natgillin/translations-raw huggingface dataset:
The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant. 
Djelatna tvar u lijeku Leflunomide ratiopharm, leflunomid je imunosupresiv.
Leflunomide ratiopharm is a medicine that contains the active substance leflunomide. 
Leflunomide ratiopharm je lijek koji sadrži djelatnu tvar leflunomid.
What are the benefits and risks of Leflunomide ratiopharm? 
Koje su koristi i rizici od lijeka Leflunomide ratiopharm?
Other information about Leflunomide ratiopharm 
Ostale informacije o lijeku Leflunomide ratiopharm
Why has Leflunomide ratiopharm been approved? 
Zašto je Leflunomide ratiopharm odobren?
The Committee recommended that Leflunomide ratiopharm be given marketing authorisation. 
Odbor preporučuje odobrenje lijeka Leflunomide ratiopharm za korištenje u EU-u.
How is Leflunomide ratiopharm used? 
Kako se Leflunomide ratiopharm koristi?
How has Leflunomide ratiopharm been studied? 
Kako je Leflunomide ratiopharm ispitivan?
What is Leflunomide ratiopharm used for? 
Za što se Leflunomide ratiopharm koristi?
What is Leflunomide ratiopharm? 
Što je Leflunomide ratiopharm?
How does Leflunomide ratiopharm work? 
Kako djeluje Leflunomide ratiopharm?
The name of the medicine was changed to Adcirca on 21 October 2009. 
Naziv lijeka promijenjen je u Adcirca 21. listopada 2009.
The full EPAR for Adcirca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Adcirca nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent'). 
Odobrenje se temeljilo na odobrenju danom cjepivu Cialis 2002. godine („informirani pristanak”).
Adcirca is taken as two tablets (40 mg) once a day, with or without food. 
Adcirca se uzima kao dvije tablete (40 mg) jednom na dan, sa ili bez hrane.
tadalafil 
Adcirca tadalafil
Adcirca was more effective than placebo at improving exercise capacity. 
Adcirca je bila djelotvornija od placeba u poboljšavanju kapaciteta vježbanja.
Before treatment, the patients could walk an average of 343 metres in six minutes. 
Prije terapije, bolesnici su mogli hodati prosječno 343 metra u šest minuta.
What is Adcirca? 
Što je Adcirca?
Previously known as Tadalafil Lilly. 
Prethodno poznat pod nazivom Tadalafil Lilly.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response. 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
What measures are being taken to ensure the safe and effective use of Adcirca? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Adcirca?
The main measure of effectiveness was the change in exercise capacity (the ability to carry out physical activity) measured by the distance the patients could walk in six minutes after 16 weeks of treatment. 
Glavna mjera djelotvornosti bila je promjena u kapacitetu tjelesne aktivnosti (sposobnosti izvođenja fizičke aktivnosti) izmjereno udaljenošću koju je bolesnik mogao prehodati unutar šest minuta nakon 16 tjedana terapije.
After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo. 
Nakon 16 tjedana, ova se udaljenost povećala za 26 metara u bolesnika koji su uzimali 40 mg lijeka Adcirca u odnosu na bolesnike koji su uzimali placebo.
Adcirca is used in patients with class II or III disease. 
Adcirca se koristi u bolesnika s klasom II ili III bolesti.
The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity. 
"Klasa" se odnosi na ozbiljnost bolesti: "klasa II" uključuje blago ograničenje fizičke aktivnosti dok "klasa III" uključuje veća ograničenja fizičke aktivnosti.
Other information about Adcirca 
Ostale informacije o lijeku Adcirca
What is the risk associated with Adcirca? 
Koji su rizici povezani s lijekom Adcirca?
Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). 
Adcirca se koristi za terapiju odraslih osoba s pulmonalnom arterijskom hipertenzijom (PAH) kako bi se poboljšao kapacitet vježbanja (sposobnost izvođenja fizičke aktivnosti).
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. 
Ovaj tlak smanjuje količinu kisika koja može ući u krv u pluća, što otežava fizičku aktivnost.
Adcirca is a medicine that contains the active substance tadalafil. 
Adcirca je lijek koji sadrži djelatnu tvar tadalafil.
Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, most of whom had class II or class III disease that was of unknown cause or caused by collagen vascular disease. 
