natgillin/translations-raw huggingface dataset:
The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.
Odbor CVMP je priporočil, da so za ustrezno spreminjanje informacij o zdravilu potrebne spremembe pogojev dovoljenj za promet z zgoraj navedenimi zdravili za uporabo v veterinarski medicini.
Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Imetniki dovoljenja za promet z zdravili so predložili lastniške podatke o izločanju ostankov ter znanstvena sklicevanja nanje.
Why were Zanil and associated names, and generic products thereof reviewed?
Zakaj so bili zdravilo Zanil in povezana imena ter njegova generična zdravila pregledani?
France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days.
Npr. karenca za govedino in organe je od 10 dni do 28 dni, za kravje mleko od nič ur do 108 ur, za ovčje meso in organe od 14 dni do 28 dni, za ovčje mleko od „ne uporabljajte pri ovcah, ki proizvajajo mleko za prehrano ljudi“ do 7 dni, za kozje meso in organe 14 dni, za kozje mleko nič dni.
The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats.
Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenco za meso, mleko in organe, pridobljene iz zdravljenega goveda, ovac in koz.
Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP zaključil, da je splošno razmerje med tveganji in koristmi za zdravilo Zanil in povezana imena ter njegova generična zdravila pozitivno, in je soglašal, da je treba zaradi zagotavljanja varnosti potrošnikov spremeniti karence (mesa, mleka in organov) za govedo, ovce in koze.
What are Zanil and associated names, and generic products thereof?
Kaj so zdravilo Zanil in povezana imena ter njegova generična zdravila?
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety.
Odbor za zdravila za uporabo v veterinarskih medicini (CVMP) pri agenciji je sklenil, da je splošno razmerje med tveganji in koristmi za zadevne proizvode pozitivno, in zaradi zagotavljanja varnosti potrošnikov priporočil spremembe karenc za govedo, ovce in koze.
Questions and answers on Zanil and associated names, and generic products thereof
Vprašanja in odgovori v zvezi z zdravilom Zanil in povezanimi imeni ter njegovimi generičnimi zdravili
The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml.
Zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila so peroralne suspenzije, ki vsebujejo 34 mg oksiklozanida na ml. Oksiklozanid je salicilanilidni antihelmintik, ki se uporablja za zdravljenje fascioloze pri govedu, ovcah in kozah ter za odstranjevanje odrivkov gravidnih trakulj (Moniezia spp).
EMA/586006/2017
september 2017
Questions and answers on Zanil and associated names, and generic products thereof EMA/586006/2017
Vprašanja in odgovori v zvezi z zdravilom Zanil in povezanimi imeni ter njegovimi generičnimi zdravili stran 2/2
The EU Member States shall ensure that:
Države članice Evropske unije bodo zagotovile:
Continue to monitor aminotransferases at least every 2 weeks.
Nadaljujte s spremljanjem vrednosti aminotransferaz najmanj vsaka 2 tedna.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI ZADEVAJO DRŽAVE ČLANICE
o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
o Kontraindikacija pri bolnikih z zvišano vrednostjo direktnega bilirubina > 2 × ZMN pred začetkom zdravljenja.
Details of such a surveillance programme should be agreed with the National Competent Authorities in each member state and put in place prior to marketing of the product.
S podrobnostmi takšnega nadzora se morajo strinjati pristojni nacionalni organi posamezne države članice, nadzor pa je potrebno vzpostaviti pred trženjem zdravila.
> 5 and ≤ 8 × ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
> 5 in ≤ 8 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, končajte zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se vrednosti ne normalizirajo.
> 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
> 8 × ZMN: zdravljenje je treba končati in ponovna uvedba zdravila Thelin ne pride v poštev.
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in mora program izvajati na nacionalni ravni, da zagotovi, da pred predpisovanjem zdravila, vsi zdravniki, ki nameravajo predpisovati zdravilo Thelin, dobijo dokumentacijo za zdravnike, ki vsebuje naslednje podatke:
• The need to tell their doctor that they are taking Thelin
• da morajo bolniki svojim zdravnikom povedati, da jemljejo zdravilo Thelin.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
• da je baza podatkov o varnosti zdravila Thelin omejena, zato so zdravniki vabljeni, da bolnike vključijo v program nadzorovanja in s tem poglobijo znanje o incidenci pomembnih neželenih učinkov zdravila (ADRs).
The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin.
Imetnik dovoljenja za promet bo vzpostavil program nadzorovanja, da zbere informacije o: demografiji bolnikov, ki jim je bilo predpisano zdravilo Thelin, neželenih učinkih in razlogih za ukinitev zdravljenja z zdravilom Thelin.
