natgillin/translations-raw huggingface dataset:
Ibuprofen may increase blood concentrations and thus increase the risk of toxicity on kidney and ear
Ibuprofen lahko zviša njihove koncentracije v krvi in tako zveča tveganje toksičnosti za ledvice in ušesa.
The active substance in Pedea is ibuprofen.
Zdravilna učinkovina v zdravilu Pedea je ibuprofen.
However, overdose has been described in infants and children administered oral ibuprofen: CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Opisani pa so primeri prevelikega odmerjanja pri dojenčkih in otrocih, zdravljenih s peroralno obliko ibuprofena: depresija CŽS, krči, gastrointestinalne motnje, bradikardija, hipotenzija, apnea, motnje ledvične funkcije, hematurija.
No case of overdose has been reported with intravenous ibuprofen in preterm newborn infants.
Ni poročil o primerih prevelikega odmerjanja intravenske oblike ibuprofena pri nedonošenčkih.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Navedba smiselno ni potrebna.
If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.
V primeru, da se ductus arteriosus ne zapre 48 ur po aplikaciji zadnjega odmerka ali pa se ponovno odpre, lahko zdravljenje z zdravilom Pedea, kot je opisano zgoraj, še enkrat ponovite.
Uncommon: Gastrointestinal haemorrhage Unknown: Gastric perforation
Neznana: gastrična perforacija
Read all of this leaflet carefully before this medicine is administered to your baby.
Preberite navodila, preden vaš dojenček dobi zdravilo!
- The active substance is ibuprofen.
- Zdravilna učinkovina je ibuprofen.
The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Potreben volumen, ki naj bi ga prejel novorojenček, mora biti prilagojen na telesno maso in injiciran intravensko v kratki 15-minutni infuziji, najbolje nerazredčen.
Common: Necrotizing enterocolitis, Intestinal perforation
Pogosto: nekrotizirajoči enterokolitis, perforacija prebavil
The total volume of solution injected should take into account the total daily fluid volume administered.
Celokupni injiciran volumen upoštevajte pri celokupnem dnevnem vnosu tekočin.
The management of ibuprofen overdose is primarily supportive.
Zdravljenje prevelikega odmerka ibuprofena obsega osnovno podporno zdravljenje.
Pedea should be administered carefully to avoid extravasation and potential resultant irritation to tissues.
Zdravilo Pedea v izogib ekstravazacije in potencialnega draženja tkiv aplicirajte previdno.
There have also been post-marketing reports of pulmonary hypertension where Pedea was administered to premature neonates in the therapeutic setting.
Iz obdobja trženja zdravila obstajajo tudi poročila o pljučni hipertenziji pri nedonošenčkih, ki so v terapevtskem okolju prejemali zdravilo Pedea.
If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.
Če po drugem zdravljenju ductus arteriosus še vedno ni zaprt, lahko zdravnik predlaga operacijo.
Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Ibuprofen je nesteroidna protivnetna in protirevmatična zdravilna učinkovina, ki deluje protivnetno, analgetično in antipiretično.
Ibuprofen may increase the risk of bleeding in the stomach and intestines.
Ibuprofen lahko poveča nevarnost krvavitev v želodcu in črevesju.
When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.
Da bi se pri razkuževanju vrata ampule z antiseptikom izognili kakeršnikoli reakciji z raztopino zdravila Pedea, je treba zagotoviti, da je ampula popolnoma suha, preden jo odpremo.
Common: - Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia), - Bleeding in the lung, - Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), - Reduced volume of urine passed, blood in the urine, fluid retention
Pogosti: - krvavitev znotraj lobanje (intraventrikularna krvavitev) in poškodba možganov (periventrikularna levkomalacija), - krvavitev v pljučih, - predrtje (perforacija) črevesa in poškodba črevesnega tkiva (nekrotizantni enterokolitis), - zmanjšan volumen izločenega urina, kri v urinu, zastoj tekočine.
- Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.
- Zdravilo Pedea naj vašemu otroku v izogib poškodbam kože in okolnih tkiv aplicira izkušen zdravstveni delavec.