Četiri doze lijeka Adcirca (2,5, 10, 20 i 40 mg jednom na dan) uspoređene su s placebom (prividnim liječenjem) u jednom glavnom ispitivanju koje je obuhvatilo 406 bolesnika s PAH-om, većina od kojih je imala klasu II ili kjlasu III bolesti, u slučaju kojih uzrok nije bio poznat ili su uzrokovane kolagenskom vaskularnom bolesti.
Patients with mild or moderate kidney or liver problems should start with a lower dose, but this can be increased if 
Bolesnici s blagim ili umjerenim problemima s bubrezima ili jetrom trebaju započeti s manjim dozama, no iste se mogu povećati ako je to potrebno ovisno o odgovoru bolesnika.
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 Adcirca. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Adcirca.
The active substance in Adcirca, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme. 
Djelatna tvar lijeka Adcirca, tadalafil, ubraja se u grupu lijekova naziva "inhibitori fosfodijesteraze tipa 5 (PDE5)", što znači da blokira enzim PFE5.
A risk management plan has been developed to ensure that Adcirca is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Adcirca.
The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet). 
Najčešće nuspojave lijeka Adcirca (uočene u više od 1 na 10 bolesnika) su glavobolja, crvenilo (crvenjenje kože), nazofaringitis (upala nosa i grla) uključujući začepljenje ili curenje nosa i začepljene sinuse, mučninu (osjećaj slabosti), dispepsiju (žgaravicu) uključujući trbuhobolju, mijalgiju (mišićnu bol), bolna leđa i bol u ektremitetima (rukama, dlanovima, nogama i stopalima).
For more information about treatment with Adcirca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Adcirca pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Why has Adcirca been approved? 
Zašto je Adcirca odobren?
Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (another medicine to treat pulmonary hypertension). 
Adcirca se ne smije uzimati s nitratima (grupom lijekova koji se koriste za liječenje angine) ili lijekovima kategorije "stimulatori guanilaz ciklaze" poput riociguata (drugog lijeka za liječenje pulmonalne hipertenzije).
This is a summary of the European public assessment report (EPAR) for Adcirca. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Adcirca.
It must not be used in patients who have ever had loss of vision because of a problem called nonarteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the eye. 
Ne smije se koristiti u bolesnika koji su ikad izgubili vid zbog problema poznatog pod nazivom nearterijsja anteriorna ishemijska optička neuropatija (NAION) koja utječe na dotok krvi u živac u oku.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adcirca, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Adcirca nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
PAH is abnormally high blood pressure in the arteries of the lungs. 
PAH je abnormalno visoki krvni tlak u arterijama pluća.
When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes the relaxation and widening of the blood vessels. 
Nakon što se enzim inhibira, tvar naziva "ciklični guanozni monofosfat" (cGMP) ne može se rastaviti i ostaje u krvnim žilama gdje uzrokuje opuštanje i širenje krvnih žila.
Adcirca treatment should only be started and monitored by a doctor who has experience in the treatment of PAH. 
Terapija lijekom Adcirca mora se primjenjivati pod nadzorom liječnika koji ima iskustva u liječenju PAH-a.
The CHMP decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka Adcirca nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Adcirca has been shown to be effective in PAH with no identified cause and in PAH caused by collagen vascular disease. 
Utvrđena je učinkovitost lijeka Adcirca za liječenje PAH-a bez identificiranog uzroka, te u slučaju PAH-a uzrokovanog kolagenskom vaskularnom bolešću.
It causes high blood pressure in the vessels taking blood from the heart to the lungs. 
Ovo uzrokuje visoki krvni tlak u krvnim žilama koje uzimaju krv iz srca u pluća.
In patients with PAH, Adcirca widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms. 
U bolesnika s PAH-om, Adcirca šiti krvne žile pluća, što smanjuje krvni tlak i poboljšava simptome.
What is Adcirca used for? 
Za što se Adcirca koristi?
The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Adcirca na snazi u Europskoj uniji od 1. listopada 2008.
Adcirca is not recommended for patients with severe kidney or liver problems. 
Primjena lijeka Adcirca ne preporuča se u bolesnika s ozbiljnim oštećenjem bubrega ili jetre.
How is Adcirca used? 
Kako se Adcirca koristi?
How does Adcirca work? 
Kako djeluje Adcirca?
What benefit has Adcirca shown during the studies? 
Koje su koristi lijeka Adcirca utvrđene u ispitivanjima?
For the full list of all side effects and restrictions with Adcirca, see the package leaflet. 
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Adcirca potražite u uputi o lijeku.
