natgillin/translations-raw huggingface dataset:
Table 2: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Preglednica 2: Interakcije med dizoproksiltenofoviratom in drugimi zdravili
Other populations
Druge populacije
These changes were mostly technical in nature and therefore not discussed in detail here.
Te spremembe so bile večinoma tehnične in jih zato ne tem mestu ne obravnavamo podrobno.
• the Committee considered the referral under Article 30 of Directive 2001/83/EC,
• odbor CHMP je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
The first marketing authorisation (MA) was granted in France on 03 April 1987.
Prvo dovoljenje za promet z zdravilom je bilo izdano 3. aprila 1987 v Franciji.
Section 1 - Name of the medicinal product and Section 2 - Qualitative and quantitative composition
Poglavje 1 - Ime zdravila in Poglavje 2 - Kakovostna in količinska sestava
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:
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:
Direct Healthcare Provider Communication (DHPC)
Neposredna komunikacija z zdravstvenimi delavci (DHPC)
Finally a wording was added to foster traceability of biological medicinal products.
Dodano je bilo tudi besedilo, da je treba omogočiti sledljivost bioloških zdravil.
Other sections such as “hyperkalaemia” were included as these were not uniformly worded across Member States.
Vključeni so bili še drugi deli, npr. „hiperkaliemija“, saj besedila po državah članicah niso bila enotna.
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.
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.
Treatment of acute STEMI
Zdravljenje akutne STEMI
• increased potential bleeding;
• večja verjetnost krvavitve;
For STEMI, the higher dose on the first day as used in the study ExTRACT-TIMI 25 should be mentioned.
Pri STEMI je treba navesti večji odmerek za prvi dan, kot so ga uporabili v študiji ExTRACT-TIMI 25.
Revisions were made to this section to add the risk of acute infectious endocarditis.
To poglavje je bilo popravljeno tako, da vključuje tveganje za akutni infekcijski endokarditis.
It is given as an injection subcutaneously or intravenously.
Daje se s podkožno ali intravensko injekcijo.
Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
Odmerki, ki so jih preučevali v kliničnih študijah, so v razponu od 0,5 mg/kg do 1,25 mg/kg.
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.
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.
The CHMP considered keeping the indication in line with the most common wording accepted in the countries.
Odbor CHMP je presodil, naj se ohrani indikacija v skladu z najpogostejšim besedilom, sprejetim v državah.
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):
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):
This anticoagulant is used in the treatment and prophylaxis of thromboembolic disorders.
Ta antikoagulant se uporablja pri zdravljenju in profilaksi trombemboličnih motenj.
Sections 4.5 to 6 have been harmonised based on relevant available information or amended according to the latest QRD template.
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.
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.
- 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.
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.
Glede odmerjanja pri tej indikaciji večina držav navaja odmerek enoksaparina 1 mg/kg, nekaj držav pa za to indikacijo navaja manjši odmerek.
Enoxaparin sodium is a low molecular weight heparin marketed under the trade names Lovenox and associated names.
Natrijev enoksaparinat je nizkomolekularni heparin, ki se trži pod trgovskim imenom Lovenox in povezanimi imeni.
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.
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.
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.
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.
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.
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.
• careful biological monitoring by anti-Xa activity measurement in renally impaired patients;
• skrbno biološko spremljanje z merjenjem aktivnosti anti-Xa pri bolnikih z okvaro ledvic;
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).
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).
- Medically managed patients (not undergoing primarily invasive procedure such as percutaneous coronary intervention (PCI) or coronary bypass artery surgery (CABG);
- internistično obravnavani bolniki (ki niso prestali primarnega invazivnega posega, kot sta perkutana koronarna intervencija (PCI) ali premostitev koronarnih arterij (CABG));
The Product Information was split as follows according to the indications the individual products are approved for:
Informacije o zdravilu so bile glede na indikacije, za katere so bila odobrena posamezna zdravila, razdeljene na naslednji način:
• The Dosage in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) has been clarified as follows:
• Odmerjanje pri zdravljenju globoke venske tromboze (DVT) in pljučne embolije (PE) je bilo pojasnjeno na naslednji način:
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.
