natgillin/translations-raw huggingface dataset:
The Committee also noted that the information presented did not support the use of Factive for chronic bronchitis because no studies were carried out to investigate whether Factive was better than other treatments for this type of infection and because there were problems with the studies that were performed.
Odbor je opozoril tudi, da predstavljene informacije niso podpirale uporabe zdravila Factive za zdravljenje kroničnega bronhitisa, ker niso bile izvedene študije, s katerimi bi raziskali, ali je zdravilo Factive boljše od drugih zdravljenj za te vrste okužb, in ker so se pri opravljenih študijah pojavili problemi.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Factive?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Factive?
Factive is a medicine that contains the active substance gemifloxacin.
Factive je zdravilo, ki vsebuje zdravilno učinkovino gemifloksacin.
When these enzymes are blocked, the bacteria cannot multiply and they eventually die.
Ko sta ta dva encima zavrta, se bakterije ne morejo razmnoževati in sčasoma odmrejo.
• acute exacerbation (flare-up) of chronic bronchitis (inflammation of the airways in the lungs).
• akutnega poslabšanja (ponovnih izbruhov) kroničnega bronhitisa (vnetja dihalnih poti v pljučih).
• mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital);
• blage ali zmerne pljučnice, pridobljene izven bolnišnice (okužbe pljuč);
On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, communityacquired pneumonia and acute exacerbation of chronic bronchitis.
Dne 17. junija 2009 je družba Menarini International Operations Luxembourg S.A. uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Factive za zdravljenje bakterijskih okužb, pljučnice, pridobljene izven bolnišnice, in akutnega poslabšanja kroničnega bronhitisa.
The active substance in Factive, gemifloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Zdravilna učinkovina zdravila Factive, gemifloksacin, je antibiotik iz skupine „fluorokinolonov“.
In four main studies, 1,874 adults with mild to moderate community-acquired pneumonia were treated for at least seven days with Factive or other antibiotics.
V štirih glavnih študijah je bilo 1 874 odraslih z blago do zmerno pljučnico, pridobljeno izven bolnišnice, zdravljenih najmanj sedem dni z zdravilom Factive ali drugimi antibiotiki.
The application was at day 196 when the company withdrew.
Družba je vlogo umaknila na 196. dan postopka.
The company informed the CHMP that there are no clinical trials or compassionate use programmes with Factive in Europe.
Družba je obvestila CHMP, da klinična preizkušanja ali programi sočasne uporabe z zdravilom Factive v Evropi ne potekajo.
What is Factive?
Kaj je zdravilo Factive?
In another study of patients with communityacquired pneumonia, 510 adults were given Factive either as a five- or seven-day treatment.
V drugi študiji bolnikov s pljučnico, pridobljeno izven bolnišnice, je 510 odraslih prejelo zdravilo Factive bodisi med pet- ali sedemdnevnim zdravljenjem.
What was Factive expected to be used for?
Za kaj naj bi se zdravilo Factive uporabljalo?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Factive could not have been approved for the treatment of community acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Factive ni mogoče odobriti za zdravljenje pljučnice, pridobljene izven bolnišnice in akutnega poslabšanja kroničnega bronhitisa, ki je posledica bakterijske okužbe.
In three other main studies, 1,652 adults with acute exacerbation of chronic bronchitis were treated with Factive for five days or with other antibiotics.
V treh preostalih glavnih študijah je bilo z zdravilom Factive ali drugimi antibiotiki pet dni zdravljenih 1 652 odraslih z akutnim poslabšanjem kroničnega bronhitisa.
The Committee was also concerned there was not enough evidence of effectiveness of Factive in patients with moderate community-acquired pneumonia when given as a five-day treatment.
Odbor je bil imel zadržke tudi o količini dokazov o učinkovitosti zdravila Factive med petdnevnim zdravljenjem pri bolnikih z zmerno pljučnico, pridobljeno izven bolnišnice.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Factive in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection did not outweigh its risks.
