natgillin/translations-raw huggingface dataset:
The full EPAR for Spedra 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 Spedra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The dose may be adjusted if necessary; lower doses may be needed in patients with liver problems or who are taking certain other medicines.
Odmerek se lahko po potrebi prilagodi; nižji odmerki bodo morda potrebni pri bolnikih z jetrnimi obolenji ali pri tistih, ki jemljejo druga zdravila.
What benefits of Spedra have been shown in studies?
Kakšne koristi je zdravilo Spedra izkazalo v študijah?
This is a summary of the European public assessment report (EPAR) for Spedra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Spedra.
The main measures of effectiveness in all three studies were the percentage of erections that lasted long enough for successful intercourse, the percentage of successful vaginal penetrations, and the change in an assessment score for erectile function.
Glavna merila učinkovitosti v vseh treh študijah so bila odstotek erekcij, ki so trajale dovolj dolgo za uspešen spolni odnos, odstotek uspešnih vaginalnih penetracij in sprememba v rezultatu ocene erektilne funkcije.
The medicine also produced about 20% more successful vaginal penetrations than placebo.
Zdravilo je povzročilo tudi približno 20 % več uspešnih vaginalnih penetracij kot placebo.
What are the risks associated with Spedra?
Kakšna tveganja so povezana z zdravilom Spedra?
A risk management plan has been developed to ensure that Spedra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Spedra je bil pripravljen načrt obvladovanja tveganj.
What is Spedra and what is it used for?
Kaj je zdravilo Spedra in za kaj se uporablja?
Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription.
Zdravilo Spedra je na voljo v obliki tablet (50 mg, 100 mg in 200 mg) in se izdaja le na recept.
It is not intended to provide practical advice on how to use Spedra.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction.
Zdravilo Spedra so proučevali v treh glavnih študijah, v katere je bilo vključenih 3 400 moških z erektilno disfunkcijo.
Other information about Spedra
Druge informacije o zdravilu Spedra
Doctors should consider the potential risks of sexual activity for the heart in men who have heart disease before prescribing Spedra.
Zdravniki naj pri moških, ki imajo srčno obolenje, pred predpisovanjem zdravila Spedra upoštevajo možna tveganja spolne dejavnosti za srce.
Spedra was more effective than placebo in all studies.
Zdravilo Spedra je bilo v vseh študijah učinkovitejše od placeba.
Why is Spedra approved?
Zakaj je bilo zdravilo Spedra odobreno?
The Committee therefore considered that Spedra'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 Spedra večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Regarding its safety, side effects were similar to other medicines of its class.
Glede njegove varnosti so bili neželeni učinki podobni neželenim učinkom drugih zdravil iz te skupine.
The improvement in assessment score was about 5 to 7 points more than with placebo.
Izboljšanje rezultata ocene erektilne funkcije je znašalo približno od 5 do 7 točk več kot pri placebu.
The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors.
Zdravilna učinkovina v zdravilu Spedra, avanafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
The recommended dose is 100 mg, taken approximately 15 to 30 minutes before sexual activity; patients should not take more than one dose a day.
Priporočeni odmerek je 100 mg, ki se vzame približno od 15 do 30 minut pred spolnim odnosom, pri čemer bolniki ne smejo vzeti več kot en odmerek na dan.
Spedra must not be taken with certain other medicines including nitrates (a type of medicine used for angina) or medicines that strongly reduce the breakdown of Spedra in the body.
Zdravilo Spedra se ne sme jemati skupaj z določenimi drugimi zdravili, vključno z nitrati (vrsto zdravil za zdravljenje angine pektoris), ali zdravili, ki močno zmanjšajo razgradnjo zdravila Spedra v telesu.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spedra, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Spedra is a medicine used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Zdravilo Spedra se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, ki ne zmorejo doseči ali ohraniti dovolj čvrstega penisa (erekcije) za zadovoljiv spolni odnos.
