FrancophonIA/ELRC3.0 huggingface dataset:
English: - Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Slovenian: To velja zlasti za našteta zdravila, kadar jih jemljete sočasno z zdravilom Tolura: - zdravila z litijem za zdravljenje nekaterih oblik depresije; - zdravila, ki lahko povečajo raven kalija v krvi (npr. nadomestki soli s kalijem), diuretiki, ki zadržujejo kalij (nekatere tablete za odvajanje vode), zaviralci angiotenzinske konvertaze (ACE), angatonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (npr. acetilsalicilna kislina ali ibuprofen), heparin, imunosupresivi (npr. ciklosporin ali takrolimus) in antibiotik trimetoprim; - diuretiki (tablete za odvajanje vode), zlasti če sočasno z zdravilom Tolura jemljete velike odmerke, ki lahko povzročijo preveliko izgubo vode iz telesa in znižajo krvni tlak (povzročijo hipotenzijo); - če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Tolura" in "Opozorila in previdnostni ukrepi"); - digoksin.
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Slovenian: Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom glede na vnaprej opredeljeni sekundarni sestavljeni opazovani dogodek, in sicer smrt zaradi srčnožilnega dogodka, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95odstotni interval zaupanja 0,76 - 1,00, p = 0,048)], medtem ko korist pri srčno-žilni umrljivosti ni bila dokazana (razmerje tveganja 1,03, 95-odstotni interval zaupanja 0,85 - 1,24).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimester of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Slovenian: - Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
English: Tel: + 356 21 445 885
Slovenian: Busuttil Ltd. Tel: + 356 21 445 885
English: - Liver disease.
Slovenian: - Obolenja z zaporo žolčevoda.
English: THU
Slovenian: ČET
English: To be taken into account with concomitant use
Slovenian: za peroralno uporabo
English: Tolura should be used only with caution in patients with mild to moderate hepatic impairment.
Slovenian: Bolnikom z zmerno hudo do hudo jetrno okvaro je treba telmisartan dajati previdno.
English: Contains lactose monohydrate and sorbitol (E420).
Slovenian: Ena tableta vsebuje sorbitol (E420) in laktozo.
English: Ref. EMEA/166909/2008
Slovenian: EMEA/166894/2008
English: London, 21 February 2008 Doc.
Slovenian: London, 21. februar 2008 Sklic dok.
English: The main measure of effectiveness was the increase in adult height.
Slovenian: Glavno merilo učinkovitosti je bilo povečanje višine pri odraslih.
English: International non-proprietary name (INN): somatropin
Slovenian: Mednarodno nelastniško ime (INN): somatropin
English: This must be confirmed by chromosome analysis (DNA testing);
Slovenian: To mora biti potrjeno s kromosomsko analizo (analizo DNA);
English: In total, the children received the medicine for up to ten years.
Slovenian: Otroci so skupaj prejemali zdravilo do deset let.
English: In addition, a benefit of the medicine in improving the child's psychological or social wellbeing had not been shown.
Slovenian: Poleg tega ni bila dokazana korist zdravila z vidika izboljšanja otrokovega psihološkega ali socialnega počutja.
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Slovenian: Družba je zahtevala ponovno presojo negativnega mnenja, ki pa še ni bila zaključena, ko je družba podala zahtevek za umik.
English: NutropinAq is already used to treat children in the following situations:
Slovenian: Zdravilo NutropinAq se že uporablja za zdravljenje otrok v naslednjih primerih:
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce human growth hormone.
Slovenian: Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNA“, pri kateri hormon izdela bakterija, ki je prejela gen (DNA), s katerim lahko tvori humani rastni hormon.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NUTROPINAQ
Slovenian: VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom NUTROPINAQ
English: There are no consequences on the use of NutropinAq in the authorised indications, for which the balance of benefits and risks remains unchanged.
Slovenian: Umik nima nobenih posledic za uporabo zdravila NutropinAq za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
English: What were the major concerns of the CHMP?
