natgillin/translations-raw huggingface dataset:
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
- Intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih).
Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Patološke zlome je imelo manj prejemnikov 4 mg zoledronske kisline.
Zoledronic acid Actavis must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Zdravila Zoledronska kislina Actavis se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Hypocalcaemia
hipokalciemija
One vial contains 4 mg zoledronic acid (as monohydrate).
Ena viala vsebuje 4 mg zoledronske kisline (kot monohidrata).
Patients should have their serum creatinine levels assessed prior to each dose of Zoledronic acid Actavis.
Bolnikom je treba pred vsakim odmerkom zdravila Zoledronska kislina Actavis določiti koncentracijo serumskega kreatinina.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
kolku ali dimljah, bolnike, ki imajo takšne simptome, pa je treba oceniti glede nepopolnega zloma stegnenice.
Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
- Huda okvara ledvic (to zdravnik po navadi ugotovi zdravnik z določenimi specifičnimi preiskavami krvi).
- If you get any side effects , talk to your doctor, pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
Efficacy results are provided in Table 3.
Rezultate učinkovitosti prikazuje Preglednica 3.
Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Pred uporabo zdravila Zoledronska kislina Actavis je treba bolnike pregledati in tako preveriti, da so ustrezno hidrirani.
Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
- Bolečine v ustih, zobeh in/ali čeljustih, oteklost ali neceljenje ran v ustni votlini ali čeljusti, izcedek, odrevenelost ali občutek teže v čeljusti ali majanje zoba.
Skeletal morbidity rate p-value
Vrednost p Stopnja obolevnosti skeleta
Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Hipertenzija, hipotenzija, atrijska fibrilacija,
Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
Zoledronska kislina 4 mg (N=86)
Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Pri enkratnih in večkratnih 5- in 15-minutnih infundiranjih 2, 4, 8 in 16 mg zoledronske kisline pri
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
mravljinčenje ali omrtvičenost dlani in stopal, driska, zaprtje, bolečine v trebuhu, suha usta.
Warnings and precautions Talk to your doctor before you are given Zoledronic acid Actavis:
Svojemu zdravniku morate povedati preden dobite zdravilo Zoledronska kislina Actavis :
Renal function impairment
Okvara delovanja ledvic
EXP Shelf life after dilution: See leaflet.
Rok uporabnosti po razredčenju: Glejte navodilo.
Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Za zdravljenje indikacij pri osteoporozi in za zdravljenje Pagetove bolezni kosti so na voljo druga zdravila, ki kot zdravilno učinkovino vsebujejo zoledronsko kislino.
4.1 ml for 3.3 mg dose
4,4 ml za odmerek 3,5 mg 4,1 ml za odmerek 3,3 mg 3,8 ml za odmerek 3,0 mg
How often Zoledronic acid Actavis is given
Kako pogosto se daje zdravilo Zoledronska kislina Actavis
- 4.1 ml for 3.3 mg dose
- 4,4 ml za odmerek 3,5 mg - 4,1 ml za odmerek 3,3 mg - 3,8 ml za odmerek 3,0 mg
Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Neuporabljenega zdravila Zoledronska kislina Actavis se ne sme izliti v gospodinjske odplake.
To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
študijah I. faze za ugotavljanje odmerka pri bolnikih z blago do zmerno hiperkalciemijo, povzročeno s tumorjem (TIH), so bili testirani učinkoviti odmerki v razponu približno 1,2-2,5 mg. Za primerjavo učinkov 4 mg zoledronske kisline in 90 mg pamidronata so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih študij pri bolnikih s TIH.
What Zoledronic acid Actavis looks like and contents of the pack
Izgled zdravila Zoledronska kislina Actavis in vsebina pakiranja
<2D barcode carrying the unique identifier included.> <Not applicable.>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
(neželeni učinek skupine bisfosfonatov) in osteonekroza na drugih anatomskih lokacijah vključno s stegnenico in kolkom
In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
- Pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 mikromolov/l),
- Keep Zoledronic acid Actavis out of the sight and reach of children.
- Zdravilo Zoledronska kislina Actavis shranjujte nedosegljivo otrokom.
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
(vključno z utrujenostjo, mrzlico, splošnim slabim počutjem in zardevanjem)
The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Rezultati kliničnih preskušanj v preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti V prvi randomizirani, dvojno slepi, s placebom kontrolirani študiji so 4 mg zoledronske kisline primerjali s placebom za preprečevanje z okostjem povezanih dogodkov (SRE) pri bolnikih z rakom prostate.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VIALE
This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Med njenimi simptomi so bolečine v kosteh, zvišana telesna temperatura, utrujenost, artralgija, mialgija, mrzlica in artritis z otekanjem sklepov.
