natgillin/translations-raw huggingface dataset:
The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited. 
Poleg tega je menil, da je zdravilo Xolair (300 mg) bistveno izboljšalo simptome kronične spontane urtikarije, kadar se je uporabljalo kot dodatek k bolnikovemu obstoječemu zdravljenju, vendar so podatki iz študij o dolgoročni uporabi tega zdravila dlje kot šest mesecev omejeni.
Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen. 
Omalizumab je zasnovan tako, da se veže na človeški IgE, ki se pri bolnikih z alergijami tvori v velikih količinah in kot odziv na alergen sproži alergijsko reakcijo.
Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE). 
Zdravljenje z zdravilom Xolair je smiselno le, če astmo povzroča protitelo, imenovano imunoglobulin E (IgE).
By attaching to IgE, omalizumab ‘mops up' the free IgE circulating in the blood. 
Omalizumab si z vezavo na IgE „pripoji“ prosti IgE, ki kroži v krvi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xolair, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Xolair in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment. 
Zdravilo Xolair so proučevali tudi v treh glavnih študijah, v katerih je sodelovalo 978 bolnikov s kronično spontano urtikarijo, ki se niso odzvali na zdravljenje z antihistaminiki.
• they must have had many severe ‘exacerbations' of asthma (where asthma gets worse, requiring rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist. 
• imeli so več resnih izbruhov astme (pri katerih se je astma poslabšala, kar je zahtevalo takojšnje zdravljenje z drugimi zdravili) kljub zdravljenju z inhaliranjem velikih odmerkov kortikosteroidov skupaj z dolgo delujočim agonistom receptorjev beta 2 za inhaliranje.
Each vial and syringe contains 75 or 150 mg of omalizumab. 
Ena viala oziroma injekcijska brizga vsebuje 75 ali 150 mg zdravilne učinkovine omalizumab.
For the full list of all side effects and restrictions with Xolair, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Xolair glejte navodilo za uporabo.
The active substance in Xolair, omalizumab, is a monoclonal antibody. 
Zdravilna učinkovina v zdravilu Xolair, omalizumab, je monoklonsko protitelo.
What is the risk associated with Xolair? 
Kakšna tveganja so povezana z zdravilom Xolair?
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 Xolair. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments. 
Zdravilo Xolair so proučevali v petih glavnih študijah pri več kot 2 000 bolnikih z alergijsko astmo, starejših od 12 let, vključno z eno študijo s 482 bolniki s hudo alergijsko astmo, ki ni bila nadzorovana z običajnimi zdravljenji.
The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma. 
Odbor je menil, da je bil iz rezultatov študij zdravljenja astme z zdravilom Xolair na splošno razviden vzorec, ki kaže na učinkovitost zdravila pri zdravljenju hude alergijske astme.
In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo. 
Poleg tega je imelo izbruhe manj bolnikov, ki so jemali zdravilo Xolair, kot tistih, ki so jemali placebo.
In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo. 
V študijah z bolniki, ki so imeli kronično spontano urtikarijo, je zdravilo Xolair v odmerku 300 mg po 12 tednih izboljšalo simptome srbenja za od 4,5 do 5,8 točk več kot placebo.
Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo. 
Med 235 otroki, ki so bili pred začetkom študije zdravljeni z visokimi odmerki inhaliranih kortikosteroidov in dolgodelujočimi inhaliranimi agonisti beta 2, so v prvih 24 tednih zdravljenja pri tistih, ki so prejemali zdravilo Xolair, zabeležili povprečno 0,4 izbruha v primerjavi z 0,6 izbruha pri tistih, ki so prejemali placebo.
The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight. 
Odmerek in pogostost dajanja zdravila Xolair sta odvisna od ravni IgE v krvi in telesne mase bolnika.
Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria. 
Zdravljenje z zdravilom Xolair mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hude trdovratne astme ali kronične spontane urtikarije.
Xolair is a medicine that contains the active substance omalizumab. 
Xolair je zdravilo, ki vsebuje zdravilno učinkovino omalizumab.
In the study in children with allergic asthma aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair. 
V študiji pri otrocih z alergijsko astmo, starih od šest do 12 let, je bilo število izbruhov nižje pri tistih, ki so prejemali zdravilo Xolair.
Xolair is used to improve the control of severe persistent asthma that is caused by an allergy. 
Zdravilo Xolair se uporablja za boljše obvladovanje hude trdovratne astme, ki jo povzroča alergija.
Why has Xolair been approved? 