How has Adcirca been studied? 
Kako je Adcirca ispitivan?
Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the last three months, or who have severe hypotension (low blood pressure). 
Adcirca se ne smije koristiti u bolesnika koji su imali akutni infarkt miokarda (iznenadni srčani udar) unutar posljednja tri mjeseca ili koji imaju ozbiljnu hipotenziju (niski krvni tlak).
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States 
Popis naziva lijekova, farmaceutskih oblika, jačina lijekova, puteva primjene i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
Nebido parenteral use 
Nebido parenteralno
Urbanización La Florida 28023 Madrid Spain 
Urbanización La Florida 28023 Madrid
MSD France 34, avenue Léonard de Vinci 
Francuska MSD France 34, avenue Léonard de Vinci
Vojvodići 25, Novaki Sveta Nedelja 
Hospitalija trgovina d.o.o. Vojvodići 25, Novaki Sveta Nedelja
Agovirin depot suspension for injection 
Agovirin depot suspenzija za injekciju
Germany MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 
Njemačka MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
94250 Gentilly France 
94250 Gentilly
FERRING SAS 7, rue Jean-Baptiste Clément 
Francuska FERRING SAS 7, rue Jean-Baptiste Clément
PIERRE FABRE IBERICA S.A. 
Španjolska PIERRE FABRE IBERICA S.A.
Germany Rotexmedica GmbH Arzneimittelwerk 
Njemačka Rotexmedica GmbH Arzneimittelwerk
Germany Lilly Deutschland GmbH Teichweg 3 
Njemačka Lilly Deutschland GmbH Teichweg 3
Germany Pierre Faber Pharma GmbH Jechtlinger Str. 13 
Njemačka Pierre Faber Pharma GmbH Jechtlinger Str. 13
Germany Dr. August Wolff GmbH&Co. 
Njemačka Dr. August Wolff GmbH&Co.
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom testosterone undecanoate Restandol 40mg capsule oral use 
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom testosterone undecanoate Restandol 40mg kapsule na usta
DESMA LABORATORIO FARMACÉUTICO, S.L. 
Španjolska DESMA LABORATORIO FARMACÉUTICO, S.L.
Germany Ferring Arzneimittel GmbH Fabrikstr.7 
Njemačka Ferring Arzneimittel GmbH Fabrikstr.7
Ferring B.V. 
Nizozemska Ferring B.V.
Germany Eifelfango ChemischPharmazeutische Wrke GmbH&Co. 
Njemačka Eifelfango ChemischPharmazeutische Wrke GmbH&Co.
BAYER HISPANIA, S.L. 
Španjolska BAYER HISPANIA, S.L. Avda.
BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate 
Francuska BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate
FERRING, S.A.U. 
Španjolska FERRING, S.A.U.
Axxeron transdermal spray, solution 
Axxeron transdermalni sprej, otopina
6090 Etterstad N-0601 
Norveška Eli Lilly Norge AS P.B. 6090 Etterstad N-0601
Germany Jenapharm GmbH&CO. 
Njemačka Jenapharm GmbH&CO.
Luxembourg Bayer S.A.-N.V. 14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium testosterone undecanoate Nebido 
Luksemburg Bayer S.A.-N.V. 14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium testosterone undecanoate Nebido
capsule, soft oral use 
kapsule, meke na usta
DE-13342 Berlin 
D-13342 Berlin
AGOVIRIN DEPOT 5 mg/2 ml suspension for injection 
AGOVIRIN DEPOT 5 mg/2 ml suspenzija za injekciju
22,5 mg/patch patch 
22,5 mg/patch flaster
capsules oral use 
kapsule na usta
Germany GALENpharm GmbH Wittland13 
Njemačka GALENpharm GmbH Wittland13
92400 Courbevoie France testosterone undecanoate PANTESTONE 40 mg, capsule molle capsule, soft oral use 
92400 Courbevoie France testosterone undecanoate PANTESTONE 40 mg, capsule molle kapsule, meke na usta
Ferring GmbH Wittland 11 + Kiel D-24109 
Bugarska Ferring GmbH Wittland 11 + Kiel D-24109
Germany Laboratoires Besins international 
Njemačka Laboratoires Besins international
Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne Billancourt France 
45, place Abel Gance 92100 Boulogne Billancourt France
