natgillin/translations-raw huggingface dataset:
The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina + tenofoviralafenamida so ocenili v 48 tednih z odprto klinično študijo (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od
Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Verjetno je, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij tenofoviralafenamida v plazmi
ANTIDIABETICS Metformin (850 mg single dose)/ Rilpivirine
ANTIDIABETIKI metformin (enkratni odmerek 850 mg)/rilpivirin metformin: AUC: ↔ Cmin: N/A Cmax: ↔
• Periodic Safety Update Reports
*na podlagi zgodovinskih kontrol
The mean baseline CD4+ cell count was 697 cells/mm3 (range
Povprečno število celic CD4+ na začetku je bilo 700 celic/mm3
Tablet core:
Torsade de Pointes.
fatigue1, 3
utrujenost1,3
Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide
(90 mg/400 mg enkrat dnevno)/tenofoviralafenamid tenofoviralafenamid:
ORAL CONTRACEPTIVES Ethinylestradiol (0.035 mg once daily)/ Rilpivirine
PERORALNI KONTRACEPTIVI etinilestradiol (0,035 mg enkrat dnevno)/rilpivirin noretindron (1 mg enkrat dnevno)/rilpivirin etinilestradiol: AUC: ↔ Cmin: ↔ Cmax: ↑ 17 %
0.7% (95% CI: -4.3% to 5.8%)
0,7 % (95 % IZ:
PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1
omeprazol (20 mg enkrat dnevno)/rilpivirin1
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased tenofovir alafenamide exposure (AUC) by 45-53%.
Odefsey zdravim odraslim osebam z obrokom, povzročilo večjo izpostavljenost tenofoviralafenamidu
QT prolonging medicinal products
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
and CD4+ T-lymphocytes.
CYP2D6.
The safety of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included TDF in 69 of 72 patients) to E/C/F/TAF.
HIV v odprti klinični študiji (GS-US-292-1249) do konca 48. tedna, v kateri so bolniki prešli z drugega protiretrovirusnega režima (ki je vključeval TDF pri 69 od 72 bolnikov) na E/C/F/TAF.
• hives (urticaria)
• koprivnica (urtikarija)
This effect was maintained for almost one year.
Ta učinek je trajal skoraj eno leto.
The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.
Priporočeni odmerek je 11 mg na kilogram telesne mase, infuzija pa traja približno eno uro.
The Agency also acknowledged that there is an unmet medical need for these patients.
Agencija je tudi menila, da za te bolnike ostaja neizpolnjena medicinska potreba.
What measures are being taken to ensure the safe and effective use of Sylvant?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sylvant?
The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Najresnejši neželeni učinek je anafilaktična reakcija (huda alergijska reakcija).
Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Za zdravilo Sylvant je bilo 22. maja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Sylvant večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Podjetje bo zagotovilo, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo, poučeni o tem, kako vnesti bolnike v register.
What benefits of Sylvant have been shown in studies?
Kakšne koristi zdravila Sylvant so se pokazale v študijah?
Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Sylvant so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
As for all medicines, data on the use of Sylvant are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sylvant stalno spremljajo.
For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.
Za več informacij glede uporabe zdravila Sylvant glejte povzetek glavnih značilnosti zdravila ali se posvetujte z zdravnikom ali farmacevtom.
During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects.
V prvih 12 mesecih zdravljenja je treba pri bolniku pred posameznim odmerkom zdravila Sylvant in vsakih devet tednov po njem izvesti krvni test; zdravljenje je morda treba odložiti pri bolnikih, ki imajo nenormalni krvni test ali nekatere neželene učinke.
The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time.
Agencija je zaključila, da je zdravilo Sylvant pokazalo pozitiven učinek glede zmanjševanja velikosti tumorjev in simptomov pri bolnikih z multicentrično Castlemanovo boleznijo ter da ta pozitivni učinek traja dalj časa.
The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Podjetje, ki trži zdravilo Sylvant, mora oblikovati register bolnikov, da se zagotovijo dodatni podatki o dolgoročni varnosti.
Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Zdravilo Sylvant se daje vsake tri tedne, dokler ima bolnik še koristi od zdravljenja.
