FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety has been assessed on the basis of results in chickens.
Slovenian: Varnost je ocenjena na podlagi izsledkov pri piščancih.
English: Glass vials: 1 year
Slovenian: Steklene viale: 1 leto
English: The import, sale, supply and/or use of Nobilis Influenza H7N1 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba Nobilisa Influenza H7N1 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: For a list of excipients see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.
Slovenian: Učinkovitost je ocenjena na podlagi začetnih rezultatov pri piščancih in rdečehrbtnih racah.
English: Supportive data in ducks suggest that minor local swellings may occur at the injection sites but disappear within 3 weeks.
Slovenian: Spremljajoči podatki za race kažejo, da lahko na mestu vboda nastane manjša lokalna oteklina, ki pa v 3 tednih mine.
English: Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Slovenian: Čeprav v raziskavah niso uporabili prav tega specifičnega seva cepiva proti aviarni influenci, študije z drugimi sevi kažejo, da trajajo pri piščancih zaščitne ravni protiteles v serumu predvidoma najmanj 12 mesecev po dveh odmerkih cepiva.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: This vaccine has been tested for safety in chickens and only supportive data for safety in ducks are available.
Slovenian: Varnost cepiva je testirana pri piščancih, o njegovi varnosti pri racah pa so na voljo samo spremljajoči podatki.
English: A revised supporting TSE compliance table should be provided with deletion of the words ‘or equivalent' after the source companies for the tryptose and NZ-Amines and ‘e.g.'
Slovenian: Predložiti je treba revidirano tabelo o skladnosti za transmisivno spongiformno encefalopatijo, v kateri je treba izbrisati besedi 'ali enakovredna' za podjetji izvora za triptozo in NZ-amini ter 'npr.'
English: or S.C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species.
Slovenian: ali s.c. odmerek po 0,25, 0,5 ml ali 1 ml, glede na starost in živalsko vrsto.
English: The distinction between what might be protective titres of antibodies and the level of antibodies generated under the conditions of the batch potency test should be taken into account and the minimum potency at the time of batch release should be sufficient to provide the claimed duration of immunity.
Slovenian: Razlikovati je treba med morebitnimi zaščitnimi titri protiteles in ravnijo protiteles, ki nastanejo ob pogojih preskusa učinkovitosti serije, poleg tega mora minimalna učinkovitost ob sproščanju serije zadoščati za trajanje imunosti, ki je navedena.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C to +8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C do +8 °C).
English: -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Slovenian: -Pri piščancih so se klinični znaki, umrljivost, izločanje in prenos virusa po provokaciji zmanjšali v dveh tednih po cepljenju z enim odmerkom.
English: Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Slovenian: Inaktivirani antigen podtipa virusa aviarne influence H7N1 (sev, A/CK/Italija/473/99), ki vzbudi titer HI ≥ 6,0 log2 pri preizkusu učinkovitosti.
English: Batch release data for all batches of H7N1 vaccine used in the efficacy trials presented in the dossier and justification for the potency release criteria should be provided.
Slovenian: Predložiti je treba podatke o sproščanju serij za vse serije cepiva H7N1, uporabljene v preskušanjih učinkovitosti, ki so navedena v dokumentaciji, in utemeljitev meril za določanje učinkovitosti.
English: Store and transport at 2°C to 8°C.
Slovenian: Shranjujte in prevažajte pri temperaturi 2 °C do 8 °C.
English: STABILITY
Slovenian: F. STABILNOST
English: If the circulating avian influenza field virus has a different H and/or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect haemagglutinin and/or neuraminidase antibodies.
Slovenian: Če ima divji virus aviarne influence sestavino H ali N, ki se razlikuje od sestavin H7N1 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti hemaglutininu ali nevraminidazi.
English: The duration of immunity in ducks is unknown.
Slovenian: Ni znano, koliko časa traja imunosti pri racah.
English: EFFICACY ASPECTS
Slovenian: VIDIKI O UČINKOVITOSTI
English: II.F.1 Stability of the bulk antigen 5.
Slovenian: II.F.1 Stabilnost nepakiranega antigena
English: Liquid light paraffin 234.8 mg/0,5 ml
Slovenian: Tekoči lahki parafin, 234,8 mg/0,5 ml
English: Chickens and ducks
Slovenian: Piščanci in race
English: CONTROL TESTS ON THE FINISHED PRODUCT
Slovenian: KONTROLA KAKOVOSTI KONČNEGA IZDELKA
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine
English: From 8 to 14 days old: 0.25 ml subcutaneously
Slovenian: Od 8 do 14 dni starosti: 0,25 ml subkutano
English: METHOD AND ROUTE(S) OF ADMINISTRATION I.M.
Slovenian: NAČIN IN POT(I) UPORABE i.m.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H7N1
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H7N1
English: Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Slovenian: Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older: 0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
Slovenian: Od 14 dni do 6 tednov starosti: 0,25 ali 0,5 ml subkutano ali intramuskularno Stari 6 tednov in starejši: 0,5 ml subkutano ali intramuskularno Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
English: II.E.2 Identification and assay of active ingredients 4.
Slovenian: II.E.2 Istovetnost in vsebnost zdravilnih učinkovin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H7N1 emulsion for injection
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H7N1, emulzija za injiciranje
English: Polysorbate 80 Sorbitan mono oleate (E494)
Slovenian: Druge določbe lahki tekoči parafin vse živali za proizvodnjo živil polisorbat 80 sorbitan monooleat (E494)
English: Adjuvant: Liquid paraffin
Slovenian: Adjuvans: Tekoči lahki parafin
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap. Not all pack sizes may be marketed.
Slovenian: Stekleničke in plastenke so zaprte z zamaški iz nitrilne gume in zatesnjene z aluminijastimi zaporkami s šifro.
English: -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Slovenian: -Pri racah sta se izločanje in prenos virusa po provokaciji zmanjšala v dveh tednih po cepljenju z enim odmerkom.
English: 6 weeks and older: 0.5 ml subcutaneously or intramuscularly
Slovenian: Stari 6 tednov in starejši: 0,5 ml subkutano ali intramuskularno
English: Batch potency test:
Slovenian: Preskus učinkovitosti serije:
English: The report of the overdose safety studies in ducks with Nobilis Influenza H7N1 administered by both s.c. and i.m.
Slovenian: Poročila študij o varnosti enkratnega odmerka in prevelikega odmerka cepiva Nobilis Influenza H7N1 pri racah po s.c. in i.m.
English: INDICATION(S) Active immunisation against avian influenza type A, subtype H7N1.
Slovenian: INDIKACIJA(E) Aktivna imunizacija proti aviarni influenci tipa A, podtip H7N1.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly
Slovenian: Od 14 dni do 6 tednov starosti: 0,25 ali 0,5 ml subkutano ali intramuskularno
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Slovenian: IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
English: 6.5 Nature and composition of immediate packaging 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Slovenian: Stekleničke po 250 ml ali 500 ml iz stekla tipa II ali plastenke po 250 ml ali 500 ml iz polietilen tereftalata (PET).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 0.5 ml contains:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI En odmerek po 0,5 ml vsebuje:
English: For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.
Slovenian: Aktivna imunizacija piščancev in rac proti aviarni influenci tipa A, podtip H7N1.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Chickens
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01AA23
Slovenian: Farmakoterapevtska skupina: inaktivirano cepivo, oznaka ATC vet: QI01AA23 Cepivo vzbudi aktivno imunost proti virusu aviarne influence tipa A, podtip H7N1.
English: ROUTE(S) OF ADMINISTRATION I.M.
Slovenian: POT(I) UPORABE ZDRAVILA i.m.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN En odmerek po 0,5 ml vsebuje:
English: Ducks
Slovenian: Race
English: SAFETY ASPECTS 6.
Slovenian: VARNOSTNI VIDIKI
English: All food producing species
Slovenian: Živalska vrsta
English: • Marketing authorisation under exceptional circumstances The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
English: Annex IV Conclusions on the granting of the marketing authorisation under exceptional circumstances presented by the European Medicines Agency
Slovenian: Sklepne ugotovitve o pridobitvi dovoljenja za promet z zdravilom v izjemnih okoliščinah, ki jih je predstavila evropska agencija za zdravila
English: Implementation of the agreement by the Member States:
Slovenian: Izvajanje sporazuma v državah članicah:
English: 25 July 2013
Slovenian: 25. julij 2013
English: 25 June 2013
Slovenian: 25. junij 2013
English: May 2013 CMDh meeting
Slovenian: Zasedanje skupine CMDh maja 2013
English: In both studies, the main measure of effectiveness was the number of patients with no sign of inflammation after two weeks.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih po dveh tednih ni bilo znakov vnetja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yellox on 18 May 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Yellox, veljavno po vsej Evropski uniji, izdala 18. maja 2011.
