FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Slovenian: Takoj obvestite svojega zdravnika, če pred ali po jemanju tega zdravila opazite katerega koli od spodaj navedenih simptomov, ki so lahko znaki druge, resnejše bolezni: - nenamerno izgubljanje telesne mase (ki ni posledica diete ali telesne vadbe),
English: Do not take PANTECTA Control tablets for more than 4 weeks without consulting your doctor.
Slovenian: Če se znaki bolezni ne izboljšajo po 2 tednih neprekinjenega jemanja tega zdravila, se posvetujte z Ne jemljite tablet PANTECTA Control več kot 4 tedne brez posveta pri zdravniku.
English: Danmark
Slovenian: Sverige
English: Ireland
Slovenian: Portugal
English: Stop taking PANTECTA Control when you are completely symptom-free.
Slovenian: Ko simptomi bolezni popolnoma minejo, zdravilo PANTECTA Control nehajte jemati.
English: България
Slovenian: Polska
English: Gastrointestinal disorders
Slovenian: Motnje ginekomastija
English: If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your doctor.
Slovenian: Če se znaki vaše bolezni poslabšajo ali ne izboljšajo v 2 tednih, se posvetujte z zdravnikom.
English: The recommended dose is one tablet a day.
Slovenian: Priporočeni odmerek je ena tableta na dan. Priporočenega odmerka 20 mg pantoprazola enkrat na dan
English: Your doctor may decide that you need some tests.
Slovenian: Morda bodo potrebne nadaljnje krvne preiskave.
English: Takeda Products Ireland Limited Tel: + 353 16 42 00 21
Slovenian: United Kingdom Takeda UK Limited Tel: +44 (0)1628 537 900
English: España
Slovenian: Österreich
English: TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6729570 gr.info@takeda.com
Slovenian: Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
English: Pantoprazole should not be used during pregnancy.
Slovenian: Pantoprazola ne smete uporabljati
English: Oral use.
Slovenian: - Navodilo shranite.
English: The main measure of effectiveness was the reduction in the number of attacks.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje števila napadov.
English: Ref. EMEA/372952/2009 EMEA/H/C/901
Slovenian: EMEA/H/C/901
English: Based on the information presented to the Committee, it was not clear whether this was due to the way the study was designed, the way the results were analysed, or to the medicine itself.
Slovenian: Glede na informacije, ki so bile predstavljene Odboru, ni bilo jasno, ali zaradi načina, na katerega je bila študija oblikovana, načina analize rezultatov ali zdravila samega.
English: Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Slovenian: Interferoni so naravne snovi, ki jih proizvaja telo za obrambo proti napadom, kot so okužbe, ki jih povzročajo virusi.
English: Relapsing-remitting means that the patient has attacks (relapses) followed by periods with milder symptoms (remission).
Slovenian: Recidivno-remitentna pomeni, da ima bolnik napade (relapse), ki jim sledijo obdobja blažjih simptomov (remisije).
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew.
Slovenian: Družba je zahtevala ponovno proučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
English: It was to be available in prefilled syringes.
Slovenian: Na voljo naj bi bilo v napolnjenih injekcijskih brizgah.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Slovenian: Multipla skleroza je obolenje živcev, pri kateri vnetje uniči zaščitni ovoj okrog njih.
English: In contrast to these medicines, Biferonex is made in such a way that it does not contain the human blood protein, albumin.
Slovenian: V nasprotju s tema zdraviloma je zdravilo Biferonex proizvedeno tako, da ne vsebuje človeške krvne beljakovine, albumina.
English: Biferonex was intended for patients who had experienced two or more attacks in the previous two years.
Slovenian: Zdravilo Biferonex je bilo namenjeno bolnikom, ki so imeli dva ali več napadov v preteklih dveh letih.
English: The effects of Biferonex were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Biferonex so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Each patient received either Biferonex or placebo for two years.
Slovenian: Bolniki so dve leti prejemali bodisi zdravilo Biferonex ali placebo.
