natgillin/translations-raw huggingface dataset:
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDLcholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels. 
V večini kliničnih preskušanj so opažali znižane skupne plazemske koncentracije trigliceridov in prostih maščobnih kislin ter povišane ravni HDL holesterola v primerjavi s placebom, z majhnimi, vendar ne klinično pomembnimi povišanji ravni LDL holesterola.
Each tablet contains 110.596 mg of lactose monohydrate (see section 4.4). 
Ena tableta vsebuje 110.596 mg laktoze monohidrata (glejte poglavje 4.4).
Pioglitazone tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption. 
Tablete pioglitazona vsebujejo laktozo monohidrat in se zato ne smejo dajati bolnikom z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorpcijo glukoze-galaktoze.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. 
Če ste vzeli večji odmerek zdravila Sepioglin , kot bi smeli Če po nesreči zaužijete preveč tablet ali če kdo drug ali otrok zaužije vaša zdravila, nemudoma obvestite svojega zdravnika ali farmacevta.
Each tablet contains 73.731 mg of lactose monohydrate (see section 4.4). 
Ena tableta vsebuje 73.731 mg laktoze monohidrata (glejte poglavje 4.4).
In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator. 
V 3,5 letni PROactive študiji je 44/870 (5,1 %) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %) žensk, zdravljenih s primerjalnim zdravilom.
Investigations weight increased5 
Preiskave povečanje telesne mase5
Each tablet contains 36.866 mg of lactose monohydrate (see section 4.4). 
Ena tableta vsebuje 36,866 mg laktoze monohidrata (glejte poglavje 4.4).
Sepioglin tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption. 
Tablete zdravila Sepioglin vsebujejo laktozo monohidrat in jih zato ne smejo jemati bolniki z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorpcijo glukoze-galaktoze.
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. 
kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku monoterapije z metforminom - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku monoterapije s sulfonilsečnino.
Reproductive system and breast disorders erectile dysfunction General disorders and administration site conditions oedema very common fatigue uncommon 
Motnje reprodukcije in dojk erektilna disfunkcija Splošne težave in spremembe na mestu aplikacije edem zelo pogosti utrujenost občasni
6 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups. 
6 V kliničnih preskušanjih pioglitazona je bila incidenca povišanih vrednosti ALT, višjih kot trikratna zgornja meja normalnih vrednosti, enaka kot pri placebu, vendar nižja kot v primerjalnih skupinah z metforminom ali sulfonilsečnino.
common (affects 1 to 10 users in 100) - respiratory infection - abnormal vision - weight gain - numbness uncommon (affects 1 to 10 users in 1,000) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia) 
pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov) - okužba dihal - motnje vida - povečanje telesne mase - otopelost občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov) - vnetje sinusov (sinusitis) - težave s spanjem (nespečnost)
5 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year. 
5 V kontroliranih preskušanjih s primerjalnim zdravilom je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2-3 kg v enem letu.
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution. 
Med zdravljenjem s pioglitazonom se je pojavljalo majhno znižanje povprečne vrednosti hemoglobina (4 % relativno znižanje) in hematokrita (4,1 % relativno znižanje), skladno s hemodilucijo.
Bladder cancer has been experienced uncommonly (1 to 10 users in 1000) in patients taking pioglitazone. 
Rak mehurja se lahko pojavi občasno (pojavijo se pri 1 do 10 bolnikih od 1000 bolnikov) pri bolnikih, ki jemljejo pioglitazon.
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029). 
O primerih raka mehurja so pogosteje poročali v meta-analizi kontroliranih kliničnih preskušanjih s pioglitazonom (19 primerov od 12.506 bolnikov, 0,15 %) kot v kontrolnih skupinah (7 primerov od 10.212 bolnikov, 0,07 %) HR = 2,64 (95% IZ 1,11-6,31, P = 0,029).
Marketing authorisation holder Vaia S.A. 
Imetnik dovoljenja za promet z zdravilom Vaia S.A.
Your doctor will ask you to have blood tests periodically during treatment with Sepioglin. 
Zdravnik vas bo v času zdravljenja z zdravilom Sepioglin naročil na redne preiskave krvi.
The risk of fractures should be considered in the long term care of women treated with pioglitazone. 
Pri dolgoročnem zdravljenju žensk s pioglitazonom je treba upoštevati tveganje za zlome.