Slovenian: Kateri so bili glavni zadržki CHMP?
English: • when they fail to grow because of a lack of growth hormone;
Slovenian: • pri motnjah v rasti zaradi pomanjkanja rastnega hormona;
English: • if they are short because of Turner syndrome (a rare genetic disorder affecting girls).
Slovenian: • če so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene dekleta).
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment begins.
Slovenian: Do pomanjkanja rastnega hormona lahko pride v odrasli dobi ali otroštvu, pred začetkom zdravljenja pa mora biti potrjeno s testi.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using NutropinAq?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila NutropinAq?
English: On 24 January 2008, Ipsen Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for NutropinAq, for the long-term treatment of children with severe idiopathic short stature.
Slovenian: Družba Ipsen Ltd je dne 24. januarja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo NutropinAq, in sicer za dolgotrajno zdravljenje otrok s hudo idiopatsko nizko telesno višino.
English: The company presented the results of one main study looking at the effectiveness of NutropinAq in 118 children with short stature who did not have growth hormone deficiency or any other identifiable condition that could cause their growth impairment.
Slovenian: Družba je predložila rezultate glavne študije, v kateri so preučevali učinkovitost zdravila NutropinAq pri 118 otrocih z nizko telesno višino, ki niso izkazovali niti pomanjkanja rastnega hormona niti katerega koli drugega določljivega razloga, ki bi lahko povzročil motnjo v rasti.
English: It was to be used if all possible causes of the child's short height had been excluded, such as low growth hormone levels.
Slovenian: Zdravilo naj bi se uporabljalo le v primeru izključitve vseh možnih razlogov za otrokovo nizko telesno višino, npr. nizke ravni rastnega hormona.
English: For the first year, the study compared the effectiveness of NutropinAq given three times a week with that of no treatment.
Slovenian: Prvo leto so v okviru študije primerjali učinkovitost zdravila NutropinAq, dajanega trikrat tedensko, s stanjem brez zdravljenja.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
Slovenian: Družba je obvestila CHMP, da trenutno v Evropi klinična preskušanja ali programi sočutne uporabe zdravila NutropinAq za to indikacijo ne potekajo.
English: It is given by injection under the skin, using the injection pen specially designed for the cartridge.
Slovenian: Daje se z injiciranjem pod kožo, in sicer z injekcijskim peresnikom, ki je posebej oblikovan za ta vložek.
English: The active ingredient in NutropinAq, somatropin, is identical to the human growth hormone.
Slovenian: Zdravilna učinkovina zdravila NutropinAq, somatropin, je identična humanemu rastnemu hormonu.
English: difference between the height that each child was predicted to reach based on their height and bone maturity before they started to receive NutropinAq, and their actual height when they had reached adulthood.
Slovenian: To je temeljilo na razliki med višino, ki naj bi jo posamezen otrok dosegel po napovedi na podlagi svoje višine in zrelosti kosti pred pričetkom prejemanja zdravila NutropinAq, ter njegovo dejansko višino, ko je dosegel odraslo dobo.
English: The Committee raised a concern that the use of NutropinAq for the long periods necessary to treat severe idiopathic short stature might increase the risk of the development of tumours or diabetes later in life.
Slovenian: Odbor je izrazil pomislek, da bi dolgotrajna uporaba zdravila NutropinAq za zdravljenje hude idiopatske nizke telesne višine utegnila povečati tveganje za razvoj tumorjev ali sladkorne bolezni kasneje v življenju.
English: What is happening for NutropinAq for treatment of failure to grow due to growth hormone deficiency, Turner syndrome or chronic renal insufficiency?
Slovenian: Kakšne so posledice za zdravilo NutropinAq, indicirano za zdravljenje zaustavitve rasti kot posledice pomanjkanja rastnega hormona, Turnerjevega sindroma ali kroničnega ledvičnega popuščanja?
