natgillin/translations-raw huggingface dataset:
Musculoskeletal and connective tissue disorders Very common pain in extremity
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti bolečine v okončinah pogosti mialgija, bolečine v hrbtu
Mysildecard is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Zdravilo Mysildecard uporabljamo za zdravljenje visokega krvnega tlaka v pljučnih žilah (pljučne arterijske hipertenzije) pri odraslih ter pri otrocih in mladostnikih, starih med 1 in 17 let.
The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18% (95% CI: 2% to 32%) and 27% (95% CI: 14% to 39%), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2%).
Tako v skupini, ki je prejemala srednji odmerek, kot tudi v skupini, ki je prejemala velik odmerek sildenafila, so ugotovili zmanjšanje žilnega upora v pljučih v primerjavi s placebom, in sicer za 18% (95% IZ: 2% do 32%) oziroma 27% (95% IZ: 14% do 39%); medtem ko v skupini, ki je prejemala majhen odmerek, niso opazili nobene pomembne razlike v primerjavi s placebom (razlika v obsegu 2%).
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
V primerjavi z bolniki, ki niso dobivali substratov CYP3A4 oz. substratov CYP3A4 in antagonistov beta, je bila izpostavljenost sildenafilu pri prejemnikih substratov CYP3A4 večja za 43%, pri prejemnikih substratov CYP3A4 in antagonistov beta pa za 66%.
Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Večina bolnikov je bila izhodiščno v funkcijskem razredu II (107/277, 39%) ali III (160/277, 58%) po razvrstitvi SZO, s povprečno doseženo razdaljo 378 metrov oz. 326 metrov na 6-minutnem testu hoje ob začetku študije; manj bolnikov je bilo ob začetku študije v razredu I (1/277, 0,4%) ali IV (9/277, 3%).
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72% those of sildenafil after 20 mg three times a day dosing (translating into a 36% contribution to sildenafil's pharmacological effects).
Pri bolnikih s pljučno arterijsko hipertenzijo je koncentracija N-dezmetilnega presnovka v plazmi približno 72% koncentracije sildenafila po uporabi 20 mg trikrat na dan (kar pomeni 36% prispevek k farmakološkim učinkom sildenafila).
Each tablet contains 20 mg of sildenafil (as the citrate).
Ena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
How to take Mysildecard
Kako jemati zdravilo Mysildecard
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Ob uporabi posamičnega 100 mg odmerka sildenafila hkrati z eritromicinom, zmernim zaviralcem CYP3A4, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182% povečanja sistemske izpostavljenosti (AUC) sildenafilu.
The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2%, 12.9%, 23.3%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%, 5.9%, 14.4%).
Odstotek znižanja pljučne žilne upornosti (11,2% za 20 mg trikrat na dan, 12,9% za 40 mg trikrat na dan in 23,3% za 80 mg trikrat na dan) je bil po 12 tednih proporcionalno večji kot znižanje sistemske žilne upornosti (7,2% za 20 mg trikrat na dan, 5,9% za 40 mg trikrat na dan in 14,4% za 80 mg trikrat na dan).
NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets
IME ZDRAVILA Mysildecard 20 mg filmsko obložene tablete
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mylan S.A.S
For subjects with primary PAH (67 subjects), mean changes from baseline were 26.39 m (95% CI: 10.70 to 42.08) and 11.84 m (95% CI: -8.83 to 32.52) for the sildenafil and placebo groups, respectively.
Pri preiskovancih s primarno PAH (67 preiskovancev) je bila povprečna sprememba od izhodišča 26,39 m (95% IZ: 10,70 do 42,08) v skupini s sildenafilom in 11,84 m (95% IZ: -8,83 do 32,52) v skupini s placebom.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold)increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Sočasna uporaba zaviralca proteaze HIV ritonavirja (zelo močan zaviralec P450) v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 300%, tj. 4-kratno, povečanje Cmax sildenafila in 1.000%, tj. 11-kratno, povečanje AUC sildenafila v plazmi.
A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steadystate sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Populacijska farmakokinetična analiza podatkov iz študije pri odraslih bolnikih s PAH na osnovnem zdravljenju z bosentanom (62,5 - 125 mg dvakrat na dan) je pokazala povečanje (20%; 95% IZ: 9,8-30,8) AUC bosentana ob sočasni uporabi s sildenafilom v stanju dinamičnega ravnovesja (20 mg trikrat na dan).
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) stabilised 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 8 mg) sočasno s sildenafilom (25 mg, 50 mg oz. 100 mg).
