FrancophonIA/ELRC3.0 huggingface dataset:
English: Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
Slovenian: V štirih študijah so proučevali zdravljenje motnje tako, da so ocenjevali zmanjšanje simptomov po devetih do desetih tednih.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeristar.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) zdravilo Xeristar ocenil, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovno prevzemanje 5-hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v živčne celice možganov in hrbtenjače.
English: Any patients taking Xeristar who have distressing thoughts or experiences at any time should tell their doctor immediately.
Slovenian: Vsak bolnik, ki jemlje zdravilo Xeristar in opazi misli ali občutke, ki povzročajo stisko, mora o tem nemudoma obvestiti svojega zdravnika.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Slovenian: Pri splošni anksiozni motnji znaša priporočeni začetni odmerek 30 mg enkrat na dan, vendar se lahko odmerek poveča na 60, 90 ali 120 mg glede na odziv bolnika.
English: Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months.
Slovenian: V šestih študijah so proučevali zdravljenje depresije in ocenjevali spremembo simptomov v obdobju šestih mesecev.
English: Xeristar must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
Slovenian: Zdravilo Xeristar se prav tako ne sme uporabljati pri bolnikih z nekaterimi vrstami obolenj jeter ali bolnikih s hudimi obolenji ledvic.
English: Xeristar is a medicine that contains the active substance duloxetine.
Slovenian: Xeristar je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
English: Xeristar must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Slovenian: Zdravilo Xeristar se ne sme uporabljati skupaj z zaviralci monoaminooksidaze (drugo skupino zdravil proti depresiji), fluvoksaminom (drugim zdravilom proti depresiji), ciprofloksacinom ali enoksacinom (vrstama antibiotikov).
English: As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Xeristar, particularly in the first few weeks of treatment for depression.
Slovenian: Kot pri drugih zdravilih proti depresiji so tudi pri zdravilu Xeristar opazili posamezne primere samomorilnih misli in samomorilnega vedenja, še zlasti v prvih nekaj tednih zdravljenja depresije.
English: What is the risk associated with Xeristar?
Slovenian: Kakšna tveganja so povezana z zdravilom Xeristar?
English: Xeristar should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Slovenian: Zdravila Xeristar ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Slovenian: Tako se prepreči, da bi želodčna kislina uničila zdravilno učinkovino.
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Xeristar.
Slovenian: V peti študiji s 429 bolniki so proučevali, kako hitro se simptomi spet pojavijo pri bolnikih, ki so se sprva odzvali na zdravilo Xeristar.
English: Why has Xeristar been approved?
Slovenian: Zakaj je bilo zdravilo Xeristar odobreno?
English: For generalised anxiety disorder, Xeristar has been compared with placebo in five studies involving a total of 2,337 patients.
Slovenian: Pri splošni anksiozni motnji so zdravilo Xeristar primerjali s placebom v petih študijah, v katere je bilo skupno vključenih 2 337 bolnikov.
English: For major depression, the recommended dose of Xeristar is 60 mg once a day.
Slovenian: Pri zdravljenju hude depresije je priporočeni odmerek zdravila Xeristar 60 mg enkrat dnevno.
English: In patients who respond to Xeristar, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Slovenian: Za bolnike, ki se odzivajo na zdravilo Xeristar, je zdravljenje priporočljivo nadaljevati še nekaj mesecev, da se prepreči ponovni pojav bolezni, za bolnike, ki so v preteklosti imeli ponavljajoča se obdobja depresije, pa še dlje.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Slovenian: Pri zdravljenju bolečine diabetične nevropatije je priporočeni odmerek 60 mg na dan, nekateri bolniki pa bodo morda potrebovali višji odmerek, 120 mg na dan.
English: For the treatment of diabetic neuropathic pain, Xeristar was more effective at reducing pain than placebo.
Slovenian: Pri zdravljenju bolečine diabetične nevropatije je bilo zdravilo Xeristar pri zmanjševanju bolečine učinkovitejše od placeba.
English: The active substance in Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina zdravila Xeristar, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
English: In the two studies where the approved dose of Xeristar was compared with placebo, Xeristar was more effective.
Slovenian: V dveh študijah, v katerih so odobreni odmerek zdravila Xeristar primerjali s placebom, se je zdravilo Xeristar izkazalo za učinkovitejše.
English: The dose of Xeristar should be reduced gradually when stopping treatment.
Slovenian: Ob prenehanju zdravljenja je treba odmerek zdravila Xeristar zmanjševati postopoma.
English: For the full list of all side effects reported with Xeristar, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xeristar, glejte navodilo za uporabo.
English: Although the results of the depression studies varied, Xeristar was more effective than placebo in four of the studies.
Slovenian: Čeprav so se rezultati študij o depresiji med seboj razlikovali, je bilo zdravilo Xeristar v štirih študijah učinkovitejše od placeba.