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of NutropinAq for the long-term treatment of children with severe idiopathic short stature.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve zdravila NutropinAq za dolgotrajno zdravljenje otrok s hudo idiopatsko nizko telesno višino.
English: It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Slovenian: Ta hormon spodbuja rast v otroštvu in obdobju pubertete ter tudi vpliva na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
English: • before puberty, when they fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Slovenian: • pred puberteto v primeru zastoja rasti zaradi dolgotrajne bolezni ledvic (kroničnega ledvičnega popuščanja).
English: NutropinAq is also used to treat adults with growth hormone deficiency, as replacement therapy.
Slovenian: Zdravilo NutropinAq se uporablja tudi za zdravljenje odraslih s pomanjkanjem rastnega hormona, in sicer kot nadomestna terapija.
English: It was to be used as long-term treatment in children who were predicted to be short, in comparison with their parents' height, once they had reached adulthood.
Slovenian: Uporabljalo naj bi se za dolgotrajno zdravljenje pri otrocih, za katere se predvideva, da bodo v odrasli dobi, v primerjavi s svojimi starši, nizke rasti.
English: NutropinAq is a solution for injection in a cartridge, which contains the active substance somatropin.
Slovenian: Zdravilo NutropinAq je raztopina za injiciranje v vložku, ki vsebuje zdravilno učinkovino somatropin.
English: In the new indication, NutropinAq was expected to be used to treat children with ‘severe idiopathic short stature' (severe growth impairment with no identifiable cause).
Slovenian: Nova indikacija je predvidevala uporabo zdravila NutropinAq pri zdravljenju otrok s „hudo idiopatsko nizko telesno višino“ (hudo motnjo v rasti z nepojasnjenim razlogom).
English: The CHMP was concerned that only a modest benefit of NutropinAq in severe idiopathic short stature had been demonstrated, with an average gain in final adult height of around 6 to 7 cm in the main study.
Slovenian: CHMP je izrazil zadržek, da je bila v glavni študiji izkazana le zmerna korist zdravila NutropinAq pri hudi idiopatski nizki telesni višini, s povprečno 6- do7-centimetrskim povečanjem končne odrasle višine.
English: What was NutropinAq expected to be used for?
Slovenian: Za kaj naj bi se zdravilo NutropinAq uporabljalo?
English: Therefore, at the time of the withdrawal, the CHMP's view was that that the benefits of NutropinAq in the long-term treatment of children with severe idiopathic short stature did not outweigh its possible risks.
Slovenian: Posledično je CHMP v času umika menil, da koristi zdravila NutropinAq pri dolgotrajnem zdravljenju otrok s hudo idiopatsko nizko telesno težo ne odtehtajo z njim povezanih tveganj.
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Slovenian: Rastni hormon je snov, ki jo izloča žleza, ki se nahaja na možganskem dnu, imenovana hipofiza.
English: NutropinAq is used until the child receives a kidney transplant.
Slovenian: Zdravilo NutropinAq se uporablja do presaditve ledvice.
English: After this, the design of the study was changed so that the patients received NutropinAq given either three times a week or once a day.
Slovenian: Nato je bila zasnova študije spremenjena tako, da so bolniki prejemali zdravilo
English: Annual reports to be submitted as part of the annual reassessment
Slovenian: Letno poročilo se predloži kot del letne ponovne ocene
English: ATC code: A16AB15.
Slovenian: Oznaka ATC: A16AB15.
English: Patients n=33
Slovenian: Bolniki n = 33
English: The reconstituted vials should stand on the table for about 5-10 minutes.
Slovenian: Rekonstituirane viale morajo stati na mizi približno 5-10 minut.
English: Date of first authorisation: 23/03/2018
Slovenian: Datum prve odobritve: 23/03/2018
English: The following information is intended for healthcare professionals only.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: Quality of Life
Slovenian: Kakovost življenja
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:
English: Lamzede Last Observation
Slovenian: Lamzede Zadnje opazovanje
English: This is known as an infusion-related reaction and can sometimes be severe.
