Summary of medicine characteristics - Gonazon
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
1. NAME OF THE VETERINARY MEDICINAL PRODUCTGonazon concentrate for solution for injection of female salmonid fish
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
V IAL CONTAINING C ONCENTRATE :
Active substance(s)
Azagly-nafarelin 1600 p,g/ml as azagly-nafarelin acetate.
Excipients
Benzyl alcohol (1%)
V IAL CONTAINING S OLVENT :
Excipients
Benzyl alcohol (1%)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for injection
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS-
4.1 Target species
Female salmonid fish such as Atlantic salmon (Salmo salar ), rainbow trout (Oncorhynchus mykiss ), brown trout (Salmo trutta ) ctic charr (Salvelinus alpinus ).
4.2 Indications for
ecifying the target species
Induction and s
4.3 Contra
ions
on of ovulation for the production of eyed-eggs and fry.
Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated
roduct should not be used in fish maintained in water temperatures that would normally inhibit tion as this can result in a decrease in egg quality.
.4 Special warnings for each target species
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin. In some cases this can be related to the use of the compound too early in the spawning season.
It is recommended to strip fish after injection at intervals of approximately 50–100 degree days.
For Arctic charr, injections should be given only if the water temperature is < 8°C.
duct to
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
4.5 Special precautions for use
High standards of biosecurity must be observed at the time of injection in order t introduction and spread of infectious diseases between broodstock fish.
Operators should wear gloves when mixing the concentrate solution with the s
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 diluted solution are spilled onto the skin or into the eyes or i The package insert or the label should be shown to the physici
of accidental self-injection.
Operators should wash their hands after use of the product.
-
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy, lactatio
Not applicable.
4.8 Interaction with other medicinal products and other forms of interactionNo information on intera
4.8 Interaction with other medicinal products and other forms of interactionNo information on interaith other veterinary medicinal products is available.
4.9 Amounts to be administered and administration route
4.9 Amounts to be administered and administration routeFish should be etised.
Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base.
The recommended dose is 32 ^g/kg body weight.
hould be administered in the preferred volume for the particular body weight of fish. The vent is used to dilute the concentrate to the correct dilution to allow for optimisation of n volumes for fish of widely varying body weights.
he empty, sterile vial is intended to be used for mixing the concentrate and solvent. Additional terile vials will be supplied on request.
The table below provides the required volume of concentrate and the required volume of solvent to obtain the preferred injection volume 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessaryAn overdose will not accelerate the onset or increase the degree of ovulation. A reduction in the egg quality is seen after administration of doses above the recommended therapeutic dose. No antidotes are available.
4.11 Withdrawal period(s)
4.11 Withdrawal period(s)Zero days.
5. PHARMACOLOGICAL PROPERTIES
Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout. The distribution and metabolism of azagly-nafarelin have not been studied in the target species. Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout. The elimination half-life (T1/2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 ^g/kg BW are 4.9 h and 6.8 h, respectively.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Benzyl alcohol
Sodium acetate (tri-hydrate)
Acetic acid, glacial
Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
Water for injection
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sage: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
Shelf life after dilution according to directions: the product should be used immediately.
6.4 Special precautions for storage
Store and transport at 2°C – 8°C (in a refrigerator). Do not freeze.
6.5 Nature and composition of immediate packaging
Carton: 1 concentrate vial and 1 solvent vial.
Concentrate vial: 3 ml brown glass vial containing 2 ml of solution
Solvent vial: 100 ml clear glass vial containing 100 ml of solution;
topper and crimp cap.
rubber stopper and crimp cap.
Sterile container: 50-ml empty
6.6 Special precautions for the materials derived from the us
used veterinary medicinal product or waste ucts
7. MARKETING AUT
Any unused veterinary medicinal product products should be disposed of in acc
aste materials derived from such veterinary medicinal with local requirements.
TION HOLDER
Intervet International BV
Wim de Korverstraat 35 5831 AN Boxmeer
The Netherlands
8. M
2.07.2003 / 13.06.2008
NG AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
13.06.2008
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon 18.5 mg implant for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Azagly-nafarelin 18.5 mg per implant
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Implant
Gonazon implant is a solid, off white, 14×3×1 mm implant.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs (bitches)
4.2 Indications for use, specifying the target s
Prevention of gonadal function in bitches via l
4.3 Contraindications
blockade of gonadotrophin synthesis.
