natgillin/translations-raw huggingface dataset:
Common: may affect up to 1 in 10 people - Unexplained bruising (accumulation of blood under the skin) or bleeding - Sore (open skin infection) on your skin
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - nepojasnjene modrice (kopičenje krvi pod kožo) ali krvavitve
At lower doses, mild, transient and reversible cytopenias are commonly reported in Sickle Cell Disease patients which is expected based on the pharmacology of hydroxycarbamide.
Pri nižjih odmerkih so pri bolnikih s srpastoceličnim sindromom pogosto poročali o blagih, prehodnih in reverzibilnih citopenijah, kar je glede na farmakologijo hidroksikarbamida skladno s pričakovanji.
0.25 ml contains 25 mg of hydroxycarbamide).
25 mg hidroksikarbamida).
Wipe up spillages immediately.
Razlito zdravilo takoj pobrišite.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Supresija kostnega mozga
Any unused product waste material should be disposed of in accordance with local requirements.
Neuporabljene iz zdravila nastale odpadne snovi zavrzite v skladu z lokalnimi predpisi.
The study also showed a statistically significant increase in HbF and Hb levels and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Študija je v skupini, ki je prejemala hidroksikarbamid, prav tako pokazala statistično pomembno zvišanje ravni HbF in Hb ter zmanjšanje števila hemolitičnih označevalcev.
LIST OF EXCIPIENTS Also contains: methyl parahydroxybenzoate (E218).
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: metilparahidroksibenzoat (E218).
PHARMACEUTICAL FORM AND CONTENTS Oral solution.
FARMACEVTSKA OBLIKA IN VSEBINA peroralna raztopina
The most common symptoms of overdose with Xromi are: - Redness of the skin, - Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly, - Skin becoming strongly pigmented (locally changes of colour), - Soreness or swelling in the mouth.
- občutljivost (dotik je boleč) in otekanje dlani in podplatov, ki mu sledi luščenje rok in stopal, - koža postane močno pigmentirana (lokalne spremembe barve), - občutljivost in otekline v ustih.
Bone-marrow suppression is the major toxic effect of hydroxycarbamide and is dose related.
Najpomembnejši toksični učinek hidroksikarbamida je supresija kostnega mozga; povezana je z odmerkom.
Store the syringe in a hygienic place with the medicine.
Hranite jo skupaj z zdravilom na higienskem mestu.
Hydroxycarbamide crosses the placental barrier, demonstrated by dams exposed to hydroxycarbamide during gestation.
Hidroksikarbamid prehaja skozi posteljico, kar je bilo dokazano pri samicah, ki so mu bile izpostavljene med gestacijo.
- to check your blood count before and during treatment with Xromi - to monitor your liver before and during treatment with Xromi - to monitor your kidneys before and during treatment with Xromi
Zdravnik bo opravil krvne preiskave: - pred zdravljenjem z zdravilom Xromi in med njim, da preveri vašo krvno sliko, - pred zdravljenjem z zdravilom Xromi in med njim, da spremlja delovanje vaših jeter, - pred zdravljenjem z zdravilom Xromi in med njim, da spremlja delovanje vaših ledvic.
Hydroxycarbamide did not reduce rates of hepatic or splenic sequestration when compared with placebo.
Hidroksikarbamid v primerjavi s placebom ni zmanjšal stopnje sekvestracije jeter ali vranice.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Če niste prepričani, ali zgoraj navedeno velja za vas, se pred uporabo zdravila Xromi posvetujte z zdravnikom ali farmacevtom.
In Sickle Cell Disease, hydroxycarbamide also helps to prevent red blood cells from taking the abnormal sickle shape.
Pri srpastoceličnem sindromu hidroksikarbamid pomaga preprečevati nastanek nenormalne srpaste oblike rdečih krvničk.
Uncommon: may affect up to 1 in 100 people - Any yellowing of the whites of the eyes or skin (jaundice)
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - kakršna koli porumenelost beločnic ali kože (zlatenica)
Patients on hydroxycarbamide wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Bolnice oziroma bolniki, ki želijo spočeti otroka, morajo zdravljenje prekiniti od 3 do 6 mesecev, preden bi lahko prišlo do spočetja.