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.
• 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;
• 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;
Enoxaparin sodium can be administered subcutaneously:
natrijev enoksaparinat se lahko daje podkožno:
Furthermore, the indications were not the same depending on the strength of the product, which was addressed as part of the referral.
Poleg tega indikacije glede na jakost zdravila niso bile enake, kar je bilo obravnavano v okviru napotitve.
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.
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.
• the scope of the referral was the harmonisation of the product information,
• namen napotitve je bila uskladitev informacij o zdravilu;
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.
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.
• the Committee considered the divergences identified in the notification for Lovenox and associated names, as well as the remaining sections of the product information,
• odbor CHMP je obravnaval razlike, ugotovljene v obvestilu za zdravilo Lovenox in povezana imena, ter preostala poglavja informacij o zdravilu;
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.
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.
The principal pharmacological properties of enoxaparin include antifactor Xa and antifactor IIa (antithrombin) activity, which are dependent on its binding affinity for antithrombin.
Med glavne farmakološke lastnosti enoksaparina spada delovanje proti faktorjema Xa in IIa (antitrombinsko delovanje), ki je odvisno od njegove vezavne afinitete do antitrombina.
• 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.
• 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.
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however some sections were left to be completed nationally.
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.
• use of multiple dose vials containing benzyl alcohol in newborns or premature neonates due to risk of gasping syndrome in this population.
• uporaba večodmernih vial z benzilalkoholom pri novorojenčkih ali nedonošenih novorojenčkih zaradi tveganja za sindrom lovljenja sape pri tej populaciji.
On the other hand, other low molecular weight heparins (LMWHs) in most European MSs are mainly expressed in IU of activity anti Xa and not in mg, which is in line with the European Pharmacopoeia (Version 8.1, 2014), which expresses the strength of heparins, including LWMH in IU of activity anti Xa.
Na drugi strani se jakost drugih nizkomolekularnih heparinov v večini evropskih držav članic v glavnem izraža v i.e. aktivnosti anti-Xa in ne v miligramih, kar je v skladu z Evropsko farmakopejo (različica 8.1., 2014), pri kateri se jakost heparinov, vključno z nizkomolekularnimi heparini, izraža v i.e. aktivnosti anti-Xa.
• The presentation 10,000 IU (100 mg)/10 mL solution for injection is used only for extracorporeal dialysis, and hence only this indication is covered in section 4.1,
• oblika 10 000 i.e. (100 mg)/10 ml raztopina za injiciranje se uporablja samo za zunajtelesno dializo, zato poglavje 4.1 zajema samo to indikacijo;
For example, for pre-filled syringes of 0.4 ml, the strength will appear as: <Local tradename> 4,000 IU (40 mg)/0.4 ml solution for injection.
Na primer pri napolnjenih injekcijskih brizgah z 0,4 ml bo jakost navedena kot: <lokalno trgovsko ime 4 000 i.e. (40 mg)/0,4 ml> raztopina za injiciranje.
• spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (with a reference to section 4.4);
• spinalna ali epiduralna anestezija ali lokalna/področna anestezija, kadar se natrijev enoksaparin uporablja za zdravljenje v zadnjih 24 urah (s sklicem na poglavje 4.4);
• the Committee agreed on a harmonised product information for Lovenox and associated names, the CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Lovenox and associated names (see Annex I).
• odbor CHMP se je strinjal z usklajenimi informacijami o zdravilu Lovenox in povezanih imenih; je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom Lovenox in povezana imena, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I).
• discontinue treatment in case of skin necrosis and cutaneous vasculitis.
• zdravljenje je treba v primeru kožne nekroze in kožnega vaskulitisa prekiniti.