The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three monthly intervals.
V programu nadzorovanja morajo zdravniki resne neželene učinke in določene izbrane neželene učinke, ki so našteti spodaj, prijaviti takoj, ostale neželene učinke pa vsake tri mesece.
If the aminotransferase levels return to pre-treatment values consider resuming the initial treatment schedule.
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, razmislite o nadaljevanju začetne sheme zdravljenja.
The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Zbrani podatki morajo vsebovati: o anonimizirane podatke o bolniku - starost, spol in etiologijo PAH, o sočasna zdravljenja, o razloge za ukinitev, o neželene učinke, ○ vsi resni neželeni učinki, ○ povišani jetrni encimi na > 3 x ZMN, ○ povišani direktni bilirubin > 2 x ZMN, ○ anemija, ○ krvavitev, ○ nosečnost in izid, ○ pljučni edem (povezan z vensko-okluzivno boleznijo), ○ možna medsebojna delovanja, ○ neželeni učinki, ki niso navedeni v povzetku glavnih značilnosti zdravila
• That Thelin is teratogenic
• da je zdravilo Thelin teratogeno;
The Patient information card should include the following information
Podatki o zdravilu za bolnika morajo vsebovati naslednje informacije:
• The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued
• da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo in da morajo bolnice svoje zdravnike obvestiti o možnosti zanositve preden jim zdravnik izda nov recept;
• That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
• da medsebojno delovanje s ciklosporinom A lahko povzroči višje koncentracije zdravila Thelin v krvi in posledično večje tveganje neželenih učinkov.
The physician information about Thelin should contain the following key elements:
Podatki o zdravilu Thelin za zdravnika morajo vsebovati naslednje ključne podatke:
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered.
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, pride v poštev ponovna uvedba zdravila Thelin.
• That Thelin is hepatotoxic and they will need to attend for regular blood tests
• da je zdravilo Thelin hepatotoksično in da morajo bolniki redno prihajati na krvne preiskave;
• That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals
• da zdravljenje z zdravilom Thelin pogosto povzroči znižanje hemoglobina in sorodnih parametrov rdečih krvnih celic oPred začetkom jemanja je potrebno narediti krvno sliko in bolnika spremljati v klinično primernih intervalih.
• The need to tell their doctor about any adverse events
• da morajo bolniki obvestiti svojega zdravnika o neželenih učinkih;
• Physician information about Thelin
• podatke o zdravilu Thelin za zdravnika;
• The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant.
• da morajo bolnice svojega zdravnika nemudoma obvestiti o morebitni nosečnosti;
• Partner of patient information card
• podatke o zdravilu za bolnikovega partnerja.
• Product information
• podatke o zdravilu;
o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 × ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
> 3 in ≤ 5 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
• Patient information card
• podatke o zdravilu za bolnika;
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class AC).
• da je zdravilo Thelin hepatotoksično o Potrebno je preverjati delovanje jeter pred in med zdravljenjem.
Partner of patient information card should include the following information: • That Thelin is teratogenic and that women of child bearing age must use effective contraception
• da je zdravilo Thelin teratogeno in da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo.
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium oNeed for regular monitoring of INR oBe aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
o Pred začetkom zdravljenja s sitaksentanatom je potrebno zmanjšati uveljavljeni odmerek antagonistov vitamina K. o Če se bolnik že zdravi s natrijevim sitaksentanatom, je potrebno začeti zdravljenje z antagonisti vitamina K z zmanjšanim odmerkom.
• That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
o Bolnice morajo biti poučene o teratogenosti ter se z zdravnikom posvetovati o kontracepciji, testu za ugotavljanje nosečnosti in kaj storiti, če zanosijo.
Tablet container (HDPE) 60 tablets
plastenka (HDPE)
Blister (OPA/Alu/PVC) 60 tablets
Številka EU Ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja pretisni omot (OPA/Alu/PVC)
This is especially important for infants and young children.
To je posebej pomembno pri dojenčkih in mladih otrocih.
This list is not intended to be inclusive or comprehensive.
Ta seznam ni vsevključujoč ali izčrpen.
Take the next dose as usual.
Naslednji odmerek vzemite kot običajno.
They will tell you how to use the syringe correctly.
Povedali vam bodo, kako pravilno uporabljati brizgo.
In some patients additional factor VIII was given.
Nekateri bolniki so dobili dodaten faktor VIII.
In this picture we have pulled out the plunger so that you can see each part clearly.
