natgillin/translations-raw huggingface dataset:
Reagila 6 mg hard capsules
Reagila 6 mg trde kapsule
Weight increased Decreased appetite Increased appetite Dyslipidaemia
Presnovne in prehranske motnje povečanje telesne mase, zmanjšan apetit,
Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Reagila 1,5 mg: Ena trda kapsula vsebuje 1,5 mg kariprazina v obliki kariprazinijevega klorida.
- dizziness on standing up due to a drop in your blood pressure, which may cause fainting - a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots - a history of stroke, especially if you are elderly or know that you have other risk factors for stroke.
- imate vi ali kdo v družini krvne strdke v zdravstveni zgodovini, ker zdravila proti shizofreniji povezujejo z nastajanjem krvnih strdkov.
Reagila 3 mg hard capsules
Reagila 3 mg trde kapsule
Akathisia was reported in 13.6%; 5.1%; 9.3% and 9.9% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
O akatiziji so poročali pri 13,6 % bolnikov, zdravljenih s kariprazinom, 5,1 % bolnikov, ki so dobivali placebo, 9,3 % bolnikov, zdravljenih z risperidonom, in
Parkinsonism was experienced in 5.2% and 7.4% in cariprazine and risperidone treated patients respectively.
Parkinsonizem je doživelo 5,2 % bolnikov v skupini s kariprazinom in 7,4 % bolnikov v skupini z risperidonom.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija, eozinofilija nevtropenija
Weight changes
Spremembe telesne mase
Increased incidence of retinal degeneration/atrophy was observed in albino rats in the 2-year study at clinically relevant exposures.
Pri albino podganah v 2-letni študiji s klinično pomembnimi izpostavljenostmi so opazili povečano incidenco mrežnične degeneracije/atrofije.
Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules cariprazine
Reagila 1,5 mg trde kapsule Reagila 3 mg trde kapsule Reagila 4,5 mg trde kapsule Reagila 6 mg trde kapsule kariprazin Za to zdravilo se izvaja dodatno spremljanje varnosti.
- The other ingredients are:
- naslednje se vidi na laboratorijskih preiskavah:
Sedation Dizziness Dystonia4 Other
sedacija, omotica, distonija4,
Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Reagila 4,5 mg: Ena trda kapsula vsebuje 4,5 mg kariprazina v obliki kariprazinijevega klorida.
Allura red AC (E 129) Brilliant blue FCF (E 133) Titanium dioxide (E 171) Yellow iron oxide (E 172) Gelatin
alurno rdeče AC (E129) briljantno modro FCF (E133) titanov dioksid (E171) rumeni železov oksid (E172) želatina
How to store Reagila
Shranjevanje zdravila Reagila
° abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood
° nenormalna količina lipidov (npr. holesterola in/ali maščobe) v krvi Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Ena trda kapsula vsebuje 0,0008 mg barvila alurno rdeče AC (E129).
NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
IME ZDRAVILA Reagila 1,5 mg trde kapsule kariprazin
Each hard capsule contains 0.0096 mg Allura red AC (E 129).
Ena trda kapsula vsebuje 0,0096 mg barvila alurno rdeče AC (E129).
Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Reagila 6 mg: Ena trda kapsula vsebuje 6 mg kariprazina v obliki kariprazinijevega klorida.
Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Reagila 3 mg: Ena trda kapsula vsebuje 3 mg kariprazina v obliki kariprazinijevega klorida.
NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
IME ZDRAVILA Reagila 4,5 mg trde kapsule kariprazin
Suicidal behaviour Delirium Depression Libido decreased Libido increased Erectile dysfunction
Psihiatrične motnje motnje spanja1, tesnoba samomorilno vedenje, delirij, depresija, zmanjšanje libida,
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS blisterfoil
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Vascular disorders
erektilna disfunkcija
Cariprazine 3 mg/day 96.1 ± 8.7 -20.2 (1.5) Cariprazine 6 mg/day 95.7 ± 9.4 -23.0 (1.5) Aripiprazole 10 mg/day 95.6 ± 9.0 -21.2 (1.4) RGH-MD-05 (n=439)
Kariprazin 6 do 9 mg/dan 96,3 ± 9,0 -25,9 (1,7)
Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Ena trda kapsula vsebuje 0,0003 mg barvila alurno rdeče AC (E129).