Why is Sylvant authorised in the EU?
Zakaj je bilo zdravilo Sylvant odobreno v EU?
Other information about Sylvant
Druge informacije o zdravilu Sylvant
Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Neželeni učinki zdravila Sylvant so sprejemljivi, vendar je treba zbrati dodatne dolgoročne podatke.
Multicentric means that the disease affects several lymph nodes as well as other organs in the body.
Multicentrična pomeni, da bolezen vpliva na več bezgavk in drugih organov v telesu.
Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Sylvant, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sylvant upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease.
Učinek zdravila so primerjali s placebom (zdravilom brez učinkovine), glavno merilo učinkovitosti pa je bil delež bolnikov, ki so se vsaj 18 tednov odzivali na zdravljenje, kar se je odražalo v 50-odstotnem zmanjšanju („delni odziv“) ali popolnem izginotju („popolni odziv“) tumorjev in simptomov bolezni.
What are the risks associated with Sylvant?
Kakšna tveganja so povezana z zdravilom Sylvant?
Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
Castlemanova bolezen je redka, zato je bilo zdravilo Sylvant 30. novembra 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Siltuksimab je bil zasnovan tako, da se veže na beljakovino v telesu, ki se imenuje interlevkin 6 (IL-6).
An overview of Sylvant and why it is authorised in the EU
Pregled zdravila Sylvant in zakaj je odobreno v EU
What is Sylvant and what is it used for?
Kaj je zdravilo Sylvant in za kaj se uporablja?
Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo.
Zdravilo Sylvant je bilo pri zmanjševanju velikosti tumorjev in bolezenskih simptomov učinkovitejše od placeba: pri 17 od 53 bolnikov, ki so prejeli zdravilo Sylvant, se je pokazal delni odziv in pri enem popolni odziv, medtem ko se ni odzval nobeden od 26 bolnikov, ki so prejeli placebo.
Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Predpisovanje in izdaja zdravila Sylvant je le na recept, zdravljenje pa lahko izvajajo samo usposobljeni zdravstveni delavci pod ustreznim zdravstvenim nadzorom.
Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman's disease who did not have HIV or HHV-8 infection.
Zdravilo Sylvant so preiskovali v eni glavni študiji, ki je vključevala 79 odraslih z multicentrično Castlemanovo boleznijo, ki niso bili okuženi z virusom HIV ali HHV-8.
Patients with Castleman's disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes.
Bolniki s Castlemanovo boleznijo proizvajajo preveč IL-6, to pa naj bi prispevalo k nenormalni rasti nekaterih celic v bezgavkah.
Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours.
Castlemanova bolezen je motnja limfnega sistema (mreže žil, po katerih se prenaša tekočina iz tkiv prek bezgavk in v krvni obtok), pri kateri začnejo celice v bezgavkah nenormalno rasti in s tem povzročajo benigne tumorje.
The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea.
Najpogostejši neželeni učinki zdravila Sylvant (ki se lahko pojavijo pri več kot 1 od 5 bolnikov) so okužbe (vključno z okužbami zgornjih dihal, kot so okužbe grla in nosu), srbenje, izpuščaji, bolečine v sklepih in driska.
Sylvant is a medicine that is used to treat multicentric Castleman's disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).
Sylvant je zdravilo, ki se uporablja za zdravljenje multicentrične Castlemanove bolezni pri odraslih, ki niso okuženi z virusom humane imunske pomanjkljivosti (HIV) in humanim virusom herpesa tipa 8 (HHV-8).
The active substance in Sylvant, siltuximab, is a monoclonal antibody.
Učinkovina v zdravilu Sylvant, siltuksimab, je monoklonsko protitelo.
Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Simptomi lahko vključujejo utrujenost, nočno potenje, povišano telesno temperaturo, periferno nevropatijo (zbadanje zaradi okvare živcev) in otekanje jeter ter vranice.
For the full list of side effects and restrictions of Sylvant, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Sylvant glejte navodilo za uporabo.
It is given by infusion (drip) into a vein.
Zdravilo se daje z infundiranjem (kapalno infuzijo) v veno.
