natgillin/translations-raw huggingface dataset:
In vitro data indicate that ambrisentan at 300 μM resulted in less than 50 % inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
UGT1A6, UGT1A9, UGT2B7 (do 30 %) ali encimov citokroma P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4 (do 25 %).
Due to the class primary pharmacologic effect, a large single dose of ambrisentan (i.e. an overdose) could lower arterial pressure and have the potential for causing hypotension and symptoms related to vasodilation.
5.3 Predklinični podatki o varnosti Zaradi primarnega farmakološkega učinka zdravil iz te skupine, se pri prevelikem enkratnem odmerku ambrisentana (to je v primeru prevelikega odmerjanja) lahko zniža arterijski krvni tlak in pojavi hipotenzija ter simptomi s tem povezane vazodilatacije.
Contents of the pack and other information
Shranjevanje zdravila Volibris Vsebina pakiranja in dodatne informacije
The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p <0.001).
V študiji ARIES-1 je pri bolnikih v skupini, ki so prejemali 10 mg odmerek, na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu znašalo 51,4 m (95 % interval zaupanja: 26,6 do 76,2; p < 0,001).
Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side.
Svetlorožnate, kvadratne, konveksne filmsko obložene tablete z oznako "GS" na eni in "K2C" na drugi strani.
Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
V in vitro ter in vivo predkliničnih študijah ambrisentan pri klinično pomembnih koncentracijah ni zaviral ali induciral encimov, ki presnavljajo zdravila v I. in II.
→ If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Volibris.
→ Če obstaja možnost zanositve, morate med zdravljenjem z zdravilom Volibris uporabljati zanesljivo obliko kontracepcije.
Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Večkratni odmerki ambrisentana ne vplivajo na izpostavljenost ciklosporinu A,zato odmerka ciklosporina A ni treba prilagoditi.
No evidence for mutagenic or genotoxic effects of ambrisentan were seen in bacteria or in two in vivo rodent studies.
Pri bakterijah in v dveh in vivo študijah na glodavcih mutagenega in genotoksičnega delovanja ambrisentana niso ugotovili.
• Obligation to conduct post-authorisation measures
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/003 10 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/451/003 10 filmsko obloženih tablet
If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
ALT ali AST ali obeh, ali zvišanje vrednosti ALT ali AST ali obeh spremljajo znaki in simptomi okvare jeter (npr. zlatenica), je treba zdravljenje z ambrisentanom prekiniti.
This is a common side effect that may affect up to one in 10 people
To je pogost neželen učinek, ki se lahko pojavi pri največ 1 od 10
The main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile and therefore hepatic impairment might be expected to increase exposure (Cmax and AUC) of ambrisentan.
Okvara jeter Ker glavna presnovna pot ambrisentana poteka preko glukuronidacije in oksidacije ter kasnejšega izločanja z žolčem, lahko pričakujemo, da se bi pri okvari jeter morda lahko povečala izpostavljenost (Cmax in AUC) ambrisentanu.
Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan.
Volibris 5 mg filmsko obložene tablete 1 tableta vsebuje 5 mg ambrisentana.
Volibris 10 mg film-coated tablets Each tablet contains 10 mg of ambrisentan.
Volibris 10 mg filmsko obložene tablete 1 tableta vsebuje 10 mg ambrisentana.
Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Anemija (znižana vrednost hemoglobina, znižana vrednost hematokrita)
Talk to your doctor if you have any questions or concerns about this.
Če imate o tem kakršnokoli vprašanje ali ste zaskrbljeni, se posvetujte s svojim zdravnikom.
Always take this medicine exactly as your doctor or pharmacist has told you to.
Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
Disease progression
Očesne bolezni
The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily)
Učinke ponavljajočih se odmerkov ciklosporina A (100-150 mg dvakrat na dan) na farmakokinetiko ambrisentana (5 mg enkrat na dan) v stanju dinamičnega ravnovesja in učinke ponavljajočih se odmerkov ambrisentana (5 mg enkrat na dan) na farmakokinetiko ciklosporina A (100-150 mg dvakrat na dan) v stanju dinamičnega ravnovesja so raziskali pri zdravih prostovoljcih.
