FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.
Latvian: Tās nedrīkst lietot pacienti ar urīna aizturi (apgrūtinātu urīna izvadīšanu), nopietniem kuņģa un zarnu trakta traucējumiem, nekontrolētu slēgtā kakta glaukomu (paaugstinātu spiedienu acīs, neskatoties uz ārstēšanu) vai myasthenia gravis (nervu un muskuļu slimību, kas izsauc muskuļu vājumu), kā arī pacienti, kas pakļauti šādu slimību riskam.
English: Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
Latvian: Kentera lieto, lai ārstētu urīna nesaturēšanu (pēkšņu kontroles zudumu pār urinēšanu), pastiprinātu urinēšanas biežumu (nepieciešamība bieži urinēt) un neatliekamību (pēkšņa vajadzība urinēt) pieaugušiem pacientiem ar hiperaktīvu urīnpūsli (kad pūšļa muskuļi pēkšņi saraujas).
English: During its assessment of the application for Kentera gel, the CHMP concluded that its effectiveness was similar to that of the previously approved patches.
Latvian: Vērtējot Kentera gēla pieteikumu CHMP secināja, ka tā iedarbīgums ir līdzīgs iepriekš apstiprināto plāksteru iedarbīgumam.
English: For more information about treatment with Kentera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Latvian: Plašāka informācija par ārstēšanu ar Kentera pieejama zāļu lietošanas pamācībā (kas arī ir daļa no EPAR) vai iegūstama, sazinoties ar ārstu vai farmaceitu.
English: In the study on the gel, after 12 weeks the average number of daily incontinence episodes, which was initially at 5.4, was reduced by 2.7 episodes per day in patients receiving Kentera gel compared with a drop on average of 2 episodes per day in patients receiving placebo.
Latvian: Gēla pētījumā pēc 12 nedēļām vidējais nesaturēšanas epizožu skaits dienā, kas sākotnēji bija 5,4, tika samazināts par 2,7 epizodēm dienā pacientiem, kas lietoja Kentera gēlu, salīdzinot ar samazinājumu par 2 epizodēm dienā placebo lietotāju grupā.
English: The main measure of effectiveness was the number of incontinence episodes over either three or seven days.
Latvian: Galvenais iedarbīguma rādītājs bija urīna nesaturēšanas epizožu skaits trīs vai septiņu dienu posmā.
English: Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients.
Latvian: Kentera nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģiju) pret oksibutinīnu vai kādu citu šo zāļu sastāvdaļu.
English: Kentera transdermal patches were studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Latvian: Divos Kentera transdermālo plāksteru pamatpētījumos kopumā bija iesaistīts 881 pacients, galvenokārt gados vecākas sievietes ar hiperaktīvu pūsli.
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin) and as a gel in a sachet or a metering pump.
Latvian: Tās ir pieejamas kā transdermāls plāksteris (plāksteris, no kura zāles organismā iekļūst caur ādu) un kā gēls maisiņā vai dozējošā sūknī.
English: What benefit has Kentera shown during the studies?
Latvian: Kāds ir Kentera iedarbīgums šajos pētījumos?
English: What is Kentera?
Latvian: Kas ir Kentera?
English: After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera patches, compared with a decrease of 15 episodes with placebo.
Latvian: 12 nedēļas lietojot Kentera plāksterus, vidējais nesaturēšanas epizožu skaits nedēļā samazinājās par 19 (apmēram par 3 dienā) salīdzinājumā ar placebo grupu, kurā bija par 15 epizodēm mazāk.
English: In the bladder, this causes the muscles that push urine out of the bladder to relax.
Latvian: Tā rezultātā urīnpūšļa muskuļi, kas izspiež urīnu, atslābst.
English: The most common side effects with Kentera patches (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Latvian: Visbiežāk novērotās blakusparādības, lietojot Kentera plāksterus (vairāk nekā vienam pacientam no desmit) ir reakcija plākstera aplikācijas vietā (tostarp nieze ap plākstera aplikācijas vietu).
English: The gel is applied to dry, intact skin on the abdomen, upper arm, shoulders or thighs.
Latvian: Gēlu uzklāj uz sausas, veselas ādas vēdera, augšdelma, plecu vai gurnu apvidū.
