FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Slovenian: Ocena neželenih učinkov temelji na randomizirani študiji (študija GS-US-174-0115) s 106 mladostniki (starimi 12 do < 18 let) s kroničnim hepatitisom B, ki so se 72 tednov zdravili z 245 mg dizoproksiltenofoviratom (n = 52) ali placebom (n = 54), in randomizirani študiji (študija GS-US-1740144) z 89 bolniki s kroničnim hepatitisom B (starih 2 do < 12 let), ki so se 48 tednov zdravili z dizoproksiltenofoviratom (n = 60) ali placebom (n = 29).
English: after the first 4 weeks of treatment, the rate of annual decline post baseline of renal function reported in tenofovir disoproxil treated patients was -1.41 ml/min per year (using Cockcroft-Gault equation) and -0.74 ml/min/1.73 m2 per year (using MDRD equation).
Slovenian: Po začetnem upadu za približno -4,9 ml/min (z uporabo Cockcroft-Gaultove enačbe) ali -3,9 ml/min/1,73 m2 (z uporabo enačbe za spremembo prehrane pri ledvičnem obolenju [MDRD, modification of diet in renal disease]) po prvih 4 tednih zdravljenja je bila stopnja letnega upada ledvične funkcije glede na izhodišče, o kateri so poročali pri bolnikih, zdravljenih z dizoproksiltenofoviratom, -1,41 ml/min (z uporabo Cockcroft-Gaultove enačbe) in -0,74 ml/min/1,73 m2 na leto (z uporabo enačbe MDRD).
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/mL rose sharply after they began treatment with open-label tenofovir disoproxil (PLB- tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Slovenian: Med bolniki, ki so v dvojno slepem obdobju prejemali placebo, je delež bolnikov s koncentracijo HBV DNA < 400 kopij/ml po začetku nezaslepljenega zdravljenja z dizoproksiltenofoviratom (skupina PLB-dizoproksiltenofovirat) strmo narasel: v 192. tednu je 74,1 % (40/54) bolnikov v skupini PLB-dizoproksiltenofovirat imelo koncentracijo HBV DNA < 400 kopij/ml.
English: Table 5: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Slovenian: Preglednica 5: Parametri učinkovitosti pri kompenziranih bolnikih, pozitivnih na HBeAg, v 96., 144., 192., 240., 288. in 384. tednu nezaslepljenega zdravljenja
English: Lumbar spine mean (SD) BMD Z-scorea Lumbar spine mean (SD) change from baseline BMD Z-score a
Slovenian: Povprečni (SD) Zindeks MGK ledvene hrbtenicea Povprečna (SD)
English: Only 1 subject randomized to the TDF group was genotype E at baseline.
Slovenian: Samo 1 bolnik, ki je bil randomiziran v skupino, ki je prejemala dizoproksiltenofovirat, je bil ob izhodišču okužen z genotipom E. Na splošno so bili odzivi na zdravljenje z dizoproksiltenofoviratom pri genotipih A, B,
English: TDF
Slovenian: ml
English: p-value = 0.0008).
Slovenian: (n = 1), 288.
English: k 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Slovenian: k 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 192-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Slovenian: emtricitabine/rilpivirin/ dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: ALT n (%)
Slovenian: HBV DNA (%)
English: EU/1/01/200/007
Slovenian: EU/1/01/200/006 EU/1/01/200/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/006 30 film-coated tablets EU/1/01/200/007 90 (3 bottles of 30) film-coated tablets
Slovenian: EU/1/01/200/007 90 (3 plastenke s 30) filmsko obloženih tablet.
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Slovenian: emtricitabine/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 163 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 123 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced adult patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve adult patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Slovenian: V drugi dvojno slepi kontrolirani primerjalni študiji je 600 še nezdravljenih odraslih bolnikov 144 tednov prejemalo 245 mg dizoproksiltenofovirata (n = 299) ali stavudin (n = 301) v kombinaciji z lamivudinom in efavirenzom.
English: Tenofovir and tenofovir disoproxil are not metabolised by liver enzymes.