What you need to know before you take Volibris
Kaj morate vedeti, preden boste vzeli zdravilo Volibris Ne jemljite zdravila Volibris
Hypotension (low blood pressure) This can cause light-headedness.
Hipotenzija (nizek krvni tlak)
Ambrisentan and its metabolites are eliminated primarily in the bile following hepatic and/or extrahepatic metabolism.
Izločanje Ambrisentan in njegovi presnovki se po jetrni in/ali izven jetrni presnovi v glavnem izločijo z žolčem.
• a runny or blocked nose, congestion or pain in the sinuses
• poslabšanje težkega dihanja kmalu po začetku uporabe zdravila Volibris, • izcedek iz nosu ali zmašen nos, kongestija ali bolečine v obnosnih votlinah (sinusih),
- 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.
Gastrointestinal disorders Nausea, vomiting, diarrhoea
Bolezni prebavil Navzea, bruhanje, driska
The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in
V skupini, ki je prejemala 5 mg odmerek, je v študiji ARIES-1 na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu v primerjavi z izhodiščem znašalo 30,6 m (95 % interval zaupanja: 2,9 do 58,3; p = 0,008), v študiji ARIES-2 pa 59,4 m (95 % interval zaupanja: 29,6 do 89,3; p < 0,001).
Breast-feeding It is not known if Volibris is transferred to breast milk.
Ni znano, če se zdravilo Volibris izloča v materino mleko.
Volibris contains the active substance ambrisentan.
Zdravilo Volibris vsebuje zdravilno učinkovino ambrisentan.
Autoimmune hepatitis (see section
Avtoimunski hepatitis (glejte poglavje 4.4)
NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited
IMETNIK DOVOLJENJA ZA PROMET GlaxoSmithKline (Ireland) Limited
→Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.
→Če se vam pojavijo ti učinki ali nastanejo nenadoma po jemanju zdravila Volibris, to takoj povejte svojemu zdravniku.
Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
0,348 do 0,724, p = 0,0002) sestavljenega opazovanega dogodka kliničnega neuspeha [slika 1 in preglednica 1].
How to store Volibris
Shranjevanje zdravila Volibris
Lecithin (soya) (E322) Allura red AC Aluminium Lake (E129)
lecitin (soja) (E322) in rdeče AC (E129).
Name and address of the manufacturer responsible for batch release
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp (see section 5.2).
Pri zdravih prostovoljcih pri uporabi ambrisentana v stanju dinamičnega ravnovesja niso opazili klinično pomembnih učinkov na farmakokinetiko enkratnega odmerka digoksina, substrata za Pgp
Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan.
Koncentracija hemoglobina V povezavi z antagonisti endotelinskih receptorjev (ERA - endothelin receptor antagonists), vključno z ambrisentanom, so poročali o znižanju koncentracije hemoglobina in hematokrita .
Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets
Volibris 5 mg filmsko obložene tablete Volibris 10 mg filmsko obložene tablete
Furthermore, ambrisentan did not induce MRP2, Pgp or BSEP protein expression in rat hepatocytes.
Poleg tega ambrisentan v podganjih jetrnih celicah ni induciral ekspresije beljakovin MRP2, Pgp ali
In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including the P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), multidrug resistance related protein 2 (MRP2), bile salt export pump (BSEP), organic anion transporting polypeptides (OATP1B1 and OATP1B3) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
P-glikoproteinom (Pgp), proteinom odpornosti na rak dojke (BRCP), proteinom 2 za odpornost na več zdravil (MRP2), iztočno črpalko žolčnih soli (BSEP), transportnim polipeptidom organskih anionov
The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Pri zdravih prostovoljkah so raziskali učinke 12-dnevne uporabe ambrisentana (10 mg enkrat na dan) na farmakokinetiko enkratnega odmerka peroralnega kontraceptiva z etinilestradiolom (35 μg) in noretindronom (1 mg).
Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Imetnik dovoljenja za promet z zdravilom GlaxoSmithKline (Ireland) Limited 12 Riverwalk
4 Data derived from routine pharmacovigilance surveillance 5 Most of the reported cases of cardiac failure were associated with fluid retention.
