FrancophonIA/ELRC3.0 huggingface dataset:
English: In male dogs administered 10 times the upper recommended therapeutic dose, diffuse atrophy of seminiferous tubules in the testes and associated decreased sperm counts were seen.
Slovenian: Pri pasjih samcih, ki so prejeli 10-kratnik najvišjega priporočenega terapevtskega odmerka, so opazili difuzno atrofijo semenskih kanalov v modih in s tem povezano zmanjšano število spermijev.
English: PACKAGE SIZE 100 tablets
Slovenian: VELIKOST PAKIRANJA 100 tablet
English: 6.5 Nature and composition of immediate packaging Pack sizes of high-density polyethylene bottle each containing 30, 100 or 250 tablets with a child resistant closure.
Slovenian: Pakiranja vsebujejo eno plastenko iz polietilena visoke gostote, ki vsebuje 30, 100 ali 250 tablet z za otroke varno zaporko.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 tablets (400 mg) and 250 tablets (100 and 400 mg)
Slovenian: Plastenka s 100 tabletami (400 mg) in 250 tabletami (100 in 400 mg)
English: Each tablet can be halved for appropriate dosing according to the individual bodyweight of the dog.
Slovenian: Vsako tableto lahko prepolovite za ustrezno doziranje glede na telesno težo psa.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/147/002 250 tablets (100 mg)
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET EU/2/12/147/002 250 tablet (100 mg)
English: Imepitoin is extensively metabolised prior to elimination.
Slovenian: Imepitoin se pred izločitvijo v veliki meri presnovi.
English: The use of the veterinary medicinal product is not recommended in male breeding dogs or in female dogs during pregnancy and lactation.
Slovenian: Uporaba tega zdravila ni priporočljiva pri psih za razplod ali pri psicah v obdobju brejosti in laktacije.
English: However, the upper limit of the confidence interval for creatinine remained within the reference range at all visits.
Slovenian: Rahlo zvišanje vrednosti kreatinina v primerjavi z izhodiščem so opazili pri psih, zdravljenih z imepitoinom, vendar pa je zgornja meja intervala zaupanja za kreatinin ostala ob vseh obiskih znotraj referenčnega razpona.
English: These CNS effects may include loss of righting reflex, decreased activity, eyelid closure, lacrimation,
Slovenian: Učinki na osrednji živčni sistem lahko vključujejo izgubo izravnalnega refleksa, zmanjšano aktivnost,
English: Transient ataxia was reported very commonly during a clinical trial for noise phobia and occurred early in the treatment course.
Slovenian: Med kliničnim preskušanjem zdravljenja fobije hrupa so zelo pogosto poročali o prehodni ataksiji, ki se je pojavila na začetku zdravljenja.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim Vetmedica GmbH
English: Oral administration at a dose of 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Slovenian: Peroralno dajanje pri odmerku 30 mg imepitoina na kg telesne mase dvakrat na dan, približno 12 ur narazen.
English: Oral administration at a dose range of 10 mg to 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Slovenian: Peroralno dajanje v razponu odmerka 10 mg do 30 mg imepitoina na kg telesne mase dvakrat na dan, v približno 12-urnem presledku.
English: The claim for the treatment of noise phobia is based on a pivotal field study which investigated a 3 day course of treatment for a noise event associated with fireworks.
Slovenian: Indikacija za zdravljenje fobije pred hrupom temelji na ključni terenski študiji, ki je raziskovala 3
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia, emesis, polyphagia at the beginning of treatment, somnolence (very common); hyperactivity, apathy, polydipsia, diarrhoea, disorientation, anorexia, hypersalivation, polyuria (common); prolapsed nictitating membrane and decreased sight (isolated reports).
Slovenian: V predkliničnih in kliničnih študijah za trditve o epilepsiji so opazili naslednje blage in običajno prehodne neželene učinke po pogostosti padajoče: ataksija, bruhanje, polifagija, somnolenca (zelo pogosto); hiperaktivnost, apatija, polidipsija, driska, dezorientiranost, anoreksija, hipersalivacija, poliurija (pogosto); prolaps žmurk in poslabšanje vida (izolirani primeri).
English: No accumulation of imepitoin in plasma occurs after repeated administration, once steady state is reached.
Slovenian: Imepitoin se po večkratnem odmerjanju ne kopiči v plazmi, ko je dosežena koncentracija dinamičnega ravnovesja.
English: dry eye and nystagmus.
Slovenian: zapiranje vek, solzenje, suhe oči in nistagmus.
English: Interaction with other medicinal products and other forms of interaction The product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section “Special warnings”).
Slovenian: Zdravilo so uporabili v kombinaciji s fenobarbitalom, kalijevim bromidom in/ali pri majhnem številu primerov z levetiracetamom vendar neželenih kliničnih interakcij niso opazili (glejte razdelek "Posebna upozorila").
English: In a US field trial that compared the efficacy of imepitoin at a fixed dose of 30 mg/kg twice daily to a placebo in 151 dogs with idiopathic epilepsy during a treatment period of 84 days, the proportion of generalized seizure-free dogs was 21% (21 dogs out of 99; 95 % CI [0.131; 0.293])
Slovenian: V ameriškem kliničnem terenskem preskušanju, kjer so primerjali učinkovitost imepitoina s fiksnim odmerkom 30 mg/kg dvakrat na dan in placeba pri 151 psih z idiopatično epilepsijo med obdobjem zdravljenja, ki je trajalo 84 dni, je delež psov brez generaliziranih epileptičnih napadov bil 21% (21 od
English: Imepitoin 400 mg
Slovenian: imepitoin 100 mg imepitoin 400 mg
English: Overdose (symptoms, emergency procedures, antidotes) In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kilogram bodyweight, neurological effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted.
Slovenian: V primeru ponavljajočega se prevelikega odmerjanja z do 5-krat večjim odmerkom od priporočenega odmerka 30 mg imepitoina na kilogram telesne mase, so opazili nevrološke učinke in, učinke na prebavila ter reverzibilno podaljšanje intervala QT.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pexion 100 mg tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Pexion 100 mg tablete za pse
English: in the imepitoin group and 8% (4 dogs out of 52; 95% CI [0.004; 0.149]) in the placebo group.
Slovenian: 99 psov; 95 % CI [0.131; 0.293]) v skupini z imepitoinom in 8% (4 od 52 psov; 95% CI [0.004;
English: Mild behavioural or muscular signs may be observed in dogs upon abrupt termination of treatment with imepitoin.
Slovenian: Pri nagli prekinitvi zdravljenja z imepitoinom je mogoče pri psih opaziti blage vedenjske spremembe ali mišične znake.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
English: PACKAGE LEAFLET:
Slovenian: Ena tableta vsebuje:
English: For the efficacy analysis, 226 dogs (104 imepitoin, 122 placebo) were eligible (at least one dose of medication & data for evaluation of co-primary endpoints), and the following results were observed for the two co-primary endpoints: Owner assessed overall effect of study treatment (based on signs during a noise event and a comparison to signs during a previous noise event(s) without treatment: The cumulative odds of a good or excellent effect were significantly greater in the imepitoin group compared with the placebo group (Odds Ratio = 4.689; p < 0.0001, 95% CI [2.79;7.89]).
Slovenian: Lastnik je ocenil splošni učinek zdravljenja (na podlagi znakov med hrupnim dogodkom in primerjavo z znaki med prejšnjim(-i) hrupnim(-i) pojavi(-om) brez zdravljenja: kumulativna verjetnost dobrega ali odličnega učinka je bila bistveno večja v skupini imepitoina v primerjavi s palcebo skupino (razmerje obetov = 4,689; p < 0,0001, 95 % CI [2,79; 7,89]).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 30 tablets (100 and 400 mg) and 100 tablets (100 mg)
Slovenian: Plastenka s 30 tabletami (100 un 400 mg) in 100 tabletami (100 mg)
English: Pexion 400 mg tablets for dogs
Slovenian: Pexion 400 mg tablete za pse
English: 400 mg tablet
Slovenian: 100-miligramska tableta 400-miligramska tableta
English: Number of tablets (to be given twice daily) for initiation of epilepsy treatment: Dose: 10 mg/kg twice daily
Slovenian: Priporočeno število tablet (dajejo se dvakrat na dan) za začetek zdravljenja epilepsije:
English: Pexion 100 mg tablets for dogs Pexion 400 mg tablets for dogs
Slovenian: NAVODILO ZA UPORABO Pexion 100 mg tablete za pse Pexion 400 mg tablete za pse
English: Pregnancy and lactation
Slovenian: Brejost in laktacija:
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section 4.8).
Slovenian: kalijevem bromidu in/ali levetiracetamu na podlagi omejenih razpoložljivih raziskav ni mogoče dokazati (glejte poglavje 4.8).
