FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee therefore concluded the benefit-risk balance of calcitonin-containing intranasal formulation indicated for the treatment of osteoporosis is no longer positive under normal conditions of use and recommends the suspension of the corresponding marketing authorisations.
Slovenian: Odbor je zato sklenil, da razmerje med tveganji in koristmi pri intranazalnih formulacijah zdravil, ki vsebujejo kalcitonin in so indicirana za zdravljenje osteoporoze, v običajnih pogojih uporabe ni več pozitivno in priporoča začasni umik ustreznih dovoljenj za promet.
English: o for the treatment of Paget's disease the benefit-risk balance remains positive provided that the duration of use is restricted to 3 months and only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.
Slovenian: • odbor je zato pretehtal razmerje med tveganji in koristmi pri zdravilih za injiciranje, ki vsebujejo kalcitonin, pri normalnih pogojih uporabe za posamezne odobrene indikacije ter sklenil, da: o razmerje med tveganji in koristmi pri zdravljenju Pagetove bolezni ostaja pozitivno, če se trajanje omeji na 3 mesece in samo na bolnike, ki se ne odzivajo na druge oblike zdravljenja ali za katere take oblike zdravljenja niso primerne, na primer bolniki s hudo ledvično okvaro.
English: After review of the available data, the CHMP (previously CPMP) adopted an opinion on 21 November 2002, on a favourable benefit/risk balance of injectable calcitonin in the following indications:
Slovenian: Po pregledu razpoložljivih podatkov je 21. novembra 2002 odbor CHMP (predhodno CPMP) sprejel sklep o pozitivnem razmerju med tveganji in koristmi kalcitonina za injiciranje pri naslednjih indikacijah: preprečevanje akutne izgube kostnine zaradi nenadne imobilizacije, kot denimo pri bolnikih z nedavnimi osteoporotičnimi zlomi; Pagetova bolezen; hiperkalciemija pri malignih boleznih.
English: o for the prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, the benefit-risk balance remains positive provided that the duration of use is restricted to 2 weeks, not exceeding 4 weeks in any case.
Slovenian: Trajanje zdravljenja se lahko podaljša na največ 6 mesecev v izjemnih okoliščinah, lahko pa se razmisli tudi o občasnem ponovnem zdravljenju; o razmerje med tveganji in koristmi pri preprečevanju akutne kostne izgube zaradi nenadne imobilizacije, kot na primer pri bolnikih z nedavnimi osteoporotičnimi zlomi, ostaja pozitivno, če je trajanje uporabe omejeno na 2 tedna in ne sme v nobenem primeru preseči 4 tednov; o razmerje med tveganji in koristmi pri zdravljenju hiperkalciemije pri malignem obolenju ostaja pozitivno, če je trajanje zdravljenja omejeno na najkrajše možno obdobje in se uporabi najmanjši še učinkoviti odmerek;
English: Grounds for the variation to the terms of the marketing authorisation for the injectable calcitonin-containing medicinal products
Slovenian: Razlogi za spremembo pogojev dovoljenja za promet z zdravili za injiciranje, ki vsebujejo kalcitonin Ob upoštevanju naslednjega:
English: The company also provided information from a variety of supportive studies.
Slovenian: Podjetje je predložilo tudi podatke iz najrazličnejših podpornih študij.
English: As for every medicine, this included studies showing that the medicine was of acceptable quality.
Slovenian: Kot to velja za vsako zdravilo, je to vključevalo študije, ki so pokazale, da je zdravilo sprejemljive kakovosti.
English: Further information on Xromi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xromi .
Slovenian: Nadaljnje informacije o zdravilu Xromi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/xromi.
English: It must not be used in pregnancy, and breast-feeding must be stopped while taking the medicine.
Slovenian: Ne sme se uporabljati med nosečnostjo, dojenje pa je treba med jemanjem zdravila prekiniti.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given as a liquid to be swallowed rather than as capsules and is authorised for different uses.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto učinkovino, vendar se daje v obliki tekočine za zaužitje in ne kapsul ter je odobreno za druge uporabe.
English: Patients are usually started at a daily dose of 15 mg for each kg of body weight, and increased if necessary every 8 weeks to a maximum of 35 mg per kg.
Slovenian: Bolniki običajno začnejo jemati dnevni odmerek 15 mg na kilogram telesne mase, ki ga po potrebi povečujejo vsakih osem tednov do največjega dnevnega odmerka 35 mg na kilogram.