Women of childbearing potential/Contraception in males and females Medicinal products which affect DNA synthesis, such as hydroxycarbamide, may be potent mutagenic active substances.
Zdravila, ki vplivajo na sintezo DNA, kot je hidroksikarbamid, so lahko močne mutagene učinkovine.
Common: may affect up to 1 in 10 people - Nausea - Headache - Dizziness - Constipation - Darkening of the skin, nails and mouth - Dry skin - Hair loss
- siljenje na bruhanje - glavobol - omotica - zaprtost - potemnitev kože, nohtov in ust - suha koža - izpadanje las in dlak
Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving hydroxycarbamide in combination with anti-retroviral medicinal products, including didanosine, with or without stavudine (see section 4.4).
Pri bolnikih, ki so okuženi z virusom HIV in so hidroksikarbamid prejemali v kombinaciji s protiretrovirusnimi zdravili, vključno z didanozinom, s stavudinom ali brez njega, so poročali o periferni nevropatiji, ki je bila v nekaterih primerih huda (glejte poglavje 4.4).
In patients receiving long-term therapy with hydroxycarbamide for myeloproliferative disorders, such as polycythemia, secondary leukaemia has been reported.
Sekundarna levkemija in kožni rak Pri bolnikih, ki se s hidroksikarbamidom dolgotrajno zdravijo zaradi mieloproliferativnih motenj, kot je policitemija, so poročali o sekundarni levkemiji.
• Full blood cell count with white cell differential and reticulocyte count to be monitored at least every 4 weeks when adjusting dosage.
• pri prilagajanju odmerka je treba vsaj vsake štiri tedne spremljati število vseh krvnih celic,
Impaired fertility has been observed in male rats (see section 5.3).
Pri podganjih samcih so opazili škodljiv vpliv na plodnost (glejte poglavje 5.3).
Red blood cell (RBC), mean cell volume (MCV), and foetal haemoglobin (HbF) levels should be monitored for evidence of consistent or progressive laboratory response.
Spremljati je treba, ali vrednosti števila eritrocitov (RBC - red blood cells), povprečnega volumna eritrocita (MCV) in fetalnega hemoglobina (HbF) padajo ali so stabilne.
One ml of solution contains 100 mg of hydroxycarbamide.
1 ml raztopine vsebuje 100 mg hidroksikarbamida.
Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections.
Cepljenje z živim cepivom lahko pri bolnikih, ki jemljejo hidroksikarbamid, povzroči hude okužbe.
Fatal and non-fatal pancreatitis has occurred in HIV-infected patients during therapy with hydroxycarbamide and didanosine, with or without stavudine.
Pri bolnikih, okuženih z virusom HIV, se je med zdravljenjem s hidroksikarbamidom in didanozinom, s stavudinom ali brez njega, pojavil pankreatitis s smrtnim izidom in z izidom, ki ni bil usoden.
Sometimes the doctor may change your dose of Xromi, for example as a result of different tests.
Xromi, na primer zaradi rezultatov različnih preiskav.
Store syringes in a hygienic place with the medicine.
Hranite ju skupaj z zdravilom na higienskem mestu.
Due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see sections 4.3 and
Zaradi varnosti je hidroksikarbamid kontraindiciran pri bolnikih s hudo jetrno okvaro (glejte poglavji 4.3 in 4.4).
NHLBI-funded Phase III multicenter, randomized clinical trial comparing 24 months of standard treatment (monthly blood transfusions) to alternative treatment (hydroxycarbamide) in 121 children aged 4-16 years with Sickle Cell Disease and abnormal TCD velocities (≥ 200 cm/s) who had received at least 12 months of chronic transfusions and did not have severe vasculopathy, documented clinical stroke, or transient ischaemic attack..
