natgillin/translations-raw huggingface dataset:
Concomitantly, in France, following a first national pharmacovigilance survey that showed that cardiovascular adverse drug reactions (ADRs) accounted for an important proportion of the AEs reported, the summary of product characteristics (SmPC) had been reinforced with respect to these ADRs.
Sočasno so v Franciji po prvi nacionalni raziskavi farmakovigilance, ki je pokazala, da srčno-žilni neželeni učinki zdravila predstavljajo pomemben delež prijavljenih neželenih dogodkov, dopolnili povzetek glavnih značilnosti zdravila z informacijami glede teh neželenih učinkov.
In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Pri nekaterih bolnicah so bili pred pojavom epileptičnih napadov ali možganske kapi prisotni hudi glavoboli in/ali prehodne motnje vida.
In addition, the PRAC was of the view that the contra-indication in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancyinduced hypertension), hypertension post-partum and in the puerperium, and patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders, already partially in place in most member states should be implemented across all Member States.
Poleg tega je odbor PRAC menil, da je kontraindikacijo pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju ter pri bolnicah z boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali s simptomi/anamnezo hudih psihiatričnih motenj, ki je delno že v veljavi v večini držav članic, treba izvajati v vseh državah članicah.
In conclusion, based on the available information a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events cannot be excluded.
Na podlagi razpoložljivih podatkov je bilo zaključeno, da vzročne povezave med uporabo bromokriptina in resnimi srčno-žilnimi, nevrološkimi in psihiatričnimi dogodki ni mogoče izključiti.
• In addition, the PRAC recommended all strengths of these products to be contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and puerperium as well as in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders;
• poleg tega je odbor PRAC priporočil, da se vse jakosti teh zdravil kontraindicirajo pri bolnicah z nenadzorovano hipertenzijo, hipertenzivnimi motnjami v nosečnosti (vključno z eklampsijo, preeklampsijo in hipertenzijo zaradi nosečnosti), hipertenzijo po porodu in v puerperiju ter pri bolnicah z boleznijo koronarnih arterij ali drugimi hudimi srčno-žilnimi boleznimi v anamnezi ali s simptomi/anamnezo hudih psihiatričnih motenj;
The PRAC reviewed the efficacy and safety data following oral treatment with bromocriptine in postpartum inhibition of lactation, in particular data related to the risk of cardiovascular, vascular neurological and psychiatric adverse events.
Odbor PRAC je pregledal podatke o učinkovitosti in varnosti peroralnega zdravljenja z bromokriptinom za zaviranje laktacije po porodu, zlasti podatke v zvezi s tveganjem za srčno-žilne, nevrovaskularne in psihiatrične neželene dogodke.
The PRAC, as a consequence, concluded that the benefit-risk balance of oral bromocriptine-containing medicinal products in the post-partum inhibition of lactation identified in Annex I remains favourable, subject to the agreed changes to the product information including restrictions and warnings.
Posledično je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu ter so navedena v Prilogi I, še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu, vključno z omejitvami in opozorili.
For that reason the PRAC considered that to avoid medication errors or misuse of the products the indication of inhibition of lactation should be removed from the PI of the 5 mg and 10 mg strengths.
Odbor PRAC je zato menil, da je za preprečitev napak pri zdravljenju ali napačne uporabe zdravil indikacijo zaviranja laktacije treba izbrisati iz informacij o zdravilu za jakosti 5 mg in 10 mg.
Avoiding the elective use of this drug in patients with pregnancy-induced hypertension might constitute a reasonable clinical response to these findings.
Smiseln klinični odgovor na te ugotovitve bi lahko bil izogibanje elektivni uporabi tega zdravila pri bolnicah s hipertenzijo zaradi nosečnosti.
The PRAC considered the relation between the use of bromocriptine-containing medicinal products for oral use in post-partum inhibition of lactation and the occurrence of serious cardiovascular, neurological and psychiatric adverse events.
Odbor PRAC je proučil povezavo med uporabo zdravil za peroralno uporabo, ki vsebujejo bromokriptin in so indicirana za zaviranje laktacije po porodu, ter pojavom resnih srčno-žilnih, nevroloških in psihiatričnih neželenih dogodkov.
Finally, the PRAC considered that, to avoid medication errors or misuse, the indication for inhibition of post-partum lactation, should be removed from the product information of the 5 mg and 10 mg strengths.
Odbor PRAC je menil še, da je za preprečitev napak pri zdravljenju ali napačne uporabe indikacijo zaviranja laktacije po porodu treba izbrisati iz informacij o zdravilu za jakosti 5 mg in 10 mg.
