FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Slovenian: Duloksetin z zaviranjem njihovega prevzemanja poveča količino teh živčnih prenašalcev v prostorih med temi živčnimi celicami in s tem stopnjo sporazumevanja med celicami.
English: What benefit has Ariclaim shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ariclaim izkazalo med študijami?
English: The dose should be reduced gradually when stopping treatment.
Slovenian: Ob prenehanju zdravljenja je treba odmerek zmanjševati postopoma.
English: Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Slovenian: Zdravilo Ariclaim je bilo v odmerku 60 mg enkrat ali dvakrat dnevno pri zmanjševanju bolečine učinkovitejše od placeba.
English: Ariclaim is a medicine that contains the active substance duloxetine.
Slovenian: Ariclaim je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
English: Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of neuropathic pain.
Slovenian: Ker ti živčni prenašalci sodelujejo pri zmanjševanju občutka bolečine, se z zaviranjem njihovega ponovnega prevzema v živčne celice izboljšajo tudi simptomi nevropatske bolečine.
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovno prevzemanje živčnih prenašalcev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v živčne celice možganov in hrbtenjače.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim's benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ariclaim pri zdravljenju bolečin pri diabetični periferni nevropatiji pri odraslih večje od z njim povezanih tveganj.
English: SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
Slovenian: Stresna urinska inkontinenca je nenamerno uhajanje urina med telesnim naporom, kašljanjem, smejanjem, kihanjem, dviganjem ali telesno vadbo.
English: What is the risk associated with Ariclaim?
Slovenian: Kakšna tveganja so povezana z zdravilom Ariclaim?
English: This prevents the active substance being destroyed by the acid in the stomach.
Slovenian: Tako se prepreči, da bi želodčna kislina uničila zdravilno učinkovino.
English: It must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Slovenian: Zdravilo Ariclaim se ne sme uporabljati skupaj z zaviralci monoaminooksidaze (skupino zdravil proti depresiji), fluvoksaminom (drugim zdravilom proti depresiji), ciprofloksacinom ali enoksacinom (vrstama antibiotikov).
English: Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Slovenian: Zdravila Ariclaim ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Slovenian: Zdravilo Ariclaim se uporablja za zdravljenje bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
English: Ariclaim must not be used in patients with certain types of liver disease or with severe kidney disease.
Slovenian: Zdravila Ariclaim ne smejo uporabljati bolniki z določenimi vrstami obolenj jeter ali s hudim obolenjem ledvic.
English: Why has Ariclaim been approved?
Slovenian: Zakaj je bilo zdravilo Ariclaim odobreno?
English: The full EPAR for Ariclaim is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ariclaim je na voljo tukaj.
English: For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Ariclaim, glejte navodilo za uporabo.
English: The active substance in Ariclaim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina zdravila Ariclaim, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
English: How does Ariclaim work?
Slovenian: Kako zdravilo Ariclaim deluje?
English: What is Ariclaim used for?
Slovenian: Za kaj se zdravilo Ariclaim uporablja?
English: How has Ariclaim been studied?
Slovenian: Kako je bilo zdravilo Ariclaim raziskano?
English: What is Ariclaim?
Slovenian: Kaj je zdravilo Ariclaim?
English: How is Ariclaim used?
Slovenian: Kako se zdravilo Ariclaim uporablja?
English: Medicinal product no longer authorised
Slovenian: Zdravilo nima več dovoljenja za promet
English: MA (EU) Number (Invented) Name
Slovenian: (Izmišljeno) ime
English: Pharmaceutical Form Route of Administration
Slovenian: Jakost Farmacevtska oblika
English: Progress through Tanner stages appeared appropriate.
Slovenian: Napredek glede na stadije po Tannerju se je pokazal kot ustrezen.
English: Historical controls did not show change over time.
Slovenian: Zgodovinski kontrolni podatki niso pokazali sprememb v času.