HOW TO TAKE SEPIOGLIN 
KAKO JEMATI ZDRAVILO SEPIOGLIN
1, 28 Octovriou Str. Ag. Varvara EL-12351 
1, 28 Octovriou str. Ag. Varvara EL-123 51 Athens, Grčija
- hypersensitivity to the active substance or to any of the excipients - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria 
- s preobčutljivostjo za zdravilno učinkovino ali katerokoli pomožno snov - s srčnim popuščanjem ali srčnim popuščanjem v anamnezi (NYHA razredi od I do IV) - z okvarjenim delovanjem jeter - z diabetično ketoacidozo - z rakom mehurja ali rakom mehurja v anamnezi - z neraziskano makroskopskao hematurijo
PA/Aluminium/PVC/Aluminium blisters, packs of 14, 28, 30, 50, 56, 90 and 98 tablets. 
PA/aluminijasti/PVC/aluminijasti pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 90 in 98 tablet.
Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator. 
Zlome so opazili pri 2,6% žensk, ki so jemale pioglitazon v primerjavi z 1,7 % žensk, zdravljenih s primerjalnim zdravilom.
Frequency of adverse reactions of pioglitazone by treatment regimen 
Pogostnost neželenih učinkov pioglitazona glede na režim zdravljenja
In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator. 
V 3,5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/870 (5,1 %; 1,0 zlom na 100 bolniških let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %; 0,5 zlomov na 100 bolniških let) žensk, zdravljenih s primerjalnim zdravilom.
HydroxypropylcelluloseLactose monohydrate Magnesium stearate 
6.1 Seznam pomožnih snovi kalcijev karmelozat hidroksipropilceluloza laktoza monohidrat magnezijev stearat
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease. 
Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni, zdravljenja s pioglitazonom ne smemo začeti.
The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are: 
Pri nekaterih bolnikih, ki so jemali pioglitazon skupaj z drugimi antidiabetičnimi zdravili, so se pojavili naslednji drugi neželeni učinki:
The tablets are supplied in PA/Aluminium/PVC/Aluminium blister packs of 14, 28, 30, 50, 56, 90 or 98 tablets. 
Tablete so na voljo v PA/aluminijastih/PVC/aluminijastih pretisnih omotih po 14, 28, 30, 50, 56, 90 ali 98 tablet.
4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. 
4 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini, zdravljeni s pioglitazonom in 7400 v skupini, zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
Athens, Greece 
123 51 Athens, Grčija
Infections and infestations upper respiratory tract infection common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon 
Infekcijske in parazitske bolezni okužba zgornjih dihal bronhitis sinusitis občasni občasni občasni
What Sepioglin looks like and contents of the pack Sepioglin 15 mg tablets are white, round, flat tablets, with “15” embossed on one side and a diameter of approximately 5.5 mm. 
Izgled zdravila Sepioglin in vsebina pakiranja Zdravilo Sepioglin 15 mg je na voljo v obliki belih, okroglih, ploščatih tablet, z oznako ‚15‘, odtisnjeno na eni strani, in približno 5,5-milimetrskim premerom.
INFORMATION IN BRAILLE Sepioglin 30 mg 
PODATKI V BRAILLOVI PISAVI Sepioglin 30 mg
INFORMATION IN BRAILLE Sepioglin 45 mg 
PODATKI V BRAILLOVI PISAVI Sepioglin 45 mg
Sepioglin should be used every day to work properly. 
Za pravilno delovanje je potrebno zdravilo Sepioglin jemati vsak dan.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to< 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 
Neželeni učinki, o katerih so poročali večkrat (> 0,5 %) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 
Neželeni učinki, o katerih so poročali večkrat (> 0,5 %) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: zelo pogosti (≥1/10) ; pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Sepioglinshould be used every day to work properly. 
Za pravilno delovanje je potrebno zdravilo Sepioglin jemanti vsak dan.
INFORMATION IN BRAILLE Sepioglin 15 mg 
PODATKI V BRAILLOVI PISAVI Sepioglin 15 mg
Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon 
Bolezni krvi in limfatičnega sistema anemija Presnovne in prehranske motnje hipoglikemija občasni zelo pogosti povečan apetit občasni
Monotherapy with metformin with sulphonylurea with metformin and sulphonylurea with insulin 
Monoterapija z metforminom s sulfonilsečnino z metforminom in sulfonilsečnino z inzulinom
White, round, flat tablets, with a break line on one side, “30” embossed on the other side and a diameter of approximately 7.0 mm. 