5 Večina opisanih primerov srčnega popuščanja je bila povezana z zastajanjem tekočine.
Contents of the pack and other information What Volibris contains The active substance is ambrisentan.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Volibris
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Treatment with ambrisentan resulted in an increase in mean cardiac index, a decrease in mean pulmonary artery pressure, and a decrease in mean pulmonary vascular resistance.
zmanjšal srednji pljučni arterijski krvni tlak in zmanjšal srednji pljučni žilni upor.
Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study (see section 5.2).
V študiji pri zdravih prostovoljcih ambrisentan ni vplival na farmakokinetiko v stanju dinamičnega ravnovesja in antikoagulatno delovanje varfarina (glejte poglavje 5.2).
The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
2. in 3. faze (vključno z zadevno odprto podaljšano fazo) je bila ugotovljena pri 17 od 483 oseb v srednjem času zdravljenja 79,5 tednov, kar pomeni 2,3 dogodka na 100 bolnikov-let (“patient years”)
Volibris 10 mg film-coated tablets
Volibris 10 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Volibris 10 mg tablets ambrisentan
IME ZDRAVILA Volibris 10 mg tablete ambrisentan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
NAME OF THE MEDICINAL PRODUCT Volibris 5 mg tablets ambrisentan
IME ZDRAVILA Volibris 5 mg tablete ambrisentan
Volibris 5 mg film-coated tablets EU/1/08/451/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Volibris 5 mg filmsko obložene tablete EU/1/08/451/001
General disorders and administration site conditions Peripheral oedema, fluid retention Very common
Periferni edemi, zastajanje tekočine Zelo pogosti
Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Glede na ti spremembi je treba odmerek ambrisentana med sočasno uporabo s ciklosporinom A omejiti na 5 mg enkrat na dan (glejte poglavje 4.2).
Volibris contains lactose, lecithin (soya), Allura red AC Aluminium Lake (E129) and sodium Volibris tablets contain small amounts of a sugar called lactose.
Zdravilo Volibris vsebuje laktozo, (sojin) lecitin, barvilo alurno rdeče AC (E129) in natrij
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
do III. funkcijskem razredu po Svetovni zdravstveni organizaciji (SZO), vključno z uporabo v kombinaciji (glejte poglavje 5.1).
The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Učinek ambrisentana v stanju dinamičnega ravnovesja (10 mg enkrat na dan) na farmakokinetiko in farmakodinamiko enkratnega odmerka varfarina (25 mg), vrednoteno s PT in INR, so raziskovali pri
Volibris 5 mg film-coated tablets
Volibris 5 mg filmsko obložene tablete
Titanium dioxide (E171) Macrogol 3350
Filmska obloga polivinilalkohol (delno hidrolizirani) smukec (E553b) titanov dioksid (E171) makrogol 3350 lecitin (soja) (E322)
Don't stop taking Volibris without your doctor's advice Volibris is a treatment that you will need to keep on taking to control your PAH.
→Ne prenehajte z jemanjem zdravila Volibris brez nasveta zdravnika.
Pregnancy Volibris may harm unborn babies conceived before, during or soon after treatment.
Če zanosite pred, med ali kmalu po koncu zdravljenja, lahko zdravilo Volibris škoduje nerojenemu otroku.
Package leaflet: Information for the user Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets ambrisentan
NAVODILO ZA UPORABO Volibris 5 mg filmsko obložene tablete Volibris 10 mg filmsko obložene tablete ambrisentan
NR - not reported
Ni znano4
The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti, je treba upoštevati njegovo klinično stanje in profil neželenih učinkov ambrisentana (npr.
• being sick (vomiting)
• siljenje na bruhanje (navzeo),
The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15%
Pojavnost anemije je bila med uporabo ambrisentana v kombinaciji s tadalafilom večja (15 %) kot med monoterapijo z ambrisentanom (7 %) ali monoterapijo s tadalafilom (11 %).
Eye disorders Blurred vision, visual impairment Not known4
Zamegljen vid, okvara vida
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
Volibris 10 mg filmsko obložene tablete Ena tableta vsebuje približno 90 mg laktoze (v obliki monohidrata), približno 0,25 mg lecitina (soja)
Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Pri podganah, ki so prejemale ambrisentan, so pri izpostavljenosti, ki je ustrezala 3-kratni vrednosti
Asthenia
bolnikov.