However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI: -65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Pri preiskovancih z boleznimi vezivnega tkiva povezano PAH (36 preiskovancev) pa je bila povprečna sprememba od izhodišča -18,32 m (95% IZ: -65,66 do 29,02) v skupini s sildenafilom in 17,50 m (95% IZ: -9,41 do 44,41) v skupini s placebom.
• if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
- če jemljete zdravila, ki vsebujejo nitrate, ali dajalce dušikovega oksida, kakršen je amilnitrat.
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).
Do not stop taking Mysildecard unless your doctor tells you to.
Zdravila ne nehajte jemati, če vam tega ne naroči zdravnik.
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.
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).
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.
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).
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, respectively.
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 -195 din.s/cm5 (p = 0,0017) in za 80 mg trikrat na dan -320 din.s/cm5 (p < 0,0001).
Titanium dioxide (E171)
Filmska obloga: hipromeloza 6 mPas titanov dioksid (E171) triacetin
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 kakršni koli obliki kontraindicirana (glejte poglavje 4.3).
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Ta zdravila se pogosto uporabljajo za olajšanje pri angini pektoris ali bolečini v prsnem košu (glejte poglavje 2, Kaj morate vedeti, preden boste vzeli zdravilo Mysildecard).
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.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section
Sočasna uporaba sildenafila pri bolnikih, ki dobivajo zdravljenje z antagonisti alfa, lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.4).
Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa, kašelj, zamašenost nosu
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 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-dezmetilnega presnovka.
BGP Products SIA Tel: +371 676 055 80
Tel: +371 676 055 80
ANNEX II
Pri II.
PVC-Al blisters unit dose perforated blister pack containing 90 x 1 film-coated tablets.
Pakiranji s pretisnimi omoti iz PVC-Al, ki vsebujeta 90 ali 300 filmsko obloženih tablet.Pakiranje s pretisnimi omoti iz PVC-Al s perforacijo za vsako odmerno enoto, ki vsebuje 90 x 1 filmsko obloženo tableto.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of sildenafil (as citrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
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.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg)
V majhni, s placebom nadzorovani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n = 9) sildenafil v enkratnem 100 mg odmerku ni povzročil pomembnih sprememb na opravljenih preiskavah vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju, Humphreyev perimeter in fotostres).
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.
How to store Mysildecard
Shranjevanje zdravila Mysildecard
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 5.1).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PRETISNI OMOT
Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mmHg (p = 0.01) and -5.1 mmHg (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 mm Hg (p = 0,04), za 40 mg trikrat na dan -3,0 mm Hg (p = 0,01) in za 80 mg trikrat na dan -5,1 mm Hg (p < 0,0001).
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).
If you experience any of the following side effects you should stop taking Mysildecard and contact a doctor immediately (see also section 2):
Če se vam pojavi kateri od naslednjih neželenih učinkov, nemudoma prenehajte z jemanjem zdravila Mysildecard in obvestite zdravnika (glejte tudi poglavje 2): - če doživite nenadno poslabšanje ali izgubo vida (pogostnost ni znana).
Possible side effects
Vazodilatacijski učinki
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%.
If you take more Mysildecard than you should
Če ste vzeli večji odmerek zdravila Mysildecard, kot bi smeli Ne vzemite več zdravila, kot vam je naročil zdravnik.
• have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Pred začetkom jemanja zdravila Mysildecard se posvetujte z zdravnikom, če: - imate bolezen zaradi zamašene ali zožene vene v pljučih, ne pa zaradi zamašene ali zožene arterije.
You should be aware of how you react to the medicine before you drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Mysildecard lahko povzroči omotico in vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na to zdravilo.
Between 20% and 31% of the women became pregnant.
Zanosilo je med 20 in 31 % žensk.
Overall, the values for the GnRH agonists were slightly higher.
Na splošno so bile vrednosti za agoniste GnRH nekoliko višje.
After treatment with Orgalutran, the average number of eggs that could be harvested was between 7.9 and 11.6 per woman.
Po zdravljenju z zdravilom Orgalutran je povprečno število jajčec, ki so jih lahko odvzeli, znašalo med 7,9 in 11,6 na žensko.
The main measures of effectiveness were the number of eggs that could be harvested and the number of women who became pregnant.
Glavni merili učinkovitosti sta bili število jajčec, ki so jih lahko odvzeli, in število žensk, ki so zanosile.
The ability of Orgalutran to prevent premature ovulation has been studied in three main studies involving 1,335 women.
Sposobnost zdravila Orgalutran za preprečitev prezgodnje ovulacije so proučevali v treh glavnih študijah, v katere je bilo vključenih 1 335 žensk.
The patient or her partner may give the injections themselves, if they have been trained and have access to expert advice.