Unstable angina and NSTEMI indications
Indikacije za nestabilno angino pektoris in NSTEMI
• reduction of dosage in patients above 75 years old treated by enoxaparin for ST-segment elevation myocardial infarction (STEMI);
• zmanjšanje odmerka pri bolnikih, starejših od 75 let, ki se zdravijo z enoksaparinom zaradi miokardnega infarkta z dvigom spojnice ST (STEMI);
The CHMP as a consequence, concluded that the benefit-risk balance of Lovenox and associated names remains favourable, subject to the agreed changes to the product information and the condition to the marketing authorisation.
Posledično je zaključil, da je razmerje med tveganji in koristmi zdravila Lovenox in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu in pogoji dovoljenja za promet z zdravilom.
o either as a once daily injection of 150 IU/kg (1.5 mg/kg): used in uncomplicated patients with low risk of VTE recurrence,
o bodisi kot enkrat dnevna injekcija s 150 i.e./kg (1,5 mg/kg), kar se uporablja pri nezapletenih bolnikih z majhnim tveganjem za ponovitev venske trombembolije;
The SmPC was aligned to state the recommended dose as accepted in most countries of 1mg/kg, which is in line with the clinical data and with the recommendations from treatment guidelines.
Povzetek glavnih značilnosti zdravila je bil usklajen tako, da navaja priporočeni odmerek, kot je sprejet v večini držav, tj. 1 mg/kg, kar je v skladu s kliničnimi podatki in priporočili iz smernic za zdravljenje.
For treatment of acute ST-segment elevation myocardial infarction, the CHMP noted that the pivotal study (ExTRACT-TIMI 25) was carried out in STEMI patients fulfilling the following criteria:
Pri zdravljenju akutnega miokardnega infarkta z dvigom spojnice ST je odbor CHMP opozoril, da je bila izvedena ključna študija (ExTRACT-TIMI 25) pri bolnikih s STEMI, ki so izpolnjevali naslednji merili:
• History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 );
• anamneza imunsko posredovane, s heparinom sprožene trombocitopenije v zadnjih 100 dneh ali v prisotnosti protiteles v obtoku (glejte tudi poglavje 4.4);
Lovenox and associated names is authorised in all EU member states (MSs) as well as in Iceland and Norway.
Zdravilo Lovenox in povezana imena je pridobilo dovoljenje za promet v vseh državah članicah EU ter na Islandiji in Norveškem.
The terminology used for the indication prophylaxis of venous thromboembolism in medical patients varied across Member States.
Uporabljena terminologija za indikacijo profilakse venske trombembolije pri internističnih bolnikih se je med državami članicami razlikovala.
In view of this indication, the CHMP noted the consensus document of the Joint ESC/American College of Cardiology Committee for the redefinition of myocardial infarction (MI), which led to the revision of the definition of acute coronary syndromes (ACS) to UA and NSTEMI.
Pri tej indikaciji je odbor CHMP opozoril na dokument o soglasju skupnega odbora ESC/Ameriškega združenja za kardiologijo o ponovni opredelitvi miokardnega infarkta, kar je privedlo do ponovnega pregleda opredelitve akutnih koronarnih sindromov kot nestabilne angine pektoris in NSTEMI.
The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and the bleeding risk.
Shemo mora izbrati zdravnik na podlagi ocene posameznika, vključno z ovrednotenjem trombemboličnega tveganja in tveganja za krvavitev.
The CHMP agreed to use this definition in the enoxaparin labelling, and the indication was harmonised to include treatment of unstable angina and NSTEMI administered concurrently with oral acetylsalicylic acid.
Odbor CHMP se je strinjal, da bo to opredelitev pojma uporabil pri označevanju enoksaparina, indikacija pa je bila usklajena tako, da vključuje zdravljenje nestabilne angine in NSTEMI ob sočasnem peroralnem jemanju acetilsalicilne kisline.
No difference exists between countries in terms of enoxaparin dosage regimen (1 mg/kg every 12 hours by subcutaneous injection) in these indications.