An additional study involving 440 adults with erectile dysfunction was also carried out, where Spedra was taken approximately 15 minutes before sexual activity.
Izvedena je bila tudi dodatna študija, v katero je bilo vključenih 440 odraslih z erektilno disfunkcijo, ki so zdravilo Spedra vzeli približno 15 minut pred spolnim odnosom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo in allowing successful intercourse.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Spedra pri omogočanju uspešnega spolnega odnosa učinkovitejše od placeba.
The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.
Odstotek uspešnih poskusov je bil približno 28 % pri jemanju zdravila Spedra v odmerku 200 mg in okoli 25 % v odmerku 100 mg v primerjavi s 14 % pri jemanju placeba.
The most common side effects with Spedra (which may affect up to 1 in 10 people) are headache, flushing (reddening of the skin) and nasal congestion; back pain has also been reported and may affect up to 1 in 100 people.
Najpogostejši neželeni učinki zdravila Spedra (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, zardevanje (pordelost kože) in zamašenost nosu, poročali pa so tudi o bolečinah v hrbtu, ki se lahko pojavi pri največ 1 bolniku od 100.
The medicine must not be used by patients with certain serious heart or circulatory problems, including those who have had a heart attack, stroke, or serious arrhythmia (irregularity of the heart rhythm) in the last six months and those who have unstable angina (a severe type of chest pain), angina during sexual intercourse, heart failure, or high or low blood pressure.
Zdravila ne smejo uporabljati bolniki z določenimi resnimi težavami s srcem ali ožiljem, vključno z bolniki, ki so v zadnjih šestih mesecih doživeli srčni infarkt, kap ali hudo aritmijo (motnje srčnega ritma), in bolniki z nestabilno angino pektoris (hudo obliko bolečine v prsnem košu), angino pektoris med spolnim odnosom, srčnim popuščanjem ter visokim ali nizkim krvnim tlakom.
The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked mainly at men who had erectile dysfunction and diabetes, and the third was in men who had erectile dysfunction after surgery on the prostate gland.
V prvo študijo so bili vključeni moški iz splošne populacije, ker pa bi lahko določena stanja, povezana z erektilno disfunkcijo, vplivala na odziv na zdravljenje, so v drugi študiji opazovali predvsem moške, ki so imeli erektilno disfunkcijo in sladkorno bolezen.
For practical information about using Spedra, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Spedra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For more information about treatment with Spedra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Spedra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
However, the fact that it was not compared directly with other medicines in its class made it hard to evaluate its potential place in treating erectile dysfunction.
Ker pa zdravila Spedra niso neposredno primerjali z drugimi zdravili iz te skupine, je težko oceniti njegovo primernost pri zdravljenju erektilne disfunkcije.
It must also not be used by patients who have severely reduced liver or kidney function, or who have had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischaemic optic neuropathy, NAION) that can be triggered by this class of medicines.
Prav tako ga ne smejo uporabljati bolniki z močno okrnjenim delovanjem jeter ali ledvic ali bolniki, ki so izgubili vid zaradi težav z dotokom krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija - NAION), ki jih lahko sproži ta skupina zdravil.
The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%.
Rezultati prve študije so pokazali, da je zdravilo Spedra v odmerku 100 mg ali 200 mg, ki se vzame približno 30 minut pred spolnim odnosom, povečalo odstotek uspešnih poskusov spolnih odnosov s 13 % pred zdravljenjem na približno 57 %, medtem ko je placebo odstotek povečal samo na 27 %.
In these studies, which lasted for 12 weeks, different doses of Spedra taken approximately 30 minutes before sexual activity were compared with placebo (a dummy tablet).
V teh študijah, ki so trajale 12 tednov, so primerjali različne odmerke zdravila Spedra, ki so ga bolniki vzeli približno 30 minut pred spolnim odnosom, s placebom (tableto brez zdravilne učinkovine).
For the full list of all side effects reported with Spedra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Spedra, glejte navodilo za uporabo.
By blocking the breakdown of cGMP, Spedra enhances its effect on erectile function.