CHMP je v času umika menil, da koristi zdravila Factive za zdravljenje pljučnice, pridobljene izven bolnišnice, in akutnega poslabšanja kroničnega bronhitisa, ki je posledica bakterijske okužbe, ne odtehtajo tveganj, povezanih z njim.
How is Factive expected to work?
Kako naj bi zdravilo Factive delovalo?
The European Commission granted a marketing authorisation valid throughout the European Union for Naglazyme to BioMarin Europe Limited on 24 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom Naglazyme, veljavno po vsej Evropski uniji, odobrila družbi BIoMarin Europe Limited dne 24. januarja 2006.
The disease is usually diagnosed in infants between one and five years of age.
Bolezen običajno odkrijejo pri otrocih, starih od ena do pet let.
The main measure of effectiveness was how far the patients could walk after 24 weeks of treatment.
Glavno merilo učinkovitosti je bila razdalja, ki jo je bolnik lahko prehodil po 24 tednih zdravljenja.
The recommended dose is 1 mg per kilogram bodyweight.
Priporočeni odmerek je 1 mg na kilogram telesne mase.
This means that because the disease is rare, it has not been possible to obtain complete information about Naglazyme.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
Naglazyme galsulfase
Naglazyme galsulfaza
After 24 weeks, the average distance walked over 12 minutes increased by 109 metres in the patients treated with Naglazyme and by 18 metres in those receiving placebo.
Po 24 tednih je bila povprečna prehojena razdalja v 12 minutah daljša za 109 metrov pri bolnikih, ki so prejemali zdravilo Naglazyme, in za 18 metrov pri bolnikih, ki so prejemali placebo.
Before each infusion, patients should be given an antihistamine to reduce the risk of an allergic reaction.
Pred vsako infuzijo je treba bolniku dati antihistaminik za zmanjšanje tveganja za alergijske reakcije.
It should be given where resuscitation equipment is available in case of a medical emergency.
Dajati se mora v okolju, kjer je na voljo oprema za oživljanje v nujnem primeru.
The company is also carrying out studies to determine the best dose to give to patients on a regular longterm basis.
Izvedli bodo tudi študije za določitev najustreznejšega odmerka za bolnike ob dolgoročni redni uporabi.
This can improve the symptoms of MPS VI, including the ability of patients to move about.
Tako se izboljšajo simptomi MPS IV, vključno s sposobnostjo bolnikovega gibanja.
The company that makes Naglazyme is carrying out studies looking at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine's side effects.
Družba, ki izdeluje zdravilo Naglazyme, bo izvedla študije za proučitev dolgoročne varnosti in učinkovitosti zdravila Naglazyme pri nosečih in doječih ženskah ter pri otrocih, mlajših od pet let, da bi ugotovili, ali pri njih nastanejo protitelesa (beljakovine, ki jih telo tvori kot odziv na zdravilo Naglazyme in ki lahko vplivajo na odziv na zdravljenje), ter proučili neželene učinke zdravila.
Naglazyme was more effective than placebo.
Zdravilo Naglazyme je bilo učinkovitejše od placeba.
Enzyme replacement therapy provides patients with the enzyme they are lacking.
Encimska nadomestna terapija zagotavlja bolnikom encim, ki jim ga primanjkuje.
Naglazyme is given as a four-hour infusion once a week.
Zdravilo Naglazyme se daje v obliki štiriurne infuzije enkrat na teden.
This causes the signs of the disease, the most noticeable being a short body, a large head and difficulty moving about.
Tako se pokažejo znaki bolezni, od katerih so najopaznejši nizka rast, velika glava in težave pri gibanju.
What benefit has Naglazyme shown during the studies?
Kakšne koristi je zdravilo Naglazyme izkazalo med študijami?
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 Naglazyme.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Naglazyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Naglazyme?
Kakšna tveganja so povezana z zdravilom Naglazyme?
For more information about treatment with Naglazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Naglazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain.
V študijah so bili najpogostejši neželeni učinki zdravila Naglazyme (opaženi pri več kot 1 bolniku od 10) bolečine v ušesih, dispneja (težave z dihanjem), bolečine v trebuhu in splošne bolečine.
Naglazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS VI or similar diseases.
Zdravljenje z zdravilom Naglazyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z MPS VI ali podobnimi boleznimi.
Because the number of patients with MPS VI is low, the disease is considered ‘rare', and Naglazyme was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 February 2001.
Ker je bolnikov z MPS VI malo, velja ta bolezen za redko, zato je bilo zdravilo Naglazyme dne 14. februarja 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
Galsulfase is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Galsulfazo proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori encim.
The summary of the opinion of the Committee for Orphan Medicinal Products for Nagalzyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Naglazyme je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
If the enzyme is not present, GAGs cannot be broken down and they build up in the cells.
Če encim ni prisoten, glikozaminoglikanov ni mogoče razgraditi, zato se kopičijo v celicah.
Naglazyme has been compared with placebo (a dummy treatment) in one main study involving 39 patients with MPS VI aged between five and 29 years.
Zdravilo Naglazyme so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 39 bolnikov z MPS VI, starih od pet do 29 let.
Naglazyme is used to treat patients who have mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy syndrome).
Zdravilo Naglazyme se uporablja za zdravljenje bolnikov z mukopolisaharidozo VI (MPS VI ali Maroteaux-Lamyjevim sindromom).
Naglazyme should not be used in people who may be hypersensitive (allergic) to galsulfase or any of the other ingredients.
Zdravila Naglazyme ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) galsulfazo ali katero koli drugo sestavino zdravila.
The CHMP decided that Naglazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Naglazyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Naglazyme.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Naglazyme.
What information is still awaited for Naglazyme?
Katere informacije o zdravilu Naglazyme še pričakujemo?
Patients can also have reactions to the infusion (such as fever, chills, rash and hives).
Opažene so bile tudi reakcije na infuzijo (kot so povišana telesna temperatura, mrazenje, izpuščaji in koprivnica).
The full EPAR for Naglazyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Naglazyme je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This disease is caused by the lack of an enzyme called N-acetylgalactosamine 4-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
To bolezen povzroča pomanjkanje encima, imenovanega Nacetilgalaktozamin-4-sulfataza, ki je potreben za razgradnjo snovi v telesu, imenovanih glikozaminoglikani (GAG).
Patients may also be given a medicine to prevent fever.
Lahko pa prejme tudi zdravilo za preprečevanje zvišanja telesne temperature.
The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI. Naglazyme has been authorised under ‘exceptional circumstances'.
Odbor je opozoril, da je za bolnike, mlajše od pet let, pomembno, da prejemajo zdravljenje, če imajo hudo obliko MPS VI, čeprav niso bili vključeni v glavno študijo z zdravilom Naglazyme.
Why has Naglazyme been approved?
Zakaj je bilo zdravilo Naglazyme odobreno?
The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase.
Zdravilna učinkovina zdravila Naglazyme, galsulfaza, je kopija humanega encima N-acetilgalaktozamin-4-sulfataze.
Naglazyme is a solution for infusion (drip into a vein) that contains the active substance galsulfase (1 mg/ml).
Zdravilo Naglazymeje raztopina za infuzijo (kapalno infuzijo v veno), ki vsebuje zdravilno učinkovino galsulfazo (1 mg/ml).
Naglazyme helps to break down the GAGs and stop them building up in the cells.
Zdravilo Naglazyme prispeva k razgradnji glikozaminoglikanov in ustavi njihovo kopičenje v celicah.
Naglazyme is an enzyme replacement therapy.
Zdravilo Naglazyme je zdravilo za encimsko nadomestno zdravljenje.
For the full list of all side effects reported with Naglazyme, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Naglazyme, glejte navodilo za uporabo.
What is Naglazyme used for?
Za kaj se zdravilo Naglazyme uporablja?
How is Naglazyme used?
Kako se zdravilo Naglazyme uporablja?
Other information about Naglazyme
Druge informacije o zdravilu Naglazyme
How has Naglazyme been studied?