English: The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Latvian: Kentera aktīvā viela oksibutinīns ir antiholīnerģisks līdzeklis.
English: This leads to an increase in the amount of urine that the bladder can hold, and to changes in the way the bladder muscles contract as the bladder fills up.
Latvian: Rezultātā palielinās urīnpūšļa ietilpība un mainās urīnpūšļa muskuļu saraušanās veids, tam piepildoties.
English: What is the risk associated with Kentera?
Latvian: Kāds pastāv risks, lietojot Kentera?
English: The most commonly reported side effect with Kentera gel is dry mouth (seen in between 1 and 10 patients in 100).
Latvian: Visbiežāk novērotās blakusparādības, lietojot Kentera gēlu, ir sausa mute (vienam līdz demit pacientiem no simts).
English: In the other, they were compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients.
Latvian: Otrajā pamatpētījumā iesaistot 361 pacientu, transdermālie plāksteri tika salīdzināti ar tolterodīna kapsulām (citu līdzekli urīna nesaturēšanas ārstēšanai).
English: In one study, they were compared with placebo (a dummy treatment) in 520 patients.
Latvian: Vienā pētījumā iesaistot 520 pacientus, transdermālie plāksteri tika salīdzināti ar placebo (fiktīvu ārstēšanu).
English: The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Latvian: Plāksteris jāuzliek uz sausas, veselas ādas vēdera, gurna vai sēžamvietas apvidū tūlīt pēc izņemšanas no plākstera maisiņa.
English: How does Kentera work?
Latvian: Kā Kentera darbojas?
English: For the full list of all side effects reported with Kentera, see the package leaflet.
Latvian: Pilns visu Kentera izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
English: Kentera gel was compared with placebo in one main study in 789 patients with overactive bladders.
Latvian: Vienā pamatpētījumā iesaistot 789 pacientus ar hiperaktīvu urīnpūsli, Kentera gēlu salīdzināja ar placebo.
English: How is Kentera used?
Latvian: Kā lietot Kentera?
English: How has Kentera been studied?
Latvian: Kā noritēja Kentera izpēte?
English: What is Kentera used for?
Latvian: Kāpēc lieto Kentera?
English: SCIENTIFIC CONCLUSIONS
Latvian: ZNANSTVENI ZAKLJUČKI
English: Whereas,
Latvian: Ob upoštevanju naslednjega:
English: All active substances are authorised at the level of the Member States.
Latvian: Vse zdravilne učinkovine so odobrene na ravni držav članic.
English: - Restriction of the maximum dose to 3 mg/day.
Latvian: - Omejitev največjega odmerka na 3 mg/dan.
English: This has been subject to previous reviews leading to risk minimisation measures at national level.
Latvian: To je bil predmet starejših pregledov, ki so privedli do ukrepov za zmanjšanje tveganja na državni ravni.
English: - The conditions of the marketing authorisations are set out in Annex IV.
Latvian: - Pogoji dovoljenj za promet z zdravili so navedeni v Dodatku IV.
English: The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Latvian: Stimulacija agonistov receptorja 5-HT2B se smatra za najbolj verjeten mehanizem, ki sproži srčno valvulopatijo, čeprav so morda vpleteni tudi drugi mehanizmi.
English: The majority of reported fibrotic events were not completely reversible although symptomatic improvement occurs for various reasons and indeed occasionally fibrosis may regress.
Latvian: Pri večini fibroznih dogodkov, o katerih se je poročalo, le-teh ni bilo mogoče popolnoma pozdraviti, čeprav je zaradi različnih razlogov prišlo do simptomatskih izboljšav, občasno celo do regresije fibroze.
English: The mechanism of fibrotic reaction induced by ergot alkaloids has not been completely clarified yet.
Latvian: Mehanizmi fibroznih reakcij, ki jih sprožijo alkaloidi rženega rožička, še niso povsem pojasnjeni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CABERGOLINE AND PERGOLIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Latvian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA KABERGOLINA IN PERGOLIDA TER Z NJIMA POVEZANIH IMEN (GLEJTE DODATEK I)
English: Whether this mechanism also applies to the non-cardiac fibrotic events is unclear.
Latvian: Ni jasno, ali ta mehanizem velja tudi za dogodke fibroze, ki niso povezani s srcem.
English: However, most trials did not include echocardiographic monitoring, thus preventing a reliable estimation of incidence rates.
Latvian: Vendar pa pri večini preskušanj niso uporabili ehokardiografskega opazovanja, kar onemogoča zanesljivo oceno deležev pojavnosti.
English: - Strengthening of the contra-indications, warnings and precautions for use, outlining the necessity for patients to be monitored for signs of fibrosis with echocardiography before and during long-term treatment.
Latvian: - Kontrindikāciju precizējums, brīdinājumi un piesardzība lietošanā, pasvītrojot nepieciešamību nodrošināt fibrozes pazīmju novērošanu pacientiem ar ehokardiogrāfiju pirms ilgstošas ārstēšanas un tās laikā.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Latvian: V štirih glavnih opazovalnih študijah so opazovali tveganje pojava srčne valvulopatije pri bolnikih, ki so jih zaradi Parkinsonove bolezni zdravili z agonisti dopamina (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
English: - In view of the available data, the Committee concluded that the risk of fibrosis, including cardiac valvulopathy, is well established for cabergoline and pergolide, and is higher at doses exceeding 3mg/day.
Latvian: - Glede na razpoložljive podatke je Odbor odločil, da je tveganje fibroze, vključno s srčno valvulopatijo, dobro ugotovljeno za kabergolin in pergolid ter da je večje pri odmerkih, večjih od 3 mg/dan.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Latvian: Dne 21. junija 2007 je Združeno kraljestvo skladno z 31. členom Direktive 2001/83/ES, kakor je bila spremenjena, zaprosilo CHMP, naj opravi pregled tveganja fibroze in srčne valvulopatije, povezanih z uporabo vseh iz rženega rožička pridobljenih agonistov dopamina, ter poda mnenje o tem, ali naj ostanejo dovoljenja za promet z vsemi zdravili te skupine še dalje veljavna, oziroma se spremenijo, začasno ukinejo ali umaknejo.
English: They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Latvian: Uporabljajo se tudi za zdravljenje stanj, med katerimi sta hiperprolaktinemija in prolaktinom, ter preprečevanje laktacije in migrene.
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline dihydroergocryptine, lisuride and pergolide,
Latvian: - CHMP je obravnaval napotitev, ki je bila sprožena v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bromokriptin, kabergolin, dihidroergokriptin, lizurid in pergolid.
English: The CHMP also recommended that marketing authorisation holders provide a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information.
Latvian: CHMP je prav tako priporočil, da imetniki dovoljenj za promet z zdravilom priskrbijo podroben protokol (npr. študije uporabe zdravila ali oceno na podlagi povezovanja zapiskov) za dolgotrajno sledenje upoštevanja in učinkovitosti dopolnjenih informacij o zdravilu.
English: Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Latvian: Iz rženega rožička pridobljeni agonisti dopamina se v glavnem uporabljajo za zdravljenje Parkinsonove bolezni bodisi kot samostojna zdravila ali v kombinaciji z drugimi zdravili.
English: - Inclusion of cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion) as “very common” undesirable effects.
Latvian: - Vključitev srčne valvulopatije (vključno z regurgitacijo) in sorodnimi motnjami (perikarditis in iztekanje perikardialne tekočine) med „zelo pogoste“ neželene učinke.
English: For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Latvian: Pri uporabi bromokriptina, dihidroergokriptina in lizurida pa povečanega tveganja, na osnovi dostopnih podatkov, ni mogoče izključiti.
English: For pergolide and cabergoline, the majority (about two thirds) of case reports of valvulopathy occurred with doses ≥ 3mg / day.
Latvian: V primeru pergolida in kabergolina se je večina (približno dve tretjini) poročil o posameznih primerih valvulopatije nanašala na primere uporabe odmerkov, ki so bili enaki ali večji od 3 mg/dan.
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Latvian: Odbor za zdravila za uporabo v humani medicini je na svojem zasedanju junija 2008 menil, da dokazi o tveganju fibroznih dogodkov, vključno z boleznimi zaklopke, kažejo, da tveganje ni enako pri vseh agonistih dopamina, pridobjenih iz rženega rožička.
English: As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Latvian: Zaradi tega so zdravila, ki vsebujejo kabergolin in pergolid, indicirana le kot zdravljenje druge izbire pri Parkinsonovi bolezni, njihova uporaba pa je kontraindicirana pri bolnikih z dokazanimi težavami s srčnimi zaklopkami.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
Latvian: PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline, and pergolide (in particular at doses > 3mg/day), compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Latvian: Rezultati študije Schade so pokazali višje prilagojeno razmerje stopnje pojavnosti (IRR) simptomatske regurgitacije valvul za kabergolin in pergolid (še posebej pri odmerkih, ki presegajo 3 mg/dan), v primerjavi z bromokriptinom, lizuridom ter agonistoma dopamina pramipeksol ter ropirinol, ki nista pridobljena iz rženega rožička in za katera ni bilo poročil o takih primerih.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Latvian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin
Latvian: Stopnja agonističnega delovanja na receptor 5-HT2B se razlikuje med posameznimi agonisti dopamina, ki so pridobljeni iz rženega rožička, in dobro ustreza razlikam v pojavnosti dogodkov fibroze v različnih skupinah zdravil, pridobljenih iz rženega rožička (C.Hofmann et al., Clin Neuropharmacol, 2006).
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for bromocriptine, dihydroergocryptine and lisuride.
Latvian: Zaradi razlik v stopnji tveganja med agonisti dopamina, pridobljenimi iz rženega rožička, je CHMP predlagal, da se za bromokriptin, dihidroergokriptin in lizurid izda ločeno mnenje.
English: - The CHMP recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets of the medicinal products containing cabergoline and pergolide (see Annex III).
Latvian: - CHMP je priporočil dopolnitve ustreznih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo zdravil, ki vsebujejo kabergolin in pergolid (glejte Prilogo III).
English: Data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Latvian: Podatki spontanih poročil kažejo, da so osebe, ki uporabljajo kabergolin in pergolid, bolj izpostavljene tveganju fibroznih dogodkov in valvulopatiji kot osebe, ki uporabljajo bromokriptin, lizurid ali dihidroergokriptin.
English: In view of the above, the CHMP recommended the maintenance of the marketing authorisation for cabergoline and pergolide containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Latvian: Zaradi tega je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo kabergolin in pergolid, s tem da se dopolnijo informacije o teh zdravilih (Povzetek glavnih značilnosti zdravila in navodilo za uporabo), kot je navedeno spodaj.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Latvian: Iz rženega rožička pridobljeni agonisti dopamina so povezani s povečanim tveganjem fibroznih motenj in obolenj srčnih zaklopk.
English: Cabergoline and pergolide belong to the class of ergot derived dopamine agonists, which also comprises bromocriptine, dihydroergocryptine and lisuride.
Latvian: Kabergolin in pergolid spadata v skupino iz rženega rožička (ergot) pridobljenih agonistov dopamina, ki vključuje tudi bromokriptin, dihidroergokriptin in lizurid.
English: Comparative trials with non-ergot and ergot derived dopamine agonist are scarce.
Latvian: Primerjalna preskušanja z agonisti dopamina, ki so pridobljeni iz rženega rožička, v primerjavi s tistimi, ki niso, so redka.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Latvian: CHMP je pregledal vse podatke o tveganju pojava fibroze in srčne valvulopatije iz kliničnih preskušanj, opazovalnih študij ter spontanih poročil, ki so jih dali na voljo imetniki dovoljenj za promet z zdravilom.
English: Cases of fibrotic reactions and valvulopathy have been reported with cabergoline and pergolide during clinical trials (open label study and randomised controlled studies).
Latvian: Med kliničnimi preskušanji (odprte študije in randomizirane nadzorovane študije) s kabergolinom in pergolidom so poročali o primerih fibroznih reakcij in valvulopatije.
English: 2nd line therapy in Parkinson's disease, and contraindicated for patients with evidence of valvulopathy.