English: Pexion 400 mg tablets for dogs imepitoin
Slovenian: Pexion 400 mg tablete za pse imepitoin
English: In non-responders, an increase in seizure frequency may be observed.
Slovenian: Pri na zdravljenje z imepitoinom neodzivnih psih je mogoče opaziti večjo pogostnost epileptičnih napadov.
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section “Interactions”).
Slovenian: kalijevem bromidu in/ali levetiracetamu na podlagi omejenih razpoložljivih raziskav ni mogoče dokazati (glejte poglavje "Interakcije").
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports).
Slovenian: V predkliničnih in kliničnih študijah za trditve o epilepsiji so opazili naslednje blage in običajno prehodne neželene učinke po pogostosti padajoče: na začetku zdravljenja ataksija (izguba koordinacije), emeza (bruhanje), polifagija (povečan apetit), somnolenca (zaspanost) (zelo pogosto);
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia (loss of coordination), increased appetite, lethargy (very common); emesis (vomiting), aggression (see section “Special warnings”) (common); hyperactivity, somnolence (drowsiness), hypersalivation (uncommon).
Slovenian: V predkliničnih in kliničnih študijah, ki so bile izvedene za podporo trditvam glede fobije pred hrupom, so opazili naslednje neželene učinke: ataksija (izguba koordinacije), povečan apetit, letargija
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: KOLIČINA UČINKOVIN(E)
English: Number of tablets per administration
Slovenian: Število tablet pri enem dajanju
English: Please refer to section 4.6 of the SPC for further details of adverse reactions.
Slovenian: 4.6 povzetka glavnih značilnosti zdravila.
English: PACKAGE SIZE 30 tablets 100 tablets 250 tablets
Slovenian: VELIKOST PAKIRANJA 30 tablet
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia, increased appetite, lethargy (very common); emesis, aggression (see section 4.5) (common); hyperactivity, somnolence, hypersalivation (uncommon).
Slovenian: V predkliničnih in kliničnih študijah, ki so bile izvedene za podporo trditvam glede fobije pred hrupom, so opazili naslednje neželene učinke: ataksija, povečan apetit, letargija (zelo pogosto);
English: This summary was last updated in March 2012.
Slovenian: Ta povzetek je bil nazadnje posodobljen 3-2012.
English: Deslorelin
Slovenian: Suprelorin deslorelin
English: Other information about Suprelorin:
Slovenian: Druge informacije o zdravilu Suprelorin:
English: There can also some be some local reaction (e.g. inflammation, hardening) for up to three months after implantation.
Slovenian: Možne so tudi lokalne reakcije (npr. vnetje, zatrdlina) do tri mesece po implantaciji.
English: It is presented in a pre-loaded applicator.
Slovenian: Na voljo je v predhodno napolnjenem aplikatorju.
English: Any swelling or local reaction resolves naturally.
Slovenian: Oteklina ali lokalna reakcija izgine sama od sebe.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suprelorin on 10/07/2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Suprelorin, veljavno po vsej Evropski uniji, odobrila dne 10. julija 2007.
English: Pregnant women should not administer the product.
Slovenian: Nosečnice zdravila ne smejo dajati.
English: Although skin contact with the product is unlikely, if this occurs the exposed area should be washed immediately, as these types of substances may be absorbed through the skin.
Slovenian: Čeprav stik kože z zdravilom ni verjeten, je treba, če do njega pride, nemudoma sprati izpostavljeni predel, ker se tovrstne snovi lahko absorbirajo skozi kožo.
English: What benefit has Suprelorin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Suprelorin izkazalo med študijami?
English: Suprelorin is not recommended for use in dogs and ferrets that have not yet reached puberty, as it has not been investigated in these animals.
Slovenian: Zdravila Suprelorin ni priporočljivo uporabljati pri psih ali belih dihurjih, ki še niso dosegli pubertete, saj pri teh živalih ni bilo proučevano.
English: What is the risk associated with Suprelorin?
Slovenian: Kakšna tveganja so povezana z zdravilom Suprelorin?
English: In some of these studies, the dogs and ferrets received Suprelorin more than once and were observed for up to a year after receiving the final implant.
Slovenian: V nekaterih izmed teh študij so psi in beli dihurji prejeli zdravilo Suprelorin več kot enkrat in so bili opazovani do eno leto po prejemu zadnjega implantata.
