natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY TEAR-OFF LID 
PODATKI NA PRETISNIH OMOTIH ALI TRAKOVIH POKROV PODSTAVKA, KI SE ODTRGA
NAME OF THE MEDICINAL PRODUCT Tegsedi 284 mg solution for injection in pre-filled syringe 
IME ZDRAVILA Tegsedi 284 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
‡ Additional risk factors for bleeding include age >60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events † It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline. 
‡ Dodatni dejavniki tveganja za krvavitev vključujejo starost > 60 let, jemanje antikoagulansov ali antitrombotikov in/ali večje krvavitve v anamnezi.
Your doctor will check your kidney function before treatment and regularly during treatment with Tegsedi. 
Vaš zdravnik bo preveril delovanje vaših ledvic pred zdravljenjem z zdravilom Tegsedi in preverjanje redno ponavljal med zdravljenjem.
Push the plunger down 
Potisnite bat navzdol
The pharmacokinetics of inotersen in patients with hepatic impairment has not been studied. 
Pri bolnikih z okvaro jeter niso preučili farmakokinetike inotersena.
Stage II Disease p<0.001 
stadiju p < 0,001
Skin and subcutaneous disorders 
Bolezni kože in podkožja pruritus izpuščaj
Do not put the needle cap back onto the pre-filled syringe. 
Pokrovčka igle ne skušajte ponovno natakniti na napolnjeno injekcijsko brizgo.
Early initiation of immunosuppressive therapy should be considered if a diagnosis of glomerulonephritis is confirmed. 
Če se potrdi diagnoza glomerulonefritisa, je treba razmisliti o zgodnjem začetku zdravljenja z imunosupresivi.
Tegsedi has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Tegsedi nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The recommended dose of Tegsedi is one dose of 284 mg inotersen. 
Priporočeni odmerek zdravila Tegsedi je en 284 mg odmerek inotersena.
You should see your doctor immediately if you have unexplained bruising or a rash of small patches of red appearing on the skin (called petechiae), bleeding from skin cuts that does not stop or oozes, bleeding from the gums or nose, blood in urine or stools, bleeding in the whites of your eyes. 
Če imate nepojasnjene podplutbe ali drobne rdeče kožne izpuščaje (imenujejo se petehije), ureznine, ki ne prenehajo krvaveti ali se iz njih izloča tekočina, krvavitev iz dlesni ali nosu, kri v urinu ali blatu ali krvavitev v očesno beločnico, morate nemudoma obiskati zdravnika.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema trombocitopenija anemija zmanjšano število trombocitov eozinofilija
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Previous treatment with tafamidis or diflunisal 
Da Ne Predhodno zdravljenje s tafamidisom ali diflusinalom1, n (%)
How to use Tegsedi 
Kako uporabljati zdravilo Tegsedi
Baseline n 
Izhodišče n
Women of child-bearing potential 
Vpliv na sposobnost razmnoževanja
Insert the needle 
Vstavite iglo v kožo
V30M TTR mutation1, n (%) 
Mutacija TTR V30M
Thrombocytopenia 
Skupina CMEhoKG
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 284 mg inotersen (as sodium). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 284 mg inotersena (kot natrijev inotersenat).
mean (SD) 1 Based on clinical database 
Na podlagi klinične podatkovne zbirke.
Put the used pre-filled syringe in a sharps disposal container right away after use. 
Po uporabi zavrzite napolnjeno injekcijsko brizgo v vsebnik za ostre predmete.
Tattoos and scars should also be avoided. 
Odsvetuje se tudi injiciranje na predelih s tetovažami in brazgotinami.
Your pre-filled syringe may make a click sound as you push the plunger down. 
Ko pritisnete bat navzdol, lahko v napolnjeni injekcijski brizgi zaslišite klik.
You should resume the vitamin A supplementation during your second and third trimesters of your pregnancy if your vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester. 
Če se vrednosti vitamina A niso vrnile na normalne ravni, morate v drugem in tretjem trimesečju nosečnosti znova začeti uporabljati dodatek z vitaminom A.
Consequently, only effects related to the chemistry of inotersen could be captured in these investigations. 