Do not use in bitches (prepubertal an intended for breeding (see section 4.7).
4.4 Special warnings
Based on field trial data, treated bitches. If the im encouraged to seek
ident that the implant may not be retained in a proportion (1.2%) of nnot be palpated in the month following administration, the owner is vice as efficacy cannot be ensured in these cases.
At the end of treatment, it may not be possible to locate and remove the implant in
approximately 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.
a single administration, return to ovarian activity after implant removal may take longer in s treated before puberty (average 255 days, range 36–429 days) than in adult bitches (average 68 , range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult itches 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.
4.5 Special precautions for use
Special precautions for use in animals
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches o giant breeds over 45 kg bodyweight.
In adult bitches, heat is commonly induced in the first month following the first administration implant. The frequency of induced heat is lower when the first treatment is administered in mets (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be admered in metoestrus. The incidence of induced heat following administration of a repeat tre bitches
that have not shown signs of oestrus following a previous administration of th t is low
(estimated to be 8%).
The risk of inducing a fertile heat is low in metoestrus (5%). Administrati stages of the cycle may induce heat that may be fertile. If a bitch becomes pre heat, embryonic resorption or abortion may occur. Therefore, if heat is obse dogs should be prevented until all signs of heat (vulvar swelling, bleeding an dogs) cease.
Induced heat is not observed if treatment is started before induced heat is lower in younger bitches than in older bitches.
addition, the frequency of
onazon at other llowing induced
rved, contact with male d attractiveness to male
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.
Personal protective equipm medicinal product.
Avoid accidental advice immediate
Special precautions to be take animals
on administering the veterinary medicinal product to
g of gloves, should be worn when handling the veterinary
tion. In case of accidental self-administration of the implant, seek medical ow the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Owing to of GnRH
pharmacological activity (inhibition of the production of sex steroids), administration ts to bitches might be associated with vaginitis.
uring pregnancy, lactation or lay
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).
The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
4.8 Interaction with other medicinal products and other forms of interaction
Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes. Therefore, drug interactions would not be expected to occur. In a limited laboratory study, co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated. However, interactions with other medicinal products have not been investigated.
-
4.9 Amounts to be administered and administration route
Age at which treatment is started
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 be
4 months – 3 years old
3 – 6 years old
Average duration of blockade
(standard deviation)
12 months
(± 24 days)
3 days)
Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and ^ 90 % of treated prepubertal bitches. However, it should be
noted that within the first month after tr induced heat (see section 4.5). The produ ineffective in bitches aged seven years or
In bitches where gonadal function ha second treatment may be administ data available for animals treate
proportion of treated bitches also experienced an ministered at the recommended treatment dose, is
for a period of 12 months, then a that time for continued prevention of oestrus. There are no e than two occasions.
ADMINISTRATION:
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique. The method of administration is as follows:
1. Positi
ab
2.
3.
7.
e bitch on her back. Prepare a small area (e.g. 4 cm2) of the ventral anterior umbilical region for an aseptic procedure.
foil pouch using the pre-cut incision to remove the sterile injection device.
8.
ve the needle cap. Unlike liquid injections, there is no need to remove air bubbles as pts to do so may displace the implant from the needle.
sing aseptic technique, raise a small piece of skin in the region of the dogs 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, subcutaneously.
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. 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 animals.
REMOVAL:
Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal.
Position the dog as described for administration of the implant.
1.
2.
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 o implant. Make a stab incision, approximately 5 mm long, along the elevated near end o
3.
implant. Push the implant gently towards the stab incision. If necessary, dissect away an 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Risk of overdose is negligible owing to the type of formulation and adminis (single dose
implant for subcutaneous administration). Simultaneous administration of five implants during a one-year period was well tolerated.
-
4.11 Withdrawal period
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic particulars
5.2 Pharmacokinetic particularsAzagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout. The distribution and metabolism of azagly-nafarelin have not been studied in the target species. Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout. The elimination half-life (T1/2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 ^g/kg BW are 4.9 h and 6.8 h, respectively.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Store and transport at 2°C – 8°C (in a refrigerator). Do not freeze.
