natgillin/translations-raw huggingface dataset:
What EMEND looks like and contents of the pack The 40 mg hard capsule is opaque with a white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.
40 mg trda kapsula je neprozorna; telo je bele barve, pokrovček gorčično rumene barve; na sredini ima odtisnjeni črni oznaki "464" in "40 mg".
The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
80 mg trda kapsula je neprozorna; telo je bele barve, pokrovček je bele barve; na sredini ima odtisnjeni črni oznaki "461" in "80 mg".
The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with aprepitant than with standard therapy in adults or postmarketing use:
Spodaj so navedeni neželeni učinki, ki so jih v metaanalizi študij HEC in MEC pri aprepitantu opazili pogosteje kot pri standardnem zdravljenju pri odraslih, in neželeni učinki iz obdobja trženja zdravila.
It may harm them, even if their signs of illness are the same.
Njim bi lahko celo škodovalo, čeprav imajo podobne znake bolezni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 2 HARD CAPSULES 80 MG)
PODATKI NA PRIMARNI OVOJNINI (Z DVEMA 80 mg TRDIMA KAPSULAMA)
Patients with moderate to severe hepatic impairment There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Število podatkov o uporabi pri bolnikih z zmerno okvaro jeter je omejeno.
In another study with intravenous administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, and 2 mg midazolam was given intravenously prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.
V drugi študiji z intravenskim odmerjanjem midazolama so zdravilo EMEND dajali po shemi 125 mg 1. dan ter 80 mg/dan 2. in 3. dan, midazolam pa v odmerku 2 mg i.v.
See enclosed leaflet for additional information about how to take EMEND.
Za dodatne informacije o načinu jemanja zdravila EMEND glejte priloženo navodilo!
The effects of EMEND or other medicines might be influenced if you take EMEND together with other medicines including those listed below.
Če jemljete zdravilo EMEND skupaj z drugimi zdravili, vključno s spodaj naštetimi, to lahko vpliva na učinek zdravila EMEND ali teh zdravil.
Sachet for EMEND 125 mg powder for oral suspension
Vrečka za zdravilo EMEND 125 mg prašek za peroralno suspenzijo
A summary of the key study results is shown in Table 2.
Povzetek ključnih rezultatov kombinirane analize je prikazan v preglednici 2.
Vascular disorders hot flush/flushing uncommon
Žilne bolezni vročinski oblivi/zardevanje občasni
125 mg orally 80 mg orally 80 mg orally none
3. dan zdravilo EMEND 125 mg peroralno 80 mg peroralno 80 mg peroralno deksametazon 12 mg peroralno brez brez antagonist 5-HT3
Uncommon side effects (may affect up to 1 in 100 people) are: - dizziness, sleepiness, - acne, rash, - anxiousness, - burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind, - increased painful or burning urination, - weakness, generally feeling unwell, - hot flush, - fast or irregular heartbeats, - fever with increased risk of infection, lowering of red blood cells.
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so: - omotica, zaspanost, - akne, izpuščaj, - tesnoba, - spahovanje, siljenje na bruhanje, bruhanje, zgaga, bolečine v trebuhu, suha usta, vetrovi, - pogostejše, boleče ali pekoče uriniranje, - oslabelost, splošno slabo počutje,
Caution is advised during concomitant administration of EMEND and active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).
Pri sočasnem dajanju zdravila EMEND in zdravilnih učinkovin, ki se primarno presnavljajo s CYP3A4 in z ozkim terapevtskim območjem, kot so ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin, svetujemo previdnost (glejte poglavje 4.4).
Keep the oral dispenser in the refrigerator (between 2
Dokler ne date zdravila otroku, hranite odmernik v hladilniku (med 2 °C in 8 °C).
Caution is advised during concomitant administration of EMEND and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).
Pri sočasnem dajanju zdravila EMEND in peroralnih zdravilnih učinkovin, ki se primarno presnavljajo s CYP3A4 in z ozkim terapevtskim območjem, kot so ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin, svetujemo previdnost (glejte poglavje 4.4).
