natgillin/translations-raw huggingface dataset:
The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; whilst the low dose group showed little difference from placebo (difference of 1.6 mmHg).
V skupinah, ki sta prejemali sildenafil v srednjem in velikem odmerku, so ugotovili spremembe pri povprečnem arterijskem tlaku v pljučih glede na izhodiščno vrednost v primerjavi s placebom, in sicer v obsegu -3,5 mm Hg (95 % IZ: -8,9, 1,9) oziroma -7,3 mm Hg (95 % IZ: -12,4, -2,1); medtem ko so pri skupini, ki je prejemala majhen odmerek, ugotovili le majhno spremembo v primerjavi s placebom (razlika v obsegu 1,6 mm Hg).
Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
da je pri bolnikih s pljučno arterijsko hipertenzijo očistek sildenafila manjši in/ali njegova peroralna biološka uporabnost večja kot pri zdravih prostovoljcih.
- have a problem with the pumping chambers of your heart - have high blood pressure in the blood vessels in the lungs.
- imate zvišan krvni tlak v krvnih žilah v pljučih.
Placebo corrected increases in 6MWD were 45 metres (p <0.0001), 46 metres (p <0.0001) and 50 metres (p <0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Za placebo korigirano povečanje 6MWD je bilo za 20 mg sildenafila trikrat na dan 45 metrov (p < 0,0001), za 40 mg trikrat na dan 46 metrov (p < 0,0001) in za 80 mg trikrat na dan 50 metrov (p < 0,0001).
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min).
Pri bolnikih z okvaro ledvic - tudi pri tistih s hudo okvaro (očistek kreatinina < 30 ml/min) - na začetku zdravljenja odmerka ni treba prilagoditi.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Sočasna uporaba zaviralca proteaze HIV sakvinavirja, ki zavira CYP3A4, v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 140 % povečanje Cmax sildenafila in 210 % povečanje AUC sildenafila.
Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.
Pogosto opisani neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so občutek siljenja na bruhanje, povečane erekcije, pljučnica in izcedek iz nosu.
Dose related improvements were observed with pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP).
Pri indeksu žilnega upora v pljučih (PVRI - pulmonary vascular resistance index) in pri povprečnem arterijskem tlaku v pljučih (mPAP - mean pulmonary arterial pressure) so opažali z odmerkom povezana izboljšanja.
Prolonged erections and priapism have been reported with sildenafil in post-marketing experience.
V obdobju trženja so pri sildenafilu poročali o podaljšanih erekcijah in priapizmu.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Poleg tega so pri preiskovancih s cirozo ugotovili pomembno večji AUC (za 154 %) in Cmax (za 87 %) N-dezmetilnega presnovka kot pri preiskovancih z normalnim delovanjem jeter.
A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions.
Pri 278 bolnikih s primarno pljučno arterijsko hipertenzijo (PAH), PAH povezano z boleznimi vezivnega tkiva in PAH po kirurški popravi prirojenih srčnih hib so izvedli randomizirano, dvojno slepo, s placebom nadzorovano študijo.
Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Pri nekaterih preiskovancih so s Farnsworth-Munsellovim testom s 100 barvnimi odtenki 1 uro po 100 mg odmerku ugotovili blage in prehodne spremembe razločevanja barv (modra/zelena); 2 uri po odmerku ta učinek ni bil več opazen.
Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals (see section 4.5).
Sildenafil je treba previdno uporabljati pri bolnikih, ki jemljejo antagonist receptorjev alfa, kajti takšna sočasna uporaba lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Sildenafil se po peroralni in intravenski uporabi izloči v obliki presnovkov, pretežno v blatu (približno 80 % peroralnega odmerka) in v manjši meri v urinu (približno 13 % peroralnega odmerka).
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil (20 mg three times a day) and placebo (13.62 m (95% CI: -3.89 to 31.12) and 14.08 m (95% CI: -1.78 to 29.95), respectively).
Rezultati kažejo, da pri sildenafilu (20 mg trikrat na dan) (13,62 m; 95 % IZ: -3,89 do 31,12) in placebu (14,08 m; 95 % IZ: -1,78 do 29,95) ni pomembne razlike v povprečni spremembi od izhodišča pri 6MWD.
Contents of the pack and other information
5 Shranjevanje zdravila Granpidam Vsebina pakiranja in dodatne informacije
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Pri bolnikih z okvaro jeter (razred A in B po Child-Pughu) na začetku zdravljenja odmerka ni treba prilagoditi.
NAME OF THE MARKETING AUTHORISATION HOLDER Accord
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI PRETISNEM TRAKU
CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in vivo interaction study with CYP3A4 inducer bosentan.