English: The company also used information relating to Avonex, and information from the published literature on other medicines containing interferon beta.
Slovenian: Družba je uporabila tudi informacije o zdravilu Avonex ter informacije iz objavljene literature o drugih zdravilih, ki vsebujejo interferon beta.
English: Biferonex contains the same active substance as other medicines called Avonex and Rebif, which have been authorised in the European Union since 1997 and 1998, respectively.
Slovenian: Zdravilo Biferonex vsebuje enako zdravilno učinkovino, kot drugi dve zdravili, imenovani Avonex in Rebif, odobreni v Evropski uniji leta 1997 oziroma 1998.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Biferonex?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Biferonex?
English: It therefore concluded that using the published studies on these interferon beta-containing medicines to support the use of Biferonex was not justified, and that studies on Biferonex itself were required.
Slovenian: Zato je zaključil, da uporaba objavljenih študij teh zdravil, ki vsebujejo interferon beta, v podporo uporabi zdravila Biferonex ni bila upravičena ter da so bile študije zdravila Biferonex potrebne.
English: Biferonex is expected to work by modulating the activity of the immune system (the body's natural defences) and preventing relapses of multiple sclerosis.
Slovenian: Zdravilo Biferonex naj bi delovalo s spreminjanjem delovanja imunskega sistema (naravnega obrambnega mehanizma telesa) ter s preprečevanjem relapsov multiple skleroze.
English: The company presented the results of one main study, in which Biferonex was compared with placebo (a dummy treatment) in 339 adults with relapsing-remitting multiple sclerosis.
Slovenian: Družba je predstavila rezultate ene glavne študije, v kateri so zdravilo Biferonex primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 339 odraslih z recidivno-remitentno multiplo sklerozo.
English: The CHMP was also of the opinion that the results of the single pivotal study of Biferonex did not show enough evidence that the medicine was effective.
Slovenian: CHMP je menil tudi, da rezultati ene same osrednje študije zdravila Biferonex niso v zadostni meri dokazali, da je zdravilo učinkovito.
English: What is Biferonex?
Slovenian: Kaj je zdravilo Biferonex?
English: On 28 May 2009, BioPartners GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Biferonex, for the treatment of relapsing-remitting multiple sclerosis.
Slovenian: Družba BioPartners GmbH je dne 28. maja 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Biferonex, namenjeno zdravljenju recidivno-remitentne multiple skleroze.
English: Questions and answers on the withdrawal of the marketing authorisation application for Biferonex interferon beta-1a
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Biferonex
English: Interferon beta-1a is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Slovenian: Interferon beta-1b proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori interferon beta-1a.
English: Biferonex was expected to be used to treat adults with relapsing-remitting multiple sclerosis.
Slovenian: Zdravilo Biferonex naj bi se uporabljalo za zdravljenje odraslih z recidivno-remitentno multiplo sklerozo.
English: At the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Biferonex for the treatment of relapsing-remitting multiple sclerosis.
Slovenian: V času umika je CHMP izrazil negativno mnenje, v katerem priporoča zavrnitev dovoljenja za promet z zdravilom Biferonex za zdravljenje recidivno-remitentne multiple skleroze.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes ongoing with Biferonex.
Slovenian: Družba je obvestila CHMP, da klinična preizkušanja ali programi sočasne uporabe z zdravilom Biferonex ne potekajo.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Biferonex in the treatment of patients with relapsing-remitting multiple sclerosis did not outweigh its risks.
Slovenian: Zato je v času umika CHMP menil, da učinki zdravila Biferonex pri zdravljenju bolnikov z recidivnoremitentno multiplo sklerozo niso odtehtali tveganj, povezanih s tem zdravilom.
English: The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market.
Slovenian: Odbor je ugotovil, da so bile razlike med zdravilno učinkovino v zdravilu Biferonex in preostalimi zdravili, ki so na voljo na trgu in vsebujejo interferon beta.