Bele, okrogle, ploščate tablete z zarezo na eni strani in oznako ‚30‘, odtisnjeno na drugi strani, ter približno 7-milimetrskim premerom.
Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking pioglitazone. 
Bolniki, ki so jemali pioglitazone, so poročali tudi o zamegljenem vidu zaradi otekanja (ali tekočine) očesnega ozadja (pogostnost ni poznana).
Investigations weight increased5 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon 
povišana vrednost keratin fosfokinaze v krvi povišana vrednost laktatne dehidrogenaze občasni povišana vrednost alanin aminotransferaze6
One tablet of 45 mg of pioglitazone should be taken once daily. 
Enkrat dnevno vzemite eno tableto s 45 mg pioglitazona.
White, round, flat tablets, with “45” embossed on one side and a diameter of approximately 8.0 mm. 
Bele, okrogle, ploščate tablete z oznako ‚45‘, odtisnjeno na eni strani, in približno 8-milimetrskim premerom.
Sepioglin 30 mg tablets Pioglitazone 
Sepioglin 30 mg tablete Pioglitazon
White, round, flat tablets, with “15” embossed on one side and a diameter of approximately 5.5 mm.. 
Bele, okrogle, ploščate tablete z oznako ‚15‘, odtisnjeno na eni strani, in približno 5,5-milimetrskim premerom.
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). 
Opazili so višjo stopnjo zlomov pri ženskah, ki so jemale pioglitazon (2,6%) v primerjavi s primerjalnim zdravilom (1,7 %).
Renal and urinary disorders haematuria glycosuria uncommon proteinuria uncommon 
Bolezni sečil hematurija glikozurija občasni proteinurija občasni
Sepioglin 45 mg tablets Pioglitazone 
Sepioglin 45 mg tablete Pioglitazon
One tablet of 15 mg of pioglitazone should be taken once daily. 
Enkrat dnevno vzemite eno tableto s 15 mg pioglitazona.
Sepioglin 15 mg tablets Pioglitazone 
Sepioglin 15 mg tablete pioglitazon
Nervous system disorders hypo-aesthesia common common headache dizziness common insomnia uncommon uncommon uncommon uncommon uncommon 
Bolezni živčevja hipestezija glavobol občasni omotica nespečnost občasni občasni občasni občasni občasni
One tablet of 30 mg of pioglitazone should be taken once daily. 
Enkrat dnevno vzemite eno tableto s 30 mg pioglitazona.
HOW TO STORE SEPIOGLIN 
SHRANJEVANJE ZDRAVILA SEPIOGLIN
Carmellose calcium 
občasni makularni edem2
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). 
zdravljenih s pioglitazonom, niso opazili povečane stopnje zlomov (1,7 %) v primerjavi s primerjalnim zdravilom (2,1 %).
NAME OF THE MEDICINAL PRODUCT Sepioglin 30 mg tablets 
IME ZDRAVILA Sepioglin 30 mg tablete
NAME OF THE MEDICINAL PRODUCT Sepioglin 45 mg tablets 
IME ZDRAVILA Sepioglin 45 mg tablete
Sepioglin may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar. 
Zdravilo Sepioglin lahko uporabljamo samo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
Gastrointestinal disorders flatulence Skin and subcutaneous tissue disorders sweating uncommon 
Bolezni kože in podkožja znojenje občasni
What Sepioglin looks like and contents of the pack Sepioglin 30 mg tablets are white, round, flat tablets, with a break line on one side, “30” embossed on the other side and a diameter of approximately 7.0 mm. 
Zdravilo Sepioglin je na voljo v obliki belih, okroglih, ploščatih tablet z zarezo na eni strani in oznako ‚30‘ odtisnjeno na drugi strani ter približno 7-milimetrskim premerom.
Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
What Sepioglin looks like and contents of the pack Sepioglin 45 mg tablets are white, round, flat tablets, with “45” embossed on one side and a diameter of approximately 8.0 mm. 
