natgillin/translations-raw huggingface dataset:
Information for doctors and patients to be aligned across EU
Informacije za zdravnike in bolnike je treba uskladiti po vsej EU
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.
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.
The recommended dose of Scandonest depends on the patient's age and body weight.
Priporočeni odmerek zdravila Scandonest je odvisen od bolnikove starosti in telesne mase.
In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Pri odraslih je največji priporočeni odmerek 4,4 mg na kilogram telesne mase, največji skupni odmerek pa 300 mg.
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.
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.
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).
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).
The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
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.
Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Uporabo zdravila Scandonest in povezanih imen (mepivakain) je treba uskladiti EMA/533239/2018
Use of Scandonest and associated names (mepivacaine) to be harmonised
Uporabo zdravila Scandonest in povezanih imen (mepivakain) je treba uskladiti
Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Zdravilo Scandonest se ne sme uporabljati pri bolnikih, ki so alergični na učinkovino mepivakain ali katero koli drugo sestavino zdravila.
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.
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.
After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Po pregledu razpoložljivih podatkov o uporabi zdravila Scandonest je agencija zaključila, da je treba uskladiti povzetke glavnih značilnosti zdravila.
What is Scandonest?
Kaj je zdravilo Scandonest?
Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Zdravilo Scandonest je lokalni anestetik, tj. zdravilo, ki se uporablja za zaviranje zaznavanja in bolečine v delu telesa pri medicinskih posegih.
It contains the active substance mepivacaine.
Daje se z injiciranjem in vsebuje učinkovino mepivakain.
The company that markets these medicines is Septodont.
Ta zdravila trži farmacevtsko podjetje Septodont.
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.
Zdravilo Scandonest se ne sme več uporabljati kot lokalni anestetik pri pedikerskih posegih (zdravljenju kurjih očes, bradavic idr.
The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Priporočeni odmerek je 35 mednarodnih enot (i.e.) na kilogram telesne mase enkrat mesečno.
The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Evropska komisija je dovoljenje za promet z zdravilom NovoThirteen, veljavno po vsej Evropski uniji, izdala 3. septembra 2012.
The full EPAR for NovoThirteen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
This is a summary of the European public assessment report (EPAR) for NovoThirteen.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NovoThirteen.
What measures are being taken to ensure the safe and effective use of NovoThirteen?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NovoThirteen?
A risk management plan has been developed to ensure that NovoThirteen is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila NovoThirteen je bil pripravljen načrt obvladovanja tveganj.
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.
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.
Other information about NovoThirteen
Druge informacije o zdravilu NovoThirteen
The study was extended for a further year in 33 of the patients, to look at the long-term safety of treatment with NovoThirteen.
Študija je bila pri 33 bolnikih podaljšana za še eno leto, da bi proučili dolgoročno varnost zdravljenja z zdravilom NovoThirteen.
This dose is given in a single, slow injection into a vein.
Daje se z enkratnim, počasnim injiciranjem v veno.
For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
It is available as a powder and solvent to be made up into a solution for injection.
Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje.
Factor XIII is a protein involved in the blood clotting process.
Faktor XIII je beljakovina, ki je vključena v proces strjevanja krvi.
What benefit has NovoThirteen shown during the studies?
Kakšne koristi je zdravilo NovoThirteen izkazalo med študijami?
The condition must be confirmed by suitable tests before starting treatment.
Pred začetkom zdravljenja je treba motnjo potrditi z ustreznimi testi.
Treatment with NovoThirteen should be started under the supervision of a doctor experienced in treating rare bleeding disorders.
Zdravljenje z zdravilom NovoThirteen je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
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.
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.
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.
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.
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'.
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.
NovoThirteen is a medicine that contains the active substance catridecacog.
NovoThirteen je zdravilo, ki vsebuje zdravilno učinkovino katridekakog.
This is an inherited blood clotting disorder characterised by bleeding episodes.
To je dedna motnja strjevanja krvi, za katero so značilne krvavitve.
During the long-term study, no bleeding episodes were observed in children below 6 years of age treated with NovoThirteen.
Med dolgoročno študijo niso opazili nobenih krvavitev pri otrocih, mlajših od šest let, zdravljenih z zdravilom NovoThirteen.
The safety and effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Varnost in učinkovitost zdravila NovoThirteen pri otrocih, mlajših od šest let, sta bili podprti s predhodnimi podatki iz potekajoče dolgoročne študije, med katero so bolniki to zdravilo prejemali za preprečevanje krvavitev.
This includes information on storage procedures, since incorrect storage after reconstitution can cause increased levels of activated NovoThirteen, thereby increasing the risk of thrombosis (formation of blood clots in the blood vessels), and information on administration procedures, since the factor XIII concentration in NovoThirteen is different from other factor XIIIcontaining medicines.