In a randomised, double-blind study in a total of 866 adult patients (864 females, 2 males) receiving chemotherapy that included cyclophosphamide 750-1,500 mg/m2; or cyclophosphamide
V randomizirani, dvojno slepi študiji, ki je skupaj zajela 866 odraslih bolnikov (864 žensk, 2 moška), ki so dobivali kemoterapijo s ciklofosfamidom 750-1500 mg/m2 ali ciklofosfamidom 500-1500 mg/m in doksorubicinom ( 60 mg/m2) ali epirubicinom ( 100 mg/m2), so primerjali aprepitant v kombinaciji z ondansetronom/deksametazonom (glejte poglavje 4.2) ter standardno terapijo (placebo in ondansetron 8 mg peroralno (dvakrat 1. dan ter na 12 ur 2. in 3. dan) ter deksametazon 20 mg peroralno 1. dan).
The European Commission issued a decision on 5 October 2010.
Evropska komisija je odločbo izdala dne 15. marca 2010.
Why was Fortipan Combi D reviewed?
Zakaj je bilo zdravilo Lescol pregledano?
Daniela Melchiorri (Italy)
Catherine Moraiti (Grčija)
24 June 2010
19. november 2009
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitveni postopek na podlagi različnih odločitev držav članic.
Kristina Dunder (Sweden)
Alar Irs (Estonija)
However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Lescol v EU, je 9. februarja 2000 zadevo napotila na CHMP.
20 May 2010
29. maja 2009, 16. oktobra 2009
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fortipan Combi D outweigh its risks, and therefore that the marketing authorisation for Fortipan Combi D should be granted in the concerned Member State.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti po vsej EU.
It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol).
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Lescol in povezana imena kapsule, ki vsebujejo 20 mg ali 40 mg fluvastatina tablete s podaljšanim sproščanjem, ki vsebujejo 80 mg fluvastatina
Blocking the action of these cells leads to less bone loss.
Zaviranje tega encima povzroči znižanje ravni holesterola v krvi.
What is Fortipan Combi D?
Kaj je zdravilo Lescol?
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Fortipan Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fortipan Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in Italy.
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Lescol potrebno usklajevanje.
The grounds for the referral were concerns over the evidence provided on the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
CHMP se strinja o dveh usklajenih indikacijah (boleznih, za kateri se lahko zdravilo uporablja): „Dislipidemija Zdravljenje primarne hiperholesterolemije ali mešane dislipidemije kot dodatek dieti, kadar je odziv na dieto ali druge vrste nefarmakološkega zdravljenja (na primer na telesno vadbo, zmanjšanje telesne mase) nezadosten.
The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Bolniki z mešano dislipidemijo imajo visoke ravni „slabega“ LDL-holesterola in trigliceridov (vrste maščobe) in nizke ravni „dobrega“ HDL-holesterola.
Fortipan Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Zdravilo Lescol se uporablja za preprečevanje dodatnih resnih srčnih dogodkov (kot je srčni infarkt) pri bolnikih po perkutani koronarni intervenciji (kirurškem posegu, ki se uporablja za odmašitev zoženih koronarnih arterij).
The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Primarna hiperholesterolemija pomeni, da so ravni holesterola v krvi visoke, primarna pa pomeni, da hiperholesterolemija nima očitnega vzroka.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Fluvastatin spada v skupino zdravil, imenovanih „statini“, ki se uporabljajo za zniževanje ravni holesterola.
The company wanted the authorisation to be recognised in Italy (the ‘concerned Member State').
Pregled je bil opravljen v skladu z napotitvenim postopkom iz „člena 30“1.
Fortipan Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol (vitamin D3).
Zdravilo Lescol je v EU na voljo tudi pod drugimi lastniškimi imeni: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon in Vaditon Prolib.
Height (cm) x ks
višina (cm) x ks
Email: info@pharmathen.com
E-pošta: info@pharmathen.com
EXP Use immediately after dilution.
EXP Uporabite takoj po razredčenju.
The use of Matever in accordance with the product information is not likely to result in an unacceptable environmental impact (see section 6.6).
Uporaba zdravila Matever v skladu z informacijami o zdravilu verjetno ne bo povzročila nesprejemljivega vpliva na okolje (glejte poglavje 6.6).
Date of first authorisation: 03 October 2011 Date of latest renewal: 29 June 2016
Datum zadnjega podaljšanja: 29. Junij 2016
After dilution the infusion is stable for 24 hours at 2 °C - 8 °C (in a refrigerator).
Po razredčitvi je infuzijska raztopina stabilna 24 ur pri 2 °C - 8 °C (v hladilniku).