Zakaj je bilo zdravilo Xolair odobreno?
In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies. 
V študiji, v kateri so sodelovali bolniki s hudo alergijsko astmo, ni bilo razlike v številu izbruhov astme med bolniki, ki so prejemali zdravilo Xolair, in bolniki, ki so prejemali placebo, je pa zdravilo Xolair povzročilo podobno zmanjšanje števila izbruhov kot v prejšnjih študijah.
For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks. 
Pri zdravljenju astme zdravilo Xolair injicira zdravstveni delavec v podkožje ramena ali stegna vsaka dva ali štiri tedne.
For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks. 
Pri zdravljenju kronične spontane urtikarije zdravilo Xolair injicira zdravstveni delavec v podkožje ramena ali stegna, in sicer v odmerku 300 mg vsake štiri tedne.
Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash). 
Zdravilo Xolair se uporablja tudi za zdravljenje kronične (dolgotrajne) spontane urtikarije (srbečega izpuščaja).
Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group. 
V prvih treh študijah je bilo v prvih 28 ali 52 tednih zdravljenja v skupini, ki je jemala zdravilo Xolair, okoli 0,5 izbruha na leto, v skupini, ki je prejemala placebo, pa približno eden na leto.
In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds). 
Pri bolnikih s kronično spontano urtikarijo so najpogostejši neželeni učinki zdravila Xolair (opaženi pri 1 do 10 bolnikih od 100) sinuzitis (vnetje sinusov), glavobol, artralgija (bolečine v sklepih), reakcije na mestu injiciranja in okužbe zgornjih dihal (prehladi).
In all of the studies, Xolair was compared with placebo, when they were added to the patients' existing treatment. 
V vseh študijah so zdravilo Xolair primerjali s placebom, ki so ju dodajali bolnikovemu obstoječemu zdravljenju.
In the treatment of asthma, Xolair is intended for long-term use. 
Zdravilo Xolair je pri zdravljenju astme namenjeno dolgoročni uporabi.
In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching. 
Pri bolnikih z alergijsko astmo, starejših od 12 let, so najpogostejši neželeni učinki zdravila Xolair (opaženi pri 1 do 10 bolnikih od 100) glavobol in reakcije na mestu injiciranja, vključno z otekanjem, rdečino, bolečino in srbenjem.
In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever). 
Pri otrocih, starih od šest do 12 let, sta bila najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) glavobol in povišana telesna temperatura.
In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients' existing treatment. 
V vseh študijah so zdravilo Xolair primerjali s placebom (zdravilom brez zdravilne učinkovine), ki so ju dodajali bolnikovemu obstoječemu zdravljenju.
In the studies in patients with allergic asthma aged 12 years or over, Xolair reduced the number of exacerbations by around half. 
V študijah, v katerih so sodelovali bolniki z alergijsko astmo, starejši od 12 let, je zdravilo Xolair zmanjšalo število izbruhov za približno polovico.
What is Xolair used for? 
Za kaj se zdravilo Xolair uporablja?
What is Xolair? 
Kaj je zdravilo Xolair?
How has Xolair been studied? 
Kako je bilo zdravilo Xolair raziskano?
How is Xolair used? 
Kako se zdravilo Xolair uporablja?
How does Xolair work? 
Kako zdravilo Xolair deluje?
This summary was last updated on 25 January 2008. 
Povzetek je bil nazadnje posodobljen 25. januarja 2008.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR). 
Če želite več informacij, ki temeljijo na priporočilih CVMP, preberite znanstveno razpravo (ki je prav tako del
The vaccine should not be handled by people with a weak immune system. 
S cepivom ne smejo ravnati osebe z oslabljenim imunskim sistemom.
If you need more information about your animal's medical condition or treatment, contact your veterinarian. 
Če potrebujete več informacij o zdravstvenem stanju ali zdravljenju vaše živali, se posvetujte z veterinarjem.
If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age. 
Če ima mačka večjo količino protiteles, ki jih je podedovala od matere, je treba prvo cepljenje začeti pri 12. tednih starosti.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005. 
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCCh, veljavno po vsej Evropski uniji, odobrila družbi MERIAL dne 23. februarja 2005.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases. 
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „naučijo“ obrambe pred boleznimi.
This document is a summary of the European Public Assessment Report. 
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
The antibodies will help to protect against the diseases caused by these viruses or bacteria. 
Protitelesa mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi in bakterije.
The benefit-risk balance may be found in module 6 of this EPAR. 
