FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical justification for the dosage in adolescents referring to the similarity of the thickness of the stratum corneum (the ratelimiting barrier for percutaneous absorption) in adults and adolescents was considered acceptable by the CHMP.
Slovenian: Klinično utemeljitev odmerka pri mladostnikih, ki je temeljila na podobnosti debeline rožene plasti pokožnice (pregrade, ki omejuje hitrost perkutane absorpcije) pri odraslih in mladostnikih, je odbor CHMP ocenil kot sprejemljivo.
English: The harmonised information on posology and on application time was presented by the MAH per indication (i.e. skin, genital mucosa, leg ulcers) and per related procedure in a tabular format.
Slovenian: Imetnik dovoljenja za promet z zdravilom je usklajene informacije o odmerjanju in času nanosa predstavil po posameznih indikacijah (npr. koža, genitalna sluznica, ulkusi na nogi) in povezanih posegih v obliki razpredelnice.
English: The CHMP did generally agree with the text proposed by the MAH.
Slovenian: Odbor CHMP se je na splošno strinjal z besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
English: The MAH's proposal was supported by the CHMP as it was consistent with the wording in the majority of the countries.
Slovenian: Odbor CHMP se je strinjal s predlogom imetnika dovoljenja za promet z zdravilom, ki je bil skladen z besedilom v večini držav.
English: The CHMP was of the view that efficacy in genital mucosa indications such as application prior to superficial surgical procedures or infiltration anaesthesia when used in adults has been demonstrated in a number of clinical studies.
Slovenian: Odbor CHMP je menil, da je bila učinkovitost pri indikacijah, povezanih z genitalno sluznico, kot sta uporaba pred površinskimi kirurškimi posegi ali infiltracijsko anestezijo pri odraslih, dokazana v številnih kliničnih študijah.
English: In addition, efficacy in genital mucosa indications such as application prior to superficial surgical procedures or infiltration anaesthesia has been demonstrated in a number of clinical studies.
Slovenian: Poleg tega je bila učinkovitost pri indikacijah, povezanih z genitalno sluznico, kot je uporaba pred površinskimi kirurškimi posegi ali infiltracijsko anestezijo, dokazana v številnih kliničnih študijah.
English: The MAH listed as rare undesirable effect “anaphylactic reaction (in the most severe cases anaphylactic shock)”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je med redkimi neželenimi učinki navedel „anafilaktično reakcijo (v najhujših primerih anafilaktični šok)“.
English: The MAH provided an updated text for pregnancy taking into consideration the comments of CHMP and the new wording was endorsed by the Committee.
Slovenian: Imetnik dovoljenja za promet z zdravilom je upošteval pripombe odbora CHMP in predložil posodobljeno besedilo za nosečnost, ki ga je odbor odobril.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Slovenian: Odbor CHMP je imetniku dovoljenja za promet z zdravilom predložil seznam vprašanj, v katerem je izpostavil poglavja povzetka glavnih značilnosti zdravila, v katerih prihaja do razhajanj.
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Slovenian: Glavne točke razprave o usklajevanju različnih poglavij povzetka glavnih značilnosti zdravila so povzete v nadaljevanju.
English: The wording proposed by the MAH was the CSP agreed wording from the last PSUR work sharing procedure.
Slovenian: Besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je bilo besedilo dokumenta CSP, dogovorjeno v okviru zadnjega postopka delitve dela pri oceni PSUR.
English: The MAH made a proposal in line with the wording of the latest work sharing CSP. Additionally, information on pulse oximetry and antidotes in glucose-6-phosphate dehydrogenase deficiency has been agreed.
Slovenian: Poleg tega so bile dogovorjene informacije o pulzni oksimetriji in antidotih pri pomanjkanju glukoza-6-fosfat dehidrogenaze.
English: Topical anaesthesia of leg ulcers
Slovenian: Topična anestezija ulkusov na nogi
English: This wording was in line with the wording of the latest work sharing CSP.
Slovenian: To besedilo je skladno z besedilom dokumenta CSP, potrjenega v okviru zadnjega postopka delitve dela.
English: Leg ulcers
Slovenian: Ulkusi na nogah
English: The wording proposed by the MAH was the CSP agreed wording from the last PSUR work sharing procedure (IE/H/PSUR/0019/002) with additions to be in accordance with the latest QRD template and to provide a recommendation for pregnant and breast feeding women.
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje Besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je bilo besedilo dokumenta CSP, dogovorjeno v okviru zadnjega postopka delitve dela pri oceni PSUR (IE/H/PSUR/0019/002), ki so ga nekoliko dopolnili, da bi ga uskladili z najnovejšo predlogo za pregled kakovosti dokumentov in vključili priporočilo za nosečnice in ženske, ki dojijo.
