natgillin/translations-raw huggingface dataset:
Nonacog gamma is not extracted from human blood but is made by a method known as ‘recombinant DNA technology': it is made by hamster cells into which a gene (DNA) has been introduced that makes the cells able to produce the human clotting factor.
Nonakog gama se ne pridobiva iz človeške krvi, temveč se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri v hrčkove celice vstavijo gen (DNK), s katerim te lahko tvorijo humani faktor strjevanja krvi.
What are the risks associated with Rixubis?
Kakšna tveganja so povezana z zdravilom Rixubis?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rixubis, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Rixubis in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is Rixubis and what is it used for?
Kaj je zdravilo Rixubis in za kaj se uporablja?
The benefits of Rixubis in treating and preventing bleeding episodes have been shown in three main studies involving patients with severe or moderately severe haemophilia B. None of the studies compared the effectiveness of Rixubis directly with another medicine.
Koristi zdravila Rixubis pri zdravljenju in preprečevanju epizod krvavitev so dokazali v treh glavnih študijah, v katerih so sodelovali bolniki s hudo ali zmerno hudo hemofilijo B. V nobeni od študij niso neposredno primerjali učinkovitosti zdravila Rixubis z drugim zdravilom.
Why is Rixubis approved?
Zakaj je bilo zdravilo Rixubis odobreno?
What benefits of Rixubis have been shown in studies?
Kakšne koristi je zdravilo Rixubis izkazalo v študijah?
Rixubis can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Izdaja zdravila Rixubis je le na recept, zdravljenje pa mora biti uvedeno pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
The Committee considered that Rixubis had been shown to be effective in preventing and treating bleeding episodes in adults and children with haemophilia B, and was also effective in allowing them to undergo surgery safely.
Odbor je menil, da je bilo dokazano, da je zdravilo Rixubis učinkovito pri preprečevanju in zdravljenju epizod krvavitev pri odraslih in otrocih s hemofilijo B, poleg tega pa jim je omogočilo varen kirurški poseg.
For more information about treatment with Rixubis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rixubis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For full details, see the package leaflet.
Za vse podrobnosti glejte navodilo za uporabo.
Patients or their carers may be able to administer Rixubis themselves at home once they have been trained appropriately.
Bolniki si lahko doma sami injicirajo zdravilo Rixubis oziroma to storijo njihovi negovalci, ko se za to ustrezno usposobijo.
Rixubis must not be used in patients who are hypersensitive (allergic) to nonacog gamma or any of its other ingredients, or who are known to be allergic to hamster protein.
Zdravila Rixubis ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) nonakog gama ali katero koli drugo sestavino zdravila ali na beljakovine hrčkov.
Rixubis is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Zdravilo Rixubis je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje v veno.
For practical information about using Rixubis, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Rixubis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Rixubis, nonacog gamma, is a version of human factor IX and helps the blood to clot in the same way.
Zdravilna učinkovina zdravila Rixubis, nonakog gama, je različica humanega faktorja IX in na enak način pomaga pri strjevanju krvi.
Patients with haemophilia B lack factor IX, which is needed for blood to clot properly.
Bolnikom s hemofilijo B primanjkuje faktorja IX, ki je potreben za pravilno strjevanje krvi.
For the full list of all side effects with Rixubis see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rixubis, glejte navodilo za uporabo.
Rixubis can therefore be used to replace the missing factor IX, giving temporary control of the bleeding disorder.
Zdravilo Rixubis se tako uporablja za nadomeščanje manjkajočega faktorja IX, s čimer se začasno vzpostavi nadzor nad motnjo strjevanja krvi.
Rixubis is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of factor IX.
Zdravilo Rixubis se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja IX.
How does Rixubis work?
Kako zdravilo Rixubis deluje?
Rixubis contains the active substance nonacog gamma.
Zdravilo Rixubis vsebuje zdravilno učinkovino nonakog gama.
How is Rixubis used?
Kako se zdravilo Rixubis uporablja?
In a third study, Rixubis was given to 14 patients undergoing surgery; treatment with Rixubis kept blood loss during the surgery to levels expected in patients without haemophilia B.
V tretji študiji je zdravilo Rixubis prejelo 14 bolnikov, ki so čakali na kirurški poseg.
PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for re-examination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Odbor PRAC je upošteval tudi razloge, ki jih je predložila družba LFB Biomedicaments kot podlago za zahtevo za ponovno preučitev priporočila odbora PRAC, ter mnenji z dveh strokovnih sestankov, ki sta potekala 22. februarja in 3. avgusta 2017;
Four-year results from the European HAemophilia Safety Surveillance (EUHASS) project.