Razmerje med koristmi in tveganji najdete v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study. 
Porasta ravni protiteles proti C. felis ni bilo mogoče zaznati zaradi visokih ravni protiteles pri mačkah na začetku študije.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them. 
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse in oslabljene bakterije kot „tuje“ ter proti njim tvori protitelesa.
The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later. 
Prva injekcija se daje mačkam od osmega tedna starosti naprej, druga injekcija pa 3 do 4 tedne pozneje.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis. 
Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju in nato vsako leto za rinotraheitis, kalicivirozo in klamidiozo.
They included young and adult cats of various breeds, but not young kittens. 
V študije so vključili mlade in odrasle mačke različnih pasem, ne pa muck.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine. 
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusoma in bakteriji iz cepiva.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks. 
Na mestu injiciranja se lahko pojavi lokalna reakcija z rahlimi bolečinami ob dotiku, srbečico ali edemom (oteklino), ki ponavadi izgine v enem do dveh tednih.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCCh za aktivno imunizacijo mačk, starejših od osem tednov, proti zgoraj navedenim boleznim večje od tveganj, in priporočil odobritev dovoljenja za promet z zdravilom Purevax RCCh.
• attenuated Chlamydophila felis (905 strain). 
• atenuirano bakterijo Chlamydophila felis (sev 905).
In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection). 
V študijah zdravila Purevax RCCh na terenu so preverili osnovni cepilni program (2 injekciji 3-4 tedne narazen) in obnovitveno cepljenje (samo ena injekcija).
Other information about Purevax RCCh: 
Druge informacije o zdravilu Purevax RCCh:
In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above. 
V laboratorijskih pogojih je zdravilo Purevax RCCh dokazalo, da nudi zaščito proti zgoraj navedenim boleznim.
Purevax RCCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above. 
Zdravilo Purevax RCCh vsebuje majhne količine oslabljenih oblik ali uničenih virusov in bakterij, ki povzročajo zgoraj navedene bolezni.
Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases: 
Zdravilo Purevax RCCh se uporablja za cepljenje mačk od 8. tedna starosti naprej proti naslednjim boleznim:
After Purevax RCCh has been made up, 1 ml is injected under the skin. 
Ko zdravilo Purevax RCCh pripravimo, ga 1 ml injiciramo pod kožo.
The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis. 
Učinkovitost zdravila Purevax RCCh so proučili v več preskušanjih v laboratorijih, kjer so mačke cepili in okužili z virulentnim herpesvirusom, kalicivirusom ali C. felis.
Purevax RCCh is a vaccine. 
Zdravilo Purevax RCCh je cepivo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCCH EPAR summary for the public 
PUREVAX RCCH Povzetek EPAR za javnost
For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCCh, glejte navodilo za uporabo.
In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor. 
Če ste si to zdravilo nenamerno injicirali, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
What benefit has Purevax RCCh shown during the studies? 
Kakšne koristi je zdravilo Purevax RCCh izkazalo med študijami?
Purevax RCCh should not be used in pregnant cats. 
Zdravilo Purevax RCCh se ne sme uporabljati za breje mačke.
Purevax RCCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection. 
Zdravilo Purevax RCCh je v obliki liofilizata (pelete, posušene v zamrznjenem stanju) in vehikla, iz katerih se pripravi suspenzija za injiciranje.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred. 
Če si takšna oseba zdravilo nenamerno injicira, morate zdravniku povedati, da je prišlo do nenamernega injiciranja živega klamidijskega cepiva.
It also helps to reduce viral excretion in case of calicivirus infection. 
Cepivo tudi zmanjša izločanje virusov pri kalicivirozi.
Purevax RCCh is a vaccine containing the following active substances: 
Zdravilo Purevax RCCh je cepivo, ki vsebuje naslednje zdravilne učinkovine:
• chlamydiosis (a flu-like illness caused by the bacterium C. felis). 
• klamidiozi (gripi podobni bolezni, ki jo povzroča bakterija C. felis).
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly. 
V študiji obnovitvenega cepljenja so ugotovili, da so ravni protiteles proti herpesvirusu rinotraheitisa mačk, kalicivirusu mačk in C. felis ostale stabilne na visoki vrednosti ali pa so se zvišale.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection. 
V terenski študiji osnovnega cepljenja so ugotovili zvišanje ravni protiteles proti herpesvirusu rinotraheitisa mačk in kalicivirusu mačk.
• feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus), 
• kalicivirozi mačk (gripi podobni bolezni z vnetjem ust, ki jo povzroča kalicivirus),
What is the risk associated with Purevax RCCh? 
Kakšna tveganja so povezana z zdravilom Purevax RCCh?
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains), 
• atenuirani (oslabljeni) herpesvirus rinotraheitisa mačk (sev FHV F2), • inaktivirane (uničene) antigene kalicivirusa mačk (seva FCV 431 in G1),
Why has Purevax RCCh been approved? 
Zakaj je bilo zdravilo Purevax RCCh odobreno?
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days. 
Občasno se lahko pri mački pojavi začasna apatija (izguba interesa za okolico) in anoreksija
• feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus), 
• virusnemu rinotraheitisu mačk (gripi podobni bolezni, ki jo povzroča herpesvirus),
What is Purevax RCCh? 
Kaj je zdravilo Purevax RCCh?
How has Purevax RCCh been studied? 
Kako je bilo zdravilo Purevax RCCh raziskano?
What is Purevax RCCh used for? 
Za kaj se zdravilo Purevax RCCh uporablja?
How does Purevax RCCh work? 
Kako zdravilo Purevax RCCh deluje?
Organ/System (Frequency) 
Organ/Sistem (pogostnost)
Just take your next capsule at the usual time, then go on as before. 
Vzemite naslednjo kapsulo ob običajnem času, nato nadaljujte kot prej.
Any new behavioural sign or symptom requires careful and immediate evaluation. 
Vsak novi vedenjski znak ali simptom zahteva natančno in neposredno oceno.
Sleeping problems do not usually last long, and most people only need a short course of treatment. 
Težave s spanjem običajno ne trajajo dolgo in večina ljudi potrebuje le kratkotrajno zdravljenje.
Psychic dependence may occur. 
Lahko se pojavi psihična odvisnost.
Date of latest renewal: 12 March 2009 
Datum zadnjega podaljšanja: 12. marec 2009
Frequencies are defined as 
Pogostnosti so definirane kot:
• Rare cases of severe allergic reactions have been reported. 
• Poročali so o redkih primerih težkih alergijskih reakcij.
The duration of treatment should usually vary from a few days to two weeks. 
Zdravljenje naj bi običajno trajalo od nekaj dni do dveh tednov.
Further, stabilization of circulatory function and intensive monitoring may be required. 
Potrebna sta lahko tudi stabilizacija delovanja obtočil in intenzivno spremljanje.
hepatotoxicity (mostly described as transaminase increased) 
hepatotoksičnost (večinoma opisana kot povišanje transminaz)
Alcohol can increase the undesirable effects of any medicine taken to help you sleep. 
Alkohol lahko okrepi neželene učinke vsakega zdravila, ki ga vzamete za pomoč pri spanju.
Be aware that such combinations may cause you to feel drowsy the next day. 
Bodite pozorni na to, da lahko takšne kombinacije povzročijo zaspanost naslednji dan.
Patients should be advised not to drive or operate machinery until it is established that their performance is not impaired. 
Bolnikom je treba svetovati, naj ne vozijo ali upravljajo s stroji, dokler se ne ugotovi, ali je njihova opravilna sposobnost zmanjšana.
These occur most often up to several hours after ingesting the product. 
Le-te se največkrat pojavijo več ur po zaužitju zdravila.
Alcohol and medicinal product abuse 
Zloraba alkohola in zdravila
As with sleep-driving, patients usually do not remember these events. 
Podobno kot pri vožnji v polsnu se bolniki teh aktivnosti navadno ne spominjajo.
Sonata will help you to sleep. 
Zdravilo Sonata vam bo pomagalo zaspati.
Sonata with food, drink and alcohol 
Zdravilo Sonata skupaj s hrano, pijačo in alkoholom
Swallow the capsule(s) with a small glass of water. 
Kapsulo/kapsule pogoltnite z majhnim kozarcem vode.
• if you have myasthenia gravis (very weak or tired muscles). 
• če imate miastenijo gravis (zelo šibke ali utrujene mišice).
The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks. 
Zdravljenje mora biti čim krajše (glejte poglavje 4.2), ne več od dveh tednov.
Some patients have required medical therapy in the emergency department. 
Pri nekaterih bolnikih je bilo potrebno zdravljenje na urgentnem oddelku.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. marec 1999
Specific patient groups 
Specifične skupine bolnikov
At least 71% of the orally-administered dose is absorbed. 
Absorbira se najmanj 71% peroralno zaužitega odmerka.