Zdravilo Sepioglin je na voljo v obliki belih, okroglih, ploščatih tablet z oznako ‚45‘, odtisnjeno na eni strani, in približno 8-milimetrskim premerom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of pioglitazone (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 45 mg of pioglitazone (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
Neoplasms benign, malignant and unspecified (including cysts 
Benigne, maligne in neopredelje ne novotvorbe (vključno s cistami in polipi) rak mehurja občasni občasni občasni občasni
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
Localised swelling (oedema) has also been experienced very commonly in patients taking pioglitazone in combination with insulin. 
Pri bolnikih, ki so jemali pioglitazon v kombinaciji z insulinom, je bilo zelo pogosto ugotovljeno lokalno otekanje (edemi).
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years. 
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8100 s pioglitazonom in 7400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3,5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
Broken bones have been reported commonly (1 to 10 users in 100) in women patients taking pioglitazone. 
Pri ženskah, ki so jemale pioglitazon, so pogosto (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov) poročali o zlomih kosti.
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). 
Pri sočasnem dajanjum z zaviralci (npr. gemfibrozil) ali induktorji (npr. rifampicin) citokroma P450 2C8 je potrebna previdnost.
NAME OF THE MEDICINAL PRODUCT Sepioglin 30 mg tablets Pioglitazone 
IME ZDRAVILA Sepioglin 30 mg tablete pioglitazon
If you stop using Sepioglin, your blood sugar may go up. 
Če ste prenehali jemati zdravilo Sepioglin , se vam lahko raven krvnega sladkorja zviša, zato se posvetujte z zdravnikom, preden prenehate s tem zdravljenjem.
NAME OF THE MEDICINAL PRODUCT Sepioglin 45 mg tablets Pioglitazone 
IME ZDRAVILA Sepioglin 45 mg tablete pioglitazon
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na recept.
NAME OF THE MEDICINAL PRODUCT Sepioglin 15 mg tablets Pioglitazone 
IME ZDRAVILA Sepioglin 15 mg tablete pioglitazon
NAME OF THE MEDICINAL PRODUCT Sepioglin15 mg tablets 
IME ZDRAVILA Sepioglin 15 mg tablete
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg pioglitazone (as hydrochloride). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pioglitazone (as hydrochloride). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg pioglitazone (as hydrochloride). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
Four field studies were conducted. 
Izvedene so bile štiri terenske študije.
This overview was last updated in July 2019. 
Pregled je bil nazadnje posodobljen julija 2019.
Further information on Simparica Trio can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio. 
Nadaljnje informacije o zdravilu Simparica Trio so na voljo na spletni strani agencije: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
The tablets should be kept in the original packaging until use in order to prevent children directly accessing the medicine. 
Tablete je treba do uporabe hraniti v originalni embalaži, da bi preprečili neposreden dostop otrok do njih.
Sarolaner acts as an ‘ectoparasiticide'. 
Sarolaner deluje kot „ektoparaziticid“.
Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog's environment. 
Sarolaner uniči bolhe, preden te lahko izležejo jajčeca, in tako pomaga zmanjšati kontaminacijo okolja psa.
The European Medicines Agency decided that Simparica Trio's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila Simparica Trio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood. 
Da bi bili bolhe in klopi izpostavljeni učinkovini, se morajo prisesati na kožo in se začeti hraniti s krvjo psa.
Two studies conducted in Australia and one in Japan that followed a similar design to the US study also showed 100% effectiveness against naturally occurring heartworm infection. 
Dve študiji, izvedeni v Avstraliji, in ena študija, opravljena na Japonskem, ki so imele podobno zasnovo kot ameriška študija, so prav tako potrdile 100 % učinkovitost zdravila proti naravnim infestacijam s srčno glisto.
It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites). 
Uporablja se lahko tudi kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
This results in uncontrolled activity of the nervous system and thus the paralysis and death of the parasites. 
S tem povzroči nenadzorovano delovanje živčnega sistema in posledično paralizo in pogin zajedavcev.
Sarolaner kills these parasites that have ingested the dog's blood by acting on their nervous system. 
Sarolaner uniči zajedavce, ki so zaužili kri psa, tako da deluje na njihov živčni sistem.
Other information about Simparica Trio 
Druge informacije o zdravilu Simparica Trio
To prevent lungworm and heartworm disease for one month, a single treatment is required. 
Za preprečevanje okužbe s pljučnimi in srčnimi glistami za obdobje enega meseca je potrebno eno samo zdravljenje.
Why is Simparica Trio authorised in the EU? 
Zakaj je bilo zdravilo Simparica Trio odobreno v EU?