natgillin/translations-raw huggingface dataset:
The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form.
Deksametazon ima dobro uveljavljeno uporabo v EU že vsaj 10 let, zato je bila vloga podprta z objavljeno literaturo in ne študijami, opravljenimi z zdravilom Dexamethasone Alapis, podlaga za napotitveni postopek pa je bilo zlasti dejstvo, da ji je bila v podporo predložena literatura, ki dokazuje varnost in učinkovitost deksametazona v obliki tablet in ne v obliki peroralne raztopine, pri čemer pa predloženi premostitveni podatki niso bili zadostni za sklep o razmerju med tveganji in koristmi peroralne raztopine.
Alapis S.A. submitted Dexamethasone Alapis to Malta for a decentralised procedure.
Družba Alapis S.A. je za zdravilo Dexamethasone Alapis na Malti predložila vlogo za decentraliziran postopek.
Further information can be found in the summary of the risk management plan.
Dodatne informacije so na voljo v povzetku načrta obvladovanja tveganj
The full EPAR and risk management plan summary for Pemetrexed Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pemetrexed Sandoz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Sandoz has been shown to be comparable to Alimta.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetrexed Sandoz primerljivo z zdravilom Alimta.
This is a summary of the European public assessment report (EPAR) for Pemetrexed Sandoz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetrexed Sandoz.
This means that Pemetrexed Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
The Committee recommended that Pemetrexed Sandoz be approved for use in the EU.
Priporočil je, da se zdravilo Pemetrexed Sandoz odobri za uporabo v EU.
Because Pemetrexed Sandoz is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pemetrexed Sandoz generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What measures are being taken to ensure the safe and effective use of Pemetrexed Sandoz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetrexed Sandoz?
Pemetrexed Sandoz is a cancer medicine used to treat two types of lung cancer:
Pemetrexed Sandoz je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
A risk management plan has been developed to ensure that Pemetrexed Sandoz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pemetrexed Sandoz je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pemetrexed Sandoz in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Pemetrexed Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pemetrexed Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Pemetrexed Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pemetrexed Sandoz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What are the benefits and risks of Pemetrexed Sandoz?
Kakšne so koristi in tveganja, povezani z zdravilom Pemetrexed Sandoz?
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Sandoz.
Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetrexed Sandoz jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
When Pemetrexed Sandoz is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Kadar se zdravilo Pemetrexed Sandoz daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
Pemetrexed Sandoz is a ‘generic medicine'.
Zdravilo Pemetrexed Sandoz je „generično zdravilo“.
The active substance in Pemetrexed Sandoz, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Zdravilna učinkovina v zdravilu Pemetrexed Sandoz, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
Other information about Pemetrexed Sandoz
Druge informacije o zdravilu Pemetrexed Sandoz
What is Pemetrexed Sandoz and what is it used for?
Kaj je zdravilo Pemetrexed Sandoz in za kaj se uporablja?
Pemetrexed Sandoz is available as a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo Pemetrexed Sandoz je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Pemetrexed Sandoz approved?
Zakaj je bilo zdravilo Pemetrexed Sandoz odobreno?
Pemetrexed Sandoz contains the active substance pemetrexed.
Zdravilo Pemetrexed Sandoz vsebuje zdravilno učinkovino pemetreksed.
How is Pemetrexed Sandoz used?
Kako se zdravilo Pemetrexed Sandoz uporablja?
How has Pemetrexed Sandoz been studied?
Kako je bilo zdravilo Pemetrexed Sandoz raziskano?
No additional studies were needed as Pemetrexed Sandoz is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Ker je zdravilo Pemetrexed Sandoz generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
How does Pemetrexed Sandoz work?
Kako zdravilo Pemetrexed Sandoz deluje?
Date of last renewal: 16/04/2018
Datum zadnjega podaljšanja dovoljenja za promet: 16/04/2018
ATCvet code: QI05AA10.
Oznaka ATC vet: QI05AA10
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje,uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovijo, da:
1 Antigenic units determined by ELISA.
Antigenske enote določene z ELISA testom.
Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Vsakdo, ki nameravaproizvajati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti lahko prepovedane v državu članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
This swelling normally resolves within 1 to 5 days.
Ta oteklina navadno izgine v 1 do 5 dneh.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v pdročje uporabeUredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
In laboratory studies and field trials:
NEŽELENI U ČINKI V laboratorijskih študijah in terenskih študijah:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti tega cepiva, kadar se uporablja s kakšnim drugim zdravilom za uporabo v veterinarski medicini.
Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.
Osnovno cepljenje: prva injekcija od 6 mesecev starosti dalje, druga injekcija 3 do 5 tednov pozneje.
The vaccine stimulates active immunity against West Nile virus in horses.
