FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy and safety
Slovenian: Klinična učinkovitost in varnost Recidivne oblike multiple skleroze
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: in common with 23-PPV.
Slovenian: Pozitivni odziv na ≥ 5 serotipov iz cepiva 23-PPV
English: What Ocrevus is and what it is used for What you need to know before you are given Ocrevus How Ocrevus is given
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ocrevus Kako se daje zdravilo Ocrevus
English: Patients with mild hepatic impairment were included in clinical trials.
Slovenian: V klinična preskušanja so bili vključeni bolniki z blago okvaro jeter.
English: There is no PK information available in patients with moderate or severe hepatic impairment.
Slovenian: Informacij o farmakokinetiki pri bolnikih z zmerno ali hudo okvaro jeter ni.
English: Infusion instruction
Slovenian: 2. infuzija
English: MRI evidence should be used to confirm inflammatory activity in all patients.
Slovenian: Vnetno aktivnost je treba pri vseh bolnikih potrditi z dokazi, vidnimi na magnetnoresonančnem posnetku.
English: If you are able to become pregnant (conceive), you must use contraception: · during treatment with Ocrevus and · for 12 months after your last infusion of Ocrevus.
Slovenian: Če bi lahko zanosili, morate uporabljati kontracepcijo:
English: Mean number of T1 Gd-enhancing lesions per MRI scan
Slovenian: Opazovani dogodki z magnetnoresonančnimi posnetki Povprečno število z gadolinijem obarvanih lezij T1 na magnetnoresonančni posnetek
English: 30 minutes to a maximum of
Slovenian: 30 minut.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: Ocrevus 600 mg (n=488)
Slovenian: Zdravilo Ocrevus 600 mg (n = 488) Placebo (n = 244)
English: Measurable levels of ocrelizumab were detected in milk (approximated 0.2% of steady state trough serum levels) during the lactation period.
Slovenian: Na potek obeh okužb pri novoskotenih mladičih je potencialno lahko vplivalo zmanjšanje števila celic B. Pri novoskotenih mladičih samic, izpostavljenih okrelizumabu, so med fazo po skotitvi opažali zmanjšano številčnost populacij celic B. Med obdobjem dojenja so v mleku ugotovili merljivo koncentracijo okrelizumaba (približno 0,2 % najnižje koncentracije v serumu v fazi dinamičnega ravnovesja).
English: Hrvatska
Slovenian: VIALA
English: The majority of these decreases reported in Ocrevus treated patients were Grade 1 (<LLN800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.
Slovenian: 3) in 2. stopnje (med 500 in 800 celic/mm
English: Malignancies
Slovenian: MedDRA
English: · You will be closely monitored while you are being given Ocrevus and for at least 1 hour after the infusion has been given.
Slovenian: • Medtem ko boste dobivali infuzijo zdravila Ocrevus in vsaj še 1 uro po koncu infuzije vas bodo natančno nadzirali, da bi odkrili kakršne koli neželene učinke (na primer z infuzijo povezane reakcije), če bi se ti pojavili.
English: Ocrevus must be diluted before it is given to you.
Slovenian: Preden dobite zdravilo Ocrevus, ga morajo razredčiti.
English: MedDRA System Organ Class (SOC)
Slovenian: Povprečna ocena po EDSS*
English: Renal Impairment
Slovenian: Okvara jeter
English: Package leaflet: Information for the patient
Slovenian: Shranjevanje zdravila Ocrevus Vsebina pakiranja in dodatne informacije
English: Immunisations
Slovenian: Imunogenost
English: The Reference Member State were Estonia, Latvia, Lithuania, Netherlands, Spain, United Kingdom.
Slovenian: Zadevne države članice so bile Estonija, Latvija, Litva, Nizozemska, Španija in Združeno kraljestvo.
English: The Sweden referred the reasons for disagreement to the EMEA on 3 March 2006.
Slovenian: Švedska je agenciji EMEA posredovala razloge za nesoglasje dne 3. marca 2006.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxastad 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
English: The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Slovenian: Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
English: Doxastad 4 mg prolonged release tablets and associated names (Doxazosin) is 1 is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Slovenian: Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa 1 in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
English: Stada Artzneimittel submitted applications for mutual recognition of Doxastad 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Sweden on 4 July 2004.
Slovenian: Družba Stada Arzneimittel je podala vloge za medsebojno priznavanje zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Švedska dne 4 julija 2004.
English: The Marketing Authorisation Holder provided written explanations on 06 April 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila dne 6. aprila 2006, ustna pojasnila pa je podal dne 27. junija 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxastad 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Slovenian: Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
English: *Relative Potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Slovenian: * Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah.