English: What measures are being taken to ensure the safe and effective use of Yellox?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yellox?
English: This is a summary of the European public assessment report (EPAR) for Yellox.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Yellox.
English: The full EPAR for Yellox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yellox je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Medicines Agency decided that Yellox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je sklenila, da so koristi zdravila Yellox večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: If more than one eye medicine is being used, they should be given at least five minutes apart.
Slovenian: Če bolnik uporablja več vrst kapljic za oči, je treba zdravila uporabiti v razmiku najmanj pet minut.
English: Other information about Yellox
Slovenian: Druge informacije o zdravilu Yellox
English: For more information see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.
Slovenian: V drugi študiji so bili deleži naslednji: 63 % (124 od 198) bolnikov, zdravljenih z zdravilom Yellox, in 40 % (39 od 98) bolnikov, ki so prejemali placebo.
English: The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%).
Slovenian: Najpogostejši ali najpomembnejši neželeni učinki, opaženi pri zdravilu Yellox, so nenormalen občutek v očesu (0,5 % bolnikov), blaga ali zmerna erozija roženice (prozorne plasti na prednji strani očesa) (0,4 %), očesni pruritus (srbenje) (0,4 %), bolečina v očesu (0,3 %) in rdečica očesa (0,3 %).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yellox have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Yellox upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Yellox bromfenac
Slovenian: Yellox bromfenak
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Slovenian: Deluje tako, da zavira encim, imenovan ciklooksigenaza, ki proizvaja prostaglandine, tj. snovi, ki sodelujejo pri vnetnih procesih.
English: In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73).
Slovenian: V eni študiji 66 % (104 od 158) bolnikov, zdravljenih z zdravilom Yellox, po dveh tednih ni kazalo znakov vnetja v primerjavi z 48 % (35 od 73) bolnikov, ki so prejemali placebo.
English: What are the risks associated with Yellox?
Slovenian: Kakšna tveganja so povezana z zdravilom Yellox?
English: What benefits of Yellox have been shown during the studies?
Slovenian: Kakšne koristi je zdravilo Yellox izkazalo v študijah?
English: It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.
Slovenian: Ne sme se uporabljati pri bolnikih, ki dobijo napade astme, urtikarijo (srbeč izpuščaj) ali akutni rinitis (zamašen nos ali izcedek iz nosu), če vzamejo acetilsalicilno kislino (aspirin) ali druga nesteroidna protivnetna zdravila.
English: For more information about treatment with Yellox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Yellox preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Yellox approved?
Slovenian: Zakaj je bilo zdravilo Yellox odobreno?
English: Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery.
Slovenian: Zdravilo Yellox je bilo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri lajšanju očesnega vnetja po operativni odstranitvi katarakte v dveh glavnih študijah, v katerih je sodelovalo skupno 527 bolnikov, pri katerih so opravili ta poseg.
English: What is Yellox and what is it used for?
Slovenian: Kaj je zdravilo Yellox in za kaj se uporablja?
English: The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Zdravilna učinkovina v zdravilu Yellox, bromfenak, je nesteroidno protivnetno zdravilo (NSAID).
English: It is not intended to provide practical advice on how to use Yellox.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Yellox, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Yellox naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Yellox, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Yellox, glejte navodilo za uporabo.
English: By reducing the production of prostaglandins in the eye, Yellox can reduce the inflammation caused by eye surgery.
Slovenian: Zdravilo Yellox lahko s tem, ko zmanjša izdelavo prostaglandinov, zmanjša vnetje, ki ga povzroča operativni poseg na očeh.
English: Yellox must not be used in people who are hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs.
Slovenian: Zdravila Yellox ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bromfenak, katero koli drugo sestavino zdravila ali na druga nesteroidna protivnetna zdravila.
English: Yellox is available as an eye drop solution and the recommended dose is one drop into the affected eye(s) twice a day.
Slovenian: Zdravilo Yellox je na voljo kot raztopina kapljic za oko, priporočeni odmerek pa je ena kapljica v prizadeto oko (prizadeti očesi) dvakrat na dan. Zdravljenje se začne dan po operaciji katarakte in traja dva tedna.
English: Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).
Slovenian: Zdravilo Yellox se uporablja za zdravljenje vnetja očesa pri odraslih, do katerega lahko pride po operaciji katarakte (zameglitve očesne leče).
English: How does Yellox work?
Slovenian: Kako zdravilo Yellox deluje?
English: How is Yellox used?
Slovenian: Kako se zdravilo Yellox uporablja?
English: Yellox contains the active substance bromfenac.
Slovenian: Zdravilo vsebuje zdravilno učinkovino bromfenak.
English: (see section 4.4).
Slovenian: (Glejte poglavje 4.4.)
English: This should be considered when interpreting laboratory data.
Slovenian: To je treba upoštevati pri analizi laboratorijskih podatkov.
English: Take your next dose at the normal time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: Elderly: Same dosage as for adults.
Slovenian: Starejši bolniki: Isti odmerek kot za odrasle.
English: Choose a time that is convenient for you and take your tablet at this time each day.
Slovenian: Izberite si čas, ki vam ustreza, in jih jemljite ob tem času vsak dan.
English: Tel 00 351 21 896 51 05 Fax 00 351 21896 51 06
Slovenian: Tel 00 351 21 896 51 05 Faks 00 351 21896 51 06
English: The food-interaction study was not performed according to the CHMP guidelines.
Slovenian: Raziskava o medsebojnem delovanju s hrano ni bila izvedena v skladu s smernicami CHMP.
English: Hertfordshire, SG1 4SZ United Kingdom Tel 00 44 207 612 7612 Fax 00 44 207 612 7620
Slovenian: Hertfordshire, SG1 4SZ Združeno kraljestvo Tel 00 44 207 612 7612 Faks 00 44 207 612 7620
English: Symptomatic treatment.
Slovenian: Simptomatsko zdravljenje.
English: If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint.
Slovenian: Če se to zgodi, ne skrbite, vendar pa zagotovite, da ne boste vozili avtomobila, upravljali strojev ali opravljali dejavnosti, ki bi lahko bile nevarne, če bi čutili omedlevico.
English: The tablets can be taken with or without food.
Slovenian: Tablete se lahko jemljejo s hrano ali brez nje.
English: Cellulose, microcrystalline Povidone K 29-32
Slovenian: Celuloza, mikrokristalna Povidon K 29-32
English: You should contact your doctor immediately or go to the nearest casualty department.
Slovenian: Takoj obvestite zdravnika ali obiščite najbližji nezgodni oddelek.
English: Remember to take the pack and any remaining tablets with you.
Slovenian: S seboj vzemite pakiranje in morebitne preostale tablete.
English: Close control of blood pressure.
Slovenian: Temeljit nadzor krvnega tlaka.
English: 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), including isolated reports
Slovenian: Zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1000, < 1/100), redki (> 1/10.000, < 1/1000), zelo redki (< 1/10.000), vključno s posameznimi poročili.
English: Some patients may experience impaired ability to react.
Slovenian: Pri nekaterih bolnikih se sposobnost reagiranja lahko zmanjša.
English: Particular caution:
Slovenian: Posebno opozorilo:
English: In hypertensive patients both conditions are treated concomitantly.
Slovenian: Pri hipertenzivnih bolnikih obe bolezni zdravimo hkrati.
English: When you start taking your tablets, make sure that your senses are not affected before you drive or operate machinery.
Slovenian: Ko začnete jemati tablete, se prepričajte, da ne vplivajo na vaše čute, preden vozite avtomobil ali upravljate stroje.
English: The tablets must be swallowed whole with a sufficient amount of liquid.
Slovenian: Tablete je treba pogoltniti cele z zadostno količino tekočine.
English: The occurrence of adverse reactions are mainly due to the pharmacological properties of the medicinal product.
Slovenian: Pojav neželenih učinkov je večinoma posledica farmakoloških lastnosti zdravila.
English: The tablets should not be chewed, divided or crushed.
Slovenian: Tablete se ne smejo žvečiti, prepoloviti ali zdrobiti.