(TWiTCH) je bilo multicentrično, randomizirano klinično preskušanje faze III, ki ga je financiral ameriški nacionalni inštitut za srce, pljuča in kri (NHLBI) in v katerem so 24 mesečno standardno zdravljenje (mesečne infuzije krvi) primerjali z alternativnim zdravljenjem (hidroksikarbamid) pri 121 otrocih, starih 4-16 let, s srpastoceličnim sindromom in abnormalnimi hitrostmi TCD (≥ 200
To assist accurate and consistent dose delivery to the stomach water should be taken after each dose of Xromi.
Po vsakem odmerku zdravila Xromi je treba popiti vodo, da se doseže točen in enakomeren odmerek zdravila v želodcu.
Push the tip of the dosing syringe into the hole in the adaptor (figure 3).
Konico brizge za odmerjanje potisnite v odprtino nastavka (slika 3).
Hydroxycarbamide has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Hidroksikarbamid ima blag vpliv na sposobnost vožnje in upravljanja strojev.
General disorders and administration site conditions Unknown
Splošne težave in spremembe na mestu aplikacije neznana zvišana telesna temperatura
The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during, treatment.
Pred zdravljenjem in večkrat med zdravljenjem je treba pridobiti celovito krvno sliko, vključno s preiskavo kostnega mozga, če je indicirana, ter ledvične in jetrne funkcije.
Ask your doctor or pharmacist for advice.
Posvetujte se z zdravnikom ali farmacevtom.
Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.
Opazili so občutljivost, vijolični eritem, edeme na dlaneh in podplatih, ki jim sledi luščenje rok in stopal, hudo generalizirano hiperpigmentacijo kože in hud akutni stomatitis.
PHARMACEUTICAL FORM Oral solution.
FARMACEVTSKA OBLIKA peroralna raztopina
- Indication; - Instructions for proper and safe use of the product, including clear instructions on the use of two different dosing syringes to avoid the risk of medication error; - Follow-up of patients treated with Xromi: o Need for periodic blood counts; Other medicines that suppress the bone marrow and radiation therapy; o Concomitant use of anti-retroviral medicines; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer);
- navodila za ustrezno in varno uporabo zdravila, vključno z jasnimi navodili za uporabo dveh različnih brizg za odmerjanje, da se prepreči tveganje za napake pri uporabi zdravila; - nadaljnje spremljanje bolnikov, ki se zdravijo z zdravilom Xromi:
Xromi contains hydroxycarbamide, a substance which reduces the growth and multiplication of some cells in the bone marrow.
Kaj je zdravilo Xromi in za kaj ga uporabljamo Zdravilo Xromi vsebuje hidroksikarbamid, učinkovino, ki zavira rast in razmnoževanje nekaterih celic v kostnem mozgu.
Xromi contains methyl parahydroxybenzoate (E218) Xromi contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Zdravilo Xromi vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (tudi zapoznele).
Hydroxycarbamide was administered at an initial dose of 20 mg/kg/day.
Začetni dnevni odmerek hidroksikarbamida je bil 20 mg/kg.
To decrease the risk of exposure disposable gloves should be used when handling Xromi.
Med rokovanjem z zdravilom Xromi je treba nositi rokavice za enkratno uporabo, da zmanjšate tveganje izpostavljenosti.
This syringe should be recommended for doses greater than 3 ml (each graduation of 0.25 ml contains 25 mg of hydroxycarbamide).
To brizgo uporabite, če je skupna količina, ki jo morate vzeti, večja od 3 ml (vsako povečanje za 0,25 ml vsebuje 25 mg hidroksikarbamida).
Weight gain, vitamin D deficiency
Presnovne in prehranske motnje neznana pridobivanje telesne mase, pomanjkanje vitamina D
Slowly and gently push the plunger down to gently squirt the medicine into the inside of your cheek and swallow it. DO NOT forcefully push down the plunger, or squirt the medicine to the back of your mouth or throat, as you may choke.
Bata NE potiskajte navzdol s silo in zdravila NE brizgajte v zadnji del ust ali žrelo, saj se lahko zadušite.
