FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja Pogosti
English: Rivastigmine Actavis 1.5 mg hard capsules
Slovenian: Rivastigmin Actavis 1,5 mg trde kapsule
English: • Heartburn
Slovenian: • Tesnoba
English: Talk to your doctor before taking Rivastigmine Actavis:
Slovenian: Pred začetkom jemanja zdravila Rivastigmin Actavis se posvetujte s svojim zdravnikom:
English: Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Slovenian: Ovojnica kapsule: Rivastigmin Actavis 1.5 mg trde kapsule: titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
English: How to store Rivastigmine Actavis
Slovenian: Shranjevanje zdravila Rivastigmin Actavis
English: Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine.
Slovenian: Ena kapsula zdravila Rivastigmin Actavis 3 mg vsebuje 3 mg rivastigmina.
English: Rivastigmine Actavis 6 mg hard capsules
Slovenian: Rivastigmin Actavis 6 mg trde kapsule
English: Rivastigmine Placebo Rivastigmine Placebo ITT + RDO population (n=329)
Slovenian: Skupina ITT + RDO (n=329)
English: - Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Slovenian: Rivastigmin Actavis 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo z belim napisom “RIV 4,5mg” na telesu.
English: • Unusually slow movements or movements you cannot control
Slovenian: • Neobičajno počasni gibi ali nehoteni gibi
English: Rivastigmine Actavis 3 mg hard capsules
Slovenian: Rivastigmin Actavis 3 mg trde kapsule
English: Contents of the pack and other information What Rivastigmine Actavis contains - The active substance is rivastigmine hydrogen tartrate.
Slovenian: Kaj vsebuje zdravilo Rivastigmin Actavis - Zdravilna učinkovina je rivastigminijev hidrogentartrat.
English: Balance disorder Musculoskeletal stiffness Rigors
Slovenian: Otrdelost mišic in skeleta
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte napotke zdravnika.
English: Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Slovenian: Rivastigmin Actavis 6 mg trde kapsule EU/1/11/693/013
English: Somnolence
Slovenian: Nespečnost
English: • Stomach pain
Slovenian: • Bolečine v trebuhu
English: EU/1/11/693/007 [112 blister]
Slovenian: EU/1/11/693/007 [112 pretisni omot]
English: • if you have, or have ever had impaired kidney function.
Slovenian: • če imate ali če ste kdaj imeli okvarjeno delovanje ledvic.
English: - Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Slovenian: Rivastigmin Actavis 3 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo z rdečim napisom “RIV 3mg” na telesu.
English: - Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Slovenian: Rivastigmin Actavis 6 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo z rdečim napisom “RIV 6mg” na telesu.
English: EU/1/11/693/015 [112 blister]
Slovenian: EU/1/11/693/015 [112 pretisni omot]
English: Abdominal pain and dyspepsia
Slovenian: Bolečine v trebuhu in dispepsija
English: • Anxiety
Slovenian: • Nespečnost
English: Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body.
Slovenian: Belkast do rahlo rumen prašek v trdi kapsuli z rdečim pokrovčkom in rdečim telesom, z belim napisom “RIV 4,5mg” na telesu.
English: Hepatic impairment
Slovenian: Splošno slabo počutje
English: Paediatric population
Slovenian: Epileptični napadi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/012
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 4,5 mg rivastigmina (v obliki hidrogentartrata).
English: Cardiac disorders Common
Slovenian: Srčne bolezni Pogosti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/016
English: associated with Parkinson's disease Total patients studied Total patients with pre-defined AE(s) Tremor
Slovenian: Vsi bolniki z neželenimi dogodki (AE - “adverse event”) Tremor
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/013[ 28 pretisni omot]
English: Malaise
Slovenian: Nemir
English: • Urinary tract infection
Slovenian: • Okužbe sečil
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 6 mg rivastigmina (v obliki hidrogentartrata).
English: Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Slovenian: Rivastigmin Actavis 4,5 mg trde kapsule EU/1/11/693/009
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 1,5 mg rivastigmina (v obliki hidrogentartrata).
English: Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Slovenian: Belkast do rahlo rumen prašek v trdi kapsuli z oranžnim pokrovčkom in oranžnim telesom, z rdečim napisom “RIV 3mg” na telesu.