Zdravilo lahko injicira tudi bolnica sama ali njen partner, če sta bila za to ustrezno usposobljena in imata na voljo strokovno svetovanje.
When treatment should start depends on how well the ovaries are responding to stimulation.
Kdaj je treba začeti zdravljenje, je odvisno od tega, kako dobro se jajčeca odzivajo na stimulacijo.
The full EPAR for Orgalutran 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 Orgalutran je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Sometimes, the ovaries can over-respond to stimulation.
Jajčniki se lahko včasih čezmerno odzovejo na stimulacijo.
This document is a summary of the European Public Assessment Report (EPAR) for Orgalutran.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Orgalutran.
Other information about Orgalutran:
Druge informacije o zdravilu Orgalutran:
It must not be used by women who are pregnant or breast-feeding, or in women with moderate or severe kidney or liver disease.
Ne smejo ga prejemati ženske, ki so noseče ali dojijo, ter ženske z zmernimi ali hudimi obolenji jeter ali ledvic.
For more information about treatment with Orgalutran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Orgalutran preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
In premature ovulation, the ovaries release eggs that may be immature and not suitable for use in techniques such as in-vitro fertilisation.
Pri prezgodnji ovulaciji jajčniki sprostijo jajčeca, ki so lahko nezrela in neprimerna za uporabo v tehnikah, kot je oploditev in vitro.
Orgalutran is given as a single 0.25-mg injection under the skin once a day.
Zdravilo Orgalutran se daje kot enkratna injekcija pod kožo v odmerku 0,25 mg enkrat dnevno.
Treatment with Orgalutran should be carried out by a doctor who has experience in this type of fertility treatment.
Zdravljenje z zdravilom Orgalutran lahko izvaja samo zdravnik z izkušnjami s to vrsto zdravljenja težav s plodnostjo.
Treatment with Orgalutran should be continued up to the day that there are enough large follicles (small sacs in the ovary that hold the eggs).
Zdravljenje z zdravilom Orgalutran je treba nadaljevati vse do dneva, ko nastane dovolj velikih foliklov (majhnih vrečic, v katerih se nahajajo jajčeca).
Treatment should start on day 5 or 6 after the start of ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin alfa (a modified FSH).
Z zdravljenjem je treba pričeti na 5. ali 6. dan po začetku ovarijske stimulacije s folikle stimulirajočim hormonom (FSH) ali korifolitropinom alfa (spremenjenim FSH).
During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more than one egg.
Med zdravljenjem težav s plodnostjo se ovarijska stimulacija običajno uporablja za spodbujanje jajčnikov k tvorbi več kot enega jajčeca.
What benefit has Orgalutran shown during the studies?
Kakšne koristi je zdravilo Orgalutran izkazalo med študijami?
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 Orgalutran.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Orgalutran, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The European Commission granted a marketing authorisation valid throughout the European Union for Orgalutran to N.V. Organon on 17 May 2000.
Evropska komisija je dovoljenje za promet z zdravilom Orgalutran, veljavno po vsej Evropski uniji, odobrila družbi N.V.
The CHMP decided that Orgalutran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Orgalutran večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In studies, the most common side effect with Orgalutran (seen in more than 1 patient in 10) was a skin reaction at the injection site, mainly redness with or without swelling.
V študijah so bili najpogostejši neželeni učinki zdravila Orgalutran (opaženi pri več kot 1 bolnici izmed 10) reakcije na mestu injiciranja, predvsem rdečina z oteklino ali brez nje.
Orgalutran should not be used in people who may be hypersensitive (allergic) to ganirelix, to any of the other ingredients, to GnRH or to other GnRH analogues (medicines that have a similar structure to GnRH and modify the activity of GnRH in the body).
Zdravila Orgalutran ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ganireliks ali katero koli drugo sestavino zdravila, na GnRH ali druge analoge GnRH (zdravila, ki imajo podobno zgradbo kot GnRH in spremenijo njegovo delovanje v telesu).
Each syringe contains 0.25 mg of the active substance, ganirelix.
Posamezna injekcijska brizga vsebuje 0,25 mg zdravilne učinkovine ganireliks.
Orgalutran is a solution for injection in a prefilled syringe.
Zdravilo Orgalutran je raztopina za injiciranje v napolnjeni injekcijski brizgi.
The active substance in Orgalutran, ganirelix, blocks the receptors for a natural hormone called gonadotrophin-releasing hormone (GnRH).
Zdravilna učinkovina zdravila Orgalutran, ganireliks, zavira receptorje za naravni hormon, imenovan gonadotropin sproščajoč hormon (GnRH).
What is the risk associated with Orgalutran?
Kakšna tveganja so povezana z zdravilom Orgalutran?