English: The harmonised paediatric wording has been taken from the UK SmPC.
Slovenian: Usklajeno besedilo za pediatrično populacijo je bilo vzeto iz povzetka glavnih značilnosti zdravila, veljavnega v Združenem kraljestvu.
English: Section 4.2 - Posology and method of administration Adults and adolescents
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe
English: The wording of the CSP from the last work-sharing procedure as well as the recent PSURs served as basis for the harmonised text proposed by the MAH.
Slovenian: Usklajeno besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je temeljilo na besedilu dokumenta CSP z zadnjega postopka delitve dela in najnovejših poročilih PSUR.
English: It works in a different way to other authorised treatments.
Slovenian: Deluje na drugačen način kot druga že odobrena zdravila.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr on 11 July 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Firazyr, veljavno po vsej Evropski uniji, izdala 11. julija 2008.
English: The dose for adolescents and children depends on their body weight.
Slovenian: Odmerek za mladostnike in otroke je odvisen od njihove telesne mase.
English: The doctor may decide that the patient or their caregiver can inject the medicine themselves, after they have been properly trained by a healthcare professional.
Slovenian: Zdravnik bo morda odobril, da lahko bolnik ali njegov negovalec sama injicirata zdravilo, potem ko ju je za to ustrezno usposobil strokovni zdravstveni delavec.
English: What measures are being taken to ensure the safe and effective use of Firazyr?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Firazyr?
English: If needed, treatment can be repeated for a third time after an additional 6 hours.
Slovenian: Po potrebi se lahko zdravljenje tretjič ponovi po naslednjih šestih urah.
English: This is a summary of the European public assessment report (EPAR) for Firazyr.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Firazyr.
English: If symptoms continue or come back, a second injection can be given after 6 hours.
Slovenian: Če se simptomi nadaljujejo ali se ponovijo, se lahko po šestih urah vbrizga druga injekcija.
English: Other information about Firazyr
Slovenian: Druge informacije o zdravilu Firazyr
English: The recommended dose of Firazyr in adults is one injection (3 ml).
Slovenian: Priporočeni odmerek zdravila Firazyr pri odraslih je ena injekcija (3 ml).
English: The European Medicines Agency decided that Firazyr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je sklenila, da so koristi zdravila Firazyr večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.
Slovenian: To zavira delovanje bradikinina in pomaga ublažiti simptome bolezni.
English: The main measure of effectiveness was how long it took for the patient's symptoms to be relieved.
Slovenian: Glavno merilo učinkovitosti je bil čas do olajšanja simptomov pri bolniku.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firazyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Firazyr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: What is Firazyr and what is it used for?
Slovenian: Kaj je zdravilo Firazyr in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Firazyr.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: No more than three injections should be given in any 24-hour period.
Slovenian: V 24 urah se smejo dati največ tri injekcije.
English: What benefits of Firazyr have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Firazyr izkazalo v študijah?
English: What are the risks associated with Firazyr?
Slovenian: Kakšna tveganja so povezana z zdravilom Firazyr?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Firazyr have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Firazyr upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml.
Slovenian: Vsaka napolnjena injekcijska brizga zdravila Firazyr vsebuje 30 mg ikabanta na 3 ml.
English: Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Slovenian: Bolniki z angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli v telesu, na primer na obrazu, okončinah ali okoli črevesja, in povzročajo nelagodje ali bolečino.
English: In another study involving 22 adolescents and children aged over 2 years with hereditary angioedema, symptoms improved on average 1 hour after the patients received Firazyr.
Slovenian: V drugi študiji, ki je vključevala 22 mladostnikov in otrok, starejših od dveh let, z dednim angioedemom, je do izboljšanja simptomov v povprečju prišlo eno uro potem, ko so bolniki prejeli zdravilo Firazyr.
English: Firazyr is a medicine used to treat the symptoms of attacks of hereditary angioedema in adults, adolescents and children aged over 2 years.
Slovenian: Firazyr je zdravilo, ki se uporablja za zdravljenje simptomov napadov dednega angioedema pri odraslih, mladostnikih in otrocih, starejših od dveh let.
English: Because the number of patients with angioedema is low, the disease is considered ‘rare', and Firazyr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Slovenian: Ker je bolnikov z angioedemom malo, velja ta bolezen za redko, zato je bilo zdravilo Firazyr 17. februarja 2003 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja za zdravljenje redkih bolezni).
English: Attacks of hereditary angioedema can be life threatening when they involve the throat.
