FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: What Zoledronic acid Actavis looks like and contents of the pack
Slovenian: Izgled zdravila Zoledronska kislina Actavis in vsebina pakiranja
English: <2D barcode carrying the unique identifier included.> <Not applicable.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Slovenian: (neželeni učinek skupine bisfosfonatov) in osteonekroza na drugih anatomskih lokacijah vključno s stegnenico in kolkom
English: 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
Slovenian: - Pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 mikromolov/l),
English: - Keep Zoledronic acid Actavis out of the sight and reach of children.
Slovenian: - Zdravilo Zoledronska kislina Actavis shranjujte nedosegljivo otrokom.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Slovenian: (vključno z utrujenostjo, mrzlico, splošnim slabim počutjem in zardevanjem)
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VIALE
English: 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.
Slovenian: Med njenimi simptomi so bolečine v kosteh, zvišana telesna temperatura, utrujenost, artralgija, mialgija, mrzlica in artritis z otekanjem sklepov.
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Slovenian: Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje
English: 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.
Slovenian: 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.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Slovenian: Po začetku zdravljenja z zdravilom Zoledronska kislina Actavis je treba natančno kontrolirati standardne presnovne parametre, povezane s hiperkalciemijo, npr. serumsko koncentracijo kalcija,
English: Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
Slovenian: 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.
English: How much Zoledronic acid Actavis is given
Slovenian: Koliko zdravila Zoledronska kislina Actavis se daje
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Slovenian: Redki (pojavijo se lahko pri 1 od 1.000 bolnikov):
English: Fractures*
Slovenian: Zlomi*
English: - Weight increase.
Slovenian: - Povečanje telesne mase.
English: Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Slovenian: Zoledronska kislina Actavis 4 mg/5 ml sterilen koncentrat zoledronska kislina i.v.
English: How Zoledronic acid Actavis is used
Slovenian: Kako se uporablja zdravilo Zoledronska kislina Actavis
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev citrat voda za injekcije
English: 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.
Slovenian: Pred začetkom zdravljenja z zdravilom Zoledronska kislina Actavis je treba izmeriti vrednost kalcija v serumu in odpraviti morebitno hipokalciemijo.
English: 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.
Slovenian: Selektivno delovanje difosfonatov na kost temelji na njihovi veliki afiniteti do mineralizirane kosti,
English: The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Slovenian: SRE podobno učinkovito kot 90 mg pamidronata.
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Slovenian: Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Slovenian: Občasni (pojavijo se lahko pri 1 od 100 bolnikov):
English: 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.
Slovenian: O tem, ali prekinitev zdravljenja z difosfonatom zmanjša tveganje za osteonekrozo čeljustnic pri bolnikih, ki potrebujejo zobozdravstvene posege, ni podatkov.
English: Zoledronic acid Actavis recommended dose*
Slovenian: Zoledronska kislina Actavis*
English: Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Slovenian: Bolniki morajo biti pred dajanjem zdravila Zoledronska kislina Actavis in po njem dobro hidrirani.
English: Blood creatinine and blood urea increased, hypocalcaemia
Slovenian: Zvišanje kreatinina in sečnine v krvi,
English: Blurred vision, scleritis and orbital inflammation Uveitis
Slovenian: Zamegljen vid, skleritis in vnetje očnice
English: 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).
Slovenian: 29,8%, v skupini s placebom pa 49,6% (p=0,003).
English: BPI mean change from baseline
Slovenian: Povprečna sprememba BPI od izhodišča
English: 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.
Slovenian: 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,
English: - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Slovenian: - Pri bolnicah, ki so dobivale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali neredno bitje srca (atrijsko fibrilacijo).
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Slovenian: - Zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
English: 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.
Slovenian: 8°C in pri temperaturi 25°C po redčenju s 100 ml 0,9% m/v raztopine natrijevega klorida ali 100 ml
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Slovenian: - Zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
English: OTHER
Slovenian: Uveitis
English: 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.
Slovenian: I, III in IV (starih od 1 do 17 let), so primerjali z intravenskim pamidronatom v eni mednarodni,
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Slovenian: Poročali so o razvoju aritmij in nevroloških neželenih dogodkov (vključno s konvulzijami, hipestezijo in tetanijo),
English: Zoledronic acid Actavis can be given to people aged 65 years and over.
Slovenian: Bolniki, stari 65 let ali več, lahko dobivajo zdravilo Zoledronska kislina Actavis.
English: 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.
Slovenian: 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.
English: Tachycardia
Slovenian: Tahikardija
English: 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.
Slovenian: 16% zmanjšanje tveganja pri prejemnikih zoledronske kisline v primerjavi s prejemniki pamidronata.
English: How to store Zoledronic acid Actavis
Slovenian: Kako se daje zdravilo Zoledronska kislina Actavis
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Slovenian: O osteonekrozi čeljustnic (ONČ) so občasno poročali pri bolnikih, ki so prejemali zdravilo
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Slovenian: Navodilo za uporabo Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: Ref.: EMEA/503246/2009 EMEA/H/C/1054
Slovenian: : EMEA/503244/2009 EMEA/H/C/1054
English: This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel 1A Pharma podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Clopidogrel 1A Pharma je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009.
