natgillin/translations-raw huggingface dataset:
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product.
Ne uporabite pri živalih z obolenji prebavil, kot so zdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih ter pri znani preobčutljivosti za zdravilo.
2/ 34 Special precautions to be taken by the person administering the veterinary medicinal product product to animals
2/ 33 Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zloženki.
Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Flexicama ne smemo dajati skupaj z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
The suspension can be given using either the drop dispenser (for very small breeds) or the Flexicam measuring syringe provided in the package.
Suspenzijo lahko dajemo s kapalko (zelo majhnim pasmam) ali s priloženo merilno brizgo za Flexicam.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
3/ 34 4.11 Withdrawal periods
3/ 33 4. 11 Karenca( e)
Dispersible cellulose Xanthan gum Sodium benzoate Glycerol Xylitol Sodium lauryl sulphate Citric acid monohydrate Sodium citrate Honey flavour
disperzibilna celuloza ksantanska guma natrijev benzoat glicerol ksilitol natrijev lavrilsulfat monohidrat citronske kisline natrijev citrat aroma medu emulzija simetikona prečiščena voda
4/ 34 Simethicone emulsion Purified water
4/ 33 6. 2 Glavne inkompatibilnosti
Flexicam 5 mg/ ml solution for injection for dogs and cats.
Flexicam 5 mg/ ml, raztopina za injiciranje za pse in mačke
Each ml of Flexicam 5 mg/ ml solution for injection contains:
1 ml raztopine za injiciranje Flexicam 5 mg/ ml vsebuje:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih še ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerno samoinjiciranje lahko povzroči bolečino.
Flexicam 1.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Zdravljenje lahko nadaljujemo s peroralno suspenzijo Flexicam 1, 5 mg/ ml za pse, ki jih damo v odmerku po 0, 1 mg meloksikama na kilogram telesne mase 24 ur po injekciji.
10/ 34 10.
9/ 33 10.
Fisher Clinical Services Langhurstwood Road Horsham West Sussex RH12 4QD UK
Fisher Clinical Services Langhurstwood Road Horsham West Sussex RH12 4QD Velika Britanija
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
10ml Bottle
Steklenica 10 ml
32ml Bottle
Steklenica 32 ml
100ml Bottle
Steklenica 100 ml
21/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20/ 33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
10ml glass vial
Steklenica 10 ml
Meloxicam.
Flexicam 1, 5 mg/ ml, peroralna suspenzija za pse
1 ml of solution for injection contains 5 mg of meloxicam.
Meloksikam 1, 5 mg/ ml
PHARMACEUTICAL FORM
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
PACKAGE SIZE
NAČIN( I) UPORABE ZDRAVILA
10 ml
Pazite, da med uporabo ne bi prišlo do kontaminacije.
TARGET SPECIES
KARENCA
INDICATION(S)
ŠTEVILKA SERIJE
METHOD AND ROUTE(S) OF ADMINISTRATION
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Read the package leaflet before use.
9 mesecev
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO ''SAMO ZA ŽIVALI''
EU/ 2/ 06/ 058/ 004
Samo za živali.
23/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21/ 33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
10 ml bottle
Steklenica 32 ml
24/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
32 ml bottle
Steklenica 100 ml
25/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 33 PODATKI NA ZUNANJI OVOJNINI
Flexicam 1.5 mg/ ml oral suspension for dogs
Flexicam 5 mg/ ml, raztopina za injiciranje za pse in mačke Meloksikam
QUANTITY OF THE ACTIVE SUBSTANCE(S)
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
FARMACEVTSKA OBLIKA
100 ml
Raztopina za injiciranje
ROUTE(S) OF ADMINISTRATION
VELIKOST PAKIRANJA
WITHDRAWAL PERIOD
CILJNE ŽIVALSKE VRSTE
Not applicable.
Psi in mačke
BATCH NUMBER
NAČIN IN POT( I) UPORABE
< Batch > {number}
Pred uporabo preberite navodila za uporabo.