English: For generalised anxiety disorder, Xeristar was also more effective than placebo at treating the disorder and preventing symptoms returning.
Slovenian: Pri splošni anksiozni motnji je bilo zdravilo Xeristar prav tako učinkovitejše od placeba pri preprečevanju ponovnega pojava simptomov.
English: For neuropathic pain, Xeristar has been compared with placebo in two 12-week studies in 809 diabetic adults.
Slovenian: Pri nevropatski bolečini so zdravilo Xeristar v 12-tedenski študiji z 809 sladkornimi bolniki primerjali s placebom.
English: The full EPAR for Xeristar can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xeristar je na voljo tukaj.
English: For major depression, Xeristar has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Slovenian: Za zdravljenje večjih depresivnih motenj so zdravilo Xeristar v osmih glavnih študijah, v katere je bilo vključenih 2 544 bolnikov, primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: What is Xeristar used for?
Slovenian: Za kaj se zdravilo Xeristar uporablja?
English: How has Xeristar been studied?
Slovenian: Kako je bilo zdravilo Xeristar raziskano?
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Xeristar, including 288 patients with a history of repeated episodes of depression for up to five years.
Slovenian: V drugih dveh študijah, v katerih je sodelovalo 288 bolnikov z anamnezo ponavljajočih se epizod depresije v največ zadnjih petih letih, so proučevali, kako hitro se simptomi povrnejo pri bolnikih, ki so se sprva odzvali na zdravljenje z zdravilom Xeristar.
English: It also took longer for symptoms to return in patients taking Xeristar than in those taking placebo.
Slovenian: Pri bolnikih, ki so jemali zdravilo Xeristar, je trajalo dalj časa, da so se simptomi ponovno pojavili, kot pri bolnikih, ki so jemali placebo.
English: What is Xeristar?
Slovenian: Kaj je zdravilo Xeristar?
English: How is Xeristar used?
Slovenian: Kako se zdravilo Xeristar uporablja?
English: How does Xeristar work?
Slovenian: Kako zdravilo Xeristar deluje?
English: Patients who also have major depression should start with 60 mg once a day.
Slovenian: Večina bolnikov bo morala jemati 60 mg na dan. Bolniki, ki imajo tudi hujše depresivne motnje, morajo začeti s 60 mg enkrat na dan. Za bolnike, ki se odzivajo na zdravilo Xeristar, je zdravljenje priporočljivo nadaljevati še nekaj mesecev, da se prepreči ponovni pojav bolezni.
English: London, 17 January 2008 EMEA/31266/2008
Slovenian: London, 17. januar 2008 EMEA/31266/2008
English: If you are in a clinical trial and have any questions, contact your doctor.
Slovenian: Če sodelujete v kliničnih preizkušanjih in imate kakršnakoli vprašanja, se posvetujte z vašim zdravnikom.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for ZOMETA
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET za zdravilo ZOMETA
English: International non-proprietary name (INN): zoledronic acid
Slovenian: Mednarodno nelastniško ime (INN): zoledronska kislina
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Slovenian: CHMP običajno potrebuje do 90 dni za sprejetje mnenja od prejema vloge za spremembo dovoljenja za promet z zdravilom.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Po tem ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: The reduction of bone loss helps to make bones less likely to break, which may be useful in preventing fractures.
Slovenian: Zahvaljujoč zmanjšanju izgube kostne mase je manj verjetno, da se bodo kosti zlomile, kar je lahko koristno pri preprečevanju zlomov.
English: The main measure of effectiveness was the change in ‘bone mineral density' (the amount of bone) in the spine, between the start of the study and one year later.
Slovenian: Glavno merilo učinkovitosti je bila sprememba „mineralne gostote v kosteh“ (količine kosti) v hrbtenici v obdobju enega leta od pričetka študije.
English: Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno šestih tednih posodobi dovoljenje.
English: Bone mineral density was measured using a special type of X-ray called ‘dual energy X-ray absorptiometry' (DEXA).
Slovenian: Mineralno gostoto v kosteh so merili s posebno vrsto rentgenskega slikanja, imenovano „dvoenergijska rentgenska absorpciometrija (dual-energy Xray absorptiometry - DEXA)“.
English: This leads to less bone loss.
Slovenian: To vodi k zmanjšanju izgube kostne mase.
English: The CHMP had concerns over the way the two main studies were designed, since they did not look directly at bone fractures.
Slovenian: CHMP je izrazil zadržke glede zasnove dveh glavnih študij, saj ti nista neposredno preučevali zlomov kosti.
English: The CHMP was also concerned that there was insufficient information to show that the dose of Zometa used in the studies was the most appropriate for these patients.