English: Therefore the European Medicines Agency decided that Xromi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Xromi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Xromi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xromi?
English: The company provided updated information showing the benefits of hydroxcarbamide in preventing complications of sickle cell disease in patients over 2 years of age.
Slovenian: Podjetje je predložilo posodobljene podatke o koristih hidroksikarbamida pri preprečevanju zapletov pri srpastoceličnem sindromu pri bolnikih, starejših od dveh let.
English: Because hydroxycarbamide is a well-established substance that has been used for many years in the EU the company provided information from the published literature on the benefits and risks of hydroxycarbamide in its approved uses.
Slovenian: Ker je hidroksikarbamid dobro uveljavljena učinkovina, ki se v EU uporablja že več let, je podjetje predložilo informacije iz objavljene literature o koristih in tveganjih učinkovine pri njenih odobrenih uporabah.
English: As for all medicines, data on the use of Xromi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xromi stalno spremljajo.
English: Xromi must also not be used in patients taking medicines to treat HIV infection.
Slovenian: Zdravila Xromi prav tako ne smejo uporabljati bolniki, ki jemljejo zdravila za zdravljenje okužbe z virusom HIV.
English: Xromi must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts.
Slovenian: Zdravilo Xromi se ne sme uporabljati pri bolnikih, ki imajo resne težave z ledvicami ali jetri ali ki imajo nevarno nizke ravni krvnih celic.
English: The company that markets Xromi will put in place an educational programme for doctors and patients about the correct use of the medicine and preventing harm, including guidance on use of the appropriate syringe for dosing and the need for regular blood testing.
Slovenian: Podjetje, ki trži zdravilo Xromi, bo pripravilo izobraževalni program za zdravnike in bolnike o pravilni uporabi zdravila in preprečevanju tveganj, vključno z navodili za uporabo ustrezne brizge za odmerjanje in potrebo po rednem izvajanju krvnih preiskav.
English: An overview of Xromi and why it is authorised in the EU
Slovenian: Pregled zdravila Xromi in zakaj je odobreno v EU
English: What benefits of Xromi have been shown in studies?
Slovenian: Kakšne koristi zdravila Xromi so se pokazale v študijah?
English: This included information from 4 main studies in sickle cell disease, including 3 studies involving 384 adults and children in whom hydroxycarbamide was shown to substantially reduce the risk of severe, painful blockages of blood supply (called vaso-occlusive crises) compared with a dummy treatment, and a fourth study involving 121 children that showed hydroxycarbamide to be at least as effective as standard treatment using blood transfusions in reducing blood vessel damage in the brain and the risk of stroke.
Slovenian: Med drugim je predložilo podatke iz štirih glavnih študij srpastoceličnega sindroma: tri študije, v katerih je sodelovalo 384 odraslih in otrok, pri katerih je bilo dokazano, da hidroksikarbamid bistveno zmanjša tveganje za hude in boleče blokade oskrbe s krvjo (imenovane vazookluzivne krize) v primerjavi z zdravljenjem s placebom, in eno študijo, v katero je bilo vključenih 121 otrok, pri katerih je bilo dokazano, da je hidroksikarbamid vsaj tako učinkovit kot standardno zdravljenje s pomočjo transfuzij krvi pri zmanjševanju poškodb žil v možganih in nevarnosti možganske kapi.
English: Patients should drink water after a dose of Xromi to ensure the full dose reaches the stomach.
Slovenian: Bolniki morajo po vsakem odmerku zdravila Xromi popiti vodo, da celoten odmerek zdravila doseže želodec.
English: Other information about Xromi
Slovenian: Druge informacije o zdravilu Xromi
English: Although the way that it works in this disease is not fully understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell disease.
Slovenian: Čeprav način delovanja hidroksikarbamida pri tej bolezni ni v celoti znan, lahko zmanjša število celic, ki krožijo v krvi, ter prepreči spreminjanje oblike rdečih krvnih celic pri bolnikih s srpastoceličnim sindromom.
English: Side effects reported with Xromi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Xromi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The most common side effects with Xromi (which may affect more than 1 in 10 people) are bone marrow suppression (reduced ability to produce blood cells) and reduced fertility in men due to oligospermia (low sperm counts) or azoospermia (absence of sperm).