The myelosuppressive activity may be potentiated by previous or concomitant radiotherapy or cytotoxic therapy.
Predhodna ali hkratna radioterapija ali citotoksična terapija lahko okrepi mielosupresivno delovanje.
The active substance is hydroxycarbamide.
Učinkovina je hidroksikarbamid.
As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of hydroxycarbamide in patients with renal impairment.
Ledvična okvara Ker je ledvično izločanje glavna pot izločanja, je treba pri bolnikih z ledvično okvaro razmisliti o zmanjšanju odmerka hidroksikarbamida.
Severe anaemia must be corrected with whole blood replacement before initiating therapy with hydroxycarbamide.
Pred začetkom zdravljenja s hidroksikarbamidom je treba hudo anemijo odpraviti s transfuzijo polne krvi.
Each pack contains one bottle, a bottle adaptor and two dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Eno pakiranje vsebuje eno steklenico, nastavek za steklenico in dve brizgi za odmerjanje (rdeča brizga je označena z lestvico do 3 ml in bela brizga je označena z lestvico do 12 ml).
How to store Xromi
Shranjevanje zdravila Xromi
- if you have extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells (anaemia).
- če ste izredno utrujeni, slabotni in zadihani, saj so to lahko simptomi pomanjkanja rdečih krvničk (anemije), - če hitro zakrvavite ali dobite modrice, saj sta to lahko simptoma nizke ravni trombocitov v krvi, - če imate okvaro jeter (morda bo potrebno dodatno spremljanje),
- Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Da bo zdravilo ostalo nedotaknjeno in da zmanjšate tveganje nenamernega razlitja, naj bo steklenica tesno zaprta.
In a comparative bioavailability study in healthy adult volunteers (n=28), 500 mg of hydroxycarbamide oral solution was demonstrated to be bioequivalent to the reference 500 mg capsule, with respect to both the peak concentration and area under the curve.
da je 500 mg peroralne raztopine hidroksikarbamida bioekvivalentnih referenčni 500-miligramski kapsuli, in sicer tako glede najvišje koncentracije kot površine pod krivuljo.
Let the syringe dry completely before you use that syringe again for dosing.
Pred ponovnim odmerjanjem brizgo posušite do suhega.
The other ingredients are xanthan gum, sucralose (E955), strawberry flavour, methyl parahydroxybenzoate (E218), sodium hydroxide, and purified water.
Druge sestavine zdravila so ksantanski gumi, sukraloza (E955), aroma jagode,
P value1
Pvredno st1
Also rates of acute chest syndrome were decreased in those taking hydroxycarbamide when compared with those taking placebo; RR 0.44 (95% CI 0.28 to 0.68) (p < 0.001).
zmanjšala tudi pogostnost akutnega sindroma bolečine v prsih; RR 0,44 (95-odstotni interval zaupanja: od 0,28 do 0,68) (p < 0,001).
Patients with normal (CrCl> 90 ml/min), mild (CrCl 60-89 ml/min), moderate (CrCl 3059 ml/min), severe (CrCl 15-29 ml/min) renal impairment, and End Stage Renal Disease (CrCL < 15 ml/min) received hydroxycarbamide as a single dose of 15 mg/kg body weight.
(CrCl 30-59 ml/min) in hudo (CrCl 15-29 ml/min) ledvično okvaro ter končno odpovedjo ledvic
disease and it may cause treatment failure and toxicities (in some cases fatal) in HIV patients (see sections 4.3 and 4.5).
Hidroksikarbamid se pri okužbi z virusom HIV ne sme uporabljati v kombinaciji s protiretrovirusnimi zdravili, saj lahko pri bolnikih, okuženih z virusom HIV, povzroči neuspešno zdravljenje in toksičnosti (v nekaterih primerih s smrtnim izidom) (glejte poglavji 4.3 in 4.5).
Close monitoring of blood parameters is advised in patients with hepatic impairment.
Pri bolnikih z jetrno okvaro se priporoča natančno spremljanje krvnih parametrov.