English: The active substance in Biferonex, interferon beta-1a, belongs to the group ‘interferons'.
Slovenian: Zdravilna učinkovina zdravila Biferonex, interferon beta-1a, spada v skupino „interferonov“.
English: The interferon beta-1a in Biferonex acts in the same way as naturally produced interferon beta.
Slovenian: Interferon beta-1a v zdravilu Biferonex deluje enako kot naravno proizvedeni interferon beta.
English: Biferonex is a solution for injection that contains the active substance interferon beta-1a.
Slovenian: Zdravilo Biferonex je raztopina za injiciranje, ki vsebuje zdravilno učinkovino interferon beta-1a.
English: What was Biferonex expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Biferonex uporabljalo?
English: How is Biferonex expected to work?
Slovenian: Kako naj bi zdravilo Biferonex delovalo?
English: Date of first authorization: 19 January 2006 Date of latest renewal: 06 December 2010
Slovenian: Datum prve odobritve: 19. januar 2006 Datum zadnjega podaljšanja: 06. december 2010
English: If this happens, you should wait until the reactions have disappeared.
Slovenian: Če se to zgodi, počakajte, da reakcije izzvenijo.
English: *CI - Confidence Interval
Slovenian: *IZ (Confidence Interval) interval zaupanja
English: 4.5 Interactions with other medicinal products and other forms of interactions
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: The listed interactions apply both to adults and children.
Slovenian: Navedene interakcije se nanašajo na odrasle in otroke.
English: Adolescents (13 to 17 years)
Slovenian: Mladostniki (od 13 do 17 let)
English: Secondary immunodeficiencies (as defined in 4.1.)
Slovenian: Sekundarne imunske pomanjkljivosti (kot je opredeljeno v 4.1)
English: The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
Slovenian: Učinek zdravljenja je treba ovrednotiti po vsakem ciklu; če po 6 mesecih zdravljenje nima vidnega učinka, je treba zdravljenje prekiniti.
English: Children (12 years or below)
Slovenian: Otroci (12 let ali manj)
English: Therefore, your baby may be protected from certain infections.
Slovenian: Vaš otrok bo torej morda tudi zavarovan pred določenimi okužbami.
English: Pharmacokinetic parameters for KIOVIG were determined in the two clinical studies in PID patients performed in Europe and the US.
Slovenian: Farmakokinetične parametre zdravila KIOVIG so določili v dveh kliničnih študijah pri bolnikih s PID, opravljenih v Evropi in ZDA.
English: These medicines contain human antibodies, which are also present in your blood.
Slovenian: Ta zdravila vsebujejo človeška protitelesa, ki so tudi v vaši krvi.
English: The median IgG half-life after administration of KIOVIG was 32.5 days.
Slovenian: Mediana vrednost razpolovne dobe IgG po dajanju zdravila KIOVIG je bila 32,5 dni.
English: Congenital AIDS
Slovenian: Kongenitalni AIDS
English: Other routes of administration have not been evaluated.
Slovenian: Drugih poti uporabe niso ovrednotili.
English: Your doctor will choose the appropriate intravenous immunoglobulin for you.
Slovenian: Vaš zdravnik bo izbral primeren intravenski imunoglobulin za vas.
English: The values obtained in the studies are comparable to parameters reported for other human immunoglobulins.
Slovenian: Vrednosti, ugotovljene v študijah, so primerljive s parametri za druge humane imunoglobuline.
English: The safety of KIOVIG has been demonstrated in several non-clinical studies.
Slovenian: Varnost zdravila KIOVIG so pokazali v več nekliničnih študijah.
English: Distribution of IgG subclasses (approx. values):
Slovenian: Porazdelitev podrazredov IgG (približne vrednosti):
English: All parameters were analysed separately for three age groups, children (below 12 years, n=5), adolescents (13 to 17 years, n=10), and adults (above 18 years of age, n=64).