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Pri bolnikih, ki so se zdravili z zdravilom Zoledronska kislina Actavis, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Po začetku zdravljenja z zdravilom Zoledronska kislina Actavis je treba natančno kontrolirati standardne presnovne parametre, povezane s hiperkalciemijo, npr. serumsko koncentracijo kalcija,
Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
Zdravljenje z zdravilom Zoledronska kislina Actavis se sme znova začeti šele, ko se serumski kreatinin vrne na vrednost, ki je znotraj 10% od izhodiščne vrednosti Zdravljenje z zdravilom Zoledronska kislina Actavis je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
How much Zoledronic acid Actavis is given
Koliko zdravila Zoledronska kislina Actavis se daje
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Redki (pojavijo se lahko pri 1 od 1.000 bolnikov):
Fractures*
Zlomi*
- Weight increase.
- Povečanje telesne mase.
Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Zoledronska kislina Actavis 4 mg/5 ml sterilen koncentrat zoledronska kislina i.v.
How Zoledronic acid Actavis is used
Kako se uporablja zdravilo Zoledronska kislina Actavis
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev citrat voda za injekcije
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Actavis and treatment should be withheld if renal function has deteriorated.
Pred začetkom zdravljenja z zdravilom Zoledronska kislina Actavis je treba izmeriti vrednost kalcija v serumu in odpraviti morebitno hipokalciemijo.
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Selektivno delovanje difosfonatov na kost temelji na njihovi veliki afiniteti do mineralizirane kosti,
The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
SRE podobno učinkovito kot 90 mg pamidronata.
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Občasni (pojavijo se lahko pri 1 od 100 bolnikov):
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
O tem, ali prekinitev zdravljenja z difosfonatom zmanjša tveganje za osteonekrozo čeljustnic pri bolnikih, ki potrebujejo zobozdravstvene posege, ni podatkov.
Zoledronic acid Actavis recommended dose*
Zoledronska kislina Actavis*
Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Bolniki morajo biti pred dajanjem zdravila Zoledronska kislina Actavis in po njem dobro hidrirani.
Blood creatinine and blood urea increased, hypocalcaemia
Zvišanje kreatinina in sečnine v krvi,
Blurred vision, scleritis and orbital inflammation Uveitis
Zamegljen vid, skleritis in vnetje očnice
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
29,8%, v skupini s placebom pa 49,6% (p=0,003).
BPI mean change from baseline
Povprečna sprememba BPI od izhodišča
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zoledronsko kislino,
- Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
- Pri bolnicah, ki so dobivale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali neredno bitje srca (atrijsko fibrilacijo).
Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
- Zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
8°C in pri temperaturi 25°C po redčenju s 100 ml 0,9% m/v raztopine natrijevega klorida ali 100 ml
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
- Zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
OTHER
Uveitis
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
I, III in IV (starih od 1 do 17 let), so primerjali z intravenskim pamidronatom v eni mednarodni,
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Poročali so o razvoju aritmij in nevroloških neželenih dogodkov (vključno s konvulzijami, hipestezijo in tetanijo),
Zoledronic acid Actavis can be given to people aged 65 years and over.
Bolniki, stari 65 let ali več, lahko dobivajo zdravilo Zoledronska kislina Actavis.
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Če ste dobili več zdravila Zoledronska kislina Actavis, kot bi ga smeli Če ste dobili odmerek, večji od priporočenega, vas mora zdravnik natančno kontrolirati, ker se lahko pojavijo nepravilnosti elektrolitov v serumu (npr. nenormalna koncentracija kalcija, fosforja in magnezija) in/ali spremenjeno delovanje ledvic, vključno z odpovedjo ledvic.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
16% zmanjšanje tveganja pri prejemnikih zoledronske kisline v primerjavi s prejemniki pamidronata.
How to store Zoledronic acid Actavis
Kako se daje zdravilo Zoledronska kislina Actavis
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
O osteonekrozi čeljustnic (ONČ) so občasno poročali pri bolnikih, ki so prejemali zdravilo
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
V 3-letnem randomiziranem dvojno slepem kontroliranem preskušanju so ocenjevali učinkovitost in varnost 5 mg zoledronske kisline enkrat na leto v primerjavi s placebom pri zdravljenju postmenopavzalne osteoporoze (PMO).
