Gonazon
azagly-nafarelin
Medicinal product no longer authorised
Medicinal product no longer authorised
Marketing authorisation holder and manufacturer
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
The Netherlands
Gonazon concentrate for solution for injection of female salmonid fish
Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate. Excipient: Benzyl alcohol
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally.
The product should not be used in fish maintained in water temperatures that would normally inhibit ovulation as this can result in a decrease in egg quality.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus).
Medicinal product no longer authorised
Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base. Fish should be anaesthetised.
The dose should be administered in the preferred volume for the particular body weight of fish. The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the preferred injection volumes for fish of widely varying body weights.
The empty, sterile vial is intended to be used for mixing the concentrate and solvent. Additional sterile vials will be supplied on request.
The table below provides the required volume of concentrate and the required volume of solvent to obtain thepreferred injection volumes of 0.1 ml/kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish.
Preferred injection volume per kg fish (depending on fish size) * | |||||
0.1 ml | 0.2 ml | 0.5 ml | 1.0 ml | ||
Total kg of fish to be injected | Concentrate volume | Solvent volume | |||
50 kg | 1 ml | 4 ml | 9 ml | 24 ml | 49 ml |
100 kg | 2 ml | 8 ml | 18 ml | 48 ml | 98 ml |
* this volume will be minimized for the species with the largest body weights.
The diluted solution for injection should be used immediately.
Zero days
Keep out of the reach and sight of children. Store at 2 – 8C (in a refrigerator).
Do not freeze.
Do not use after the expiry date stated on the label.
After first opening the container, the solvent may be stored for 28 days. After dilution, the product should be used immediately.
Do not mix with other medicinal products.
Operators should wear gloves when mixing the concentrate solution with the solvent. Avoid self injection.
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. Medical advice should be sought immediately in cases in which the concentrated solution or several ml of the
Medicinal product no longer authorised
diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection. The package insert or the label should be shown to the physician
Operators should wash their hands after use of the product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
13.06.2008
None.
Medicinal product no longer authorised
Marketing authorisation holder: Intervet International BV
Wim de Körverstraat 35 5831 AN Boxmeer
The Netherlands
Manufacturer responsible for the batch release: Intervet GesmbH
Siemensstraβe 107 A-1210 Wien Austria
Gonazon 18.5 mg implant for dogs
Azagly-nafarelin 18.5 mg
Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
Do not use in bitches (prepubertal and adult) intended for breeding.
Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dog (bitches).
Medicinal product no longer authorised
For subcutaneous administration.
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of giant breeds over 45 kg bodyweight.
The recommended dose is one implant per bitch.
The implant may be administered to bitches from the age of four months.
In adult bitches, the first treatment should be administered preferably in metoestrus.
The duration of prevention of gonadal function is obtained as detailed in the table below:
Age at which treatment is started | ||
4 months – 3 years old | 3 - 6 years old | |
Average duration of blockade (standard deviation) | 12 months ( 24 days) | 11 months ( 93 days) |
In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus. There are no data available for animals treated on more than two occasions.
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique.
Position the bitch on her back. Prepare a small area (e.g. 4 cm²) of the ventral anterior abdominal/umbilical region for an aseptic procedure (Fig. 1).
Open the foil pouch using the pre-cut incision to remove the sterile injection device.
Remove the needle cap. Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the implant from the needle.
Using aseptic technique, raise a small piece of skin in the region of the dog’s umbilicus. With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion (Fig. 2).
Take care to avoid penetrating the abdominal wall musculature or fat tissue.
With your free hand, use the thumb grip to hold the injection device in position, and depress the plunger as far as it can go. This retracts the needle and withdraws it, leaving the implant beneath the skin (Fig. 3). Withdraw the needle from the skin.
Ensure that the administration site is clean and dry. Instruct the owner to keep the administration site clean and dry for 24 hours. Record the date of treatment in the clinical records of the animal.
Medicinal product no longer authorised
Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal. Position the dog as described for administration of the implant.
Locate the implant by gentle digital palpation of the administration site. Prepare the site for an
aseptic technique.
After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the implant. Make a stab incision, approximately 5 mm long, along the elevated near end of the implant. Push the implant gently towards the stab incision. If necessary, dissect away any fibrous tissue to free the implant. Grasp it with forceps and remove.
Instruct the owner to keep the administration site clean and dry for 24 hours.
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
In adult bitches, heat is commonly induced in the first month following the first administration of the implant. The frequency of induced heat is lower when the first treatment is administered in metoestrus (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be administered in metoestrus. The incidence of induced heat following administration of a repeat treatment to bitches that have not shown signs of oestrus following a previous administration of the product is low (estimated to be 8%).
The risk of inducing a fertile heat is low in metoestrus (5%). Administration of Gonazon at other stages of the cycle may induce heat that may be fertile. If a bitch becomes pregnant following induced heat, embryonic resorption or abortion may occur. Therefore, if heat is observed, contact with male dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male dogs) cease.
Induced heat is not observed if treatment is started before puberty. In addition, the frequency of induced heat is lower in younger bitches than in older bitches.
A proportion of bitches that show induced heat may subsequently develop pseudopregnancy. However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater than in control (untreated) bitches.
The product when administered at the recommended treatment dose is ineffective in bitches aged 7 years or older.
Not applicable.
Medicinal product no longer authorised
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the label ‘EXP’ Do not store above 25C.
The implant may not be retained in a proportion (1.2%) of treated bitches. If the implant cannot be palpated in the month following administration, the owner is encouraged to seek veterinary advice as efficacy cannot be ensured in these cases.
At the end of a one year treatment, it may not be possible to locate and remove the implant in approximately 10% of cases. To minimise this problem, caution needs to be exercised to ensure that the implant is administered by subcutaneous injection, particularly in dogs with pronounced depots of subcutaneous fat. Inability to locate and remove Gonazon will not have serious effects on the general health of the dog. However, the timing of return to heat cannot be predicted.
Following a single administration, return to ovarian activity after implant removal may take longer in bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68 days, range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult bitches were non-ovulatory. In addition following a repeat treatment, the timing of a return to heat cannot be accurately predicted. No data are available on repeat treatments in prepubertal bitches.
Accidental ingestion of the implant by the dog will not affect its health, since the oral bio-availability of GnRH agonists is very low.
The use is not recommended during pregnancy and lactation. Laboratory studies have shown that administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy (that is, pregnancy will be carried to full term with the birth of viable pups).
Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product.
Avoid accidental self-injection. In the event of accidental self-administration of the implant, seek medical advice immediately and show the package leaflet or the label to the physician.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
13.06.2008
Medicinal product no longer authorised
An individual carton box contains a single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.