English: --1 Each dose of 2 ml of vaccine contains one of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Slovenian: --1 Odmerek (2 ml) vsebuje naslednje inaktivirane seve virusa modrega jezika: inaktiviran virus modrega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 RP* ≥ 1 inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1 inaktiviran virus modrega jezika, serotip 4, sev SPA-1/2004 RP** ≥ 0,8 * Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah in govedu.
English: 1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2
Slovenian: 1 odmerek (1 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Slovenian: 3Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) 4Adsorbiran na aluminijev fosfat
English: (glass)
Slovenian: (Izmišljeno) ime
English: More information
Slovenian: Več informacij
English: Recommendations for patients and carers
Slovenian: Priporočila za bolnike in negovalce
English: • If you have any questions speak to your healthcare professional.
Slovenian: • Če imate kakršna koli vprašanja, se posvetujte z zdravstvenim delavcem.
English: Always follow the instructions of your healthcare professional.
Slovenian: Vedno upoštevajte navodila zdravstvenega delavca.
English: Recommendations for healthcare professionals
Slovenian: Priporočila za zdravstvene delavce
English: Focus on colour differentiation, warning statements on carton/label and other safety design features (such as tactile elements on the pre-filled pen).
Slovenian: Osredotočite se na razlike v barvi, opozorilne izjave na škatli/nalepki in druge varnostne značilnosti zasnove (kot so otipni elementi na napolnjenem peresniku).
English: • Always carefully check the product selected in electronic prescribing or dispensing systems.
Slovenian: • Izbrano zdravilo vedno skrbno preverite v elektronskih sistemih predpisovanja ali izdajanja.
English: • Pharmacists should be aware that insulins are now available in different strengths.
Slovenian: • Farmacevti se morajo zavedati, da so insulini zdaj na voljo v različnih jakostih.
English: More detailed information on such dose adjustment is provided in the product information.
Slovenian: Več informacij o prilagajanju odmerka je na voljo v informacijah o zdravilu.
English: Pharmacists should also check that patients have been trained on how to use the new pen.
Slovenian: Farmacevti naj preverijo tudi, da so bolniki usposobljeni za uporabo novega peresnika.
English: • Ensure that your patients are adequately informed on how to use their high-strength insulin.
Slovenian: • Poskrbite, da so vaši bolniki ustrezno seznanjeni s tem, kako morajo uporabljati insulin velike jakosti.
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors with these medicines can be found in the guidance on risk minimisation strategies for high-strength and fixed-combination insulin products.
Slovenian: Več informacij o varni uporabi teh zdravil in drugih načinih zmanjševanja morebitnih tveganj za napake pri zdravljenju s temi zdravili je na voljo v navodilu o strategijah zmanjševanja tveganja za insulinska zdravila z veliko jakostjo in v fiksnih kombinacijah.
English: Guidance on prevention of medication errors with highstrength insulins
Slovenian: Navodilo za preprečevanje napak pri zdravljenju z insulini velike jakosti
English: The strength of the insulin formulation should also be always included in the prescription.
Slovenian: Jakost insulinskega pripravka je treba vedno vključiti v recept.
English: • During the switch to high-strength insulin and in the weeks after the switch you should measure your blood sugar levels more frequently.
Slovenian: • Med prehodom na insulin velike jakosti in v tednih po prehodu si morate krvni sladkor meriti pogosteje.
English: • If different short-and long-acting insulins are being prescribed together, the differences in appearance and use between the two pen devices must be highlighted.
Slovenian: • Če so skupaj predpisani kratko- in dolgodelujoči insulini, je treba poudariti razlike med videzom in uporabo obeh peresnikov.
English: Read the instructions in your package leaflet carefully before using this medicine.
Slovenian: Pred uporabo tega zdravila natančno preberite navodilo za uporabo.
English: Medicines containing high-strength insulin may allow patients to receive a high dose in a single injection, and help meet an increasing need for higher doses of insulin.
Slovenian: Zdravila, ki vsebujejo insulin velike jakosti, omogočajo bolnikom večji odmerek v eni sami injekciji in jim pomagajo pri pokrivanju naraščajoče potrebe bo večjih odmerkih insulina.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the insulin pen device.
Slovenian: • Slepe ali slabovidne bolnike je treba poučiti, naj vedno poiščejo pomoč nekoga, ki dobro vidi in je usposobljen za uporabo insulinskega peresnika.
English: The dose counter of the pen device displays the number of units of insulin irrespective of strength.
Slovenian: Števec odmerkov na peresniku prikazuje število enot insulina, ne glede na jakost.
English: • Always prescribe the insulin dose in units (“units” to be spelled out and stated in lower case) and include the dose frequency.
Slovenian: • Odmerek insulina vedno predpisujte v enotah („enote“ je treba izpisati in navesti z malimi črkami) in določite pogostnost odmerjanja.
English: A high-strength insulin is a medicine that contains insulin at a concentration of more than the standard 100 units/ml, which for many years has been the only strength available across the EU.
Slovenian: Insulin velike jakosti je zdravilo, ki vsebuje insulin v koncentraciji, ki presega standardnih 100 enot/ml, kar je bila dolgo let edina možna jakost, na voljo v EU.
English: • Ensure that electronic and paper systems used to prescribe and dispense these medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Slovenian: • Poskrbite, da elektronski in papirnati sistemi, ki jih uporabljate za predpisovanje in izdajanje teh zdravil, omogočajo pravilno izbiro zdravila in preprečujejo zamenjavo z drugimi zdravili.
English: Patients and healthcare professionals are therefore advised to take extra care when using highstrength insulin medicines and to carefully follow the recommendations given below.
Slovenian: Bolnikom in zdravstvenim delavcem zato svetujemo, da so pri uporabi insulina velike jakosti posebno previdni in da skrbno upoštevajo spodaj navedena priporočila.
English: Examples of high-strength insulin formulations are Tresiba (200 units/ml insulin degludec) and Humalog (insulin lispro 200 units/ml).
Slovenian: Primera insulinskih pripravkov velike jakosti sta Tresiba (200 enot/ml insulina degludek) in Humalog (200 enot/ml insulina lispro).
English: • If the concentration of insulin stated on your medicine pack is higher than 100 units/ml, you are using high-strength insulin.
Slovenian: • Če je koncentracija insulina, navedena na ovojnini zdravila, večja od 100 enot/ml, uporabljate insulin velike jakosti.
English: Toujeo (insulin glargine 300 units/ml), although it is also a high-strength insulin, is not bioequivalent to insulin glargine 100 units/ml (such as Lantus) which means that these insulins are not interchangeable.
Slovenian: Toujeo (insulin glargin 300 enot/ml) je sicer tudi insulin velike jakosti, vendar ni bioekvivalenten insulinu glarginu 100 enot/ml (kot je Lantus), kar pomeni, da ta insulina nista zamenljiva.
English: • Ensure that storage arrangements for combination insulin medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
Slovenian: • Poskrbite, da način shranjevanja kombiniranih insulinskih zdravil omogoča pravilno izbiro zdravila in preprečuje zamenjavo z drugimi zdravili.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing and dispensing high strength insulins:
Slovenian: Poleg tega zdravstvenim delavcem priporočamo tudi, da pri shranjevanju in izdajanju insulinov velike jakosti upoštevajo naslednje previdnostne ukrepe:
English: 1 In exceptional cases your dose may need to be changed because of differences in the way the high-strength and standard strength solutions are taken up into the body - your doctor will advise you if this is needed.
Slovenian: 1 V izjemnih primerih bo morda treba vaš odmerek spremeniti, ker telo raztopino z veliko in raztopino s standardno jakostjo privzema drugače.
English: However, there are differences in the way high-strength insulin products are used compared with existing insulin formulations of standardstrength and there is therefore a risk of medication errors and accidental mix-ups.
Slovenian: Vendar pa se zdravila z insulinom velike jakosti uporabljajo drugače kot obstoječi insulinski pripravki standardne jakosti, zato obstaja tveganje za napake pri zdravljenju in nenamerne zamenjave.
English: Therefore, when switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approx. 10-18%) may be needed to achieve target ranges for plasma glucose level.
Slovenian: Zato se pri prehodu z insulina glargina 100 enot/ml na zdravilo Toujeo lahko ohrani enako število enot, vendar bo za doseganje ciljnih razponov ravni glukoze v plazmi morda potreben večji odmerek zdravila Toujeo (približno 10-18 %).
English: • Explain differences in the design of the package and the pre-filled pen for high-strength insulins and standard-strength insulins, especially if the patient has been transferred from standardstrength insulin to high-strength insulin.
Slovenian: • Pojasnite razlike v zasnovi pakiranja in napolnjenega peresnika med insulini velike jakosti in insulini standardne jakosti, zlasti če je bolnik prešel z insulina standardne jakosti na insulin velike jakosti.
English: • If you are using other types of insulin alongside your high-strength insulin, always check the strength on the packaging and the label of each type of insulin before every injection to avoid mixing them up.
Slovenian: • Če poleg insulina velike jakosti uporabljate še druge vrste insulina, pred vsakim injiciranjem na ovojnini in nalepki vedno preverite jakost vsake vrste insulina, da jih ne zamenjate.
English: • When switching patients from standard-strength insulin to an insulin formulation that is not bioequivalent (such as Toujeo, insulin glargine 300 units/ml), switching can be done on a unit to unit basis, but the dose may need to be adjusted to achieve target ranges for plasma glucose level.
