natgillin/translations-raw huggingface dataset:
Treatment-related adverse reactions reported by system organ class and frequency Very common
Preglednica 1: Z zdravljenjem povezani neželeni učinki, razvrščeni glede na organski sistem in pogostnost
However, patients who are transferred from long-term administration of systemically active corticosteroids to NASONEX Nasal Spray require careful attention.
Kljub temu pa je pri bolnikih, ki so po dolgotrajnem zdravljenju s sistemsko aktivnim kortikosteroidom prešli na zdravljenje z zdravilom NASONEX pršilo za nos, potrebna posebna previdnost.
Effects noted were umbilical hernia in rats, cleft palate in mice and gallbladder agenesis, umbilical hernia, and flexed front paws in rabbits.
Pri podganah se je pojavila umbilikalna hernija, pri miših razpoka na nebu, pri kuncih pa se ni oblikoval žolčnik, nastala je umbilikalna hernija in fleksija sprednjih tačk.
Children between the ages of 3 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
Otroci, stari od 3 do 11 let: Običajni priporočeni odmerek je en vpih (50 mikrogramov/vpih) v vsako nosnico enkrat na dan (skupni odmerek 100 mikrogramov).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL NASONEX 50 µg/actuation 60 and 140 actuations
PODATKI NA PRIMARNI OVOJNINI NALEPKA NASONEX 50 µg/vpih , 60 in 140 vpihov
Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function.
Pri teh bolnikih lahko prekinitev uporabe sistemskega kortikosteroida povzroči nezadostno delovanje nadledvične žleze, ki lahko traja več mesecev, preden se spet vzpostavi delovanje osi hipotalamus-hipofiza-nadledvična žleza.
Following the use of intranasal corticosteroids, instances of increased intraocular pressure have been reported (see section 4.8).
Po uporabi intranazalnih kortikosteroidov so poročali o primerih zvišanega intraokularnega tlaka
Distribution Not applicable as mometasone is poorly absorbed via the nasal route.
Porazdelitev Navedba smiselno ni potrebna, saj se mometazon pri nazalni uporabi slabo absorbira.
At the end of the pollen season your hayfever symptoms should get better and treatment may then not be needed.
Ob koncu sezone cvetenja bi se morali simptomi senenega nahoda izboljšati,
In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
krvavitve iz nosu (6 %), glavobola (3 %), draženja nosne sluznice (2 %) in kihanja (2 %), primerljiva s pojavnostjo pri placebu.
Nasonex contains benzalkonium chloride which may cause nasal irritation.
Zdravilo Nasonex vsebuje benzalkonijev klorid, ki lahko povzroči draženje nosne sluznice.
NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be achieved in the first 48 hours.
NASONEX pršilo za nos pojavi v 12 urah po prvem odmerku, vendar pa polna korist zdravljenja v prvih 48 urah morda ne bo dosežena.
If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four actuations in each nostril once daily (total dose 400 micrograms).
Če simptomi niso pod zadovoljivim nadzorom, se odmerek lahko poveča na največji dnevni odmerek, ki znaša štiri vpihe v vsako nosnico enkrat na dan (skupni odmerek 400 mikrogramov).
INFORMATION IN BRAILLE Nasonex 50 µg nasal spray [To be completed nationally]
PODATKI V BRAILLOVI PISAVI Nasonex 50 µg pršilo za nos
There is no known information on the effect of Nasonex on the ability to drive or use machinery.
Vpliv na sposobnost upravljanja vozil in strojev O vplivu zdravila Nasonex na sposobnost upravljanja vozil in strojev ni podatkov.
No toxicological effects unique to mometasone furoate exposure were demonstrated.
Toksikoloških učinkov, značilnih samo za mometazonfuroat, niso dokazali.
Upper respiratory tract infection†
Infekcijske in parazitske bolezni faringitis okužba zgornjih dihal†
What Nasonex looks like and contents of the pack Nasonex is a nasal spray suspension.
Izgled zdravila Nasonex in vsebina pakiranja Zdravilo Nasonex je pršilo za nos v obliki suspenzije.
Epistaxis was generally self-limiting and mild in severity (see section 4.8).
Krvavitve iz nosu so bile običajno blage in so spontano minile (glejte poglavje 4.8).