By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease.
Siltuksimab z vezavo na IL-6 zavira njegovo delovanje in ustavi nenormalno rast celic ter s tem zmanjša velikost bezgavk in simptome bolezni.
How does Sylvant work?
Kako zdravilo Sylvant deluje?
How is Sylvant used?
Kako se zdravilo Sylvant uporablja?
Sylvant contains the active substance siltuximab.
Zdravilo Sylvant vsebuje učinkovino siltuksimab.
The child should then be given water or milk to swallow the granules.
Otroku nato damo vodo ali mleko, da zrnca pogoltne.
The dose is chosen to be lowest possible that controls the child's symptoms.
Določiti je treba najmanjši možni odmerek, s katerim je še mogoče obvladovati otrokove simptome.
The capsules are opened and the granules are placed in the child's mouth.
Kapsule odpremo in zrnca položimo v otrokova usta.
The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.
Zrnca lahko tudi posipamo na žlico mehke hrane in jih takoj damo otroku.
What measures are being taken to ensure the safe and effective use of Alkindi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alkindi?
It must also not be used in children with difficulty swallowing or in premature babies who haven't started feeding by mouth.
Prav tako se ne sme uporabljati pri otrocih, ki imajo težave s požiranjem, ali pri nedonošenčkih, ki se še niso začeli hraniti preko ust.
The full EPAR for Alkindi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Alkindi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Alkindi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alkindi.
A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.
Pomanjkanje hormona povzroča več simptomov, vključno s hujšanjem, mišično oslabelostjo, utrujenostjo in nizkim krvnim tlakom.
As for every medicine, the company provided studies on the quality of Alkindi.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Alkindi.
This means that it is similar to a ‘reference medicine' containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako zdravilno učinkovino (v tem primeru tabletam hidrokortizona Auden Mckenzie), vendar je zdravilo Alkindi na voljo v drugačni obliki (v obliki zrnc in ne tablet) in je bilo razvito samo za otroke.
The European Medicines Agency concluded that the benefits of Alkindi are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Alkindi večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
The company also carried out studies to show that it is ‘bioequivalent' to the reference medicine.
Opravila je tudi študije, ki so pokazale, da je zdravilo biološko enakovredno referenčnemu zdravilu.
These include changes in behaviour, nausea, inflammation in the lining of the stomach and changes in blood potassium levels and excess acid in the blood.
Ti so vključevali spremenjeno obnašanje, siljenje na bruhanje, vnetje želodčne sluznice in spremenjene ravni kalija v krvi ter povečano količino kisline v krvi.
Cortisol is needed to control many body processes (including inflammation and the control of sugar and mineral levels) and is sometimes referred to as the ‘stress hormone' because it helps the body respond to stress.
Telo potrebuje kortizol za nadzor številnih procesov (vključno z vnetnimi procesi ter nadzorom ravni sladkorja in mineralov), imenujemo pa ga tudi „stresni hormon“, saj telesu pomaga pri odzivanju na stres.
Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.
Študije o koristih in tveganjih zdravilne učinkovine so že bile izvedene z referenčnim zdravilom, zato jih ni treba ponoviti za zdravilo Alkindi.
For the full list of side effects see the package leaflet.
Za celoten seznam neželenih učinkov glejte navodilo za uporabo.
Other information about Alkindi
Druge informacije o zdravilu Alkindi
Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
Alkindi je zdravilo, namenjeno otrokom (od rojstva do starosti 18 let), pri katerih nadledvične žleze ne morejo izdelati dovolj hormona, imenovanega kortizol.
Alkindi is also available in a form suitable for children and it is easier to give a precise dose with Alkindi than with other treatments which require crushing tablets and weighing up the right dose.
Zdravilo Alkindi je prav tako na voljo v obliki, primerni za otroke, zato ga je lažje natančno odmeriti kot druga zdravila, pri katerih sta potrebna drobljenje tablet in tehtanje pravilnega odmerka.
Alkindi is a ‘hybrid medicine'.
Zdravilo Alkindi je „hibridno zdravilo“.
What is Alkindi and what is it used for?
Kaj je zdravilo Alkindi in za kaj se uporablja?
