FrancophonIA/ELRC3.0 huggingface dataset:
English: What Kinzalmono looks like and contents of the pack Kinzalmono 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side.
Slovenian: Izgled zdravila Kinzalmono in vsebina pakiranja Tablete Kinzalmono so bele, podolgovate tablete z vtisnjenim logom podjetja in oznako 52H.
English: Kinzalmono 40 mg and 80 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Slovenian: Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableta.
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Slovenian: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov): okužbe sečil, okužbe zgornjih dihal (npr. bolečine v grlu, vneti sinusi, prehlad), pomanjkanje rdečih krvničk (anemija), visoka raven kalija, težave z uspavanjem, občutek žalosti (depresija), omedlevica (sinkopa), vrtoglavica, počasen srčni utrip (bradikardija), nizek krvni tlak (hipotenzija) pri osebah, ki se zdravijo zaradi visokega krvnega tlaka, omotica pri vstajanju (ortostatska hipotenzija), zasoplost, kašelj, trebušne bolečine, driska, nelagodje v trebuhu, napenjanje, bruhanje, srbež, povečano znojenje, medikamentni izpuščaj, bolečine v hrbtu, mišični krči, mišična bolečina (mialgija), ledvična okvara, tudi akutna ledvična odpoved, bolečina v prsnem košu, občutek oslabelosti in zvišana raven kreatinina v krvi.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), severe allergic reaction (anaphylactic reaction), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): sepsa* (pogosto poimenovana tudi zastrupitev krvi, je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna), povečanje določenih belih krvničk (eozinofilija), majhno število trombocitov (trombocitopenija), huda alergijska reakcija (anafilaktična reakcija), alergijska reakcija (npr. izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka), hitro otekanje kože in sluznice, ki lahko povzroči tudi smrt (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica, izpuščaji (urtikarija), hud medikamentni izpuščaj, bolečina v sklepih (artralgija), bolečina v okončini, bolečina v kitah, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
English: Progressive scarring of lung tissue (interstitial lung disease)**.
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): Progresivno brazgotinjenje pljučnega tkiva (intersticijska pljučna bolezen)**
English: Kinzalmono is available in blister packs containing 14, 28, 56 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Slovenian: Kinzalmono je na voljo v pretisnih omotih po 14, 28, 28 x 1, 56 ali 98 tablet.
English: It must not be given to patients with active cancers.
Slovenian: Ne sme se dajati bolnikom z aktivnim rakom.
English: This treatment course is repeated one year later.
Slovenian: Ta cikel zdravljenja se ponovi čez eno leto.
English: Mavenclad cladribine
Slovenian: Mavenclad kladribin
English: The first year, patients take one to two tablets a day for 4 or 5 days; after one month, they again take one to two tablets a day for 4 or 5 days, adding up to a total dose of 1.75 mg per kg body weight over the two periods.
Slovenian: Prvo leto bolniki 4 do 5 dni zaporedoma jemljejo eno do dve tableti na dan; po enem mesecu ponovno 4 do 5 dni jemljejo eno do dve tableti na dan, tako da skupni odmerek znaša 1,75 mg na kg telesne mase v dveh obdobjih.
English: The full EPAR for Mavenclad 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 Mavenclad 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 Mavenclad.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mavenclad.
English: What measures are being taken to ensure the safe and effective use of Mavenclad?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mavenclad?
English: The European Medicines Agency therefore decided that Mavenclad's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Mavenclad večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Mavenclad is used in patients whose disease is highly active.
Slovenian: Zdravilo Mavenclad se uporablja pri bolnikih, pri katerih je bolezen zelo aktivna.
English: Cladribine is already approved in the EU for the treatment of certain leukaemias (cancers affecting lymphocytes).
Slovenian: Kladribin je v EU že odobren za zdravljenje nekaterih levkemij (rakov, ki prizadenejo limfocite).
