will gradually separate and sediment out on standing.
10.Use an appropriately sized sterile syringe with an 18 G or 20 G 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). Administer promptly after filling the syringe. If administration is delayed, gently rock the syringe prior to injection to maintain an even suspension of
microspheres and ensure accurate dosing.
11.Store unused product under aseptic conditions at 2-8°C
(Refrigerate. Do not freeze). Protect from direct light. The suspended product remains stable for 8 weeks under these storage conditions.
MIXING DIRECTIONS (Large Pack)
Follow the same directions as those for the small vial, except that 40 mL of sterile vehicle should be transferred to the microsphere vial.
Dosage & Administration
Recommended for use in dogs from 12 weeks of age. Administer 1 mL of suspension per 20 kg body weight subcutaneously to provide a dose of 0.5 mg moxidectin/kg body weight.
Rock the syringe to maintain the suspension and inject subcutaneously under the loose skin on the dorsum or the side of the neck, anterior to the scapula. To maintain full protection in adult dogs, repeat the treatment every 12 months.
First Aid: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126 or in New Zealand 0800 764 766.
Disposal: Dispose of empty container by wrapping with paper and putting in garbage. Discarded needles should be immediately placed in a designated and appropriately labelled ‘sharps’ container. Please note instruction leaflet and cardboard carton only are recyclable.
Storage: Before suspending, store below 30°C (room temperature). Product suspended for injection as directed may be stored for up to 8 weeks between 2 and 8°C (Refrigerate. Do not freeze).
Contents
Each small pack contains:
• 1 vial containing 0.9 g Pro-Cardia 365 Injection microspheres
(100 mg/g moxidectin).
• 1 vial containing at least 9 mL Pro- Cardia 365 Injection sterile vehicle (use only 8 mL when suspending).
• 1 transfer needle and syringe.
• 1 vent needle.
Directions For Use
Each large pack contains:
• 1 vial containing 4.5 g Pro-Cardia 365 Injection microspheres
(100 mg/g moxidectin).
• 1 vial containing at least 44 mL Pro- Cardia 365 Injection sterile vehicle (use only 40 mL when suspending).
• 1 transfer needle and syringe. • 1 vent needle.
PRECAuTIONS: Do not inject suspended product intravenously. Use aseptic technique at all times. In a small number of cases, there may be short-lived pain at the time of injection or slight transient (1-2 weeks) swelling at the site of injection. Allergic reactions such as anaphylaxis (facial and aural swelling, urticaria, vomiting) occur rarely and may require parenteral treatment with an antihistamine, a corticosteroid or adrenalin as appropriate.
MIXING DIRECTIONS (Small Pack)
1. Use only the Pro-Cardia 365 Injection sterile vehicle provided in this pack. Do not
substitute with other solutions of any type.
www.randlab.com.au
Pro-Cardia is a registered trademark of Ferrari Animal Health.
36