English: EU/1/11/693/011 [112 blister]
Slovenian: EU/1/11/693/011 [112 pretisni omot]
English: EU/1/11/693/014 [56 blister]
Slovenian: EU/1/11/693/014 [56 pretisni omot]
English: Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body.
Slovenian: Belkast do rahlo rumen prašek v trdi kapsuli z rdečim pokrovčkom in oranžnim telesom, z rdečim napisom “RIV 6mg” na telesu.
English: EU/1/11/693/006 [56 blister]
Slovenian: EU/1/11/693/006 [56 pretisni omot]
English: Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Slovenian: Rivastigmin Actavis 1,5 mg trde kapsule EU/1/11/693/001
English: • Chest pain
Slovenian: • Bolečina v prsih
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/005[ 28 pretisni omot]
English: Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Slovenian: Rivastigmin Actavis 3 mg trde kapsule EU/1/11/693/005
English: • if you have, or have ever had, impaired liver function.
Slovenian: • če imate ali če ste kdaj imeli okvarjeno delovanje jeter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 3 mg rivastigmina (v obliki hidrogentartrata).
English: Mean baseline ± SD 24.0 ± 10.3 24.5 ± 10.6 n/a n/a
Slovenian: 24,0 ± 10,3 24,5 ± 10,6 ni podatka ni podatka
English: Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Slovenian: Belkast do rahlo rumen prašek v trdi kapsuli z rumenim pokrovčkom in rumenim telesom, z rdečim napisom “RIV 1,5mg” na telesu.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Slovenian: Poglavitna pot odstranjevanja iz telesa je izločanje presnovkov skozi ledvice.
English: EU/1/11/693/010 [56 blister]
Slovenian: EU/1/11/693/010 [56 pretisni omot]
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
English: Urinary infection
Slovenian: Okužba sečil
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/009[ 28 pretisni omot]
English: • Uneven heartbeat
Slovenian: • Neredno bitje srca
English: Mean baseline ± SD 23.8 ± 10.2 24.3 ± 10.5 n/a n/a
Slovenian: 23,8 ± 10,2 24,3 ± 10,5 ni podatka ni podatka
English: • Generally feeling unwell
Slovenian: • Splošno slabo počutje
English: • Fainting
Slovenian: • Hujšanje
English: Anxiety
Slovenian: Rivastigmin
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules Red iron oxide (E172)
Slovenian: Rivastigmin Actavis 3 mg, 4,5 mg in 6 mg trde kapsule rdeči železov oksid (E172) titanov dioksid (E171) rumeni železov oksid (E172) želatina
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine.
Slovenian: Rivastigmin Actavis 6 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 6 mg rivastigmina.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Slovenian: Rivastigmin Actavis 1,5 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 1,5 mg rivastigmina.
English: Dizziness
Slovenian: Vrtoglavost
English: Insomnia
Slovenian: Somnolenca
English: • Weight loss
Slovenian: • Vrtoglavost
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Slovenian: Rivastigmin Actavis 4,5 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 4,5 mg rivastigmina.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine.
Slovenian: Rivastigmin Actavis 3 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 3 mg rivastigmina.
English: 5 pre-filled pens
Slovenian: 5 napolnjenih injekcijskih peresnikov
English: The package leaflet will be updated accordingly.
Slovenian: Navodilo za uporabo bo ustrezno posodobljeno.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 August 2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2.
English: Scandonest has been authorised in the EU via national procedures.
Slovenian: Zdravilo Scandonest je bilo v EU odobreno po nacionalnih postopkih.
English: The amended information to doctors and patients is available here.
Slovenian: Dopolnjene informacije za zdravnike in bolnike so na voljo tukaj.
English: Why was Scandonest reviewed?
Slovenian: Zakaj je bilo zdravilo Scandonest pregledano?
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Slovenian: Po pregledu razpoložljivih podatkov je bilo za več drugih kontraindikacij, ki so veljale samo v nekaterih državah, ugotovljeno, da niso podprte z zadostnimi podatki ali so odvečne in že vključene v trenutni, zgoraj navedeni, seznam.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Slovenian: Evropska komisija je 2. avgusta 2018 izdala pravno zavezujoči sklep za vse države članice EU, da uvedejo te spremembe.
English: In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Slovenian: Poleg tega se ne sme uporabljati pri otrocih, mlajših od štirih let, pri bolnikih s hudimi težavami v zvezi z električno aktivnostjo srca, ki jih ni mogoče odpraviti s srčnim spodbujevalnikom, ter pri bolnikih z epilepsijo, pri katerih bolezen ni zadostno nadzorovana.
English: Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Slovenian: Druga usklajena poglavja povzetka glavnih značilnosti zdravila vključujejo poglavja 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje z drugimi zdravili), 4.6 (Plodnost, nosečnost in dojenje), 4.7 (Vpliv na sposobnost vožnje in upravljanja strojev) in 4.8 (Neželeni učinki).
English: In children, the recommended dose is 0.75 mg/kg.
Slovenian: Pri otrocih je priporočeni odmerek 0,75 mg/kg.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Slovenian: Kadar je bilo to utemeljeno s podatki, so bile nekatere od predhodnih kontraindikacij vključene v poglavje 4.4 Posebna opozorila in previdnostni ukrepi.
English: Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
Slovenian: V EU je na voljo tudi pod trgovskima imenoma Biocaine in Scandicaine.
English: In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Slovenian: Poleg tega sta bila usklajena modul 3 dokumentacije o zdravilu (v njem je opisano, kako je zdravilo proizvedeno in kako se nadzoruje njegova kakovost).
English: Information for doctors and patients to be aligned across EU
Slovenian: Informacije za zdravnike in bolnike je treba uskladiti po vsej EU
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.
Slovenian: To je med državami članicami povzročilo nedoslednosti v načinu, kako se zdravilo proizvaja in lahko uporablja, kar pa se odraža v razlikah med informacijami o predpisovanju (povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo) v državah, v katerih se zdravilo trži.
English: The recommended dose of Scandonest depends on the patient's age and body weight.
Slovenian: Priporočeni odmerek zdravila Scandonest je odvisen od bolnikove starosti in telesne mase.
English: In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Slovenian: Pri odraslih je največji priporočeni odmerek 4,4 mg na kilogram telesne mase, največji skupni odmerek pa 300 mg.
English: On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Slovenian: Evropska agencija za zdravila (EMA) je 31. maja 2018 zaključila pregled zdravila Scandonest in povezanih imen ter priporočila spremembe informacij o predpisovanju, da bi se uskladil način uporabe zdravila v EU.
English: Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).
Slovenian: Zdravilo Scandonest je zdaj odobreno za uporabo kot lokalni anestetik pri dentalnih kirurških posegih pri odraslih, mladostnikih in otrocih, starejših od štirih let (ki tehtajo okoli 20 kg).
English: The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Slovenian: Pregled zdravila Scandonest se je začel na zahtevo imetnika dovoljenja za promet z zdravilom, podjetja Septodont, v skladu s členom 30 Direktive 2001/83/ES.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Slovenian: Uporabo zdravila Scandonest in povezanih imen (mepivakain) je treba uskladiti EMA/533239/2018
English: Use of Scandonest and associated names (mepivacaine) to be harmonised
Slovenian: Uporabo zdravila Scandonest in povezanih imen (mepivakain) je treba uskladiti
English: Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Slovenian: Zdravilo Scandonest se ne sme uporabljati pri bolnikih, ki so alergični na učinkovino mepivakain ali katero koli drugo sestavino zdravila.
English: On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.
Slovenian: Podjetje Septodont, ki zdravilo Scandonest trži, je 25. avgusta 2017 zadevo napotilo na agencijo EMA, da bi ta uskladila dovoljenja za promet z zdravilom Scandonest v EU.
English: After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Slovenian: Po pregledu razpoložljivih podatkov o uporabi zdravila Scandonest je agencija zaključila, da je treba uskladiti povzetke glavnih značilnosti zdravila.
English: What is Scandonest?
Slovenian: Kaj je zdravilo Scandonest?
English: Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Slovenian: Zdravilo Scandonest je lokalni anestetik, tj. zdravilo, ki se uporablja za zaviranje zaznavanja in bolečine v delu telesa pri medicinskih posegih.
English: It contains the active substance mepivacaine.
Slovenian: Daje se z injiciranjem in vsebuje učinkovino mepivakain.
English: The company that markets these medicines is Septodont.
Slovenian: Ta zdravila trži farmacevtsko podjetje Septodont.
English: Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.
Slovenian: Zdravilo Scandonest se ne sme več uporabljati kot lokalni anestetik pri pedikerskih posegih (zdravljenju kurjih očes, bradavic idr.
English: The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Slovenian: Priporočeni odmerek je 35 mednarodnih enot (i.e.) na kilogram telesne mase enkrat mesečno.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom NovoThirteen, veljavno po vsej Evropski uniji, izdala 3. septembra 2012.
English: The full EPAR for NovoThirteen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NovoThirteen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for NovoThirteen.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NovoThirteen.
English: What measures are being taken to ensure the safe and effective use of NovoThirteen?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NovoThirteen?
English: NovoThirteen catridecacog
Slovenian: NovoThirteen katridekakog
English: A risk management plan has been developed to ensure that NovoThirteen is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila NovoThirteen je bil pripravljen načrt obvladovanja tveganj.
English: The CHMP concluded that the main study provided satisfactory results in terms of effectiveness, since no severe or life-threatening bleedings took place during treatment with NovoThirteen.
Slovenian: CHMP je zaključil, da so rezultati glavne študije z vidika učinkovitosti zadovoljivi, saj med zdravljenjem z zdravilom NovoThirteen ni prišlo do resnih ali življenjsko nevarnih krvavitev.
English: Other information about NovoThirteen
Slovenian: Druge informacije o zdravilu NovoThirteen
English: The study was extended for a further year in 33 of the patients, to look at the long-term safety of treatment with NovoThirteen.
Slovenian: Študija je bila pri 33 bolnikih podaljšana za še eno leto, da bi proučili dolgoročno varnost zdravljenja z zdravilom NovoThirteen.
English: This dose is given in a single, slow injection into a vein.
Slovenian: Daje se z enkratnim, počasnim injiciranjem v veno.
English: For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom NovoThirteen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is available as a powder and solvent to be made up into a solution for injection.
Slovenian: Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje.
English: Factor XIII is a protein involved in the blood clotting process.
Slovenian: Faktor XIII je beljakovina, ki je vključena v proces strjevanja krvi.
English: What benefit has NovoThirteen shown during the studies?
Slovenian: Kakšne koristi je zdravilo NovoThirteen izkazalo med študijami?
English: The condition must be confirmed by suitable tests before starting treatment.
Slovenian: Pred začetkom zdravljenja je treba motnjo potrditi z ustreznimi testi.
English: Treatment with NovoThirteen should be started under the supervision of a doctor experienced in treating rare bleeding disorders.
Slovenian: Zdravljenje z zdravilom NovoThirteen je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
English: Additionally, the company that markets NovoThirteen will provide all doctors who are expected to prescribe it with an information pack for doctors and patients containing important information on the correct use of the medicine.
Slovenian: Družba, ki trži zdravilo NovoThirteen, bo vsem zdravnikom, za katere se pričakuje, da ga bodo predpisovali, zagotovila informativne brošure, ki bodo vsebovale pomembne informacije za zdravnike in bolnike o pravilni uporabi zdravila.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NovoThirteen.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with NovoThirteen (seen in between 1 and 10 patients in 100) are headache, leucopenia (low white blood cell counts), aggravated neutropenia (low levels of neutrophils, a type of white blood cell), pain in the extremities, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer'.
Slovenian: Najpogostejši neželeni učinki zdravila NovoThirteen (opaženi pri 1 do 10 bolnikih od 100) so glavobol, levkopenija (nizko število belih krvničk), poslabšanje nevtropenije (nizke ravni nevtrofilcev, vrste belih krvničk), bolečine v okončinah, bolečina na mestu injiciranja ter prisotnost protiteles, ki se vežejo na faktor XIII, in drobnih beljakovinskih delcev, imenovanih fibrinski D-dimer, v krvi.
English: NovoThirteen is a medicine that contains the active substance catridecacog.
Slovenian: NovoThirteen je zdravilo, ki vsebuje zdravilno učinkovino katridekakog.
English: This is an inherited blood clotting disorder characterised by bleeding episodes.
Slovenian: To je dedna motnja strjevanja krvi, za katero so značilne krvavitve.