Pierre FABRE MEDICAMENT 45, place Abel Gance, 92100 Boulogne Billancourt France 
45, place Abel Gance, 92100 Boulogne Billancourt France
Axiron 30mg/1,5ml Lösung zur Anwendung auf der Haut solution 
Axiron 30mg/1,5ml Lösung zur Anwendung auf der Haut otopina
Ferring Legemidler AS Nydalsveien 36B 0484 Oslo 
Norveška Ferring Legemidler AS Nydalsveien 36B
ANDROTARDYL 250 mg/1 ml, solution injectable intramusculaire solution 
ANDROTARDYL 250 mg/1 ml, solution injectable intramusculaire otopina
Andriol Testocaps 40 mg - Kapseln capsule, soft oral use 
Andriol Testocaps 40 mg - Kapseln kapsule, meke na usta
Germany testosterone undecanoate Andriol Testocaps capsule oral use 
Germany testosterone undecanoate Andriol Testocaps kapsule na usta
Sweden Laboratoires Besins International 
Mađarska Laboratoires Besins International
Andriol Testocaps, 40 mg capsules capsule, soft oral use 
Andriol Testocaps, 40 mg capsules kapsule, meke na usta
Ferring GmbH Wittland 11 
Slovenija Ferring GmbH Wittland 11
50 mg/5 g transdermal gel 
50 mg/5 g transdermalni gel
Ramón Trías Fargas, 7-11 08005 Barcelona Spain 
Ramón Trías Fargas, 7-11
Pierre Fabre Farmaka AE l. Mesogion 350 
Pierre Fabre Farmaka AE l.
30 mg/patch patch 
30 mg/patch flaster
2,5 mg/25 mg/ ml suspension for injection 
2,5 mg/25 mg/ ml suspenzija za injekciju
15 mg/patch patch 
15 mg/patch flaster
PROSTRAKAN LIMITED Galabank Bussines Park Galashield 
Španjolska PROSTRAKAN LIMITED Galabank Bussines Park Galashield
Ferring Magyarország Gyógyszerkereskedelmi Kft. Tomori u. 34. 
Mađarska Ferring Magyarország Gyógyszerkereskedelmi Kft.
25 mg/ml 2,5 mg/ml suspension for injection 
25 mg/ml 2,5 mg/ml suspenzija za injekciju
Ferring Lægemidler A/S (F) Kay Fiskers Plads 11. 
Ferring Lægemidler A/S (F) Kay Fiskers Plads 11. 2300 Köbenhavn S Denmark testosteronum
Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate 
GEYMONAT S.P.A. Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate
Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Germany 
Bayer Pharma AG Müllerstrasse 170-178 DE-13342 Berlin Germany
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co. Dublin Ireland testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use 
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co.
The Netherlands testosterone undecanoate Andriol capsule, soft oral use 
The Netherlands testosterone undecanoate Andriol kapsule, meke na usta
TESTIM 50 mg transdermalni gel transdermal gel 
TESTIM 50 mg transdermalni gel transdermalni gel
The Netherlands testosterone undecanoate Testocaps capsule, soft oral use 
The Netherlands testosterone undecanoate Testocaps kapsule, meke na usta
5340 BH Oss The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula capsule, soft oral use 
The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula kapsule, meke na usta
PharmaSwiss Ceska republika s.r.o. 
Bugarska PharmaSwiss Ceska republika s.r.o.
1000 mg/dose solution for injection 
1000 mg/dose otopina za injekciju
Bayer Pharma AG 13342 Berlin Germany 
Bayer Pharma AG DE-13342 Berlin Germany
ProStrakan Ltd Galabank Business Park Galashiels, TD1 1PR United Kingdom 
Norveška ProStrakan Ltd Galabank Business Park Galashiels, TD1 1PR United Kingdom
Pierre Fabre Farmaka AE l. Mesogion 350, 15341 Ag. Paraskevi Greece 
Mesogion 350, 15341 Ag.
2,4mg/24h, transdermales Pflaster transdermal patch 
2,4mg/24h, transdermales Pflaster transdermalni flaster
Axxeron cutaneous solution 
Axxeron otopina za kožu za kožu
Luxembourg Besins International S.A. 3, rue du Bourg l'Abbe 75003 Paris 
Luksemburg Besins International S.A. 3, rue du Bourg l'Abbe 75003 Paris
Lithuania Bayer Pharma AG Mullerstrasse 178 
Bugarska Bayer Pharma AG Müllerstraße 178
Lithuania N.V. ORGANON P.O. 