Slovenian: To se imenuje reakcija, povezana z infuzijo, ki je včasih lahko resna.
English: Example:
Slovenian: Primer:
English: Thereafter each vial should be tilted and rolled gently for 15-20 seconds to enhance the dissolution process.
Slovenian: Nato je treba vsako vialo nagniti in 15-20 sekund nežno valjati, da se izboljša postopek raztapljanja.
English: Lamzede 12 months
Slovenian: Lamzede 12 mesecev
English: In the most severe cases, the current medical standards for emergency treatment are to be observed.
Slovenian: V najresnejših primerih je treba upoštevati trenutne zdravstvene standarde za nujno zdravljenje.
English: See sections 4.4 and 5.1.
Slovenian: Glejte poglavji 4.4 in 5.1.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano {MM/LLLL}.
English: (<1/10,000) or not known (cannot be estimated from the available data).
Slovenian: < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: All patients who experienced IRRs recovered.
Slovenian: Vsi bolniki, ki so imeli IRR, so okrevali.
English: There is a potential for immunogenicity.
Slovenian: Obstaja možnost imunogenosti.
English: This may improve the symptoms of the disease.
Slovenian: Z njim lahko izboljšamo simptome bolezni.
English: Lamzede may be given to children and adolescents at the same dose and frequency as in adults.
Slovenian: Zdravilo Lamzede se lahko daje otrokom in mladostnikom z enakim odmerkom in pogostnostjo kot pri odraslih.
English: Only the volume corresponding to the recommended dose should be administered.
Slovenian: Aplicirati je treba samo količino, ki ustreza priporočenemu odmerku.
English: When this enzyme is missing or does not work properly, these sugar compounds build up inside cells and cause the signs and symptoms of the disease.
Slovenian: Ko tega encima primanjkuje ali ko ne deluje pravilno, se te sestavine sladkorja kopičijo v celicah in povzročajo znake in simptome bolezni.
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Slovenian: Predhodno zdravljenje z antihistaminiki in/ali kortikosteroidi lahko prepreči kasnejše reakcije v primerih, ko je bilo potrebno simptomatsko zdravljenje.
English: Patients with the most severe rapidly progressing phenotype (with a deterioration within one year and central nervous system involvement) were excluded.
Slovenian: Bolniki z najresnejšim, hitro napredujočim fenotipom (poslabšanje v enem letu in vpletenost osrednjega živčnega sistema) so bili izključeni.
English: As no patients older than 41 years have been identified across Europe, no relevant use in elderly patients is expected.
Slovenian: Ker v Evropi nismo našli bolnikov, starejših od 41 let, ne pričakujemo potrebne uporabe pri starejših bolnikih.
English: Aseptic technique is to be used during preparation.
Slovenian: Med pripravo je treba uporabljati aseptično tehniko.
English: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim Germany
Slovenian: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim
English: The effects of velmanase alfa were more evident in patients younger than 18 years.
Slovenian: Učinki velmanaze alfa so bili bolj očitni pri bolnikih, mlajših od 18 let.
English: (1) MCID: minimal clinically important difference
Slovenian: Nobeno področje (1) MCID: najmanjša klinično pomembna razlika (minimal clinically important difference)
English: Patients were diagnosed based on alpha-mannosidase activity <10% of normal activity in blood leukocytes.
Slovenian: Bolniki so bili diagnosticirani na podlagi aktivnosti alfamanozidaze < 10 % običajne aktivnosti v krvnih levkocitih.
English: Loss of consciousness
Slovenian: Izguba zavesti
English: a) The number of vials to be used should be calculated based on the individual patient's weight.
Slovenian: a) Potrebno število vial za uporabo je treba preračunati na podlagi telesne mase posameznega bolnika.
English: In patients over 18 years old a stabilisation has been demonstrated.