Slovenian: Vse parametere so analizirali ločeno za tri starostne skupine, otroke (mlajše od 12 let, n=5), mladostnike (od 13 do 17 let, n=10), in odrasle (starejše od 18 let, n=64).
English: No evidence is available to require a dose adjustment.
Slovenian: Dokazov o tem, da bi bila potrebna prilagoditev odmerka, ni na voljo.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Slovenian: Pogostnosti so bile ovrednotene po naslednjih dogovorjenih kriterijih: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10 000); neznani (ocena pogostnosti iz razpoložljivih podatkov ni možna).
English: if you are allergic to immunoglobulins or to any other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na imunoglobuline ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This medicinal product must not be mixed with other medicinal products.
Slovenian: Tega zdravila ne smete mešati z drugimi zdravili.
English: • monitoring for signs and symptoms of thrombosis
Slovenian: • spremljanje za znake in simptome tromboze
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: Če se razvije šok, uvedite standardno medicinsko zdravljenje za šok.
English: Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: In-vivo recovery (%)
Slovenian: In vivo uporabnost (%)
English: What you need to know before you use KIOVIG
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KIOVIG
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Slovenian: Mehanizem delovanja pri indikacijah, kjer ne gre za nadomestno zdravljenje, ni popolnoma pojasnjen, vendar vključuje učinke imunomodulacije.
English: The recommended infusion rate given under section 4.2 must be closely followed.
Slovenian: Priporočeno hitrost infundiranja, ki je navedena v poglavju 4.2, morate natančno upoštevati.
English: • assessment of blood viscosity in patients at risk for hyperviscosity
Slovenian: • ocenjevanje viskoznosti krvi pri bolnikih, ki so ogroženi zaradi hiperviskoznosti
English: KIOVIG does not contain sucrose, maltose or glucose.
Slovenian: Zdravilo KIOVIG ne vsebuje saharoze, maltoze ali glukoze.
English: In such cases, you will be closely monitored during your infusion and for an hour after your infusion has stopped.
Slovenian: V teh primerih vas bodo natančno spremljali med infundiranjem in še eno uro po koncu infuzije.
English: Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1-2 hours.
Slovenian: Simptomi TRALI se praviloma pojavijo med transfuzijo ali v 6 urah po njej, pogosto v 1-2 urah.
English: It is given to you by your doctor or nurse.
Slovenian: Zdravilo vam bo dal vaš zdravnik ali medicinska sestra.
English: There are no paediatric specific risks with regard to any of the above adverse events.
Slovenian: Pri pediatrični populaciji ni posebnega tveganja v zvezi z zgoraj navedenimi neželenimi učinki.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Slovenian: Nadomestno zdravljenje je treba uvesti in spremljati pod nadzorom zdravnika, izkušenega v zdravljenju imunskih pomanjkljivosti.
English: • The other ingredients (excipients) are glycine and water for injections.
Slovenian: • Drugi sestavini zdravila (pomožni snovi) sta glicin in voda za injekcije.
English: • If you are breast-feeding and receive KIOVIG, the antibodies of the medicine can also be found in the breast milk.
Slovenian: • Če dojite in prejemate zdravilo KIOVIG, lahko protitelesa iz zdravila najdemo tudi v materinem mleku.
English: • If you have already received KIOVIG previously and received the last treatment recently, then you will only be observed during the infusion and for at least 20 minutes after your infusion.
Slovenian: • Če ste že kdaj prej prejeli zdravilo KIOVIG in ste ga zadnjič prejeli nedavno, pa vas bodo spremljali le med infuzijo in najmanj 20 minut po koncu infuzije.
English: Muscle twitching and weakness were reported only in patients with MMN.
Slovenian: O trzanju in šibkosti mišic so poročali le pri bolnikih z MMN.
English: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: Antibodies help your body to fight infections.
Slovenian: S protitelesi se vaše telo bori proti okužbam.
English: It is usually prepared from pooled plasma from not fewer than 1000 donations.
