natgillin/translations-raw huggingface dataset:
Viracept has been studied in combination with other antiviral medicines in two main studies involving 605 patients aged 13 years or more, who were infected with HIV.
Zdravilo Viracept v kombinaciji z drugimi protivirusnimi zdravili so raziskali v dveh glavnih študijah, ki sta vključevali 605 bolnikov, starih 13 let in več, ki so bili okuženi z virusom HIV.
What is the risk associated with Viracept?
Kakšna tveganja so povezana z zdravilom Viracept?
Doctors should only prescribe Viracept to patients who have already taken medicines in the same class as Viracept (protease inhibitors) once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Zdravniki lahko zdravilo Viracept predpišejo le bolnikom, ki so že jemali zdravila iz istega razreda kot zdravilo Viracept (zaviralci proteaz), ko se seznanijo s protivirusnimi zdravili, ki jih je posameznik prejemal v preteklosti, in ocenijo verjetnost, da se bo virus odzval na zdravilo.
In the second study, Viracept, in combination with zidovudine and lamivudine (other antiviral medicines) was compared with the combination of zidovudine and lamivudine in 297 treatment-naïve patients (who had not taken any antiviral medicines to treat HIV infection before).
V drugi študiji so zdravilo Viracept v kombinaciji z zidovudinom in lamivudinom (drugima protivirusnima zdraviloma) primerjali s kombinacijo zidovudina in lamivudina pri 297 bolnikih, ki se pred tem še niso zdravili zaradi okužbe s HIV.
In the first study, Viracept in combination with stavudine (another antiviral medicine) was compared with stavudine alone in 308 patients who had not taken stavudine or a protease inhibitor in the past.
V prvi študiji so zdravilo Viracept v kombinaciji s stavudinom (drugim protivirusnim zdravilom) primerjali s stavudinom kot samostojnim zdravilom pri 308 bolnikih, ki v preteklosti še niso jemali stavudina ali zaviralcev proteaz.
Viracept brought about similar reductions in viral load whether it was taken twice or three times a day.
Zdravilo Viracept je povzročilo podobna znižanja virusne obremenitve pri dvakratnem ali trikratnem jemanju na dan.
Three studies have compared the effectiveness of dosing Viracept twice and three times a day, in combination with stavudine and lamivudine in 635 patients.
V treh študijah so pri 635 bolnikih primerjali učinkovitost odmerjanja zdravila Viracept v kombinaciji s stavudinom in lamivudinom dvakrat oziroma trikrat na dan.
Viracept is a medicine containing the active substance nelfinavir.
Viracept je zdravilo, ki vsebuje zdravilno učinkovino nelfinavir.
Doctors should consider using alternatives to medicines that speed up the breakdown of Viracept, such as phenobarbital and carbamazepine (used to treat epilepsy), in patients taking Viracept.
Pri bolnikih, ki jemljejo Viracept, morajo zdravniki razmisliti o uporabi alternativnih zdravil namesto zdravil, ki pospešujejo razgradnjo zdravila Viracept, kot sta fenobarbital ali karbamazepin (ki se uporabljata za zdravljenje epilepsije).
For the full list of all side effects seen with Viracept, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Viracept, glejte navodilo za uporabo.
Caution is needed when Viracept is taken at the same time as other medicines.
Pri sočasnem jemanju zdravila Viracept z drugimi zdravili je potrebna previdnost.
Why has Viracept been approved?
Zakaj je bilo zdravilo Viracept odobreno?
The active substance in Viracept, nelfinavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Viracept je nelfinavir, ki spada med zaviralce proteaz.
The CHMP decided that Viracept's benefits are greater than its risks in antiviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viracept pri kombiniranem protiretrovirusnem zdravljenju odraslih, mladostnikov in otrok, starih 3 leta ali več, okuženih z virusom HIV-1, večje od z njim povezanih tveganj.
• St John's wort (a herbal preparation used to treat depression);
• šentjanževko (rastlinski pripravek za zdravljenje depresije);
How has Viracept been studied?
Kako je bilo zdravilo Viracept raziskano?
What is Viracept used for?
Za kaj se zdravilo Viracept uporablja?
How is Viracept used?
Kako se zdravilo Viracept uporablja?
Viracept should be used with caution in patients who have problems with their liver or kidneys.
