natgillin/translations-raw huggingface dataset:
It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke 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).
EPAR summary for the public
Povzetek EPAR za javnost telmisartan
The CHMP decided that Micardis's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Micardis večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Micardis is a medicine that contains the active substance telmisartan.
Micardis je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
What benefit has Micardis shown during the studies?
Kakšne koristi je zdravilo Micardis izkazalo med študijami?
Micardis is used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Micardis se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For more information about treatment with Micardis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Micardis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems.
Hipotenzija je lahko pogostejša pri bolnikih, ki zdravilo Micardis jemljejo za preprečevanje kardiovaskularnih težav.
If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Če želena vrednost krvnega tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je hidroklorotiazid.
The active substance in Micardis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Micardis, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Vendar so bili pri 1 do 10 bolnikih od 1 000 opaženi naslednji neželeni učinki: okužbe zgornjih dihal (prehladi), vključno z vnetjem grla in sinusov, okužbe sečil (okužbe struktur za odvajanje urina), vključno z vnetjem mehurja, anemija (nizko število rdečih krvničk), hiperkaliemija (visoke ravni kalija v krvi), depresija, nespečnost, sinkopa (kratkotrajna izguba zavesti), vrtoglavica, bradikardija (zelo počasen srčni utrip), hipotenzija (nizek krvni tlak), dispneja (oteženo dihanje), bolečine v trebuhu (bolečine v želodcu), driska, dispepsija (zgaga),
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 Micardis.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Micardis, 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 Micardis?
Kakšna tveganja so povezana z zdravilom Micardis?
For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Za preprečevanje kardiovaskularnih težav so zdravilo Micardis v odmerku 80 mg enkrat dnevno proučevali v eni glavni študiji, v katero je bilo vključenih skoraj 26 000 bolnikov, starih 55 let ali več, ki so imeli srčno ali arterijsko bolezen, so doživeli kap ali imeli sladkorno bolezen in pri katerih je obstajalo veliko tveganje za kardiovaskularne težave.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganja, povezana s previsokim krvnim tlakom, kot sta na primer srčni napad ali možganska kap.
The main measure of effectiveness was the reduction in the number of patients who died or were admitted to hospital, or who had a heart attack or stroke.
Glavno merilo učinkovitosti je bilo znižanje števila bolnikov, ki so umrli, bili hospitalizirani oziroma so doživeli srčni infarkt ali možgansko kap.
Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Bolniki z blažje ali zmerno prizadetim delovanjem ledvic ne smejo jemati odmerkov, ki presegajo 40 mg na dan.
Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Zdravilo Micardis so primerjali z ramiprilom (drugim zdravilom za preprečevanje kardiovaskularnih težav) in kombinacijo obeh zdravil.
Micardis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Zdravilo Micardis se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni napad ali možganska kap.
Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Različne odmerke zdravila Micardis so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenololom, lizinoprilom, enalaprilom in amlodipinom).
Side effects with Micardis are not common.
Neželeni učinki zdravila Micardis niso pogosti.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Ker telmisartan zavira receptorje, na katere se angiotenzin II običajno veže, hormonu prepreči delovanje, zaradi česar se krvne žile lahko razširijo.
Why has Micardis been approved?
Zakaj je bilo zdravilo Micardis odobreno?
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.