Slovenian: Najpogostejši neželeni učinki zdravila Xromi (ki se lahko pojavijo pri več kot 1 bolniku od 10) so supresija kostnega mozga (zmanjšana sposobnost za tvorjenje krvnih celic) in manjša plodnost pri moških zaradi oligospermije (majhnega število semenčic) ali azoospemije (odsotnost semenčic).
English: Why is Xromi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Xromi odobreno v EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xromi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xromi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Xromi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Xromi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been used for many years to treat sickle cell disease, and has been authorised in EU countries for several decades as Hydrea for use in some types of cancer.
Slovenian: Hidroksikarbamid, nekdaj znan kot hidroksisečnina, se že več let uporablja za zdravljenje srpastoceličnega sindroma in je v državah članicah Evropske unije (EU) že nekaj desetletij na voljo za uporabo pri nekaterih vrstah rakavih obolenj.
English: Xromi is available as a liquid to be swallowed containing hydroxycarbamide 100 mg/mL, and doses are based on the patient's body weight.
Slovenian: Zdravilo Xromi je na voljo v obliki tekočine za zaužitje, ki vsebuje hidroksikarbamid v jakosti 100 mg/ml, odmerki pa so odvisni od bolnikove telesne mase.
English: The active substance in Xromi, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Slovenian: Učinkovina v zdravilu Xromi, hidroksikarbamid, zavira rast in reprodukcijo nekaterih celic, npr. krvnih celic.
English: What are the risks associated with Xromi?
Slovenian: Kakšna tveganja so povezana z zdravilom Xromi?
English: What is Xromi and what is it used for?
Slovenian: Kaj je zdravilo Xromi in za kaj se uporablja?
English: The medicine is supplied with two oral syringes for measuring the dose, a smaller red one for measuring doses up to a total of 300 mg (3 mL of liquid), and a larger white one for use if doses are bigger than this.
Slovenian: Zdravilu sta priloženi dve peroralni brizgi za odmerjanje odmerkov: manjša, rdeča brizga je namenjena odmerjanju prostornine do 300 mg (3 ml tekočine), večja, bela brizga pa se uporablja za večje odmerke.
English: The safety issues with hydroxycarbamide are well understood, and Xromi has been shown to be bioequivalent to an authorised hydroxycarbamide medicine.
Slovenian: Varnostna vprašanja v zvezi s hidroksikarbamidom so dobro znana, za zdravilo Xromi pa je bilo dokazano, da je bioekvivalentno odobrenemu zdravilu, ki vsebuje hidroksikarbamid.
English: It also carried out a study that showed Xromi is bioequivalent to the reference medicine, Hydrea.
Slovenian: Izvedlo je tudi študijo, ki je pokazala, da je zdravilo Xromi „bioekvivalentno“ referenčnemu zdravilu Hydrea.
English: Xromi is a medicine used in adults, adolescents and children over two years of age who have sickle cell disease, a genetic disease where the red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle).
Slovenian: Xromi je zdravilo za zdravljenje odraslih, mladostnikov in otrok, starejših od dveh let, ki imajo srpastoceličnisindrom, tj. gensko bolezen, pri kateri rdeče krvne celice postanejo toge in lepljive ter spremenijo obliko iz okroglo-ploščate v srpasto.
English: Xromi is used to prevent so-called vaso-occlusive complications - problems that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to parts of the body.
Slovenian: Uporablja se za preprečevanje t. i. vazookluzivnih zapletov, tj. težav, ki nastanejo, ko nenormalne rdeče krvne celice zamašijo krvne žile in s tem omejijo pretok krvi do različnih delov telesa.
English: Xromi can only be obtained with a prescription and treatment must be supervised by a healthcare professional experienced in the management of sickle cell disease.
Slovenian: Predpisovanje in izdaja zdravila Xromi je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s srpastoceličnim sindromom.
English: Xromi is a ‘hybrid medicine'.
Slovenian: Zdravilo Xromi je „hibridno zdravilo“.
English: Xromi (hydroxycarbamide)
Slovenian: Xromi (hidroksikarbamid)
English: The reference medicine for Xromi is Hydrea.
Slovenian: Referenčno zdravilo za zdravilo Xromi je zdravilo Hydrea.
English: For the full list of side effects of Xromi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Xromi glejte navodilo za uporabo.