Slovenian: Ponavadi se pripravlja iz združene plazme najmanj 1.000 darovanih enot.
English: It is recommended that during dilution the risk of microbial contamination is minimised.
Slovenian: Priporočljivo je, da med redčenjem kar najbolj zmanjšate tveganje za mikrobno kontaminacijo.
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Slovenian: Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so bile enake kot pri odraslih.
English: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Slovenian: Odmerjanje pri otrocih in mladostnikih (0-18 let) se ne razlikuje od odmerjanja pri odraslih, saj je odmerjanje za vsako indikacijo podano glede na telesno maso in prilagojeno kliničnemu izidu omenjenih stanj.
English: If you have a blood test after receiving KIOVIG, please inform the person taking your blood or your doctor that you have received the medication.
Slovenian: Če morate po prejemu zdravila KIOVIG opraviti preiskave krvi, obvestite osebo, ki vam jemlje kri, ali svojega zdravnika, da ste prejeli to zdravilo.
English: Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Slovenian: Bolnike, pri katerih se pojavijo tovrstni znaki in simptomi, je treba temeljito nevrološko pregledati, vključno s preiskavami likvorja, da se izključijo drugi vzroki meningitisa.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Slovenian: Sindrom se ponavadi začne v več urah do 2 dneh po zdravljenju z i.v.
English: Solution for infusion (10%) 1 vial
Slovenian: raztopina za infundiranje (10 %) 1 viala
English: There are five groups:
Slovenian: Obstaja pet skupin teh bolnikov:
English: • monitoring of urine output
Slovenian: • spremljanje izločanja urina
English: They can also be used in patients who need additional antibodies for the cure of certain inflammatory disorders (autoimmune diseases).
Slovenian: Uporabljajo se lahko tudi za bolnike, ki potrebujejo dodatna protitelesa za zdravljenje določenih vnetnih bolezni (avtoimunskih bolezni).
English: No negative effects on the breastfed newborn/infants are anticipated.
Slovenian: Negativnih učinkov na dojene novorojenčke/dojenčke ni pričakovati.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm
Slovenian: Študije likvorja so pogosto pozitivne s pleocitozo do več tisoč celic na mm
English: The treatment required depends on the nature and severity of the adverse reaction.
Slovenian: Potrebno zdravljenje je odvisno od vrste in resnosti neželenih učinkov.
English: KIOVIG contains a wide variety of different antibodies, some of which can affect blood tests.
Slovenian: Zdravilo KIOVIG vsebuje številna različna protitelesa in nekatera od njih lahko vplivajo na krvne preiskave.
English: • adequate hydration prior to the initiation of the infusion of IVIg
Slovenian: • zadostna hidracija pred začetkom infundiranja i.v.
English: In addition, children with Kawasaki Disease are at especially high risk due to underlying cardiac compromise so dose and rate of administration should be carefully controlled.
Slovenian: Poleg tega pri otrocih s Kawasakijevim sindromom obstaja še zlasti visoko tveganje zaradi osnovne srčne okvare, zato je treba odmerek in hitrost aplikacije skrbno nadzorovati.
English: This should be taken into account by physicians, since initiation of treatment for true hyponatremia (i.e. decreasing serum free water) in these patients may lead to a further increase in serum viscosity and a possible predisposition to thromboembolic events.
Slovenian: To morajo zdravniki upoštevati, ker lahko uvedba zdravljenja prave hiponatriemije (tj. zmanjšanje proste vode v serumu) pri teh bolnikih povzroči dodatno povečanje viskoznosti seruma in možno predispozicijo za tromboembolične dogodke.
English: Dose and frequency of the infusion will vary depending on your condition and your body weight.
Slovenian: Odmerek in pogostnost infundiranja sta odvisna od vašega stanja in telesne mase.
English: This may persist during the weeks following infusion of the product.
Slovenian: Ta učinek lahko vztraja več tednov po infundiranju zdravila.