Slovenian: Napadi dednega angioedema so lahko smrtno nevarni, kadar se pojavijo v grlu.
English: For more information about treatment with Firazyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Firazyr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Firazyr approved?
Slovenian: Zakaj je bilo zdravilo Firazyr odobreno?
English: The full EPAR for Firazyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Firazyr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Firazyr (seen in more than 1 patient in 10) are injection site reactions including erythema (redness), swelling, burning, itching and pain at injection sites.
Slovenian: Najpogostejši neželeni učinki zdravila Firazyr (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja, ki vključujejo eritem (pordelost), otekanje, pekoč občutek, srbenje in bolečino na mestu injiciranja.
English: In both studies, the time it took for symptoms to improve was shorter for patients taking Firazyr than the comparator medicine.
Slovenian: V obeh študijah je bil čas do izboljšanja bolnikovih simptomov krajši pri bolnikih, ki so jemali zdravilo Firazyr, kot pri tistih, ki so jemali primerjalno zdravilo.
English: Patients' symptoms were relieved on average 2 to 2.5 hours after receiving Firazyr, compared with 12 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.
Slovenian: Bolniki so olajšanje občutili v povprečju od 2 do 2,5 ure po prejetju zdravila Firazyr v primerjavi z 12 urami po prejetju traneksamične kisline v prvi študiji oziroma 4,6 ure po prejetju placeba v drugi študiji.
English: Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Slovenian: Zdravilo Firazyr se uporablja pri bolnikih z angioedemom, ki je povezan z naravno nizkimi ravnmi beljakovine, imenovane zaviralec esteraze C1.
English: For practical information about using Firazyr, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Firazyr naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients.
Slovenian: V prvi študiji so zdravilo Firazyr primerjali s traneksamično kislino (drugim zdravilom za zdravljenje dednega angioedema) pri 74 bolnikih, v drugi študiji pa so zdravilo Firazyr primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 56 bolnikih.
English: For the list of all side effects and restrictions with Firazyr, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Firazyr glejte navodilo za uporabo.
English: Firazyr was also found effective among patients included in the two studies who had attacks of angioedema that affected the throat.
Slovenian: Učinkovitost zdravila Firazyr je bila ugotovljena tudi pri bolnikih, vključenih v obe študiji, ki so imeli napade angioedema, ki so prizadeli grlo.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which is involved in causing inflammation and swelling.
Slovenian: Bolniki z dednim angioedemom imajo visoke koncentracije snovi, imenovane bradikinin, ki sodeluje pri povzročanju vnetja in otekanja.
English: The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches to.
Slovenian: Zdravilna učinkovina v zdravilu Firazyr, ikatibant, zavira receptorje, na katere se bradikinin običajno veže.
English: Firazyr was found to relieve swelling in the skin and abdomen, as well as swelling of the throat.
Slovenian: Za zdravilo Firazyr je bilo ugotovljeno, da zmanjšuje otekline kože in trebuha ter grla.
English: Firazyr was found effective in two main studies in adults with hereditary angioedema involving the skin or the abdomen.
Slovenian: Učinkovitost zdravila Firazyr so potrdili v dveh glavnih študijah pri odraslih bolnikih z angioedemom, ki prizadene kožo ali trebuh.
English: The medicine is given by injecting it slowly under the skin, preferably in the abdomen (belly).
Slovenian: Zdravilo se počasi injicira v podkožje, po možnosti v trebuh.
English: Firazyr can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Firazyr je le na recept.
English: How is Firazyr used?
Slovenian: Kako se zdravilo Firazyr uporablja?
English: How does Firazyr work?
Slovenian: Kako zdravilo Firazyr deluje?
English: Firazyr contains the active substance icatibant.
Slovenian: Zdravilo Firazyr vsebuje zdravilno učinkovino ikatibant.
English: Firazyr icatibant
Slovenian: Firazyr ikatibant
English: This summary was last updated in 11/2013.
Slovenian: Povzetek je bil nazadnje posodobljen 11/2013.
English: Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, taken with food.
Slovenian: Zdravilo Vitekta je na voljo v obliki tablet (85 in 150 mg); priporočeni odmerek je ena tableta na dan, ki se vzame skupaj s hrano.
English: The full EPAR for Vitekta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vitekta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Vitekta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vitekta.
English: Vitekta must not be used with certain other medicines that may reduce its effectiveness or increase the risks of resistance.
Slovenian: Zdravilo Vitekta se ne sme uporabljati z nekaterimi drugimi zdravili, ki lahko zmanjšajo njegovo učinkovitost ali povečajo tveganje odpornosti.