English: How does Xromi work?
Slovenian: Kako zdravilo Xromi deluje?
English: How is Xromi used?
Slovenian: Kako se zdravilo Xromi uporablja?
English: The active substance in Xromi is hydroxycarbamide.
Slovenian: Učinkovina v zdravilu Xromi je hidroksikarbamid.
English: Make sure you have ready:
Slovenian: Prepričajte, da imate pripravljeno:
English: In this case continue with step “2.
Slovenian: V tem primeru nadaljujte s korakom "2.
English: First use: 1.
Slovenian: Prva uporaba: 1.
English: telephone number: XXXXXXXXXXX e-mail: XXXXXXXXXXX
Slovenian: telefonska številka: XXXXXXXXXXX e-pošta: XXXXXXXXXXX
English: The volume of distribution is approximately 1.7 L/kg.
Slovenian: Volumen porazdelitve je približno 1,7 l/kg.
English: This is not necessary when the rod is already in the starting position, such as at the very first use.
Slovenian: To ni potrebno, če je palica že v začetnem položaju, na primer kot pri prvi uporabi.
English: • improper or careless use, handling or cleaning
Slovenian: • nepravilna ali neprevidna uporaba, ravnanje ali čiščenje
English: The warranty does not cover damages caused by:
Slovenian: Garancija ne zajema škode, ki jo povzroči:
English: The primary objective of the study was to collect safety data of teriparatide.
Slovenian: Primarni cilj študije je bil zbrati podatke o varnosti teriparatida.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 January 2017
Slovenian: Datum prve odobritve: 04. januar 2017
English: To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Slovenian: Za preprečitev enega ali več novih zlomov vretenc so morali 11 žensk zdraviti mediano 19 mesecev.
English: Not to be sold separately.
Slovenian: Ni za posamično prodajo.
English: Protect it from water, dust and moisture.
Slovenian: Zaščitite ga pred vodo, prahom in vlago.
English: Teriparatide (N = 541) (%)
Slovenian: Teriparatid (N = 541) (%)
English: Do not repeat this before each daily injection, otherwise you will not have enough Terrosa for 28 days.
Slovenian: Ne ponovite tega pred vsakodnevnim injiciranjem, saj tako ne boste imeli dovolj zdravila Terrosa za 28 dni.
English: • Do not use your Terrosa Pen if it is damaged or if you have any doubts about its correct functioning.
Slovenian: • Ne uporabljajte svojega Terrosa Pen če je poškodovan, ali če imate kakršne koli dvome o njegovem pravilnem delovanju.
English: Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.
Slovenian: Ne ponovite koraka G več kot štirikrat, vendar sledite navodilom v razdelku Odpravljanje težav na zadnji strani.
English: The Terrosa Pen has a service life of two years.
Slovenian: Terrosa Pen ima življenjsko dobo dveh let.
English: Wash your hands carefully with soap to minimise the risk of infection.
Slovenian: Pazljivo si umijte roke z milom, da zmanjšate tveganje za okužbo.
English: • loss of energy
Slovenian: • izguba energije
English: If no drops emerge, repeat step G until you see some drops.
Slovenian: Če se kapljice ne pojavijo, ponovite korak G, dokler ne vidite nekaj kapljic.
English: Never share your pen with others.
Slovenian: Svojega peresnika nikoli ne delite z drugimi.
English: Otherwise tell your doctor.
Slovenian: V nasprotnem primeru obvestite svojega zdravnika.
English: Needles and used cartridges must be disposed of separately and safely.
Slovenian: Igle in uporabljene vložke je treba odstraniti ločeno in varno.
English: No medicine comes out of the needle during pen preparation step “G: Priming”.
Slovenian: Nič zdravila ne pride iz igle med pripravo zdravila pri koraku “G: Priprava”.
English: Warning: Ensure the use of the correct drug liquid.
Slovenian: Opozorilo: Zagotovite uporabo pravilne tekočine z zdravilom.
English: Terrosa can be given with or without food.
Slovenian: Zdravilo Terrosa se lahko daje s hrano ali brez nje.
English: The Terrosa Pen can be disposed of according to the instructions of the local authorities.
Slovenian: Terrosa Pen lahko odstranite v skladu z navodili lokalnih organov.
English: No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 years).
Slovenian: V farmakokinetiki teriparatida niso zaznali razlik glede na starost (razpon od 31 do 85 let).