Weigth increase
povečanje libida,
21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
90 trdih kapsul 98 trdih kapsul
In the short term studies the incidence of EPS was observed in 27%; 11.5%; 30.7% and 15.1% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
11,5 % bolnikov, ki so dobivali placebo, 30,7 % bolnikov, zdravljenih z risperidonom, in 15,1 %
NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
IME ZDRAVILA Reagila 6 mg trde kapsule kariprazin
NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
IME ZDRAVILA Reagila 3 mg trde kapsule kariprazin
Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Ena trda kapsula vsebuje 1,5 mg kariprazina v obliki kariprazinijevega klorida.
Blood thyroid stimulating hormone decreased
Bolezni endokrinega sistema zmanjšanje ravni tiroideo stimulirajočega hormona v krvi hipotiroidize m
- decreased or increased sexual desire, erectile problems - eye irritation, high pressure in the eye, poor vision - focusing problems seeing at a distance to or seeing close-to - low blood pressure - abnormal ECG reading, abnormal nerve impulses in the heart - slow, irregular heart rate - hiccups - heartburn - thirst - pain when passing urine - abnormally frequent and large urinations - itching, rash - diabetes - the following can be seen in laboratory tests:
- zmanjšana ali povečana spolna sla, težave z erekcijo - draženje očesa, visok očesni tlak, oslabljen vid - težave pri fokusiranju vida na daleč ali vida na blizu
Reagila 4.5 mg and Reagila 6 mg hard capsules are available in pack sizes containing 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Zdravilo Reagila 4,5 mg in Reagila 6 mg trde kapsule so na voljo v velikostih pakiranja po 21, 28, 30,
Significant weight gain has been observed with the use of cariprazine.
Med uporabo kariprazina so opazili znatno povečanje telesne mase.
Reagila 4.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).
Reagila 4,5 mg trde kapsule: predgeliran (koruzni) škrob, magnezijev stearat, barvilo alurno rdeče AC (E129), barvilo briljantno modro FCF (E133), titanov dioksid (E171), rumen železov oksid (E172), želatina, belo črnilo (šelak, titakov oksid (E171), propilenglikol, simetikon).
Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Ena trda kapsula vsebuje 4,5 mg kariprazina v obliki kariprazinijevega klorida.
- anxiety - sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking - dizziness - involuntary twisting movements and strange postures - excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms) - blurred vision - high blood pressure - fast, irregular heartbeat - decreased or increased appetite - nausea, vomiting, constipation - weight increased - tiredness - the following can be seen in laboratory tests:
- nehotno trzanje in čudna telesna drža - pretirano drgnjenje z zobmi ali stiskanje čeljusti, slinjenje, neprestano mežikanje zaradi udarjanja z roko ob čelo (nenormalen refleks), težave z gibanjem, motnje gibanja jezika (to se imenuje ekstrapiramidni simptomi)
- Reagila 1.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
- Reagila 1,5 mg trde kapsule: Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z belim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila »GR 1.5« na telesu kapsule.
Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Škatla vsebuje 21, 28, 30, 49, 56, 60, 84, 90 ali 98 trdih kapsul Na trgu morda ni vseh navedenih pakiranj.
Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Reagila 6 mg trde kapsule: predgeliran (koruzni) škrob, magnezijev stearat, barvilo briljantna modra FCF (E133), barvilo alurno rdeče AC (E129), titanov dioksid (E171), želatina, črno črnilo (šelak, črni železov oksid (E172), propilenglikol, kalijev hidroksid).
Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Ena trda kapsula vsebuje 3 mg kariprazina v obliki kariprazinijevega klorida.
Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Ena trda kapsula vsebuje 6 mg kariprazina v obliki kariprazinijevega klorida.
Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Reagila 3 mg trde kapsule: predgeliran (koruzni) škrob, magnezijev stearat, barvilo alurno rdeče AC (E129), barvilo briljantno modro FCF (E133), titanov dioksid (E171), rumeni železov oksid (E172), želatina, črno črnilo (šelak, črn železov oksid (E172), propilenglikol, kalijev hidroksid).
Efficacy parameter
UČINKOVITO UPORABO ZDRAVILA
- Reagila 6 mg hard capsules: ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
- Reagila 6 mg trde kapsule: Trda želatinska kapsula velikosti 3 (približno 15,9 mm dolžine), s škrlatnim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila »GR 6« na telesu kapsule.