2,000/μL to 4,000/μL) is achieved, up to a maximum of 35 mg/kg/day.
• povečevanje odmerka se nadaljuje, dokler ni dosežena blaga mielosupresija (absolutno število nevtrofilcev je od 2.000/μl do 4.000/μl), in sicer do največjega dnevnega odmerka 35 mg/kg,
- Isolated cases of malignant disease of blood cells (leukaemia)
- posamezni primeri malignih bolezni krvnih celic (levkemija) - kožni rak pri starejših bolnikih - virusne okužbe s parvovirusom B19
Any unused product should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
• A patient/carer guide
• vodnik za bolnike/skrbnike.
Embryotoxicity manifesting as decreased foetal viability, reduced live litter sizes, and developmental delays has been reported in species including mice, hamsters, cats, dogs, and monkeys at doses comparable to human doses.
Pri določenih vrstah živali, vključno z mišmi, hrčki, mačkami, psi in opicami, so pri odmerkih, primerljivih z odmerki pri človeku, poročali o embriotoksičnosti, ki se je izražala kot zmanjšanje viabilnosti plodu, zmanjšano število živih mladičev v leglu in upočasnitve razvoja.
Use in elderly
Uporaba pri starejših osebah
The total body clearance of hydroxycarbamide in adult patients with Sickle Cell Disease is 0.17L/h/kg.
Izločanje Celotni telesni očistek hidroksikarbamida pri odraslih bolnikih s srpastoceličnim sindromom je
Hepatotoxicity and hepatic failure resulting in death were reported during post-marketing surveillance in HIV-infected patients treated with hydroxycarbamide and other antiretroviral medicinal products.
Med spremljanjem v obdobju trženja zdravila so pri bolnikih, ki so okuženi z virusom HIV in so se zdravili s hidroksikarbamidom in drugimi protiretrovirusnimi zdravili, poročali o smrti zaradi hepatotoksičnosti in odpovedi jeter.
Patients who have received irradiation therapy in the past may have an exacerbation of post irradiation erythema when hydroxycarbamide is given.
Pri bolnikih, ki so bili v preteklosti zdravljeni z obsevanjem, se lahko pri uporabi hidroksikarbamida poslabša eritem po obsevanju.
Strawberry flavour Methyl parahydroxybenzoate (E218) Sodium hydroxide (E524) Purified water
metilparahidroksibenzoat (E218), natrijev hidroksid in prečiščena voda.
Rare
neznačilna
Each pack contains one bottle, an HDPE bottle adaptor and 2 polyethylene dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Eno pakiranje vsebuje eno steklenico, nastavek za steklenico iz HDPE in 2 brizgi za odmerjanje iz polietilena (rdeča brizga je označena z lestvico do 3 ml in bela brizga je označena z lestvico do
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at a dosage several times greater than that recommended.
Pri bolnikih, ki so prejemali hidroksikarbamid v nekajkrat višjih odmerkih od priporočenega, so poročali o akutni mukokutani toksičnosti.
A clinical response to treatment with hydroxycarbamide may take 3-6 months and therefore, a 6month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure (whether due to lack of adherence or failure to respond to therapy).
zato je pred morebitno prekinitvijo jemanja zdravila zaradi neuspešnega zdravljenja (bodisi zaradi slabše adherence bodisi zaradi neodzivanja na zdravljenje) potrebno šestmesečno preskušanje najvišjega dovoljenega odmerka.
• Patient information pack
• paket gradiv z informacijami za bolnika.
Skin ulcer, oral, nail and skin hyperpigmentation, dry skin, alopecia
Bolezni kože in podkožja pogosti kožni ulkus, oralna hiperpigmentacija ter hiperpigmentacija nohtov in kože, suha koža, alopecija občasni izpuščaj redki ulkusi na nogah zelo redki sistemski in kožni eritematozni lupus
Hydroxycarbamide is cytotoxic.
Hidroksikarbamid je citotoksičen.