If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed, before next use.
Če se pršilnika ne uporablja 14 dni ali več, ga je treba pred naslednjo uporabo zopet pripraviti tako, da se pršilnik sproži 2-krat, dokler pršenje ni enakomerno.
Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high concentrations.
Tako kot drugi glukokortikoidi tudi mometazonfuroat v velikih koncentracijah in vitro deluje klastogeno.
Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Redkeje se lahko pojavijo različni psihološki ali vedenjski učinki, vključno s psihomotorično hiperaktivnostjo, motnjami spanja, anksioznostjo, depresijo ali agresivnostjo (predvsem pri otrocih).
While you are using Nasonex, talk to your doctor if your immune system is not functioning well (if you have difficulty in fighting infection) and you come into contact with anyone with measles or chickenpox.
• če vaš imunski sistem ne deluje dobro (težavno spopadanje z okužbami) in pridete v stik z bolnikom, ki preboleva ošpice ali norice.
increase in pressure in the eye (glaucoma) and/or cataracts causing visual disturbances, damage to the partition in the nose which separates the nostrils changes in taste and smell difficulty in breathing and/or wheezing
Pri zdravljenju s kortikosteroidnimi pršili za nos, kot je zdravilo Nasonex, je prišlo do povečanja tlaka v očesu (glavkoma) in/ali pojava sive mrene (katarakte), ki povzroči motnje vida, do poškodbe nosne pregrade, ki ločuje nosnici, in do spremembe okušanja in vonjanja.
If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, you should contact your doctor.
• Če se simptomi po 5 do 6 tednih uporabe zdravila dvakrat na dan ne izboljšajo, se morate posvetovati z zdravnikom.
There were also reductions in maternal body weight gains, effects on foetal growth (lower foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in mice.
Breje podgane, zajklje in miši so slabo pridobivale telesno maso, kar je vplivalo na rast ploda (manjša telesna masa plodov in/ali zapoznela okostenitev), pri miših pa se je zmanjšalo tudi število preživelih mladičev.
What is Nasonex used for?
Za kaj uporabljamo zdravilo Nasonex?
Prime by pumping 10 times before initial use, or 2 times if unused for 14 days or more, until a fine mist is produced.
Pred prvo uporabo 10-krat, po 14-dnevni ali daljši neuporabi pa 2-krat pritisnite na pršilnik, da iz njega začne pršeti fina meglica.
Nasonex reduces the swelling and irritation in your nose and thereby relieving sneezing, itching and a blocked-up or runny nose caused by hay fever or perennial rhinitis.
Zdravilo Nasonex zmanjša otekanje in draženje nosne sluznice in tako olajša kihanje, srbenje in zamašenost ali izcedek iz nosu, ki so posledica senenega nahoda ali celoletnega rinitisa.
White to off-white opaque suspension.
FARMACEVTSKA OBLIKA pršilo za nos, suspenzija bela do skoraj bela neprozorna suspenzija
What you need to know before you use Nasonex
Kaj morate vedeti, preden boste uporabili zdravilo Nasonex Ne uporabljajte zdravila Nasonex
How to store Nasonex
Shranjevanje zdravila Nasonex
If you have not used the spray for 14 days or more, you need to “re-prime” the bottle by pumping the spray 2 times until a fine mist is produced.
Če pršila niste uporabljali 14 dni ali več, ga morate znova “pripraviti” za uporabo.
METHOD AND ROUTE(S) OF ADMINISTRATION For nasal use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA nazalna uporaba
Do not use Nasonex if you are allergic (hypersensitive) to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični (preobčutljivi) na mometazonfuroat ali katero koli sestavino tega zdravila
Nasonex contains benzalkonium chloride
Zdravilo Nasonex vsebuje benzalkonijev klorid
LIST OF EXCIPIENTS Contains benzalkonium chloride
SEZNAM POMOŽNIH SNOVI Vsebuje benzalkonijev klorid.
Also contains : dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: disperzibilno celulozo, glicerol, natrijev citrat, citronsko kislino monohidrat, polisorbat
Push the nozzle back onto the bottle and replace the dust cap.
• Nosnik potisnite nazaj na pršilnik in ga pokrijte s pokrovčkom.