6.5 Nature and composition of immediate packaging
Carton: 1 concentrate vial and 1 solvent vial.
Concentrate vial: 3 ml brown glass vial containing 2 ml of solution
Solvent vial: 100 ml clear glass vial containing 100 ml of solution;
topper and crimp cap.
rubber stopper and crimp cap.
Sterile container: 50-ml empty
6.6 Special precautions for the materials derived from the us
used veterinary medicinal product or waste ucts
7. MARKETING AUT
Any unused veterinary medicinal product products should be disposed of in acc
aste materials derived from such veterinary medicinal with local requirements.
TION HOLDER
Intervet International BV
Wim de Korverstraat 35 5831 AN Boxmeer
The Netherlands
8. M
2.07.2003 / 13.06.2008
NG AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
13.06.2008
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon 18.5 mg implant for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Azagly-nafarelin 18.5 mg per implant
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Implant
Gonazon implant is a solid, off white, 14×3×1 mm implant.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs (bitches)
4.2 Indications for use, specifying the target s
Prevention of gonadal function in bitches via l
4.3 Contraindications
blockade of gonadotrophin synthesis.
Do not use in bitches (prepubertal an intended for breeding (see section 4.7).
4.4 Special warnings
Based on field trial data, treated bitches. If the im encouraged to seek
ident that the implant may not be retained in a proportion (1.2%) of nnot be palpated in the month following administration, the owner is vice as efficacy cannot be ensured in these cases.
At the end of treatment, it may not be possible to locate and remove the implant in
approximately 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.
a single administration, return to ovarian activity after implant removal may take longer in s treated before puberty (average 255 days, range 36–429 days) than in adult bitches (average 68 , range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult itches 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.
4.5 Special precautions for use
Special precautions for use in animals
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches o giant breeds over 45 kg bodyweight.
In adult bitches, heat is commonly induced in the first month following the first administration implant. The frequency of induced heat is lower when the first treatment is administered in mets (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be admered in metoestrus. The incidence of induced heat following administration of a repeat tre bitches
that have not shown signs of oestrus following a previous administration of th t is low
(estimated to be 8%).
The risk of inducing a fertile heat is low in metoestrus (5%). Administrati stages of the cycle may induce heat that may be fertile. If a bitch becomes pre heat, embryonic resorption or abortion may occur. Therefore, if heat is obse dogs should be prevented until all signs of heat (vulvar swelling, bleeding an dogs) cease.
Induced heat is not observed if treatment is started before induced heat is lower in younger bitches than in older bitches.
addition, the frequency of
onazon at other llowing induced
rved, contact with male d attractiveness to male
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.
Personal protective equipm medicinal product.
Avoid accidental advice immediate
Special precautions to be take animals
on administering the veterinary medicinal product to
g of gloves, should be worn when handling the veterinary
tion. In case of accidental self-administration of the implant, seek medical ow the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Owing to of GnRH
pharmacological activity (inhibition of the production of sex steroids), administration ts to bitches might be associated with vaginitis.
uring pregnancy, lactation or lay
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).
The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
4.8 Interaction with other medicinal products and other forms of interaction
Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes. Therefore, drug interactions would not be expected to occur. In a limited laboratory study, co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated. However, interactions with other medicinal products have not been investigated.
-
4.9 Amounts to be administered and administration route
Age at which treatment is started
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 be
4 months – 3 years old
3 – 6 years old
Average duration of blockade
(standard deviation)
12 months
(± 24 days)
3 days)
Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and ^ 90 % of treated prepubertal bitches. However, it should be
noted that within the first month after tr induced heat (see section 4.5). The produ ineffective in bitches aged seven years or
In bitches where gonadal function ha second treatment may be administ data available for animals treate
proportion of treated bitches also experienced an ministered at the recommended treatment dose, is
for a period of 12 months, then a that time for continued prevention of oestrus. There are no e than two occasions.
ADMINISTRATION:
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique. The method of administration is as follows:
1. Positi
ab
2.
3.
7.
e bitch on her back. Prepare a small area (e.g. 4 cm2) of the ventral anterior umbilical region for an aseptic procedure.
foil pouch using the pre-cut incision to remove the sterile injection device.