Very common: - Decrease in the number of platelets in the blood (thrombocytopenia), - Decrease in white blood cells called neutrophils (neutropenia), - Increase in creatinine level in the blood, - Decrease in sodium level in the blood, - Breathing problems (bronchopulmonary dysplasia),
Zelo pogosti: - zmanjšanje koncentracije krvnih ploščic v krvi (trombocitopenija), - zmanjšanje koncentracije belih krvničk, ki se imenujejo nevtrofilci (nevtropenija), - zvečanje koncentracije kreatinina v krvi, - zmanjšanje koncentracije natrija v krvi, - težave z dihanjem (bronhopulmonalna displazija).
As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Kot vse parenteralne pripravke je potrebno ampule zdravila Pedea pred uporabo pregledati glede prisotnosti delcev in integritete vsebnika.
Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure
Pogosto: oligurija, retenca tekočin, hematurija Občasno: akutna odpoved ledvic
As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of bleeding.
Ker ibuprofen zavira agregacijo trombocitov, je potrebno nedonošenčke nadzorovati glede znakov krvavitve.
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Zdravljenje hemodinamično pomembnega odprtega arterioznega duktusa (ductus arteriosus) pri nedonošenčkih, z gestacijsko starostjo manj od 34 tednov.
In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age.
V kliničnem preskušanju, v katerem so nedonošenčki profilaktično prejemali zdravilo Pedea v prvih 6 urah življenja, se je pri 3 novorojenčkih, z gestacijsko starostjo manj kot 28 tednov, pojavila huda hipoksemija s pljučno hipertenzijo.
As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels is recommended during co-administration with ibuprofen.
Ker ibuprofen lahko zmanjša očistek aminoglikozidov, priporočajo takrat, ko jih dajete skupaj z ibuprofenom, natančen nadzor njihovih serumskih koncentracij.
It is 10 mg/kg for the first administration and 5 mg/kg for the second and the third administrations.
V prvem odmerku bo prejel 10 mg/kg, v drugem in tretjem pa po 5 mg/kg.
Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary haemorrhage, as compared to curative use.
Profilaktična uporaba zdravila Pedea v prvih 3 dneh življenja (začeta v prvih 6 urah po rojstvu) pri nedonošenčkih, z gestacijsko starostjo manj kot 28 tednov, je bila, za razliko od kurativne uporabe, povezana s povečano pogostnostjo ledvične odpovedi ter neželenih učinkov na dihalih vključujoč hipoksijo, pljučno hipertenzijo, krvavitve iz dihal.
Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for injections.
Pomožne snovi: trometamol, natrijev klorid, natrijev hidroksid, 25 % klorovodikova kislina, voda za injekcije.
To avoid any possible microbiological contamination, the product should be used immediately after first opening.
Zdravilo moramo uporabiti takoj po prvem odpiranju, da preprečimo možno mikrobiološko kontaminacijo.
Common: Intraventricular haemorrhage, Periventricular leukomalacia
Pogosto: intraventrikularne krvavitve, periventrikularna levkomalacija
Ibuprofen may increase the risk of bleeding.
Ibuprofen lahko poveča nevarnost krvavitve.
Since prophylactic use in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased pulmonary and renal adverse events, Pedea should not be used prophylactically at any gestational age (see sections 4.8 and 5.1).
Zaradi povečanja pljučnih in ledvičnih neželenih učinkov pri profilaktični uporabi v prvih 3 dneh življenja (z začetkom 6 ur po rojstvu) pri nedonošenčkih, z gestacijsko starostjo manj kot 28 tednov, se zdravilo Pedea ne sme uporabljati profilaktično pri nobeni gestacijski starosti (glejte poglavji 4.8 in 5.1).
What Pedea is and what it is used for Before Pedea is administered to your baby How Pedea is used
Kaj je zdravilo Pedea in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Pedea Kako uporabljati zdravilo Pedea Možni neželeni učinki
The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
Celoten volumen injicirane raztopine pri nedonošenčkih je potrebno upoštevati pri celotnem dnevnem vnosu tekočin.
