FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov o rezultatih študije za zdravilo (zdravila), ki vsebuje(jo) zdravilno učinkovino domperidon, ter ob izraženi zaskrbljenosti zaradi končnega poročila študije PASS skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenega zdravila (zdravil) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance domperidone concerned by the noninterventional imposed PASS final report
Slovenian: Spremembe pogoja (pogojev) za promet z zdravili, ki vsebujejo zdravilno učinkovino domperidon, ki jih je treba vnesti in ki jih zadeva končno poročilo odrejene neintervencijske študije PASS
English: Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the scientific conclusions are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o končnem poročilu odrejene neintervencijske študije varnosti zdravila po pridobitvi dovoljenja za promet (PASS) za zdravilo (zdravila), ki vsebujejo zdravilno učinkovino domperidon, in ob izraženi zaskrbljenosti zaradi končnega poročila te študije so bili sprejeti naslednji znanstveni zaključki:
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint PASS (physician survey) final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0010), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Slovenian: Odbor PRAC je glede na razpoložljive podatke o končnem poročilu študije skupne zbirke podatkov o uporabi zdravila, skupaj s skupnim končnim poročilom študije varnosti zdravila po pridobitvi dovoljenja za promet (PASS) (raziskava zdravnikov), predloženim v ločenem postopku (EMEA/H/N/PSR/J/0010), menil, da so spremembe dovoljenja za promet z zdravilom upravičene.
English: Grounds for the variation to the terms of the Marketing Authorisation(s)
Slovenian: Podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Annex III Timetable for the implementation of this position
Slovenian: Priloga III
English: EU Number Tradename Strength
Slovenian: EU številka Izmišljeno ime
English: ContentPackage size Withdrawal period
Slovenian: Vsebina Velikost pakiranja
English: Live attenuated Aujeszky's Disease Virus, strain NIA3783: ≥ 105.2 CCID50*
Slovenian: 1 viala z 10 odmerki in 1 stekleničko za rekonstitucijo
English: EU Number Invented name
Slovenian: Številka EU Izmišljeno ime
English: Page 1 of 1
Slovenian: Stran 1 od 1
English: 1.2 Application Form - Annex A
Slovenian: 1.2 Obrazec za prijavo - Priloga A
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe
English: Zonisamide
Slovenian: Zonisamid
English: Confidential
Slovenian: Zaupno
English: - Tell your doctor:
Slovenian: - Povejte svojemu zdravniku:
English: Some patients have committed suicide.
Slovenian: Nekateri bolniki so storili samomor.
English: As of week 144:
Slovenian: Od 144. tedna naprej:
English: - if you are over 65.
Slovenian: če ste starejši od 65 let.
English: Keep the bottle tightly closed.
Slovenian: Steklenico shranjujte tesno zaprto.
English: A risk to the infants cannot be excluded.
Slovenian: Tveganja za otroke ni mogoče izključiti.
English: • disturbances of coordination and balance
Slovenian: • motnje koordinacije in ravnotežja;
English: ** based on historical comparison.
Slovenian: **glede na predhodno primerjavo.
English: The virus may then become harder to treat.
Slovenian: Virus bo potem morda težje zdraviti.
English: - any signs of inflammation or infection.
Slovenian: - kakršnekoli znake vnetja ali okužbe.
English: - if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Slovenian: - če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen s težavami srca.
English: PC: {number} SN: {number} NN: {number} [outer packaging only]
Slovenian: PC: {številka} SN: {številka} NN: {številka} [samo zunanja ovojnina]
English: M=Failure
Slovenian: M = neuspeh
English: *lower than recommended doses; similar findings are expected with recommended doses.
Slovenian: *manjši odmerki od priporočenih; tudi pri priporočenih odmerkih se pričakujejo podobni izsledki.
English: M=Excluded
Slovenian: M = izključeno
English: Date of first authorisation: 13 December 2007 Date of latest renewal: 17 September 2012
Slovenian: DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. december 2007 Datum zadnjega podaljšanja: 17. september 2012
English: • feeling worried or depressed
Slovenian: • zaskrbljenost ali depresija;
English: A summary of resistance mutation development is shown in Table 3.
Slovenian: Povzetek pojava mutacij za razvoj odpornosti je prikazan v tabeli 3.
English: • proteins in urine
Slovenian: • beljakovine v urinu;
English: It may harm them,
Slovenian: Njim bi lahko celo škodovalo,
English: Values for Test and Reference are mean (% coefficient of variation).
Slovenian: Vrednosti za test in referenco so srednje vrednosti (% koeficienta variabilnosti).
English: Interaction studies with these agents have only been performed in adults.