English: In addition, the fact that Mavenclad is given by mouth, and requires only 2 short courses 12 months apart, offers an advantage to patients.
Slovenian: Poleg tega tudi to, da se zdravilo Mavenclad daje peroralno in sta potrebna le dva kratka cikla v razmiku 12 mesecev, predstavlja prednost za bolnike.
English: The results suggested that the effects were greatest in patients with highly active disease and that benefit might be expected in other relapsing forms of multiple sclerosis.
Slovenian: Rezultati so nakazali, da so bili učinki največji pri bolnikih z visoko aktivno boleznijo in da bi korist lahko pričakovali tudi pri drugih recidivnih oblikah multiple skleroze.
English: In a follow-up study for up to a further 2 years, benefit of the original treatment was maintained but there seemed no additional benefit from giving more than 2 courses of Mavenclad treatment.
Slovenian: V kontrolni študiji, ki je trajala največ nadaljnji dve leti, so se koristi prvotnega zdravljenja ohranile, ni pa kazalo na dodatno korist več kot dveh ciklov zdravljenja z zdravilom Mavenclad.
English: Relapsing means that the patient has repeated flare-ups of the symptoms.
Slovenian: Recidivna pomeni, da imajo bolniki ponavljajoče se izbruhe simptomov.
English: Rashes, hair loss and lowered counts of another type of white blood cell, neutrophils, may also affect up to 1 patient in 10.
Slovenian: Izpuščaji, izpadanje las in dlak ter znižano število druge vrste belih krvnih celic, nevtrofilcev, se lahko pojavijo pri največ 1 bolniku od 10.
English: This appeared to be most marked in patients with highly active disease, in whom the clinical benefits were considered to outweigh the risks of a severe long-term lowering in lymphocyte numbers, which increases the risk of infection and possibly of cancer.
Slovenian: To se je najizraziteje pokazalo pri bolnikih z zelo aktivno boleznijo, pri katerih je bilo ocenjeno, da klinične koristi odtehtajo tveganja dolgotrajnega znižanja števila limfocitov, zaradi katerega se poveča tveganje za okužbo in morda za rak.
English: Treatment must also be avoided in patients whose kidney function is moderately or severely reduced, and in women who are pregnant or breast feeding.
Slovenian: Izogibati se mu je treba tudi pri bolnikih z zmerno ali hudo okvaro delovanja ledvic in pri ženskah, ki so noseče ali dojijo.
English: The active substance in Mavenclad, cladribine, has a similar chemical structure to purine, one of the substances needed to make up the DNA.
Slovenian: Zdravilna učinkovina v zdravilu Mavenclad, kladribin, ima podobno kemično strukturo kot purin, ena od snovi, ki so potrebne za izgradnjo DNK.
English: Effects on lymphocytes reduce the body's immune defence against infections and cancer: Mavenclad must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are weakened for other reasons such as treatment with medicines that suppress the immune system.
Slovenian: Učinki na limfocite zmanjšujejo imunsko obrambo telesa pred okužbami in rakom: zdravila Mavenclad se ne sme dajati bolnikom z aktivnimi dolgotrajnimi okužbami, kot je tuberkuloza ali hepatitis, ali bolnikom, okuženim z virusom HIV ali pri katerih je imunski odziv oslabljen iz drugih razlogov, npr. zaradi zdravljenja z zdravili, ki zavirajo imunski sistem.
English: Other information about Mavenclad
Slovenian: Druge informacije o zdravilu Mavenclad
English: The company that markets Mavenclad will provide information on the medicine for healthcare professionals and patients, including advice on the side effects and safety concerns, the need for monitoring before and during treatment, and on pregnancy prevention and effective contraception in both female and male patients.
Slovenian: Družba, ki trži zdravilo Mavenclad, bo zagotovila informacije o zdravilu za zdravstvene delavce in bolnike, vključno z nasveti o neželenih učinkih in zadržkih glede varnosti, potrebi po spremljanju pred in med zdravljenjem ter o preprečevanju nosečnosti in učinkoviti kontracepciji pri bolnicah in bolnikih.
English: The study compared the effect of Mavenclad and placebo (a dummy treatment) in reducing the relapse rate 96 weeks after the start of treatment.
Slovenian: V študiji so primerjali učinek zdravila Mavenclad in placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju stopnje ponovitve 96 tednov po začetku zdravljenja.
English: Patients treated with Mavenclad had a relapse rate of 0.14 per year on average, compared with 0.33 for patients given placebo; at the end of 96 weeks, around 8 out 10 patients given standard doses of Mavenclad and 6 out of 10 given placebo had not had a relapse.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Mavenclad, je bila stopnja ponovitve povprečno 0,14 na leto, v primerjavi z 0,33 pri bolnikih, ki so prejemali placebo; po preteku 96 tednov do ponovitve ni prišlo pri 8 bolnikih od 10, ki so prejemali standardne odmerke zdravila Mavenclad, in 6 bolnikih od 10, ki so prejemali placebo.
English: The dose depends on patients' body weight and treatment consists of two courses spread over 2 years.
Slovenian: Odmerek je odvisen od telesne mase bolnika, zdravljenje pa je sestavljeno iz dveh ciklov v času dveh let.
English: Mavenclad has been shown to be effective in one main study involving 1,326 patients with relapsingremitting multiple sclerosis.
Slovenian: Zdravilo Mavenclad se je kot učinkovito pokazalo v eni glavni študiji, v katero je bilo vključenih 1 326 bolnikov z recidivno-remitentno multiplo sklerozo.
English: In multiple sclerosis, the body's immune (defence) system attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Slovenian: Pri multipli sklerozi imunski (obrambni) sistem telesa napade in poškoduje zaščitno ovojnico okoli živčnih celic v osrednjem živčevju (možganih in hrbtenjači).
English: In addition, patients given Mavenclad were nearly 50% less likely to have disease progression (indicated as an increase in disability that lasted for at least 6 months).
Slovenian: Poleg tega je bilo napredovanje bolezni skoraj 50 % manj verjetno pri bolnikih, ki so prejemali zdravilo Mavenclad (opredeljeno kot povečanje nezmožnosti, ki je trajalo vsaj 6 mesecev).
English: For more information about treatment with Mavenclad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Mavenclad preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mavenclad have also 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 Mavenclad upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Mavenclad can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating multiple sclerosis.
Slovenian: Predpisovanje in izdaja zdravila Mavenclad je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje multiple skleroze.
English: What is Mavenclad and what is it used for?
Slovenian: Kaj je zdravilo Mavenclad in za kaj se uporablja?
English: The most common side effects with Mavenclad are lymphopenia (reduction in lymphocytes, which may affect more than 1 in 10 people) and infections with herpes zoster virus, in up to 1 patient in 10.
Slovenian: Najpogostejši neželeni učinki zdravila Mavenclad so limfopenija (zmanjšanje števila limfocitov, ki lahko prizadene več kot 1 bolnika od 10) in okužbe z virusom herpesa zostra pri največ 1 bolniku od 10.
English: Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Slovenian: Mavenclad je zdravilo, ki se uporablja za zdravljenje odraslih z recidivno obliko multiple skleroze (bolezni, pri kateri vnetje poškoduje zaščitno ovojnico okrog živčnih celic v možganih in hrbtenjači).
English: This brings about the death of the lymphocytes, slowing down the progression of multiple sclerosis.
Slovenian: To povzroči odmiranje limfocitov in s tem upočasnitev napredovanja multiple skleroze.
English: What are the risks associated with Mavenclad?
Slovenian: Kakšna tveganja so povezana z zdravilom Mavenclad?
English: What benefits of Mavenclad have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Mavenclad izkazalo v študijah?
English: Why is Mavenclad approved?
Slovenian: Zakaj je bilo zdravilo Mavenclad odobreno?
English: For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Mavenclad naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Mavenclad, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mavenclad, glejte navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Mavenclad.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: It contains the active substance cladribine.
Slovenian: Vsebuje zdravilno učinkovino kladribin.
English: The immune cells called lymphocytes play a key role in this process.
Slovenian: V tem procesu imajo osrednjo vlogo imunske celice, imenovane limfociti.
English: No other medicines should be taken within 3 hours of a Mavenclad tablet.
Slovenian: Tri ure po zaužitju tablete zdravila Mavenclad se ne sme vzeti nobeno drugo zdravilo.
English: In the body, cladribine is taken up by cells such as lymphocytes and interferes with the production of new DNA.
Slovenian: V telesu kladribin privzamejo celice, kot so limfociti, kar ovira tvorbo nove DNK.
English: Mavenclad has been shown to reduce relapse rates and delay disease progression in patients with relapsing multiple sclerosis.
Slovenian: Dokazano je bilo, da zdravilo Mavenclad pri bolnikih z recidivno multiplo sklerozo zmanjšuje stopnjo ponovitve in upočasnjuje napredovanje bolezni.
English: How is Mavenclad used?
Slovenian: Kako se zdravilo Mavenclad uporablja?
English: How does Mavenclad work?
Slovenian: Kako zdravilo Mavenclad deluje?
English: This new oral formulation has not been submitted for approval in any of the EU member states.
Slovenian: Ta nova peroralna formulacija ni bila predložena v odobritev v nobeni od držav članic EU.
English: Grounds for re-examination were received on 22 September 2012.
Slovenian: Razlogi za ponovno presojo so bili sprejeti 22. septembra 2012.
English: A Commission Decision for this previous referral procedure was issued on 12 June 2003.
Slovenian: Komisija je odločbo za ta prejšnji napotitveni postopek izdala 12. junija 2003.
English: Pharmacovigilance
Slovenian: Farmakovigilanca
English: Calcitonin is currently authorised in most European member states.
Slovenian: Kalcitonin je trenutno odobren v večini evropskih držav članic.
English: Statistical issues (meta-analysis)
Slovenian: Statistična vprašanja (metaanaliza)
English: Treatment duration is recommended to be 2 weeks and not exceeding 4 weeks in any case.
Slovenian: Priporočeno trajanje zdravljenja je 2 tedna in ne sme v nobenem primeru preseči 4 tednov.
English: Another factor that could explain low reporting rate is the fact that calcitonin have been authorised for nearly 40 years.
Slovenian: Drug dejavnik, ki bi lahko razložil nizko stopnjo poročanja, pa je dejstvo, da je kalcitonin odobren že skoraj 40 let.
English: Parenteral formulations of calcitonin were first licensed in Europe in 1973.
Slovenian: Parenteralne formulacije kalcitonina so bile v Evropi prvič odobrene leta 1973.
English: One IU corresponds to approximately 0.2μg of synthetic salmon calcitonin.
Slovenian: Ena i.e. ustreza približno 0,2 μg sintetičnega lososovega kalcitonina.
English: The CHMP also consulted a group of experts on 6 November 2012 to gain their view on a number issues.
Slovenian: Odbor CHMP se je 6. novembra 2012 posvetoval tudi s skupino strokovnjakov, da je pridobil njihov pogled na izpostavljena vprašanja.
English: Overall summary of the scientific evaluation of calcitonin-containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo kalcitonin (glejte Prilogo I)
English: Moreover, beyond any discussion of whether the statistical significance is achieved in some cases or not, there is an evident, consistent and clear trend of an increased risk of cancer.
Slovenian: Poleg tega mimo vseh razprav o tem, ali je v nekaterih primerih dosežena statistična pomembnost ali ne, obstaja očiten, konsistenten in jasen trend povečanega tveganja raka.
English: As expected, the risk of cancer increases when excluding the four studies with no events.
Slovenian: Po pričakovanjih se tveganje raka poveča, če izključimo štiri študije brez dogodkov.
English: The issue was however kept under close monitoring.
Slovenian: Skrbno spremljanje te težave se je zato nadaljevalo.
English: The product can be administered intramuscularly, subcutaneously or intravenously.
Slovenian: Zdravilo se lahko uporablja intramuskularno, subkutano ali intravensko.
English: The intranasal formulation is available at 100 or 200 International Units (IU)/ml.
Slovenian: Intranazalna formulacija je na voljo v odmerku 100 ali 200 mednarodnih enot (i.e.)/ml.
English: A reduction in hip fractures has not been demonstrated.
Slovenian: Zmanjšanja kolčnih zlomov niso pokazali.
English: In view of the safety concerns the CHMP was of the view that it was necessary to restrict the target population for this indication.
Slovenian: Glede varnostnih težav je odbor CHMP menil, da je nujno omejiti ciljno populacijo za to indikacijo.
English: For Paget's disease, the evidence of efficacy is based on published literature of a number of small studies, where the treatment duration was in most cases between 3-18 months.
Slovenian: Pri Pagetovi bolezni dokazi o učinkovitosti temeljijo na objavljeni literaturi iz številnih majhnih študij, v katerih je zdravljenje večinoma trajalo od 3 do 18 mesecev.
English: Concerns on the efficacy of certain indications were previously raised, which resulted in a referral under Article 12 of Directive 75/319/EC (corresponding to Article 31 of Directive 2001/83/EC) in 2000.
Slovenian: Pred tem so se pojavili pomisleki glede učinkovitosti nekaterih indikacij, zaradi česar je bil leta 2000 sprožen napotitveni postopek v skladu z 12. členom Direktive 75/319/ES (kar ustreza 31. členu Direktive 2001/83/ES).
English: Non-clinical aspects
Slovenian: Neklinična vprašanja
English: However, review of available data at the time by National Competent Authorities did not indicate a causal relationship.
Slovenian: Vendar pa takratni pregled razpoložljivih podatkov, ki so ga opravili nacionalni pristojni organi, ni pokazal vzročne povezave.
English: Since 1987 calcitonin has also been available as an intranasal formulation.
Slovenian: Od leta 1987 je kalcitonin na voljo v obliki intranazalne formulacije.
English: The MAH also discusses the lack of causality based on the Bradford-Hill criteria, which have been taken into account and assessed.
Slovenian: Imetnik dovoljenja za promet z zdravilom razpravlja tudi o pomanjkanju vzročnosti na podlagi kriterijev Bradford-Hill, ki so bili upoštevani in ocenjeni.
English: Therefore, the scarce number of cases of cancer in patients who are or have been treated with calcitonin that are found in global safety databases cannot lead to any conclusions, mainly when balanced against data coming from clinical trials.
Slovenian: Zato skromno število primerov raka pri bolnikih, ki so ali ki so bili zdravljeni s kalcitoninom, ki jih je najti v svetovnih bazah podatkov o varnosti, ne more voditi v zaključke, še posebej kadar so uravnoteženi s podatki iz kliničnih preizkušanj.
English: The majority of the cancer cases reported in the calcitonin trials occurred after 12 months of treatment.
Slovenian: Večina primerov raka, o katerih so poročali v preskušanjih kalcitonina, se je pojavila po 12 mesecih zdravljenja.
English: • Overall benefit-risk assessment
Slovenian: • Splošna ocena tveganj in koristi
English: The inconsistency in the summary statistics given is recognised by the CHMP but the impact on the overall interpretation must be regarded as marginal or non-existing.
Slovenian: Odbor CHMP priznava neskladnost podanih statistik povzetka, vendar pa je treba vpliv na splošno interpretacijo upoštevati kot marginalen ali neobstoječ.