Residual concentrations are around 1015 mg/l 24 hours after the last dose of 5 mg/kg.
24 ur po zadnjem odmerku 5 mg/kg je končna koncentracija 10-15 mg/l.
The dose to be administered will be calculated from the weight of your baby.
Odmerek, ki ga bo vaš otrok prejel, bo prilagojen masi vašega otroka.
Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.
Pedea 5 mg/ml raztopina za injiciranje je na voljo v kartonskih škatlah s po štirimi ampulami z 2 mililitroma.
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.
Razen podatkov, vključenih v ostalih poglavjih povzetka glavnih značilnosti zdravila, ni relevantnih predkliničnih podatkov o klinični varnosti.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 mg/2 ml
In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy.
Pri treh novorojenčkih se je v prvi uri po infuziji pojavila huda hipoksemija s pljučno hipertenzijo, ki pa se je izboljšala v 30 minutah po začetku inhalacij dušikovega oksida.
After opening, Pedea should be administered immediately.
Zdravilo Pedea morate uporabiti takoj po odpiranju.
Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Nasprotno pa je bila ob profilaktični uporabi zdravila Pedea manjša pogostnost neonatalne intraventrikularne krvavitve stopnje III-IV in manjša potreba po kirurški ligaciji odprtega duktusa arteriozusa.
What Pedea contains
Kaj vsebuje zdravilo Pedea
Uncommon: - Acute failure of the kidney's functions - Bleeding in the intestine - Below normal oxygen content in the arterial blood (hypoxemia)
Občasni: - akutna odpoved delovanja ledvic, - krvavitev v črevo, - nenormalno nizka vsebnost kisika v arterijski krvi (hipoksemija).
Very common: Bronchopulmonary dysplasia* Common: Pulmonary haemorrhage Uncommon: Hypoxemia*
Zelo pogosto: bronhopulmonalna displazija Pogosto: krvavitve v pljučih Občasno: hipoksemija
Since ibuprofen was shown in vitro to displace bilirubin from its binding site to albumin, the risk of bilirubin encephalopathy in premature newborn infants may be increased (see section 5.2).
Dokazano je, da ibuprofen v in vitro pogojih izpodriva bilirubin iz vezavnega mesta na albuminih, zato je pri nedonošenčkih povečana nevarnost bilirubinske encefalopatije (glejte poglavje 5.2).
Pedea should be administered as a short infusion over 15 minutes, preferably undiluted.
Zdravilo Pedea morate dajati v kratkih 15-minutnih infuzijah, najbolje nerazredčeno.
Each ampoule of 2 ml contains 10 mg ibuprofen.
Ena ampula z 2 mililitroma vsebuje 10 mg ibuprofena.
Do not use Pedea - if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea; - if your baby has a life-threatening infection which has not been treated; - if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines; - if your baby has a decrease of blood cells called platelets (thrombocytopenia) or other problems with their blood clotting; - if your baby has kidney problems; - if your baby has other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained; - if your baby has or is suspected to have certain problems with their intestines (a condition called necrotising enterocolitis);
Ne uporabljajte zdravila Pedea: - če je vaš otrok alergičen (preobčutljiv) na ibuprofen ali katerokoli sestavino zdravila Pedea; - če ima vaš otrok smrtno nevarno okužbo, ki ni bila zdravljena; - če vaš otrok krvavi, še posebno če krvavi v lobanjo ali črevo; - če ima vaš otrok zmanjšano koncentracijo krvnih celic, ki se imenujejo krvne ploščice
OUTER CARTON TEXT
TEKST NA ZUNANJI OVOJNINI
In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
V izogib pomembnim spremembam pH-ja zaradi prisotnosti kislih zdravil, ki bi lahko ostali v infuzijskih sistemih, je potrebno le-te pred aplikacijo zdravila Pedea sprati z 1,5 do 2 ml 0,9% (9 mg/ml) raztopine natrijevega klorida za injiciranje ali 5 % (50 mg/ml) raztopine glukoze za injiciranje.
What Pedea looks like and contents of the pack Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution.
