FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 8 mg lornoxicam.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 8 mg lornoksikama.
English: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Slovenian: Pri bolnikih z amnezijo hipertenzije in/ali blagega do zmernega kongestivnega srčnega popuščanja je potrebno ustrezno spremljanje in svetovanje, saj so v zvezi z zdravljenjem z NSAID poročali o zadrževanju tekočine in edemih.
English: Particular care should be taken if you are receiving any of the following substances: - Cimetidine - Anticoagulantia as heparin, phenprocoumon - Corticosteroids - Methotrexate - Lithium - Immunosuppresive agents as ciclosporine, tacrolimus - Heart medicine as digoxin, ACE-inhibitors, beta-adrenergic blockers - Diuretics - Quinolone antibiotics - Anti-platelet agents - NSAIDs as ibuprofen, acetylsalicylic acids - SSRI - Sulphonylureas - Inducer and inhibitors of CYP2C9-isoenzymes
Slovenian: Bodite zlasti pozorni, če prejemate katerokoli od naslednjih učinkovin: - cimetidin, - antikoagulante, kot sta heparin in fenprokumon, - kortikosteroide, - metotreksat, - litij, - imunsko supresijska zdravila, kot sta ciklosporin in takrolimus, - zdravila za srce, kot so digoksin, zaviralci angiotenzinske konvertaze in zaviralci beta adrenergičnih receptorjev, - diuretike, - kinolonske antibiotike, - antitrombotike, - nesteroidna protivnetna zdravila, kot sta ibuprofen in acetilsalicilna kislina, - selektivni zaviralec ponovnega privzema serotonina, - sulfonilsečnino, - induktor in zaviralec izoencimov CYP2C9.
English: Xefo Rapid should not be taken during the first six months of pregnancy and by breast-feeding women.
Slovenian: Zdravila Xefo Rapid naj ne bi jemali prvih šest mesecev nosečnosti ali med dojenjem.
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni: Artralgija
English: Possible side effects How to store Xefo Further information
Slovenian: Shranjevanje zdravila Xefo Dodatne informacije
English: Xefo Rapid tablets must be swallowed with sufficient fluid.
Slovenian: Tablete Xefo Rapid morate pogoltniti z zadostno količino tekočine.
English: Reconstituted solution: One ml contains 4 mg lornoxicam
Slovenian: Pripravljena raztopina: En ml vsebuje 4 mg lornoksikama
English: General disorders and administrative site conditions Uncommon: Malaise, face oedema.
Slovenian: Splošne težave in spremembe na mestu aplikacije Občasni: neugodje, edem obraza.
English: Lornoxicam is a non steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams.
Slovenian: Lornoksikam je nesteroidno protivnetno zdravilo z analgetičnimi lastnostmi.
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni: artralgija.
English: Pack sizes: 6, 10, 20, 30, 50, 100, 250 film-coated tablets
Slovenian: Pakiranja: 6, 10, 20, 30, 50, 100, 250 filmsko obloženih tablet.
English: Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Slovenian: Podatki iz kliničnih preizkušanj in epidemiološki podatki kažejo na to, da je uporaba nekaterih NSAID (zlasti pri visokih odmerkih in pri dolgoročnem zdravljenju) povezana s povečanim tveganjem arterijskih trombotičnih zapletov (kot sta na primer miokardni infarkt ali kap) (glejte poglavje 4.4).
English: If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, mucosal lesions or other signs of hypersensitivity, you should stop taking Xefo Rapid and contact you doctor immediately.
Slovenian: Če se pri vas pojavijo kakršnikoli simptomi v trebuhu (kot so krvavitve v trebuhu), kožne reakcije (kot je izpuščaj), spremembe na sluznicah ali drugi znaki preobčutljivosti, morate prenehati z jemanjem zdravila Xefo Rapid in nemudoma obvestite svojega zdravnika.
English: No specific antidote is known to date.
Slovenian: Proti zdravilu Lornoxicam ni specifičnega antidota.
English: Lornoxicam “Nycomed” 4 mg Film-coated tablet
Slovenian: Lornoxicam „Nycomed“ 4 mg/ml
English: - Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).
Slovenian: - Antitrombotiki: Zvišano tveganje gastrointestinalne krvavitve (glejte poglavje 4.4).
English: One vial powder for solution for injection One ampoule solvent for solution for injection
Slovenian: 1 komplet vsebuje: eno vialo praška za raztopino za injiciranje eno ampulo vehikla za raztopino za injiciranje
English: Route of administration Content
Slovenian: Pot uporabe zdravila Vsebina
English: Lornoxicam 8 mg powder for injection is intended for intravenous (IV) as well as intramuscular (IM) administration.
