natgillin/translations-raw huggingface dataset:
Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter.
Zato ni mogoče izključiti drugih mehanizmov, ki povzročajo fibrozo, kar kaže na vzročno povezavo med fibrozo in agonizmom receptorjev 5-HT2A ter 5HT1B in tudi na verjetni učinek na transmitorje serotonina.
For the indication “orthostatic hypotension” the submitted studies were considered by the CHMP of poor methodological quality: they were mainly uncontrolled trials with only 1 double-blind study but with low number of patients.
Odbor CHMP je menil, da je kakovost metodologije pri študijah, predloženih za indikacijo „ortostatska hipotenzija“, slaba: večinoma so bila to nenadzorovana preskušanja s samo 1 dvojno slepo študijo, ki pa je vključevala majhno število bolnikov.
The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Povezava med fibrozo in aktivacijo serotoninergičnih receptorjev, predvsem receptorjev 5-HT2B, ki jo povzročajo derivati ergot-alkaloidov, je obširno opisana v literaturi.
In addition, given that fibrosis is a serious life threatening reaction, observed after long duration of treatment with dihydroergotamine (a drug used in indications requiring long duration of treatment) this has an impact on the benefit-risk balance of the products.
Ker je fibroza resna, smrtno nevarna reakcija, ki se pojavi po dolgem času od zdravljenja z dihidroergotaminom (zdravilom, ki se uporablja z indikacijami, ki zahtevajo dolgotrajno zdravljenje), ima to vpliv na razmerje med tveganji in koristmi teh zdravil.
A total of 363 subjects were treated with dihydroergotamine or placebo during 4 months after 1 month of placebo “run-in”.
Skupno 363 preskušancev so po enomesečnem uvajalnem obdobju s placebom 4 mesece zdravili z dihidroergotaminom ali placebom.
However, given the number of cases reported with dihydroergotamine, with symptoms related to ergotism (despite probable lacking cases) even when dihydroergotamine is used as recommended (no overdosage, no contraindicated drug, and short time treatment), the high pharmacological plausibility and a suggestive chronology in most of the cases, it is considered that patients are exposed to a high risk of ergotism when treated with dihydroergotamine.
Vendar glede na število primerov, o katerih so poročali pri dihidroergotaminu, s simptomi, povezanimi z ergotizmom (kljub verjetno preredko poročanim primerom), tudi če se je dihidroergotamin uporabljal, kot je priporočeno (brez prevelikega odmerjanja, brez kontraindiciranega zdravila in s kratkotrajnim zdravljenjem), veliko farmakološko verjetnost in sugestivni časovni potek v večini primerov menijo, da so bolniki pri zdravljenju z dihidroergotaminom izpostavljeni velikemu tveganju ergotizma.
Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis.
Znano je, da lahko derivati ergot-alkaloidov povzročijo fibrozo, predvsem fibrozo srčne zaklopke.
The CHMP noted the position of several MAHs that there is not enough evidence to support an indication of oral dihydroergotamine in the symptomatic treatment of veno-lymphatic insufficiency and was of the opinion that no scientific conclusion can be drawn regarding the efficacy of dihydroergotamine based on these study results.
Odbor CHMP je upošteval stališče več imetnikov dovoljenj za promet z zdravilom, da ni zadostnih dokazov, ki bi podprli indikacijo peroralnega dihidroergotamina pri simptomatskem zdravljenju veno-limfatične insuficience, in je menil, da na podlagi teh rezultatov študij ni mogoče sklepati o znanstvenih zaključkih glede učinkovitosti dihidroergotamina.
Almost all cases were serious (93% of the cases where seriousness was reported) and treatment with dihydroergotamine was discontinued in 91% of the cases (for which information is available) and in 57% of these cases, the outcome has been reported as improved or recovered.
Zdravljenje z dihidroergotaminom so prekinili pri 91 % primerov (za katere so na voljo podatki), od katerih so pri 57 % poročali o izboljšanju ali okrevanju.
However, a total of 134 cases of ergostim or symptoms potentially related to ergotism have been reported by the MAHs.
Imetniki dovoljenj za promet z zdravilom so poročali o skupno 134 primerih ergotizma ali simptomih, morebitno povezanih z ergotizmom.
The authorised oral doses seem to have weak or null efficacy due to the low bioavailability of the drug.