Z zaviranjem razgradnje cGMP zdravilo Spedra ponovno vzpostavi erektilno funkcijo.
How is Spedra used?
Kako se zdravilo Spedra uporablja?
Spedra contains the active substance avanafil.
Vsebuje zdravilno učinkovino avanafil.
For Spedra to be effective, sexual stimulation is required.
Zdravilo je učinkovito le ob spolnem vzburjenju.
The safety was considered sufficiently shown.
Varnost se šteje za zadostno dokazano.
Your symptoms may reoccur.
Vaši simptomi se lahko ponovno pojavijo.
- If you suffer from asthma.
- če trpite za astmo.
Pharmacovigilance reporting, mainly from Sweden and Spain, does not indicate any new safety issues.
Poročila farmakovigilance, v glavnem iz Švedske in Španije, ne kažejo novih varnostnih vprašanj.
ATC code: M01AX05
ATC oznaka: M01AX05
This was considered appropriate.
To se je zdelo ustrezno.
The applicant provided bibliographical data from a number of studies.
Vlagatelj je predložil bibliografske podatke iz številnih raziskav.
Approximately 38% of an intravenous dose is excreted in the urine as unchanged substance.
Približno 38% intravensko danega odmerka se izloči z urinom v nespremenjeni obliki.
Children and Adolescents
Otroci in mladostniki
The open, comparative study by Qiu 2005 did not identify any efficacy differences between the two formulations.
V odprti primerjalni raziskavi Qiu 2005 ni bilo opaženih nobenih razlik v učinkovitosti med obema formulacijama.
Two Cochrane reviews indicate efficacy but in the second review the conclusion are more hesitant.
Dva Cochranova pregleda nakazujeta učinkovitost, vendar je drugi pregled bolj nedoločen v zaključkih.
The distribution volume is approximately 5 litres and the half-life after intravenous administration is approximately 2 hours.
Volumen porazdelitve je približno 5 litrov, razpolovni čas po intravenski uporabi je približno 2 uri.
The clinical relevance is unknown.
Klinični pomen ni znan.
The period to onset of response cannot be assessed.
Čas začetka delovanja ni mogoče oceniti.
The tablets should be swallowed together with some water or other suitable liquid.
Tablete pogoltnite skupaj z nekaj vode ali z drugo primerno tekočino.
D-glucosamine has low acute toxicity.
D-glukozamin ima nizko akutno toksičnost.
Tablets can be taken with or without food.
Tablete se lahko zaužije skupaj s hrano ali brez nje.
For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1
Additional information on special populations.
Dodatne informacije o posebnih skupinah bolnikov.
The reported adverse reactions are usually mild and transitory.
Neželeni učinki o katerih so poročali so običajno blagi in prehodnega značaja.
The safety in all the performed studies covering thousands of patients is reassuring and was comparable to placebo.
Varnost je bila v vseh raziskavah, ki so zajele na tisoče bolnikov, pomirjujoča in primerljiva s placebom.
These indicate efficacy even if modest.
Iz obeh je razvidna učinkovitost, čeprav je skromna.
The absolute bioavailability is unknown.
Absolutna biološka uporabnost ni znana.
The applicant nonetheless mainly referred to the two large and long-term studies by Reginster and Pavelka.
Vlagatelj se je kljub temu v glavnem skliceval na dve veliki, dolgoročni raziskavi, ki sta ju opravila Reginster in Pavelka.
13 C 1327 Lysaker Norway
13 C 1327 Lysaker Norveška
Since 1980 many clinical studies of glucosamine have been performed, with varying scientific relevance and quality.
Od leta 1980 je bilo opravljenih veliko kliničnih raziskav glukozamina, ki se razlikujejo v znanstvenem pomenu in kakovosti.
1250 mg glucosamine once daily for relief of symptoms.
1250 mg glukozamina enkrat dnevno za lajšanje simptomov.
From animal studies only insufficient data are available.
