natgillin/translations-raw huggingface dataset:
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
The distribution volume in healthy elderly men is approximately 1 l/kg.
Volumen distribucije u zdravih muškaraca starije dobi približno je 1 l/kg.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste dobili bez recepta.
What FIRMAGON is and what it is used for
Što je FIRMAGON i za što se koristi
Of the 610 patients treated
Od 610 liječenih bolesnika bilo ih je
Plasma protein binding is estimated to be approximately 90%.
Procjenjuje se da je vezanje za proteine plazme približno 90%.
DK-2300 Copenhagen S Denmark
DK-2300 Copenhagen S Danska
Do not give this medicine to children or adolescents.
Ne primjenjujte ovaj lijek u djece ili adolescenata.
Hence, the procedure described below need to be repeated a second time.
Stoga postupak opisan u nastavku treba ponoviti još jedanput.
Do not inject directly into a vein.
Ne ubrizgavajte izravno u venu.
If blood appears in the syringe, the medicinal product can no longer be used.
Ako se u štrcaljki pojavi krv, lijek se više ne može upotrijebiti.
The median age was 74 years (range 47 to 98 years).
Medijan dobi bio je 74 godine (raspon od 47 do 98 godina).
• 7% had an unknown metastatic status
• 7% s nepoznatim metastatskim statusom
Please tell your doctor if you have any of the following:
Molimo obavijestite svog liječnika ako imate nešto od sljedećeg:
Instructions for proper use NOTE:
Upute za pravilnu primjenu NAPOMENA:
FIRMAGON is available in 2 pack-sizes.
FIRMAGON je dostupan u 2 veličine pakiranja.
Long-term effect
Dugotrajni učinak
Effect on prostate volume
Učinak na volumen prostate
Therefore, no other dose concentrations than the recommended should be used.
Zbog toga se ne smiju primjenjivati druge koncentracije doza osim preporučenih.
− Osteoporosis or any condition that affects the strenght of your bones.
− osteoporozu ili stanje koje utječe na čvrstoću Vaših kostiju.
This is due to the pharmacological effect; and the effect was reversible.
To je posljedica farmakološkog učinka, a taj je učinak bio reverzibilan.
− excessive sweating (including night sweats), rash
− prekomjerno znojenje (uključujući noćna znojenja), osip
Other medicines and FIRMAGON
Drugi lijekovi i FIRMAGON
If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.
Smatrate li da ste zaboravili na svoju mjesečnu dozu lijeka FIRMAGON, molimo obratite se svom liječniku.
Due to the risk of microbial contamination, this medicine should be used immediately.
Zbog rizika od kontaminacije mikroorganizmima, ovaj lijek treba upotrijebiti odmah.
Perform a deep subcutaneous injection.
Primijenite duboku supkutanu injekciju.
If not used immediately, the use of this medicine are the responsibility of the user.
Ako se ne upotrijebi odmah, primjena ovog lijeka odgovornost je korisnika.
The first maintenance dose should be given one month after the starting dose.
Prvu dozu održavanja potrebno je dati mjesec dana nakon početne doze.
Mannitol (E421), water for injections
manitol (E421), voda za injekcije
These side effects may be due to the treatment or effects resulting from the underlying disease.
Te nuspojave mogu biti posljedica liječenja ili učinaka koji su posljedica osnovne bolesti.
• Information on the identified and potential risks
• podatke o utvrđenim i potencijalnim rizicima.
• Information on gel depot formation and possible injections site reactions
• informacije o stvaranju gel depoa i moguće reakcije na mjestu primjene injekcije
Contents of the pack and other information What FIRMAGON contains
Sadržaj pakiranja i druge informacije Što FIRMAGON sadrži
Neutropenic fever
neutropenijska vrućica
Choose a different injection site and inject 3 ml.
Izaberite drugo mjesto za primjenu injekcije i ubrizgajte 3 ml.
The instructions for reconstitution must be followed carefully.
Pažljivo slijedite upute za rekonstituciju.
In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary.
U slučaju predoziranja bolesnika je potrebno nadzirati i, u slučaju potrebe, primijeniti odgovarajuće potporno liječenje.
UNIQUE IDENTIFIER - HUMAN READABLE DATA
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKO
Therefore in such patients, the benefit/risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Stoga se u takvih bolesnika mora temeljito procijeniti omjer koristi i rizika pri primjeni lijeka FIRMAGON (vidjeti dijelove 4.5 i 4.8).
Preclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential revealed no special hazard for humans.
Neklinička ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala nisu pokazala poseban rizik za ljude.
Baseline demographics were similar between the arms.
Početni demografski podaci bili su slični u sve tri skupine.
This medicine is stable for 2 hours at 25ºC.
Ovaj lijek je stabilan 2 sata na temperaturi od 25 ºC.
The European Medicines Agency has waived the obligation to submit the results of studies with FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka FIRMAGON u svim podskupinama pedijatrijske populacije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Prekinite postupak i bacite štrcaljku i iglu (za bolesnika rekonstituirajte novu dozu).
Intramuscular administration is not recommended as it has not been studied.
Intramuskularna primjena se ne preporučuje jer nije ispitana.
− If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).
− ako ste alergični na degareliks ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Maintenance dose - monthly administration
Doza održavanja - mjesečna primjena