natgillin/translations-raw huggingface dataset:
The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances.
Sklenil je, da lahko zdravilo pomaga pri klinično pomembnem znižanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 2 in da so bile koristi ter tveganja skladna s koristmi in tveganji pri posameznih zdravilnih učinkovinah.
Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.
Študije so prav tako pokazale, da je zdravilo Synjardy enako učinkovito kot ločeno jemanje empagliflozina in metformina ter da je kombinacija pomagala znižati raven HbA1c, če je bila dodana zdravljenju, ki vključuje insulin.
Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Zabeležili so tudi, da je zdravilo Synjardy zmanjšalo pojavnost kardiovaskularnih dogodkov pri bolnikih s sladkorno boleznijo tipa 2, ki so kardiovaskularno obolenje že imeli.
Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.
Zdravilo Synjardy je na voljo v obliki tablet, ki vsebujejo 5 ali 12,5 mg empagliflozina in 850 ali 1 000 mg metformina.
• in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;
• v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni pri bolnikih, pri katerih sladkorna bolezen ni zadovoljivo uravnana s temi zdravili v kombinaciji z metforminom;
Synjardy is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes.
Synjardy je zdravilo za zdravljenje sladkorne bolezni, ki se skupaj z dieto in telesno vadbo uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2.
Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant.
Dodatno zmanjšanje pri kombinaciji s 5 mg empagliflozina dvakrat na dan je bilo 0,58 odstotne točke, pri kombinaciji z 12,5 mg pa 0,62 odstotne točke.
For the full list of all side effects reported with Synjardy, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Synjardy, glejte navodilo za uporabo.
The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination.
Najpogostejši neželeni učinki zdravila Synjardy so hipoglikemija (nizke ravni sladkorja v krvi), kadar se to zdravilo jemlje skupaj s sulfonilsečnino ali insulinom, okužbe sečil in spolovil ter povečano izločanje urina.
The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin.
V študijah so pokazali večje zmanjšanje vrednosti HbA1c pri kombinaciji empagliflozina in metformina kot pri kombinaciji placeba in metformina.
If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body's production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Če se zdravilo Synjardy uporablja v kombinaciji z insulinom ali sulfonilsečnino (zdravilom, ki spodbuja izločanje insulina), bo za preprečitev hipoglikemije (nizkih ravni sladkorja v krvi) morda treba njun odmerek zmanjšati.
The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.
Zdravilni učinkovini v zdravilu Synjardy, empagliflozin in metformin, glukozo v krvi zmanjšujeta na različna načina in tako nadzorujeta simptome te bolezni.
It contains the active substances empagliflozin and metformin.
Vsebuje zdravilni učinkovini, empagliflozin in metformin.
How is Synjardy used?
Kako se zdravilo Synjardy uporablja?
How does Synjardy work?
Kako zdravilo Synjardy deluje?
The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin.
V študijah so primerjali učinek kombinacije empagliflozina in metformina s kombinacijo placeba (zdravila brez zdravilne učinkovine) in metformina.
By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.
Empagliflozin z zaviranjem delovanja koprenašalca SGLT2 povzroči večje izločanje glukoze z urinom, kar zniža njene ravni v krvi.
It should be used in combination with safer sex practices, such as use of condoms.
Uporabljati bi se moralo v kombinaciji z varnejšimi spolnimi praksami, na primer uporabo kondomov.
This means that it is converted into tenofovir in the body.
To pomeni, da se v tenofovir pretvori v telesu.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dve zdravili sta bioekvivalentni, kadar dosegata enake ravni učinkovine v telesu in imata zato po pričakovanjih enak učinek.
Further information on Emtricitabine/Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Nadaljnje informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Zentiva so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Emtricitabine/Tenofovir disoproxil Zentiva received a marketing authorisation valid throughout the EU on 9 November 2016.
Za zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva je bilo 9. novembra 2016 izdano dovoljenje za promet, veljavno po vsej EU.
Both active substances have been authorised in the EU since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.
Za obe učinkovini je bilo v začetku 21. stoletja izdano dovoljenje za promet v EU: emtricitabin je odobren kot zdravilo Emtriva od leta 2003, dizoproksiltenofovirat pa kot zdravilo Viread od leta 2002.
The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Opravilo je tudi študijo, ki je pokazala, da je zdravilo bioekvivalentno referenčnemu zdravilu.
In addition it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.
Poleg tega se lahko uporablja tudi pri mladostnikih, starejših od 12 let, ki so okuženi z virusom HIV in so odporni proti zdravilom prve izbire ali teh zaradi neželenih učinkov ne morejo jemati.
The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Truvada.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva primerljivo raven kakovosti kot referenčno zdravilo Truvada ter da mu je bioekvivalentno.
Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for pre-exposure prophylaxis.
Zdravstveni delavci bodo prav tako prejeli brošuro in opozorilno kartico za posameznike, ki zdravilo jemljejo za predekspozicijsko profilakso.