Nasal polyps Nasonex is used to treat nasal polyps in adults aged 18 and over.
Nosni polipi Zdravilo Nasonex uporabljamo za zdravljenje nosnih polipov pri odraslih, starih 18 let in več.
Gently shake the bottle.
Plastenko nežno pretresite.
If your eyes are itching or irritated, your doctor may recommend that you use other treatments with Nasonex.
Če imate težave zaradi srbenja ali draženja oči, vam lahko zdravnik poleg zdravila Nasonex priporoči še uporabo drugih zdravil.
In clinical studies, epistaxis occurred at a higher incidence compared to placebo.
V kliničnih študijah so o krvavitvah iz nosu poročali pogosteje kot pri placebu.
NASONEX Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Zdravilo NASONEX pršilo za nos je indicirano za zdravljenje nosnih polipov pri odraslih, starih 18 let in več.
Most people do not have any problems after using the nasal spray.
Drugi neželeni učinki Večina bolnikov pri uporabi pršila za nos nima nobenih težav.
Contents of the pack and other information
Shranjevanje zdravila Nasonex Vsebina pakiranja in dodatne informacije
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Pri otrocih, ki se dolgotrajno zdravijo z nazalnimi kortikosteroidi, je priporočljivo redno nadziranje telesne višine.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with NASONEX Nasal Spray.
Ni dokazov, da bi dolgotrajno zdravljenje z zdravilom NASONEX pršilo za nos supresivno delovalo na os hipotalamus-hipofiza-nadledvična žleza.
In a placebo-controlled clinical trial in which paediatric patients (n=49/group) were administered NASONEX Nasal Spray 100 micrograms daily for one year, no reduction in growth velocity was observed.
eno leto prejemali zdravilo NASONEX pršilo za nos v odmerku 100 mikrogramov na dan, niso opazili zmanjšanja hitrosti rasti.
PHARMACEUTICAL FORM AND CONTENTS Nasal Spray Suspension
FARMACEVTSKA OBLIKA IN VSEBINA pršilo za nos, suspenzija 60 vpihov
In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose.
Pri 28 % bolnikov s sezonskim alergijskim rinitisom se je klinično pomembni učinek zdravila
Treatment with NASONEX Nasal Spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.
Pri bolnikih z anamnezo zmernih do hudih simptomov sezonskega alergijskega rinitisa je zdravljenje z zdravilom NASONEX pršilo za nos morda treba uvesti nekaj dni pred pričakovanim začetkom sezone cvetnega prahu.
This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
[glejte Prilogo I - izpolni država članica] Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
The usual dose is two sprays into each nostril once a day.
Največji dnevni odmerek so štirje vpihi v vsako nosnico enkrat na dan.
In a study involving 48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200 µg/day for 14 days, there was no significant differences from placebo in the mean change in plasma cortisol level in response to the tetracosactrin stimulation test.
200 µg/dan, se povprečna sprememba vrednosti kortizola v plazmi po stimulacijskem testu s tetrakozaktidom ni pomembneje razlikovala od placeba.
Nasal Spray, Suspension.
- Navodilo shranite.
(Figure 2) Tilt your head forward slightly, keeping the bottle upright.
Glavo rahlo nagnite naprej, plastenka pa naj ostane v pokončnem položaju.
Shake the bottle gently and remove the dust cap. (Figure 1) Gently blow your nose.
Plastenko rahlo pretresite in snemite pokrovček (slika 1).
Increased intraocular pressure
Očesne bolezni glavkom zvišan intraokularni tlak katarakte
[See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
določena z uporabo občutljivega testa s spodnjo mejo kvantivikacije 0,25 pg/ml.
NASONEX Nasal Spray contains benzalkonium chloride which may cause nasal irritation.
Zdravilo NASONEX pršilo za nos vsebuje benzalkonijev klorid, ki lahko draži nosno sluznico.
The spray will need to be primed again with 2 sprays when first used after cleaning.
• Pri prvi uporabi pršilnika po čiščenju morate pršilnik z 2 pršenjema znova pripraviti za uporabo.
Keep this leaflet.
Nosnika ne predirajte.
NASONEX Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, or systemic viral infections.