Glede sheme odmerjanja enoksaparina pri teh indikacijah med državami ni razlik (1 mg/kg na 12 ur s podkožno injekcijo).
Further sub-sections were added to provide information on switch between enoxaparin sodium and oral anticoagulants as well as recommendations for administration in spinal/epidural anaesthesia or lumbar puncture.
Dodana so bila nadaljnja podpoglavja z informacijami o prehodu med natrijevim enoksaparinatom in peroralnimi antikoagulanti ter priporočila za dajanje spinalne/epiduralne anestezije ali izvedbo lumbalne punkcije.
• The pen presentation (10 x 4,000 IU (10x 40 mg)) contains all approved indications except use in extracorporeal dialysis.
• oblika v peresniku (10 x 4 000 i.e. (10 x 40 mg)) vključuje vse odobrene indikacije, razen uporabe pri zunajtelesni dializi.
• use of enoxaparin is not recommended for patients with end stage renal disease due to lack of data in this population outside the prevention of thrombus formation in dialysis patients;
• uporaba enoksaparina ni priporočena pri bolnikih z zadnjim stadijem ledvičnega obolenja zaradi pomanjkanja podatkov o varnosti pri tej populaciji, razen preprečevanja nastajanja strdkov pri bolnikih na dializi;
• increase in the risk of hepatic impairment;
• povečano tveganje za okvaro jeter;
The CHMP noted that in the current ESC guideline, ASA is recommended for all patients without contraindications at an initial oral loading dosed of 150-300 mg (in aspirin-naive patients) and a maintenance dose of 75-100 mg/day longterm regardless of the treatment strategy.
Odbor CHMP je opozoril, da se acetilsalicilna kislina v trenutni smernici ESC priporoča za vse bolnike brez kontraindikacij z začetnim peroralnim polnilnim odmerkom 150-300 mg (za bolnike, ki se še niso zdravili z acetilsalicilno kislino) in dolgoročnim vzdrževalnim odmerkom 75100 mg/dan, ne glede na strategijo zdravljenja.
The section was harmonised to address variations in the exact wording in prophylaxis and treatment indications.
Poglavje je bilo usklajeno z upoštevanjem sprememb besedila za indikacije profilakse in zdravljenja.
The treatment of UA and NSTEMI was not authorised in all Member States prior to the finalisation of this referral.
Zdravljenje nestabilne angine pektoris in NSTEMI pred zaključkom te napotitve ni bilo odobreno v vseh državah članicah.
• Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients;
• preobčutljivost za natrijev enoksaparinat, heparin ali njegove derivate, vključno z nizkomolekularnimi heparini, ali katero koli pomožno snov;
The CHMP also considered that the regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
Odbor CHMP je menil tudi, da mora shemo izbrati zdravnik na podlagi ocene posameznika, vključno z ovrednotenjem trombemboličnega tveganja in tveganja za krvavitev.
In general, the sub-sections on posology and method of administration were aligned with the harmonised indications for enoxaparin.
Na splošno so bila podpoglavja o odmerjanju in načinu uporabe v skladu z usklajenimi indikacijami za enoksaparin.
A previously existing contraindication for use in patients with end stage renal disease (creatinine clearance <15 mL/min) was also removed due to lack of safety data in this population justifying a contraindication, however use in this population is not recommended, as outlined below.
Izločena je bila tudi predhodna kontraindikacija za uporabo pri bolnikih z zadnjim stadijem ledvične bolezni (očistek kreatinina < 15 ml/min) zaradi pomanjkanja podatkov o varnosti pri tej populaciji, ki bi utemeljevali kontraindikacijo, vendar uporaba pri tej populaciji ni priporočena, kot je navedeno spodaj.
Dosing in prophylaxis of venous thromboembolism in medical patients was harmonised to be aligned with ACCP guidelines.
Odmerjanje pri profilaksi venske trombembolije pri internističnih bolnikih je bilo usklajeno tako, da je v skladu s smernicami ACCP.