8.
ve the needle cap. Unlike liquid injections, there is no need to remove air bubbles as pts to do so may displace the implant from the needle.
sing aseptic technique, raise a small piece of skin in the region of the dogs 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, subcutaneously.
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. 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 animals.
REMOVAL:
Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal.
Position the dog as described for administration of the implant.
1.
2.
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 o implant. Make a stab incision, approximately 5 mm long, along the elevated near end o
3.
implant. Push the implant gently towards the stab incision. If necessary, dissect away an 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Risk of overdose is negligible owing to the type of formulation and adminis (single dose
implant for subcutaneous administration). Simultaneous administration of five implants during a one-year period was well tolerated.
-
4.11 Withdrawal period
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotrophin-Releasing Hormone (GnRH) ATCvet code: QH01CA
Azagly-nafarelin, a GnRH agonist, ha continuously. Initially, it stimulates p
(luteinising hormone) and FSH heat within one to four weeks fo term administration results in
le
ic effects on the pituitary gland when administered ituitary function and secretion of the gonadotrophins LH stimulating hormone). This brief phase may result in induced the first administration of the implant (see section 4.5). Long-
tary desensitisation to the effects of GnRH resulting in a
suppression of LH and FSH secretion by the pituitary. As a consequence, there is no follicular follicle growth (hence no oestrus is observed) and no ovulation. The transition between the stimulatory and inhibitory effects is completed within approximately one month.
5.2 Pharmacokinetic particulars
Absorption of 10 k 3.5 ho
ing subcutaneous administration of a single implant to dogs (approximate weight maximum serum concentrations (0.13 ^g/ml) of azagly-nafarelin are reached around ese maximal azagly-nafarelin concentrations are followed by a slow decline in
circulating azagly-nafarelin concentrations lasting up to 12 months.
on: The apparent volume of distribution of azagly-nafarelin following intravenous bolus dministration, at a dose equivalent to the content of one implant, is 0.12 l/kg.
bolism and excretion: The clearance of azagly-nafarelin following intravenous administration of e same dose is 0.46 l/h and the elimination half-life is 1.8 hours.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cured elastomer, resulting from the polymerisation of polydimethylsiloxane and tetrapropylorthosilicate in the presence of stannous octoate.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
6.4 Special precautions for storage
Store and transport at 2°C – 8°C (in a refrigerator). Do not freeze.
6.5 Nature and composition of immediate packaging
Carton: 1 concentrate vial and 1 solvent vial.
Concentrate vial: 3 ml brown glass vial containing 2 ml of solution
Solvent vial: 100 ml clear glass vial containing 100 ml of solution;
topper and crimp cap.
rubber stopper and crimp cap.
Sterile container: 50-ml empty
6.6 Special precautions for the materials derived from the us
7. MARKETING AUT
Any unused veterinary medicinal product products should be disposed of in acc
aste materials derived from such veterinary medicinal with local requirements.
TION HOLDER
Intervet International BV
Wim de Korverstraat 35 5831 AN Boxmeer
The Netherlands
8. M
2.07.2003 / 13.06.2008
NG AUTHORISATION NUMBER(S)
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT13.06.2008
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon 18.5 mg implant for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Azagly-nafarelin 18.5 mg per implant
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Implant
Gonazon implant is a solid, off white, 14×3×1 mm implant.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs (bitches)
4.2 Indications for use, specifying the target s
Prevention of gonadal function in bitches via l
4.3 Contraindications
blockade of gonadotrophin synthesis.
Do not use in bitches (prepubertal an intended for breeding (see section 4.7).
4.4 Special warnings
Based on field trial data, treated bitches. If the im encouraged to seek
ident that the implant may not be retained in a proportion (1.2%) of nnot be palpated in the month following administration, the owner is vice as efficacy cannot be ensured in these cases.
At the end of treatment, it may not be possible to locate and remove the implant in
approximately 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.
a single administration, return to ovarian activity after implant removal may take longer in s treated before puberty (average 255 days, range 36–429 days) than in adult bitches (average 68 , range 12 to 264 days). A large proportion (68%) of the first heat after a single treatment in adult itches 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.
4.5 Special precautions for use
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches o giant breeds over 45 kg bodyweight.