English: The main measure of effectiveness was based on the reduction in the levels of HIV in the blood (viral load).
Slovenian: Glavno merilo učinkovitosti je temeljilo na zmanjšanju ravni virusov HIV v krvi (virusnega bremena).
English: A risk management plan has been developed to ensure that Vitekta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vitekta je bil pripravljen načrt obvladovanja tveganj.
English: The Committee also noted that there is a significant potential for interactions with other medicines, and this has been reflected in the product information.
Slovenian: Prav tako je izpostavil, da obstaja znatna možnost za medsebojno delovanje z drugimi zdravili, zato je bilo to dejstvo vključeno v informacije o zdravilu.
English: After 48 weeks, around 59% of patients treated with Vitekta (207 out of 351) responded to treatment compared with around 58% of patients treated with
Slovenian: Po 48 tednih se je na zdravljenje odzvalo približno 59 % (207 od 351) bolnikov, zdravljenih z zdravilom Vitekta, v primerjavi z 58 % (203 od 351) bolnikov, zdravljenih z raltegravirjem.
English: Patients who attained a viral load of less than 50 copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Slovenian: Bolniki, ki so po 48 tednih zdravljenja dosegli virusno breme, manjše od 50 kopij/ml, so bili opredeljeni kot odzivni na zdravljenje.
English: What is Vitekta and what is it used for?
Slovenian: Kaj je zdravilo Vitekta in za kaj se uporablja?
English: Vitekta has been investigated in one main study involving 712 patients with HIV-1 who had not been treated before with an integrase inhibitor.
Slovenian: Zdravilo Vitekta so preučevali v eni glavni študiji, ki je vključevala 712 bolnikov z virusom HIV-1, ki se pred tem še niso zdravili z zaviralcem integraze.
English: It is used to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Slovenian: Uporablja se za zdravljenje odraslih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: It is used in combination with ‘protease inhibitor' medicines taken together with ritonavir, and with other anti-HIV medicines in patients whose disease is not expected to be resistant
Slovenian: Uporablja se v kombinaciji z „zaviralci proteaze“, ki se jemljejo skupaj z ritonavirjem, in z drugimi zdravili proti okužbi z virusom HIV pri bolnikih, za katere se ne pričakuje, da bodo odporni na elvitegravir.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vitekta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vitekta večje od z njim povezanih tveganj, in priporočil, da se zdravilo odobri za uporabo v EU.
English: When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Slovenian: Z zaviranjem tega encima se virus ne more normalno razmnoževati, kar upočasni širjenje okužbe.
English: In this study, Vitekta was at least as effective as raltegravir (another integrase inhibitor) when taken in combination with other anti-HIV medicines.
Slovenian: V tej študiji je bilo zdravilo Vitekta najmanj tako učinkovito kot raltegravir (drug zaviralec integraze), če se je jemalo v kombinaciji z drugimi zdravili proti virusu HIV.
English: The most common side effects with Vitekta (which may affect up to 1 in 10 people) are headache, abdominal pain (stomach ache), diarrhoea, vomiting, nausea (feeling sick), rash, fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Vitekta (ki lahko prizadenejo največ 1 osebo od 10) so glavobol, bolečine v trebuhu (bolečine v želodcu), driska, bruhanje, slabost (siljenje na bruhanje), izpuščaji, utrujenost.
English: What are the risks associated with Vitekta?
Slovenian: Kakšna tveganja so povezana z zdravilom Vitekta?
English: For more information about treatment with Vitekta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vitekta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Slovenian: Zavira encim, imenovan integraza, ki je vključen v proces razmnoževanja virusa HIV.
English: Vitekta 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.
Slovenian: Zdravilo Vitekta ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema in razvoj okužb ter bolezni, povezanih z aidsom.
English: Regarding the safety profile of the medicine, this was not considered of concern, with side effects comparable to other similar medicines.
Slovenian: Menil je, da varnostni profil tega zdravila ni vprašljiv, saj so neželeni učinki primerljivi z neželenimi učinki podobnih zdravil.
English: What benefits of Vitekta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vitekta izkazalo v študijah?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vitekta, including the appropriate precautions to be followed by healthcare
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vitekta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati
English: The choice of dose of Vitekta depends on which other medicines it is given with.
Slovenian: Izbira odmerka zdravila Vitekta je odvisna od drugih zdravil, s katerimi se sočasno uporablja.
English: It is not intended to provide practical advice on how to use Vitekta.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Vitekta is an antiviral medicine that contains the active substance elvitegravir.
Slovenian: Vitekta je protivirusno zdravilo, ki vsebuje zdravilno učinkovino elvitegravir.