Pedea 5 mg/ml raztopina za injiciranje je bistra, brezbarvna do rahlo rumenkasta tekočina.
Each ml contains 5 mg ibuprofen.
En ml vsebuje 5 mg ibuprofena.
Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Trometamol, natrijev klorid, natrijev hidroksid (za uravnavanje pH), klorovodikova kislina 25 % (za uravnavanje pH) voda za injekcije.
- The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
- Pomožne snovi so trometamol, natrijev klorid, natrijev hidroksid (za uravnavanje pH), klorovodikova kislina 25 % (za uravnavanje pH) in voda za injekcije.
A rinse of the infusion line must be performed between each product administration (see section 6.6).
Med aplikacijami posameznih zdravil je potrebno infuzijske sisteme sprati (glej poglavje
Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
Pred vsako aplikacijo zdravila Pedea, v izogib stika s kislimi raztopinami, spirajte infuzijski sistem 15 minut z 1,5 do 2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopino glukoze za injiciranje.
HOW PEDEA IS USED
KAKO UPORABLJATI ZDRAVILO PEDEA
Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
Zdravilo Pedea bo vaš otrok prejel samo na posebnem intenzivnem neonatalnem oddelku.
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Tega zdravila ne smete mešati z drugimi zdravili, razen z 0,9% (9 mg/ml) raztopino natrijevega klorida za injiciranje ter 5% (50 mg/ml) raztopino glukoze za injiciranje.
This medicine has been prescribed for your baby.
- Zdravilo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Ibuprofen pri nedonošenčkih pomembno zniža plazemsko koncentracijo prostaglandinov in njihovih presnovkov, predvsem PGE2 in 6-keto-PGF-1-alfa.
- Your baby may develop some bleeding from the intestines and the kidneys.
- Pri vašem otroku se lahko pojavijo krvavitve iz prebavil ali sečil.
If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
V primeru neizboljšanja stanja po drugem zdravljenju, bo verjetno potrebno kirurško zdravljenje odprtega duktusa arteriozusa.
- corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding.
- kortikosteroidi: ibuprofen lahko poveča nevarnost krvavitev iz prebavil.
Pedea 5 mg/ml solution for injection
Pedea 5 mg/ml raztopina za injiciranje
Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
Za prilagajanje volumna uporabljajte le 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopino glukoze za injiciranje.
A course of therapy is defined as three intravenous injections of Pedea given at 24-hour intervals.
Zdravljenje z zdravilom Pedea sestoji iz treh intravenskih injekcij zdravila Pedea, danih v 24-urnih intervalih.
If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Če je potrebno, prilagodite volumen z 0,9 % raztopino (9 mg/ml) natrijevega klorida za injiciranje ali 5 % raztopino (50 mg/ml) glukoze za injiciranje.
Clear, colourless to slightly yellow solution.
raztopina za injiciranje Prozorna, brezbarvna do nekoliko rumenkasta raztopina.
Pedea 5mg/ml solution for injection Ibuprofen
Pedea 5mg/ml raztopina za injiciranje ibuprofen
Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea.
Trenutno so na voljo podatki o 1000 nedonošenčkih, tako iz literature o ibuprofenu kot iz kliničnih preskušanj z zdravilom Pedea.Vzročno povezanost poročanih neželenih učinkov je zaradi povezanosti le teh, tako s hemodinamičnimi posledicami odprtega duktusa arteriozusa kot direktnimi učinki ibuprofena, težko ocenjevati.
- other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the increased risk of adverse reactions.
- ostala nesteroidna protivnetna in protirevmatična zdravila: sočasno jemanje večih nesteroidnih protivnetnih in protirevmatičnih zdravil ni proporočljivo zaradi povečane nevarnosti neželenih učinkov.
Pedea is supplied in packs of 4 x 2 ml ampoules.
Zdravilo Pedea je na voljo v škatlah s 4 ampulami po 2 ml.
Ibuprofen may increase the anti-clotting effect of this product.
Ibuprofen lahko poveča učinek teh zdravil.