English: An aseptic technique should be used.
Slovenian: Uporabiti je treba aseptično tehniko.
English: You are now ready to inject the correct dose.
Slovenian: Zdaj ste pripravljeni injicirati pravilni odmerek.
English: Always follow the instructions provided by your doctor.
Slovenian: Vedno upoštevajte navodila zdravnika.
English: SN {number}
Slovenian: SN {številka} NN {številka}
English: Pay attention not to hurt yourself with the needle.
Slovenian: Bodite pozorni, da se z iglo ne poškodujete.
English: Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Zdravila Strensiq ne segrevajte na noben drug način (na primer, ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
English: These effects were restricted to injection sites and were partially or completely reversible.
Slovenian: Ti učinki so bili omejeni na mesta injiciranja in so bili delno ali povsem reverzibilni.
English: Craniosynostosis can lead to increased intracranial pressure.
Slovenian: Kraniosinostoza lahko povzroči povečan intrakranialni tlak.
English: The patients were randomly assigned to treatment group for the primary treatment period.
Slovenian: Bolniki so bili naključno razporejeni v skupino zdravljenja za primarno obdobje zdravljenja.
English: For more information, please consult:
Slovenian: Za več informacij glejte:
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, 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: • The dose you receive is based on your body weight.
Slovenian: • Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase.
English: Annually within annual reassessment
Slovenian: vsako leto v okviru vsakoletne ponovne ocene zdravila
English: Read section 3 carefully to know the injection recommendations.
Slovenian: Skrbno preberite poglavje 3, da se seznanite s priporočili za injiciranje.
English: Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research.
Slovenian: Nomenklatura, simboli in enote so sledili priporočilom Ameriškega združenja za raziskovanje kosti in mineralov (American Society for Bone and Mineral Research).
English: Rotation of injection sites may help to minimize these reactions.
Slovenian: Menjavanje mesta injiciranja lahko pomaga kar najbolj zmanjšati te reakcije.
English: These reference data were drawn from a representative sample of healthy children and are not specific for children with special health care needs: they have been used in the absence of growth charts for children with hypophosphatasia.
Slovenian: Ti referenčni podatki so bili izdelani iz reprezentativnega vzorca zdravih otrok in niso specifični za otroke s posebnimi potrebami v zvezi z zdravstveno oskrbo; uporabljajo se, kadar ni na voljo tablic rasti za otroke s hipofosfatazijo.
English: After opening the vial, the product should be used immediately (within 3 hours maximum).
Slovenian: Po odprtju viale morate zdravilo takoj uporabiti (v roku največ 3 ur).
English: There is potential for immunogenicity.
Slovenian: Obstaja možnost imunogenosti.
English: It is not intended for intravenous or intramuscular injection.
Slovenian: Ni namenjeno za intravensko ali intramuskularno injiciranje.
English: The adolescent (and adult) patients in this study did not display apparent height-gain.
Slovenian: Bolniki mladostniki (in odrasli bolniki) v tej študiji niso kazali navidezne rasti.
English: Of these 11 patients, 9 patients had their doses increased specifically to improve clinical response.
Slovenian: Od teh 11 bolnikov so 9 bolnikom odmerke zvečali posebej zato, da bi izboljšali klinični odziv.
English: Green (x2)
Slovenian: zelena (x2)
English: Always use a new syringe contained in a protective plastic.
Slovenian: Vedno uporabite novo brizgo, priloženo v zaščitni plastiki.
English: Alexion Pharma International Operations Unlimited Company College Business and Technology Park, Blanchardstown Dublin 15
Slovenian: Alexion Pharma International Operations Unlimited Company College Business and Technology Park, Blanchardstown
English: Chemical and physical in-use stability has been demonstrated for up to 3 hours at a temperature between 23°C to 27°C.
Slovenian: 2 leti Kemijska in fizikalna stabilnost med uporabo je bila dokazana za največ 3 ure pri temperaturi med 23 °C
English: The safety and efficacy of Strensiq in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.