HAemophilia Safety Surveillance (EUHASS) project.
• Patient-related risk factors include type of F8 gene mutation, severity of haemophilia, ethnicity, family history of inhibitor development and possibly HLA-DR (Human Leukocyte Antigenantigen D Related) constitution.
• dejavniki tveganja, povezani z bolniki, obsegajo vrsto mutacije gena F8, resnost hemofilije, etnično pripadnost, družinsko anamnezo pojava zaviralcev in morda sestavo HLA-DR (humani levkocitni antigen - povezan z antigenom D);
However the PRAC is of the view that there are uncertainties with regards to the findings of the SIPPET study which preclude the conclusion that there is a higher risk of inhibitor development in PUPs treated with rFVIII products than pdFVIII products studied in this clinical trial, as detailed below:
Vendar odbor PRAC meni, da obstajajo negotovosti v zvezi z ugotovitvami študije SIPPET, ki preprečujejo zaključek, da obstaja večje tveganje za pojav zaviralcev pri predhodno zdravljenih bolnikih z rFVIII kot s pdFVIII v zdravilih, preučenih v tem kliničnem preskušanju, kot je podrobno opisano v nadaljevanju:
T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, RousselRobert V, Serban M, Tagliaferri A, Windyga J, Zanon E: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
Iorio A, Barbara AM, Makris M, Fischer K, Castaman G, Catarino C, Gilman E, Kavakli K, Lambert T, Lassila R, Lissitchkov T, Mauser-Bunschoten E, Mingot-Castellano ME0, Ozdemir N1, Pabinger I, Parra R1, Pasi J, Peerlinck K, Rauch A6, RousselRobert V, Serban M, Tagliaferri A, Windyga J, Zanon E: Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series.
Therefore, there is a high degree of uncertainty around extrapolating the SIPPET findings to the entire rFVIII class, particularly for more recently-authorised rFVIII products which were not included in the SIPPET trial.
Zato obstaja velika negotovost glede ekstrapolacije ugotovitev študije SIPPET na celoten razred rFVIII, zlasti za nedavno odobrena zdravila z rFVIII, ki niso bila vključena v preskušanje SIPPET;
However, despite the lack of robust evidence to support differential risks between rFVIII products, differential risks cannot be excluded, as this is a heterogeneous product class with differences in composition and formulations.
različnega tveganja med zdravili z rFVIII slednjega ni mogoče izključiti, saj gre za heterogen razred zdravil z razlikami v sestavi in formulacijah.
For high-titre inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98).
Za zaviralce z visokim titrom je bilo razmerje ogroženosti 1,69 (95-odstotni IZ od 0,96 do 2,98).
It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Ugotovili so, da je pri bolnikih, zdravljenih z zdravili z rFVIII, za 87 % večja pojavnosti vseh zaviralcev kot pri bolnikih, zdravljenih s pdFVIII (ki je vseboval VWF) (razmerje ogroženosti 1,87; 95-odstotni IZ od 1,17 do
The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4-1.3).
V študiji CANAL2 niso našli dokazov o razlikah med razredi, vključno z zdravili s pdFVIII z znatnimi količinami von Willebrandovega faktorja, tako da je bilo za „klinično pomembne“ ravni zaviralcev popravljeno razmerje tveganja 0,7 (95-odstotni IZ 0,4-1,1), za visoke titre zaviralcev (≥ 5 BU) pa 0,8 (95-odstotni IZ 0,4-1,3).
Results of clinical studies not sufficiently robust (e.g. suffering from methodolical
Rezultati kliničnih študij, ki niso dovolj robustni (npr. imajo metodološke omejitve), se ne smejo odražati v informacijah o zdravilih s FVIIII.
Inhibitors are less likely to occur in previouslytreated patients (PTPs).
Pri predhodno zdravljenih bolnikih (PTP) se zaviralci manj pogosto pojavijo.
The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII
Študija SIPPET je bila neslepo, randomizirano, multicentrično, večnacionalno preskušanje, v kateri so preučili pojavnost nevtralizirajočih aloprotiteles pri bolnikih s hudo prirojeno hemofilijo A (plazemska koncentracija FVIII < 1 %) s koncentrati pdFVIII ali rFVIII.
- http://www.bloodjournal.org/content/121/20/4046.full.pdf
- http://www.bloodjournal.org/content/121/20/4046.full.pdf so iz študije izključili bolnike iz Združenega kraljestva (vključeni tudi v študijo RODIN/Pednet).
(another 3rd generation rFVIII) vs Advate, but only for all inhibitor development.