Slovenian: Študije interakcij s temi učinkovinami so opravili samo pri odraslih.
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Slovenian: Takoj povejte zdravniku, če ste noseči ali načrtujete nosečnost.
English: - if you have severe liver disease.
Slovenian: - če imate hudo jetrno bolezen.
English: Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Slovenian: Tabela 6: Povzetek farmakokinetičnih podatkov iz študije GS-US-177-0105
English: EU/1/07/430/001 EU/1/07/430/002
Slovenian: EU/1/07/430/002
English: • allergic reactions
Slovenian: • alergijske reakcije;
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Kakršnekoli vnetne simptome je treba oceniti in po potrebi uvesti zdravljenje.
English: Also, tell your doctor if you are taking maraviroc.
Slovenian: Zdravnika obvestite tudi, če jemljete maravirok.
English: Adverse reactions were generally consistent with those seen in previous studies of the individual components.
Slovenian: Neželeni učinki so bili načeloma konsistentni s tistimi iz predhodnih študij posameznih učinkovin.
English: If you are affected, do not drive and do not use any tools or machines.
Slovenian: Če se pri vas pojavijo ti neželeni učinki, ne upravljajte vozil in ne uporabljajte orodja ali strojev.
English: • changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Slovenian: • spremembe barve kože, vključno s potemnjeno kožo v zaplatah, ki pogosto začnejo nastajati na dlaneh in stopalih.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Slovenian: Plastični vsebnik s tabletami imejte pri sebi, da lahko hitro razložite, kaj ste vzeli.
English: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Slovenian: Zdravnika takoj obvestite o kakršnihkoli novih ali nenavadnih simptomih po prenehanju zdravljenja, zlasti o simptomih, ki jih povezujete z okužbo z virusom hepatitisa B.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Slovenian: Če imate okužbo z virusom hepatitisa B, bo vaš zdravnik skrbno pretehtal, kateri je najboljši režim zdravljenja za vas.
English: Based on the different elimination pathways, no interaction is expected.
Slovenian: Glede na različne poti izločanja interakcij ni pričakovati.
English: Tell your doctor if you are taking other medicines which may damage your kidneys.
Slovenian: Povejte zdravniku, če jemljete druga zdravila, ki lahko škodijo ledvicam.
English: • swelling of the face, lips, tongue or throat
Slovenian: • otekanje obraza, ustnic, jezika ali grla;
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta in vsebina vsebnika
English: - if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Slovenian: če imate ali ste imeli bolezen ledvic ali če so testi pokazali, da imate bolezni ledvic.
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika pri posebnih populacijah
English: Atripla must be taken every day.
Slovenian: Zdravilo Atripla morate jemati vsak dan.
English: These metabolites are essentially inactive against HIV-1.
Slovenian: Ti presnovki so večinoma neaktivni proti virusu HIV-1.
English: Tests may also show:
Slovenian: Preiskave lahko pokažejo tudi:
English: Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Slovenian: Bolnikom je treba povedati, da se bodo ti običajni simptomi, če se pojavijo, najverjetneje z nadaljevanjem zdravljenja izboljšali in ne napovedujejo poznejšega pojava katerihkoli manj pogostih psihiatričnih simptomov.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Slovenian: Takoj povejte zdravniku, če ste depresivni, imate samomorilne misli ali imate nenavadne misli (glejte poglavje 4, Možni neželeni učinki).
English: Do not wait until your next dose is due.
Slovenian: Ne čakajte do naslednjega odmerka.
English: If available, 90% confidence intervals are shown in parentheses.
Slovenian: 90odstotni intervali zaupanja so prikazani v oklepajih, če so na voljo.
English: This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 1,2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Slovenian: Odmerek bupropiona je treba povečati glede na klinični odziv, vendar se največji priporočeni odmerek bupropiona ne sme preseči.
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Slovenian: če ste kdaj imeli duševne bolezni, vključno z depresijo ali zlorabo alkohola in drugih substanc.
English: hypokalaemia2
Slovenian: hipokaliemija2
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1000 do <1/100) ali redki (≥1/10.000 do <1/1000).
English: even if their signs of illness are the same as yours.
Slovenian: čeprav imajo znake bolezni, podobne vašim.
English: Efavirenz does not bind to cannabinoid receptors.
Slovenian: Efavirenz se ne veže na kanabinoidne receptorje.
English: Interrupting treatment with Atripla should also be considered in case of progressive decline of renal function when no other cause has been identified.
Slovenian: O prekinitvi zdravljenja z zdravilom Atripla je treba razmisliti tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog.