Slovenian: Jetrni encimi ne presnavljajo dizoproksiltenofovirata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/008 30 film-coated tablets EU/1/01/200/009 90 (3 bottles of 30) film-coated tablets
Slovenian: EU/1/01/200/009 90 (3 plastenke s 30) filmsko obloženih tablet.
English: NA 5.14% 8.08% 10.05% 11.21%
Slovenian: 0/0 0/0 0/0 0/0 0/0 1/1n
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001 30 film-coated tablets EU/1/01/200/002 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/200/001 30 filmsko obloženih tablet.
English: Hepatic impairment
Slovenian: • zamaščena jetra
English: Viread should not be given to children with existing kidney problems.
Slovenian: Otroci, ki imajo težave z ledvicami, ne smejo prejeti zdravila Viread.
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-TDF).
Slovenian: n Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, brez podatkov zbranih po dodajanju emtricitabina k odprtemu zdravljenju z dizoproksiltenofoviratom (KM-dizoproksiltenofovirat).
English: (E421) and silicon dioxide (E551).
Slovenian: 6.1 Seznam pomožnih snovi etilceluloza (E462) hidroksipropilceluloza (E463) manitol (E421) silicijev dioksid (E551)
English: EU/1/01/200/005
Slovenian: EU/1/01/200/004 EU/1/01/200/005
English: l Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-TDF).
Slovenian: l Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, brez podatkov zbranih po dodajanju emtricitabina k odprtemu zdravljenju z dizoproksiltenofoviratom (KM-dizoproksiltenofovirat).
English: Cmin: N/A Velpatasvir: AUC: ↔
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↔
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Slovenian: sofosbuvir/velpatasvir (400 mg/100 mg enkrat dnevno) + atazanavir/ritonavir (300 mg q.d./100 mg enkrat dnevno) + emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: Whole body BMD at least 6% decrease b
Slovenian: Najmanj 6-% zmanjšanje MGK za celo telob navedba smiselno ni potrebna navedba smiselno ni potrebna
English: Tell your doctor before taking Viread.
Slovenian: Preden začnete jemati zdravilo Viread, obvestite zdravnika.
English: AUC: ↔ Cmax: ↓ 19%
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↓ 19%
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasnega dajanja dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksilapre virja in darunavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic.
English: h 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Slovenian: h 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje.
English: m 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Slovenian: m 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko nezaslepljeno zdravljenje.
English: • Don't stop any anti-HIV medicines prescribed by your doctor when you start Viread if you have both HBV and HIV.
Slovenian: • Če imate okužbo z virusom HBV in virusom HIV, potem takrat, ko začnete jemati zdravilo Viread, ne prenehajte jemati drugih zdravil proti okužbi z virusom HIV, ki vam jih je predpisal zdravnik.
English: Parameter a
Slovenian: PRILOGA I
English: Table 2: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Slovenian: Preglednica 2: Interakcije med dizoproksiltenofoviratom in drugimi zdravili
English: Other populations
Slovenian: Druge populacije
English: These changes were mostly technical in nature and therefore not discussed in detail here.
Slovenian: Te spremembe so bile večinoma tehnične in jih zato ne tem mestu ne obravnavamo podrobno.
English: • the Committee considered the referral under Article 30 of Directive 2001/83/EC,
Slovenian: • odbor CHMP je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
English: The first marketing authorisation (MA) was granted in France on 03 April 1987.
Slovenian: Prvo dovoljenje za promet z zdravilom je bilo izdano 3. aprila 1987 v Franciji.
English: Section 1 - Name of the medicinal product and Section 2 - Qualitative and quantitative composition
Slovenian: Poglavje 1 - Ime zdravila in Poglavje 2 - Kakovostna in količinska sestava
English: This section was harmonised to reflect in a uniform way the following contraindications, of which not all were included across the EU, or different terminologies were used:
Slovenian: To poglavje je bilo usklajeno tako, da enotno vključuje naslednje kontraindikacije, od katerih vse pred tem niso bile vključene povsod v EU ali pa je bila uporabljena različna terminologija:
English: Direct Healthcare Provider Communication (DHPC)
Slovenian: Neposredna komunikacija z zdravstvenimi delavci (DHPC)
English: Finally a wording was added to foster traceability of biological medicinal products.