V študiji so odkrili tudi dokaze za povečano tveganje z zdravilom Refacto AF (drugo zdravilo z rFVIII 3. generacije) v primerjavi z zdravilom Advate, vendar le za vse titre zaviralcev.
ATC vet code: QI07AJ06.
Oznaka ATC vet: QI07AJ06.
Suspension: pink colour with fine sediment.
Suspenzija: rožnato obarvana s finim sedimentom.
MARKETING AUTHORISATION NUMBER(S) EU/2/14/163/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/163/001
In case of need, dogs younger than 8 weeks can be vaccinated as safety of this product has been demonstrated in 6 weeks old dogs.
Če je potrebno, lahko cepimo pse, mlajše od 8 tednov, saj je bila varnost tega cepiva dokazana pri psih, starih 6 tednov.
Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae) - živa in inaktivirana virusna in inaktivirana bakterijska cepiva.
MANUFACTURER'S BATCH NUMBER Lot {number}
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot{številka}
The duration of immunity against CAV-2 was not established by challenge.
Trajanje imunosti proti CAV-2 ni bilo določeno s preizkusom provokacije.
In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
V primeru potovanja na območja z večjim tveganjem ali izven EU se lahko veterinarji odločijo za dodatna cepljenja proti steklini po 12. tednu starosti, da zagotovijo titer protiteles v višini ≥ 0,5 i.e./ml, ki na splošno velja za učinkovito zaščito in obenem izpolnjuje zahteve za potovanje živali (titer protiteles ≥
A single dose of Versican Plus DHPPi/L4R should be given every 3 years.
Enkratni odmerek Versican Plus DHPPi/L4R je potrebno dati vsaka 3 leta.
Two doses of Versican Plus DHPPi/L4R 3-4 weeks apart from 8-9 weeks of age.
Dva odmerka cepiva Versican Plus DHPPi/L4R v razmaku 3-4 tednov od starosti 8-9 tednov naprej.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje kuge, pasji parvovirus, pasji adenovirus tipa 1 in 2, virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae in virus stekline.
At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and rabies.
Vsaj tri leta po osnovnem cepljenju proti virusu pasje kuge, pasjemu adenovirusu tipa 1, pasjemu adenovirusu tipa 2, pasjemu parvovirusu in steklini.
Annual re-vaccination is required for Parainfluenza and Leptospira components therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Vsako leto je treba ponoviti cepljenje proti virusu parainfluence in komponente Leptospire, za kar se lahko letno uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi/L4 na leto kot je potrebno.
Name and address of the manufacturer of the biological active substances
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin):
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
In this case the second vaccination with Versican Plus DHPPi/L4R should not be given before 12 weeks.
Za prvi odmerek se lahko uporabi cepivo Versican Plus DHPPi/L4, vendar pa v tem primeru cepiva Versican plus DHPPi/L4R za drugo cepljenje ne smete uporabiti pred 12 tednom starosti.
Lyophilisate (live attenuated):
Učinkovina(e): Liofilizat (živi atenuirani):
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Vsak odmerek po (1 ml) vsebuje:
PACKAGE LEAFLET: Versican Plus DHPPi/L4R lyophilisate and suspension for suspension for injection for dogs
Versican Plus DHPPi/L4R liofilizat in suspenzija za suspenzijo za injiciranje za pse
Name and address of the manufacturer responsible for batch release
ČEŠKA Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
ADVICE ON CORRECT ADMINISTRATION Aseptically reconstitute the lyophilisate with suspension.
Odmerjanje in pot uporabe: Aseptično rekonstituirajte liofilizat s suspenzijo.
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R lyophilisate and suspension for suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus DHPPi/L4R liofilizat in suspenzija za suspenzijo za injiciranje za pse
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju 10- krat prevelikega odmerka cepiva ni bilo opaziti neželenih učinkov, razen tistih, navedenih v poglavju 4.6.
Suspension (inactivated) : L. interrogans serovar Icterohaemorrhagiae
L. interrogans serovar Icterohaemorrhagiae titer ALR ≥ 1:51
Australis serovar Bratislava, - to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, - to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, and - to prevent mortality, clinical signs and infection caused by rabies virus.
− za preprečevanje kliničnih znakov, izločanja virusa z urinom in zmanjšanje okužb, ki jih povzroča L.interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae,
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R suspension for dogs
Versican Plus DHPPi/L4R suspenzijaza pse
Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after the first vaccination for CDV, CAV, CPV, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after completion of the primary course for Leptospira components.