Slovenian: CHMP je imel tudi zadržke, da ni dovolj informacij, ki bi dokazale, da je odmerek zdravila Zometa, uporabljen v študijah, najprimernejši za te bolnice.
English: This includes fractures (broken bones), spinal compression (pressure on the spinal cord), bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Slovenian: Ti zapleti vključujejo frakture (zlome kosti), spinalno kompresijo (pritisk na hrbtenjačo), kostne zaplete, ki zahtevajo obsevanje ali operacijo, ter hiperkalciemijo (visoko raven kalcija v krvi).
English: There are no consequences on the use of Zometa in its approved indications, for which the balance of benefits and risks remains positive.
Slovenian: Za uporabo zdravila Zometa za odobrene indikacije, za katere ostaja razmerje med koristmi in tveganji pozitivno, ni nikakršnih posledic.
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein), and as a concentrate for infusion.
Slovenian: Na voljo je kot prašek in vehikel za pripravo raztopine za infundiranje (kapalna infuzija v veno ter kot koncentrat za pripravo raztopine za infundiranje.
English: The company also compared the results of these studies with results from studies of Aclasta, another medicine that also contains zoledronic acid, but which is used to prevent fractures in postmenopausal women with osteoporosis.
Slovenian: Podjetje je rezultate teh študij primerjalo tudi z rezultati študij z zdravilom Aclasta, drugim zdravilom, ki prav tako vsebuje zoledronsko kislino, vendar pa se uporablja za preprečevanje zlomov pri ženskah po menopavzi z osteoporozo.
English: The company informed the CHMP that this withdrawal does not have any effect on patients currently included in clinical trials with Zometa.
Slovenian: Podjetje je CHMP obvestilo, da ta umik nima posledic za bolnice, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Zometa.
English: Zometa can also be used to treat the hypercalcaemia caused by tumours.
Slovenian: Zdravilo Zometa se lahko uporablja tudi za zdravljenje hiperkalciemije, ki jo povzročijo tumorji.
English: This was not overcome by providing information on fractures from studies looking at Aclasta in the treatment of osteoporosis.
Slovenian: Ta pomanjkljivost ni bila odpravljena z zagotovitvijo informacij o zlomih iz študij, v katerih so preučevali zdravilo Aclasta pri zdravljenju osteoporoze.
English: Zometa is a medicine containing the active substance zoledronic acid.
Slovenian: Zometa je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
English: What are the consequences of the withdrawal for patients in clinical trials using Zometa?
Slovenian: Kakšne so posledice umika za bolnice, ki sodelujejo v kliničnih preizkušanjih zdravila Zometa?
English: The application was at day 90 when the company withdrew.
Slovenian: Podjetje je vlogo umaknilo na 90. dan postopka.
English: The effectiveness of Zometa in preventing bone loss was studied in two main studies involving a total of 1,667 postmenopausal women treated for early-stage breast cancer with letrozole (an aromatase inhibitor).
Slovenian: Učinkovitost zdravila Zometa pri preprečevanju izgube kostne mase so preučevali v dveh glavnih študijah s skupno 1.667 ženskami po menopavzi, ki so se zdravile zaradi raka dojke v zgodnji fazi z letrozolom (zaviralcem aromataze).
English: What is Zometa?
Slovenian: Kaj je zdravilo Zometa?
English: On 15 November 2007, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
Slovenian: Podjetje Novartis Europharm Limited je dne 15. novembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za novo indikacijo za zdravilo Zometa, in sicer za preprečevanje zlomov in izgube kostne mase pri ženskah po menopavzi z rakom dojke v zgodnji fazi, zdravljenimi z zaviralci aromataze.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the prevention of fractures and bone loss in women being treated with aromatase inhibitors.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge določene zadržke in je začasno menil, da za zdravilo Zometa ni mogoče odobriti dovoljenja za preprečevanje zlomov in izgube kostne mase pri ženskah, zdravljenih z zaviralci aromataze.
English: This comparison was intended to provide information on the effect of zoledronic acid on bone fractures in women being treated with aromatase inhibitors.
Slovenian: Ta primerjava naj bi podala informacije o učinku zoledronske kisline na zlome kosti pri ženskah, zdravljenih z zaviralci aromataze.
English: Although Zometa seemed to reduce bone loss when it was started at the same time as letrozole, the CHMP was not convinced of the relevance of this finding in the absence of adequate information on fractures.
Slovenian: Čeprav se je zdelo, da zdravilo Zometa zmanjša izgubo kostne mase, če se prične uporabljati sočasno z letrozolom, CHMP zaradi pomanjkanja ustreznih informacij o zlomih ni bil prepričan o pomembnosti te ugotovitve.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Zometa had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je zato v času umika menil, da korist zdravila Zometa ni bila zadostno dokazana in da ni večje od znanih tveganj.