English: It is believed that these symptoms are due to improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Slovenian: Ti simptomi so verjetno posledica izboljšanja imunskega odziva, ki telesu omogoča boj proti okužbam, ki so morda obstajale brez očitnih simptomov.
English: Tenofovir concentrations not measured, no effect is expected.
Slovenian: Koncentracij tenofovirja niso merili, učinkov ni pričakovati.
English: What Atripla is and what it is used for
Slovenian: Kaj je zdravilo Atripla in za kaj ga uporabljamo
English: Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Slovenian: Zdravnik bo skrbno pretehtal, ali vam bo predpisal zdravila, ki vsebujejo tenofovir in didanozin.
English: • allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
Slovenian: • alergijska reakcija (preobčutljivost), ki lahko povzroči hude kožne reakcije (Stevens-Johnsonov sindrom, multiformni eritem, glejte poglavje 2);
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Stopping Atripla can seriously affect your response to future treatment.
Slovenian: Prenehanje jemanja zdravila Atripla lahko resno vpliva na vaš odziv na prihodnje zdravljenje.
English: In particular, severe depression was more common in those with a history of depression.
Slovenian: Zlasti huda depresija je bila pogostejša pri bolnikih z depresijo v anamnezi.
English: Women of childbearing potential (see below and section 5.3)
Slovenian: Ženske v rodni dobi (glejte spodaj in poglavje 5.3)
English: Lopinavir concentrations: ↓ 30-40%
Slovenian: Koncentracije lopinavirja: ↓ 30-40 %
English: • No virus analysed contained the K65R or K70E mutation.
Slovenian: • Noben analiziran virus ni vseboval mutacije K65R ali K70E.
English: • increased fatty acids (triglycerides), bilirubin or sugar levels in the blood
Slovenian: • povišane ravni maščobnih kislin (trigliceridov), bilirubina ali sladkorja v krvi.
English: Efavirenz is highly bound (> 99%) to human plasma proteins, predominantly albumin.
Slovenian: Efavirenz se močno (> 99 %) veže na človeške plazemske beljakovine, predvsem na albumin.
English: 1 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Slovenian: 1 Anemija je bila pogosta in sprememba obarvanosti kože (povečana pigmentacija) je bila zelo pogosta, ko so emtricitabin prejemali pediatrični bolniki.
English: These tumours are unlikely to be of relevance to humans.
Slovenian: Ti tumorji verjetno niso pomembni za človeka.
English: This leaflet was last revised in .
Slovenian: Navodilo je bilo nazadnje revidirano dne.
English: One tablet taken each day by mouth.
Slovenian: Ena tableta na dan, ki jo zaužijete skozi usta.
English: Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Slovenian: Zdravilo Atripla vsebuje tri učinkovine, ki se uporabljajo za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV):
English: In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Slovenian: Pri takih bolnikih je treba pretehtati možnost prekinitve ali prenehanja zdravljenja (glejte poglavje 4.8).
English: - if you have a history of liver disease, including chronic active hepatitis.
Slovenian: če ste v preteklosti imeli bolezen jeter, vključno s kroničnim aktivnim hepatitisom.
English: The use of Atripla in children and adolescents has not been studied.
Slovenian: Uporabe zdravila Atripla pri otrocih in mladostnikih niso preučevali.
English: - if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Slovenian: - če vam je zdravnik povedal, da imate v krvi visok ali nizek nivo elektrolitov, kot sta kalij ali magnezij.
English: Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
Slovenian: V teh primerih je priporočeno izvesti potrjevalne preskuse, z bolj specifično metodo, kot je plinska kromatografija/masna spektrometrija.
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Slovenian: - hudo motnjo elektrolitskega ravnotežja, npr. hipokaliemijo ali hipomagneziemijo.
English: -3.3 (-8.3% to 2.7%) patients with HIV-1 RNA < 200 copies/ml
Slovenian: -3,3 % (-8,3 % do 2,7 %) bolniki s HIV-1 RNA < 200 kopij/ml
English: • liver failure, in some cases leading to death or liver transplant.
Slovenian: • jetrna odpoved, ki v nekaterih primerih povzroči smrt ali zahteva presaditev jeter.
English: Renal clearance has been estimated to be approximately 210 ml/min, which is in excess of the glomerular filtration rate.
Slovenian: Ocenili so, da znaša ledvični očistek približno 210 ml/min, kar presega stopnjo glomerularne filtracije.
English: Decreases in bone mineral density of the hip were significantly greater in this group until 96 weeks.
Slovenian: Zmanjšanje mineralne gostote kosti v kolku je bilo v tej skupini pomembno večje v prvih 96 tednih.
English: Table 1: Interactions between Atripla or its individual components and other medicinal products
Slovenian: Tabela 1: Interakcije med zdravilom Atripla ali posameznimi učinkovinami zdravila in drugimi zdravili
English: Patients coinfected with HIV and HBV
Slovenian: Bolniki, sočasno okuženi z virusoma HIV in HBV
English: The clinical effect of this dose adjustment has not been adequately evaluated.
Slovenian: Klinični učinek te prilagoditve odmerka še ni ustrezno ovrednoten.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Slovenian: Efavirenz ima relativno dolg končni razpolovni čas, vsaj 52 ur po enkratnem odmerku (glejte tudi podatke iz bioekvivalenčne študije, opisane zgoraj) in 40 do 55 ur po večkratnih odmerkih.
English: Atripla tablets should be swallowed whole with water, once daily.
Slovenian: Tableta Atripla se pogoltne cela, z vodo, enkrat na dan.
English: Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
Slovenian: Jemanje teh zdravil skupaj z zdravilom Atripla lahko povzroči resne ali smrtno nevarne neželene učinke ali pa prepreči pravilno delovanje teh zdravil.
English: This medicine is not a cure for HIV infection.
Slovenian: To zdravilo ne pozdravi okužbe z virusom HIV.
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Slovenian: Kljub zmanjšanju izpostavljenosti buprenorfinu nobeden od bolnikov ni kazal odtegnitvenih simptomov.
English: • increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Slovenian: • povišano raven kreatin-kinaze v krvi, ki lahko povzroči bolečino v mišicah in šibkost.
English: However, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on exposure to efavirenz is likely to be minimal.
Slovenian: Vendar pa se manj kot 1 % odmerka efavirenza izloči nespremenjenega v urinu, zato je verjetno vpliv ledvične okvare na izpostavljenost efavirenzu minimalen.
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Slovenian: Vendar v 144 tednih ni bilo povečanega tveganja za zlome ali dokazov za klinično pomembne kostne anomalije.
English: Atripla may make hormonal contraceptives less likely to work.
Slovenian: Zaradi zdravila Atripla so lahko hormonski kontraceptivi manj učinkoviti.
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Slovenian: Ugotovili so pozitivno povezavo med koncentracijo efavirenza in podaljšanjem interval QTc.
English: There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour, and catatonia.
Slovenian: V postmarketinškem obdobju so poročali tudi o hudi depresiji, smrti zaradi samomora, blodnjah, vedenju, podobnem psihozam in katatoniji.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Atripla treatment without talking to your doctor first.
Slovenian: Če ste hkrati okuženi z virusom HIV in virusom hepatitisa B, je zlasti pomembno, da ne prenehate jemati zdravila Atripla, ne da bi se prej posvetovali z zdravnikom.
English: If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
Slovenian: Če ste starejši od 65 let in vam zdravnik predpiše zdravilo Atripla, vas bo med zdravljenjem pozorno spremljal.
English: Parameters Test Reference
Slovenian: test referenca
English: • anaemia (low red blood cell count)
Slovenian: • anemija (majhno število rdečih krvničk);
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Slovenian: 101, 108, 138, 188, 190 ali 225, vendar redkeje in pogosto le v kombinaciji s K103N.
English: Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms.
Slovenian: Nekateri bolniki, ki so pomotoma vzeli 600 mg efavirenza dvakrat na dan, so poročali o večjem pojavljanju simptomov živčevja.
English: If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose.
Slovenian: Če je že skoraj čas (manj kot 12 ur) za naslednji odmerek, izpuščenega odmerka ne vzemite.
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, co-administration of Atripla and another NNRTI is not recommended.
Slovenian: Ker uporaba dveh zdravil iz skupine NNRTI ni pokazala koristi pri učinkovitosti in varnosti, sočasne uporabe zdravila Atripla in drugega zdravila iz skupine NNRTI ne priporočamo.
English: Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Slovenian: Profili navzkrižne odpornosti na efavirenz, nevirapin in delavirdin in vitro so pokazali, da substitucija K103N povzroči izgubo občutljivosti za vse tri NNRTI-je.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving and operating machinery.
Slovenian: Bolnike je treba poučiti, naj se v primeru teh simptomov izogibajo potencialno nevarnim opravilom, kakršna sta vožnja ali upravljanje s stroji.
English: Rare photoallergic dermatitis angioedema
Slovenian: Redki fotoalergijski dermatitis angioedem
English: In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
Slovenian: Pričakuje se lahko, da bo pri bolnikih z virološko supresijo klinični pomen tega zmanjšanja omejen (glejte poglavje 5.1).
English: The mechanism of tumour formation and the potential relevance for humans are not known.
Slovenian: Mehanizem nastanka tumorjev in morebitni pomen za človeka nista znana.