natgillin/translations-raw huggingface dataset:
• The tube goes through the wall of the large intestine.
• Cevka predre steno debelega črevesa.
• Inflamed colon (colitis).
• Vnetje debelega črevesa (kolitis).
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Bolnike je treba pred začetkom zdravljenja z zdravilom (LASTNIŠKO IME ZDRAVILA) testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom LASTNIŠKO IME ZDRAVILA, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
Adverse Reaction Data Derived From Clinical Trials and Postmarketing Experience Uncommon (> 1/1,000 to < 1/100)
Občasni (≥ 1/1 000 do < 1/100)
• Sliding of one part of the gut into an adjacent part of the gut (intussusception)
• Premik dela črevesa v sosednji del črevesa (invaginacija).
Device- and Procedure-Related Adverse Reactions Gastrointestinal disorders
Z napravo in s postopkom povezani neželeni učinki Bolezni prebavil
What are the recommendations for patients and carers?
Kakšna so priporočila za bolnike in negovalce?
• Patients and carers who have any questions should speak to their doctor or pharmacist.
• Bolniki in negovalci, ki imajo kakršna koli vprašanja, naj se pogovorijo z zdravnikom ali farmacevtom.
They are currently marketed in Belgium, France, Luxembourg, Finland, Italy, Portugal and Spain under various trade names.
Trenutno so na trgih v Belgiji, Franciji, Luksemburgu, na Finskem, v Italiji, na Portugalskem in v Španiji pod različnimi tržnimi imeni.
They include camphor, cineole, terpineol, terpine, citral and menthol.
Vključujejo kafro, cineol, terpineol, terpin, citral in mentol.
It also decided that there was a risk of these medicines causing local anorectal lesions.
Dodal je, da obstaja pri teh zdravilih tudi tveganje za povzročitev lokalnih anorektalnih lezij.
The approved indications vary in different EU countries, but typically include supportive treatment for mild, sudden bronchial disorders, particularly productive and non-productive cough.
Odobrene indikacije se v različnih državah EU razlikujejo, vendar običajno vključujejo podporno zdravljenje blagih nenadnih bolezni sapnic, zlasti produktivnega in neproduktivnega kašlja.
Questions and answers on the review of suppositories containing terpenic derivatives EMA/CHMP/763180/2011 Corr to Rev 1
Vprašanja in odgovori v zvezi s pregledom svečk, ki vsebujejo terpenske derivate EMA/CHMP/763180/2011 Corr∗ to Rev 1
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there was a risk of these medicines inducing neurological disorders, especially convulsions, in infants and small children.
Na podlagi ocene podatkov, ki so trenutno na voljo, in znanstvene razprave v Odboru je CHMP zaključil, da ta zdravila predstavljajo tveganje za nastanek nevroloških motenj, zlasti konvulzij, pri dojenčkih in majhnih otrocih.
The medicines concerned by this review are used to treat coughs and colds in children and adolescents.
Zdravila, na katere se nanaša ta dokument, se uporabljajo za zdravljenje kašlja in prehlada pri otrocih in mladostnikih.
Questions and answers on the review of suppositories containing terpenic derivatives
Vprašanja in odgovori v zvezi s pregledom svečk, ki vsebujejo terpenske derivate
11 April 2012 EMA/CHMP/763180/2011 Corr to Rev 1
11. april 2012 EMA/CHMP/763180/2011 popravlj.
The Committee noted that the effectiveness of these medicines had not been clearly demonstrated, as no clinical trials with suppositories containing terpenic derivatives had been performed and there were no studies focused on infants and children.
Odbor je opozoril, da učinkovitost teh zdravil ni bila jasno dokazana, saj klinična preskušanja s svečkami, ki vsebujejo terpenske derivate, niso bila izvedena, in ker ni študij, ki bi se osredotočile na dojenčke in otroke.
In the EU, suppositories containing terpenic derivatives are authorised by national procedures and are available without prescription.
V EU so svečke, ki vsebujejo terpenske derivate, odobrene z nacionalnimi postopki in so na voljo brez recepta.