Vsebovale bodo informacije o postopkih shranjevanja, saj lahko nepravilno shranjevanje po pripravi povzroči povišane ravni aktiviranega zdravila NovoThirteen in s tem poveča tveganje za trombozo (tvorjenje krvnih strdkov v ožilju), ter informacije o načinih uporabe, saj je koncentracija faktorja XIII v zdravilu NovoThirteen drugačna kot pri drugih zdravilih, ki ga vsebujejo.
The patients were given NovoThirteen for one year for preventative use.
Bolniki so eno leto preventivno prejemali zdravilo NovoThirteen.
A specific component of factor XIII called the A-subunit is involved in stabilising blood clots and increasing the strength of the clot.
Posebna sestavina faktorja XIII, imenovana podenota A, sodeluje pri stabilizaciji krvnih strdkov in povečevanju njihove trdnosti.
NovoThirteen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila NovoThirteen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with NovoThirteen?
Kakšna tveganja so povezana z zdravilom NovoThirteen?
NovoThirteen was investigated in a main study involving 41 adults and children above 6 years of age with congenital factor XIII A-subunit deficiency who had been treated in the past with medicines containing factor XIII.
Zdravilo NovoThirteen so proučevali v glavni študiji, v katero je bilo vključenih 41 odraslih in otrok, starejših od šest let, s prirojenim pomanjkanjem podenote A faktorja XIII, ki so se v preteklosti zdravili z zdravili, ki vsebujejo faktor XIII.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoThirteen, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila NovoThirteen in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The factor XIII A-subunit in NovoThirteen is made by a method known as ‘recombinant DNA technology': it is produced by yeast cells that have received the gene (DNA) which makes the cells able to produce it.
Podenoto A faktorja XIII v zdravilu NovoThirteen proizvajajo z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri kvasovke prejmejo gen (DNK), s katerimi jo lahko tvorijo.
Patients with congenital factor XIII A-subunit deficiency do not have enough of the factor XIII A-subunit, or it does not work correctly, which makes them prone to bleeding.
Bolniki s prirojenim pomanjkanjem podenote A faktorja XIII imajo te enote premalo ali jim ne deluje pravilno, zaradi česar so nagnjeni h krvavitvam.
NovoThirteen works by providing the factor XIII A-subunit, which helps to prevent bleeding in these patients.
Zdravilo NovoThirteen deluje tako, da zagotavlja podenoto A faktorja XIII, kar pomaga pri preprečevanju krvavitev pri teh bolnikih.
The active substance in NovoThirteen, catridecacog, is structurally the same as the human factor XIII A-subunit.
Zdravilna učinkovina zdravila NovoThirteen, katridekakog, je po zgradbi enaka človeški podenoti A faktorja XIII.
The study looked at the number of bleeding episodes requiring treatment with a factor XIII-containing medicine in these patients, compared with patients who had not received NovoThirteen, based on earlier data from 16 patients with congenital factor XIII A-subunit deficiency.
V študiji so proučevali število krvavitev, pri katerih je bilo pri teh bolnikih potrebno zdravljenje z zdravilom, ki vsebuje faktor XIII, v primerjavi z bolniki, ki niso prejemali zdravila NovoThirteen, na podlagi predhodnih podatkov 16 bolnikov s prirojenim pomanjkanjem podenote A faktorja XIII.
Why has NovoThirteen been approved?
Zakaj je bilo zdravilo NovoThirteen odobreno?
NovoThirteen does not work in patients lacking the factor XIII B-subunit.
Zdravilo ne deluje pri bolnikih, ki jim primanjkuje podenota B faktorja XIII.
The rate of bleeding episodes in patients receiving NovoThirteen preventatively was lower than the rate seen in the earlier data from patients treated on demand with another medicine containing factor XIII.
Pri bolnikih, ki so zdravilo NovoThirteen prejemali preventivno, je bila pogostost krvavitev manjša od pogostosti, razvidne iz predhodnih podatkov bolnikov, zdravljenih po potrebi z drugim zdravilom, ki vsebuje faktor XIII.
NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called ‘congenital factor XIII A-subunit deficiency'.
Zdravilo NovoThirteen se uporablja za dolgoročno preprečevanje krvavitev pri bolnikih z motnjo, imenovano prirojeno pomanjkanje podenote A faktorja XIII.
On average, there were approximately 0.15 bleeding episodes requiring factor XIII treatment per year per patient treated preventatively with NovoThirteen.
V povprečju je pri bolniku, preventivno zdravljenem z zdravilom NovoThirteen, na leto prišlo do približno 0,15 krvavitve, pri kateri je bilo potrebno zdravljenje s faktorjem XIII.
In certain situations the doctor may decide to adjust the dose required to prevent bleeding, based on the patient's factor XIII levels in the blood.
V določenih primerih se lahko zdravnik na podlagi analize bolnikove ravni faktorja XIII v krvi odloči, da prilagodi odmerek, potreben za preprečevanje krvavitev.
Moreover, no major side effects were seen with long term use of NovoThirteen.
Poleg tega pri dolgoročnem zdravljenju z zdravilom NovoThirteen niso bili opaženi resnejši neželeni učinki.
How has NovoThirteen been studied?
Kako je bilo zdravilo NovoThirteen raziskano?
What is NovoThirteen?
Kaj je zdravilo NovoThirteen?
What is NovoThirteen used for?
Za kaj se zdravilo NovoThirteen uporablja?
How does NovoThirteen work?
Kako zdravilo NovoThirteen deluje?
How is NovoThirteen used?
Kako se zdravilo NovoThirteen uporablja?
This compared with around 2.9 episodes per year per patient treated on demand with another medicine containing factor XIII.
Pri bolniku, zdravljenem po potrebi z drugim zdravilom, ki vsebuje faktor XIII, pa je na leto prišlo do 2,9 krvavitve.
The name of the medicine was changed to Vantavo on 26 March 2010.
Ime zdravila je bilo 26. marca 2010 spremenjeno v Vantavo.
The recommended dose is one tablet once a week.
Priporočeni odmerek zdravila Vantavo je ena tableta enkrat na teden.
Other information about Vantavo:
Druge informacije o zdravilu Vantavo:
What measures are being taken to ensure the safe and effective use of Vantavo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vantavo?
The full EPAR for Vantavo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vantavo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Ta odobritev je temeljila na dovoljenju za promet z zdravilom Fosavance, izdanemu leta 2005 (uporaba dokumentacije s soglasjem).
The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Bolnica mora tableto zaužiti s polnim kozarcem vode (vendar ne mineralne), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
This document is a summary of the European Public Assessment Report (EPAR) for Vantavo.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vantavo.
A risk management plan has been developed to ensure that Vantavo is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Vantavo je bil pripravljen načrt obvladovanja tveganj.
the day, which should be at least 30 minutes after taking the tablet.
prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
For more information about treatment with Vantavo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vantavo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vantavo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Bolnice morajo tableto pogoltniti celo in je ne smejo zdrobiti, žvečiti ali raztopiti v ustih.
Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Vitamin D3 je hranilna snov, ki jo najdemo v nekaterih vrstah hrane, z izpostavljanjem naravni sončni svetlobi pa nastaja tudi v koži.
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Vantavo.
Ker bolniki z osteoporozo z izpostavljanjem sončni svetlobi morda ne dobijo dovolj vitamina D3, je ta vključen v zdravilo Vantavo.
What benefit has Vantavo shown during the studies?
Kakšne koristi je zdravilo Vantavo izkazalo med študijami?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena, ki prispeva k ohranjanju zdravih kosti, upade.
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 Vantavo.
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.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantavo, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Alendronate Sodium And Colecalciferol, MSD, veljavno po vsej Evropski uniji, izdala 16. oktobra 2009.
Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Ker se alendronska kislina in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v EU, je družba predložila podatke iz starejših študij ter iz objavljene literature o ženskah, ki so že prestale menopavzo in so jemale alendronsko kislino in vitamin D kot ločeni tableti.
What is the risk associated with Vantavo?
Kakšna tveganja so povezana z zdravilom Vantavo?
1 Previously known as Alendronate Sodium And Colecalciferol, MSD.
1 Prej znano kot Alendronate Sodium and Colecalciferol, MSD.
Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Skupaj z drugimi vrstami vitamina D je potreben za absorpcijo kalcija in normalno tvorbo kostne mase.
It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Na voljo je v obliki tablet (70 mg alendronske kisline in 2 800 mednarodnih enot [i.e.] holekalciferola; 70 mg alendronske kisline in 5 600 i.e. holekalciferola).
The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Vantavo was the same as the dose needed to prevent bone loss.
Podatki iz starejših študij in objavljene literature, ki jih je predstavila družba, so pokazali, da je odmerek alendronske kisline v zdravilu Vantavo enak odmerku, ki je potreben za preprečevanje izgube kostne mase.
For the full list of all side effects reported with Vantavo, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vantavo, glejte navodilo za uporabo.
Why has Vantavo been approved?
Zakaj je bilo zdravilo Vantavo odobreno?
Vantavo must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Zdravila Vantavo ne smejo uporabljati bolnice z nepravilnostmi v požiralniku, bolnice s hipokalciemijo (nizkimi ravnmi kalcija) ali tiste, ki vsaj 30 minut ne morejo vzravnano stati ali sedeti.