Pri bolnikih, ki imajo aktivno ali latentno tuberkulozo dihal, nezdravljeno glivno, bakterijsko ali sistemsko virusno okužbo, je treba zdravilo NASONEX pršilo za nos previdno uporabljati, če je uporaba sploh primerna.
The safety and efficacy of NASONEX Nasal Spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Nosni polipi Varnosti in učinkovitosti uporabe zdravila Nasonex pršilo za nos pri zdravljenju enostranskih polipov,
Seasonal Allergic Rhinitis and Perennial Rhinitis The safety and efficacy of NASONEX Nasal Spray in children under 3 years of age have not been established.
Varnost in učinkovitost zdravila NASONEX pršilo za nos pri otrocih, mlajših od 3 let, nista bili dokazani.
swollen face, tongue or pharynx trouble swallowing hives wheezing or trouble breathing
Bolezni dihal, prsnega koša in mediastinalnega prostora krvavitev iz nosu* krvavitev iz nosu vnetje nosne sluznice draženje nosne sluznice razjede nosne sluznice perforacija nosnega pretina
Always use Nasonex exactly as your doctor has told you.
Med uporabo zdravila Nasonex se posvetujte z zdravnikom
NASONEX and associated names strength pharmaceutical form [See Annex I - To be completed nationally]
IME ZDRAVILA Nasonex in povezana imena jakost farmacevtska oblika
If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in each nostril twice daily.
Običajni začetni odmerek sta dva vpiha v vsako nosnico enkrat na dan. • Če po 5 do 6 tednih simptomi niso pod nadzorom, vam zdravnik odmerek lahko poveča na dva vpiha v vsako nosnico dvakrat na dan.
Repeat step 4 to inhale a second spray in the same nostril if applicable.
Če morate skozi isto nosnico vdihniti še drugi vpih pršila, ponovite korak 4.
It is recommended that the height of children receiving long-term treatment with nasal corticosteroids is regularly monitored and if any changes are noted, their doctor should be notified.
Pri otrocih, ki se dolgotrajno zdravijo z nazalnimi kortikosteroidi, je priporočljivo redno nadzirati telesno višino.
Cleaning your nasal spray
Čiščenje pršila za nos
You should wait until the infection is resolved before you start using the nasal spray.
V tem primeru morate, preden začnete uporabljati pršilo za nos, počakati, da se okužba pozdravi.
NASONEX Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Zdravilo NASONEX pršilo za nos je indicirano za uporabo pri odraslih in otrocih, starih 3 leta ali več,
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Vpliv zdravila Nasonex pršilo za nos na sposobnost vožnje in upravljanja s stroji ni znan.
Treatment of Hayfever and Perennial Rhinitis
Druga zdravila in zdravilo Nasonex
Talk to your doctor or pharmacist before using Nasonex if you have or have ever had tuberculosis.
Pred začetkom uporabe zdravila Nasonex se posvetujte z zdravnikom ali farmacevtom
However, some people, after using Nasonex or other corticosteroid nasal sprays, may find that they suffer from:
Pri nekaterih bolnikih pa se pri uporabi zdravila Nasonex ali drugih kortikosteroidnih pršil za nos lahko pojavi kateri od naslednjih neželenih učinkov: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
Throat irritation*
• glavobol • kihanje
Dose reduction is recommended following control of symptoms.
Ko so simptomi pod nadzorom, je odmerek priporočljivo zmanjšati.
if you have persistent irritation to the nose or throat.
• če imate težave z neprestanim draženjem nosu ali žrela.
Infections and infestations
• okužba dihal
Dispersable cellulose (microcrystalline cellulose and carmellose sodium) Glycerol
6.1 Seznam pomožnih snovi disperzibilna celuloza (mikrokristalna celuloza in natrijev karmelozat) glicerol natrijev citrat citronska kislina monohidrat polisorbat 80 benzalkonijev klorid prečiščena voda
This leaflet was last approved in [To be completed nationally]
[glejte Prilogo I - izpolni država članica] Navodilo je bilo nazadnje revidirano dne
It has been used in medicines for several decades.
V zdravilih se uporablja že več desetletij.
It is available as modified-release tablets (5 mg and 20 mg).
Na voljo je v obliki tablet s prirejenim sproščanjem (5 mg in 20 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Plenadren on 3 November 2011.