Slovenian: Zdravilo Lornoxicam 8 mg prašek za injiciranje je namenjeno intravenski (i.v.)
English: Xefo should not be taken during the first six months of pregnancy and by breast-feeding women.
Slovenian: Zdravila Xefo naj ne bi jemali prvih šest mesecev nosečnosti ali med dojenjem.
English: Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5).
Slovenian: Previdnost je priporočljiva pri bolnikih, ki sočasno jemljejo zdravila, ki lahko povečajo tveganje ulkusa ali krvavitve, na primer peroralne kortikosteroide, antikoagulante, na primer varfarin, selektivne zaviralce ponovnega privzema serotonina ali antitrombocitna zdravila, na primer acetilsalicilno kislino (glejte poglavje 4.5).
English: - ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease.
Slovenian: - Zaviralci angiotenzinske konvertaze: Lahko se zmanjša antihipertenzivni učinek zaviralca angiotenzinske konvertaze.
English: Xefo is not recommended for use in children and adolescents below age 18 due to lack of data.
Slovenian: Zaradi pomanjkanja podatkov uporaba zdravila Xefo pri otrocih in mladostnikih pod 18 let ni priporočljiva.
English: The maximum recommended dose is 16 mg daily.
Slovenian: Največji priporočeni odmerek je 16 mg dnevno.
English: What Xefo is and what it is used for Before you take Xefo How to take Xefo
Slovenian: Kaj je zdravilo Xefoin za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xefo Kako jemati zdravilo Xefo Možni neželeni učinki
English: HOW TO TAKE XEFO
Slovenian: KAKO JEMATI ZDRAVILO XEFO
English: Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.
Slovenian: Občasni: obstipacija, flatulenca, spahovanje, suha usta, gastritis, želodčna razjeda, bolečine v zgornjem predelu trebuha, razjeda dvanajstnika, razjeda v ustih.
English: Unless compatibility is proven, Xefo 4 mg/ml solution for injection should always be administered separately.
Slovenian: Zdravilo Xefo 4 mg/ml raztopina za injiciranje je treba vedno dajati ločeno od drugih zdravil, razen če je združljivost dokazana.
English: Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria, alopecia.
Slovenian: Občasni: izpuščaj, srbečica, hiperhidroza, eritemski: izpuščaj, urtikarija, alopecija.
English: The above mentioned product Xefo and its associated names, do not have the same Product Information (Summary of Product Characteristics (SPC), package leaflet (PL) and labelling) across all EU Member States with respect to e.g.
Slovenian: Informacije o izdelku (Povzetek glavnih značilnosti zdravila (SPC), Navodilo za uporabo (PL) in označevanje) za zgoraj navedeno zdravilo Xefo in z njim povezana imena se med posameznimi državami članicami EU razlikujejo in sicer v poglavjih: Indikacije, Odmerjanje, Kontraindikacije, Neželeni učinki in v poglavjih s priporočili za uporabo.
English: Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4).
Slovenian: Pri teh bolnikih zdravilo Lornoxicam dajemo previdno, saj slabše prenašajo gastrointestinalne neželene učinke zdravila (glejte poglavje 4.4).
English: The most frequent adverse effects of lornoxicam include nausea, dyspepsia, indigestion, abdominal pain, vomiting, and diarrhoea.
Slovenian: Najpogostejši neželeni učinki lornoksikama so med drugim slabost, prebavne motnje, trebušne bolečine, bruhanje in driska.
English: Powder for injection, 8 mg: Amber glass (class I) vial (4R/8R) with rubber stopper, sealed with aluminium snap-off closure.
Slovenian: 1 komplet vsebuje: prašek za raztopino za injiciranje, 8 mg: viala iz stekla (tipa I) jantarne barve z gumijastim zamaškom, ki je zatesnjen z aluminijasto povlečno zaporko.
English: For further instructions on handling of the product before administration, see section 6.1.
Slovenian: Glejte poglavje 6.1 za dodatna navodila o ravnanju z zdravilom pred uporabo.
English: Take special care with Xefo Rapid - if you have impaired renal function - if you have a history of hypertension and⁄or heart failure as fluid retention and oedema - if you suffer from ulcerative colitis or Crohn's disease - if you have a history of bleeding tendency
Slovenian: Bodite posebno pozorni pri uporabi zdravila Xefo Rapid - če imate okvarjeno delovanje ledvic, - če imate anamnezo hipertenzije ali srčnega popuščanja ali obojega z zadrževanjem tekočin in nastajanjem edemov, - če imate ulcerativni kolitis ali Crohnovo bolezen, - če ste bolj nagnjeni h krvavitvam.