Cepivo stimulira aktivno imunost proti virusu Zahodnega Nila pri konjih.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leta
A mild body temperature increase (max. 1.5 °C) may very commonly occur for 1 to 2 days.
Telesna temperatura se lahko zelo pogosto rahlo poviša (največ za 1,5 °C) za 1 do 2 dni.
Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
Farmakoterapevtska skupina: imunološka zdravila za enoprste kopitarje (Equidae), inaktivirana virusna cepiva
Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Aktivna imunizacija konj proti virusu Zahodnega Nila (WNV) za zmanjšanje kliničnih znakov bolezni in poškodb v možganih in za zmanjšanje viremije.
Revaccination: a yearly booster injection of one dose (1 ml) should be sufficient to achieve a reduction of fever, lesions in the brain and viraemia.
Revakcinacija: Letna revakcinacija z enim odmerkom (1 ml) naj bi zadostovala, da se doseže zmanjšanje vročine, poškodb v možganih in viremije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2013.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/06/2013
- common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- pogosti (pri več kot 1 toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali)
EU/2/13/151/002 (5 pre-filled syringes) EU/2/13/151/003 (10 pre-filled syringes)
EU/2/13/151/001 (10 vial) EU/2/13/151/002 (5 napolnjenih injekcijskih brizg) EU/2/13/151/003 (10 napolnjenih injekcijskih brizg)
Inactivated chimeric flavivirus strain YF-WN
Inaktiviran himerični sev flavivirusa YF-WN
After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter).
Po cepljenju se lahko zelo pogosto pojavi rahla prehodna oteklina na mestu vboda (z največ 3 cm premera).
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila ali po njej odločamo od primera od primera.
250 micrograms
250 mikrogramov holesterol
4.6 Adverse reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostost in resnost) V laboratorijskih študijah in terenskih študijah:
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile [a clear pictogram of a horse]
Equilis West Nile [piktogram konja]
Adjuvant:
Dodatki:
TARGET SPECIES Horses
CILJNE ŽIVALSKE VRSTE
6.5 Nature and composition of immediate packaging
6.5 Vrsta in sestava stične ovojnine
Antigenic units Opalescent suspension.
Antigenske enote Opalescentna suspenzija
PACKAGE SIZE 10 vials x 1 dose 5 pre-filled syringes x 1 dose 10 pre-filled syringes x 1 dose
5 napolnjenih injekcijskih brizg x 1 odmerek 10 napolnjenih injekcijskih brizg x 1 odmerek
DATE OF REVISION OF THE TEXT {MM/YYYY}
DATUM REVIZIJE BESEDILA
Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Viale po 1 ml iz stekla tipa I (1 odmerek), zaprte z zamaškom iz halogenobutilne gume in zatesnjene z aluminijasto zaporko.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE(BIOLOŠKIH) UČINKOVINE(UČINKOVIN) IN PROIZVAJALEC(PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
PACKAGE LEAFLET: Equilis West Nile suspension for injection for horses
Equilis West Nile suspenzija za injiciranje za konje
Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
Cardboard box or plastic box with 10 vials of 1 ml, or 5 or 10 pre-filled syringes of 1 ml
Kartonska škatla ali plastična škatla z 10 vialami po 1 ml ali s 5 ali 10 napolnjenimi brizgami po 1 ml
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Wim de Körverstraat 35 5831 AN Boxmeer
Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Napolnjena injekcijska brizga po 1 ml iz stekla tipa I (1 odmerek), v kateri je bat z nastavkom iz halogenobutila, zaprta z zamaškom iz halogenobutilne gume.
Onset of immunity: 2 weeks after primary vaccination course of two injections.
Nastop imunosti: 2 tedna po osnovnem cepljenju (2 injekciji) Trajanje imunosti: 12 mesecev
Iscom-Matrix containing: Purified saponin
Iscom-Matrix, ki vsebuje:
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses
NAVODILO ZA UPORABO Equilis West Nile suspenzija za injiciranje za konje
Vaccination schedule: Administer one dose (1 ml) by intramuscular injection, according to the following schedule:
En odmerek (1 ml) intramuskularno po naslednji shemi:
Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v poglavju 4.6. 4.11 Karenca
1 ml vial, 1 ml pre-filled syringe
Viala po 1 ml, napolnjena injekcijska brizga po 1ml
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca(proizvajalcev) biološke(bioloških) učinkovine (učinkovin) Intervet International B.V.
Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Plastična škatla s 5 ali 10 napolnjenimi injekcijskimi brizgami po 1 ml (1 odmerek).
Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Kartonska škatla s 5 ali 10 napolnjenimi injekcijskimi brizgami po 1 ml (1 odmerek).