Odobreni peroralni odmerki imajo šibek učinek ali ga sploh nimajo, saj je biološka uporabnost zdravila majhna.
The CHMP also stated that the study population, consisting only of drug induced orthostatic hypotension patients, is not representative to conclude on the efficacy of dihydroergotamine in the total population of orthostatic hypotension patients.
Odbor CHMP je prav tako navedel, da populacija v študiji, ki vključuje samo bolnike z ortostatsko hipotenzijo, ki so jo povzročila zdravila, ni dovolj reprezentativna, da bi lahko sklepali na učinkovitost dihidroergotamina v celotni populaciji bolnikov z ortostatsko hipotenzijo.
• Acute retinopathies of vascular origin
• akutna retinopatija žilnega izvora;
In the preventive treatment of migraine, dihydroergotamine is administered orally for long term.
Pri preprečevalnem zdravljenju migrene se dihidroergotamin daje peroralno in dolgotrajno.
The efficacy of dihydroergotamine in the prevention of migraine in this study has not been demonstrated taking into account that there was no statistically significant difference between dihydroergotamine and placebo with respect to the reduction of the frequency of migraine attacks (the primary efficacy criterion) in the overall population.
Učinkovitost dihidroergotamina pri preprečevanju migrene se v tej študiji ni pokazala, saj v splošni populaciji ni bilo statistično pomembne razlike med dihidroergotaminom in placebom glede zmanjšanja pogostnosti migrenskih napadov (primarno merilo za učinkovitost).
With regard to the risk of ergotism, the review of cases provided by the MAHs was not exhaustive and the methodology used to retrieve cases of ergotism was unclear for most of the MAHs.
Pri tveganju za ergotizem pregled primerov, ki so jih priložili imetniki dovoljenj za promet, ni bil izčrpen, metodologija, uporabljena za ugotavljanje primerov ergotizma, pa je bila večini imetnikov dovoljenj za promet z zdravilom nejasna.
In addition, a scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the treatment of orthostatic hypotension.
Znanstveno svetovalna skupina je na pobudo odbora CHMP decembra 2012 sklicala sestanek, na katerem so strokovnjaki na podlagi svojih kliničnih izkušenj razpravljali o tem, ali ima ta učinkovina vlogo pri zdravljenju ortostatske hipotenzije.
In addition, a scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the prophylaxis of migraine headache.
Znanstveno svetovalna skupina je na pobudo odbora CHMP decembra 2012 sklicala sestanek, na katerem so strokovnjaki na podlagi svojih kliničnih izkušenj razpravljali o tem, ali ima ta učinkovina vlogo pri preprečevanju migrenskega glavobola.
In the only recent, large study with appropriate design (PROMISE study) there was no statistically significant difference between dihydroergotamine and placebo with respect to the reduction of the frequency of migraine attacks (the primary efficacy criterion) in the overall population.
V edini nedavni veliki študiji z ustreznim načrtom (študiji PROMISE) ni bilo statistično pomembne razlike med dihidroergotaminom in placebom pri zmanjševanju pogostnosti migrenskih napadov (primerno merilo za učinkovitost) v splošni populaciji.
The Committee concluded that the benefit-risk balance of dihydroergotamine containing products for oral use is not favourable pursuant to Article 116 of Directive 2001/83/EC for prophylaxis of migraine, for orthostatic hypotension and for symptomatic treatment of veno-lymphatic insufficiency.
Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih za peroralno uporabo, ki vsebujejo dihidroergotamin, ni ugodno za preprečevanje migrene, ortostatske hipotenzije in simptomatsko zdravljenje veno-limfatične insuficience.
• Orthostatic hypotension
• ortostatska hipotenzija;
Although significant reduction in venous capacity, capillary flow of erythrocytes and peak flow of reactive hyperemia were demonstrated, due to a very small study group, the uncontrolled design and other methodological limitations, the CHMP could not draw any conclusion on the efficacy of dihydroergotamine.
Čeprav so pokazali pomembno zmanjšanje venske kapacitete, kapilarnega pretoka eritrocitov in največjega pretoka pri reaktivni hiperemiji, odbor CHMP ni mogel podati zaključkov glede učinkovitosti dihidroergotamina zaradi zelo majhne skupine v študiji, nenadzorovanega načrta in drugih metodoloških omejitev.