Inotersen pri miših in kuncih ni farmakološko aktiven, zato so v teh raziskavah lahko ugotovili samo učinke, povezane s kemijo inotersena.
Tray with tear-off lid. 
Podstavek s pokrovom, ki se odtrga.
Inotersen showed no effects on fertility, embryo-foetal, or postnatal development in mice and rabbits at approximately 3-fold the maximum recommended human equivalent dose. 
Inotersen pri odmerku, ki je ustrezal približno 3-kratnemu največjemu priporočenemu odmerku za ljudi, ni pokazal nobenih učinkov na plodnost, embrio-fetalni ali postnatalni razvoj pri miših in kuncih.
The study evaluated 284 mg inotersen administered as one subcutaneous injection once per week, for 65 weeks of treatment. 
ki se je v 65-tedenskem obdobju zdravljenja uporabljal v obliki ene subkutane injekcije enkrat tedensko.
Inotersen should permanently be discontinued if acute glomerulonephritis is confirmed. 
Če se potrdi akutni glomerulonefritis, je treba trajno prenehati zdravljenje z inotersenom.
Dublin 2, Ireland 
Dublin 2 D02 HW77
Inotersen was not evaluated in patients undergoing liver transplantation in clinical trials (section 4.2). 
Pri bolnikih po presaditvi jeter inotersena v kliničnih preskušanjih niso preučevali.
Other medicines and Tegsedi 
Druga zdravila in zdravilo Tegsedi
The plunger can feel stiff towards the end of the injection. 
Ko je bat že blizu konca brizge, je lahko na občutek bolj tog.
Do not try to replace the cap on the retracted needle. 
Ne skušajte ponovno namestiti pokrovčka, ko je igla že umaknjena v notranjost brizge.
Influenza like illness Peripheral swelling Injection site discolouration 
Splošne težave in spremembe na mestu aplikacije pireksija mrazenje reakcije na mestu injiciranja periferni edem bolezen, podobna gripi periferno otekanje sprememba barve mesta injiciranja
Discontinuation of Inotersen should be considered in patients who develop liver transplant rejection during treatment. 
Pri bolnikih, pri katerih med zdravljenjem pride do zavrnitve presajenih jeter, je treba razmisliti o prenehanju zdravljenja z inotersenom.
This summary was last updated in December 2013. 
Povzetek je bil nazadnje posodobljen decembra 2013.
The European Commission granted a marketing authorisation valid throughout the European Union, for Contacera on 6 December 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Contacera, veljavno po vsej Evropski uniji, izdala 6. decembra 2012.
Other information about Contacera: 
Druge informacije o zdravilu Contacera:
Symptoms were reversible. 
Simptomi so bili prehodne narave.
If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately. 
Če se zdravilo nenamerno injicira, se je treba takoj posvetovati z zdravnikom.
What benefit has Contacera shown during the studies? 
Kakšne koristi je zdravilo Contacera izkazalo med študijami?
It is available as a solution for injection (20 mg/ml) and an oral suspension (15 mg/ml). 
Na voljo je v obliki raztopine za injiciranje (20 mg/ml) in peroralne suspenzije (15 mg/ml).
In horses, a temporary swelling at the injection site can occur but resolves without intervention. 
Pri konjih se lahko pojavi prehodna oteklina na mestu injiciranja, vendar uplahne brez ukrepanja.
What is the risk associated with Contacera? 
Kakšna tveganja so povezana z zdravilom Contacera?
Contacera must not be used in horses less than six weeks of age or in cattle less than one week of age when used in the treatment of diarrhoea. 
Zdravilo se ne sme uporabljati pri konjih, mlajših od šest tednov, ali govedu, mlajšemu od enega tedna, kadar se ta uporablja za zdravljenje driske.
Contacera is a ‘generic', which means that Contacera is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam). 
Zdravilo Contacera je generično zdravilo, kar pomeni, da je podobno referenčnemu veterinarskemu zdravilu, ki je že odobreno v EU (zdravilu Metacam).
Why has Contacera been approved? 
Zakaj je bilo zdravilo Contacera odobreno?
It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients. 
Ne sme se uporabljati pri živalih, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
Consequently, Contacera's benefit is taken as being the same as that of the reference medicine. 