Sodium chloride
prečiščeni saponin
IM
NALEPKA
Phosphatidylcholine
83 mikrogramov fosfatildiholin
Plastic box with 10 glass vials of 1 ml (1 dose).
Plastična škatla z 10 steklenimi vialami po 1 ml (1 odmerek).
Cardboard box with 10 glass vials of 1 ml (1 dose).
Kartonska šlatla z 10 steklenimi vialami po 1 ml (1 odmerek).
Cholesterol
KARENCA
Potassium chloride
Brejost in laktacija:
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml (1 dose)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Pred uporabo preberite navodilo za uporabo.
Capsule, hard blister (alu/PVC) 42 capsules
Peroralna uporaba pretisni omot (alu/PVC) 42 kapsul
Strength Pharmaceutical Form Route of Administration
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
50 mg
600 mg Filmsko obložena tableta Peroralna uporaba plastenka (HDPE)
What you need to know before you take CHAMPIX
Kaj morate vedeti, preden boste vzeli zdravilo CHAMPIX
Adopted at the 11-14 June 2018 PRAC
Sprejeto na seji odbora PRAC med 11. in 14. junijem 2018
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first two months of treatment.
Zdi se, da te reakcije bolnike najbolj ogrožajo zgodaj v poteku zdravljenja, saj se reakcija večinoma pojavi v prvih dveh mesecih zdravljenja.
Varenicline - Loss of consciousness (EPITT no 19146)
Vareniklin - izguba zavesti (EPITT št. 19146)
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Ko se zdravilo predpiše, je treba bolnikom svetovati glede znakov in simptomov ter jih skrbno spremljati glede kožnih reakcij.
If signs and symptoms suggestive of these reactions appear, nabumetone should be withdrawn immediately and an alternative treatment considered (as appropriate).
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z nabumetonom takoj prekiniti in razmisliti o drugi vrsti zdravljenja (kot je ustrezno).
Effects on ability to drive and use machines
Vpliv na sposobnost upravljanja vozil in strojev
Stop using <medicine> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Če se pri vas pojavijo ti simptomi, prenehajte uporabljati <zdravilo> in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
Nabumetone should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Zdravljenje z nabumetonom je treba prekiniti ob prvem pojavu kožnega izpuščaja, sluzničnih lezij ali katerega koli drugega znaka preobčutljivosti.
You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Ne vozite, ne upravljajte zapletenih strojev in ne opravljajte drugih morebitno nevarnih dejavnosti, dokler ne veste, ali to zdravilo vpliva na vašo sposobnost za te dejavnosti.
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of nabumetone, treatment with nabumetone must not be restarted in this patient at any time.
Če je pri bolniku zaradi uporabe nabumetona prišlo do hude kožne reakcije, kot so SJS, TEN in DRESS, se zdravljenje z nabumetonom pri tem bolniku ne sme nikoli več ponovno začeti.
Not known Transient loss of consciousness
Neznana pogostnost Prehodna izguba zavesti
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Bolniki naj ne vozijo, ne upravljajo zapletenih strojev in ne opravljajo drugih možnih nevarnih dejavnosti, dokler ni znano, ali to zdravilo vpliva na njihovo sposobnost za te dejavnosti.
Nabumetone - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 19241)
Nabumeton - reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)(EPITT št. 19241)
CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines.
Zdravilo CHAMPIX lahko povzroči omotico, zaspanost in prehodno izgubo zavesti ter lahko tako vpliva na sposobnost vožnje in upravljanja strojev.
CHAMPIX may be linked with produce dizziness, sleepiness and transient loss of consciousness.
Zdravilo CHAMPIX je lahko povezano zpovzroči omotico, zaspanostjo in začasno izgubo zavesti.
Possible side effects - Not known o Transient loss of consciousness
Možni neželeni učinki - Neznana pogostnost o Začasna izguba zavesti
CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo CHAMPIX ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia
Zelo redki: bulozne reakcije, vključno s toksično epidermalno nekrolizo, Stevens-Johnsonovim sindromom, reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi, multiformnim eritemom, angioedemom, psevdoporfirijo in alopecijo.
Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Razširjen izpuščaj, visoka telesna temperatura, zvišani jetrni encimi, nepravilnosti krvi (eozinofilija), povečane bezgavke in prizadetost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo).
Undesirable effects Nervous system disorders
Preglednica neželenih učinkov
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported very rarely in association with the use of NSAIDs, including nabumetone (see section 4.8).
V povezavi z uporabo nesteroidnih protivnetnih zdravil, vključno z nabumetonom so zelo redko poročali o resnih kožnih reakcijah, nekaterih od njih smrtnih, vključno z eksfoliativnim dermatitisom, Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko nevarni ali smrtni (glejte poglavje 4.8).