English: Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Lornoxicam pri otrocih in mladostnikih pod 18 let ni priporočljiva.
English: If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, mucosal lesions or other signs of hypersensitivity, you should stop taking Xefo and contact you doctor immediately.
Slovenian: Če se pri vas pojavijo kakršnikoli simptomi v trebuhu (kot so krvavitve v trebuhu), kožne reakcije (kot je izpuščaj), spremembe na sluznicah ali drugi znaki preobčutljivosti, morate prenehati z jemanjem zdravila Xefo in nemudoma obvestite svojega zdravnika.
English: Total
Slovenian: Skupno
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 4 mg lornoxicam Excipients: Lactose 94 mg
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 4 mg lornoksikama Pomožne snovi: laktoza 94 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: As with most NSAIDs occasional increase in serum transaminases level, increase in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen as well as other laboratory abnormalities have been reported.
Slovenian: Za večino nesteroidnih protivnetnih zdravil so ugotovili občasna zvišanja ravni serumskih transaminaz, serumskega bilirubina in povečanje drugih parametrov jetrne funkcije.
English: Meta-analysis 1
Slovenian: 1. metaanaliza
English: Due to a local gastrointestinal irritation and a systemic ulcerogenic effect related to the inhibition of prostaglandin (PG)-synthesis, gastrointestinal sequela are common undesirable effects after treatment with lornoxicam as seen with other NSAIDs.
Slovenian: Ker sta z zaviranjem sinteze prostaglandinov (PG) povezana lokalno draženje v prebavilih in sistemski ulcerogeni učinek, so gastrointestinalne bolezni pogosti neželeni učinki po zdravljenju z lornoksikamom in z ostalimi nesteroidnimi protivnetnimi zdravili.
English: Reduction of dose frequency of Xefo Rapid to once daily in patients suffering from hepatic impairment is recommended.
Slovenian: Pri bolnikih z okvaro jeter je priporočljivo znižanje pogostnosti jemanja odmerka zdravila Xefo Rapid na enkrat dnevno.
English: Maximum recommended daily dose is 16 mg.
Slovenian: Največji priporočeni dnevni odmerek je 16 mg.
English: Due to genetic polymorphism, slow and extensive metabolisers exist for this enzyme which could result in markedly increased plasma levels of lornoxicam in slow metabolisers.
Slovenian: Zaradi tega so lahko pri osebah s počasnejšo presnovo s tem encimom plazemske ravni lornoksikama bistveno višje.
English: Take special care with Xefo - if you have impaired renal function - if you have a history of hypertension and⁄or heart failure as fluid retention and oedema - if you suffer from ulcerative colitis or Crohn's disease - if you have a history of bleeding tendency
Slovenian: Bodite posebno pozorni pri uporabi zdravila Xefo - če imate okvarjeno delovanje ledvic, - če imate anamnezo hipertenzije ali srčnega popuščanja ali obojega z zadrževanjem tekočin in nastajanjem edemov, - če imate ulcerativni kolitis ali Crohnovo bolezen, - če ste bolj nagnjeni h krvavitvam.
English: or i.v.
Slovenian: Pred i.v.
English: WHAT XEFO RAPID IS AND WHAT IT IS USED FOR Xefo Rapid is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class.
Slovenian: Xefo Rapid je nesteroidno protivnetno zdravilo in antirevmatično zdravilo iz razreda oksikamov.
English: Meta-analysis 2
Slovenian: 2. metaanaliza
English: - One film-coated tablet contains 4 mg lornoxicam - The other ingredients are: Core: Lactose monohydrate, Cellulose, microcrystalline, Povidone, Croscarmellose sodium, Magnesium stearate Film: Macrogol, Titanium dioxide (E171), Talc, Hypromellose
Slovenian: - Pomožne snovi so: Sredica: laktoza monohidrat, mikrokristalinična celuloza, povidon, kroskarmeloza natrij, magnezijev stearat Film: makrogol, titanov dioksid (E171), smukec, hipromeloza.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica] {Ime}
English: Xefo is distributed in pack sizes of 10, 20, 30, 50, 100, 250 and 500 film-coated tablets.
Slovenian: Zdravilo Xefo je na voljo v pakiranjih po 10, 20, 30, 50, 100, 250 in 500 filmsko obloženih tablet.
