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Date: Tuesday, December 1, 2020 9:32

Description: Virbac 2013
Release 2.18
Suprelorin 9.4 mg Implant for Dogs and Ferrets
 
Species: Dogs, Ferrets
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: GnRH products
Active ingredient: Deslorelin Acetate
Product:Suprelorin 9.4 mg Implant for Dogs and Ferrets
Product index: Suprelorin 9.4mg Implant for Dogs & Ferrets
Qualitative and quantitative composition
9.4mg deslorelin (as deslorelin acetate)
Pharmaceutical form
White to pale yellow cylindrical implant
Clinical particulars
Target species
Dogs (male) and ferrets (male)
Indications for use
For the induction of temporary infertility in healthy, entire, sexually mature male dogs for up to at least 12 months and ferrets for up to 4 years. Insert one implant per dog or ferret, irrespective of size.
Contra-indications
None
Special warnings for each target species
Dogs
Infertility is achieved from 8 weeks up to at least 12 months after initial treatment. Treated dogs should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals are not capable of successfully siring offspring.
Should a treated dog mate with a bitch between 8 and 12 weeks after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Any mating that occurs more than 12 months after the administration of Suprelorin may result in pregnancy. However, it is not necessary to keep bitches away from treated dogs following subsequent implantations for the initial 8 week period, provided that the veterinary medicinal product is administered every 12 months.
In certain cases, the implant may be lost from a treated dog. If loss of the implant is suspected in connection with the first implantation, this can be confirmed by observing no reduction in scrotal circumference or plasma testosterone levels after 8 weeks from the suspected date of loss, as both should reduce under correct implantation. If loss of the implant is suspected following re-implantation after 12 months, a progressive increase will be seen in scrotal circumference and/or plasma testosterone levels. In both of these circumstances a replacement implant should be administered.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the veterinary medicinal product, has not been investigated.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials 68 % of dogs administered one implant, returned to fertility within 2 years of implantation. 95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation. However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or repeated implantation, are limited.
Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight should be subject to a risk/benefit assessment performed by the veterinarian. During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs (<10 kg) compared with all larger dogs.
Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressiveness. Thus dogs with sociopathic disorders and showing episodes of intra-specific (dog to dog) and/or inter-specific (dog to another species) aggressions should not be castrated either surgically or with the implant.
Ferret
Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml, and suppression of musky odor) is achieved between 5 weeks and 14 weeks after initial treatment under laboratory conditions. Treated ferrets should therefore still be kept away from jills on heat within the first weeks after initial treatment.
Levels of testosterone remain below 0.1 ng/ml for up to 16 months. Not all parameters of sexual activity have been tested specifically (seborrhoea, urine marking, and aggressiveness). Any mating that occurs more than 16 months after the administration of the product may result in pregnancy.
The need for subsequent implantations should be based on the increase in testis size and/or increase in plasma testosterone concentrations and return to sexual activity.
The reversibility of effects and ability of treated hobs to produce offspring subsequently has not been investigated. Therefore, the use of Suprelorin should be subject to a benefit/risk assessment performed by the responsible veterinarian.
In certain cases, the implant may be lost from a treated ferret. If loss of the implant is suspected in connection with the first implantation, this can be confirmed by observing no reduction in testis size or plasma testosterone levels as both should reduce under correct implantation. If loss of the implant is suspected following re-implantation, a progressive increase will be seen in testis size and/or plasma testosterone levels. In both of these circumstances a replacement implant should be administered.
Special precautions for use
Special precautions for use in animals
Dogs
The use of Suprelorin in pre-pubertal dogs has not been investigated. It is therefore recommended that dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Data demonstrate that treatment with Suprelorin will reduce the libido of the dog, but other behavioural changes (e.g. male-associated aggression) have not been investigated.
Ferrets
The use of the product in pre-pubertal ferrets has not been investigated. It is therefore recommended that ferrets should be allowed to reach puberty before treatment with the product is initiated.
Treatment in ferrets should be initiated at the beginning of the breeding season.
The treated hobs may remain infertile up to four years. The product should therefore be used prudently in hobs intended for future reproduction.
The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Pregnant women should not administer Suprelorin. Another GnRH analogue has been shown to be foetotoxic in laboratory animals. Specific studies to evaluate the effect of deslorelin when administered during pregnancy have not been conducted. Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin. When administering the veterinary medicinal product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician, with a view to having the implant removed.
Adverse reactions(frequency and seriousness)
In dogs, moderate swelling at the implant site may be observed for 14 days. Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration. A significant decrease in testicle size will be seen during the treatment period. In very rare cases,
(<0.01%) a testicle may be able to ascend the inguinal ring.
In ferrets, the following have been described: Transient moderate swelling, pruritus and erythema at the implant site.
Use during pregnancy, lactation or lay
Not applicable
Interactions
None known
Amounts to be administered and administration route
Dogs
Subcutaneous use.
The recommended dose is one implant per dog, irrespective of the size of the dog.
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.
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock connection.
The veterinary medicinal product should be implanted subcutaneously in 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. Lift the loose skin between the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds. Examine the syringe and needle to ascertain 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 12 months to maintain efficacy.
Ferrets
Subcutaneous use.
The recommended dose is one implant per ferret, irrespective of the size of the ferret.
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.
Remove Luer Lock cap from the implanter. Attach the actuator to the implanter using the Luer Lock connection.
It is recommended that the product should be administered under general anaesthesia in ferrets.
The product should be implanted subcutaneously in the loose skin on the back in the intrascapular space. Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation. Lift the loose skin between the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator plunger and, at the same time, slowly withdraw the needle. Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds. Examine the syringe and needle to ascertain 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. Tissue glue is recommended to close the site of administration if required.
The need for subsequent implantations should be based on the increase of testis size and/or increase in plasma testosterone concentrations as well as return to sexual activity.
Dogs and ferrets
Do not use the veterinary medicinal product if the foil pouch is broken.
The biocompatible implant does not require removal. However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian. Implants may be located using ultrasound.
Overdose
No adverse reactions other than those described above have been observed following simultaneous subcutaneous administration of the equivalent of six implants.
Withdrawal periods
Not applicable
Pharmacological particulars
Pharmacodynamic properties
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose. This suppression results in the failure of treated animals to synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the hormones responsible for the maintenance of fertility.
The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs, libido and spermatogenesis and lower the plasma testosterone levels, from 4 to 6 weeks after 10 implantation. A short transient increase in plasma testosterone may be seen immediately after implantation. Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least 12 months following administration of the veterinary medicinal product.
Pharmacokinetic properties
It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin. The substance can be directly measured in the plasma up to approximately 2.5 months post implantation. The metabolism of deslorelin is rapid.
Pharmaceutical particulars
Excipients
Hydrogenated palm oil
Lecithin
Major incompatibilities
None known
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Store in a refigerator (2°C – 8°C).
Do not freeze.
Immediate packaging
The implant is supplied in a pre-loaded implanter. Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised. The final sales presentation consists of a cardboard carton containing either two or five individually foil wrapped implanters that have been sterilised, together with an implanting device (actuator) that is not sterilised. The actuator is attached to the implanter using the Luer Lock connection.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The actuator can be re-used.
Marketing Authorisation Holder (if different from distributor)
Virbac S.A.
1ère avenue 2065 m L.I.D.
06516 Carros
France
11
Marketing Authorisation Number
EU/2/07/072/003
EU/2/07/072/004
Significant changes
Date of the first authorisation or date of renewal
01/07/2010
Date of revision of the text
01/07/2010
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Suprelorin 9.4mg implant for Dogs and Ferrets x 2
GTIN:3597133046700