Bolniki s težavami z jetri ali ledvicami morajo zdravilo Viracept uporabljati previdno.
What is Viracept?
Kaj je zdravilo Viracept?
How does Viracept work?
Kako zdravilo Viracept deluje?
Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Germany
Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Nemčija
(Invented) Name Strength Pharmaceutica l form
(Izmišljeno) ime Jakost
Diotop 75 mg / 20 mg modified release hard capsules
Diotop 75 mg/20 m g, trde kapsule s prirejenim sproščanjem
Protect from light.
Zaščite pred svetlobo.
The events were most frequently reported during the first months on treatment.
O teh učinkih so najpogosteje poročali v prvih mesecih zdravljenja.
You may then hear or feel a click.
Ob tem lahko zaslišite ali začutite klik.
Appetite, energy intake and food choice
Apetit, energijski vnos in izbira hrane
The mean duration of diabetes was 13.9 years.
Povprečno trajanje sladkorne bolezni je bilo 13,9 leta.
Using the wrong medicine could cause severe harm to your health.
Uporaba napačnega zdravila lahko zelo škoduje vašemu zdravju.
If you forgot to inject a dose and:
Če ste pozabili injicirati odmerek in:
Atorvastatin Cmax was decreased by 38%.
Cmax atorvastatina se je zmanjšala za 38 %.
• You should use this medicine once a week on the same day each week if possible.
• To zdravilo morate uporabljati enkrat na teden, vedno na isti dan v tednu, če je le mogoče.
This is especially important if you have kidney problems.
To je še posebej pomembno, če imate težave z ledvicami.
The treatment difference appeared early and persisted throughout the trial.
Razlika v zdravljenju se je pojavila zgodaj in se je ohranila skozi celotno preskušanje.
Talk to your doctor for further information.
Za dodatne informacije se posvetujte z zdravnikom.
Patients with event (%)
Bolniki z dogodkom (%)
This was assessed not to be clinically relevant.
Ocenili so, da to ni klinično pomembno.
The relevance for humans is considered to be low, but cannot be completely excluded.
Pomen tega za človeka je domnevno majhen, a ga ni mogoče povsem izključiti.
Number of subjects at risk
Število izpostavljenih tveganju
These patients should be monitored closely and treated according to clinical guidelines.
Te bolnike je treba skrbno nadzirati in jih zdraviti v skladu s kliničnimi smernicami.
It is important that you drink plenty of fluids to prevent dehydration.
Pomembno je, da pijete veliko tekočine in tako preprečite dehidracijo.
• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na semaglutid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 February 2018
Datum prve odobritve: 08. februar 2018
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Zdravnik vam bo povedal, kako zdraviti prenizek krvni sladkor in kaj storiti, če opazite te opozorilne znake.
This medicine is not an insulin and should not be used if:
To zdravilo ni insulin in ga ne smete uporabljati:
Primary endpoint - MACE Components of MACE
Primarni opazovani dogodek - MACE Elementi MACE
Needles and other waste material should be disposed of in accordance with local requirements.
Igle in preostali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
Check the flow
Preverite pretok
• You can give yourself the injection at any time of the day - regardless of meals.
• Zdravilo si lahko injicirate ob kateri koli uri, ne glede na obroke.
Detailed instructions for use are on the other side of this leaflet.
Podrobni napotki so opisani na drugi strani tega navodila za uporabo.
This medicine is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established.
Uporaba tega zdravila ni priporočljiva za otroke in mladostnike, mlajše od 18 let, ker njegova varnost in učinkovitost v tej starostni skupini še nista bili dokazani.
This is normal, but you must still check the flow, if you use a new pen for the first time.
To je normalno, vendar morate kljub temu preveriti pretok, ko nov injekcijski peresnik uporabite prvič.
The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established.
Varnost in učinkovitost semaglutida pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
If you wish to become pregnant, you should stop using this medicine at least two months in advance.
Če želite zanositi, morate to zdravilo prenehati uporabljati vsaj dva meseca prej.
Then inject your next dose as usual on your scheduled day.
Nato injicirajte naslednji odmerek kot po navadi na vaš redni dan po urniku.
• change in the way food or drink tastes
• spremenjen okus hrane ali pijač
Therefore, it is recommended to use contraception while using this medicine.