What you need to know before you take Xromi
Kaj morate vedeti, preden boste vzeli zdravilo Xromi Ne jemljite zdravila Xromi:
Xromi can make you feel drowsy.
Zdravilo Xromi lahko povzroči zaspanost.
Contents of the pack and other information
Shranjevanje zdravila Xromi Vsebina pakiranja in dodatne informacije
Please contact your doctor immediately if you think you may be pregnant.
Če menite, da bi lahko bili noseči, o tem nemudoma obvestite zdravnika.
60 children (aged 5-18 years) with three or more blood transfusions or vaso-occlusive crises requiring hospitalisation per year, were randomised to fixed dose 10 mg/mg per day hydroxycarbamide (n=30) or to a matched placebo (n=30).
zaradi katerih je bila potrebna hospitalizacija, randomizirali za prejemanje fiksnega dnevnega odmerka 10 mg/mg hidroksikarbamida (n = 30) ali ujemajočega se placeba (n = 30).
An increase in HbF and a decrease in absolute neutrophil count were reported in the hydroxycarbamide group.
V skupini, ki je prejemala hidroksikarbamid, so poročali o zvišanju ravni HbF in zmanjšanju absolutnega števila nevtrofilcev.
Skin cancer has been reported in patients receiving long term hydroxycarbamide.
Pri bolnikih, ki prejemajo dolgotrajno zdravljenje s hidroksikarbamidom, so poročali o kožnem raku.
In keeping with the mechanism of action of hydroxycarbamide, the MSH study also showed a statistically significant increase in HbF (mean difference 3.9% (95% CI 2.69 to 5.11 (p < 0.0001)) and haemoglobin levels (mean difference 0.6 g/dL (95% CI 0.28 to 0.92, p < 0.0014) and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Študija MSH je v skladu z mehanizmom delovanja hidroksikarbamida prav tako pokazala statistično pomembno zvišanje ravni HbF (povprečna razlika 3,9 % (95-odstotni interval zaupanja: od 2,69 do
NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution hydroxycarbamide
Xromi 100 mg/ml peroralna raztopina hidroksikarbamid
Talk to your doctor, pharmacist or nurse before taking Xromi:
Pred začetkom jemanja zdravila Xromi se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
It appears that nitroxyl, the corresponding carboxylic acid and nitric oxide are metabolites: Urea has also been shown to be a metabolite of hydroxycarbamide.
Kaže, da so presnovki nitroksil, ustrezna karboksilna kislina in dušikov oksid.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema zelo pogosti depresija kostnega mozga,
Uncommon: may affect up to 1 in 100 people - Itching red eruption of the skin (rash) - Diarrhoea - Vomiting
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - srbeči rdeči kožni izpuščaj (izpuščaj)
There was a statistically significant difference between the hydroxycarbamide group and placebo group in the mean annual crisis rate (all crises), mean difference -2.80 (95% CI -4.74 to -0.86) (p = 0.005), and for crises requiring hospitalisation, mean difference -1.50 (95% CI -2.58 to -0.42) (p = 0.007).
2,80 (95-odstotni interval zaupanja: od -4,74 do -0,86) (p = 0,005) in glede kriz, v katerih je bila potrebna hospitalizacija: povprečna razlika -1,50 (95-odstotni interval zaupanja: od -2,58 do -0,42) (p = 0,007).
- Inflammation or ulceration of the mouth
- driska - bruhanje - vnetje ali razjede v ustih - zvišane vrednosti jetrnih encimov
Thrombocytopenia, anaemia
retikulocitopenijo, makrocitozo pogosti trombocitopenija, anemija
These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy (see section 4.4).
O teh toksičnih vaskulitisih so najpogosteje poročali pri bolnikih, ki so bili v preteklosti ali v času terapije zdravljeni z interferonom
Two dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml) are provided for accurate measurement of the prescribed dose of the oral solution.
Za natančno odmerjanje predpisanega odmerka peroralne raztopine sta priloženi dve brizgi (rdeča brizga je označena z lestvico do 3 ml in bela brizga je označena z lestvico do 12 ml).