The marketing authorisation was renewed on 13 March 2002 and on 13 March 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 13. marca 2002 in 13. marca 2007.
Other information about Refludan:
Druge informacije o zdravilu Refludan:
The marketing authorisation holder is Celgene Europe Ltd.
Imetnik dovoljenja za promet z zdravilom je družba Celgene Europe Ltd.
The recommended dose is 0.4 mg per kilogram body weight as a single injection into a vein, followed by a continuous infusion at a dose of 0.15 mg/kg per hour for two to 10 days, or longer if needed.
Priporočeni odmerek je 0,4 mg na kilogram telesne mase z eno injekcijo v veno, ki ji sledi neprekinjena intravenska infuzija v odmerku 0,15 mg/kg telesne mase na uro, ki traja od 2 do 10 dni ali celo dlje, če je to potrebno.
What benefit has Refludan shown during the studies?
Kakšne koristi je zdravilo Refludan izkazalo med študijami?
During the study period, 9% of the patients died (11 out of 125), 6% had amputations (7 out of 125) and 10% had new thromboembolic complications (12 out of 125).
V času študije je umrlo 9 % bolnikov (11 od 125), 6 % jih je moralo na amputacijo (7 od 125), 10 % bolnikov pa je imelo nove tromboembolične zaplete (12 od 125).
Some patients can have a serious allergic shock when they receive Refludan for a second time.
Pri nekaterih bolnikih lahko pride do hudega alergijskega šoka, ko zdravilo Refludan prejmejo drugič zapovrstjo.
It must not be used in patients who are pregnant or breast-feeding.
Ne sme se uporabljati pri nosečnicah ali doječih materah.
Bleeding leading to death occurs in around 1 patient in 100.
Do krvavitev, katerih posledica je smrt bolnika, pride pri približno 1 bolniku od 100.
The European Commission granted a marketing authorisation valid throughout the European Union for Refludan on 13 March 1997.
Evropska komisija je dovoljenje za promet z zdravilom Refludan, veljavno po vsej Evropski uniji, odobrila dne 13. marca 1997.
Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and thromboembolic disease.
Zdravilo Refludan so preučevali v dveh glavnih študijah, v katerih je sodelovalo 198 bolnikov, med katerimi jih je 125 imelo HIT in tromboembolijo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REFLUDAN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) REFLUDAN Povzetek EPAR za javnost
As the disease is very severe and there are no other effective treatments approved, the Committee for Medicinal Products for Human Use (CHMP) decided that Refludan's benefits are greater than its risks for the treatment of patients with HIT and thromboembolic disease.
Ker je bolezen zelo huda in zanjo ne obstajajo nobena druga odobrena učinkovita zdravila, je Odbor za zdravila za uporabo v humani medicini (CHMP) zaključil, da so koristi zdravila Refludan pri zdravljenju bolnikov s HIT in tromboembolijo večje od z njim povezanih tveganj.
The studies did not compare Refludan with any other treatments, so the results were judged against historical controls (the results expected in untreated patients, based on past studies).
V teh študijah zdravila Refludan niso primerjali z drugimi oblikami zdravljenja, zato so njune rezultate ovrednotili v primerjavi s historičnimi raziskavami (pričakovanimi rezultati pri nezdravljenih bolnikih, ki temeljijo na preteklih študijah).
What is the risk associated with Refludan?
Kakšna tveganja so povezana z zdravilom Refludan?
Refludan is used to prevent blood clotting.
Refludan se uporablja za preprečevanje krvnih strdkov.
The Committee recommended that Refludan be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Refludan odobri dovoljenje za promet.
In the comparison with historical controls, the two trials taken together showed a significant benefit of Refludan on the rate of new thromboembolic complications and a trend towards increased survival.
V primerjavi s historičnimi raziskavami sta obe študiji skupaj pokazali znatno korist zdravila Refludan pri zmanjševanju pogostosti novih tromboemboličnih zapletov in trend podaljševanja preživetja.
Doctors should be very careful when re-exposing a patient to the medicine.
Zdravniki morajo zato biti zelo pozorni, kadar bolnika ponovno zdravijo s tem zdravilom.
By blocking thrombin, Refludan greatly reduces the risk of blood clots forming, preventing subsequent damage.
Z blokiranje trombina zdravilo Refludan bistveno zmanjša tveganje za nastanek krvnih strdkov, s čimer preprečuje nadaljnje okvare.
Its use is not advisable in patients who are bleeding or are at risk of bleeding because of a recent biopsy, stroke or major surgery, or because they are over the age of 65 years, among other reasons.
Uporaba zdravila ni priporočljiva pri bolnikih, ki trenutno krvavijo ali pri katerih obstaja tveganje za pojav krvavitve zaradi nedavne biopsije, kapi ali večje operacije ali ki so starejši od 65 let.
The diagnosis must be confirmed using specific tests, such as the heparin-induced platelet aggregation assay (HIPAA) test.
Diagnozo je treba potrditi s posebnimi testi, kot je denimo test aktivacije trombocitov s heparinsko indukcijo (HIPAA).
It contains the active substance lepirudin.
Vsebuje zdravilno učinkovino lepirudin.
Lepirudin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce lepirudin.
Lepirudin proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK) s katerim lahko tvori lepirudin.
See the Package Leaflet for the full list of restrictions.
Za celoten seznam omejitev glejte navodilo za uporabo.
It is used in adults with heparin-induced thrombocytopenia (HIT, a type of allergy to heparin that causes a lack of platelets in the blood or clots in the blood vessels) and who have thromboembolic disease (abnormal development of blood clots) that needs injected anti-clotting treatment, usually heparin.
Uporablja se pri odraslih bolnikih, ki imajo s heparinom inducirano trombocitopenijo (HIT, določeno vrsto alergije na heparin, ki povzroča pomanjkanje trombocitov v krvi ali strdke v krvnih žilah), in bolnikih s tromboembolijo (nenormalno tvorbo krvnih strdkov), ki zahteva zdravljenje proti strdkom z injiciranjem zdravila, ponavadi heparina.
As with other antithrombotic drugs, the most common side effect with Refludan (seen in more than 1 patient in 10) is bleeding.
Kot pri vseh ostalih antitrombotičnih zdravilih so najpogostejši neželeni učinek zdravila Refludan (opaženi pri več kot 1 bolniku izmed 10) krvavitve.
The doses need to be reduced in patients with kidney problems.
Pri bolnikih z ledvičnimi težavami morajo biti odmerki nižji.
Refludan should not be used in people who may be hypersensitive (allergic) to lepirudin, any other hirudin derivative, or any of the other ingredients.
Zdravila Refludan ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) lepirudin, katerikoli drugi derivat hirudina ali katero koli drugo sestavino zdravila.
Lepirudin specifically blocks a substance called thrombin, which is central for the complete process of blood clotting.
Lepirudin specifično zavira delovanje snovi, imenovane trombin, ki ima osrednjo vlogo v procesu strjevanja krvi.
Refludan is an antithrombotic medicine (a medicine that prevents the blood from clotting).
Zdravilo Refludan je antitrombotično zdravilo (zdravilo, ki preprečuje strjevanje krvi).
Why has Refludan been approved?
Zakaj je bilo zdravilo Refludan odobreno?
For the full list of all side effects reported with Refludan, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Refludan, glejte navodilo za uporabo.
Refludan is a powder that is dissolved to make up a solution for injection or infusion (drip into a vein).
Zdravilo Refludan je prašek za pripravo raztopine za injiciranje ali infundiranje (kapalno infuzijo v veno).
The full EPAR for Refludan is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Refludan je na voljo tukaj.
What is Refludan used for?
Za kaj se zdravilo Refludan uporablja?
The active substance in Refludan, lepirudin, is nearly identical to hirudin, the anti-clotting substance produced by leeches.
Zdravilna učinkovina v zdravili Refludan, lepirudin, je skoraj popolnoma enaka hirudinu, snovi, ki zavira strjevanje krvi in ki jo proizvajajo pijavke.
How is Refludan used?
Kako se zdravilo Refludan uporablja?
How has Refludan been studied?
Kako je bilo zdravilo Refludan raziskano?
What is Refludan?
Kaj je zdravilo Refludan?
The studies looked at the numbers of patients who died, had an amputation, and had new thromboembolic (clotting) complications.
prestalo amputacijo in imelo nove tromboembolične zaplete (zaplete zaradi krvnih strdkov).
Treatment with Refludan should be started by a doctor who has experience in the treatment of coagulation (clotting) disorders.
ki ima izkušnje z zdravljenjem koagulacijskih motenj (motenj strjevanja krvi).
How does Refludan work?
Kako zdravilo Refludan deluje?
Isolated limb perfusion (intra-arterial use)
Izolirana perfuzija okončine (intraarterijska uporaba)
Powder for solution for infusion
1 mg Prašek za raztopino za infundiranje
vial (glass)
viala (steklenica) 1 mg
MA (EU) number Invented name Strength Pharmaceutical form
Številka (EU) dovoljenja za promet
Allergic reactions have been reported with these medicines.
Pri teh zdravilih so poročali o alergijskih reakcijah.
Primula veris L. and/or Primula elatior (L.) Hill, flos
Primula veris L. in/ali Primula elatior (L.) Hill, flos
Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Zdravila, ki vsebujejo cvet jegliča, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
What is primula flower?
Kaj je cvet jegliča?
If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified
Če simptomi med uporabo zdravila trajajo več kot en teden ali se poslabšajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
This summary is not intended to provide practical advice on how to use medicines containing primula flower.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet jegliča.
Primula flower is the common name for the flowers of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Cvet jegliča je splošno ime za cvetove rastline Primula veris L. in/ali Primula elatior (L.) Hill.
No clinical studies have been carried out with primula flower.
Klinične študije s cvetom jegliča niso bile izvedene.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta jegliča.
The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Zaključki odbora HMPC zajemajo samo pripravke s cvetom jegliča, ki se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) cvetov ali z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
Further information on the risks associated with these primula flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo cvet jegliča, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC conclusions on the use of these primula flower medicines for coughs are based on their ‘traditional use' .
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo cvet jegliča, za zdravljenje kašlja temeljijo na njihovi „tradicionalni uporabi“.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula flower.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo cvet jegliča.
Primula flower medicines must not be used in patients who are allergic to primula flower or to other plants of the primula species.
Zdravila, ki vsebujejo cvet jegliča, se ne smejo uporabljati pri bolnikih, ki so alergični na cvet jegliča ali druge rastline iz vrst jegličev.
Herbal medicines containing these primula flower preparations are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo te pripravke s cvetom jegliča, so navadno na voljo kot zdravilni čaj, ki se popije, in v tekoči obliki za jemanje skozi usta.
How are primula flower medicines approved in the EU?
Kako so zdravila, ki vsebujejo cvet jegliča, odobrena v EU?
Further information on the HMPC assessment of primula flower medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo cvet jegliča, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Any applications for the licensing of medicines containing primula flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo cvet jegliča, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Information on the use and licensing of primula flower medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo cvet jegliča, v državah članicah EU se obrnite na pristojni nacionalni organ.
Primula flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Pripravki s cvetom jegliča so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Other information about primula flower medicines
Druge informacije o zdravilih, ki vsebujejo cvet jegliča
What evidence supports the use of primula flower medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo cvet jegliča?
In its assessment, the HMPC considered laboratory studies which showed primula flower increased production of airway secretions, making phlegm less thick and easier to expel.
V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so pokazale, da je cvet jegliča povečal izločanje sluzi v dihalih, zaradi česar je bila sluz manj gosta in jo je bilo laže izkašljati.
The HMPC concluded that, on the basis of its long-standing use, these primula flower primula flower preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo cvet jegliča, uporabljajo kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
What are the risks associated with primula flower medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo cvet jegliča?
For more information about treatment with primula flower medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo cvet jegliča, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using primula flower medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Detailed instructions on how to take primula flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
zdravil, ki vsebujejo cvet jegliča, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
The company that applied for authorisation is Teva B.V.
Podjetje, ki je zaprosilo za dovoljenje, je Teva B.V.
To support this claim, the company referred to published data and provided an expert opinion.
V podporo tej trditvi se je podjetje sklicevalo na objavljene podatke in predložilo strokovno mnenje.
It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
V 15 dneh od prejema uradnega obvestila o negativnem mnenju lahko zahteva ponovno proučitev mnenja.
Data from clinical studies also showed differences in the safety profile of the two active substances.
Podatki iz kliničnih študij so pokazali tudi razlike v varnostnem profilu učinkovin.
Furthermore, patients receiving cabazitaxel are exposed to the unchanged substance plus two active breakdown products, which are not formed when docetaxel is given.
Poleg tega so bolniki, ki prejemajo kabazitaksel, izpostavljeni nespremenjeni učinkovini in dvema aktivnima produktoma razgradnje, ki pri dajanju docetaksela ne nastajata.
Additionally, laboratory data suggest that cabazitaxel can be effective at treating cancer that is resistant to docetaxel.
Poleg tega laboratorijski podatki kažejo, da je kabazitaksel lahko učinkovit pri zdravljenju raka, ki je odporen proti docetakselu.