Zato je priporočljivo, da med uporabo tega zdravila uporabljate kontracepcijo.
Postnatal growth and development were evaluated in cynomolgus monkeys.
Postnatalno rast in razvoj so ocenili pri opicah cynomolgus.
once weekly
enkrat na teden
In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
V primeru prevelikega odmerjanja je treba začeti ustrezno podporno zdravljenje v skladu z bolnikovimi kliničnimi znaki in simptomi.
• severe allergic reactions (anaphylactic reactions).
• hude alergijske reakcije (anafilaktične reakcije).
- In this case, you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
- V tem primeru niste prejeli nič zdravila, tudi če se je števec odmerka premaknil od začetnega odmerka, ki ste ga nastavili.
The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours).
Dan tedenskega odmerjanja je po potrebi mogoče spremeniti; pogoj za to je, da je presledek med dvema odmerkoma vsaj 3 dni (> 72 ur).
Whether these effects are related to the decreased maternal food consumption as a direct GLP-1 effect is unknown.
Ali so bili ti učinki povezani z zmanjšanim uživanjem hrane pri samicah, kar je neposreden učinek GLP-1, ni znano.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zeliščnimi zdravili ali drugimi zdravili, ki ste jih kupili brez recepta.
In total 98% of the patients completed the trial and the vital status was known at the end of the trial for 99.6% of the patients.
Skupaj je preskušanje dokončalo 98 % bolnikov in za 99,6 % bolnikov je bilo ob koncu preskušanja znano vitalno stanje.
• Turn the dose selector until the dose counter shows the flow check symbol (
• Vrtite izbirnik odmerka, dokler se na števcu odmerka ne pokaže simbol za preverjanje pretoka (
Higher body weight results in lower exposure; a 20% difference in body weight between individuals will result in an approximate 16% difference in exposure.
Višja telesna masa zmanjša izpostavljenost; 20-odstotna razlika v telesni masi med posamezniki povzroči približno 16-odstotno razliko v izpostavljenosti.
You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.
Nemudoma poiščite zdravniško pomoč in takoj obvestite zdravnika, če imate simptome, kot so težave z dihanjem, otekanje obraza in grla ter hiter srčni utrip.
Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Iglo zamenjajte, kot je opisano v točki 5, "Po injiciranju", in ponovite vse korake, začenši s točko 1, "Pripravite injekcijski peresnik z novo iglo".
Avoid driving or using machines if you get any signs of low blood sugar.
Ne vozite in ne upravljajte strojev, če imate kateri koli znak prenizkega krvnega sladkorja.
See step 2 ‘Check the flow'.
Glejte točko 2, "Preverite pretok".
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Za rezultate študij v zvezi s kombinacijami, učinki na urejenost glikemije in srčno-žilne dogodke ter skupinami bolnikov, ki so jih preučili, glejte poglavja 4.4, 4.5 in 5.1.
• you have type 1 diabetes - a condition where your body does not produce any insulin
• če imate sladkorno bolezen tipa 1; bolezen, pri kateri vaše telo ne proizvaja insulina,
Weekly doses higher than 1 mg are not recommended.
Tedenski odmerki, večji od 1 mg, niso priporočljivi.
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
Še zlasti morate zdravnika, farmacevta ali medicinsko sestro obvestiti, če uporabljate zdravila, ki vsebujejo kaj od naslednjega:
In 8 phase 3a trials 4,792 patients were exposed to semaglutide.
V 8 preskušanjih faze 3a je bilo semaglutidu izpostavljenih 4.792 bolnikov.
Semaglutide is not a substitute for insulin.
Semaglutid ni nadomestilo za insulin.
There were 158 events of new or worsening nephropathy.
Opaženih je bilo 158 dogodkov novonastale nefropatije in poslabšanja nefropatije.
Rough handling or misuse may cause inaccurate dosing.
Grobo ravnanje ali nepravilna uporaba lahko povzročita netočno odmerjanje.
Maximum concentration was reached 1 to 3 days post dose.
Največja koncentracija je bila dosežena 1 do 3 dni po injiciranju odmerka.
If you become pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be changed.
Če med uporabo tega zdravila zanosite, se takoj posvetujte z zdravnikom, ker bo treba zdravljenje spremeniti.