Kaže, da induktorji CYP3A4 pri bolnikih s pljučno arterijsko hipertenzijo močno vplivajo na farmakokinetiko sildenafila.
Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
S tem se sklada ugotovitev, da sildenafil okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje
How to store Granpidam
Shranjevanje zdravila Granpidam
Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Zelo pogosto opisani neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so glavobol, zardevanje obraza, prebavne motnje, driska in bolečine v rokah ali nogah.
The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD.
Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje pri 6MWD od izhodišča do 12. tedna.
What Granpidam contains - The active substance is sildenafil.
Vsebina pakiranja in dodatne informacije informacije Kaj vsebuje zdravilo Granpidam - Zdravilna učinkovina je sildenafil.
Higher than recommended doses should not be used in paediatric patients with PAH (see sections 4.2 and 4.4).
Pri pediatričnih bolnikih s PAH se ne sme uporabljati odmerkov, večjih od priporočenih (glejte poglavji 4.2 in 4.4).
Lactose monohydrate is present in the tablet film coat.
Filmska obloga tablete vsebuje laktozo monohidrat.
The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
Razmerje med koristjo in tveganjem sildenafila ni bilo preverjeno pri bolnikih s pljučno arterijsko hipertenzijo v funkcijskem razredu I po SZO.
Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) compared to those on placebo.
Bolnikom na vseh treh odmerkih sildenafila sta se povprečni pljučni arterijski tlak in sprememba pljučne žilne upornosti statistično pomembno znižali v primerjavi z bolniki, ki so dobivali placebo.
Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Rezultati so bili po podskupinah praviloma skladni glede na etiologijo (primarna PAH in PAH,
A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥7 years old and developmentally able to perform the test. Children <7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
CPET je bilo mogoče ovrednotiti pri skupno 106 izmed 234 (45 %) preiskovancev, v tem številu pa so bili zajeti otroci, stari ≥7 let, ki so bili glede na stopnjo razvoja sposobni opraviti preskus.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Poleg tega sta se pri preiskovancih s hudo okvaro ledvic v primerjavi s preiskovanci z normalnim delovanjem ledvic pomembno povečali AUC (za 200 %) in Cmax (za 79 %) N
Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mm Hg (p = 0.01) and -5.1 mm Hg (p <0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Za placebo korigiran učinek zdravljenja na povprečni pljučni arterijski tlak je bil za 20 mg sildenafila trikrat na dan -2,7 mmHg (p = 0,04), za 40 mg trikrat na dan -3,0 mmHg (p = 0,01) in za 80 mg trikrat na dan -5,1 mmHg (p < 0,0001).
Prolonged and sometimes painful erections have been reported in men after taking sildenafil.
Pri moških so po jemanju sildenafila poročali o podaljšanih erekcijah, ki so bile včasih boleče.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
V treh specifičnih študijah interakcij med zdravili so bolnikom z benigno hiperplazijo prostate (BPH), stabiliziranim na zdravljenju z doksazosinom, dali antagonist receptorjev alfa doksazosin (4 mg ali
In pups of rats which were pre- and postnatally treated with 60 mg/kg sildenafil, a decreased litter size, a lower pup weight on day 1 and a decreased 4-day survival were seen at exposures which were approximately fifty times the expected human exposure at 20 mg three times a day.
Pri izpostavljenosti, ki je približno petdesetkrat presegala pričakovano izpostavljenost ob odmerku 20 mg trikrat na dan pri človeku, so pri mladičih podgan, tretiranih pred skotitvijo in po njej s 60 mg sildenafila/kg, ugotovili zmanjšanje velikosti legla, manjšo telesno maso mladičev 1. dan in manjše 4-dnevno preživetje.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Ena filmsko obložena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
You should not take more medicine than your doctor tells you to.
Če ste vzeli večji odmerek zdravila Granpidam, kot bi smeli Ne vzemite več zdravila, kot vam je naročil zdravnik.
A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Le če bolnik zdravljenja ne prenaša dobro, je treba po natančni oceni koristi in tveganj razmisliti o zmanjšanju odmerka na 20 mg dvakrat na dan.
You should be aware of how you react to the medicine before you drive or use machines.
Zdravilo Granpidam lahko povzroči omotico in vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na to zdravilo.
After oral three times a day dosing of sildenafil, AUC and Cmax increase in proportion with dose over the dose range of 20-40 mg. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed.
Po peroralni uporabi sildenafila trikrat na dan se AUC in Cmax v priporočenem razponu odmerkov (od 20 do 40 mg) večata sorazmerno z odmerkom.