In adult bitches, heat is commonly induced in the first month following the first administration implant. The frequency of induced heat is lower when the first treatment is administered in mets (32%) than in anoestrus (84%). Therefore, the first treatment should preferably be admered in metoestrus. The incidence of induced heat following administration of a repeat tre bitches
that have not shown signs of oestrus following a previous administration of th t is low
(estimated to be 8%).
The risk of inducing a fertile heat is low in metoestrus (5%). Administrati stages of the cycle may induce heat that may be fertile. If a bitch becomes pre heat, embryonic resorption or abortion may occur. Therefore, if heat is obse dogs should be prevented until all signs of heat (vulvar swelling, bleeding an dogs) cease.
Induced heat is not observed if treatment is started before induced heat is lower in younger bitches than in older bitches.
addition, the frequency of
onazon at other llowing induced
rved, contact with male d attractiveness to male
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.
Personal protective equipm medicinal product.
Avoid accidental advice immediate
Special precautions to be take animals
g of gloves, should be worn when handling the veterinary
tion. In case of accidental self-administration of the implant, seek medical ow the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Owing to of GnRH
pharmacological activity (inhibition of the production of sex steroids), administration ts to bitches might be associated with vaginitis.
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).
The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Interaction with other medicinal products and other forms of interactionAzagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes. Therefore, drug interactions would not be expected to occur. In a limited laboratory study, co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated. However, interactions with other medicinal products have not been investigated.
4.9 Amounts to be administered and administration route
Age at which treatment is started
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 be
4 months – 3 years old
3 – 6 years old
Average duration of blockade
(standard deviation)
12 months
(± 24 days)
3 days)
Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and ^ 90 % of treated prepubertal bitches. However, it should be
noted that within the first month after tr induced heat (see section 4.5). The produ ineffective in bitches aged seven years or
In bitches where gonadal function ha second treatment may be administ data available for animals treate
proportion of treated bitches also experienced an ministered at the recommended treatment dose, is
for a period of 12 months, then a that time for continued prevention of oestrus. There are no e than two occasions.
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique. The method of administration is as follows:
1. Positi
ab
2.
3.
7.
e bitch on her back. Prepare a small area (e.g. 4 cm2) of the ventral anterior umbilical region for an aseptic procedure.
foil pouch using the pre-cut incision to remove the sterile injection device.
8.
ve the needle cap. Unlike liquid injections, there is no need to remove air bubbles as pts to do so may displace the implant from the needle.
sing aseptic technique, raise a small piece of skin in the region of the dogs 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, subcutaneously.
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. 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 animals.
Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal.
Position the dog as described for administration of the implant.
1.
2.
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 o implant. Make a stab incision, approximately 5 mm long, along the elevated near end o
3.
implant. Push the implant gently towards the stab incision. If necessary, dissect away an 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessaryRisk of overdose is negligible owing to the type of formulation and adminis (single dose
implant for subcutaneous administration). Simultaneous administration of five implants during a one-year period was well tolerated.
4.11 Withdrawal period
4.11 Withdrawal periodNot applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic particulars
5.2 Pharmacokinetic particularsAbsorption of 10 k 3.5 ho
ing subcutaneous administration of a single implant to dogs (approximate weight maximum serum concentrations (0.13 ^g/ml) of azagly-nafarelin are reached around ese maximal azagly-nafarelin concentrations are followed by a slow decline in
circulating azagly-nafarelin concentrations lasting up to 12 months.
on: The apparent volume of distribution of azagly-nafarelin following intravenous bolus dministration, at a dose equivalent to the content of one implant, is 0.12 l/kg.
bolism and excretion: The clearance of azagly-nafarelin following intravenous administration of e same dose is 0.46 l/h and the elimination half-life is 1.8 hours.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Single disposable injection device, preloaded inside a hypoderm cap. The unit is sterile and comes in a sealed, light-proof, aluminiu individual carton box.
le covered with a protective aminate pouch, packed in an
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal p products should be disposed of in a
aterials derived from such veterinary medicinal al requirements.
OLDER
HORISATION NUMBER(S)
7. MARKETING AUTHORISA
Intervet International BV Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/03/0
9.
8. MARKE
003 / 13.06.2008