Latvian: CHMP je upošteval tudi, da so ta zdravila že indicirana samo kot zdravila za zdravljenje druge izbire pri Parkinsonovi bolezni in so kontraindicirana pri bolnikih z dokazano valvulopatijo.
English: For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Latvian: Povečano tveganje fibroznih dogodkov je dobro potrjeno pri uporabi karbergolina in pergolida.
English: No cases were reported for bromocriptine, dihydroergocryptine and lisuride by MAHs.
Latvian: Pri bromokriptinu, dihidroergokriptinu in lizuridu imetniki dovoljenj za promet z zdravilom niso poročali o takih primerih.
English: DORA (Part 1)
Latvian: DORA (1. daļa)
English: f. VOYAGE-1 and VOYAGE-2 were Asian regional studies.
Latvian: f. VOYAGE-1 un VOYAGE-2 bija Āzijas reģionālie pētījumi.
English: This is not an exclusive list.
Latvian: Tas nav izsmeļošs saraksts.
English: Appropriate symptomatic treatment should be instituted immediately.
Latvian: Nekavējoties jāsāk atbilstoša simptomātiska ārstēšana.
English: Iron oxide red (E172)
Latvian: Sarkanais dzelzs oksīds (E172)
English: Not studied.
Latvian: Nav pētīta.
English: 8017 JV Zwolle NETHERLANDS
Latvian: 8017 JV Zwolle NĪDERLANDE
English: This is so that your doctor can decide if:
Latvian: Tas vajadzīgs tāpēc, lai ārsts varētu izlemt:
English: This allows the infection to be eliminated from the body.
Latvian: Tas ļauj likvidēt infekciju organismā.
English: Do not take a double dose (two doses too close together).
Latvian: Nelietojiet dubultu devu (divas devas ar pārāk neilgu starplaiku).
English: Do not take Maviret if any of the above apply to you.
Latvian: Nelietojiet Maviret, ja uz Jums var attiecināt jebko no iepriekš minētā.
English: The risk of failure was, as expected, highest for those exposed to both classes.
Latvian: Neveiksmes risks, kā jau sagaidāms, vislielākais bija tiem, kuri bija lietojuši abu grupu zāles.
English: Then take the next dose at your usual time.
Latvian: Pēc tam lietojiet nākamo devu ierastajā laikā.
English: Do not give this medicine to children under 12 years of age.
Latvian: Nedodiet šīs zāles bērniem vecumā līdz 12 gadiem.
English: The doctor may need to change your dose of these medicines.
Latvian: Ārstam var nākties mainīt Jums šo zāļu devu.
English: Patients should be instructed not to take a double dose.
Latvian: Pacienti jāinformē, ka nedrīkst lietot dubultu devu.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Latvian: Paņemiet līdzi zāļu iepakojumu, lai varētu parādīt ārstam, kādas zāles esat lietojis.
English: Very common: may affect more than 1 in 10 people
Latvian: Ļoti bieži: var rasties vairāk nekā 1 no 10 cilvēkiem
English: Not known: cannot be estimated from the available data • itching
Latvian: Nav zināmi: nevar noteikt pēc pieejamiem datiem • Nieze
English: If the combination is unavoidable, use can be considered if the benefit outweighs the risk with a close clinical monitoring.
Latvian: Ja no kombinācijas izvairīties nav iespējams, par lietošanu var lemt, ja ieguvums pārsniedz risku, īstenojot rūpīgu klīnisko novērošanu.
English: Tmax (h)a
Latvian: Uzsūkšanās Tmax (h)a
English: The effects of Maviret during pregnancy are not known.
Latvian: Maviret ietekme grūtniecības laikā nav zināma.
English: Your doctor will tell you how long you need to take Maviret for.
Latvian: Jūsu ārsts Jums izstāstīs, cik ilgi Jums būs jālieto Maviret.
English: Frequencies are defined as follows: 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) or not known (cannot be estimated from the available data).
Latvian: Biežums tiek definēts šādi: ļoti bieži (≥1/10), bieži (≥1/100 līdz <1/10), retāk (≥1/1000 līdz <1/100), reti (≥1/10 000 līdz <1/1000), ļoti reti (<1/10 000) vai nav zināmi (nevar noteikt pēc pieejamiem datiem).