Suprelorin 4.7 mg ( deslorelin acetate) – 2 chips and applicator for injection
COMPOSITION AND FORM OF RELEASE
The non-steroidal contraceptive contains 4.7 mg of deslorelin (acetate) as an active ingredient. Excipients: hydrogenated palm oil, lecithin, anhydrous sodium acetate.
The drug is a white or pale yellow cylindrical implant inserted under the skin by a veterinarian.
The implant is supplied in pre-loaded implanter needles. Each needle is packed in a sealed sterile package.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: gonadotropin-releasing hormone (LH).
Suprelorin is a non-steroidal contraceptive.
GnRH antagonist deslorelin acts by suppressing the function of the pituitary gland, germ cells when used in low, continuous doses. This leads to suppression of the ability of experimental animals to synthesize and/or release follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which are responsible for maintaining fertility. Continuous release from the implant of low doses of deslorelin reduces the functionality of the male genital organs, libido, and spermatogenesis. The decrease in plasma testosterone levels occurs 4-6 weeks after implantation. A short-term (passing) increase in plasma testosterone can occur immediately after implantation. Measurement of plasma testosterone concentrations demonstrated a persistent pharmacological effect of the continuous presence of deslorelin for at least six months after drug administration.
Peak plasma levels of deslorelin have been shown to occur 7 to 35 days after implant placement. The drug can be measured in plasma up to about 2.5 months after implantation. Deslorelin is rapidly metabolized.
INDICATIONS
Used to induce temporary infertility in healthy, mature male dogs, cats, and ferrets. Temporary sterilization is indispensable in the case when the mating of the animal is undesirable at the present time (for example, cattery owners) or simply the owners of the animals do not want to surgically castrate their pet.
The introduction of the implant allows you to suppress sexual function, for at least 6 months.
In addition, Suprelorin is used to treat diseases of the adrenal glands (a common problem in ferrets).
DOSES AND METHOD OF APPLICATION
The route of administration is subcutaneous. Similar to the procedure for microchipping animals. The recommended dose is one implant per dog, regardless of size. When administering the drug, aseptic and antiseptic measures must be observed. If the hair is long, a small section should be trimmed if required. Remove the protective cap at the base of the needle. Attach the needle to the implanter with a threaded connection.
Suprelorin can be implanted under the skin on the back between the neck and the lumbar region. Avoid inserting the implant into fat, as the release of the active substance may be impaired in areas of low vascularity. Lift the area of skin between the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the plunger and slowly withdraw the needle. Apply pressure to the skin at the insertion site while the needle is removed and maintain pressure for 30 seconds. Check the syringe and needle to make sure that the implant is not left in the needle and that the spacer is visible. It may be possible to feel the implant at the insertion site.
Repeat the procedure every six months to maintain effectiveness. Biocompatible implants do not require removal. However, if it is necessary to stop treatment, the implant can be removed surgically. It can be detected using ultrasound.
Special Warnings: Infertility is achieved 6 weeks after injection and lasts at least 6 months after injection. Treated males should continue to be kept away from bitches for the first six weeks after implant placement. Any mating, if it occurs more than six months after the administration of the drug, can lead to pregnancy. If the product is administered every 6 months, bitches and males can be kept together. The ability of dogs to produce offspring after their return to normal plasma testosterone levels after administration of the drug has not been investigated. In terms of testosterone levels (a surrogate marker of fertility), in clinical studies more than 80% of dogs after the management of one or more implants returned to normal plasma testosterone levels (= 0.4 ng/mL) within 12 months. 98% of dogs returned to normal plasma testosterone levels within 18 months of implantation. However, there is limited evidence of complete reversibility of the clinical effect (reduced testicular size, decreased ejaculatory volume, reduced sperm count, and reduced libido), including fertility after six months or re-implantation, is limited. During clinical trials, most smaller dogs (less than 10 kg) maintained low testosterone levels for more than 12 months after implantation. For very large dogs (>40 kg), data are limited, but the duration of testosterone suppression was comparable to that in medium to large dogs. evidence of complete reversibility of the clinical effect (reduced testicles, reduced ejaculatory volume, decreased sperm count, and reduced libido), including fertility after six months or re-implantation, is limited. During clinical trials, most smaller dogs (less than 10 kg) maintained low testosterone levels for more than 12 months after implantation. For very large dogs (>40 kg), data are limited, but the duration of testosterone suppression was comparable to that in medium to large dogs. evidence of complete reversibility of the clinical effect (reduced testicles, reduced ejaculatory volume, decreased sperm count, and reduced libido), including fertility after six months or re-implantation, is limited. During clinical trials, most smaller dogs (less than 10 kg) maintained low testosterone levels for more than 12 months after implantation. For very large dogs (>40 kg), data are limited, but the duration of testosterone suppression was comparable to that in medium to large dogs. most smaller dogs (less than 10 kg) maintained low testosterone levels for more than 12 months after implantation. For very large dogs (>40 kg), data are limited, but the duration of testosterone suppression was comparable to that in medium to large dogs. most smaller dogs (less than 10 kg) maintained low testosterone levels for more than 12 months after implantation. For very large dogs (>40 kg), data are limited, but the duration of testosterone suppression was comparable to that in medium to large dogs.
The use of Suprelorin in dogs less than 10 kg or more than 40 kg should be evaluated by a veterinarian.
Overdose (symptoms, emergency measures, antidotes): No adverse reactions were observed after simultaneous subcutaneous injection of up to 10 implants.
SIDE EFFECTS
Moderate swelling at the implant site may be observed for up to 14 days.
Some males histologically showed a local reaction with chronic inflammation of the connective tissue and the formation of a collagen capsule 3 months after injection. A significant reduction in the size of the testes will be seen during the entire period of treatment. In very rare cases, the testicle can rise above the external inguinal ring.
CONTRAINDICATIONS
Use during pregnancy, lactation is unacceptable.
SPECIAL INSTRUCTIONS
Interaction with other drugs: Not known.
Special Precautions:
The use of the product in adolescent dogs has not been studied. Therefore, it is recommended that dogs should be fully mature prior to initiation of Suprelorin. The data show that the product can reduce the dog’s libido, but other behavioral changes (eg, those associated with aggression) have not been investigated.
Special precautions for the destruction of veterinary medicinal products:
Any unused veterinary medicinal product and waste derived from such veterinary medicinal products must be disposed of in accordance with local requirements.
The drive can be reused.
Personal Safety Measures
Special precautions must be taken by those handling this veterinary medicinal product.
Pregnant women should not work with the drug.
Specific studies to evaluate the effect of deslorelin when taken during pregnancy have not been conducted.
Although skin contact with the product is unlikely, if this occurs, flush the affected area immediately as GnRH analogs may be absorbed through the skin.
When handling Suprelorin, be careful to avoid accidental self-injection. The animal must be properly restrained and the drug needle must be protected until implantation. In case of accidental self-injection, seek medical advice immediately.
Storage conditions
Store the drug in a closed package of the manufacturer, in a dark place, out of reach of children and animals, separate from food and feed at a temperature of 2 ° C to 8 ° C. Do not freeze.
Do not use the product if the packaging is broken