Slovenian: Varnost in učinkovitost zdravila Strensiq pri bolnikih z ledvično ali jetrno okvaro ni bila ovrednotena, zato specifičnih režimov odmerjanja za te bolnike ni mogoče priporočati.
English: Age at treatment initiation in the study was between 0.5 to 35 months.
Slovenian: Starost ob začetku zdravljenja v študiji je bila med 0,5 in 35 mesecev.
English: NOTE: do not use any areas in which you feel lumps, firm knots, or pain; talk to your doctor about anything you find.
Slovenian: OPOMBA: ne uporabljajte predelov, v katerih čutite zatrdline, čvrste vozliče ali bolečino; o vsem, kar opazite, se pogovorite z zdravnikom.
English: Dietary supervision is recommended.
Slovenian: Priporoča se nadzor prehrane.
English: Strensiq may cause some tests to show wrongly higher or lower results.
Slovenian: Zdravilo Strensiq lahko povzroči, da nekateri testi nepravilno pokažejo višje ali nižje rezultate.
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Slovenian: Če niste prepričani, kaj so spodaj navedeni neželeni učinki, prosite zdravnika, da vam jih razloži.
English: • You may experience a reaction at the injection site.
Slovenian: • Morda boste doživeli reakcijo na mestu injiciranja.
English: It is expected that pharmacokinetic exposures will increase with body weight.
Slovenian: Pričakuje se, da se bo farmakokinetika izpostavljenosti s telesno maso povečala.
English: Most suitable areas for injection are marked grey in the picture.
Slovenian: Najprimernejša mesta za injiciranje so na sliki sivo označena.
English: Do not inject this medicine yourself unless you have received training and you understand the procedure.
Slovenian: Tega zdravila si ne injicirajte sami, če o tem niste bili ustrezno poučeni in če ne razumete postopka.
English: Data from post-marketing cases suggests that the development of antibodies may affect clinical efficacy.
Slovenian: Podatki iz primerov v obdobju trženja zdravila kažejo, da bi razvoj protiteles lahko vplival na klinično učinkovitost.
English: As a consequence, your doctor may ask you to take supplements of calcium and oral vitamin D if needed.
Slovenian: Zato vam lahko zdravnik naroči, da jemljite kalcij in peroralni vitamin D, če je treba.
English: Pack sizes of 1 or 12 vials.
Slovenian: Velikosti pakiranja 1 ali 12 vial.
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Slovenian: 103-105 rue Anatole France 92300 Levallois-Perret
English: The MAH should set up an observational, longitudinal, prospective, long-term registry of patients with HPP to collect information on the epidemiology of the disease, including clinical outcomes and quality of life, and to evaluate safety and effectiveness data in patients treated with Strensiq.
Slovenian: MAH mora vzpostaviti opazovalen, longitudinalen, prospektiven, dolgoročen register bolnikov s HPP za zbiranje informacij o epidemiologiji bolezni, vključno s kliničnimi izidi in kvaliteto življenja, in za ocenjevanje podatkov o varnosti in učinkovitosti pri bolnikih, zdravljenih z zdravilom Strensiq.
English: Some patients required oral vitamin D supplements during the study (see sections 4.4 and 4.8).
Slovenian: Pri nekaterih bolnikih so bili med študijo potrebni peroralni dodatki vitamina D (glejte poglavji 4.4 in 4.8).
English: If you need to undergo laboratory tests (giving blood for testing), tell your doctor that you are treated with Strensiq.
Slovenian: Če je pri vas treba opraviti laboratorijske teste (če boste dali kri za preiskave), povejte zdravniku, da se zdravite z zdravilom Strensiq.
English: In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety (see section 5.2).
Slovenian: V kliničnih preskušanjih se je pokazalo, da razvoj protiteles ne vpliva na klinično učinkovitost ali varnost (glejte poglavje 5.2).