English: This suppresses (blocks) the production of follicle stimulating hormone (FSH) and luteinising hormone (LH).
Slovenian: To zavira (blokira) nastajanje folikle stimulirajočega hormona (FSH) in luteinizirajočega hormona (LH).
English: The majority of dogs regained normal semen characteristics approximately one year after the last treatment and dogs have been able to successfully mate with bitches, after treatment with Suprelorin was stopped.
Slovenian: Pri večini psov so se normalne značilnosti semena povrnile po približno enem letu od zadnjega zdravljenja, psi pa so se po prenehanju zdravljenja z zdravilom Suprelorin lahko uspešno sparili s samicami.
English: The return to normal fertility after the end of the treatment has not been investigated in ferrets.
Slovenian: Pri belih dihurjih vrnitve normalne plodnosti po koncu zdravljenja niso proučevali.
English: The active substance in Suprelorin, deslorelin, acts like the natural hormone gonadotropinreleasing hormone (GnRH) which controls the secretion of other hormones involved in fertility.
Slovenian: Zdravilna učinkovina zdravila Suprelorin, deslorelin, deluje kot naravni hormon gonadotropin sproščujoči hormon (GnRH), ki uravnava izločanje drugih hormonov, ki sodelujejo pri zagotavljanju plodnosti.
English: All studies showed a reduction of testosterone levels in the blood, a reduction in the size of the testicles, decreased libido and decreased spermatogenesis (when fewer sperm are produced by the testicles).
Slovenian: Vse študije so pokazale zmanjšanje ravni testosterona v krvi, zmanjšanje velikosti mod, zmanjšan libido in zmanjšanje spermatogeneze (moda proizvajajo manj spermijev).
English: Suprelorin has been studied under field conditions in dogs weighing between 10 and 25 kg which were implanted before being followed up for up to a year and in ferrets weighing between 1 and 1.7 kg which were implanted at the beginning of the breeding season before being followed up for up to 6 months.
Slovenian: Zdravilo Suprelorin so proučevali v pogojih na terenu pri psih, težkih med 10 in 25 kg ter so jih po implantaciji spremljali do eno leto, in pri belih dihurjih, težkih med 1 in 1,7 kg, ki so jim implantat vbrizgali na začetku paritvene sezone in jih nato spremljali 6 mesecev.
English: The implant is inserted subcutaneously, under the loose skin on the back between the lower neck and the lumbar area in dogs and between the shoulder blades in ferrets.
Slovenian: Implantat se aplicira subkutano, pri psih pod ohlapno kožo na hrbtu med spodnjim delom vratu in ledvenim predelom, pri belih dihurjih pa med lopatici.
English: Suprelorin is given as an implant that slowly releases a continuous low dose of deslorelin.
Slovenian: Zdravilo Suprelorin se daje kot implantat, iz katerega se počasi kontinuirano sprošča nizek odmerek deslorelina.
English: In case of accidental self-injection, medical advice should be sought immediately and the Package Leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suprelorin outweigh its risks for the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets and recommended that Suprelorin be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Suprelorin za zagotavljanje začasne neplodnosti pri zdravih, neskopljenih, spolno zrelih psih samcih in samcih belih dihurjev večje od z njim povezanih tveganj, zato je priporočil, da se za zdravilo Suprelorin odobri dovoljenje za promet.
English: It is used in healthy, sexually-mature dogs and ferrets that have not been neutered.
Slovenian: Uporablja se pri zdravih, spolno zrelih, neskopljenih psih in belih dihurjih.
English: Why has Suprelorin been approved?
Slovenian: Zakaj je bilo zdravilo Suprelorin odobreno?
English: The studies looked at the effect of Suprelorin on blood testosterone levels and the size of the testicles for dogs and ferrets and the ability of the dogs to produce semen for collection.
Slovenian: V študijah so proučevali učinek zdravila Suprelorin na raven testosterona v krvi, na velikost mod in sposobnost psov in belih dihurjev, da proizvajajo seme za zbiranje.
English: Dogs can have some moderate swelling at the implant site in the two weeks after implantation.
Slovenian: Psi imajo lahko dva tedna po implantaciji zmerno oteklino na mestu implantacije.
English: As a result in male dogs and ferrets less testosterone circulates in the blood, the dog and ferret stop producing sperm and its libido is reduced.