GLASS AMPOULE LABEL
BESEDILO NA STEKLENI AMPULI
Pedea must therefore be used cautiously in the presence of an infection (see also section 4.3).
Kot nesteroidno protivnetno zdravilo (NSAID) lahko ibuprofen zakrije običajne znake okužbe, zato zdravilo Pedea v prisotnosti okužbe uporabljajte previdno (glejte tudi poglavje 4.3).
Pedea 5 mg/ml solution for injection Ibuprofen
Pedea 5 mg/ml raztopina za injiciranje ibuprofen
A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
Zdravljenje z zdravilom Pedea sestoji iz treh intravenskih odmerkov, apliciranih v 24-urnih intervalih.
After first opening of an ampoule any unused portions must be discarded.
Po odprtju ampule vse neuporabljeno zdravilo zavrzite.
Intravenous use as short infusion Read the package leaflet before use
Za intravensko uporabo kot kratka infuzija.
Elimination
uporaba
See leaflet
Odmerjanje
HOW TO STORE PEDEA
SHRANJEVANJE ZDRAVILA PEDEA
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux France
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux
rd injections: 5 mg/kg.
Odmerek ibuprofena se prilagaja glede na telesno maso: -1. odmerek: 10 mg/kg -2. in 3. odmerek: 5 mg/kg
Recordati Rare Diseases Τηλ : +33 1 47 73 64 58 Γαλλία
Τηλ : +33 1 47 73 64 58 Γαλλία
CLINICAL PARTICULARS
Bolezni sečil
If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.
V primeru neizboljšanja stanja po drugem zdravljenju bo verjetno potrebno kirurško zdravljenje odprtega duktusa arteriozusa.
Any unused portion of the solution should be discarded.
Neuporabljeno raztopino zavrzite.
Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux France
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux Francija ali
IV use
NAVODILO ZA UPORABO
The expiry date refers to the last day of that month.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Ref. EMEA/307582/2009 EMEA/H/C/895
: EMEA/307582/2009 EMEA/H/C/895
London, 29 May 2009 Doc.
London, 29. maja 2009 Sklic dok.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje in potrebujete več informacij o svojem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The company presented the results of eight main studies involving over 4,000 adults to support its application.
Družba je v podporo svoji vlogi predstavila rezultate osmih glavnih študij, ki so vključevale več kot 4 000 odraslih.
Zopiclone has been available in the European Union (EU) as a treatment for insomnia since the mid-1980s.
Zopiklon je za zdravljenje nespečnosti na voljo v Evropski uniji (EU) od sredine osemdesetih let prejšnjega stoletja.
The letter from the company notifying the Agency of the withdrawal of the application is available here.
Dopis, s katerim družba Agencijo obvešča o umiku vloge, je na voljo tukaj.
The company withdrew before the European Commission had issued a decision on this opinion.
Družba je umaknila vlogo, preden je Evropska komisija izdala odločbo o mnenju.
The effects of Lunivia were first tested in experimental models before being studied in humans.
Učinki zdravila Lunivia so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The evaluation had finished and the CHMP had given a positive opinion.
Postopek ocenjevanja je bil zaključen in CHMP je izrazil pozitivno mnenje.
The studies looked at ‘transient' insomnia (in this case, insomnia caused by spending a night in an unfamiliar setting), at primary insomnia (insomnia with no other cause) and at insomnia caused by other conditions (major depression, generalised anxiety disorder, the menopause and rheumatoid arthritis).
V študijah so proučevali „prehodno“ nespečnost (v tem primeru gre za nespečnost, ki jo povzroči prenočevanje v nedomačem okolju), primarno nespečnost (nespečnost, ki nima znanega vzroka) in nespečnost, ki jo povzročajo drugi dejavniki (težja depresija, generalizirana anksiozna motnja, menopavza in revmatoidni artritis).
The main measures of effectiveness were how long it took for the patients to fall asleep or how long the patients were awake during the night after first falling asleep.
Glavno merilo učinkovitosti je bil čas, potreben, da so bolniki zaspali, ali trajanje njihovega bedenja ponoči, potem ko so prvič zaspali.