Podatki iz študij na živalih so nepopolni.
When it comes to relative benefit and risk assessment, the influence of publication bias may be less.
Kar se tiče relativnosti ocene razmerja med koristmi in tveganji, bo vpliv pristranskosti izhajajoče iz publikacij, verjetno manjši.
Benefit/risk assessment
Vrednotenje koristi in tveganj
The safety profiles are, however, inferior to glucosamine.
Vendar so varnostni profili slabši kot pri glukozaminu.
Different views on glucosamine, due to different interpretations of regulatory/legal systems have resulted in glucosamine being classified as a medicinal product in many regions of the world, including some Member States.
Zaradi različnih pogledov na glukozamin, ki so posledica različnih interpretacij zakonskih/pravnih sistemov, je glukozamin v veliko delih sveta, med drugim nekaterih državah članicah, uvrščen med zdravila.
Overall the safety profile is favourable with mainly mild gastrointestinal symptoms reported.
Na splošno je varnostni profil ugoden, poročali so večinoma o blagih gastrointestinalnih simptomih.
Glucosamine is considered to be an simple substance with a high solubility, and therefore, a comparative bioavailability study was not considered necessary for an approval.
Glukozamin se šteje za preprosto spojino, ki ima veliko topnost, zato se je zdelo, da primerjalna raziskava biološke uporabnosti za odobritev ni potrebna.
Weifa AS, Hausmannsgate 6, P. O. box 9113, Grønland, 0133 Oslo, Norway This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Weifa AS, Hausmannsgate 6, P. O. box 9113, Grønland, 0133 Oslo, Norveška Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija
Pack-sizes of 40, 60 or 180 tablets.
Velikosti pakiranj: 40, 60 ali 180 tablet.
No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.
Pri starejših ljudeh niso bile opravljene posebne študije, vendar v skladu z dosedanjimi kliničnimi izkušnjami prilagajanje odmerkov pri starejših, sicer zdravih ljudeh, ni potrebno.
These two studies use authorised glucosamine-containing medicinal products, are long-term 3-years placebo-controlled studies, include an appropriate number of patients with appropriate inclusion criteria and look at relevant endpoints.
Obe raziskavi uporabljata odobreno zdravilo, ki vsebuje glukozamin, sta dolgoročni 3 leta trajajoči, s placebom nadzorovani raziskavi, obsegata dovolj veliko število bolnikov z ustreznimi vključitvenimi kriteriji in določata pomembne končne točke.
Concurrent treatment with glucosamine may increase the absorption and serum concentration of tetracyclines, but the clinical relevance of this interaction is probably limited.
Hkratno zdravljenje z glukozaminom lahko poveča absorpcijo in serumsko koncentracijo tetraciklinov, vendar je klinični pomen teh interakcij verjetno omejen.
Sporadic, spontaneous cases of hypercholesterolaemia have been reported, but causality has not been established.
Poročali so o posameznih spontanih primerih hiperholesterolemije, vendar vzročnost ni bila ugotovljena.
In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions (ADRs), to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/benefit profile of glucosamine hydrochloride in the intended indication.
Poleg tega je bil vlagatelj naprošen, da upraviči predlagani odmerek in odmerjanja; da opiše varnostni profil, vključno z razpravo o navedenih neželenih učinkih zdravila (ADR); da upraviči ustreznost literature, saj navedena literatura opisuje formulacijo glukozamin sulfata (kot kompleks z natrijevim kloridom), ki se razlikuje od formulacije v zadevni vlogi, ter navede, ali razlike v formulaciji spremenijo učinkovitost in varnost zdravila; da razjasni možnost medsebojnega delovanja z drugimi zdravili; ter kot zadnje, da dokaže pozitivno razmerje med koristmi in tveganji za glukozamin hidroklorid za predvideno indikacijo.
Glucosamine is not indicated for the treatment of acute painful symptoms.
Glukozamin ni indiciran za zdravljenje akutnih bolečinskih simptomov.