Slovenian: Pri bolnikih, starejših od 18 let, je bila dokazana stabilizacija.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is used.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: The development of antibodies has not been shown to affect clinical efficacy or safety.
Slovenian: Ni bilo dokazano, da bi razvoj protiteles vplival na klinično učinkovitost ali varnost.
English: In case the patient's condition deteriorates during ERT, cessation of treatment should be considered.
Slovenian: Če se bolnikovo stanje med ERT poslabša, je treba razmisliti o prenehanju zdravljenja.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo je bila dokazana 24 ur pri temperaturi 2 °C- 8 °C.
English: If the number of calculated vials includes a fraction, it should be rounded up to the next whole number.
Slovenian: Če število izračunanih vial ni celo število, ga je treba zaokrožiti navzgor na naslednje celo število.
English: Reflux gastritis
Slovenian: refluksni gastritis
English: As the accumulation of end organ damage progresses over time, it is more difficult for the treatment to reverse the damage or to show improvements.
Slovenian: Ker kopičenje poškodb tarčnega organa sčasoma napreduje, je pri zdravljenju težje izničiti poškodbe ali pokazati izboljšanje.
English: Placebo 12 months
Slovenian: Placebo 12 mesecev
English: In total 15 patients (7 paediatrics and 8 adults) received active treatment and 10 patients received placebo (5 paediatrics and 5 adults).
Slovenian: Skupaj 15 bolnikov (7 pediatričnih in 8 odraslih) je prejemalo aktivno zdravljenje, 10 bolnikov pa je prejemalo placebo (5 pediatričnih in 5 odraslih).
English: Each carton contains 1, 5 or 10 vials.
Slovenian: Vsaka škatla vsebuje 1, 5 ali 10 vial.
English: For further instructions, see section 4.4.
Slovenian: Za nadaljnja navodila glejte poglavje 4.4.
English: The vials should reach ambient temperature (between 15°C and 25°C) prior to reconstitution.
Slovenian: Viale morajo pred rekonstitucijo doseči sobno temperaturo (med 15 °C in 25 °C).
English: The results observed in patients below 18 years of age showed an improvement.
Slovenian: Rezultati, ki so jih opazili pri bolnikih, mlajših od 18 let, so pokazali izboljšanje.
English: For patients weighing less than 18 kg, and receiving less than 9 mL reconstituted solution, the infusion rate should be calculated so that the infusion time is ≥50 minutes.
Slovenian: Za bolnike, ki tehtajo manj kot 18 kg in prejemajo manj kot 9 ml rekonstituirane raztopine, je treba hitrost infundiranja preračunati tako, da je čas infundiranja ≥ 50 minut.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Huda alergijska reakcija na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Lamzede has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Lamzede nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: - If you have an infusion-related reaction you may be given additional medicines to treat or help prevent future reactions.
Slovenian: - Če doživite reakcijo, povezano z infuzijo, lahko dobite dodatna zdravila za zdravljenje ali preprečevanje reakcij v prihodnje.
English: The infusion duration should be a minimum of 50 minutes.
Slovenian: Infundiranje mora trajati najmanj 50 minut.
English: - if you are allergic to velmanase alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na velmanazo alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: A slower infusion rate may be prescribed when clinically appropriate according to the physician's judgment, for example at the beginning of the treatment or in case of previous infusion-related reactions (IRRs).
Slovenian: Nižjo hitrost infundiranja se lahko predpiše, če je to po zdravnikovi presoji klinično primerno, na primer na začetku zdravljenja ali v primeru predhodnih reakcij, povezanih z infuzijo (IRR-infusion-related reactions).
English: - Most of the time you can still be given Lamzede even if you experience an infusion-related reaction.
Slovenian: - Večinoma lahko zdravilo Lamzede prejemate še naprej, čeprav doživite reakcijo, povezano z infuzijo.
English: 6MWT (metres)
Slovenian: 6MWT (metri)