Zato velja, da so njegove koristi enake kot pri referenčnem zdravilu.
Therefore the CVMP's view was that, as for Metacam, Contacera's benefits are greater than its risks when used for the approved indications and the Committee recommended that Contacera be given a marketing authorisation. 
Zato je menil, da so njegove koristi tako kot pri zdravilu Metacam večje od z njim povezanih tveganj pri uporabi za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
For meat the withdrawal period is 15 days and for milk it is five days. 
Karenca za meso je 15 dni, za mleko pa pet dni.
Contacera contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). 
Zdravilo Contacera vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically. 
Po injiciranju se lahko v zelo redkih primerih pojavijo možne resne ali smrtne anafilaktične reakcije (podobne hudim alergijskim reakcijam), ki jih je treba zdraviti simptomatsko.
For meat the withdrawal period is five days. 
Karenca za meso je pet dni.
It is also the time allowed after administration of the medicine before the milk can be used for human consumption. 
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
People who are hypersensitive to NSAIDs should avoid contact with Contacera. 
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Contacera.
Contacera is a medicine that contains the active substance meloxicam. 
Contacera je zdravilo, ki vsebuje zdravilno učinkovino meloksikam.
The product is not authorised for use in horses producing milk for human consumption. 
Zdravilo ni odobreno za uporabo pri konjih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
The CVMP considered that, in accordance with European Union requirements, Contacera has been shown to be bioequivalent to Metacam. 
CVMP je menil, da je bilo dokazano, da je zdravilo Contacera v skladu z zahtevami Evropske unije biološko enakovredno zdravilu Metacam.
For meat the withdrawal period with the 20 mg/ml solution for injection is five days and with the 15 mg/ml oral suspension it is three days. 
Pri uporabi raztopine za injiciranje 20 mg/ml je karenca za meso pet dni, pri uporabi peroralne suspenzije 15 mg/ml pa tri dni.
Information on the prescription status of this product may be found on the label of the carton. 
Podatki o predpisovanju tega zdravila so navedeni na nalepki na zunanji ovojnini.
How has Contacera been studied? 
Kako je bilo zdravilo Contacera raziskano?
Contacera must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract. 
Zdravilo Contacera se ne sme uporabljati pri živalih, ki imajo težave z jetri, srcem ali ledvicami, motnje strjevanja krvi, razdražena prebavila ali razjede v prebavilih.
It can be used for the relief of postoperative pain following dehorning in calves. 
Lahko se uporablja tudi za lajšanje bolečin po kirurški odstranitvi rogov pri teletih.
What is Contacera used for? 
Za kaj se zdravilo Contacera uporablja?
Contacera should not be used in pregnant or lactating mares but it can be used during pregnancy and lactation for cattle and pigs. 
Zdravilo Contacera se ne sme uporabljati pri brejih ali doječih kobilah, lahko pa se v obdobju brejosti uporablja pri govedu in prašičih.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption. 
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
It can be used for diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle. 
Uporablja se lahko tudi pri driski v kombinaciji s peroralno rehidracijo (zdravili, ki jih žival zaužije za vzpostavitev ustrezne ravni vode v telesu) za zmanjševanje kliničnih znakov bolezni pri teletih, starejših od enega tedna, ter pri mladem govedu zunaj obdobja laktacije.
In pigs, Contacera is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome). 
Pri prašičih se zdravilo Contacera uporablja za ublažitev simptomov šepavosti in vnetij pri neinfekcijskih boleznih gibal (boleznih, ki vplivajo na zmožnost gibanja) ter pri zdravljenju bolezni po oprasitvi, kot sta puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalactia), skupaj z ustreznim antibiotičnim zdravljenjem.
Contacera is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder). 
Zdravilo Contacera se pri govedu uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih bolezenskih znakov pri akutni okužbi dihal (okužbi pljuč in dihalnih poti) in za zdravljenje mastitisa (vnetja vimena).
Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine. 
V študijah je bilo ugotovljeno, da je zdravilo Contacera biološko enakovredno referenčnemu zdravilu.
In horses, Contacera is used for the relief of pain associated with colic (abdominal pain) and for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. 