In conclusion, the studies provided by the MAHs were not carried out with up-to-date methodology.
Študije, ki so jih predložili imetniki dovoljenj za promet z zdravilom, niso vključevale sodobne metodologije.
• Ancillary treatment of Raynaud's syndrome
• dodatno zdravljenje Raynaudovega sindroma.
− Symptomatic treatment of veno-lymphatic insufficiency.
• simptomatsko zdravljene veno-limfatične insuficience.
No significant improvement over placebo was observed in the subset of patients with unaffected QOL.
Pri podskupini bolnikov z normalno kakovostjo življenja niso opazili nobenega pomembnega izboljšanja v primerjavi s placebom.
• The variation to the terms of the marketing authorisation for dihydroergotamine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
• spremembo pogojev dovoljenja za promet z zdravili iz Priloge I, ki vsebujejo dihidroergotamin, tako da se iz informacij o zdravilu izbrišejo spodaj navedene indikacije (natančno besedilo za indikacijo se lahko med zdravili in državami razlikuje) ter druge zadevne reference na te indikacije, kadar so kot del dovoljenja za promet z zdravilom odobrene druge terapevtske indikacije: preprečevanje migrenskega glavobola; ortostatska hipotenzija; simptomatsko zdravljenje veno-limfatične insuficience.
• Adverse drug reactions with a substance marketed for a long time are generally less reported
• se o neželenih učinkih pri učinkovini, ki je v prometu dolgo časa, navadno poroča redkeje;
However the CHMP noted that beta blockers are not widely recognised as a cause of fibrosis.
Vendar je odbor CHMP izpostavil, da ni splošno priznano, da zaviralci betaadrenergičnih receptorjev povzročajo fibrozo.
The CHMP also noted the position of several MAHs that there is not enough evidence to support an indication of oral dihydroergotamine in orthostatic hypotension.
Odbor CHMP je prav tako upošteval stališče mnogih imetnikov dovoljenj za promet z zdravilom, da ni dovolj dokazov, ki bi podprli indikacijo peroralnega dihidroergotamina pri ortostatski hipotenziji.
For the percentage of responders (61.1% in the dihydroergotamine group vs. 55.9% in the placebo group) the difference was not statistically significant.
Razlika v deležu bolnikov z odzivom ni bila statistično pomembna (61,1 % v skupini z dihidroergotaminom v primerjavi s 55,9 % v skupini s placebom).
Grounds for the suspension/variation to the terms of the marketing authorisations
Razlogi za spremembo pogojev dovoljenj za promet z zdravilom ali njihov začasni umik
To conclude, given the cases reported for a reaction difficult to diagnose early (delayed symptoms) and probably under reported, the use of the drug at an approved dosage, added to a plausible pharmacological profile, dihydroergotamine is considered to be strongly associated with a risk of fibrotic reactions.
Glede na to, da so poleg verjetnega farmakološkega profila poročani primeri povezani z reakcijo, ki je težavna za diagnosticiranje (zapozneli simptomi) in verjetno preredko poročana, lahko sklenemo, da je uporaba dihidroergotamina z odobrenim odmerkom povezana s tveganjem fibrotičnih reakcij.
The open label study (Wenzel-E et al, 1989) that became available after the granting of the initial marketing authorisation discusses the use of dihydroergotamine in venous insufficiency.
Uporabo dihidroergotamina pri venski insuficienci je obravnavala odprta študija (Wenzel-E in sodelavci 1989), ki je bila objavljena po odobritvi prvotnega dovoljenja za promet z zdravilom.
There is little evidence from double-blind, placebo-controlled clinical trials and no uniform picture of the efficacy of oral ergotamine compared to placebo or other substances in the prevention of migraine emerges from these studies since studies reported both positive and negative results.
Rezultati teh študij glede učinkovitosti peroralnega dihidroergotamina v primerjavi s placebom ali drugimi učinkovinami pri preprečevanju migrene niso bili dosledni, saj so poročali o pozitivnih in negativnih rezultatih.
− Prophylaxis of migraine headache.
• preprečevanje migrenskega glavobola.
• Prophylaxis of migraine headache
• preprečevanje migrenskega glavobola;
How to report side effects
Kako poročati o stranskih učinkih
What does the black triangle mean?
Kaj pomeni črn trikotnik?