The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance.
Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6-minutnim testom hoje, od izhodišča do 16. tedna.
The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance (6MWD).
Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6-minutnim testom hoje (6MWD - 6 minute walk distance), od začetka študije do 12. tedna.
- if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
- če imate erekcijo, ki neprekinjeno traja več kot 4 ure.
NAME OF THE MEDICINAL PRODUCT Granpidam 20 mg film-coated tablets
Granpidam 20 mg filmsko obložene tablete
A greater percentage of patients on each of the sildenafil doses (i.e. 28%, 36% and 42% of subjects who received sildenafil 20 mg, 40 mg and 80 mg TID doses, respectively) showed an improvement by at least one WHO functional class at week 12 compared to placebo (7%).
Po 12 tednih je v primerjavi s placebom (7 %) v vseh skupinah s sildenafilom večji odstotek bolnikov kazal izboljšanje vsaj enega funkcijskega razreda po SZO (28 % za bolnike, ki so prejemali 20 mg trikrat na dan; 36 % za bolnike, ki so prejemali 40 mg trikrat na dan in 42 % za bolnike, ki so prejemali 80 mg trikrat na dan).
Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID,
Za placebo korigiran učinek zdravljenja na pljučno žilno upornost je bil za 20 mg sildenafila trikrat na dan -178 din.s/cm5 (p = 0,0051), za 40 mg trikrat na dan
Non-arteritic anterior ischaemic optic neuropathy (NAION)*, Retinal vascular occlusion*, Visual field defect*
Žilne bolezni zmanjšanje ostrine vida, diplopija, nenormalni občutki v očesu nearteritična anteriorna ishemična optična nevropatija (NAION)*, zapora mrežnične vene*, izpad vidnega polja*
If you experience any of the following side effects you should stop taking Granpidam and contact a doctor immediately (see also section 2):
Če se vam pojavi kateri od naslednjih neželenih učinkov, nemudoma prenehajte z jemanjem zdravila Granpidam in obvestite zdravnika (glejte tudi poglavje 2): - če doživite nenadno poslabšanje ali izgubo vida (pogostnost ni znana).
Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano in med opazovalno študijo poročali o primerih nearteritične anteriorne ishemične optične nevropatije, redke bolezni (glejte poglavje 4.8).V primeru kakršnekoli nenadne okvare vida je treba zdravljenje nemudoma prekiniti ter razmisliti o alternativnem zdravljenju (glejte poglavje 4.3).
Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano poročali o primerih okvar vida.
Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure <90/50 mmHg) at initiation.
Ker varnost sildenafila ni raziskana v naslednjih podskupinah bolnikov, je uporaba sildenafila pri leteh kontraindicirana: - s hudo okvaro jeter, - z anamnezo o nedavni možganski kapi ali miokardnem infarktu, - s hudo hipotenzijo (krvni tlak < 90/50 mmHg) ob uvedbi.
Hepatic impairment
dezmetilnega presnovka.
Higher than recommended doses should not be used in paediatric patients with PAH (see also sections 4.4 and 5.1).
Pri pediatričnih bolnikih s PAH se ne sme uporabljati odmerkov, večjih od priporočenih (glejte tudi poglavji 4.4 in
In volunteers with severe renal impairment (creatinine clearance <30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Zaradi tega se je v primerjavi s prostovoljci brez okvare ledvic enake starosti AUC povečala za 100 % in Cmax za 88 %.
OTHER
Accord
Tablet core:
Laboratori Fundació DAU
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
in III. funkcijskem razredu po razvrstitvi Svetovne zdravstvene organizacije (SZO) za izboljšanje sposobnosti za telesno obremenitev.
Musculoskeletal and connective tissue disorders
Antagonisti adrenergičnih receptorjev alfa
Tabulated list of adverse reactions
Preglednica neželenih učinkov
Not known sudden hearing loss
Neželeni učinek neznana izpuščaj
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Podatkov o sildenafilu pri bolnikih s pljučno arterijsko hipertenzijo, povezano s pljučno venookluzivno boleznijo, ni. So pa pri uporabi pri takšnih bolnikih poročali o primerih smrtno nevarnega pljučnega edema ob uporabi vazodilatatorjev (predvsem prostaciklina).
sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
8 mg) sočasno s sildenafilom (25 mg, 50 mg oz. 100 mg).
Invented name Strength Pharmaceutical Form Route of administration Packaging
Številka EU Izmišljeno ime Jakost
(PAOD Stage II)
(PAOD stadij II);
(excluding Alzheimer's disease and other dementia)
(izključujoč Alzheimerjevo bolezen in druge oblike demence);
Néphrologie Vol. 24 n° 4 2003, pp. 173-180).