Evropska komisija je dovoljenje za promet z zdravilom Plenadren, veljavno po vsej Evropski uniji, izdala 3. novembra 2011.
What measures are being taken to ensure the safe and effective use of Plenadren?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Plenadren?
Other information about Plenadren
Druge informacije o zdravilu Plenadren
In situations of excessive physical or mental stress or illness, patients may need further doses of hydrocortisone.
Pri izjemnem fizičnem ali psihičnem stresu ali bolezni bo bolnik morda potreboval dodatne odmerke hidrokortizona.
Treatment may need to be individually adjusted according to how the patient responds.
Zdravljenje je treba prilagoditi posamezniku glede na njegov odziv.
Symptoms include weight loss, muscle weakness, fatigue, low blood pressure, and sometimes darkening of the skin.
Med simptomi so izguba telesne mase, mišična oslabelost, utrujenost, nizek krvni tlak in včasih potemnenje kože.
This is a summary of the European public assessment report (EPAR) for Plenadren.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Plenadren.
The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.
Odbor je zaključil, da so koristi zdravila Plenadren večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Adrenal insufficiency (including primary insufficiency or Addison's disease) is a condition where the adrenal glands (located just above the kidneys) do not produce enough of a steroid hormone called cortisol (also known as the stress hormone because it is released in response to stress).
Adrenalna insuficienca (vključno s primarno insuficienco ali Addisonovo boleznijo) je obolenje, pri katerem nadledvične žleze (ki so neposredno nad ledvicami) ne proizvajajo dovolj steroidnega hormona, imenovanega kortizol (znanega tudi kot stresni hormon, saj se izloči kot odgovor na stres).
Why is Plenadren approved?
Zakaj je bilo zdravilo Plenadren odobreno?
What is Plenadren and what is it used for?
Kaj je zdravilo Plenadren in za kaj se uporablja?
The study looked at the levels of cortisol in the patients' blood during a 24-hour period following three months of treatment.
V študiji so opazovali ravni kortizola v bolnikovi krvi v 24 urah po treh mesecih zdravljenja.
It is taken early in the morning to mimic the fact that in healthy people the blood level of cortisol increases early in the morning.
Jemlje se zgodaj zjutraj, kar ustreza dejstvu, da se ravni kortizola v krvi pri zdravih ljudeh zgodaj zjutraj povišajo.
It is not intended to provide practical advice on how to use Plenadren.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This may be given as Plenadren tablets twice or three times daily or as conventional immediate-release tablets or injections, either alone or in combination with Plenadren.
Ti se lahko dajo v obliki dodatnih tablet zdravila Plenadren dvakrat ali trikrat na dan ali konvencionalnih tablet s takojšnjim sproščanjem ali injekcij, samostojno ali v kombinaciji z zdravilom Plenadren.
The summary of the opinion of the Committee for Orphan Medicinal Products for Plenadren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Plenadren je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
What are the risks associated with Plenadren?
Kakšna tveganja so povezana z zdravilom Plenadren?
Adrenal insufficiency can require life-long treatment to replace the missing cortisol.
Adrenalna insuficienca lahko zahteva doživljenjsko zdravljenje, da se nadomešča manjkajoči kortizol.
What benefits of Plenadren have been shown in studies?
Kakšne koristi je zdravilo Plenadren izkazalo v študijah?
The effects of Plenadren were investigated in one main study involving 64 patients with adrenal insufficiency.
Koristi zdravila Plenadren so raziskovali v eni glavni študiji, v katero je bilo vključenih 64 bolnikov z adrenalno insuficienco.
For more information about treatment with Plenadren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Plenadren preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Because the number of patients with adrenal insufficiency is low, the disease is considered ‘rare', and Plenadren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Ker je bolnikov s to boleznijo malo, velja ta bolezen za redko, zato je bilo zdravilo Plendaren 22. maja 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Plenadren have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The overall amount of cortisol absorbed into the blood was around 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatment.
Celotna količina kortizola, absorbiranega v krvi, je bila približno 20 % nižja pri bolnikih, ki so jemali zdravilo Plenadren, v primerjavi z bolniki, ki so prejemali konvencionalno zdravljenje s hidrokortizonom.