EXPIRY DATE
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
9 months.
Ne uporabite pri brejih živalih in v obdobju laktacije.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
Meloxicam.
Flexicam 5 mg/ ml, raztopina za injiciranje za pse in mačke Meloksikam
28/ 34 PACKAGE LEAFLET FOR FLEXICAM 1.5 MG/ ML ORAL SUSPENSION FOR DOGS
27/ 33 NAVODILO ZA UPORABO FLEXICAM 1, 5 MG/ ML ORALNA SUSPENZIJA ZA PSE
Marketing authorisation holder Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD UK
Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD Velika Britanija
Manufacturer Fisher Clinical Services UK Ltd Langhurstwood Road Horsham West Sussex RH12 4QD UK
Fisher Clinical Services UK Ltd Langhurstwood Road Horsham West Sussex RH12 4QD Velika Britanija
The suspension can be given using either the drop dispenser (for very small breeds) or the Flexicam measuring syringe provided in the package (see below).
Suspenzijo lahko dajemo s kapalko (zelo majhnim pasmam) ali s priloženo merilno brizgo za Flexicam (glejte spodaj).
Flexicam must not be administered in conjunction with other NSAIDS or glucocorticosteroids.
Flexicama ne smemo dajati skupaj z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
31/ 34 PACKAGE LEAFLET Flexicam 5 mg/ ml solution for injection for dogs and cats
30/ 33 NAVODILO ZA UPORABO Flexicam 5 mg/ ml, raztopina za injiciranje za pse in mačke
Meloxicam
Flexicam 5 mg/ ml, raztopina za injiciranje za pse in mačke Meloksikam
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Pri lajšanju pooperativne bolečine pri mačkah je varnost dokumentirana samo za anestezijo s tiopentalom in halotanom.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
32/ 33 Previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z zveterinarjem.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
Zaradi nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih še ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
In the case of overdosage symptomatic treatment should be initiated.
Uporaba v obdobju brejosti in laktacije Glejte poglavje Kontraindikacije
For post-operative pain relief in cats, safety has only been documented after thiopental/ halothane anaesthesia.
Flexicama ne smemo dajati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Pri živalih, pri katerih je večja verjetnost, da bodo potrebovale anestezijo (npr. pri starejših živalih), je treba presoditi o potrebi po intravenskem ali podkožnem dajanju tekočine med anestezijo.
Accidental self-injection may give rise to pain.
Predzdravljenje z zdravili s protivnetnim delovanjem lahko povzroči dodatne neželene učinke ali jih okrepi, zato teh zdravil ne smemo dajati najmanj 24 ur pred začetkom zdravljenja.
People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
Pri določanju obdobja brez zdravljenja je treba upoštevati tudi farmakološke lastnosti zdravil, ki smo jih dajali predhodno.
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Preveliko odmerjanje Pri prevelikem odmerjanju je treba uvesti simptomatsko zdravljenje.
Gonazon contains the active substance azagly-nafarelin.
Zdravilo Gonazon vsebuje zdravilno učinkovino azagli- nafarelin.
Gonazon implant is rectangular in shape, off white, with dimensions of 14x3x1 mm.
Implantat Gonazon je pravokotne oblike sivo- bele barve velikosti 14x3x1 mm.
Following anaesthesia, the fish are injected intraperitoneally (into the area that contains the abdominal organs) along the central line, 1/ 2 to 1 fin length in front of the pelvic fin base.
Po anesteziji dobijo ribe intraperitonealno injekcijo (injekcijo v predel, kjer so trebušni organi) vzdolž osrednje linije, 1/ 2 do 1 dolžine plavuti pred osnovo pelvične plavuti.
The recommended dose is 32 µg/ kg bodyweight.
Priporočeni odmerek je 32 µg/ kg telesne mase.
Gonazon contains azagly-nafarelin, which is an analogue of a natural hormone called gonadotrophin- releasing hormone (GnRH).