• Do not inject Ozempic which has been exposed to direct sunlight.
• Ne injicirajte zdravila Ozempic, ki je bilo izpostavljeno neposredni sončni svetlobi.
Semaglutide improves beta-cell function.
Semaglutid izboljša delovanje celic beta.
This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child.
Tega zdravila ne smete uporabljati med nosečnostjo, ker ni znano, ali lahko škoduje nerojenemu otroku.
Severe and on-going stomach pain which could be due to acute pancreatitis If you have severe and on-going pain in the stomach area - see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas).
Hude in dolgotrajne bolečine v trebuhu so lahko posledica akutnega pankreatitisa Če imate hude in dolgotrajne bolečine v trebuhu, se nemudoma posvetujte z zdravnikom, kajti lahko gre za znak akutnega pankreatitisa (vnetja trebušne slinavke).
These side effects can cause dehydration (loss of fluids).
Ti neželeni učinki lahko povzročijo dehidracijo (izgubo tekočine).
The reactions are listed below by system organ class and absolute frequency.
Učinki so navedeni spodaj glede na organski sistem in absolutno pogostnost.
Frequencies are defined as: 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) and very rare: (<1/10,000).
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
In each case, patients can then resume their regular once weekly dosing schedule.
V vsakem primeru lahko bolniki nato nadaljujejo zdravljenje po ustaljenem urniku enkrat na teden.
See section 2, ‘Warning and precautions' for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar.
Glejte poglavje 2, podpoglavje "Opozorila in previdnostni ukrepi", za informacije o večjem tveganju za prenizek krvni sladkor in poglavje 4 za opozorilne znake prenizkega krvnega sladkorja.
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1.
Semaglutid je analog GLP-1 s 94 % sekvenčno homologijo s človeškim GLP-1.
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
• reflux or heartburn - also called ‘gastro-esophageal reflux disease' (GERD)
• refluks ali zgaga; to imenujemo tudi "gastroezofagealna refluksna bolezen (GERB)"
Do not use this medicine after the expiry date which is stated on the pen label and carton after 'EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika in na škatli poleg oznake "EXP".
The injection site can be changed without dose adjustment.
Mesto injiciranja je mogoče spreminjati brez prilagoditve odmerka.
Decreased appetite
zmanjšanje apetita
• Unscrew the needle and dispose of it carefully in accordance with local guidelines.
• Iglo odvijte in jo pazljivo zavrzite v skladu z lokalnimi predpisi.
SUSTAIN 1 - Monotherapy
SUSTAIN 1 - Monoterapija
Treat your pen with care.
S peresnikom ravnajte previdno.
Semaglutide has no or negligible influence on the ability to drive or use machines.
Semaglutid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Therefore, semaglutide should not be used during pregnancy.
Zato se semaglutida med nosečnostjo ne sme uporabljati.
To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.
Da si boste lažje zapomnili injiciranje tega zdravila le enkrat na teden, je priporočljivo, da si izbrani dan (npr. sreda) zapišete na škatlo; poleg tega je priporočljivo tudi, da na škatlo vedno zapišete datum,
Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Semaglutida se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
GLP-1 receptors are also expressed in the heart, vasculature, immune system and kidneys.
Receptorji GLP-1 so izraženi tudi v srcu, ožilju, imunskem sistemu in ledvicah.
If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
Če pred prvim injiciranjem z vsakim novim injekcijskim peresnikom ne preverite pretoka, morda ne boste dobili predpisanega odmerka in želeni učinek zdravila Ozempic ne bo dosežen.
As a risk to a breast-fed child cannot be excluded, semaglutide should not be used during breast-feeding.
Ker ni mogoče izključiti tveganja za dojenega otroka, se semaglutida med obdobjem dojenja ne sme uporabljati.
GLP--1 is a physiological hormone that has multiple actions in glucose and appetite regulation, and in the cardiovascular system.
GLP-1 je fiziološki hormon, ki opravlja več nalog v regulaciji glukoze in apetita ter v srčno-žilnem sistemu.
It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease.
To zdravilo telesu pomaga zmanjšati koncentracijo krvnega sladkorja, le kadar je krvni sladkor previsok, in lahko pomaga preprečiti bolezni srca.
Cardiac electrophysiology (QTc)
Srčna elektrofiziologija (QTc)
In general, these reactions were mild or moderate in severity and of short duration.
Na splošno so bili ti učinki blagi ali zmerni in kratkotrajni.
The events led to treatment discontinuation in 3.9% and 5% of patients.
Prenehanje zdravljenja so omenjeni neželeni učinki povzročili pri 3,9 % oz. 5 % bolnikov.
This was observed in insulin-treated patients with known diabetic retinopathy.
To je bilo opaženo pri bolnikih, zdravljenih z insulinom, ki so imeli znano diabetično retinopatijo.
Five trials (SUSTAIN 1-5) had the glycaemic efficacy assessment as the primary objective, while one trial (SUSTAIN 6) had cardiovascular outcome as the primary objective.
V petih preskušanjih (SUSTAIN 1-5) je bil primarni cilj ocena glikemične učinkovitosti, v enem preskušanju (SUSTAIN 6) pa je bil primarni cilj srčno-žilni izid.
How to handle a blocked needle
Kako ravnati z zamašeno iglo?
Make sure you select the full dose you need.
Poskrbite, da izberete celoten predpisani odmerek.
There were 61% males, the mean age was 65 years and mean BMI was 33 kg/m2.
61 % je bilo moških, povprečna starost je bila 65 let in povprečni ITM je bil 33 kg/m2.
Cmax was not affected for any of the compounds.
Cmax se ni spremenila za nobeno od učinkovin.
Due to species differences in yolk sac anatomy and function, and due to lack of GLP-1 receptor expression in the yolk sac of non-human primates, this mechanism is considered unlikely to be of relevance to humans.
Zaradi razlik v anatomiji in funkciji rumenjakove vrečke med živalskimi vrstami in zaradi odsotnosti izraženosti receptorjev GLP-1 v rumenjakovi vrečki ne-človeških primatov, velja, da ta mehanizem za človeka verjetno ni pomemben.
The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial.
Vpliv semaglutida na repolarizacijo srca so preverili s podrobnim preskušanjem QTc.
After one year of treatment, a weight loss of ≥5% and ≥10% was achieved for more subjects with
Telesna masa Po enem letu zdravljenja je zmanjšanje telesne mase za ≥ 5 % in ≥ 10 % doseglo več bolnikov z
This was also shown for subjects with type 2 diabetes and with renal impairment based on data from phase 3a studies, although the experience in patients with end-stage renal disease was limited.
Prav tako je bilo to dokazano pri bolnikih s sladkorno boleznijo tipa 2 in okvaro ledvic na podlagi podatkov študij faze 3a, toda izkušenj pri bolnikih s končno odpovedjo ledvic je malo.
• increase of pancreatic enzymes (such as lipase and amylase).
• zvišanje koncentracije encimov trebušne slinavke (npr. lipaze in amilaze)
What Ozempic is and what it is used for
Kaj je zdravilo Ozempic in za kaj ga uporabljamo
Ozempic is to be administered once weekly at any time of the day, with or without meals.
Zdravilo Ozempic je treba injicirati enkrat na teden, ob kateri koli uri, ne glede na obroke.
Frequency based on cardiovascular outcomes trial.
Pogostnost na podlagi preskušanja srčno-žilnih izidov.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin.
Prenizek krvni sladkor je bolj verjeten, če uporabljate tudi sulfonilsečnino ali insulin.
With an elimination half-life of approximately 1 week, semaglutide will be present in the circulation for about 5 weeks after the last dose.
Ker je eliminacijski razpolovni čas približno 1 teden, je semaglutid v obtoku prisoten še približno 5 tednov po zadnjem odmerku.
Get help from a person with good eyesight who is trained to use the Ozempic pre-filled pen.
Pomaga naj vam oseba, ki dobro vidi in je usposobljena za uporabo napolnjenega injekcijskega peresnika Ozempic.
EXP Discard pen 6 weeks after first use.
EXP Injekcijski peresnik zavrzite 6 tednov po prvi uporabi.
If no drop appears, you will not inject any medicine even though the dose counter may move.
Če se kapljica ne pojavi, zdravila ne boste injicirali, tudi če se števec odmerka premakne.
You will need it after the injection, to safely remove the needle from the pen.
Potrebovali ga boste po injiciranju, da boste iglo varno sneli s peresnika.