For more information, visit www.ema.europa.eu
Za več informacij obiščite spletno stran www.ema.europa.eu
It does not mean that the medicine is unsafe.
To ne pomeni, da zdravilo ni varno.
Why are medicines monitored after they are approved?
Zakaj se zdravila spremljajo po tem, ko so odobrena za uporabo?
The European Union (EU) has introduced a new way of identifying medicines that are being monitored particularly closely.
Evropska unija (EU) je uvedla nov način označevanja zdravil, ki se posebej pozorno spremljajo.
This ensures that patients can access the treatments they need without being exposed to unacceptable side effects.
S tem se zagotovi dostop bolnikov do potrebnih zdravljenj, ne da bi bili izpostavljeni nesprejemljivim stranskim učinkom.
They may have other diseases and they may be taking other medicines.
Bolniki bodo morda imeli druge bolezni in bodo jemali druga zdravila.
In a real-life setting, a larger and more diverse group of patients will use the medicine.
V resničnem življenju bo zdravilo uporabljala večja in bolj raznolika skupina bolnikov.
European regulatory authorities decide to authorise medicines after assessing the results of laboratory tests and clinical trials.
Evropski regulativni organi odobrijo zdravila za promet, potem ko ocenijo rezultate laboratorijskih preiskav in kliničnih preskušanj.
Clinical trials usually involve a limited number of patients for a defined time period in controlled conditions.
V klinična preskušanja je običajno vključeno omejeno število bolnikov za določeno časovno obdobje v nadzorovanih pogojih.
Examples of medicines under additional monitoring include new medicines authorised since the start of 2011 and medicines for which regulators require more studies to be carried out, e.g. on long-term use or on rare side effects seen in clinical trials.
Med primere zdravil, za katere se zahteva dodatno spremljanje, spadajo nova zdravila, odobrena od začetka leta 2011, in zdravila, za katera regulativni organi zahtevajo izvedbo več študij, npr. o dolgotrajni uporabi ali redkih neželenih učinkih, o katerih so poročali v kliničnih preskušanjih.
This is generally because there is less information available about them compared with other medicines, for example because they are new on the market.
Razlog za to je običajno, da je o teh zdravilih manj razpoložljivih podatkov kot o drugih, na primer, ker je zdravilo novo na trgu.
It is therefore vital that the safety of all medicines continues to be monitored while they are on the market.
Zato je bistvenega pomena, da se varnost vseh zdravil na trgu nadalje spremlja.
You can report side effects to your doctor, pharmacist or nurse.
O stranskih učinkih lahko poročate svojemu zdravniku, farmacevtu ali medicinski sestri.
You should report any suspected side effects with a medicine you are taking, particularly if it displays the black triangle.
Poročati morate o vseh domnevnih stranskih učinkih zdravila, ki ga jemljete, zlasti kadar je zdravilo označeno s črnim trikotnikom.
Only medicines whose benefits have been shown to be greater than their risks can be marketed.
Tržijo se lahko samo zdravila, katerih koristi so dokazano večje od z njimi povezanih tveganj.
However, medicines with the black triangle are being monitored even more closely than others.
Vendar pa se tista, označena s črnim trikotnikom, spremljajo natančneje kot druga.
Some less common side effects may only be apparent when a medicine has been used for a long time by a large number of people.
Nekateri manj pogosti stranski učinki se lahko pokažejo šele, ko večje število ljudi zdravilo uporablja dalj časa.
By reporting side effects, you can help medicines regulators assess whether the benefits of a medicine remain greater than its risks.
S poročanjem o stranskih učinkih organom za regulacijo zdravil pomagate pri oceni, ali so koristi zdravila še naprej večje od z njim povezanih tveganj.
You can also report side effects directly to your national medicines regulator, using the reporting system in your country.
O stranskih učinkih lahko poročate tudi neposredno svojemu nacionalnemu organu za regulacijo zdravil prek sistema poročanja v vaši državi.
Information on how to do this can be found in the package leaflet of your medicine or on your national medicines regulator's website.
Informacije o tem lahko najdete v navodilu za uporabo vašega zdravila ali na spletni strani vašega nacionalnega organa za regulacijo zdravil.
These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads:
Ta zdravila imajo v navodilu za uporabo črn navzdol obrnjen trikotnik in kratek stavek z naslednjim opisom:
Visit your national medicines regulator at: www.mhra.gov.uk (United Kingdom) www.imb.ie (Ireland) www.medicinesauthority.gov.mt (Malta)
www.jazmp.si
All medicines are carefully monitored after they are placed on the EU market.
„Za to zdravilo se izvaja dodatno spremljanje varnosti.″ Vsa zdravila se po dajanju na trg EU pozorno spremljajo.
EU Number
EU Število
Pharmaceutical Form Route of Administration Packaging
Farmacevtska oblika
Repeat every 24 hours.
Ponavljajte na vsakih 24 ur.
Use immediately.
Uporabite nemudoma.
It is not known whether they respond differently from younger subjects.
Ni znano, ali se odzivajo drugače kot mlajše osebe.
If not coinciding with week 26 visit.
Če se ne ujema s 26. tednom.
The contents of the pack are:
Vsebnosti pakiranja je:
ATC code: B02BD04.
Oznaka ATC: B02BD04.
Your doctor may need to treat you promptly for these reactions.
Zdravnik vas bo morda moral nemudoma zdraviti zaradi teh reakcij.
Your doctor may need to treat you promptly for these reactions (see section 2 ‘Warnings and precautions').
Zdravnik vas bo morda moral nemudoma zdraviti zaradi teh reakcij (glejte poglavje 2 „Opozorila in previdnostni ukrepi“).
Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30°C.
Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi do 30 °C.
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je treba začeti s standardnimi medicinskimi postopki za šok.
Date of first authorisation: 19 December 2014 Date of latest renewal: DD month YYYY
Datum prve odobritve: 19. december 2014 Datum zadnjega podaljšanja: DD. mesec LLLL
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Pričakuje se, da so pogostnost, vrsta in resnost neželenih reakcij pri otrocih enake kot pri odraslih.
Side effects with unknown frequency (frequency cannot be estimated from the available data) - allergic reactions (hypersensitivity).
Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - alergijske reakcije (preobčutljivost).
Pack size of 1.
Velikost pakiranja po 1.
The product dissolves rapidly (within 2 minutes).
Prašek se hitro raztaplja (ponavadi prej kot v 2 minutah).
Frequency of doses (hours)/Duration of therapy (days)
Pogostnost odmerkov (ure)/trajanje zdravljenja (dnevi)
The osmolality is greater than 240 m osmol/kg.
Osmolalnost je večja od 240 m osmol/kg.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates and published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
For intravenous use, single use only.
Za intravensko uporabo, samo za enkratno uporabo.
Haemophilia B very rarely occurs in women.
Hemofilija B je pri ženskah zelo redka.
Be sure that RIXUBIS is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Prepričajte se, da se je prašek RIXUBIS popolnoma raztopil, sicer vsa rekonstituirana raztopina ne bo prešla skozi filter v pripomočku.
This is of importance particularly when changing the laboratory and/or reagents used in the assay.
To je zlasti pomembno pri menjavi laboratorija in/ali reagentov za test.
One vial contains 19 mg sodium.
Ena viala vsebuje 19 g natrija.
Frequencies have been evaluated according to the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnost je bila ocenjena z naslednjimi dogovorjenimi izrazi: zelo pogosti (1/10), pogosti (1/100 do < 1/10), občasni (1/1000 do <1/100), redki (1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
6.5 Nature and contents of container and special equipment for use
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo
Posology is the same in adults and paediatric population from 12 to 17.
Odmerjanje je enako pri odraslih in pediatrični populaciji v starosti od 12 do 17 let.
Do not use RIXUBIS - if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins
Ne uporabljajte zdravila RIXUBIS - če ste alergični na nonakog gama ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če ste alergični na proteine hrčka.
A-2304 Orth an der Donau Austria
A-2304 Orth an der Donau Avstrija
Therefore if you are known to have such a mutation, your doctor will monitor you more closely for signs of an allergic reaction.
Če imate dokazano mutacijo, vas bo zdravnik natančneje spremljal za pojav znakov alergijske reakcije.
Tell your doctor if you are using or have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katero koli drugo zdravilo.
Paediatric population (previously treated patients younger than 12 years)
Pediatrična populacija (predhodno zdravljeni bolniki, mlajši od 12 let)
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni 'brez natrija'.