Glucomed United Kingdom [To be completed nationally]
Glucomed Velika Britanija [izpolni država članica]
If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
Če olajšanje bolečine ne nastopi po 2-3 mesecih zdravljenja, je potrebno nadaljnje zdravljenje z glukozaminom ponovno ovrednotiti.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJA, IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GLUCOMED AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA GLUCOMED IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
In the most recent meta-analysis from the Cochrane group in 2005, the results are positive when a glucosamine-containing medicinal product was used, positive for placebo-controlled studies in general and negative when the studies with adequate allocation concealment are retained.
V zadnji metaanalizi Cochranove skupine leta 2005 so bili rezultati pozitivni kadar se jemljejo zdravila, ki vsebuje glukozamin, pozitivni za s placebom nadzorovane raziskave na splošno in negativni, ko so obdržali le raziskave z zadostno zaslepljenostjo načina zdravljenja.
Like all medicines, Glucomed can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Glucomed neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The mechanism of action of glucosamine in humans is unknown.
Mehanizem delovanja glukozamina pri ljudeh ni znan.
For both studies the results are statistically significant for the WOMAC scale (Reginster) and for WOMAC and Lequesne scale (Pavelka) at 3 years.
V obeh raziskavah so bili rezultati po 3 letih statistično pomembni po lestvici WOMAC (Reginster) in lestvici WOMAC in Lequesne (Pavelka).
Luxembourg Glucomed Netherlands
Luksemburg Glucomed Nizozemska Glucomed Norveška
Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvents.
Glukozamin je relativno majhna molekula (molekulska masa 179), ki je dobro topna v vodi in topna v hidrofilnih organskih topilih.
Dose selection in this bibliographical application is made from experience from other related glucosamine products and the dose and posology chosen is the same as used in almost all performed studies.
Izbira odmerka v tej bibliografski vlogi je temeljila na izkušnjah iz drugih sorodnih glukozaminskih zdravil, izbrana odmerek in način odmerjanja pa sta bila enaka kot v skoraj vseh ostalih opravljenih raziskavah.
¾ The scope of the referral was to discuss the benefit/risk of glucosamine hydrochloride in the proposed indication ¾ The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
¾ Namen napotitvenega postopka je bil razpravljati o razmerju med koristmi in tveganji glukozamin hidroklorida za predlagano indikacijo, ¾ Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, ki jih je predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
Within this referral procedure, a question was raised, whether Glucomed containing glucosamine hydrochloride, was as effective as glucosamine sulphate.
Med tem napotitvenim postopkom se je pojavilo vprašanje, ali je zdravilo Glucomed, ki vsebuje glukozamin hidroklorid, enako učinkovito kot glukozamin sulfat.
Pharmacovigilance surveillance has resulted in some reports indicating a potential interaction with warfarin, and hence a warning has been added in the SPC text.
V okviru farmakovigilančnega spremljanja se je pojavilo nekaj poročil o potencialnem medsebojnem delovanju z varfarinom, zato je bilo v besedilo SPC dodano opozorilo.
PHARMACEUTICAL FORM AND CONTENTS 40 tablets
FARMACEVTSKA OBLIKA IN VSEBINA 40 tablet
There is no data available on the excretion of glucosamine in human milk.
Ni podatkov o izločanju glukozamina v humano mleko.
A report on exacerbated asthma symptoms triggered after initiation of glucosamine therapy has been described (symptoms resolved after withdrawal of glucosamine).
Opisano je poročilo o poslabšanju simptomov astme, ki se je pojavilo po začetku zdravljenja z glukozaminom (simptomi so izginili po prenehanju jemanja glukozamina).
Take special care with Glucomed - if you suffer from impaired glucose tolerance.
Bodite posebno pozorni pri uporabi zdravila Glucomed - če trpite zaradi okvarjene tolerance za glukozo.
Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of symptoms.
Bolniki z astmo, ki začenjajo z jemanjem glukozamina, se morajo zavedati možnosti poslabšanja simptomov.