Patient leaflet - Gonazon
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Active substance(s)
Azagly-nafarelin 1600 pg/ml as azagly-nafarelin acetate.
Excipients
Benzyl alcohol
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Excipients
Benzyl alcohol
3. PHARMACEUTICAL FORM
Concentrate for solution for injection.
Female s brow
4. PACKAGE SIZE
Carton containing o empty sterile mixing
5. TARG
IES
ml of concentrate solution and 1 bottle with 100 ml of solvent. An plied separately. Additional sterile vials will be supplied on request.
NDICATION(S)
d fish such as Atlantic salmon (Salmo salar ), rainbow trout (Oncorhynchus mykiss ), mo trutta ) and Arctic charr (Salvelinus alpinus ).
duction and synchronisation of ovulation for the production of eyed-eggs and fry.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
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8. WITHDRAWAL PERIOD
sh
Zero days.
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9. SPECIAL WARNING(S), IF NECESSARY
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed i treated with azagly-nafarelin too early in the spawning season. It is recommended to strip fish after
r to prevent
injection at intervals of approximately 50–100 degree days. For Arctic charr, injecti given only if the water temperature is < 8°C.
d be
High standards of biosecurity must be observed at the time of introduction and spread of infectious diseases between broodstock fish.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
the solvent. Read the
Operators should wear gloves when mixing the concentrate so package insert before use.
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10. EXPIRY DATE „Month/Year“
After dilution, the product should be used immedi a
Store and transport at 2°C – 8°C (in a Do not freeze.
Any unused vet products should
12. SPECIAL PRECAUTI WASTE MATE
13.
11. SPECIAL STORAGE CONDITI
tor).
S FOR THE DISPOSAL OF UNUSED PRODUCTS OR ANY
icinal product or waste materials derived from such veterinary medicinal of in accordance with local requirements.
RDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
ICTIONS REGARDING SUPPLY AND USE, if applicable __________
mal treatment only – to be supplied only on veterinary prescription.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
Carton Box
via long term blockade of gonadotrophin synthesis.
OF ADMINISTRATION
tration.
et before use.
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon 18.5 mg implant for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Azagly-nafarelin (18.5 mg)
3. PHARMACEUTICAL FORM
Implant
4. PACKAGE SIZE
One implant.
5. TARGET SPECIES
Dog (bitches)
6. INDICATION(S)
Prevention of gonadal function
7. METHOD AN
Subcutaneous a Read the packa
8.
RAWAL PERIOD
10. EXPIRY DATE
SPECIAL WARNING(S), IF NECESSARY
EXP {month/year}
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11. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C.
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12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
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14. THE WORDS “KEEP OUT OF THE REACH AND SI GH T OF CHILDREN”
Keep out of the reach and sight of children.
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15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International BV
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
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16. MARKETING AUTHORISATION NUMBER(S)
EU/2/03/040/002
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17. MANUFACTURER’S BATCH NUMBER
Gonazon concentrate for solution for injection of female salmonid fish
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DO
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2 ml concentrate vials
Intraperitoneal (IP) use
<Batch> <Lot> {number}
6. BATCH NUMBER
7. EXPIRY DAT
ORDS “FOR ANIMAL TREATMENT ONLY
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Azagly-nafarelin 1600 pg/ml as azagly-nafarelin acetate.
2 ml
4. ROUTE(S) OF ADMINISTRATION
5. WITHDRAWAL PERIOD
Zero days
EXP {month/yea
After dilution, the product should be used immediately.
8.
l treatment only- to be supplied only on veterinary prescription.
Sachet
One implant.
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOS
Gonazon 18.5 mg implant for dogs
Azagly-nafarelin
Subcutaneous administration.
Batch < number >
EXP {month/year}
FOR ANIMAL TREATMENT ONLY
4. ROUTE(S) OF ADMINISTRATION
5. WITHDRAWAL PERIOD
6. BATCH NUMBER
7. EXPIRY DATE
For an
8. THE W
ent only.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Vial containing solvent
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon concentrate for solution for injection of female salmonid fish
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Excipients
Benzyl alcohol
3. PHARMACEUTICAL FORM
Solvent for solution for injection.
4. PACKAGE SIZE
Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent. An empty sterile mixing vial is supplied separa onal sterile vials will be supplied on request.
5. TARGET SPECIES
Female salmonid fish such as Atlantic n (Salmo salar ), rainbow trout (Oncorhynchus mykiss ),
brown trout (Salmo trutta ) and Arctic charr (Salvelinus alpinus ).
6. INDICATION(S)
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
7. METH
D ROUTE(S) OF ADMINISTRATION
e leaflet before use.
Read t
ITHDRAWAL PERIOD
ays.
9. SPECIAL WARNING(S), IF NECESSARY
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin 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.
High standards of biosecurity must be observed at the time of injection in order to pr introduction and spread of infectious diseases between broodstock fish.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied
ead the
Operators should wear gloves when mixing the concentrate solution with the s package insert before use.
10. EXPIRY DATE
„Month/Year“
After dilution, the product should be used immediately.
11. SPECIAL STORAGE CONDITIONS
Store and transport at 2°C – 8°C (in a refrigerator). Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF AN
Any unused veterinary medicin products should be disposed of i
ct or waste materials derived from such veterinary medicinal ance with local requirements.
13. THE WORDS “F
RESTRICTIO
For animal treatment
MAL TREATMENT ONLY” AND CONDITIONS OR
ARDING SUPPLY AND USE, if applicable ___________
14. T
to be supplied only on veterinary prescription.
RDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
ut of the reach and sight of children.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
The Netherlands
16. MARKETING AUTHORISATION NUMBER(S)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Separate empty sterile containers
S “FOR ANIMAL TREATMENT ONLY
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Azagly-nafarelin 1600 pg/ml as azagly-nafarelin acetate.
3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOS
50 ml
4. ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
5. WITHDRAWAL PERIOD
Zero days.
6. BATCH NUMBER
<Batch> <Lot> {number}
7. EXPIRY DAT
EXP {month/ye
8.
For
eatment only
PACKAGE LEAFLET
Gonazon concentrate for solution for injection of female salmonid fish
R INGREDIENT(S)
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon concentrate for solution for injection of female salmonid fish
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND
Azagly-nafarelin 1600 p,g/ml as azagly-nafarelin acetate.
Excipient: Benzyl alcohol
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4. INDICATION(S)
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Do not use Gonazon before naturally.
5. CONTRAINDICATIO
ately 10% of the specific broodstock population has ovulated
The product should not ed in fish maintained in water temperatures that would normally inhibit
ovulation as this can result in a decrease in egg quality.
vete
6. AD
EACTIONS
TARGET SPECIES
any serious effects or other effects not mentioned in this leaflet, please inform your surgeon.
Female salmonid fish such as Atlantic salmon (Salmo salar ), rainbow trout (Oncorhynchus mykiss ), brown trout (Salmo trutta ) and Arctic charr (Salvelinus alpinus ).
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
9.
ADVICE ON CORRECT ADMINISTRATION
dditional
Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base. should be anaesthetised.
The dose should be administered in the preferred volume for the particular body weight of fis supplied solvent is used to dilute the concentrate to the correct dilution to allow for opti 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 sol sterile vials will be supplied on request.
The table below provides the required volume of concentrate and the require obtain thepreferred injection volumes of 0.1 ml/kg fish, 0.2 ml/kg fish, 0.5 ml/kg 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
e of solvent to 1 ml/kg fish.
depending on fish
Preferred injection volume per size)
| 0.1 ml | 0.2 ml J | J).j\il | 1.0 ml | ||
| Total kg of fish to be injected | Concentrate volume | Solvent volume | |||
| 50 kg | 1 ml | 4 ml | 9 W | 24 ml | 49 ml |
| 100 kg | 2 ml | 8 ml | 18 mH | 48 ml | 98 ml |
this volume will be minimized for the species with the largest body
The diluted solution for injection should be us
diately.
10. WITHDRAWAL PERIOD
Zero days
Keep out of the reac
11. SPECIAL STO
ght of children. erator).
PRECAUTIONS
Store at 2 – 8 °C Do not freeze. Do not use after After first openi After
ECIAL WARNING(S)
Avoid self injection.
the expiry date stated on the label.
g the container, the solvent may be stored for 28 days. e product should be used immediately.
not mix with other medicinal products.
perators should wear gloves when mixing the concentrate solution with the solvent.
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
Operators should wash their hands after use of the product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary me products should be disposed of in accordance with local requirements.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVE 13.06.2008
15. OTHER INFORMATION
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA)
None.
PACKAGE LEAFLET
Gonazon 18.5 mg implant for dogs
(S) AND OTHER INGREDIENT(S)
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
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2. NAME OF THE VETERINARY MEDICINAL PRODU
Gonazon 18.5 mg implant for dogs
-
3. STATEMENT OF THE ACTIVE SUBST
Azagly-nafarelin 18.5 mg
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4. INDICATION(S)
Prevention of gonadal function in b
ia long term blockade of gonadotrophin synthesis.
5.
Do not
6. ADVE
and adult) intended for breeding.
ACTIONS
Owing to of GnRH
pharmacological activity (inhibition of the production of sex steroids), administration ts to bitches might be associated with vaginitis.
f you notice any serious effects or other effects not mentioned in this leaflet, please inform your eterinary surgeon.
Dog (bitches).
7. TARGET SPECIES
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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
Average duration of blockade
(standard deviation)
12 months
(± 24 days)
3 – 6 years ol
11 mont
In bitches where gonadal function has been successsfully prevente second treatment may be administered at that time for continued pr data available for animals treated on more than two occasions.
period of 12 months, then a n of oestrus. There are no
9. ADVICE ON CORRECT ADMINISTRATION
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique.
ADMINISTRATION:
1. Position the bitch on her back.
abdominal/umbilical region for
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2. Open the foil pouch using th
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3. Remove the needle cap. Unli
e a small area (e.g. 4 cm2) of the ventral anterior procedure (Fig. 1).
incision to remove the sterile injection device.
to do so may displace the impl
4. Using aseptic technique, ra bevel of the needle facing upw
liquid injections, there is no need to remove air bubbles as attempts from the needle.
ise a small piece of skin in the region of the dog’s umbilicus. With the ards, insert the needle at a 30 degree angle to the tented skin in a single
motion (Fig. 2). 5. Take care to 6. With your f plunger as skin (Fig.
7. En
site
enetrating the abdominal wall musculature or fat tissue.
d, use the thumb grip to hold the injection device in position, and depress the t can go. This retracts the needle and withdraws it, leaving the implant beneath the draw the needle from the skin.
the administration site is clean and dry. Instruct the owner to keep the administration d dry for 24 hours. Record the date of treatment in the clinical records of the animal.
Fig.1
REMOVAL:
he site for an
1.
the far end of the
2.
Chemical restraint (sedation and/or general anaesthesia) may be required for im Position the dog as described for administration of the implant.
Locate the implant by gentle digital palpation of the administration site. aseptic technique.
After adequate (local) anaesthesia is present, apply gentle digital pressu
Fig.4
Fig.2
Fig.3
3.
implant. Make a stab incision, approximately 5 mm long, alon implant. Push the implant gently towards the stab incision. I fibrous tissue to free the implant. Grasp it with forceps and remo Instruct the owner to keep the administration site clean and dry
elevated near end of the ssary, dissect away any
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 stages of the cycle may induce heat, embryonic resorption or dogs should be prevented until dogs) cease.
in metoestrus (5%). Administration of Gonazon at other may be fertile. If a bitch becomes pregnant following induced n may occur. Therefore, if heat is observed, contact with male l signs of heat (vulvar swelling, bleeding and attractiveness to male
Induced heat is not induced heat is lowe
ed if treatment is started before puberty. In addition, the frequency of nger 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.
duct when administered at the recommended treatment dose is ineffective in bitches aged 7 older.
Not applicable.
10. WITHDRAWAL PERIOD
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11. SPECIAL STORAGE PRECAUTIONS
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 25°C.
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12. SPECIAL WARNING(S)
The implant may not be retained in a proportion (1.2%) of treated bitches. If the implant cannot b palpated in the month following administration, the owner is encouraged to seek veterinary advice a 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 pregn
actation. 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, cons medicinal product.
gloves, should be worn when handling the veterinary
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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANYAsk your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.