Slovenian: • Kadar bolniki preidejo z insulina standardne jakosti na insulinski pripravek, ki ni bioekvivalenten (kot je Toujeo, insulin glargin 300 enot/ml), se pri prehodu lahko ohrani enako število enot, morda pa bo treba odmerek prilagoditi tako, da se doseže ciljno območje ravni glukoze v plazmi.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of insulin and the dose counter of the pen device before dispensing the medicine.
Slovenian: • Farmacevtom priporočamo, da pred izdajo zdravila preverijo, ali bolniki in negovalci lahko odčitajo jakost insulina in števec odmerkov na peresniku.
English: • If you are being transferred from standard-strength insulin to a high-strength insulin you will usually be using the same number of units that you were when using the standard-strength insulin.1 This also applies if you are being transferred from a high-strength to a standard-strength insulin.
Slovenian: • Če preidete z insulina standardne jakosti na insulin velike jakosti, boste običajno uporabljali enako število enot, kot ste jih pri insulinu standardne jakosti.1 To velja tudi, če preidete z insulina velike jakosti na insulin standardne jakosti.
English: • The insulin is supplied in a pre-filled pen and it should only be used with this device.
Slovenian: • Insulin je na voljo v napolnjenem peresniku in ga morajo tudi uporabljati samo s peresnikom.
English: Healthcare professionals must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose can result.
Slovenian: Zdravstveni delavci insulina nikoli ne smejo z brizgo potegniti iz napolnjenega peresnika, saj lahko pride do resnega prevelikega odmerjanja.
English: • You must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose may result.
Slovenian: • Insulina nikoli ne potegnite z brizgo iz napolnjenega peresnika, saj lahko pride do resnega prevelikega odmerjanja.
English: • If you are being transferred from standard strength insulin to high-strength insulin, your healthcare professional will highlight any differences in design between your high-strength insulin pen and other standard-strength insulin pens.
Slovenian: • Če preidete z insulina standardne jakosti na insulin velike jakosti, vam bo zdravstveni delavec pojasnil razlike v zasnovi med peresnikom za insulin velike jakosti in drugimi peresniki za insuline standardne jakosti.
English: • The high-strength insulin is supplied in a pre-filled pen and it should only be used with this device.
Slovenian: • Insulin velike jakosti je na voljo v napolnjenem peresniku in ga morate tudi uporabljati samo s peresnikom.
English: • Tell patients to closely monitor their blood sugar levels when starting high-strength insulin and in the weeks after.
Slovenian: • Bolnikom povejte, naj ob prehodu na insulin velike jakosti in v tednih za tem skrbno spremljajo krvni sladkor.
English: Call your doctor immediately.
Slovenian: Nemudoma pokličite zdravnika.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
Slovenian: Datum prve odobritve: 15. maj 2009 Datum zadnjega podaljšanja: 15. maj 2014
English: In a small number of cases, these may be signs of a second degree burn and need urgent attention.
Slovenian: V manjšem številu primerov, so lahko to znaki opeklin druge stopnje in zahtevajo nujno pozornost.
English: Do not touch the patch with your hands.
Slovenian: Ne dotikajte se obliža z rokami.
English: • Risk Management Plan (RMP)
Slovenian: o Načrt za obvladovanje tveganj (RMP)
English: Sensory function
Slovenian: Senzorična funkcija
English: For all three aetiologies efficacy was maintained throughout the 12-week study period.
Slovenian: Pri vseh treh etiologijah se je učinkovitost ohranila vseh 12 tednov trajanja študije.
English: Cleansing gel contains:
Slovenian: Čistilni gel vsebuje:
English: Latex gloves should NOT be worn as they do not provide adequate protection.
Slovenian: Rokavice iz lateksa NISO primerne, saj ne zagotavljajo zadostne zaščite.
English: No more than 4 patches should be used at the same time.
Slovenian: Hkrati se lahko uporabijo največ 4 obliži.
English: o Frequency not known: frequency cannot be estimated from the available data
Slovenian: o neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: Remove anaesthetic.
Slovenian: Odstranite anestetik.
English: Do not touch your eyes, mouth or other sensitive areas.
Slovenian: Ne dotikajte se oči, ust ali drugih občutljivih predelov.
English: 52078 Aachen Germany
Slovenian: 52078 Aachen
English: For instructions on handling and disposal of the treatment materials see section 6.6.
Slovenian: Za navodila o rokovanju in odstranjevanju materialov za zdravljenje glejte poglavje 6.6.
English: Do not attempt to remove the patch yourself.
Slovenian: Ne poskušajte sami odstraniti obliža.
English: • administration of capsaicin should only be done under medical supervision
Slovenian: • aplikacija kapsaicina lahko poteka samo pod zdravniškim nadzorom
English: Cleansing gel
Slovenian: Čistilni gel
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca
English: Monitoring and management of application site reactions
Slovenian: Spremljanje in obvladovanje reakcij na mestu uporabe