Because Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.
Študije o koristih in tveganjih obeh učinkovin pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Truvada, zato jih ni treba ponoviti za zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva.
If patients with HIV1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Če morajo bolniki, okuženi z virusom HIV-1, prekiniti jemanje bodisi emtricitabina bodisi tenofovirja oziroma je treba njune odmerke spremeniti, morajo jemati zdravila, ki ločeno vsebujejo emtricitabin ali tenofovirdizoproksil.
Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Emtricitabin/dizoproksiltenofovirat Zentiva, 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 Emtricitabine/Tenofovir disoproxil Zentiva 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 Emtricitabin/dizoproksiltenofovirat Zentiva upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Emtricitabine/Tenofovir disoproxil Zentiva and why it is authorised in the EU
Pregled zdravila Emtricitabin/dizoproksiltenofovirat Zentiva in zakaj je odobreno v EU
What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emtricitabin/dizoproksiltenofovirat Zentiva?
As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Zentiva are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Emtricitabin/dizoproksiltenofovirat Zentiva stalno spremljajo.
This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Truvada.
Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje dve učinkovini, emtricitabin (200 mg) in dizoproksiltenofovirat (245 mg).
Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja v kombinaciji z vsaj enim drugim zdravilom proti virusu HIV za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva.
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Emtricitabin/dizoproksiltenofovirat Zentiva.
Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja tudi kot pomoč pri preprečevanju spolno prenosljive okužbe z virusom HIV-1 pri odraslih in mladostnikih, pri katerih je tveganje za okužbo veliko (predekspozicijska profilaksa oziroma PrEP).
For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Zentiva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva, ki se uporablja za zdravljenje okužbe z virusom HIV-1 v kombinaciji z vsaj enim drugim zdravilom proti okužbi z virusom HIV, zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
For more information about using Emtricitabine/Tenofovir disoproxil Zentiva, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Emtricitabin/dizoproksiltenofovirat Zentiva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Emtricitabin in tenofovir podobno zavirata delovanje reverzne transkriptaze, tj. encima, ki ga tvori virus HIV, s katerim lahko ta okuži celice ter tvori še več virusov.
The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Zentiva on kidney function, and information about use in adults for pre-exposure prophylaxis.
Podjetje, ki trži zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva, bo pripravilo informacijsko gradivo za zdravnike, ki bo vključevalo opis možnih škodljivih učinkov tega zdravila na delovanje ledvic in informacije o njegovi uporabi za predekspozijsko profilakso pri odraslih.
Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets.
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva je na voljo v obliki tablet.
What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Zentiva?
Kakšne so koristi in tveganja, povezani z zdravilom Emtricitabin/dizoproksiltenofovirat Zentiva?
Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Predpisovanje in izdaja zdravila Emtricitabin/dizoproksiltenofovirat Zentiva je le na recept, zdravljenje z njim pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje dve učinkovini: emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, in dizoproksiltenofovirat, ki je „predzdravilo“ tenofovirja.
Other information about Emtricitabine/Tenofovir disoproxil Zentiva
Druge informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Zentiva
What is Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?
Kaj je zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva in za kaj se uporablja?
Why is Emtricitabine/Tenofovir disoproxil Zentiva authorised in the EU?
Zakaj je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva odobreno v EU?
Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil)
Emtricitabin/dizoproksiltenofovirat Zentiva (emtricitabin/dizoproksiltenofovirat)
Therefore, the Agency's view was that, as for Truvada, the benefits of Emtricitabine/Tenofovir disoproxil Zentiva outweigh the identified risks and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Emtricitabin/dizoproksiltenofovirat Zentiva, enako kot pri zdravilu Truvada, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Zentiva in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva naj bi pri predekspozicijski profilaksi pred okužbo z virusom HIV-1 po pričakovanjih v primeru izpostavljenosti posameznika virusu preprečilo razmnoževanje in širjenje virusa z mesta okužbe.
How is Emtricitabine/Tenofovir disoproxil Zentiva used?
Kako se zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva uporablja?
How has Emtricitabine/Tenofovir disoproxil Zentiva been studied?
Kako je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva raziskano?
How does Emtricitabine/Tenofovir disoproxil Zentiva work?
Kako zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva deluje?
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN
1 Previously known as Nymusa.
1 Prej znano kot Nymusa.
The name of the medicine was changed to Peyona on 24 November 2010.
Ime zdravila je bilo 24. novembra 2010 spremenjeno v Peyona.
Peyona caffeine citrate
Peyona kofein citrat
The main measure of effectiveness in this review was the number of patients who did not have ‘treatment failure'.
Glavno merilo učinkovitosti v tej recenziji je bilo število bolnikov brez „neuspešnega zdravljenja“.
The European Commission granted a marketing authorisation valid throughout the European Union for Nymusa on 02 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Nymusa, veljavno po vsej Evropski uniji, izdala 2. julija 2009.
What measures are being taken to ensure the safe and effective use of Peyona?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Peyona?