Slovenian: Dodano je bilo tudi besedilo, da je treba omogočiti sledljivost bioloških zdravil.
English: Other sections such as “hyperkalaemia” were included as these were not uniformly worded across Member States.
Slovenian: Vključeni so bili še drugi deli, npr. „hiperkaliemija“, saj besedila po državah članicah niso bila enotna.
English: On one hand, an expression and dosing in mg is consistent with the approvals in the majority of the EU and allows both identification and distinction between different presentations whilst favouring ease of prescribing, dosing, dispensing and administration.
Slovenian: Na eni strani je izražanje in odmerjanje v miligramih skladno z odobritvami v večini držav EU in omogoča identifikacijo in razlikovanje med različnimi oblikami ter hkrati lažje predpisovanje, odmerjanje, izdajo in dajanje.
English: Treatment of acute STEMI
Slovenian: Zdravljenje akutne STEMI
English: • increased potential bleeding;
Slovenian: • večja verjetnost krvavitve;
English: For STEMI, the higher dose on the first day as used in the study ExTRACT-TIMI 25 should be mentioned.
Slovenian: Pri STEMI je treba navesti večji odmerek za prvi dan, kot so ga uporabili v študiji ExTRACT-TIMI 25.
English: Revisions were made to this section to add the risk of acute infectious endocarditis.
Slovenian: To poglavje je bilo popravljeno tako, da vključuje tveganje za akutni infekcijski endokarditis.
English: It is given as an injection subcutaneously or intravenously.
Slovenian: Daje se s podkožno ali intravensko injekcijo.
English: Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
Slovenian: Odmerki, ki so jih preučevali v kliničnih študijah, so v razponu od 0,5 mg/kg do 1,25 mg/kg.
English: Due to the divergent national decisions taken by Member States (MSs) concerning the authorisation of the above-mentioned product and its associated names, France notified the CHMP/European Medicines Agency of a referral under Article 30 of Directive 2001/83/EC for the above-mentioned product, in order to resolve divergences amongst the nationally authorised product information (PI) and thus to harmonise its divergent PIs across the EU.
Slovenian: Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila in povezanih imen, je Francija obvestila odbor CHMP/Evropsko agencijo za zdravila o napotitvi v skladu s členom 30 Direktive 2001/83/ES za navedeno zdravilo z namenom razrešitve razhajanj med nacionalno odobrenimi informacijami o zdravilu in uskladitve razhajajočih se informacij po vsej EU.
English: The CHMP considered keeping the indication in line with the most common wording accepted in the countries.
Slovenian: Odbor CHMP je presodil, naj se ohrani indikacija v skladu z najpogostejšim besedilom, sprejetim v državah.
English: Taking into account the risk of medication errors and the clarification as regards indications and contraindications, the CHMP agreed the following key messages to be used in a direct healthcare professional communication (DHPC) to general practitioners, orthopaedics, internists, cardiologists, haematologists, surgeons, pharmacists, nurses (or other as per national health care system):
Slovenian: Z upoštevanjem tveganja za napake pri uporabi zdravila in pojasnila glede indikacij in kontraindikacij se je odbor CHMP dogovoril o naslednjih ključnih sporočilih, ki jih je treba uporabljati v neposredni komunikaciji z zdravstvenimi delavci, tj. zdravniki splošne medicine, ortopedi, internisti, kardiologi, hematologi, kirurgi, farmacevti, medicinskimi sestrami (ali drugimi, glede na zdravstveni sistem v posamezni državi):
English: This anticoagulant is used in the treatment and prophylaxis of thromboembolic disorders.
Slovenian: Ta antikoagulant se uporablja pri zdravljenju in profilaksi trombemboličnih motenj.
English: Sections 4.5 to 6 have been harmonised based on relevant available information or amended according to the latest QRD template.
Slovenian: Poglavja od poglavja 4.5 do poglavja 6 so usklajena na podlagi ustreznih razpoložljivih informacij ali pa so spremenjena v skladu z najnovejšo predlogo za pregled kakovosti dokumentov.