English: - One film-coated tablet contains 8 mg lornoxicam - The other ingredients are: Core: Cellulose, microcrystalline, Sodium hydrogen carbonate, Calcium hydrogen phosphate, anhydrous, Low substituted hydroxypropylcellulose, Hydroxypropylcellulose, Calcium stearate Film: Titanium dioxide (E171), Talc, Propylen glycol, Hypromellose.
Slovenian: - Pomožne snovi so: Sredica: mikrokristalinična celuloza, natrijev hidrogenkarbonat, brezvodni kalcijev hidrogenfosfat, nizkosubstituirana hidroksipropilceluloza, hidroksipropilceluloza, kalcijev stearat Film: titanov dioksid (E171), smukec, propilenglikol, hipromeloza.
English: Rare (less than 1 in 1000, but more than 1 in 10.000 patents treated) Pharyngitis, anaemia, thrombocytopenia, leukopenia, hypersensitivity, confusion, nervousness, agitation, somnolence, paraesthesia, dysgeusia, tremor, migraine, visual disturbances, hypertension, hot flush, haemorrhage, haematoma, dyspnoea, cough, melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, hepatic function abnormal, dermatitis, bone pain, muscle spasms, myalgia, nocturia, micturition disorders, asthenia, prolonged bleeding time, purpura, bronchospasm, increase in blood urea nitrogen and creatinine levels, perforated peptic ulcer
Slovenian: Redki (pri manj kot 1 od 1.000, vendar pri več kot 1 od 10.000 zdravljenih bolnikov) faringitis, anemija, trombocitopenija, levkopenija, preobčutljivost, zmedenost, živčnost, agitiranost, somnolenca, parestezija, motnje okušanja, tremor, migrena, motnje vida, zvišan krvni tlak, vročinsko oblivanje, krvavitev, hematom, dispneja, kašelj, črno blato, bruhanje krvi, vnetje ustne sluznice, vnetje požiralnika, gastroezofagealni refluks, moteno požiranje, aftozni stomatitis, vnetje jezika, nenormalna jetrna funkcija, dermatitis, bolečine v kosteh, mišični krči, mišične bolečine, pogosto uriniranje ponoči, motnje uriniranja, astenija, podaljšan čas krvavitve, purpura, bronhospazem, zvišanje ravni dušika iz sečnine in kreatinina v krvi, perforirajoča peptična razjeda.
English: The route of administration is intravenous (IV) or intramuscular injection (IM).
Slovenian: Pot uporabe zdravila je intravenska (i.v.)
English: What Xefo looks like and contents of the pack Xefo 8 mg film-coated tablet is a white to yellowish oblong film-coated tablet with imprint “L08”.
Slovenian: Xefo 8 mg filmsko obložene tablete so bele do rumenkaste podolgovate filmsko obložena tablete z vrezanim napisom „L08“.
English: Uncommon (less than 1 in 100, but more than 1 in 1000 patients treated) Anorexia, insomnia, depression, conjunctivitis, vertigo, tinnitus, palpitations, tachycardia, flushing, constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration, increase in liver function tests, SGPT (ALT) or SGOT (AST), rash, pruritus, hyperhidrosis, rash erythematous, urticaria, alopecia, arthralgia, rheumatoid arthritis, osteoarthritis, malaise, face oedema, weight changes, oedema, rhinitis.
Slovenian: Občasni (pri manj kot 1 od 100, vendar pri več kot 1 od 1.000 zdravljenih bolnikov) Izguba apetita, nespečnost, depresija, vnetje veznice, vrtoglavica, šumenje v ušesih, hitro ali močno utripanje srca, oblivanje, zaprtost, flatulenca, spahovanje, suha usta, gastritis, želodčna razjeda, bolečine v zgornjem predelu trebuha, razjeda dvanajstnika, razjeda v ustih, zvišane ravni v preiskavah jetrne funkcije, SGPT (ALT) ali SGOT (AST), izpuščaj, srbečica, čezmerno znojenje, izpuščaj z rdečino, koprivnica, plešavost, bolečine v sklepih, revmatoidni artritis, osteoartritis, neugodje, otekel obraz, spremembe telesne mase, oteklina, vnetje nosne sluznice.
English: The dose-recommendations in the SPC for the 8 mg film-coated tablets are supported by the presented data.
Slovenian: Predloženi podatki potrjujejo odmerke, priporočene v SPC glede 8 mg filmsko obloženih tablet.
English: Dissolve lornoxicam 8 mg powder for solution for injection with the accompanying 2 ml solvent for solution for injection before i.v.
Slovenian: injiciranjem zdravilo Xefo 8 mg prašek za raztopino za injiciranje raztopite s priloženimi 2 ml vehikla za raztopino za injiciranje.