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Actavis or after stopping treatment.
Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kislina Actavis pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
Respiratory, thoracic and mediastinal disorders Common:
Bolezni dihal, prsnega koša in mediastinalnega prostora
Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Navodilo za uporabo Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Ref.: EMEA/503246/2009 EMEA/H/C/1054
: EMEA/503244/2009 EMEA/H/C/1054
This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je zdravilo Clopidogrel 1A Pharma podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Clopidogrel 1A Pharma je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel 1A Pharma, veljavno po vsej Evropski uniji, odobrila družbi Acino Pharma GmbH dne 28. julija 2009.
Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel 1A Pharma se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Zdravilo Clopidogrel 1A Pharma se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel 1A Pharma primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Because Clopidogrel 1A Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Clopidogrel 1A Pharma generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel 1A Pharma can be given to the following groups of patients:
Zdravilo Clopidogrel 1A Pharma se lahko daje naslednjim skupinam bolnikov:
Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel 1A Pharma se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Pri akutnem koronarnem sindromu se zdravilo Clopidogrel 1A Pharma uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih
Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Clopidogrel 1A Pharma generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Clopidogrel 1A Pharma clopidogrel EPAR summary for the public
Clopidogrel 1A Pharma klopidogrel Povzetek EPAR za javnost
Other information about Clopidogrel 1A Pharma:
Druge informacije o zdravilu Clopidogrel 1A Pharma:
Clopidogrel 1A Pharma can be started between seven days and six months after
Zdravilo Clopidogrel 1A Pharma se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Clopidogrel 1A Pharma odobri dovoljenje za promet.
What are the benefit and risk of Clopidogrel 1A Pharma?
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel 1A Pharma?
Clopidogrel 1A Pharma is a ‘generic medicine'.
Clopidogrel 1A Pharma je „generično zdravilo“.
Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Clopidogrel 1A Pharma je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel 1A Pharma, klopidogrel, je zaviralec agregacije trombocitov.
The full EPAR for Clopidogrel 1A Pharma can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel 1A Pharma je na voljo tukaj.
Why has Clopidogrel 1A Pharma been approved?
Zakaj je bilo zdravilo Clopidogrel 1A Pharma odobreno?
How has Clopidogrel 1A Pharma been studied?
Kako je bilo zdravilo Clopidogrel 1A Pharma raziskano?
What is Clopidogrel 1A Pharma?
Kaj je zdravilo Clopidogrel 1A Pharma?
What is Clopidogrel 1A Pharma used for?
Za kaj se zdravilo Clopidogrel 1A Pharma uporablja?
How does Clopidogrel 1A Pharma work?
Kako zdravilo Clopidogrel 1A Pharma deluje?
How is Clopidogrel 1A Pharma used?
Kako se zdravilo Clopidogrel 1A Pharma uporablja?
Results are heterogeneous and inconsistent.
Rezultati so heterogeni in nedosledni.
In six of the evaluable studies with population under 100 patients there were similar findings.
V šestih ocenljivih študijah s populacijo, manjšo od 100 bolnikov, so bile ugotovitve podobne.
It produces a decrease in blood pressure and an increase in peripheral blood flow.
Povzroča znižanje krvnega tlaka in poveča periferni krvni pretok.
In Europe, dihydroergocristine is also available in combination with etofyllinum.
V Evropi je dihidroergokristin na voljo tudi v kombinaciji z etofilinom.
Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergokristin (glejte Prilogo I)
The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies.
Odbor CHMP je menil, da na podlagi teh študij ni mogoče sklepati o učinkovitosti.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergokristina.
There were 3 placebo controlled studies with a study population of 200-240 patients.
Opravljene so bile 3 s placebom nadzorovane študije, ki so vključile populacijo od 200 do 240 bolnikov.
Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months).
Od 6 randomiziranih, dvojno slepih, s placebom nadzorovanih študij jih 5 po mnenju odbora CHMP ni bilo ustreznih, saj opredelitev diagnoze ni bila standardizirana, med večrazsežnostno oceno ni bilo izbrano nobeno primarno merilo za učinkovitost, število bolnikov na skupino je bilo majhno (od 47 do 65), zdravljenje pa je bilo kratko (2 in 3 mesece).
• The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocristine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
• odbor meni, da so dokazi o klinično pomembni učinkovitosti dihidroergokristina v zvezi s trenutno ocenjenimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;