- Reagila 4.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
- Reagila 4,5 mg trde kapsule: Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z zelenim neprozornim pokrovčkom in zelenim neprozornim telesom z napisom iz črnega črnila »GR 4.5« na telesu kapsule.
‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z zelenim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila »GR 3« na telesu kapsule.
Blood creatine phosphokinase increased
Bolezni mišičnoskeletnega sistema in vezivnega tkiva povečanje ravni kreatinin fosfokinaze v krvi rabdomioliza
Shellac
polakisurija
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z belim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila »GR 1.5« na telesu kapsule.
Reagila 6 mg hard capsules ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Trda želatinska kapsula velikosti 3 (približno 15,9 mm dolžine), s škrlatnim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila »GR 6« na telesu kapsule.
Neuroleptic malignant syndrome extrapyramidal diseases and abnormal movement disorders5
druge ekstrapiramidn e bolezni in motnje z letargija, disestezija, diskinezija6, tardivna diskinezija epileptični napadi/
PARTICULARS TO APPEAR ON THE OUTER PACKAGING folded carton
PODATKI NA ZUNANJI OVOJNINI škatla
In rat studies lower female fertility and conception indices were observed (see section 5.3).
V študijah na podganah so opazili zmanjšane indekse plodnosti in zanositve pri samicah.
Therefore, co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole verapamil) is contraindicated (see section 4.3).
telaprevir, telitromicin, vorikonazol, diltiazem, eritromicin, flukonazol, verapamil) je zato kontraindicirana (glejte poglavje 4.3).
Reagila 4.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z zelenim neprozornim pokrovčkom in zelenim neprozornim telesom z napisom iz črnega črnila »GR 4.5« na telesu kapsule.
Neutropenia
- depresija
Electrocardiog ram QT prolonged Electrocardiog ram T wave abnormal
nenormalen val T na elektrokardiogram u
Blood sodium abnormal Blood glucose increased Diabetes mellitus
Bolezni jeter, žolčnika in žolčevodov povišanje vrednosti jetrnih encimov zvišanje ravni bilirubina v krvi toksični hepatitis
- Reagila 3 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
- Reagila 3 mg trde kapsule: Trda želatinska kapsula velikosti 4 (približno 14,3 mm dolžine), z zelenim neprozornim pokrovčkom in belim neprozornim telesom z napisom iz črnega črnila
Potential for other medicinal products to affect cariprazine
Prehod z drugih antipsihotikov na kariprazin
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Gedeon Richter Plc.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Gedeon Richter Plc.
Immune system disorders
Bolezni imunskega sistema preobčutljivo st
This means that the effects of these components in Odefsey should be similar to their effects in other medicines.
To pomeni, da bi morali biti učinki teh sestavin v zdravilu Odefsey podobni njihovim učinkom v drugih zdravilih.
What measures are being taken to ensure the safe and effective use of Odefsey?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Odefsey?
Other information about Odefsey
Druge informacije o zdravilu Odefsey
The full EPAR for Odefsey 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 Odefsey 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 Odefsey.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Odefsey.
The CHMP therefore decided that Odefsey's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Odefsey večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Odefsey have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Odefsey, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Odefsey must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Odefsey:
Zdravilo Odefsey se ne sme uporabljati skupaj z naslednjimi zdravili, ki lahko povzročijo znižane ravni rilpivirina v krvi in posledično zmanjšajo učinkovitost zdravila Odefsey:
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Odefsey is an alternative treatment option to Eviplera with similar effectiveness.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je zdravilo Odefsey alternativna možnost zdravljenja zdravilu Eviplera s podobno učinkovitostjo.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Izdaja zdravila je le na recept, zdravljenje pa mora uvesti zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
• rifabutin, rifampicin, rifapentine (antibiotics);
• rifabutin, rifampicin, rifapentin (antibiotiki);
• dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) except when used as a single dose treatment;
• deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema), razen pri zdravljenju z enkratnim odmerkom;
In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil and may lead to reduced side effects in the kidneys and bones.
Z vidika varnosti je alafenamidtenofovirat učinkovit pri nižjem odmerku kot dizoproksiltenofovirat in lahko povzroči zmanjšanje neželenih učinkov na ledvice in kosti.
All three active substances block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Vse tri zdravilne učinkovine zavirajo delovanje reverzne transkriptaze, tj. virusnega encima, ki omogoča, da se HIV-1 razmnožuje v celicah, ki jih je okužil.