This study looked at how long the babies survived and whether or not they had neurological disabilities after 18 months.
V tej študiji so proučevali, kako dolgo so novorojenčki preživeli in ali so po 18 mesecih imeli nevrološke okvare.
Primary means that the apnoea has no obvious cause.
Izraz „primarna“ pa pomeni, da za apnejo ni očitnega vzroka.
This reduces the effect of adenosine, stimulating the brain to resume breathing.
To zmanjša učinek adenozina in stimulira možgane, da se dihanje ponovno začne.
Other information about Peyona
Druge informacije o zdravilu Peyona
This is a summary of the European public assessment report (EPAR) for Peyona.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Peyona.
The doctor will stop treatment with Peyona when the baby has five to seven consecutive days without apnoea attacks.
Zdravnik bo zdravljenje z zdravilom Peyona prekinil, ko bo novorojenček pet do sedem zaporednih dni brez napadov apneje.
For more information about treatment with Peyona, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Peyona preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Peyona shown during the studies?
Kakšne koristi je zdravilo Peyona izkazalo med študijami?
A baby was considered to be in treatment failure if there was no halving of the number of apnoea episodes, if the baby required a machine to assist in breathing or if the baby did not survive.
Zdravljenje je veljalo za neuspešno, če se pri novorojenčku število epizod apneje ni prepolovilo, če je ta potreboval aparat za pomoč pri dihanju ali če ni preživel.
Because caffeine citrate has been used in premature babies for a long time, the company presented information from the scientific literature.
Ker se kofein citrat že dolgo uporablja pri nedonošenčkih, je družba predstavila podatke iz strokovne literature.
Caffeine citrate is an ‘antagonist' of adenosine, a substance that blocks the activity of some parts of the brain, including the part responsible for controlling breathing.
Kofein citrat je „antagonist“ adenozina, snovi, ki zavira dejavnost določenih delov možganov, vključno z delom, ki je odgovoren za nadzor dihanja.
In the large published study, 46% of babies given placebo (431 out of 932) died or had neurological disabilities compared with 40% of babies given caffeine citrate (377 out of 937).
V večji objavljeni študiji je 46 % novorojenčkov, ki so prejeli placebo (431 otrok od 932), umrlo ali imelo nevrološke posledice, med novorojenčki, ki so prejeli kofein citrat, pa je bilo takih 40 % (377 otrok od 937).
When judged necessary, the doctor may monitor the level of caffeine in the baby's blood and adjust the dose accordingly.
Zdravnik se lahko po potrebi odloči nadzirati ravni kofeina v krvi novorojenčka in skladno z njimi prilagajati odmerke.
The summary of opinion of the Committee for Orphan Medicinal Products for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Peyona je na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
A risk management plan has been developed to ensure that Peyona is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Peyona je bil pripravljen načrt obvladovanja tveganj.
Apnoea in newborns is the cessation of breathing for more than 20 seconds.
Apneja pri nedonošenčkih je prekinitev v dihanju za dlje kot 20 sekund.
For the full list of all side effects and restrictions with caffeine citrate, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi kofein citrata glejte navodilo za uporabo.
The active substance in Peyona, caffeine citrate, is a stimulant of the nervous system.
Zdravilna učinkovina v zdravilu Peyona, kofein citrat, je spodbujevalec živčnega sistema.
Because the number of patients with primary apnoea of premature newborns is low, the disease is considered ‘rare', and Peyona was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Ker je nedonošenčkov s primarno apnejo malo, velja ta bolezen za redko, zato je bilo zdravilo Peyona 17. februarja 2003 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja za zdravljenje redkih bolezni).
The most common side effects with caffeine citrate (seen in between 1 and 10 patients in 100) are hyperglycaemia (high blood glucose levels), tachycardia (rapid heartbeat) and phlebitis (inflammation of a vein) and inflammation at the site of infusion.
Najpogostejši neželeni učinki kofein citrata (opaženi pri 1 do 10 bolnikih od 100) so hiperglikemija (visoke koncentracije glukoze v krvi), tahikardija (pospešen srčni utrip) in flebitis (vnetje vene) ter vnetje na mestu infundiranja.
Apnoea in premature babies is due to the baby's breathing centres in the brain not being fully developed.
Do apneje pri nedonošenčkih pride zato, ker dihalni centri v njihovih možganih še niso povsem razviti.
The full EPAR for Peyona 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 Peyona je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was based on the reduction by at least a half in the daily number of apnoea episodes over ten days.
Glavno merilo učinkovitosti je bilo zmanjšanje števila dnevnih epizod apneje v desetih dneh za vsaj polovico.
Treatment is started with a dose of 20 mg per kilogram bodyweight given once by slow infusion over 30 minutes.
Začetni odmerek znaša 20 mg na kg telesne mase, odmerjen s počasno 30-minutno infuzijo.
What is the risk associated with Peyona?
Kakšna tveganja so povezana z zdravilom Peyona?