Pri konjih se zdravilo Contacera uporablja za lajšanje bolečin, povezanih s kolikami (trebušnimi bolečinami) ter vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
Since Contacera is a generic medicine, studies have been conducted to show that Contacera has the same characteristics as the reference medicine, Metacam. 
Ker je zdravilo Contacera generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Metacam.
Side effects that occurred with the oral suspension in horses included isolated cases of adverse reactions typically associated with NSAIDs (slight urticaria and diarrhoea). 
Pri dajanju peroralne suspenzije konjem so se pojavili neželeni učinki, ki so značilni za nesteroidna protivnetna zdravila (blažja urtikarija, driska).
What is Contacera? 
Kaj je zdravilo Contacera?
A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs. 
Pri govedu in prašičih so opazili blago prehodno oteklino na mestu injiciranja v podkožje.
How does Contacera work? 
Kako zdravilo Contacera deluje?
The treatment will be repeated every 3 weeks. 
Zdravljenje se ponovi vsake 3 tedne.
Therefore, risks of clinically significant interactions should be unlikely. 
Zato tveganje klinično pomembnih interakcij ni verjetno.
Unopened vial 3 years. 
Neodprta viala 3 leta.
Recent (within 2 weeks) or current severe infection. 
Nedavna (v zadnjih 2 tednih) ali potekajoča huda okužba.
The use of gloves, goggles and protective clothing is recommended. 
Priporočamo uporabo zaščitnih rokavic, zaščitnih očal in zaščitnih oblačil.
All cases resolved rapidly without treatment discontinuation. 
Vsi primeri so izzveneli hitro brez prekinitve zdravljenja.
First Event 
Prvi dogodek
This is considered the most relevant population for the efficacy analysis, as it most closely reflects the population intended for treatment. 
Ta se šteje za najbolj pomembno populacijo za analizo učinkovitosti, saj najbolj odraža populacijo, ki se lahko zdravi.
Therefore, caution should be excercised when this type of combination is used. 
Zato je pri uporabi tovrstnih kombinacij potrebna previdnost.
Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014 
Datum prve odobritve: 09/2009 Datum zadnjega podaljšanja: 05/2014
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
Genetic counselling is also recommended for patients wishing to have children after therapy. 
Genetsko posvetovanje je priporočljivo za bolnike, ki želijo imeti otroke po zdravljenju.
The carcinogenic potential of vinflunine has not been studied. 
Karcinogeni potencial vinflunina ni bil preučen.
Used in children and adolescents 
Uporaba pri otrocih in mladostnikih
Javlor with food and drink 
Zdravilo Javlor skupaj s hrano in pijačo
Store in a refrigerator. 
Zdravilo shranjujte v hladilniku.
Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors. 
Uvesti je treba druge ustrezne ukrepe, kot so transfuzije krvi, dajanje antibiotikov in rastnih faktorjev.
You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor. 
Zdravniku povejte, če pijete sok grenivk, ker lahko poveča učinek zdravila Javlor
You should also drink water and eat high fibre foods. 
Piti morate vodo in uživati živila z visoko vsebnostjo vlaknin.
Procedure for proper handling and disposal of anticancer medicinal products should be considered. 
Upoštevati morate postopek za pravilno ravnanje in odstranjevanje zdravil proti raku.