To support the use of tenofovir alafenamide, the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.
V podporo uporabi alafenamidtenofovirata je družba predložila podatke iz študij, ki kažejo, da so kombinirana zdravila, ki vsebujejo alafenamidtenofovirat, enako učinkovita pri zmanjšanju količine virusa HIV-1 v krvi kot tista, ki vsebujejo dizoproksiltenofovirat.
Odefsey does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo ne zdravi okužbe z virusom HIV-1 ali AIDS-a, lahko pa podaljša čas do pojava okvare imunskega sistema ter razvoja okužb in bolezni, ki so povezane z AIDS-om.
By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood and keeps it at a low level.
Zdravilo Odefsey z zaviranjem tega encima zniža količino virusa HIV-1 v krvi in jo zadržuje na nizki ravni.
Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Odefsey je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov (starih 12 let in več s telesno maso vsaj 35 kg), okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
For more information about treatment with Odefsey, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Odefsey preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Odefsey have been shown in studies?
Kakšne koristi je zdravilo Odefsey izkazalo v študijah?
Odefsey is available as tablets, each containing 200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide.
Zdravilo Odefsey je na voljo v obliki tablet, od katerih vsaka vsebuje 200 mg emtricitabina, 25 mg rilpivirina in 25 mg alafenamidtenofovirata.
What are the risks associated with Odefsey?
Kakšna tveganja so povezana z zdravilom Odefsey?
It is only used in patients where the virus has not developed resistance to a class of HIV medicines called nonnucleoside reverse transcriptase inhibitors, tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Uporablja se samo pri bolnikih, pri katerih virus še ni razvil rezistence na razred zdravil za zdravljenje okužbe z virusom HIV, imenovanih nenukleozidni zaviralci reverzne transkriptaze (NNRTI), tenofovir ali emtricitabin, in pri katerih so ravni virusa HIV v krvi (virusna obremenitev) manjše od 100 000 HIV-1 RNA kopij/ml.
Odefsey contains three active substances.
Zdravilo Odefsey vsebuje tri zdravilne učinkovine.
Why is Odefsey approved?
Zakaj je bilo zdravilo Odefsey odobreno?
What is Odefsey and what is it used for?
Kaj je zdravilo Odefsey in za kaj se uporablja?
For practical information about using Odefsey, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Odefsey naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Very common side effects with rilpivirine also include increased cholesterol levels (total cholesterol and LDL-cholesterol), insomnia (difficulty sleeping) and increased liver and pancreas enzymes.
Zelo pogosti neželeni učinki rilpivirina vključujejo tudi zvišane ravni holesterola (skupnega holesterola in LDL-holesterola), nespečnost (težave s spanjem) ter zvišane ravni encimov jeter in trebušne slinavke.
The most common side effects seen with the active substance rilpivirine and with the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick).
Najpogostejši neželeni učinki, povezani z zdravilno učinkovino rilpivirin in s kombinacijo emtricitabina in alafenamidtenofovirata (ki lahko prizadenejo več kot 1 osebo od 10), so glavobol, omotičnost in navzea (občutek siljenja na bruhanje).
Odefsey emtricitabine / rilpivirine / tenofovir alafenamide
Odefsey emtricitabin/rilpivirin/alafenamidtenofovirat
It is not intended to provide practical advice on how to use Odefsey.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In addition, to support its application, the company performed a ‘bioequivalence' study comparing Odefsey with two other HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide).
Poleg tega je družba v podporo svoji vlogi izvedla bioekvivalenčno študijo primerjave zdravila Odefsey z dvema drugima zdraviloma proti virusu HIV: Edurant (rilpivirin) in Genvoya (elvitegravir, kobicistat, emtricitabin in alafenamidtenofovirat).
The combination of active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) is already approved in the EU as Eviplera to treat HIV-1 infection, although in Eviplera tenofovir is present as tenofovir disoproxil whereas in Odefsey it is present as tenofovir alafenamide.
Kombinacija zdravilnih učinkovin v zdravilu Odefsey (emtricitabin, rilpivirin in tenofovir) je že odobrena v EU kot zdravilo Eviplera za zdravljenje okužbe z virusom HIV-1, čeprav je v zdravilu Eviplera tenofovir prisoten kot dizoproksiltenofovirat, v zdravilu Odefsey pa kot alafenamidtenofovirat.