The CHMP looked at the benefit-risk assessment carried out by France, and information requested from the companies that market suppositories containing terpenic derivatives in the EU.
CHMP je pregledal oceno razmerja med tveganji in koristmi, ki jo je opravila Francija, in informacije, za katere je zaprosil družbe, ki v EU tržijo svečke, ki vsebujejo terpenske derivate.
Consequently, on 27 October 2010 the French agency asked the CHMP to carry out a full assessment of the benefit-risk balance of suppositories containing terpenic derivatives in children younger than 30 months of age and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU in this population.
Francoska regulativna agencija je zato 27. oktobra 2010 zaprosila CHMP za izvedbo celovite ocene razmerja med tveganji in koristmi svečk, ki vsebujejo terpenske derivate, pri otrocih, mlajših od 30 mesecev, in za izdajo mnenja o tem, ali naj se dovoljenje za promet v EU s temi zdravili za to populacijo ohrani, spremeni, začasno umakne ali prekliče.
Terpenic derivatives are mainly obtained from natural substances originating from plants such as conifers.
Terpenski derivati se v glavnem pridobivajo iz naravnih sestavin iz rastlin, kot so iglavci.
This included study data supporting the marketing authorisations and safety data including reports of side effects from post-marketing surveillance and the published literature.
To je vključevalo tudi podatke iz študij, ki so bili predloženi v podporo dovoljenjem za promet, in podatke o varnosti zdravila, vključno s poročili o neželenih učinkih spremljanja po izdaji dovoljenja za promet in podatki iz objavljene literature.
The European Medicines Agency has completed a review of the safety and effectiveness of suppositories containing terpenic derivatives.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti svečk, ki vsebujejo terpenske derivate.
The French medicines regulatory agency had concerns about the safety of suppositories containing terpenic derivatives, particularly the risk of serious neurological side effects in young children such as
Francoska regulativna agencija za zdravila je imela pomisleke glede varnosti svečk, ki vsebujejo terpenske derivate, zlasti zaradi tveganja resnih nevroloških neželenih učinkov pri majhnih otrocih, denimo konvulzij.
• Terpenic derivatives in other forms, such as solutions to be inhaled or rubbed into the skin, may continue to be used as currently approved.
• Terpenske derivate v drugih oblikah, kot so raztopine za inhaliranje ali vtiranje v kožo, je dovoljeno še naprej uporabljati v skladu z odobritvijo.
Medicines containing terpenic derivatives are available in various forms, including solutions to be inhaled or rubbed into the skin as well as suppositories.
Zdravila, ki vsebujejo terpenske derivate, so na voljo v različnih oblikah, vključno z raztopinami za inhaliranje ali vtiranje v kožo, pa tudi kot svečke.
Suppositories containing terpenic derivatives are medicines given rectally used to treat various conditions.
Svečke, ki vsebujejo terpenske derivate, so zdravilo, ki se uporablja rektalno za zdravljenje različnih stanj.
What are suppositories containing terpenic derivatives?
Kaj so svečke, ki vsebujejo terpenske derivate?
They are also found in essential oils obtained from plants, such as niaouli, wild thyme or eucalyptus.
Prav tako jih najdemo v eteričnih oljih, pridobljenih iz rastlin, kot na primer niaouli, materina dušica ali evkaliptus.
They are often found in herbal substances and herbal preparations, such as pine needle or turpentine.
Pogosto jih najdemo v rastlinskih snoveh in rastlinskih pripravkih, kot so borove iglice in terpentin.
 Editorial revisions have been made in the description of terpenic derivatives to ensure accuracy.
∗ Za zagotovitev natančnosti so bile pri opisu terpenskih derivatov opravljene uredniške spremembe.
The CHMP noted that children aged up to 30 months and children with a history of epilepsy or febrile convulsion were most at risk of these neurological side effects because their nervous system is not yet fully developed.