Zdravilo Gonazon vsebuje azagli- nafarelin, ki je analog naravnega hormona, imenovanega gonadotropin sproščajoči hormon (GnRH).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In bitches, the results of two field studies with Gonazon implants were provided, one investigating a single administration, another one the repeated application over a second year.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Pri psicah so bili predloženi rezultati dveh terenskih raziskav implantatov Gonazon, pri čemer je ena preučevala enkratno uporabo, druga pa ponovljeno aplikacijo v naslednjem letu.
Data on the return to oestrus, ovulatory oestrus and subsequent fertility once treatment has ended (i. e. once the implant had been removed) were limited, especially for repeated treatment.
Na voljo so bili samo omejeni podatki o povratku estrusa, ovulacijskega estrusa in plodnosti po končanem zdravljenju (tj. ko je implantat odstranjen), še posebej pri ponovljenem zdravljenju.
In most cases, an effect was induced within 6-11 days of treatment, and ovulation was generally advanced by 2-3 weeks.
V večini primerov se je učinek pokazal po 6- 11 dneh zdravljenja, ovulacija se je navadno sprožila 2- 3 tedne prej.
This summary was last updated in December 2006.
Ta povzetek je bil nazadnje posodobljen 12- 2006.
Invented Strength name
Izmišljeno Jakost ime
EU/ 2/ 03/ 040/ 001 Gonazon
koncentrat in EU/ 2/ 03/ 040/ 001 Gonazon
1,600 microgram/ ml
1. 600
concentrate and solvent for solution for injection
vehikel za
Female salmonid fish
plemenke
Intraperitoneal injection
intraperitonealno
Concentrate: vial (glass) Solvent: vial (glass) Sterile empty vial:
koncentrat: viala
2 ml 1 vial Solvent:
2 ml
100 ml concentrate 1 vial solvent 1 sterile empty vial
mikrogramov/ ml
Zero days
vehikel:
Subcutaneous
subkutana uporaba
Preloaded injection device, (hypodermic needle covered with a protective cap)
napolnjen injektor (igla za podkožno dajanje z zaščitnim pokrovčkom)
1/ 37 1.
1/ 34 1.
Active substance(s)
Zdravilna( e) učinkovina( e):
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagli- nafarelin, 1600 µg/ ml, v obliki azagli- nafarelin acetata
Benzyl alcohol (1%)
Benzilni alkohol (1%)
Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally.
Gonazona ne smemo uporabiti, preden ne pride do naravne ovulacije pri približno 10% specifičnih plemenskih rib.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin.
Pri ribah, ki so jim dajali azagli- nafarelin, so zasledili manjšo plodnost, slabšo kakovost iker in slabše preživetje do stopnje z očmi.
2/ 37 It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
Ribe je po injekciji priporočljivo smukati v presledkih po približno 50– 100 dnevnih stopinj.
For Arctic charr, injections should be given only if the water temperature is < 8°C.
2/ 34 Jezerskim zlatovčicam smemo injekcije dajati samo pri temperaturi vode < 8 ºC.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
Dolgoročni učinki azagli- nafarelina na plemenske ribe niso raziskani.
The package insert or the label should be shown to the physician
Če na kožo ali v oči nanesete koncentrirano raztopino ali več mililitrov razredčene raztopine ali si raztopino nenamerno samo- injicirate, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
Inject intraperitoneally along the central line, 1/ 2 to 1 fin length in front of the pelvic fin base.
Injiciramo intraperitonealno vzdolž osrednje linije, 1/ 2 do 1 dolžino plavuti pred osnovo pelvične plavuti.
The recommended dose is 32 µg/ kg body weight.
Priporočeni odmerek je 32 µg/ kg telesne mase.
3/ 37 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.
3/ 34 V tabeli sta navedena potrebna volumna koncentrata in vehikla za pripravo volumnov raztopine za injiciranje 0, 1 ml/ kg rib, 0, 2 ml/ kg rib, 0, 5 ml/ kg rib in 1 ml/ kg rib.