EU/1/09/550/001 (box of 1 vial of 2 mL with grey stopper) EU/1/09/550/002 (box of 10 vials of 2 mL with grey stopper) EU/1/09/550/003 (box of 1 vial of 4 mL with grey stopper) EU/1/09/550/004 (box of 10 vials of 4 mL with grey stopper) EU/1/09/550/005 (box of 1 vial of 10 mL with grey stopper) EU/1/09/550/006 (box of 10 vials of 10 mL with grey stopper) EU/1/09/550/007 (box of 1 vial of 2 mL with black stopper) EU/1/09/550/008 (box of 10 vials of 2 mL with black stopper) EU/1/09/550/009 (box of 1 vial of 4 mL with black stopper) EU/1/09/550/010 (box of 10 vials of 4 mL with black stopper) EU/1/09/550/011 (box of 1 vial of 10 mL with black stopper) EU/1/09/550/012 (box of 10 vials of 10 mL with black stopper) 
EU/1/09/550/001 (škatla z 1 vialo z 2 ml s sivim zamaškom) EU/1/09/550/002 (škatla z 10 vialami po 2 ml s sivim zamaškom) EU/1/09/550/003 (škatla z 1 vialo s 4 ml s sivim zamaškom) EU/1/09/550/004 (škatla z 10 vialami po 4 ml s sivim zamaškom) EU/1/09/550/005 (škatla z 1 vialo z 10 ml s sivim zamaškom) EU/1/09/550/006 (škatla z 10 vialami po 10 ml s sivim zamaškom) EU/1/09/550/007 (škatla z 1 vialo z 2 ml s črnim zamaškom) EU/1/09/550/008 (škatla z 10 vialami po 2 ml s črnim zamaškom) EU/1/09/550/009 (škatla z 1 vialo s 4 ml s črnim zamaškom) EU/1/09/550/010 (škatla z 10 vialami po 4 ml s črnim zamaškom) EU/1/09/550/011 (škatla z 1 vialo z 10 ml s črnim zamaškom) EU/1/09/550/012 (škatla z 10 vialami po 10 ml s črnim zamaškom)
All resolved during the study. 
V vseh primerih je stanje izzvenelo med študijo.
Vinflunine did not induce peripheral neuropathy in animals. 
Vinflunin ni induciral periferne nevropatije pri živalih.
Each pack contains 1 or 10 vials. 
Pakiranje vsebuje 1 ali 10 vial.
Radiological signs are white matter abnormalities in the posterior regions of the brain. 
Radiološki znaki so nepravilnosti v beli možganovini zadnjih regij možganov.
To avoid extravasations it is important to be sure that the needle is correctly introduced before starting the infusion. 
Za preprečevanje ekstravazacij je pomembno, da se pred začetkom infundiranja prepričate, ali je igla pravilno vstavljena.
No specific clinical studies of vinflunine in combination with these compounds have been carried out yet. 
Specifične klinične študije vinflunina v kombinaciji s tema spojinama niso bile opravljene.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting your therapy. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
There are no data available on the use of vinflunine in pregnant women. 
Nosečnost Ni podatkov o uporabi vinflunina pri nosečnicah.
These toxic effects were dose-related and fully or-partially reversible following a 1-month recovery period. 
Ti toksični učinki so bili odvisni od odmerka ter popolnoma ali delno reverzibilni po enomesečnem obdobju okrevanja.
Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary. 
Zato vinflunina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water. 
Če raztopina pride v stik s kožo, morate ta predel kože nemudoma in temeljito umiti z milom in vodo.
On the basis of the results of animal studies and the pharmacological action of the medicinal product, there is a potential risk of embryonic and foetal abnormalities. 
Na osnovi rezultatov študij na živalih in farmakološkega delovanja zdravila obstaja potencialno tveganje nenormalnosti zarodka in plodu.
In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored. 
V primeru prevelikega odmerjanja mora biti bolnik v specializirani enoti z natančnim spremljanjem življenjskih funkcij.
The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues. 
Terminalni volumen porazdelitve je velik, tj. 2422±676 litrov (približno 35 l/kg), kar nakazuje obsežno porazdelitev v tkivih.
Javlor must not be given intrathecally (into the spine). 
Zdravilo Javlor se ne sme dajati intratekalno (v hrbtenico).
Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2. 
Učinkovitost in varnost vinflunina nista bili preučeni pri bolnikih s telesno zmogljivostjo ≥ 2.
Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3). 
Študije na živalih so pokazale embriotoksičnost in teratogenost (glejte poglavje 5.3).
Organ toxicity: moderate, severe or life threatening 
Na posamezen organ usmerjena toksičnost: zmerna, huda, življenjsko nevarna
Javlor is not intended for use in children and adolescents. 
Zdravilo Javlor ni namenjeno zdravljenju otrok in mladostnikov.
One patient died after myocardial infarction and another one due to a cardiopulmonary arrest. 
En bolnik je umrl po miokardnem infarktu, en bolnik pa zaradi kardiopulmonalnega zastoja.
Other medicines and Javlor 
Druga zdravila in zdravilo Javlor
- No dose adjustment is necessary in patients: 
- Prilagoditev odmerka ni potrebna: