natgillin/translations-raw huggingface dataset:
In the treatment of essential hypertension, Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. 
Za zdravljenje esencialne hipertenzije je bilo zdravilo Micardis pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje povišanega krvnega tlaka.
For the treatment of essential hypertension, the usual recommended dose of Micardis is 40 mg once a day, but some patients may benefit from using 20 mg once a day. 
Za zdravljenje esencialne hipertenzije znaša običajni priporočeni odmerek zdravila Micardis 40 mg enkrat dnevno, čeprav za nekatere bolnike zadostuje že 20-miligramski odmerek.
Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. 
Bolniki z močno prizadetim delovanjem ledvic morajo jemati nižji začetni odmerek, ki znaša 20 mg enkrat dnevno.
The doctor should monitor the patient's blood pressure closely when starting Micardis, and may decide to adjust the patient's blood pressure-lowering medication. 
Ob začetku zdravljenja z zdravilom Micardis mora zdravnik skrbno spremljati bolnikov krvni tlak in se lahko odloči za prilagoditev odmerka zdravila za zniževanje bolnikovega krvnega tlaka.
For the treatment of essential hypertension, Micardis has been studied in 2,647 patients who took Micardis either alone or in combination with hydrochlorothiazide. 
Za zdravljenje esencialne hipertenzije so zdravilo Micardis raziskali pri 2 647 bolnikih, ki so zdravilo Micardis jemali bodisi kot samostojno zdravilo ali v kombinaciji s hidroklorotiazidom.
For the full list of all side effects reported with Micardis, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Micardis, glejte navodilo za uporabo.
In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke. 
Pri preprečevanju kardiovaskularnih težav je bilo zdravilo Micardis enako učinkovito kot ramipril, pri čemer je okoli 17 % bolnikov umrlo, bilo hospitaliziranih zaradi kardiovaskularnih težav oziroma je doživelo srčni napad ali možgansko kap.
For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day. 
Za preprečevanje kardiovaskularnih težav je priporočeni odmerek 80 mg enkrat dnevno.
Micardis must not be used in people who have severe liver problems or bile problems. 
Zdravila Micardis prav tako ne smejo uporabljati osebe, ki imajo huda obolenja jeter ali žolčnika.
What is Micardis used for? 
Za kaj se zdravilo Micardis uporablja?
How does Micardis work? 
Kako zdravilo Micardis deluje?
What is Micardis? 
Kaj je zdravilo Micardis?
How has Micardis been studied? 
Kako je bilo zdravilo Micardis raziskano?
How is Micardis used? 
Kako se zdravilo Micardis uporablja?
This summary was last updated in 07-2013. 
Povzetek je bil nazadnje posodobljen 07-2013.
The body is able to remove this salt from the cells. 
Telo lahko to sol odstrani iz celic.
It is available as capsules (50 and 150 mg). 
Na voljo je v obliki kapsul (50 in 150 mg).
It should also not be used in women who are breastfeeding, or who are pregnant (particularly during the first three months) unless it is clearly necessary. 
Prav tako ga ne smejo uporabljati ženske, ki dojijo ali so noseče (zlasti v prvih treh mesecih nosečnosti), razen če je to res nujno potrebno.
The starting dose should be increased gradually over 4 to 6 weeks. 
Začetni odmerek se povečuje postopoma v obdobju 4 do 6 tednov.
The European Commission granted a marketing authorisation valid throughout the European Union for Cystagon on 23 June 1997. 
Evropska komisija je dovoljenje za promet z zdravilom Cystagon, veljavno po vsej Evropski uniji, odobrila dne 23. junija 1997.
Starting doses should be one quarter to one sixth of the final expected doses. 
Začetni odmerek mora znašati eno četrtino do eno šestino končnega pričakovanega odmerka.
It also improves survival and growth rate in the children treated. 
Obenem izboljšuje stopnjo preživetja in rasti pri zdravljenih otrocih.
Cystagon has been investigated in three main studies including 234 patients over a 12-year period. 
Cystagon so raziskovali v treh glavnih študijah, ki so zajemale 234 bolnikov v obdobju 12 let.
The full EPAR for Cystagon 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 Cystagon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These studies included children and newly recruited patients in whom two different doses were tested. 
Študije so vključevale otroke in nove bolnike, na katerih so testirali dva različna odmerka.
This is a summary of the European public assessment report (EPAR) for Cystagon. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cystagon.
Other information about Cystagon 
Druge informacije o zdravilu Cystagon
For patients over the age of 12 and over 50 kg in weight, the recommended daily dose is 2 g divided into 4 doses. 
Pri bolnikih, starejših od 12 let in težjih od 50 kg, je priporočeni dnevni odmerek 2 g, ki se razdeli na 4 odmerke.
The three studies showed that Cystagon delays kidney problems and the need for dialysis or renal transplantation, when treatment is started at an early age. 
Tri študije so pokazale, da zdravilo Cystagon odloži težave z ledvicami in potrebo po dializi ali presaditvi ledvic, če se zdravljenje prične v zgodnji starosti.
The studies looked at the kidney function, the survival and the growth rate of the patients. 
V študijah so proučevali delovanje ledvic, stopnjo preživetja in rasti pri bolnikih.
For more information about treatment with Cystagon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cystagon preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Cystagon's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Cystagon večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For children up to the age of 12 years, the recommended daily dose is calculated according to body surface area (which is calculated from the patient's height and weight), as 1.30 g per m2 divided into 4 doses. 
Pri otrocih do 12. leta starosti se priporočeni dnevni odmerek izračuna na podlagi njihove telesne površine (izračunane na osnovi telesne višine in mase), in sicer znaša 1,30 g na m2 telesne površine, kar se razdeli na 4 odmerke.
What benefit has Cystagon shown during the studies? 
Kakšne koristi je zdravilo Cystagon izkazalo med študijami?
Because the disease is very serious, it was not possible for ethical reasons to compare Cystagon directly to placebo (a dummy treatment). 
Zaradi etičnih razlogov in ker je bolezen zelo resna, ni bilo možno primerjati zdravila Cystagon neposredno s placebom (zdravilom brez zdravilne učinkovine).
The comparison was done instead with a group of patients who had been treated with a dummy treatment as part of another, unrelated trial. 
Namesto tega je bila narejena primerjava s skupino bolnikov, ki so bili zdravljeni z zdravilom brez zdravilne učinkovine kot del drugega preskušanja, ki ni bilo povezano s to študijo.
Cystine levels in white blood cells should be monitored and used to adjust the dose. 
Pri bolnikih je treba spremljati raven cistina v belih krvničkah in na podlagi tega prilagajati odmerek.
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 Cystagon. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Cystagon, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The maximum dose should never exceed 1.95 g per m2 per day. 
Največji odmerek nikoli ne sme preseči 1,95 g na m2 na dan. Za več informacij glejte navodilo za uporabo.
Cystinosis is a rare inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them. 
Cistinoza je redka dedna bolezen, pri kateri se prevelike količine cistina, tj. aminokisline, ki je naravno prisotna v telesu, kopičijo v celicah, zlasti v ledvicah in očeh, kar povzroča njihove poškodbe.
The most common side effects with Cystagon (seen in more than 1 patient in 10) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever). 
Najpogostejši neželeni učinki zdravila Cystagon (opaženi pri 1 bolniku od 10) so izguba teka, bruhanje, driska, navzeja (slabost), driska, letargija (pomanjkanje energije) in pireksija (povišana telesna temperatura).
What is the risk associated with Cystagon? 
Kakšna tveganja so povezana z zdravilom Cystagon?
Cystagon must not be used in people who are hypersensitive (allergic) to cysteamine or any of the other ingredients, or to another medicine called penicillamine. 
Zdravila Cystagon ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) cisteamin ali katerokoli drugo sestavino zdravila ali na drugo zdravilo, imenovano penicilamin.
Cystinosis is a rare, fatal disease, and Cystagon is considered a useful medicine for this disease. 
Cistinoza je redka, smrtno nevarna bolezen in zdravilo Cystagon velja za koristno zdravilo zanjo.
The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs. 
S tem se zmanjša količina cistina v organih, s tem pa tudi njihove okvare.
Cystagon is a medicine containing the active substance mercaptamine (also known as cysteamine). 
Cystagon je zdravilo, ki vsebuje zdravilno učinkovino merkaptamin (znan tudi kot cisteamin).
Cystagon treatment should be started by a doctor who has experience in the treatment of cystinosis. 
Zdravljenje z zdravilom Cystagon lahko uvede samo zdravnik, ki ima izkušnje z zdravljenjem cistinoze.
For the full list of all side effects reported with Cystagon, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cystagon, glejte navodilo za uporabo.
The active substance in Cystagon, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt. 
Zdravilna učinkovina v zdravilu Cystagon, merkaptamin, reagira s cistinom tako, da tvori drugo aminokislino, imenovano cistein, in snov, imenovano cistein-cisteaminska sol.
Why has Cystagon been approved? 
Zakaj je bilo zdravilo Cystagon odobreno?
Cystagon is used in patients who have nephropathic (kidney) cystinosis. 
Zdravilo Cystagon se uporablja za zdravljenje bolnikov, ki imajo nefropatsko (ledvično) cistinozo.
How does Cystagon work? 
Kako zdravilo Cystagon deluje?
How has Cystagon been studied? 
Kako je bilo zdravilo Cystagon raziskano?
What is Cystagon used for? 
Za kaj se zdravilo Cystagon uporablja?
What is Cystagon? 
Kaj je zdravilo Cystagon?
How is Cystagon used? 
Kako se zdravilo Cystagon uporablja?
A-2304 Orth/Donau Austria 
A-2304 Orth/Donau Avstrija
In such cases, the Western Blot method is negative. 
V takšnih primerih je bil rezultat na osnovi metode Western Blot negativen.
• you have a severe infection with a high temperature (over 38 °C). 
• če imate hudo okužbo in zvišano temperaturo (nad 38 °C).
21 Days After 
21 dni po
The frequency of these adverse reactions is not known. 
Pogostnost teh neželenih učinkov ni znana.
Results from Vaccine Effectiveness Study in Jersey 
Rezultati študije učinkovitosti cepiva v Jerseyu
Dispose of in accordance with local requirements. 
Zavrzite v skladu z lokalnimi predpisi.
However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature. 
Kemična in fizikalna stabilnost cepiva med uporabo je dokazana za čas 3 ur pri sobni temperaturi.
For further information, see sections 4.8 and 5.1. 
Za dodatne informacije glejte poglavji 4.8 in 5.1.
It allows continued monitoring of the benefit/risk balance of the medicinal product. 
Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji za zdravilo.
• you have problems with your immune system, since your response to the vaccine may then be poor. 
• če imate težave z imunskim sistemom, saj je zato lahko vaš odziv na cepivo slab;
In the first few weeks after vaccination with Celvapan the results of these tests may not be correct. 
V prvih nekaj tednih po cepljenju s cepivom Celvapan izvidi teh preiskav morda ne bodo pravilni.
This leaflet was last revised in {month/YYYY} 
Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}
If this applies to you then your vaccination will usually be postponed until you are feeling better. 
Če je tako, potem bo cepljenje prestavljeno na čas, ko se boste počutili bolje.
What Celvapan is and what it is used for 2. 
Kaj je cepivo Celvapan in za kaj ga uporabljamo 2.
For storage conditions after first opening of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3.
Doctors are aware of this possibility and have emergency treatment available for use in such cases. 
Zdravniki se zavedajo te možnosti in so v takšnih primerih pripravljeni na postopke nujnega zdravljenja.
• Safety and immunogenicity data obtained three weeks after administration of two doses of 
• Podatki o varnosti in imunogenosti, dobljenih tri tedne po dajanju dveh odmerkov cepiva
Influenza-like illness 
Gripi podobna bolezen
Anaphylactic reaction*, Hypersensitivity* 
Anafilaktična reakcija*, preobčutljivost*
This is because the vaccination may not be recommended, or may need to be delayed. 
Cepljenje morda ni priporočljivo ali pa ga bo treba prestaviti na poznejši čas.
• Side effects observed with flu vaccines given routinely every year The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. 
• Neželeni učinki, ugotovljeni pri uporabi cepiv proti gripi, ki se dajejo rutinsko vsako leto Spodaj navedeni neželeni učinki so se pojavljali v dneh ali tednih po cepljenju s cepivi, ki so jih rutinsko uporabili vsako leto za preprečevanje gripe.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine. 
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli
See section 4.4 for Special warnings and special precautions for use. 
Glejte poglavje 4.4 za posebna opozorila in previdnostne ukrepe.
• Safety and immunogenicity data in healthy adults, including older people. 
• Podatki o varnosti in imunogenosti pri zdravih odraslih, vključno s starostniki.
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC J07BB01
Trivalent seasonal influenza vaccines 
Trivalentna cepiva proti sezonski gripi
• If a specific notification system has been put in place, how to report adverse 
• Način poročanja, če je bil uveljavljen specifičen sistem poročanja
6.5 Nature and contents of the container 
6.5 Vrsta ovojnine in vsebina
The vaccine will be injected into a muscle (usually in the upper arm). 
Cepivo vam bodo injicirali v mišico (običajno v nadlaket).
In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
However, some differences in frequency and type of side effects were observed. 
Vendar je bilo nekaj razlik v pogostnosti in vrsti opaženih neželenih učinkov.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you. 
Pred cepljenjem natančno preberite navodilo za uporabo, ker vsebuje za vas pomembne podatke!
• you are having a blood test to look for evidence of infection with certain viruses. 
• če ste naročeni za odvzem krvi, da se potrdi okužba z določenimi virusi.
Tell the doctor requesting these tests that you have recently been given Celvapan. 
Povejte zdravniku, ki je naročil te preiskave, da ste bili pred kratkim cepljeni s cepivom Celvapan.
It should be noted that the adverse reactions may be intensified. 
Zavedati se je treba, da so neželeni učinki lahko izrazitejši.
ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000) 
Pogostost neželenih učinkov temelji na naslednji lestvici: 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)
The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant 
Varnost zdravila Celvapan v nosečnosti in obdobju dojenja je bila preverjena pri majhnem številu
A protective response may not be elicited in all vaccinees (see section 5.1). 
S cepljenjem verjetno ne boste izzvali zaščitnega odziva pri vseh cepljenih osebah (glejte poglavje 5.1).
Children aged less than 6 months Vaccination is not currently recommended in this age group. 
Otroci, mlajši od 6 mesecev Pri tej starostni skupini cepljenje trenutno ni priporočljivo.
Very common: Feeling tired, headache 
Zelo pogosti: utrujenost, glavobol
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80. 
Pomožne snovi so: trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
Do not use Celvapan after the expiry date which is stated on the carton. 
Cepiva Celvapan ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
Cepivo vam bo dal zdravnik ali medicinska sestra v skladu z uradnimi priporočili.
Allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock. 
alergijske reakcije, vključno z anafilaktičnimi reakcijami, ki so povzročile nevaren padec krvnega tlaka, ki lahko vodi v šok, če ni zdravljen.
• The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/(H1N1)v vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions. 
• Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost cepiva A/(H1N1)v, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
Allergic reactions may occur following vaccination, in rare cases leading to shock. 
Po cepljenju se lahko pojavijo alergijske reakcije, ki so v redkih primerih povzročile šok.
Such alterations in liver function have not been seen to date in human clinical studies. 
Takšnih sprememb delovanja jeter doslej še niso opazili v kliničnih študijah pri ljudeh.
• The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the 
• Minimalne podatkovne elemente, ki jih je treba sporočiti v vsakem poročilu, da se olajša vrednotenje in identifikacija uporabljenega cepiva pri posamezni osebi, vključno z imenom cepiva, izdelovalcem in številko serije.
What you need to know before you receive Celvapan 
Kaj morate vedeti, preden boste cepljeni s cepivom Celvapan
Children and adolescents aged 3 to 17 years One dose of 0.5 ml at an elected date. 
Otroci in mladostniki od 3 do 17 let En odmerek 0,5 ml na izbran datum.
Detailed information on this medicinal product is available on the website of the European Medicines 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA)
PSYCHIATRIC DISORDERS 
PSIHIATRIČNE MOTNJE
Shake before use. 
Pred uporabo pretresite.
* propagated in Vero cells (continuous cell line of mammalian origin) 
* razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora)
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings. 
Zato mora zdravnik oceniti koristi in morebitna tveganja cepljenja oseb s trombocitopenijo ali motnjami strjevanja krvi, ki bi povzročile kontraindikacije za intramuskularno injiciranje, razen če morebitni koristni učinki odtehtajo tveganje
Name and address of the manufacturers of the biological active substance(s) 
Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines. 
Večina neželenih učinkov je bilo blagih, kratkotrajnih in glede na zvrst podobnih tistim, ki jih povzročijo cepiva proti gripi.
However, if this cannot be avoided, the vaccines should be injected into separate limbs. 
Če se temu ni mogoče izogniti, je treba cepiva injicirati v različne okončine.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 
Kot pri vseh cepivih za injiciranje morata biti vedno takoj na voljo ustrezno medicinsko zdravljenje in zdravniški nadzor, če bi po cepljenju prišlo do sicer redke anafilaktične reakcije.
Immune response against A/California/07/2009(H1N1)v 
Odziv imunskega sistema na sev A/California/07/2009(H1N1)v
Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4). 
Preprečevanje gripe, ki jo povzroča virus A(H1N1)v 2009 (glejte poglavje 4.4).
Vaccination is not currently recommended in this age group. 
Pri tej starostni skupini cepljenje trenutno ni priporočljivo.
In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the nature of adverse events was consistent with those observed in other clinical studies in adults and children. 
V opazovalni varnostni študiji, v katero je bilo vključenih 3216 oseb, starih od 6 mesecev do 60 let in več, je bila narava neželenih učinkov skladna z neželenimi učinki, opaženimi v drugih kliničnih študijah pri odraslih in otrocih.
Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1. 
Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov na osnovi metode ELISA za določanje protiteles proti virusu humane imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in še posebej virusu HTLV-1.
If you have any further questions, ask your doctor or nurse. 
Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali medicinsko sestro.
These transitory false-positive results may be due to IgM production in response to the vaccine. 
Prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM kot odziv