Preferred injection volume per kg fish (depending on fish size)* Total kg of fish
Primeren injekcijski volumen na kg rib (glede na velikost ribe) * Skupna teža rib Volumen
24 ml
v kg
49 ml
koncentrata
* this volume will be minimized for the species with the largest body weights.
* Volumen zmanjšamo na minimum za vrste rib z največjo telesno maso.
ATC vet code:
Farmakoterapevtska skupina: gonadotropin sproščajoči hormon Oznaka ATCvet:
Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH).
Azagli- nafarelin je sintetični analog gonadotropin sproščajočega hormona (GnRH).
It controls reproduction in fish by modulating the secretion of the pituitary gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), also known in fish endocrinology as GtH-II and GtH-I, respectively.
Pri ribah uravnava reprodukcijo, tako da spreminja izločanje hipofiznih gonadotropinov, luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH), ki ju v endokrinologiji rib imenujemo tudi GtH- II in GtH- I.
Azagly-nafarelin, like other GnRH analogues, mimics the action of GnRH, through modulation of the secretion of LH and FSH in mammals and fish.
Azagli- nafarelin tako kot drugi analogi GnRH posnema delovanje GnRH, tako da pri sesalcih in ribah spreminja izločanje LH in FSH.
Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout.
Azagli- nafarelin se pri kalifornijskih postrvih (šarenkah) po intraperitonealnem dajanju hitro absorbira.
The distribution and metabolism of azagly-nafarelin have not been studied in the target species.
Porazdelitve in presnove azagli- nafarelina pri ciljni živalski vrsti niso raziskovali.
Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout.
Pri kalifornijskih postrvih (šarenkah) se azagli- nafarelin po intraperitonealnem dajanju hitro izloči iz plazme.
The elimination half-life (T1/ 2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/ kg BW are 4.9 h and 6.8 h, respectively.
Razpolovni čas izločanja (T1/ 2) in srednji čas zadrževanja azagli- nafarelina sta pri postrvih po intraperitonealnem dajanju odmerka po 32 µg/ kg telesne mase 4, 9 ure in 6, 8 ure.
Benzyl alcohol Sodium acetate (tri-hydrate) Acetic acid, glacial Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
benzilni alkohol natrijev acetat (trihidrat) ocetna kislina, koncentrirana; ledocet natrijev klorid / klorovodikova kislina 4N (za uravnavo pH)
4/ 37 Water for injection
4/ 34 voda za injekcije
Shelf life of the veterinary medicinal product as packaged for sage:
Rok uporabnosti zdravila v pakiranju za prodajo:
Store and transport at 2°C - 8°C (in a refrigerator).
Shranjujte in prevažajte pri temperaturi 2 ºC– 8 ºC (v hladilniku).
Carton:
Kartonska zloženka:
1 concentrate vial and 1 solvent vial.
1 viala s koncentratom in 1 viala z vehiklom.
3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
Viala s koncentratom: viala po 3 ml iz rjavega stekla, ki vsebuje 2 ml raztopine; gumijasti zamašek in zaporka brez navoja.
100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
Viala z vehiklom: viala po 100 ml iz prozornega stekla, ki vsebuje 100 ml raztopine; gumijasti zamašek in zaporka brez navoja.
50-ml empty
Sterilni vsebnik: po 50 ml, prazen
5/ 37 10.
5/ 34 10.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu
6/ 37 1.
6/ 34 1.
Gonazon 18.5 mg implant for dogs
Gonazon 18, 5 mg, implantat za pse
18.5 mg per implant
18, 5 mg v implantatu
Do not use in bitches (prepubertal and adult) intended for breeding (see section 4.7).
Ne uporabite pri psicah (pred puberteto in odraslih), namenjenih za vzrejo (glejte poglavje 4. 7).
Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of treated bitches.
Podatki s terena kažejo, da implantat pri določenem deležu (1, 2%) psic ne ostane na mestu.
At the end of a one year treatment, it may not be possible to locate and remove the implant in approximately 10% of cases.