What benefits of Alkindi have been shown in studies?
Kakšne koristi je zdravilo Alkindi izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alkindi have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Alkindi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Alkindi approved?
Zakaj je bilo zdravilo Alkindi odobreno?
What are the risks associated with Alkindi?
Kakšna tveganja so povezana z zdravilom Alkindi?
Hydrocortisone replaces the natural cortisol that is missing in children whose adrenal glands do not produce enough of the hormone, thereby helping to relieve their symptoms.
Hidrokortizon nadomešča naravni kortizol, ki ga otroci, pri katerih nadledvične žleze ne tvorijo dovolj hormona, nimajo, in tako lajša njihove simptome.
Alkindi is available as capsules containing granules.
Zdravilo Alkindi je na voljo v obliki kapsul, ki vsebujejo zrnca.
Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi.
Zdravila Alkindi ne smejo uporabljati bolniki s preobčutljivostjo za (alergijo na) zdravilno učinkovino ali katero koli sestavino zdravila Alkindi.
For more information about treatment with Alkindi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Alkindi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland.
Zdravilna učinkovina v zdravilu Alkindi, hidrokortizon, je enaka kot kortizol, tj. glavni steroidni hormon, ki ga sprošča nadledvična žleza v telesu.
Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU.
Količina hidrokortizona, ki jo v krvi ustvari zdravilo Alkindi, je podobna kot pri referenčnem zdravilu, ki je že odobreno v EU.
It is not intended to provide practical advice on how to use Alkindi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Alkindi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Alkindi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines.
Iz študij z zdravilom Alkindi niso poročali o nobenih neželenih učinkih, medtem ko so o določenih neželenih učinkih poročali pri drugih zdravilih, ki vsebujejo hidrokortizon.
How does Alkindi work?
Kako zdravilo Alkindi deluje?
Alkindi contains the active substance hydrocortisone.
Zdravilo Alkindi vsebuje zdravilno učinkovino hidrokortizon.
How is Alkindi used?
Kako se zdravilo Alkindi uporablja?
on 9 August 2002.
dne 9. avgusta 2002.
The Marketing Authorisation was subsequently renewed.
Dovoljenje za promet je bilo kasneje podaljšano.
This summary was last updated in July 2007.
Ta povzetek je bil nazadnje posodobljen 07-2007.
The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs.
Študije so bile izvedene v skladu z zahtevami ustreznih monografij Evropske farmakopeje.
The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks.
Zaščita nastopi od drugega tedna dalje in traja do devet tednov.
The vaccine is also effective against Marek's disease.
Cepivo je učinkovito tudi proti Marekovi bolezni.
The onset of protection is from 4 days onwards.
Zaščita nastopi od četrtega dne dalje.
It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Zato odsvetujemo uporabo kateregakoli cepiva v obdobju 14 dni po cepljenju s tem cepivom.
Studies have shown that the strain appears safe for turkeys, however precautionary measures should be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Študije so pokazale, da se zdi sev varen tudi za purane, vendar pa je kljub temu treba slediti varnostnim ukrepom, da bi se izognili neposrednemu ali posrednemu stiku med cepljenimi piščanci in purani.
The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated.
Dokazana je bila tudi varnost pri neobčutljivih vrstah ptic (fazani, race, jerebice, prepelice in golobi) ter pri vrstah sesalcev (miši in morski prašički).
The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens.
Varnost zdravila je bila dokazana v več laboratorijskih preizkusih in preizkusih na populaciji pri posebnih piščancih brez patogenov in drugih piščancih.
It is presented as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing.
Zdravilo je na voljo v obliki zamrznjene suspenzije, ki se jo rekonstituira z razredčilom in vbrizga v piščance ter jajca, v katerih se razvijajo piščanci.
As the product is stored in a tank under liquid nitrogen, particular instructions for reconstitution of the vaccine are provided in the product information module of the EPAR.
Ker je zdravilo shranjeno v vsebniku s tekočim dušikom, so posebna navodila podana v modulu s podatki o zdravilu tega Evropskega javnega poročila o oceni zdravila (EPAR).