Monotherapy pooled
Monoterapija kumulativno
9 Rash includes rash erythematous, rash generalised, rash papular and rash pruritic
9 Izraz izpuščaj obsega eritematozen izpuščaj, generaliziran izpuščaj, papularen izpuščaj in pruritičen izpuščaj.
Patients with WHO FC II and III had a mean baseline 6MWD of 353 metres.
in III. funkcijskem razredu po SZO so imeli izhodiščno 6-minutno prehojeno razdaljo 353 metrov.
→ Don't breast-feed while you're taking Volibris.
→ Med jemanjem zdravila Volibris ne smete dojiti.
Nasal congestion
Peroralna uporaba
The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
- smrt ali - sprejem v bolnišnico zaradi poslabšanja PAH, - napredovanje bolezni,
Therefore breast-feeding is contraindicated in patients taking ambrisentan (see section 4.3).
Zato je pri bolnicah, ki jemljejo ambrisentan, dojenje kontraindicirano (glejte poglavje
Please read the information under ‘Pregnancy'
• če dojite; glejte poglavje ‘Dojenje';
Ambrisentan
Astenija
Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
V nadaljevanju so po organskih sistemih in pogostnosti navedeni neželeni učinki zdravila, ugotovljeni v 12-tedenskih s placebom nadzorovanih kliničnih preskušanjih.
Therefore hepatic aminotransferases (ALT and AST) should be evaluated prior to initiation of ambrisentan and treatment should not be initiated in patients with baseline values of ALT and/or AST >3xULN (see section 4.3).
Pri bolnikih z izhodiščnimi vrednostmi ALT ali AST ali obeh > 3x ZMN se zdravljenje z ambrisentanom ne sme uvesti (glejte poglavje 4.3).
GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Malta GlaxoSmithKline (Malta) Limited
Uncommon3
Občasni3
Tablet core
Pretisni omot
The Cmax and AUC(0-τ) of ambrisentan increased (48% and 121%, respectively) in the presence of multiple doses of cyclosporine A. Based on these changes, the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Med uporabo večkratnih odmerkov ciklosporina A se je Cmax ambrisentana povečala za 48 % in AUC(0- τ) ambrisentana za 121 %.
The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of tadalafil, and the effects of steady-state tadalafil (40 mg once daily) on the pharmacokinetics of a single dose of ambrisentan were studied in 23 healthy volunteers.
Pri 23 zdravih prostovoljcih so raziskali vpliv ambrisentana (10 mg enkrat na dan) v stanju dinamičnega ravnovesja na farmakokinetiko enkratnega odmerka tadalafila in vpliv tadalafila (40 mg enkrat na dan) v stanju dinamičnega ravnovesja na farmakokinetiko enkratnega odmerka ambrisentana.
Vial (glass) 2 ml (150 mg/ml) 1 vial + 1 syringe +
Velikost pakiranja viala (steklo) 2 ml (150 mg/ml) 1 viala + 1 injekcijska brizga + 2 igli
EU (MA) Number (Invented) name Strength Pharmaceutical Form
Številka (EU) dovoljenja za promet
The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Priporočeni odmerek za odrasle in mladostnike (stare 12 let in več) je 5 mg enkrat na dan.
It is available as tablets (5mg).
Na voljo je v obliki tablet (5 mg).
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Če so receptorji blokirani, histamin ne more učinkovati, zaradi česar se simptomi alergije zmanjšajo.
The full EPAR for Desloratadine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Desloratadine ratiopharm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine ratiopharm on 13 January 2012.
Evropska komisija je dovoljenje za promet z zdravilom Desloratadine ratiopharm, veljavno po vsej Evropski uniji, odobrila dne 13. januarja 2012.
EPAR summary for the public desloratadine
Povzetek EPAR za javnost desloratadin
This means that Desloratadine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aerius.
For more information about treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Desloratadine ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Desloratadine ratiopharm.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Desloratadine ratiopharm.
Desloratadine ratiopharm is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Zdravilo Desloratadine ratiopharm se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Desloratadine ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine ratiopharm.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Desloratadine ratiopharm, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Aerius, odtehtajo znana tveganja.
Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Ker je zdravilo Desloratadine ratiopharm generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Aerius.
Other information about Desloratadine ratiopharm
Druge informacije o zdravilu Desloratadine ratiopharm