English: Zometa is already approved for use in the prevention of bone complications in patients with advanced cancer that affects the bone.
Slovenian: Zdravilo Zometa je že odobreno za uporabo za preprečevanje zapletov, povezanih z okostjem, pri bolnikih z napredovalim rakom, ki zajame kosti.
English: Both studies looked at the effects of starting Zometa at the same time as starting letrozole treatment, compared with the effects of waiting until there was significant bone loss or evidence of a fracture before starting Zometa.
Slovenian: V obeh študijah so preučevali učinke začetka zdravljenja z zdravilom Zometa sočasno s pričetkom zdravljenja z letrozolom, ki so jih primerjali z učinki v primeru čakanja s pričetkom zdravljenja z zdravilom Zometa do večje izgube kostne mase ali dokazanega zloma.
English: What was Zometa expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Zometa uporabljalo?
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Zometa, zoledronska kislina, je difosfonat.
English: What is happening for Zometa for the prevention of bone complications and hypercalcaemia?
Slovenian: Kakšne so posledice za zdravilo Zometa pri uporabi za preprečevanje zapletov na kosteh in hiperkalciemije?
English: Aromatase inhibitors include anastrozole, letrozole and exemastane, and can cause bone loss and fractures as a side effect.
Slovenian: Med zaviralce aromataze sodijo anastrozol, letrozol in eksemestan, ta vrsta zdravil pa lahko kot neželeni učinek povzroči izgubo kostne mase in zlome.
English: In the new indication, Zometa was expected to be used to prevent fractures and bone loss in postmenopausal women with early-stage breast cancer who were being treated with anticancer medicines called aromatase inhibitors.
Slovenian: Nova indikacija je predvidevala uporabo zdravila Zometa za preprečevanje zlomov in izgube kostne mase pri ženskah po menopavzi z rakom dojke v zgodnji fazi, ki se zdravijo z zdravili proti raku, imenovanimi zaviralci aromataze.
English: How is Zometa expected to work?
Slovenian: Kako naj bi zdravilo Zometa delovalo?
English: Uxbridge UB9 6LS United Kingdom
Slovenian: Uxbridge UB9 6LS Velika Britanija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 March 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 13. marec 2001
English: In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal.
Slovenian: Izjemoma, še posebno pri starejših in občutljivih psih so neželjeni učinki lahko resni ali smrtni.
English: Monitor the hematocrit frequently.
Slovenian: Pogosto nadzorujte vrednosti hematokrita.
English: Alopecia and erythema may also occur occasionally.
Slovenian: Občasno se lahko pojavita tudi alopecija in rdečina (eritem).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B. V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B. V.
English: The duration of treatment is dependent on clinical response.
Slovenian: Trajanje zdravljenja je odvisno od kliničnega odziva.
English: The weight of the animal should be accurately determined before start of treatment.
Slovenian: Teža živali mora biti natančno določena pred pričetkom zdravljenja.
English: If you notice any other side effects, please inform your veterinary surgeon.
Slovenian: Če opazite kakršnekoli druge stranske učinke, obvestite svojega veterinarja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu.
English: Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting.
Slovenian: Držite gobec psa zaprt še nekaj sekund, zato da se tableta v celoti navlaži.
English: Long term treatment should be under regular veterinary supervision.
Slovenian: Dolgotrajno zdravljenje naj bo pod rednim veterinarskim nadzorom.
English: Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids ATCvet code: QM01AE92
Slovenian: Farmakoterapevtska skupina: nesteroidno protivnetno zdravilo Oznaka ATCvet: QM01AE92
English: 200 mg / oral lyophilisate For a full list of excipients, see section 6.1.
Slovenian: 200 mg / peroralni liofilizat Celoten seznam pomožnih snovi, glej razdelek 6.1.
English: The recommended dose should not be exceeded.
Slovenian: Ne prekoračite priporočenega odmerka.
English: Maintain the animal on intravenous fluids and, if necessary, administer whole blood.
Slovenian: Žival vzdržujte s intravenoznim vnosom tekočin in, če je potrebno, uporabite transfuzijo krvi.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
English: Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk.
Slovenian: Uporaba zdravila pri živalih, ki so mlajše od 6 mesecev, s telesno maso manj kot 5 kg ali starih živalih je lahko dodatno tvegana.
English: The oral lyophilisates are available in the following pack sizes:
Slovenian: Peroralni liofilizati se nahajajo v naslednjih velikostih pakiranj:
English: If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
Slovenian: Če se peroralni liofilizat prehitro razgradi, dobro umijte roke.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
English: Place the tablet in the dog's mouth.
Slovenian: Daj tableto živali v gobec.
English: Push the bottom of the blister and the tablet will pop out.
Slovenian: Pritisni dno pretisnega omota in tableta se prikaže.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Tepoksalin