English: Hypromellose
Slovenian: Hematološki
English: Skin
Slovenian: Na kožo
English: The following information is intended for medical or healthcare professionals only Xefo 8 mg powder and solvent for solution for injection: - The active substance is lornoxicam One vial with powder contains 8 mg lornoxicam Reconstituted solution: One ml contains 4 mg lornoxicam - The other ingredients are mannitol, trometamol, disodium edetate.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju Xefo 8 mg prašek in vehikel za raztopino za injiciranje: - Zdravilna učinkovina je lornoksikam.
English: Careful monitoring of INR should be undertaken - Phenprocoumon: Decreased effect of phenprocoumon treatment.
Slovenian: - Fenprokumon: Zmanjšan učinek zdravljenja s fenprokumonom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA PRETISNE OMOTE
English: application the pooling of the data is questionable and does not support the oral application.
Slovenian: Zaradi različne farmakokinetike med peroralno uporabo in intramuskularno ali intravensko uporabo je združevanje podatkov vprašljivo in ne podpira peroralne uporabe.
English: Titanium dioxide (E171) Talc
Slovenian: Film: makrogol, titanov dioksid (E171), smukec, hipromeloza.
English: 4.3 Contraindications - Hypersensitivity to lornoxicam or any of the excipients - Thrombocytopenia - Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid - Severe heart failure - Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - Severe hepatic impairment - Severe renal impairment (Serum creatinine > 700 µmol/l) - The third trimester of pregnancy (see section 4.6)
Slovenian: - Trombocitopenija - Preobčutljivost (simptomi, podobni astmi; rinitis; angioedem ali urtikarija) za druga nesteroidna protivnetna zdravila, vključno z acetilsalicilno kislino - Hudo srčno popuščanje - Krvavitev v prebavilih, cerebrovaskularna krvavitev ali druge bolezni s krvavitvijo - Anamneza krvavitve ali perforacije v prebavilih, povezane s predhodnim zdravljenjem z nesteroidnimi protivnetnimi zdravili - Aktivna peptična razjeda/krvavitev ali anamneza takšne rekurentne bolezni z najmanj dvema ločenima epizodama dokazane razjede ali krvavitve - Huda okvara jeter - Huda okvara ledvic (serumski kreatinin >700 µmol/l) - Tretje tromesečje nosečnosti (glejte poglavje 4.6)
English: Renal function must therefore be monitored closely in patients receiving combination therapy.
Slovenian: Pri bolnikih, ki prejemajo kombinirano zdravljenje s takrolimusom, morate zato natančno spremljati funkcijo ledvic.
English: HOW TO STORE XEFO
Slovenian: KAKO UPORABLJATI ZDRAVILO XEFO
English: What Xefo looks like and contents of the pack Xefo 4 mg film-coated tablet is a white to yellowish oblong film-coated tablet with imprint “L04”.
Slovenian: Lornoxicam 4 mg filmsko obložene tablete so bele do rumenkaste podolgovate filmsko obložene tablete z vrezanim napisom „L04“.
English: Psychiatric disorders Uncommon: Insomnia, depression.
Slovenian: Občasni: nespečnost, depresija.
English: or i.m.
Slovenian: ali i.m.
English: In this leaflet:
Slovenian: Z upoštevanjem naslednjega
English: Respiratory
Slovenian: intramuskularn
English: Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5).
Slovenian: Pri teh bolnikih in pri bolnikih, ki potrebujejo sočasno zdravljenje z nizkimi odmerki acetilsalicilne kisline ali drugimi zdravilnimi učinkovinami, je treba preučiti možnost uvedbe kombiniranega zdravljenja z zaščitnimi zdravili (npr. misoprostol ali zaviralci protonskih črpalk) (glejte besedilo v nadaljevanju in poglavje 4.5).
English: BEFORE YOU TAKE XEFO RAPID
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO XEFO RAPID
English: HOW TO STORE XEFO RAPID
Slovenian: SHRANJEVANJE ZDRAVILA XEFO RAPID
English: Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Slovenian: Pogosti: navzea, trebušne bolečine, dispepsija, driska, bruhanje.
English: Xefo and associated names (see Annex I) 4 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Xefo in povezana imena (glejte Dodatek I) 4 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Slovenian: Previdnost je potrebna pri bolnikih z anamnezo hipertenzije ali srčnega popuščanja ali obojega, saj so opazili povezavo med zdravljenjem z nesteroidnimi protivnetnimi zdravili, posledičnim zadrževanjem tekočin in nastajanjem edemov.
English: injection, and over not less than 5 seconds as i.m.
Slovenian: injekcijo pa najmanj 5 sekund.