natgillin/translations-raw huggingface dataset:
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?
What benefits of Simparica Trio have been shown in studies?
Kakšne koristi zdravila Simparica Trio so se pokazale v študijah?
An overview of Simparica Trio and why it is authorised in the EU
Pregled zdravila Simparica Trio in zakaj je odobreno v EU
The appropriate tablet strength should be used according to the dog's weight.
Ustrezna jakost tablete se določi glede na telesno maso psa.
In areas where lungworm and heartworm are present, treatments are required at monthly intervals.
Na območjih, kjer so prisotne pljučne in srčne gliste, so zdravljenja potrebna v enomesečnih intervalih.
What is Simparica Trio and what is it used for?
Kaj je zdravilo Simparica Trio in za kaj se uporablja?
It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey signals between nerves (neurotransmitters).
Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata signale med živci (živčna prenašalca).
What are the risks associated with Simparica Trio?
Kakšna tveganja so povezana z zdravilom Simparica Trio?
This means that it kills parasites present on the skin or in the fur of animals, such as fleas and ticks.
To pomeni, da uniči parazite na koži ali v dlaki živali, kot so bolhe in klopi.
It acts by blocking signals, normally associated with the neurotransmitter acetylcholine, from their nerves to their muscles, causing sudden contraction followed by paralysis and death.
Deluje tako, da zavira signale, ki so običajno povezani z živčnim prenašalcem acetilholinom in ki potujejo od živcev do mišic, s čimer povzroči nenadno krčenje, ki mu sledita paraliza in smrt.
For the list of restrictions, see the package leaflet.
Znanih neželenih učinkov ni. Za celoten seznam omejitev glejte navodilo za uporabo.
Roundworms and hookworms
Valjasti in kavljasti črvi
Moxidectin causes paralysis and death of these parasites by interfering in a different way to sarolaner with the flow of chloride ions in nerve cells associated with GABA and glutamate.
Moksidektin povzroči paralizo in pogin teh parazitov tako, da na drugačen način kot sarolaner onemogoči pretok kloridnih ionov v živčnih celicah, povezanih z GABA in glutamatom.
The study showed Simparica Trio to be comparable to the comparator medicine as measured by the percentage reduction in live tick counts on day 7, 14, 21 and 30 after treatment.
Študija je pokazala, da je zdravilo Simparica Trio primerljivo s primerjalnim zdravilom, merjeno z odstotkom zmanjšanja števila živih klopov na 7., 14., 21. in 30. dan po zdravljenju.
In a field study involving 622 dogs in an area of Denmark and Italy known to be affected by lungworm disease, dogs treated with Simparica Trio every 30 days until day 270 did not test positive for lungworm until day 300 after first treatment and therefore the effectiveness was 100% with some dogs testing positive in the control group which was given a dummy treatment.
V terenski študiji, v katero je bilo vključenih 622 psov na Danskem in v Italiji, za katere je bilo znano, da so bili infestirani s pljučnimi glistami, so bili psi, ki so bili vsakih 30 dni do 270. dne zdravljeni z zdravilom Simparica Trio, do 300. dne po prvem zdravljenju negativni na prisotnost pljučnih glist, zaradi česar se učinkovitost tega zdravila šteje za 100 %, medtem ko bili nekateri psi v kontrolni skupini, zdravljeni s placebom, pri testiranju pozitivni.
Pyrantel also kills roundworms and hookworms present in the gut but acts differently to moxidectin.
Pirantel prav tako uniči valjaste in kavljaste črve v črevesju, vendar na drugačen način kot moksidektin.
For flea or tick infestations, one treatment with Simparica Trio is effective for up to 5 weeks.
Za zdravljenje infestacij z bolhami ali klopi zadostuje eno zdravljenje z zdravilom Simparica Trio, ki učinkuje do pet tednov.
For gut worms only a single treatment is required.
Pri črevesnih črvih je potrebno samo eno zdravljenje.
Further flea or tick treatment should be continued using a different veterinary medicine with a narrower range of action.
Za nadaljnje zdravljenje infestacij z bolhami ali klopi je treba uporabiti druga zdravila za uporabo v veterinarski medicini z ožjim spektrom delovanja.
For more information about using Simparica Trio, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Simparica Trio glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
In a US study of 410 dogs in an area affected by heartworm disease, dogs treated with Simparica Trio every 30 days until day 300 showed 100% effectiveness based on blood tests at days 120, 240 and 330 after first treatment.
V ameriški študiji s 410 psi z območja, kjer razsajajo srčne gliste, so bili psi, ki so bili vsakih 30 dni do 300. dne zdravljeni z zdravilom Simparica Trio, so na podlagi krvnih preiskav na 120., 240. in 330. dan po prvem zdravljenju potrdili 100 % učinkovitost zdravila.
Simparica Trio is a veterinary medicine used to treat dogs with flea or tick infestations and roundworm or hookworm infections in the gut.
Simparica Trio je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih za zdravljenje infestacij z bolhami ali klopi ter okužb z valjastimi ali kavljastimi črvi.
Safety information has been included in the summary of product characteristics and the package leaflet for Simparica Trio, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Simparica Trio in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Fleas
Bolhe
Effectiveness, based on faecal egg counts on day 7 after treatment, for dogs treated with Simparica Trio was comparable to the comparator medicine.
Učinkovitost zdravljenja, ki je bila izmerjena s številom jajčec v blatu na sedmi dan po zdravljenju, je bila pri psih, ki so bili zdravljeni z zdravilom Simparica Trio, primerljiva s primerjalnim zdravilom.
At the same time, Simparica Trio is used to prevent heartworm and lungworm disease (both caused by blood worms that infect the heart and blood vessels supplying the lungs).
Prav tako se uporablja za preprečevanje obolenj, ki jih povzročajo srčne in pljučne gliste (gliste v krvi, ki se naselijo v srcu in žilah, ki oskrbujejo pljuča).
Simparica Trio must only be used when there is a need to treat both fleas or ticks and worms in the gut.
Zdravilo Simparica Trio se lahko uporablja le, kadar je treba istočasno zdraviti bolhe ali klope in črevesne črve.
Simparica Trio is available as chewable tablets and can only be obtained with a prescription.
Zdravilo Simparica Trio je na voljo v obliki žvečljivih tablet, predpisovanje in izdaja zdravila pa je le na recept.
The study showed Simparica Trio to be comparable to the comparator medicine as measured by flea counts on day 14 and 30 after treatment.
Študija je pokazala, da je zdravilo Simparica Trio primerljivo s primerjalnim zdravilom, merjeno s številom bolh na 14. in 30. dan po zdravljenju.
Simparica Trio received a marketing authorisation valid throughout the EU on 17 September 2019.
Zdravilo Simparica Trio je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, dne
Heartworms
Klopi
In a field study in dogs infested with at least 5 live fleas, 297 dogs were treated with Simparica Trio and 164 dogs with afoxolaner and milbemycin oxime (an authorised treatment for fleas and ticks).
V terenski študiji pri psih, ki so bili infestirani z vsaj petimi živimi bolhami, je bilo 297 psov zdravljenih z zdravilom Simparica Trio, 164 psov pa z afoksolanerjem in milbemicin oksimom (odobrenima zdraviloma proti bolham in klopom).
How does Simparica Trio work?
Kako zdravilo Simparica Trio deluje?
In a field study involving dogs infected with roundworms or hookworms, 194 dogs were treated with Simparica Trio and 97 dogs with afoxolaner and milbemycin oxime.
V terenski študiji pri psih, ki so bili infestirani z valjastimi ali kavljastimi črvi, je bilo 194 psov zdravljenih z zdravilom Simparica Trio, 97 psov pa z afoksolanerjem in milbemicin oksimom.
In a further field study in dogs infested with at least 3 live ticks, 189 dogs were treated with Simparica Trio and 91 dogs with afoxolaner and milbemycin oxime.
V dodatni terenski študiji pri psih, ki so bili infestirani z vsaj tremi živimi klopi, je bilo 189 psov zdravljenih z zdravilom Simparica Trio, 91 psov pa z afoksolanerjem in milbemicin oksimom.
Moxidectin kills parasites present inside the body of animals, such as roundworms, hookworms, lungworm and heartworm.
Moksidektin uniči parazite v telesu živali, kot so valjasti in kavljasti črvi ter pljučne in srčne gliste.
Simparica Trio contains the active substances sarolaner, moxidectin and pyrantel.
Zdravilo Simparica Trio vsebuje učinkovine sarolaner, moksidektin in pirantel.
How is Simparica Trio used?
Kako se zdravilo Simparica Trio uporablja?
Simparica contains three active substances: sarolaner, moxidectin and pyrantel.
Zdravilo Simparica Trio vsebuje tri učinkovine: sarolaner, moksidektin in pirantel.
Lungworms
Pljučne gliste
EPAR summary for the public telmisartan
Povzetek EPAR za javnost telmisartan
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Če želena vrednost krvnega stran 2/2
It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).
Na voljo je v obliki belih tablet (okroglih: 20 mg; ovalnih: 40 mg; v obliki kapsule: 80 mg).
Other information about Tolura:
Druge informacije o zdravilu Tolura:
The European Commission granted a marketing authorisation valid throughout the EU for Tolura to Krka, d.d., Novo mesto on 4 June 2010.
Evropska komisija je dovoljenje za promet z zdravilom Tolura, veljavno po vsej Evropski uniji, odobrila družbi Krka, d.d., Novo mesto, dne 4. junija 2010.
It is used in patients who have had problems due to blood clots in the past (such as heart disease or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Uporablja se pri bolnikih, ki so imeli težave zaradi krvnih strdkov v preteklosti (kot so srčno obolenje, možganska kap ali arterijska bolezen) ali ki imajo sladkorno bolezen tipa 2, ki je poškodovala določen organ (npr. oči, srce ali ledvice).
Tolura is used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Tolura se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
This document is a summary of the European Public Assessment Report (EPAR) for Tolura.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tolura.
This means that Tolura is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Micardis.
For more information about treatment with Tolura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tolura preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What are the benefit and risk of Tolura?
Kakšne so koristi in tveganja, povezani z zdravilom Tolura?
The doctor should monitor the patient's blood pressure closely when starting Tolura, and may decide to adjust the patient's blood pressure-lowering medication.
Zdravnik mora skrbno spremljati bolnikov krvni tlak ob začetku zdravljenja z zdravilom Tolura in se lahko odloči za prilagoditev zdravila za zniževanje bolnikovega krvnega tlaka.
The full EPAR for Tolura can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tolura je na voljo na spletni strani agencije: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
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 Tolura.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Tolura, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The Committee recommended that Tolura be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tolura odobri dovoljenje za promet.
Because Tolura is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Ker je zdravilo Tolura generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Tolura is a ‘generic medicine'.
Zdravilo Tolura je „generično zdravilo“.
Tolura is a medicine that contains the active substance telmisartan.
Tolura je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.