English: This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.
Slovenian: To je pomembno zato, ker lahko nekatera zdravila (npr. digoksin/digitalis, zdravilo za zdravljenje bolezni srca) medsebojno delujejo s teriparatidom.
English: 4.7 Effects on ability to drive and use machines Teriparatide has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Teriparatid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Your doctor will advise you and decide how long you should be treated with Terrosa.
Slovenian: Vaš zdravnik vam bo svetoval in se odločil, kako dolgo se morate zdraviti z zdravilom Terrosa.
English: • other cases of exposure and wear, not in accordance with the instructions for use.
Slovenian: • drugi primeri izpostavljenosti in obrabe, ki niso v skladu z navodili za uporabo.
English: A small air bubble will not affect the dose, or harm.
Slovenian: Majhen zračni mehurček ne vpliva na odmerek ali škoduje.
English: • Select an appropriate injection site and prepare your skin as recommended by your doctor.
Slovenian: • Izberite primerno mesto injiciranja in kožo pripravite tako, kot vam je priporočil vaš zdravnik.
English: Do not use alcohol, other solvents or cleaning agents.
Slovenian: Ne uporabljajte alkohola, drugih topil ali čistilnih sredstev.
English: Colourless, clear solution for injection with a pH of 3.8 - 4.5.
Slovenian: Brezbarvna, bistra raztopina za injiciranje s pH 3,8-4,5.
English: If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection.
Slovenian: Če ne sledite navodilom, obstaja tveganje nepravilnega zdravljenja, netočnega odmerjanja, prenosa bolezni ali okužbe.
English: • if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na teriparatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Follow the instructions presented in this instructions for use.
Slovenian: Upoštevajte navodila v teh navodilih za uporabo.
English: This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83).
Slovenian: Ta študija je vključevala ženske po menopavzi (N = 277), ženske pred menopavzo (N = 67) in moške (N = 83).
English: Local, healthcare professional or institutional policies may replace the instructions regarding needle handling and disposal.
Slovenian: Lokalne, zdravstvene ali institucionalne smernice lahko nadomestijo navodila za ravnanje z iglami in njihovo odstranjevanje.
English: B: Remove the cartridge holder by turning it (bayonet coupling).
Slovenian: B: Odstranite nosilec vložka tako, da ga obračate (bajonetni spoj).
English: Do not press the push button.
Slovenian: Ne pritiskajte na gumb.
English: Set the dose and complete the injection as described in section “2.
Slovenian: Nastavite odmerek in dokončajte injiciranje, kot je opisano v poglavju "2.
English: G: Priming
Slovenian: G: Priprava
English: The Terrosa Pen must not be used by blind or visually impaired patients without help from a trained able-bodied person.
Slovenian: Terrosa Pen ne smejo uporabljati slepi ali slabovidni bolniki brez pomoči usposobljene osebe.
English: • use contrary to the instructions for use
Slovenian: • uporaba v nasprotju z navodili za uporabo
English: • if you have ever had bone cancer or if other cancers have spread (metastasised) to your bones.
Slovenian: • če ste že kdaj imeli kostnega raka ali če so se druge oblike raka razširile (metastazirale) v vaše kosti.
English: The pivotal study included 1,637 postmenopausal women (mean age 69.5 years).
Slovenian: Ključna študija je vključevala 1637 žensk po menopavzi (povprečna starost 69,5 let).
English: • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget's disease of bone (disease with abnormal bone changes).
Slovenian: • če imate nepojasnjene visoke ravni alkalne fosfataze v krvi, kar pomeni, da imate morda Pagetovo bolezen kosti (bolezen z abnormalno spremembo kosti).
English: It is limited to replacement of the pen.
Slovenian: To je omejeno na zamenjavo peresnika.
English: The warranty covers manufacturing and material defects of your Terrosa Pen for two years of use, from purchase.
Slovenian: Garancija Garancija zajema napake pri izdelavi in materialne napake vašega Terrosa Pen za dve leti uporabe, od nakupa.
English: Consult your doctor in the case of hearing or handling problems.
Slovenian: Posvetujte se s svojim zdravnikom v primeru težav s sluhom ali težavah z rokovanjem.
English: - Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Slovenian: - Nosečnost in dojenje (glejte poglavji 4.4 in 4.6).