Kako je bilo zdravilo Naglazyme raziskano?
The European Commission granted a marketing authorisation valid throughout the European Union for Dafiro HCT on 4 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Dafiro HCT, veljavno po vsej Evropski uniji, odobrila dne 4. novembra 2009.
The full EPAR for Dafiro HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dafiro HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Na voljo je v obliki tablet, ki vsebujejo amlodipin, valsartan in hidroklorotiazid v naslednjih količinah: 5/160/12,5 mg, 10/160/12,5 mg, 5/160/25 mg, 10/160/25 mg in 10/320/25 mg.
This is a summary of the European public assessment report (EPAR) for Dafiro HCT.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dafiro HCT.
For more information about treatment with Dafiro HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Dafiro HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure.
Glavna študija je pokazala koristnost uporabe največjega odmerka zdravila Dafiro HCT pri zniževanju krvnega tlaka.
The CHMP therefore decided that Dafiro HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Dafiro HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Zdravilo Dafiro HCT se jemlje peroralno, in sicer se zaužije ena tableta enkrat na dan ob isti uri, če je le mogoče, zjutraj.
The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Tri zdravilne učinkovine v zdravilu Dafiro HCT so zdravila proti zvišanemu krvnemu tlaku, ki se že uporabljajo v Evropski uniji (EU).
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 Dafiro HCT.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dafiro HCT, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Pri vseh odmerkih je zdravilo Dafiro HCT izpolnilo tudi zahteve, s katerimi je bilo dokazano, da je primerljivo s kombinacijami posameznih zdravilnih učinkovin, vzetih ločeno.
Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Zdravilo Dafiro HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno uravnan z uporabo kombinacije amlodipina, valsartana in hidroklorotiazida.
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Povprečno znižanje krvnega tlaka je bilo okrog 39,7/24,7 mmHg pri bolnikih, ki so prejemali zdravilo Dafiro HCT, v primerjavi z 32/19,7 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/hidroklorotiazid, 33,5/21,5 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/amlodipin, in 31,5/19,5 mmHg pri bolnikih, ki so prejemali kombinacije hidroklorotiazid/amlodipin.
The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Dafiro HCT (opaženi pri 1 do 10 bolnikih od 100) so hipokaliemija (nizka raven kalija v krvi), omotica, glavobol, hipotenzija (nizek krvni tlak), dispepsija (zgaga), polakisurija (neobičajno pogosto uriniranje), utrujenost in edem (zadrževanje tekočine).
Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Dafiro HCT je zdravilo, ki vsebuje tri zdravilne učinkovine amlodipin, valsartan in hidroklorotiazid.
The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Dnevni odmerek učinkovin zdravila Dafiro HCT ne sme biti večji od 10 mg amlodipina, 320 mg valsartana in 25 mg hidroklorotiazida.
For the full list of all side effects reported with Dafiro HCT, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dafiro HCT, glejte navodilo za uporabo.
The dose of Dafiro HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Odmerek učinkovin zdravila Dafiro HCT mora biti enak odmerkom treh posameznih zdravilnih učinkovin, ki jih je bolnik jemal pred tem.
What benefit has Dafiro HCT shown during the studies?
Kakšne koristi je zdravilo Dafiro HCT izkazalo med študijami?
Treatment with the highest strength of Dafiro HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Zdravljenje z največjim odmerkom zdravila Dafiro HCT je bilo pri zdravljenju hipertenzije učinkovitejše od zdravljenja z dvojnimi kombinacijami, ki so vsebovale po dve zdravilni učinkovini.
Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Zdravila Dafiro HCT ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine zdravila, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila
What is the risk associated with Dafiro HCT?
Kakšna tveganja so povezana z zdravilom Dafiro HCT?
Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Zdravila Dafiro HCT poleg tega ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
Other information about Dafiro HCT
Druge informacije o zdravilu Dafiro HCT
Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Prav tako se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
Why has Dafiro HCT been approved?
Zakaj je bilo zdravilo Dafiro HCT odobreno?