This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Ta učinek je bil izrazit pri mlajših dojenčkih, z naraščanjem starosti je upadal in postal zanemarljiv okoli 4. leta starosti.
No special precautions for storage prior to reconstitution.
Ni posebnih navodil za shranjevanje pred rekonstitucijo.
A doctor or a nurse will administer you Matever as an intravenous infusion.
Zdravnik ali medicinska sestra vam bosta zdravilo Matever dala kot intravensko infuzijo.
This is equivalent to 2.86 % of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 2,86 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms;
• encefalopatija (glejte podpoglavje »Takoj obvestite zdravnika« za podroben opis simptomov)
When you will first start taking Matever, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Na začetku jemanja zdravila Matever vam bo zdravnik, preden vam bo predpisal najmanjši običajni odmerek, za dva tedna predpisal manjši odmerek.
The following information is intended for healthcare professionals only: Directions for the proper use of Matever is provided in section 3.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za pravilno uporabo zdravila Matever se nahajajo v poglavju 3.
Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Levetiracetam se uporablja pri obliki epilepsije, pri kateri napadi najprej vplivajo le na eno stran možganov, vendar se lahko kasneje razširijo na večjo površino na obeh straneh (parcialni napadi s sekundarno generalizacijo ali brez nje).
The other strengths of Matever tablets do not contain this ingredient.
Druge jakosti zdravila Matever tablete ne vsebujejo te sestavine.
Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two medicinal products.
Koncentracijo metotreksata in levetiracetama v krvi je treba skrbno spremljati pri bolnikih, ki se sočasno zdravijo z obema učinkovinama.
Epilepsy is a condition where the patients have repeated fits (seizures).
Epilepsija je stanje, pri katerem imajo bolniki ponavljajoče napade (krče).
Box of 10 vials
Škatla z 10 vialami
Dose recommendations for children and adolescents:
Priporočeno odmerjanje za otroke in mladostnike:
You should continue Matever treatment for as long as your doctor has told you.
Zdravljenje z zdravilom Matever morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60% glede na običajno koncentracijo pred nosečnostjo).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
Matever is used:
Zdravilo Matever se uporablja:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material moramo odstraniti v skladu z lokalnimi zahtevami.
This medicine contains 57.21 mg sodium (main component of cooking/table salt) in each maximum single dose.
To zdravilo vsebuje 57,21 mg natrija (glavne sestavine kuhinjske soli) na vsak največji enkratni odmerek.
The plasma half-life in adults was 71 hours and did not vary either with dose, route of administration or repeated administration.
Plazemski razpolovni čas pri odraslih je 7  1 ura in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
Matever must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Matever morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
Levetiracetam has been given to you by your doctor to reduce the number of fits.
Levetiracetam vam je zdravnik predpisal za zmanjšanje števila napadov.
You may take Matever with or without food.
Zdravilo Matever lahko vzamete s hrano ali brez nje.
•Sodium chloride (0.9 %) injection
• injekcija natrijevega klorida (0,9 %)
Matever therapy can be initiated with either intravenous or oral administration.
Terapija z zdravilom Matever se lahko prične bodisi z intravenskim ali peroralnim dajanjem.
•Dextrose 5 % injection
• injekcija dekstroze 5 %
The total daily dose and frequency of administration should be maintained.
Ohranjen mora biti celokupni dnevni odmerek in pogostnost odmerjanja.
At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Na začetku zdravljenja ali pri povečanju odmerka so neželeni učinki, kot na primer zaspanost, utrujenost in omotica, lahko pogostejši.
Matever concentrate for solution for infusion (Matever concentrate) is a clear, colorless, sterile liquid.
Matever koncentrat za raztopino za infundiranje (koncentrat zdravila Matever) je bistra, brezbarvna, sterilna tekočina.
Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
Ob sočasni uporabi levetiracetama in metotreksata so poročali o zmanjšanem izločanju metotreksata, ki povzroči zvišano/podaljšano koncentracijo metotreksata v krvi do potencialno toksične ravni.
Swallow Matever tablets with a sufficient quantity of liquid (e.g. a glass of water).
Tablete zdravila Matever zaužijte z dovolj tekočine (npr. s kozarcem vode).
Warnings and precautions Talk to your doctor before taking Matever
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Matever se posvetujte s svojim zdravnikom
In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.
Poleg tega jakosti tablet, ki so na voljo, niso primerne za začetno zdravljenje pri otrocih, težkih manj kot 25 kg, pri bolnikih, ki ne morejo požirati tablet, ali za dajanje odmerkov, manjših od 250 mg.
Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Neželeni učinki, o katerih so poročali v kliničnih študijah (odrasli, mladostniki, otroci in dojenčki, starejši od 1 meseca) in v obdobju trženja, so navedeni v spodnji preglednici po organskih sistemih in pogostnosti.
What Matever is and what it is used for
Kaj je zdravilo Matever in za kaj ga uporabljamo
He/she may decide if your dose should be adjusted.
Odločil, se bo ali je vaš odmerek potrebno prilagoditi.
Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Levetiracetam ima ima manjhen do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• simptome, kot so nizek volumen urina, utrujenost, slabost, bruhanje, zmedenost in otekanje nog, gležnjev ali stopal, saj so lahko to znaki nenadnega zmanjšanja delovanja ledvic
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi ( 10 %).
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Neželeni učinki so razporejeni po padajoči resnosti ter sledeči pogostnosti: zelo pogosti: (≥1/10); pogosti: (≥1/100 do <1/10); občasni: (≥1/1.000 do <1/100); redki: (≥1/10.000 do <1/1.000) in zelo redki: (<1/10.000).
General dose: between 1000 mg and 3,000 mg each day.
Običajni odmerek: med 1000 mg in 3000 mg na dan.
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
• hude alergijske reakcije (DRESS), anafilaktična reakcija (resna in pomembna alergijska reakcija),
Other medicines and Matever
Druga zdravila in zdravilo Matever
• If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti, se posvetujte z zdravnikom.
In all of the above cases an oral solution should be used.
V vseh teh primerih se mora uporabiti peroralno raztopino.
Multipack: 200 (2 packs of 100) film-coated tablets
Skupno pakiranje: 200 (2 pakiranji po 100) filmsko obloženih tablet
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
• znake resnih mentalnih sprememb ali če kdo okoli vas opazi znake zmedenosti, somnolenco (zaspanost), amnezijo (izgubo spomina), oslabljen spomin (pozabljivost), neobičajno vedenje ali druge nevrološke znake, vključno z nehotenim ali nenadzorovanim gibanjem.
Should your doctor decide to stop your Matever treatment, he/she will instruct you about the gradual withdrawal of Matever.
Če se bo vaš zdravnik odločil za prekinitev zdravljenja z zdravilom Matever, vas bo poučil o postopnem zmanjševanju odmerka zdravila.
• Matever is used as a chronic treatment.
• Zdravilo Matever se uporablja za dolgotrajno zdravljenje.
You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Prehod od filmsko obloženih tablet ali od peroralne raztopine k intravenski obliki ali obratno je lahko neposreden, brez prilagajanja odmerka.
Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25 °C.
Koncentrat zdravila Matever je fizikalno kompatibilen in kemijsko stabilen vsaj 24 ur pri mešanju z naslednjimi raztopinami ter shranjen v PVC vrečkah pri kontrolirani sobni temperaturi 15 °C do 25 °C.
Quincke's oedema [swelling of the face, lips, tongue and throat]);
Quinckov edem (otekanje obraza, ustnic, jezika in grla))
These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Ti podatki so dopolnjeni s podatki iz ustreznih odprtih, razširjenih študij o uporabi levetiracetama ter s podatki iz obdobja trženja zdravila.
Orion Pharma A/S Tlf: +45 49 12 66 00
Danmark Orion Pharma A/S Tlf: +45 49 12 66 00
Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Bolezni imunskega sistema reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), preobčutljivost (vključno z angioedemom in anafilakso)
At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in fetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Pri 3600 mg/kg/dan se je samo v eni od dveh študij embrio-fetalnega razvoja telesna masa plodu rahlo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
• A small number of people being treated with anti-epileptics such as Matever have had thoughts of harming or killing themselves.
• pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Matever, so se pojavile misli na samopoškodovanje ali samomor.
Matever concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Koncentrat zdravila Matever je samo za intravensko uporabo, priporočeni odmerek mora biti razredčen v vsaj 100 ml kompatibilnega topila in uporabljen intravensko kot 15-minutna intravenska infuzija (glejte poglavje 6.6).
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
• hude alergijske reakcije (DRESS), anafilaktična reakcija (resna in pomembna alergijska reakcija), Quinckov edem (otekanje obraza, ustnic, jezika in grla)