N.V. ORGANON P.O. Box 20
N.V. Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor capsule, soft oral use 
N.V. Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor kapsule, meke na usta
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol capsule, soft oral use 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol kapsule, meke na usta
1,8mg/24h, transdermales Pflaster transdermal patch 
1,8mg/24h, transdermales Pflaster transdermalni flaster
1,2mg/24h, transdermales Pflaster transdermal patch 
1,2mg/24h, transdermales Pflaster transdermalni flaster
Denmark Bayer Pharma AG Müllerstrasse 170-178 
Mađarska Bayer Pharma AG Müllerstrasse 178
Bayer Pharma AG Müllerstraße 178 D-13353 Berlin Germany testosteron undecanoate Nebido 
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosterone undecanoate Nebido
2.4 mg/24 h transdermal patch 
2.4 mg/24 h transdermalni flaster
N.V. ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule oral use 
N.V. ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsule na usta
2.4 mg/24h transdermal patch 
2.4 mg/24h transdermalni flaster
Sweden Bayer Pharma AG DE-13342 Berlin 
Slovenija Bayer Pharma AG 13342 Berlin
Germany ProStrakan Limited Galabank Business Park TD1 QH Galashiels United Kingdom 
Njemačka ProStrakan Limited Galabank Business Park TD1 QH Galashiels United Kingdom
1.8 mg/24 h transdermal patch 
1.8 mg/24 h transdermalni flaster
1.8 mg/24h transdermal patch 
1.8 mg/24h transdermalni flaster
1050 Brussels 
08005 Barcelona
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg kapsule, meke na usta
Androgel 50 mg gel in sachet gel in sachet 
Androgel 50 mg gel in sachet gel u vrećici
1.2 mg/24 h transdermal patch 
1.2 mg/24 h transdermalni flaster
1.2 mg/24h transdermal patch 
1.2 mg/24h transdermalni flaster
50 mg/dose gel in sachetdose 
50 mg/dose gel u vrećici
3, rue du Bourg l´ Abbé FR-75003 Paris 
3, rue du Bourg l'Abbé 75003 Paris
BESINS INTERNACIONAL 3, Rue du Bourg l'Abbe 75003 Paris 
Španjolska BESINS INTERNACIONAL 3, Rue du Bourg l'Abbe 75003 Paris
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate UNDESTOR TESTOCAPS 40 mg, capsule moi capsules soft 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsule, meke na usta
Androgel 25 mg gel in sachet gel in sachet 
Androgel 25 mg gel in sachet gel u vrećici
ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom 
Mađarska ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
Androtop 50 mg gel v blazinici gel in sachet 
Androtop 50 mg gel v blazinici gel u vrećici
Androtop 25 mg gel v blazinici gel in sachet 
Androtop 25 mg gel v blazinici gel u vrećici
25 mg/dose gel in sachetdose 
25 mg/dose gel u vrećici
Denmark ProStrakan Ltd. Galabank Business Park TD1 1QH Galashiels United Kingdom 
Francuska PROSTRAKAN Ltd Galabank Business Park TD1 1QH Galashiels United Kingdom
The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases. 
Postupak rekonstitucije obično traje nekoliko minuta, ali u nekim slučajevima može biti potrebno do 15 minuta.
Key elements to be included in the educational material 
Ključni sadržaji koje treba uključiti u edukacijski materijal
This medicine is usually injected by a nurse or a doctor. 
Ovaj lijek obično daje medicinska sestra ili liječnik.
A very serious allergic reaction to this medicine is rare. 
Vrlo ozbiljna alergijska reakcija na ovaj lijek je rijetka.
These could be symptoms of a severe allergic reaction. 
To mogu biti simptomi teške alergijske reakcije.
Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013 
Datum prvog odobrenja: 17/02/2009 Datum posljednje obnove: 19/09/2013
Repeat the reconstitution procedure for the second dose. 
Ponovite postupak rekonstitucije za drugu dozu.
Liver function may need to be monitored. 
Može biti potrebno nadzirati funkciju jetre.
Results of the confirmatory Phase III study 
Rezultati potvrdnog ispitivanja faze III
Therefore, all cardiovascular risk factors should be taken into account. 
Stoga treba uzeti u obzir sve čimbenike rizika za kardiovaskularnu bolest.
This difference was statistically significant (p<0.001). 
Ta je razlika bila statistički značajna (p<0,001).
Changes in laboratory parameters 
Promjene laboratorijskih parametara