English: Patients in whom PCIs could be performed at any time for failed fibrinolysis or urgently in case of recurrent myocardial ischemia/infarction, but had to be deferred in other situations at least for 48 hours.
Slovenian: - bolniki, pri katerih bi lahko kadar koli izvedli perkutano koronarno intervencijo zaradi neuspešne fibrinolize ali v nujnem primeru pri ponavljajoči se miokardni ishemiji/infarktu, vendar je bilo treba poseg v drugih razmerah odložiti za vsaj 48 ur.
English: In terms of posology for this indication most of the countries stated a dose of enoxaparin 1mg/kg and a few countries stated a lower dose for this indication.
Slovenian: Glede odmerjanja pri tej indikaciji večina držav navaja odmerek enoksaparina 1 mg/kg, nekaj držav pa za to indikacijo navaja manjši odmerek.
English: Enoxaparin sodium is a low molecular weight heparin marketed under the trade names Lovenox and associated names.
Slovenian: Natrijev enoksaparinat je nizkomolekularni heparin, ki se trži pod trgovskim imenom Lovenox in povezanimi imeni.
English: Lovenox and associated names solution for injection is currently approved in more than 140 countries worldwide including all the European Union (EU) member states as well as Norway and Iceland.
Slovenian: Zdravilo Lovenox in povezana imena raztopina za injiciranje je trenutno pridobilo dovoljenje za promet v več kot 140 državah po svetu, vključno z vsemi državami članicami Evropske unije (EU) ter Norveško in Islandijo.
English: The wording for the indication in this population therefore includes now disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Slovenian: Besedilo za indikacijo pri tej populaciji torej zdaj vključuje bolezen pri internističnih bolnikih z akutno boleznijo (kot so akutno srčno popuščanje, respiratorna insuficienca, hude okužbe ali revmatsko obolenje) in zmanjšano mobilnostjo, ki imajo povečano tveganje za vensko trombembolijo.
English: The harmonised indication is based on treatment guidelines (European Society of Cardiology (ESC), and ACCP), as well as clinical study and literature data presented by the MAH.
Slovenian: Usklajena indikacija temelji na smernicah za zdravljenje (Evropsko združenje za kardiologijo (ESC) in ACCP), klinični študiji in podatkih iz literature, ki jih je predložil imetnik dovoljenja za promet z zdravilom.
English: • careful biological monitoring by anti-Xa activity measurement in renally impaired patients;
Slovenian: • skrbno biološko spremljanje z merjenjem aktivnosti anti-Xa pri bolnikih z okvaro ledvic;
English: The CHMP adopted a wording, which is in agreement with the clinical data and treatment guidelines (grade IIbB in ESC guidelines 2012, American Heart Association (AHA) guideline 2011).
Slovenian: Odbor CHMP je sprejel besedilo, ki je v skladu s kliničnimi podatki in smernicami za zdravljenje (priporočilo razreda IIbB v smernicah ESC iz leta 2012 in smernici Ameriškega združenja za srce (AHA) iz leta 2011).
English: - Medically managed patients (not undergoing primarily invasive procedure such as percutaneous coronary intervention (PCI) or coronary bypass artery surgery (CABG);
Slovenian: - internistično obravnavani bolniki (ki niso prestali primarnega invazivnega posega, kot sta perkutana koronarna intervencija (PCI) ali premostitev koronarnih arterij (CABG));
English: The Product Information was split as follows according to the indications the individual products are approved for:
Slovenian: Informacije o zdravilu so bile glede na indikacije, za katere so bila odobrena posamezna zdravila, razdeljene na naslednji način:
English: • The Dosage in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) has been clarified as follows:
Slovenian: • Odmerjanje pri zdravljenju globoke venske tromboze (DVT) in pljučne embolije (PE) je bilo pojasnjeno na naslednji način:
English: The harmonised indication therefore states prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
Slovenian: Usklajena indikacija torej navaja profilakso venske trombembolije pri kirurških bolnikih z zmernim in velikim tveganjem, zlasti tistih, pri katerih bo opravljen ortopedski ali splošni kirurški poseg, vključno z operacijo raka.