Po enem letu v približno 10% primerov ne moremo določiti mesta implantata in ga odstraniti.
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).
Pri enkratni uporabi se lahko delovanje jajčnikov po odstranitvi implantata pri psicah, ki jim vnesemo implantat pred puberteto, povrne po daljšem času (povprečno 255 dni; razpon 36– 429 dni) kot pri odraslih psicah (povprečno 68 dni; razpon 12– 264 dni).
A large proportion (68%) of the first heat after a single treatment in adult bitches were non-ovulatory.
Pri velikem deležu (68%) prve gonitve po enkratni uporabi pri odraslih psicah ni prišlo do ovulacije.
7/ 37 4.5 Special precautions for use
7/ 34 4. 5 Posebni previdnostni ukrepi
The frequency of induced heat is lower when the first treatment is administered in metoestrus (32%) than in anoestrus (84%).
Pogostnost spodbujene gonitve je manjša, če ga prvič vnesemo v metestrusu (32%) kot če ga vnesemo v anestrusu (84%).
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%).
Pogostnost spodbujene gonitve je pri psicah, ki po prejšnji uporabi izdelka niso imele znakov estrusa, po ponovljeni uporabi majhna (ocenjujejo, da je 8%).
The risk of inducing a fertile heat is low in metoestrus (5%).
Tveganje, da bi spodbudili fertilni estrus, je v metestrusu majhno (5%).
Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, in sicer rokavice.
8/ 37 4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes.
Azagli- nafarelin je peptid, ki ga pretežno razgrajujejo peptidaze in ne encimi P- 450.
4.9 Amounts to be administered and administration route
8/ 34 4. 9 Odmerjanje in pot uporabe
3
3 – 6 let
Average duration of blockade
Povprečno trajanje blokade
(standard deviation)
(standardno odstopanje)
(± 24 days)
(± 24 dni)
(± 93 days)
(± 93 dni)
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.
Po podatkih s terena je preprečevanje estrusa po enkratni uporabi trajalo 12 mesecev ali dlje pri 75% odraslih psic in pri ≥ 90% psic pred puberteto.
However, it should be noted that within the first month after treatment a proportion of treated bitches also experienced an induced heat (see section 4.5).
Omeniti pa je treba, da imelo v prvem mesecu po uporabi določeno število psic spodbujeno gonitev (glejte poglavje 4. 5).
4 cm²) of the ventral anterior abdominal/ umbilical region for an aseptic procedure.
Pripravimo majhno mesto (na primer 4 cm²) na ventralni, anteriorni abdominalni steni v predelu popka za aseptični postopek.
9/ 37 REMOVAL:
ODSTRANITEV:
Chemical restraint (sedation and/ or general anaesthesia) may be required for implant removal.
Za odstranitev implantata je lahko potrebna umiritev z zdravili (sedacija in/ ali splošna anestezija).
Push the implant gently towards the stab incision.
9/ 34 Implantat narahlo potisnemo proti vbodnemu rezu.
Gonadotrophin-Releasing Hormone (GnRH) ATCvet code:
Farmakoterapevtska skupina: gonadotropin sproščajoči hormon (GnRH) Oznaka ATCvet:
Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously.
Azagli- nafarelin, agonist GnRH, deluje pri trajnem dajanju dvofazno na hipofizo.
This brief phase may result in induced heat within one to four weeks following the first administration of the implant (see section 4.5).
Posledica te kratke faze je lahko indukcija gonitve v enem do štirih tednih po prvi uporabi implantata (glejte poglavje 4. 5).
Following subcutaneous administration of a single implant to dogs (approximate weight of 10 kg), maximum serum concentrations (0.13 µg/ ml) of azagly-nafarelin are reached around 3.5 hours.
Po subkutana uporaba vnosu enega implantata psom (težkim približno 10 kg) doseže azagli- nafarelin največjo koncentracijo v serumu (0, 13 µg/ ml) približno v 3, 5 ure.