Slovenian: Posledično je v krvnem obtoku psov samcev in belih dihurjev manj testosterona, pes in beli dihur prenehata proizvajati spermo, njun libido pa se zmanjša.
English: This veterinary medicine has been developed especially for dogs and ferrets and is not for use in humans.
Slovenian: To veterinarsko zdravilo je namenjeno samo psom in belim dihurjem in se ne sme uporabljati za ljudi.
English: Suprelorin is an implant containing the active substance deslorelin.
Slovenian: Zdravilo Suprelorin je implantat, ki vsebuje zdravilno učinkovino deslorelin.
English: Suprelorin is used for male dogs and male ferrets to make them temporarily infertile.
Slovenian: Zdravilo Suprelorin se uporablja pri psih samcih in samcih belega dihurja za povzročitev začasne neplodnosti.
English: In more than 95% of dogs, these effects started at six weeks after implantation and between 5 and 14 weeks in treated ferrets after implantation.
Slovenian: Pri več kot 95 % psov so se učinki pokazali šest tednov po implantaciji, pri belih dihurjih pa 5 do 14 tednov po vbrizganju implantata.
English: Suprelorin starts being effective after about six weeks in dogs and between 5 to 14 weeks in ferrets.
Slovenian: Zdravilo Suprelorin začne učinkovati po približno 6 tednih pri psih in 5 do 14 tednih pri belih dihurjih.
English: The safety of Suprelorin was studied after giving dogs more than 10 times and ferrets more than 6 times the recommended dose rate.
Slovenian: Varnost zdravila Suprelorin je bila proučevana potem, ko so psi prejeli zdravilo v odmerku, več kot 10-krat večjem od priporočenega, beli dihurji pa v odmerku, več kot 6-krat večjem od priporočenega.
English: When administering the product, care should be taken to avoid accidental self-injection by ensuring that animals are suitably restrained and that the application needle is shielded until the moment of implantation.
Slovenian: Pri dajanju zdravila pazite, da bodo živali primerno imobilizirane in da bo igla za dajanje zdravila zaščitena s pokrovčkom vse do trenutka implantacije, da si zdravila ne bi nehote samoinjicirali.
English: How has Suprelorin been studied?
Slovenian: Kako je bilo zdravilo Suprelorin raziskano?
English: What is Suprelorin used for?
Slovenian: Za kaj se zdravilo Suprelorin uporablja?
English: If a dog or a ferret under treatment with Suprelorin were to mate with a female dog (“bitch”) or female ferret (“jill”) on heat, the chance of the bitch or jill becoming pregnant would be extremely low.
Slovenian: Če bi se pes ali beli dihur, ki je dobil zdravilo Suprelorin, sparil s samico, ki se goni, bi bila verjetnost brejosti izjemno nizka.
English: The effect continues for six months in the case of the 4.7 mg implant for dogs and 12 months in the case of the 9.4 mg implant for dogs (16 months for ferrets) after which the dog and ferret can be re-implanted if necessary.
Slovenian: Pri psih traja učinek šest mesecev, če je bil uporabljen 4,7-miligramski implantat oziroma 12 mesecev, če je bil uporabljen 9,4-miligramski implantat.
English: How does Suprelorin work?
Slovenian: Kako zdravilo Suprelorin deluje?
English: What is Suprelorin?
Slovenian: Kaj je zdravilo Suprelorin?
English: Ferrets can have transient moderate swelling, itching and redness at the implant site.
Slovenian: Pri belih dihurjih se lahko na mestu implantacije pojavi oteklina, srbenje ali rdečina.
English: The size of the testicles will decrease during treatment.For a full list of all side effects reported with Suprelorin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Suprelorin, glejte navodilo za uporabo.
English: It is most important to increase the dose gradually.
Slovenian: Najpomembneje je, da se odmerek povečuje postopoma.
English: The therapeutic effect is normally seen after 2-4 weeks of dosing.
Slovenian: Terapevtski učinek je po navadi viden po 2-4 tednih uporabe.
English: If necessary, the dose can be increased by 25 mg every other week.
Slovenian: Po potrebi se lahko odmerek poveča za 25 mg vsak drugi teden.
English: Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Slovenian: Priporočljivo je redno ocenjevanje, s katerim se potrdi, da je nadaljevanje zdravljenja za bolnika še naprej primerno.
English: Amitriptyline is authorised worldwide in more than 56 countries.
Slovenian: Amitriptilin ima dovoljenje za promet v več kot 56 državah po svetu.