Na tej skici smo izvlekli bat, da lahko jasno vidite vsak del posebej.
Component of a multipack, can't be sold separately.
Sestavni del multipakiranja, se ne prodaja ločeno.
Date of first authorisation: 20 March 2001 Date of latest renewal: 20 March 2011
Datum pridobitve dovoljenja za promet: 20. marec 2001 Datum podaljšanja dovoljenja za promet: 20. marec 2011
How do I measure the correct dose?
Kako naj odmerim pravi odmerek
Do not transfer it to any other container.
Ne prelivajte je v noben drug vsebnik.
Given twice daily with food
Dvakrat na dan s hrano
Precautions to prevent transmission should be taken in accordance with national guidelines.
Potrebni so previdnostni ukrepi za prenos v skladu z nacionalnimi smernicami.
Lopinavir can be used during pregnancy if clinically needed.
Lopinavir se lahko uporablja med nosečnostjo, če je to klinično potrebno.
Individual SmPCs should be consulted.
Upoštevati je potrebno posamezen SmPC.
Discuss with your doctor the precautions needed to avoid infecting other people.
Posvetujte se s svojim zdravnikom o ukrepih, ki so potrebni, da se izognete okužbi drugih ljudi.
A causal relationship had been evoked, although the mechanism of action had not been elucidated.
Pokazalo se je vzročno razmerje, a mehanizem delovanja ni razjasnjen.
This leaflet was last revised in: {MM/YYYY}
Navodilo je bilo nazadnje revidirano: {MM/LLLL}
These changes may be seen on an ECG (electrocardiogram).
Te spremembe je mogoče videti na EKG-ju (elektrokardiogramu).
Adults and adolescents
Odrasli in mladostniki
Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a doctor.
Zaradi možnosti neodkrite intolerance za fruktozo se sme to zdravilo dajati dojenčkom in otrokom samo po posvetu z zdravnikom.
See further the detailed description of the clinical studies.
Glejte podroben opis kliničnih študij.
Other medicines may also contain alcohol and alcohol may be consumed in food and drinks.
Druga zdravila lahko prav tako vsebujejo alkohol, možno pa ga je zaužiti tudi s hrano in pijačo.
On rare occasions these muscle disorders have been serious.
redkih primerih so bile te mišične motnje resne.
Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Zaključki o pomembnosti določenih mutacij ali mutacijskih vzorcev se lahko spreminjajo z dodatnimi podatki, zato je priporočljivo, da se vedno upošteva trenutne sisteme interpretacije za analiziranje rezultatov preizkusa odpornosti.
Your doctor can explain these symptoms to you.
Te simptome vam lahko razloži zdravnik.
The mean (SD) for the studies are reported in the table below.
Povprečja (SD) za študije so opisana v preglednici spodaj.
If the condition persists or worsens, seek medical attention.
Če stanje traja ali se poslabša, poiščite zdravniško pomoč.
The amount of alcohol in this medicine may affect your ability to drive or use machines and may affect your judgement and reaction times.
Količina alkohola v tem zdravilu lahko vpliva na vašo sposobnost vožnje, upravljanja strojev ter vašo presojo in odzivne čase.
• increased appetite;
- povečan apetit;
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
V več kot polovici primerov so zdravljenje z zaviralci proteaz nadaljevali ali znova uvedli, če je bilo zdravljenje prekinjeno.
Around 85% of patients had a viral load of < 100,000 copies/ml.
Približno 85 % bolnikov je imelo virusno breme < 100.000 kopij/ml.
* Body surface area can be calculated with the following equation:
* Telesno površino lahko izračunate po naslednji enačbi:
Animal studies have shown no effects on fertility.
Študije na živalih niso pokazale vpliva na plodnost.
• If you cannot contact your doctor, go to the hospital.
- Če ne morete kontaktirati svojega zdravnika, pojdite v bolnišnico.
• Continue to take this medicine until your doctor tells you otherwise.
- To zdravilo jemljite, dokler vam zdravnik ne naroči drugače.
This is similar to an adult drinking 4-22 ml of beer or 1-4 ml of wine.
To je podobno, kot če bi odrasli spil 4-22 ml piva ali 1-4 ml vina.
• loss or changed sense of taste;
- odsotnost ali spremenjen občutek za okus;
1 See section 4.4: pancreatitis and lipids c. Description of selected adverse reactions
1glejte poglavje 4.4: pankreatitis in lipidi c. Opis izbranih neželenih učinkov
Effects on the electrocardiogram
Učinki na elektrokardiogram
2 years
2 leti.
After multiple dosing, less than 3% of the lopinavir dose is excreted unchanged in the urine.
Po večkratnem odmerjanju se manj kot 3 % odmerka lopinavirja izloči nespremenjenega v urinu.
• a sound in one ear or both ears, such as buzzing, ringing or whistling;
- zvoki v enem ali v obeh ušesih, kot so brenčanje, zvonenje ali žvižganje;
* n = 18 for Cmax
* n = 18 za Cmax
Patients should be closely monitored for signs related to venetoclax toxicities.
Bolnike je potrebno pozorno spremljati glede znakov povezanih s toksičnostjo venetoklaksa.
Your doctor will discuss with you and determine which medicines are best for you.
Vaš zdravnik se bo pogovoril z vami in bo presodil, katera zdravila so za vas najprimernejša.
• You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
- Še vedno lahko prenašate HIV medtem, ko jemljete to zdravilo, čeprav je tveganje zmanjšano z učinkovitim protivirusnim zdravljenjem.
Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Poleg tega je lahko v primeru opustitve glukokortikoidov potrebno postopno zmanjševanje odmerka v daljšem obdobju.
For erectile dysfunction:
Za erektilno disfunkcijo:
Effects of food on oral absorption
Učinek hrane na peroralno absorpcijo
Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Kot pomoč za odstranitev neabsorbirane zdravilne učinkovine se lahko uporabi tudi aktivno oglje.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Če erekcija traja več kot 4 ure, takoj potrebujete zdravniško pomoč, da bi preprečili trajno okvaro spolnega uda.
The frequency category includes all reported events of moderate to severe intensity, regardless of the individual causality assessment.
Kategorija pogostnosti vključuje vse zmerne do hude neželene učinke, o katerih so poročali, ne glede na individualno oceno vzroka.
Check with your pharmacist that you have the correct size of syringe.
S farmacevtom preverite, da imate pravo velikost brizge.
• low number of red blood cells, low number of white blood cells which are usually used to fight infection;
- nizko število rdečih krvničk, nizko število belih krvničk, ki so potrebne za boj proti okužbi;
Voriconazole: Concentrations may be decreased.
Vorikonazol: koncentracije se lahko znižajo.
Lopinavir/ritonavir has been evaluated in over 3000 women during pregnancy, including over 1000 during the first trimester.
Lopinavir/ritonavir sta bila ocenjena pri preko 3000 ženskah med nosečnostjo, vključno s preko 1000 ženskami v prvem trimesečju nosečnosti.
Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Znana in teoretična medsebojna delovanja z izbranimi protiretrovirusnimi in neprotiretrovirusnimi zdravili so navedena v spodnji preglednici.
Important information
Pomembni podatki
Currently available data are described in section 5.2 but no recommendation on the posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočila o odmerjanju ni mogoče podati.
Wash the plunger and the syringe with washing up liquid and warm water as soon as you can; you may soak both in soapy water for up to 15 minutes.
Bat in brizgo čim prej operite s tekočino za pomivanje posode in toplo vodo; oba lahko tudi do 15 minut namakate v milnati vodi.
The median follow-up was 48 weeks in Cohort I and 72 weeks in Cohort II.
Mediana spremljanja bolnikov je bila 48 tednov v kohorti I in 72 tednov v kohorti II.
Body Surface Area (m2)
Telesna površina (m2)
DM-6705 (delamanid active metabolite):
DM-6705 (aktivni presnovek delamanida):
Studies in rats revealed that lopinavir is excreted in the milk.
Študije pri podganah so pokazale, da se lopinavir izloča v mleku.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas ali vašega otroka pomembne podatke!
It is therefore important that you remain under the supervision of your doctor while taking Kaletra.
Zato je pomembno, da med jemanjem zdravila Kaletra ostanete pod nadzorstvom svojega zdravnika.
Virologic Response of Study Subjects at Week 48 and Week 96 Week 48
Virološki odziv preiskovancev v študiji po 48 in 96 tednih 48. teden
Based on the data mentioned, the malformative risk is unlikely in humans.
Na osnovi omenjenih podatkov je tveganje za pojav anomalij pri ljudeh malo verjetno.
These medicinal products include:
Med takšna zdravila spadajo:
Medicinal products that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse events are listed in section 4.3.
Zdravila, ki so kontraindicirana prav zaradi pričakovane izrazitosti interakcije in potenciala za resne neželene učinke, so navedena v poglavju 4.3.
The mechanism of this interaction may result from inhibition of transport proteins.
Mehanizem tega medsebojnega delovanja je morda posledica zavrtja transportnih beljakovin.