CHMP je opozoril, da je tveganje za neželene nevrološke učinke največje pri otrocih, starih do 30 mesecev, in pri otrocih z anamnezo epilepsije ali febrilne konvulzije, ker njihov živčni sistem še ni v celoti razvit.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the use of these medicines should be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion (precancerous growths in the anus or rectum).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da mora biti uporaba teh zdravil kontraindicirana pri otrocih, mlajših kot 30 mesecev, otrocih z anamnezo epilepsije ali febrilne konvulzije in pri otrocih z nedavno anamnezo anorektalne lezije (predrakavih rašč v zadnjiku ali danki).
Why were suppositories containing terpenic derivatives reviewed?
Zakaj je bil opravljen pregled svečk, ki vsebujejo terpenske derivate?
• Suppositories containing terpenic derivatives should not be used in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
• Svečk, ki vsebujejo terpenske derivate, ni dovoljeno uporabljati pri otrocih, mlajših od 30 mesecev, otrocih z anamnezo epilepsije ali febrilne konvulzije in pri otrocih z nedavno anamnezo anorektalne lezije.
The Committee therefore recommended that the use of suppositories containing terpenic derivatives be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
Odbor zato priporoča, da se uporaba svečk, ki vsebujejo terpenske derivate, kontraindicira za uporabo pri otrocih, mlajših od 30 mesecev, pri otrocih z anamnezo epilepsije ali febrilne konvulzije in pri otrocih z nedavno anamnezo anorektalne lezije.
The French agency was also concerned that reliable data on the effectiveness of these medicines were not available, and that the medicines did not fulfil the latest clinical recommendations for treating cough in children.
teh zdravil in ker zdravilo ni izpolnjevalo najnovejših kliničnih priporočil za zdravljenje kašlja pri otrocih.
convulsions.
v Rev 1
How does it work?
Kako deluje?
The recommended dose is one tablet daily, swallowed whole with water.
Priporočeni odmerek je ena tableta na dan, ki se pogoltne cela z vodo.
The full EPAR 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) je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to one of the active substances in the medicine.
Uporablja se le pri bolnikih, ki so se dobro odzvali na dosedanje zdravljenje okužbe z virusom HIV in ki niso okuženi z virusom HIV, odpornim proti zdravljenju ali verjetno neodzivnim na eno od zdravilnih učinkovin v zdravilu.
Why is the medicine approved?
Zakaj je bilo to zdravilo odobreno?
It is recommended that the medicine be taken on an empty stomach, preferably at bedtime.
Priporočljivo je, da se jemlje na prazen želodec, po možnosti pred spanjem.
Patients should take the medicine regularly and avoid missing doses.
Bolniki morajo zdravilo jemati redno in odmerkov ne smejo izpuščati.
The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as this one.
Družba, ki trži zdravilo, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo informacije o povečanem tveganju ledvične bolezni pri zdravilih,
All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Vse tri zdravilne učinkovine zavirajo dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV in ki mu omogoča razmnoževanje v okuženih celicah.
For more information about treatment with this medicine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju s tem zdravilom preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Atripla, zato jih ni treba ponoviti za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva.
Because Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva se uporablja za zdravljenje odraslih, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa-1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva keeps the amount of HIV in the blood at a low level.
Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva ohranja nizko raven virusa HIV v krvi.
This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva.
For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?
Kaj je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva in za kaj se uporablja?
This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
To zdravilo vsebuje tri zdravilne učinkovine: efavirenz, ki je nenukleozidni zaviralec reverzne transkriptaze (NNRTI), emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, in dizoproksiltenofovirat, ki je predzdravilo tenofovirja, kar pomeni, da se v zdravilno učinkovino tenofovir pretvori v telesu.
This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
To zdravilo se ne sme jemati sočasno z drugimi zdravili, ki vsebujejo efavirenz, emtricitabin, dizoproksiltenofovirat ali lamivudin (tudi protivirusno zdravilo).
Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Druge informacije o zdravilu Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Efavirenz/emtricitabin/dizoproksiltenofovirat Zentiva efavirenz/emtricitabin/dizoproksiltenofovirat
Date of first authorisation: 28 September 2012 Date of latest renewal: 26 July 2017
Datum prve odobritve: 28. september 2012 Datum zadnjega podaljšanja: 26. julij 2017
Then take the next dose as usual.
Naslednjega dne vzemite odmerek kot običajno.