Néphrologie Vol. 24 n° 4 2003, str. 173-180).
Available data is in fact indicative of such causal relationship.
Razpoložljivi podatki pravzaprav kažejo na tako vzročno povezavo.
Clinical safety
Klinična varnost
The relevance of clinical endpoints is questionable.
Pomembnost kliničnih opazovanih dogodkov je vprašljiva.
Although some of the proposed measures could help the early identification of patients with fibrosis, it may be too late as these reactions are sometimes irreversible.
Čeprav bi lahko nekateri predlagani ukrepi pomagali pri zgodnjem odkrivanju bolnikov s fibrozo, bi bilo to lahko prepozno, saj so te reakcije včasih ireverzibilne.
Overall summary of the scientific evaluation of dihydroergotamine containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergotamin (glejte Prilogo I)
Therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
zato odbor CHMP skladno s členom 116 Direktive 2001/83/ES priporoča:
The number of patients included was small and the duration of treatment was too short.
Število vključenih bolnikov je bilo majhno, trajanje zdravljenja pa prekratko.
Some of them assessed the injection route or doses higher than recommended (up to 42mg daily, instead of 10mg daily).
Nekatere od njih so ocenjevale injiciranje ali odmerek, večji od priporočenih (do 42 mg na dan namesto 10 mg na dan).
Efficacy was assessed by comparing absolute blood pressure measurements after treatment rather than comparing the differences between supine and standing position which was not considered acceptable.
Učinkovitost so ocenili s primerjavo meritev absolutnega krvnega tlaka po zdravljenju in ne s primerjanjem razlike med ležečim ter stoječim položajem, kar ni bilo sprejemljivo.
It has long been used in the treatment of migraine on the grounds of its vasoconstrictor activity, which is milder than that of ergotamine.
Že dolgo se uporablja za zdravljenje migrene zaradi svoje vazokonstriktorne dejavnosti, ki je blažja kot pri ergotaminu.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergotamine.
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergotamina.
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and oral dihydroergotamine cannot be excluded.
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in peroralnim dihidroergotaminom ni mogoče izključiti.
Patient population was heterogeneous, or patients with hypotension induced by treatment with psychotropic drugs.
Populacija bolnikov je bila heterogena ali pa so imeli bolniki hipotenzijo, ki jo je povzročilo zdravljenje s psihotropnimi zdravili.
Therefore, the group was of the opinion that based on the available evidence there is no need for this substance as there is no clear subset of patients that would benefit from it.
Skupina je zato menila, da glede na razpoložljive dokaze ni potrebe po tej učinkovini, saj ni nobene jasne podskupine bolnikov, ki bi jim koristila.
• Fibrosis is mentioned in several current European Summaries of Product Characteristics (SmPCs) and expected reactions are often under-reported
• je fibroza omenjena v mnogih trenutnih evropskih povzetkih glavnih značilnosti zdravila, pričakovane reakcije pa so pogosto preredko poročane;
On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Francija je 18. januarja 2012 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za naslednja zdravila, ki vsebujejo derivate ergot-alkaloidov: dihidroergokriptin/kofein, dihidroergokristin, dihidroergotamin, dihidroergotoksin in nicergolin.
The number of patients included was small and the duration of treatment was too short and the clinical efficacy parameters used are not in line with the European Guidelines on clinical investigation of medicinal products for the treatment of migraine.
Število vključenih bolnikov je bilo majhno, trajanje zdravljenja prekratko, uporabljeni parametri za klinično učinkovitost pa niso bili skladni z evropskimi smernicami za klinično raziskovanje zdravil za zdravljenje migrene.
The design of this study was considered acceptable by the CHMP (i.e. controlled, randomised, double-blind) but the size of the study was considered small (n=58).
Odbor CHMP je menil, da je načrt te študije sprejemljiv (tj. nadzorovana, randomizirana, dvojno slepa), vendar pa je menil, da je bila velikost študije majhna (n = 58).
In the reported cases, dihydroergotamine is mostly indicated for migraine or headache (30 patients) and used with the recommended daily dosage.
Pri poročanih primerih je dihidroergotamin večinoma indiciran za migreno ali glavobol (30 bolnikov) in se je uporabljal v priporočenem dnevnem odmerku.
However, more than half of the cases of ergotism reported have been described out of a context of overdose or without the use of a contraindicated drug.
Vendar pa je bila več kot polovica poročanih primerov ergotizma opisana zunaj sklopa prevelikega odmerjanja ali brez uporabe kontraindiciranega zdravila.