Slovenian: 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.
English: Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel 1A Pharma se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Clopidogrel 1A Pharma can be given to the following groups of patients:
Slovenian: Zdravilo Clopidogrel 1A Pharma se lahko daje naslednjim skupinam bolnikov:
English: Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel 1A Pharma se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: 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.
Slovenian: Pri akutnem koronarnem sindromu se zdravilo Clopidogrel 1A Pharma uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih
English: 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.
Slovenian: Ker je zdravilo Clopidogrel 1A Pharma generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Clopidogrel 1A Pharma clopidogrel EPAR summary for the public
Slovenian: Clopidogrel 1A Pharma klopidogrel Povzetek EPAR za javnost
English: Other information about Clopidogrel 1A Pharma:
Slovenian: Druge informacije o zdravilu Clopidogrel 1A Pharma:
English: Clopidogrel 1A Pharma can be started between seven days and six months after
Slovenian: Zdravilo Clopidogrel 1A Pharma se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
English: The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel 1A Pharma odobri dovoljenje za promet.
English: What are the benefit and risk of Clopidogrel 1A Pharma?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel 1A Pharma?
English: Clopidogrel 1A Pharma is a ‘generic medicine'.
Slovenian: Clopidogrel 1A Pharma je „generično zdravilo“.
English: Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel 1A Pharma je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel 1A Pharma, klopidogrel, je zaviralec agregacije trombocitov.
English: The full EPAR for Clopidogrel 1A Pharma can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel 1A Pharma je na voljo tukaj.
English: Why has Clopidogrel 1A Pharma been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel 1A Pharma odobreno?
English: How has Clopidogrel 1A Pharma been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel 1A Pharma raziskano?
English: What is Clopidogrel 1A Pharma?
Slovenian: Kaj je zdravilo Clopidogrel 1A Pharma?
English: What is Clopidogrel 1A Pharma used for?
Slovenian: Za kaj se zdravilo Clopidogrel 1A Pharma uporablja?
English: How does Clopidogrel 1A Pharma work?
Slovenian: Kako zdravilo Clopidogrel 1A Pharma deluje?
English: How is Clopidogrel 1A Pharma used?
Slovenian: Kako se zdravilo Clopidogrel 1A Pharma uporablja?
English: Results are heterogeneous and inconsistent.
Slovenian: Rezultati so heterogeni in nedosledni.
English: In six of the evaluable studies with population under 100 patients there were similar findings.
Slovenian: V šestih ocenljivih študijah s populacijo, manjšo od 100 bolnikov, so bile ugotovitve podobne.
English: It produces a decrease in blood pressure and an increase in peripheral blood flow.
Slovenian: Povzroča znižanje krvnega tlaka in poveča periferni krvni pretok.
English: In Europe, dihydroergocristine is also available in combination with etofyllinum.
Slovenian: V Evropi je dihidroergokristin na voljo tudi v kombinaciji z etofilinom.
English: Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergokristin (glejte Prilogo I)
English: The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies.
Slovenian: Odbor CHMP je menil, da na podlagi teh študij ni mogoče sklepati o učinkovitosti.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
Slovenian: CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergokristina.
English: There were 3 placebo controlled studies with a study population of 200-240 patients.
Slovenian: Opravljene so bile 3 s placebom nadzorovane študije, ki so vključile populacijo od 200 do 240 bolnikov.
English: 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).
Slovenian: 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).
English: • 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.
Slovenian: • 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;
English: Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Slovenian: Poleg tega je treba izpostaviti resnost teh neželenih učinkov, njihov morebitni smrtni izid in povečano tveganje za razvoj fibrotične motnje pri dolgotrajni uporabi, skladni z odobrenimi indikacijami.
English: Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Slovenian: Prav tako obstaja sum na preredko poročanje, saj je učinkovina v prometu že dolgo časa in je fibroza že omenjena kot neželeni učinek v informacijah o zdravilu.
English: Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
Slovenian: Od teh se jih je 18 nanašalo na s placebom nadzorovana preskušanja, 2 na z zdravilno učinkovino nadzorovani preskušanji, 7 pa na odprte študije.
English: Although some of the proposed measures could help identify patients with pre-existing fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Slovenian: Čeprav lahko nekateri od predlaganih ukrepov pomagajo odkriti bolnike z obstoječo fibrozo, zadevna sočasna zdravila in povečano tveganje, je Odbor izpostavil, da to ni zadostno za preprečevanje razvoja fibroze in ergotizma med zdravljenjem pri nekaterih bolnikih.
English: Dihydroergocristine is a partial agonist of α-adrenoreceptors that decreases the activity of sympathetic centres and is responsible for a peripheral adrenolytic effect with an increased venous wall tone.
Slovenian: Dihidroergokristin je delni agonist alfa-adrenoreceptorjev, ki zmanjša dejavnost simpatičnih centrov in je odgovoren za periferni adrenolitični učinek s povečanim tonusom venskih sten.
English: From the approved indications of the dihydroergocristine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product):
Slovenian: Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergokristin, so indikacije, ki spadajo v sklop tega napotitvenega postopka in so odobrene v vsaj eni državi članici, naslednje (natančno besedilo za indikacijo se lahko med zdravili razlikuje):