English: • gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
Slovenian: • gastrointestinalni ulkus, prisotnost maligne novotvorbe z velikim tveganjem za krvavitev, nedavni kirurški poseg na možganih, hrbtenjači ali očeh, znane varice v požiralniku ali sum nanje, arteriovenske malformacije, žilne anevrizme ali večje intraspinalne ali intracerebralne žilne nepravilnosti;
English: Enoxaparin sodium can be administered subcutaneously:
Slovenian: natrijev enoksaparinat se lahko daje podkožno:
English: Furthermore, the indications were not the same depending on the strength of the product, which was addressed as part of the referral.
Slovenian: Poleg tega indikacije glede na jakost zdravila niso bile enake, kar je bilo obravnavano v okviru napotitve.
English: Due to divergent information across Member States, updates were also made in further subsections including paediatric population, elderly, hepatic and renal impairment in line with the agreed indications and based on available data in these populations.
Slovenian: Zaradi razhajajočih se informacij med državami članicami so se posodobila tudi nadaljnja podpoglavja, vključno s pediatrično populacijo, starejšimi bolniki, bolniki z okvaro jeter in ledvic, in sicer v skladu z dogovorjenimi indikacijami in na podlagi razpoložljivih podatkov za omenjene populacije.
English: • the scope of the referral was the harmonisation of the product information,
Slovenian: • namen napotitve je bila uskladitev informacij o zdravilu;
English: The CHMP referred also for this indication to the existing ACCP guidelines, and further preferred a wording more in line with the current recommendations for thromboprophylaxis in acutely ill medical patients in the literature.
Slovenian: Odbor CHMP je tudi glede te indikacije napotil na obstoječe smernice ACCP in dal prednost besedilu, ki je bolj v skladu s trenutnimi priporočili iz literature za tromboprofilakso pri akutno bolnih internističnih bolnikih.
English: • the Committee considered the divergences identified in the notification for Lovenox and associated names, as well as the remaining sections of the product information,
Slovenian: • odbor CHMP je obravnaval razlike, ugotovljene v obvestilu za zdravilo Lovenox in povezana imena, ter preostala poglavja informacij o zdravilu;
English: In view of prevention of extracorporeal thrombus during haemodialysis, all Member States had this indication in the PI, except the Netherlands who did not find the data using the dosing scheme proposed at the time of initial Marketing authorisation sufficient.
Slovenian: Glede preprečevanje zunajtelesnega strdka med hemodializo so imele vse države članice to indikacijo vključeno v informacije o zdravilu, razen Nizozemske, ki se ji podatki o shemi odmerjanja, predlagani v času prvega dovoljenja za promet z zdravilom, niso zdeli zadostni.
English: The principal pharmacological properties of enoxaparin include antifactor Xa and antifactor IIa (antithrombin) activity, which are dependent on its binding affinity for antithrombin.
Slovenian: Med glavne farmakološke lastnosti enoksaparina spada delovanje proti faktorjema Xa in IIa (antitrombinsko delovanje), ki je odvisno od njegove vezavne afinitete do antitrombina.
English: • Enoxaparin strength will now be expressed both in international units (IU) of anti-Xa activity and in milligram (mg): One mg of enoxaparin sodium is equivalent to 100 IU anti-Xa activity.
Slovenian: • Jakost enoksaparina bo od zdaj naprej izražena v mednarodnih enotah (i.e.) aktivnosti anti-Xa in v miligramih (mg): en miligram natrijevega enoksaparinata ustreza 100 i.e. aktivnosti anti-Xa.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however some sections were left to be completed nationally.
Slovenian: Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, kadar je bilo to ustrezno, vendar je bilo treba nekatera poglavja dopolniti na nacionalni ravni.
English: • use of multiple dose vials containing benzyl alcohol in newborns or premature neonates due to risk of gasping syndrome in this population.
Slovenian: • uporaba večodmernih vial z benzilalkoholom pri novorojenčkih ali nedonošenih novorojenčkih zaradi tveganja za sindrom lovljenja sape pri tej populaciji.