English: The antibody response (with or without presence of neutralizing antibodies) was time variant in nature.
Slovenian: Odziv protiteles (s prisotnostjo nevtralizirajočih protiteles ali brez nje) se je spreminjal s časom.
English: Fluctuation in height-gain was apparent and may reflect the more severe disease and higher rate of morbidity in these younger patients.
Slovenian: Fluktuacija pri pridobivanju višine je bila očitna in lahko kaže težjo bolezen in višjo stopnjo obolevnosti pri teh mladih bolnikih.
English: Adult patients Efficacy and safety data in patients with hypophosphatasia >18 years old are limited.
Slovenian: Odrasli bolniki Podatki o učinkovitosti in varnosti zdravila pri bolnikih s hipofosfatazijo, starih > 18 let, so omejeni.
English: It is used for long-term enzyme replacement treatment to manage symptoms.
Slovenian: Uporablja se za dolgotrajno encimsko nadomestno zdravljenje za zdravljenje simptomov.
English: • Should you experience anaphylactic reaction, or an event with similar symptoms, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision.
Slovenian: • Če pri vas pride do anafilaktične reakcije ali stanja s podobnimi simptomi, se bo zdravnik z vami pogovoril o naslednjih korakih in možnosti, da začnete ponovno jemati zdravilo Strensiq pod zdravniškim nadzorom.
English: If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated.
Slovenian: Če se pojavijo te reakcije, se priporoča takojšnja prekinitev zdravljenja in uvedba ustreznega zdravljenja.
English: Step 5: Disposing of supplies
Slovenian: 5. korak: Odstranjevanje odpadnega materiala
English: Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.
Slovenian: Bolnike je treba spremljati glede ponovnega pojava znakov in simptomov resne preobčutljivostne reakcije.
English: You may need to use several vials to withdraw the complete amount needed to reach the correct dose.
Slovenian: Morda boste morali uporabiti več vial, da izvlečete celotno količino, potrebno za pravilni odmerek.
English: Pack sizes: cartons of 1 or 12 vials Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranja: škatle z 1 vialo ali 12 vialami Na trgu morda ni vseh navedenih pakiranj.
English: The current medical standards for emergency treatment should be observed.
Slovenian: Upoštevati je treba najnovejše zdravstvene standarde za zdravljenje v urgentnih primerih.
English: • When injecting regularly, the injection site should be changed between different areas of the body to help reduce potential pain and irritation
Slovenian: • Pri rednem injiciranju morate mesto injiciranja menjavati med različnimi predeli telesa, da zmanjšate morebitno bolečino in draženje.
English: If you are allergic to asfotase alfa (see section ‘Warnings and precautions' below) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na asfotazo alfa (glejte poglavje "Opozorila in previdnostni ukrepi" spodaj) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Frequency category
Slovenian: Stopnja pogostnosti
English: Before injecting Strensiq, please read the following instructions carefully
Slovenian: Pred injiciranjem zdravila Strensiq natančno preberite naslednja navodila
English: Other medicines and Strensiq Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Druga zdravila in zdravilo Strensiq Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The MAH shall ensure that in each Member State where Strensiq is marketed all patients/parents or caregivers who are expected to use Strensiq are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Strensiq trži, vsi bolniki in njihovi starši ali skrbniki, za katere se pričakuje, da bodo uporabljali zdravilo Strensiq, prejeli naslednji paket izobraževalnih gradiv:
English: The average ± SD elimination half-life following subcutaneous administration was 2.28 ± 0.58 days.
Slovenian: Povprečni razpolovni čas izločanja ± SD po subkutanem dajanju je bil 2,28 ± 0,58 dni.
English: Doses will need to be adjusted regularly by your doctor as the body weight changes.
Slovenian: Odmerek bo zdravnik redno prilagajal glede na spreminjanje telesne mase.