You can inhale this medicine anytime before or after food or drink.
To zdravilo lahko inhalirate kadarkoli, pred ali po uživanju hrane oziroma pijače.
Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Tega zdravila ne dajajte otrokom ali mladostnikom, ki so stari manj kot 18 let.
Therefore the frequency was calculated from clinical trial experience.
Iz tega razloga je pogostnost izračunana na podlagi izkušenj v kliničnih preskušanjih.
• Painful and frequent urination
• boleče in pogosto uriniranje
• Voice alteration (hoarseness)
• sprememba glasu (hripavost)
The most common anticholinergic adverse reaction was dry mouth (2.4%).
Najbolj pogost antiholinergični neželeni učinek so bila suha usta (2,4 %).
If a dose is missed, the next dose should be taken as soon as possible.
V primeru izpuščenega odmerka je treba naslednji odmerek vzeti čimprej.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signifcant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Elderly people You can use this medicine if you are aged 75 years and over at the same dose as for other adults.
Starejši ljudje Če ste stari 75 let ali več, lahko uporabljate to zdravilo v enakem odmerku kot drugi odrasli.
This medicine contains lactose.
To zdravilo vsebuje laktozo.
In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Pri tem razvrstitev posameznega neželenega učinka v ustrezno kategorijo pogostnosti temelji na naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
- COPD is a long-term disease and you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD.
- KOPB je dolgotrajna bolezen in to zdravilo morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
In both studies, the percentage of patients experiencing a moderate or severe exacerbation (defined as requiring treatment with systemic corticosteroids and/or antibiotics or hospitalisation) was reduced.
V obeh študijah je prišlo do zmanjšanja odstotka bolnikov, pri katerih je prišlo do zmernega oziroma hudega poslabšanja (ki je bilo opredeljeno s potrebo po zdravljenju s sistemskimi kortikosteroidi in/ali z antibiotiki ali s hospitalizacijo).
There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk.
O uporabi tega zdravila v nosečnosti ni na voljo nobenih podatkov in prav tako ni znano, ali zdravilna učinkovina tega zdravila prehaja v materino mleko.
Some side effects may be serious, but the frequency of these side effects is not known (frequency cannot be estimated from the available data)
Nekateri neželeni učinki so lahko resni, vendar njihova pogostnost ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
• High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination)
• zvišana raven sladkorja v krvi (hiperglikemija: značilni simptomi pri tem so huda žeja ali lakota in pogosto odvajanje vode)
Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB06
Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, antiholinergiki, oznaka ATC: R03BB06
Gastrointestinal effects including gastroenteritis and dyspepsia were also observed.
Opažali so še gastrointestinalne učinke, med drugim gastroenteritis in dispepsijo.
The European Medicines Agency has waived the obligation to submit the results of studies with Tovanor Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Tovanor Breezhaler za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
To zdravilo zmanjša napetost teh mišic v pljučih, tako da zrak lažje vstopi v pljuča in izstopi iz njih.
If you use more Tovanor Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Če ste uporabili večji odmerek zdravila Tovanor Breezhaler, kot bi smeli Če ste vdihnili preveč tega zdravila ali če kdo drug pomotoma uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno pomoč.
1) More frequent for glycopyrronium than placebo in the 12 months database only.
1) Bolj pogosti pri uporabi glikopironija kot pri uporabi placeba samo v 12-mesečni podatkovni bazi.
High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated.
Visoki odmerki glikopironija lahko povzročijo antiholinergične znake in simptome, pri katerih je indicirano simptomatsko zdravljenje.
Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 23,6 mg laktoze (v obliki monohidrata).
The capsules must be administered only using the Tovanor Breezhaler inhaler (see section 6.6).
Kapsule so namenjene samo uporabi z inhalatorjem Tovanor Breezhaler (glejte poglavje 6.6).
Glycopyrronium has no or negligible influence on the ability to drive and use machines.
Glikopironij nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
Insufficient pharmacokinetic data is available for other ethnicities or races.
O uporabi pri pripadnikih drugih etničnih skupin in ras ni na voljo dovolj farmakokinetičnih podatkov.