Suprelorin
Active substance
ATC code
Species
Dog, cat (male).
Indications
Male dog:
For the induction of temporary infertility in healthy, intact, sexually mature male dogs.
Prepubertal female dog:
For the induction of temporary infertility to delay the first oestrus and heat signs, and to prevent pregnancy at a young age in intact and healthy sexually immature female dogs. The implant should be administered between 12 and 16 weeks of age.
Male cat:
For the induction of temporary infertility and suppression of urine odour and of sexual behaviours such as libido, vocalisation, urine marking, and aggressiveness in intact male cats from 3 months of age.
Dose to be administered and administration route
Subcutaneous use.
The recommended dose is one implant per dog or cat, irrespective of the size of the dog or the cat (see also point 4.4).
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction of infection. If the hair is long, a small area should be clipped, if required.
The veterinary medicinal product should be implanted subcutaneously under the loose skin on the back between the lower neck and the lumbar area. Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
1. Remove Luer Lock cap from the implanter.
2. Attach the actuator to the implanter using the Luer Lock connection.
3. Lift the loose skin between the shoulder blades. Insert the entire length of the needle subcutaneously.
4. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
5. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.
6. Examine the syringe and needle to ensure that the implant has not remained within the syringe or needle, and that the spacer is visible. It may be possible to palpate the implant in situ.
Repeat administration every 6 months to maintain efficacy in male dogs and every 12 months to maintain efficacy in male cats.
Do not use the veterinary medicinal product if the foil pouch is broken.
The implant is biocompatible and does not require removal. However, should it be necessary to end treatment, the implant or its fragments may be surgically removed by a veterinarian. Implants may be located using ultrasound.
Adverse reactions
All target species:
Prepubertal surgical gonadectomy as well as prepubertal hormonal suppression may delay physeal closure in long-bones, typically without clinical or pathological consequences.
Dog (male and female):
Moderate swelling or scabbing at the implant site was commonly observed for 14 days during safety/efficacy studies. Local dermatitis lasting up to 6 months was commonly reported in a field trial.
During the treatment period, rare clinical effects have been reported:
Hair coat disorders (e.g. hair loss, alopecia, hair modification), urinary incontinence, down-regulation associated signs (e.g. decrease in testicle size, reduced activity, weight gain) have been reported rarely during the treatment period.
A testicle may be able to ascend up through the inguinal ring , in very rare cases.
Transitory increased sexual interest, increased testicle size and testicular pain immediately following implantation were reported very rarely. These signs resolved without treatment.
Transient behavioural change with the development of aggression have been reported very rarely (see section 4.4).
In humans and animals, sexual hormones (testosterone and progesterone) modulate seizure susceptibility. Epileptic seizures have been observed very rarely and have been reported on average 40 days after implantation, the median time to onset of signs was 14 days after implantation, on the same day of implantation at the earliest, and 36 weeks after implantation at the latest.
Cat:
Local reactions consisting of redness and pain or heat on the day of implantation, that were transient, were commonly observed. Swellings (<5mm) were commonly seen for up to 45 days, in a field study. Severe swelling (>4 cm) lasting for more than 7 months was reported in 1 out 18 cats in a laboratory study.
Increased sexual activity and roaming may be observed transiently in mature male cats during the first weeks post implantation
Increased food intake and increase of body weight are known to be associated with neutering. Some treated cats increase their body weight up to 10% during the period of effect.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