English: Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months).
Slovenian: Osemintrideset bolnikov so zdravili vsaj 2 leti (24 mesecev), 6 bolnikov pa so zdravili vsaj 5 let (60 mesecev).
English: Therefore another type of test may need to be used if you are treated with Strensiq.
Slovenian: Zato bo morda treba uporabiti drugo vrsto testa, če se zdravite z zdravilom
English: Patients can self-inject only if they have properly been trained on administration procedures.
Slovenian: Bolniki si lahko zdravilo samoinjicirajo le, če so bili ustrezno poučeni o postopkih dajanja.
English: If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately.
Slovenian: Če opazite katerega koli od teh simptomov, nehajte jemati zdravilo Strensiq in takoj poiščite medicinsko pomoč.
English: The effects of asfotase alfa on x-ray appearance
Slovenian: Učinek asfotaze alfa na izgled rentgenskih posnetkov
English: 4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.
Slovenian: Pri 4 bolnikih je bilo na voljo premalo podatkov za presojo, pri 1 bolniku pa se ni bilo mogoče z gotovostjo odločiti.
English: Your doctor will advise you on the possible injection sites.
Slovenian: Zdravnik vam bo svetoval o možnih mestih injiciranja.
English: * produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Slovenian: * izdelano s tehnologijo rekombinantne DNA v sesalskih celičnih kulturah ovarijskih celic kitajskega hrčka (CHO, Chinese Hamster Ovary).
English: • Injection guide for parents or caregivers with infant patients
Slovenian: • Vodnik za injiciranje za starše ali skrbnike otroških bolnikov.
English: For patients who have little fat under the skin or thin skin, a 45º angle may be preferable.
Slovenian: Pri bolnikih, ki imajo malo podkožne maščobe ali tanko kožo, je morda boljši kot 45°.
English: Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.
Slovenian: Nekateri bolniki, pri katerih so potrdili pozitivno prisotnost protiteles proti zdravilu, so imeli reakcije na mestu injiciranja (injection site reactions - ISR) in/ali preobčutljivost, vendar ni bilo doslednega trenda v pogostnosti teh reakcij v času, ki bi ga opazili med bolniki, ki so bili kdaj ADA-pozitivni, in bolniki, ki so bili vedno ADA-negativni.
English: Driving and using machines This medicine is not expected to have any effect on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne pričakuje se, da bi to zdravilo vplivalo na sposobnost vožnje ali upravljanja strojev.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from asfotase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z asfotazo alfa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If more than 1 ml is required, you need to do multiple injections immediately one after the other.
Slovenian: Če je treba uporabiti več kot 1 ml, morate dati več injekcij takoj eno za drugo.
English: The dose of asfotase alfa was increased for 11 patients during the study.
Slovenian: Odmerek asfotaze alfa so med študijo zvečali 11 bolnikom.
English: Thirteen patients were enrolled, 12 completed, and 1 discontinued (discontinuation early in the study due to a previously planned elective scoliosis surgery).
Slovenian: 12 bolnikov je študijo zaključilo, 1 bolnik pa jo je prekinil (prekinitev na začetku študije je bila posledica predhodno načrtovane elektivne operacije skolioze).
English: Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays.
Slovenian: Alkalna fosfataza (AF) se uporablja kot detekcijski reagent pri mnogih rutinskih laboratorijskih analizah.
English: Ectopic calcification
Slovenian: Ektopična kalcifikacija
English: If you experience any severe reaction at the injection site, tell your doctor immediately.
Slovenian: Če se pojavijo hude reakcije na mestu injiciranja, takoj povejte zdravniku.
English: The study employed historical controls from the same centres as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.
Slovenian: V študiji so uporabljeni zgodovinski kontrolni podatki istih raziskovalnih centrov kot za bolnike, ki so prejemali asfotazo alfa in ki so bili predmet podobnega protokola klinične obravnave.