− 3 tedne po prvem cepljenju proti CDV, CAV, CPV,
Date of latest renewal: 7 January 2019
Datum zadnjega podaljšanja: 7. januar 2019
• Information about the risk of hepatic reactions and clinical signs of liver problems
• informacije o tveganju za jetrne reakcije in o kliničnih znakih težav z jetri
The Patient's Booklet should contain the following key messages:
Brošura za bolnike mora vsebovati naslednja ključna sporočila:
Thymanax should not be used in children and adolescents (under 18 years old).
Zdravilo Thymanax se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let).
If you stop taking Thymanax Do not stop taking your medicine without the advice of your doctor even if you feel better.
Če ste prenehali jemati zdravilo Thymanax Ne prenehajte jemati zdravila brez zdravniškega nasveta, niti če se počutite bolje.
In healthy volunteers agomelatine preserved sexual function in comparison with paroxetine.
Pri zdravih prostovoljcih se je ob jemanju agomelatin, v primerjavi s paroksetinom, ohranjala spolna funkcija.
9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation : 19 February 2009
Datum prve odobritve: 19. februar 2009
You must not use Thymanax if your liver does not work properly.
Zdravila Thymanax ne smete jemati, če vaša jetra ne delujejo pravilno.
Thymanax should therefore not be used in these patients.
Zdravila Thymanax se zato pri teh bolnikih ne sme uporabljati.
The expected benefits of Thymanax are to reduce and gradually remove the symptoms related to your depression.
Pričakovane koristi zdravila Thymanax so zmanjšanje in postopna odprava simptomov, povezanih z depresijo.
Bipolar disorder/ mania / hypomania
Bipolarna motnja / manija / hipomanija
[EU/1/08/498/002] 14 film-coated tablets [EU/1/08/498/003] 28 film-coated tablets [EU/1/08/498/005] 56 film-coated tablets [EU/1/08/498/006] 84 film-coated tablets [EU/1/08/498/007] 98 film-coated tablets [EU/1/08/498/008] 100 film-coated tablets
[EU/1/08/498/002] 14 filmsko obloženih tablet [EU/1/08/498/003] 28 filmsko obloženih tablet [EU/1/08/498/005] 56 filmsko obloženih tablet [EU/1/08/498/006] 84 filmsko obloženih tablet [EU/1/08/498/007] 98 filmsko obloženih tablet [EU/1/08/498/008] 100 filmsko obloženih tablet
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Thymanax therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Thymanax, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances.
Prišlo je do blagih, od odmerka neodvisnih znižanj telesne mase, povezanih s farmakološkimi lastnostmi, in nekaj manjših učinkov na reproduktivni trakt pri samcih, brez okvare uspešnosti razmnoževanja.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Thymanax, are provided with patient booklets to be distributed to their patients being prescribed this medicine.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, ki bodo predvidoma predpisovali ali uporabljali zdravilo Thymanax, prejeli brošure za bolnike, da jih bodo razdelili svojim bolnikom, katerim bodo predpisali to zdravilo.
There is no data on the influence of race on agomelatine pharmacokinetics.
Podatkov o vplivu etnične pripadnosti na farmakokinetiko agomelatina ni.
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Thymanax” in section 3).
Glede na rezultate preiskav se bo zdravnik odločil, ali boste prejeli oz. nadaljevali z jemanjem zdravila Thymanax (glejte tudi poglavje 3 »Kako jemati zdravilo Thymanax«).
How to switch from an antidepressant medicine (SSRI/SNRI) to Thymanax?
Kako zamenjati antidepresiv iz skupine SSRI/SNRI z zdravilom Thymanax?
- alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury.
- motnja uporabe alkohola in/ali uživanje znatnih količin alkohola, ali pri bolnikih, ki sočasno jemljejo zdravila, ki jih spremlja tveganje za poškodbe jeter.
Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
Treatment with Thymanax should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.:
Zdravljenje z zdravilom Thymanax lahko predpišete le po skrbnem pretehtanju koristi in tveganja pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter, kot so npr.:
What Thymanax is and what it is used for What you need to know before you take Thymanax How to take Thymanax
Kaj je zdravilo Thymanax in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Thymanax Kako jemati zdravilo Thymanax
5 How to store Thymanax Contents of the pack and other information
Shranjevanje zdravila Thymanax Vsebina pakiranja in dodatne informacije
The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are expected to prescribe or use Thymanax are provided with the updated educational material containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu na trg in po prihodu na trg vsi zdravniki, ki predpisujejo ali uporabljajo zdravilo Thymanax, prejeli posodobljeno izobraževalno gradivo, ki vsebuje naslednje: