FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients at chronic high risk of helminth infection, a placebo-controlled trial in allergic patients showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered.
Slovenian: Pri bolnikih s kroničnim velikim tveganjem infestacije s helminti je s placebom kontrolirano preskušanje pri bolnikih z alergijo med zdravljenjem z omalizumabom pokazalo rahel porast pogostnosti infestacije, čeprav so bili potek, stopnja izraženosti in odziv na zdravljenje infestacije nespremenjeni.
English: Renal or hepatic impairment
Slovenian: Bolniki z okvaro ledvic ali jeter
English: It is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.
Slovenian: Uporablja se za preprečevanje poslabšanja astme z obvladovanjem simptomov težke alergijske astme pri odraslih, mladostnikih in otrocih (starih 6 let ali več), ki že prejemajo zdravila za astmo, vendar pri njih simptomov astme zdravila, kot so steroidi v velikih odmerkih za inhaliranje ali agonisti adrenergičnih receptorjev beta, ne obvladujejo dobro.
English: Powder: sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbate 20.
Slovenian: Prašek: saharoza, L-histidin, L-histidinijev klorid hidrat in polisorbat 20.
English: Your doctor will decide how much Xolair you need and how often you will need it.
Slovenian: Vaš zdravnik bo določil, koliko zdravila Xolair potrebujete in kako pogosto ga boste morali uporabljati.
English: Carefully remove the needle cap from the syringe.
Slovenian: Z injekcijske brizge previdno snemite pokrovček igle in ga zavrzite.
English: Your doctor will decide how much Xolair you need and how often you will be given it.
Slovenian: Zdravnik bo določil, koliko zdravila Xolair potrebujete in kako pogosto ga boste prejemali.
English: Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair.
Slovenian: Zato morajo biti ob aplikaciji zdravila Xolair vedno na voljo zdravila za zdravljenje anafilaktičnih reakcij, pripravljena za takojšnjo uporabo.
English: Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.
Slovenian: - sistemski eritematozni lupus (SLE): simptomi lahko vključujejo bolečine v mišicah, bolečine in otekanje sklepov, izpuščaj, zvišano telesno temperaturo, zmanjšanje telesne mase in utrujenost.
English: Multipack: 4 (4 x 1) pre-filled syringes Multipack: 10 (10 x 1) pre-filled syringes
Slovenian: Skupno pakiranje: 4 (4 x 1) napolnjene injekcijske brizge Skupno pakiranje: 10 (10 x 1) napolnjenih injekcijskih brizg
English: Powder: white to off-white lyophilisate Solvent: clear and colourless solution
Slovenian: prašek in vehikel za raztopino za injiciranje Prašek: bel do skoraj bel liofilizat Vehikel: bistra in brezbarvna raztopina
English: The primary endpoint was the change from baseline to week 12 in weekly itch severity score.
Slovenian: Primarni cilj opazovanja je bila sprememba ocene izraženosti srbenja v enem tednu od izhodišča do 12. tedna.
English: Symptoms may include one or more of the following: swelling, pain or rash around blood or lymph vessels, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) - Churg-Straussov ali hipereozinofilni sindrom: simptomi lahko vključujejo eno ali več naslednjih težav : oteklina, bolečina ali izpuščaj okrog krvnih ali limfnih žil, povečano število posebne vrste belih krvnih celic (izrazita eozinofilija), poslabševanje težav z dihanjem, kongestija nosne sluznice (zamašen nos), težave s srcem, bolečina, odrevenelost, mravljinčenje v rokah in nogah.
English: Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Slovenian: Viala naj bo še naprej zasukana na glavo, zabodite konico igle čisto na dnu raztopine v viali, ko vsrkavate raztopino v brizgo.
English: Xolair 75 mg solution for injection is supplied in a single-use pre-filled syringe for individual use.
Slovenian: Xolair 75 mg raztopina za injiciranje je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo za posameznega bolnika.
English: What Xolair looks like and contents of the pack Xolair solution for injection is supplied as a clear to slightly opalescent, colourless to pale brownish-yellow solution in a pre-filled syringe.
Slovenian: Zdravilo Xolair raztopina za injiciranje je na voljo v obliki bistre do rahlo opalescentne, brezbarvno do bledo rjavorumeno obarvane raztopine v napolnjeni injekcijski brizgi.
English: Xolair 150 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1), 6 (6 x 1) or 10 (10 x 1) pre-filled syringes.
Slovenian: Zdravilo Xolair 150 mg raztopina za injiciranje je na voljo v pakiranjih, ki vsebujejo 1 napolnjeno injekcijsko brizgo in v skupnih pakiranjih, ki vsebujejo 4 (4 x 1) napolnjene injekcijske brizge oziroma 6 (6 x 1) ali 10 (10 x 1) napolnjenih injekcijskih brizg.
English: Multipack: 4 (4 x 1) vials and 4 (4 x 1) ampoules Multipack: 10 (10 x 1) vials and 10 (10 x 1) ampoules
Slovenian: prašek in vehikel za raztopino za injiciranje Skupno pakiranje: 4 (4 x 1) viale in 4 (4 x 1) ampule Skupno pakiranje: 10 (10 x 1) vial in 10 (10 x 1) ampul
English: In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered.
Slovenian: Pri bolnikih s kroničnim velikim tveganjem infestacije s helminti je s placebom kontrolirano preskušanje med zdravljenjem z omalizumabom pokazalo rahel porast pogostnosti infestacije, čeprav so bili potek, stopnja izraženosti in odziv na zdravljenje infestacije nespremenjeni.
English: Symptoms may include one or more of the following: joint pain with or without swelling or stiffness, rash, fever, swollen lymph nodes, muscle pain.
Slovenian: - serumska bolezen: simptomi lahko vključujejo eno ali več naslednjih težav: bolečine v sklepih z otekanjem ali otrdelostjo ali brez njiju, izpuščaj, zvišana telesna temperatura, povečane bezgavke, bolečine v mišicah .
English: 375 mg 1 blue (75 mg)
Slovenian: 375 mg 1 modra (75 mg)
English: Xolair 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use.
Slovenian: Xolair 150 mg raztopina za injiciranje je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo za posameznega bolnika.
English: Xolair 150 mg injection omalizumab SC
Slovenian: Xolair 150 mg injekcija omalizumab s.c.
English: Xolair 75 mg injection omalizumab SC
Slovenian: Xolair 75 mg injekcija omalizumab s.c.
English: There is limited experience with self-administration of Xolair powder and solvent for solution for injection.
Slovenian: Izkušnje pri bolnikih, ki si zdravilo Xolair prašek in vehikel za raztopino za injiciranje aplicirajo sami, so omejene.
English: - The other ingredients are sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbate 20.
Slovenian: - Druge sestavine zdravila so saharoza, L-histidin, L-histidinijev klorid hidrat in polisorbat 20.
English: 525 mg 1 blue (75 mg)
Slovenian: 525 mg 1 modra (75 mg)
English: Pyrexia**
Slovenian: Vrednost p **
English: In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
Slovenian: Pri bolnikih, ki uporabljajo zdravila za zdravljenje astme, vključno z omalizumabom, se v redkih primerih izrazita oziroma razvijeta sistemska eozinofilija in vaskulitis, kar se običajno zgodi v povezavi z nižanjem odmerkov peroralnih kortikosteroidov.
English: 225 mg 1 blue (75 mg)
Slovenian: 225 mg 1 modra (75 mg)
English: You may not see an immediate improvement in your asthma after beginning Xolair therapy.
Slovenian: Ko se boste začeli zdraviti z zdravilom Xolair, mogoče ne boste opazili takojšnjega izboljšanja astme.
English: The powder is reconstituted in the water before it is injected by a doctor or nurse.
Slovenian: Zdravnik ali medicinska sestra mora prašek pred injiciranjem raztopiti v vodi.
English: In allergic patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant.
Slovenian: Pri bolnikih z alergijo in s kroničnim velikim tveganjem infestacije s helminti je s placebom kontrolirano preskušanje pokazalo pri zdravljenju z omalizumabom rahlo številčno povečanje pogostnosti infestacije, ki ni bilo statistično značilno.
English: Xolair can be given to adolescents aged 12 years and older, who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines.
Slovenian: Zdravilo Xolair je mogoče dajati mladostnikom, ki so stari 12 let ali več in že prejemajo antihistaminike, vendar njihovi simptomi kronične spontane urtikarije s temi zdravili niso dobro urejeni.
English: CARTON FOR UNIT PACK
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE
English: In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant.
Slovenian: Pri bolnikih s kroničnim velikim tveganjem infestacije s helminti je s placebom kontrolirano preskušanje pokazalo pri zdravljenju z omalizumabom rahlo številčno povečanje pogostnosti infestacije, ki ni bilo statistično značilno.
English: Statistically significant results were further observed in the responder rates for UAS7≤6 (at week 12) which were higher for the 300 mg treatment groups, ranging from 52-66% (p<0.0001) compared to 11-19% for the placebo groups, and complete response (UAS7=0) was achieved by 34-44% (p<0.0001) of patients treated with 300 mg compared to 5-9% of patients in the placebo groups.
Slovenian: Popoln odziv (UAS7=0) je doseglo 34-44 % (p<0,0001) tistih bolnikov, ki so prejemali odmerek 300 mg, v primerjavi s 5-9 % bolnikov v skupinah s placebom.
English: How to store Xolair
Slovenian: Kako boste prejeli zdravilo Xolair
English: Xolair can be used in adolescents aged 12 years of age and older, who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines.
Slovenian: Zdravilo Xolair je mogoče uporabljati pri mladostnikih, ki so stari 12 let ali več in že prejemajo antihistaminike, vendar njihovi simptomi kronične spontane urtikarije s temi zdravili niso dobro urejeni.
English: Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab*.
Slovenian: Vsaka napolnjena injekcijska brizga z 1 ml raztopine vsebuje 150 mg omalizumaba*.
English: Xolair can be given to children and adolescents aged 6 years and older, who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high dose steroid inhalers or beta-agonist inhalers.
Slovenian: Zdravilo Xolair je mogoče dajati otrokom in mladostnikom, ki so stari 6 let ali več in že prejemajo zdravila za astmo, vendar zdravila, kot so steroidi v velikih odmerkih za inhaliranje ali agonisti adrenergičnih receptorjev beta, pri njih simptomov ne obvladujejo dobro.
English: One syringe of 0.5 ml solution contains 75 mg omalizumab.
Slovenian: Ena injekcijska brizga z 0,5 ml raztopine vsebuje 75 mg omalizumaba.
English: Gripping the middle of the purple syringe guard, lift the syringe out of the tray.
Slovenian: Injekcijsko brizgo primite za srednji del vijoličnega zapirala brizge in jo dvignite iz ovitka.
English: Xolair 75 mg powder for solution for injection is supplied in a single-use vial.
Slovenian: Xolair 75 mg prašek za raztopino za injiciranje je na voljo v viali za enkratno uporabo.
English: Anaphylactic reaction, other serious allergic conditions, antiomalizumab antibody development
Slovenian: Bolezni imunskega sistema redki anafilaktična reakcija, druga resna alergijska stanja, razvoj protiteles proti omalizumabu pogostnost neznana serumska bolezen, lahko vključuje zvišano telesno temperaturo in limfadenopatijo
English: - The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
Slovenian: - Druge sestavine zdravila so L-argininijev klorid, L-histidinijev klorid, L-histidin, polisorbat 20,
English: Xolair can be used in children and adolescents aged 6 years and older, who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high dose steroid inhalers or beta-agonist inhalers.
Slovenian: Zdravilo Xolair je mogoče uporabljati pri otrocih in mladostnikih, ki so stari 6 let ali več in že prejemajo zdravila za astmo, vendar zdravila, kot so steroidi v velikih odmerkih za inhaliranje ali agonisti adrenergičnih receptorjev beta, pri njih simptomov ne obvladujejo dobro.
English: Xolair 150 mg powder for solution for injection is supplied in a single-use vial.
Slovenian: Xolair 150 mg prašek za raztopino za injiciranje je na voljo v viali za enkratno uporabo.
English: 75 mg solution for injection in pre-filled syringe (10 x 1)
Slovenian: 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (10 x 1)
English: Mean (SD)
Slovenian: Odmerek (mg)
English: It is not entirely understood how this results in an improvement of CSU symptoms.
Slovenian: To posledično povzroči zmanjšanje števila receptorjev za IgE (FcεRI) na celicah, ni pa povsem jasno, na kakšen način to povzroči izboljšanje simptomov kronične spontane urtikarije.
English: 75 mg solution for injection in pre-filled syringe (4 x 1)
Slovenian: 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (4 x 1)
English: Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Slovenian: Za subkutano injiciranje zamenjajte iglo številka 18 z iglo številka 25.
English: Caution: Keep the syringe out of the sight and reach of children.
Slovenian: Opozorilo: Injekcijsko brizgo shranjujte nedosegljivo otrokom.
English: Dyspeptic signs and symptoms, diarrhoea, nausea Skin and subcutaneous tissue disorders Uncommon
Slovenian: Bolezni kože in podkožja občasni preobčutljivost za svetlobo, urtikarija, izpuščaj, pruritus redki angioedem pogostnost neznana alopecija
English: Do not stop treatment with Xolair unless your doctor tells you to. Interrupting or stopping the treatment with Xolair may cause your asthma or CSU symptoms to come back.
Slovenian: Začasna ali stalna prekinitev zdravljenja z zdravilom Xolair lahko povzroči povrnitev simptomov vaše astme.
English: 150 mg solution for injection in pre-filled syringe
Slovenian: 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: 1 purple (150 mg)
Slovenian: 1 vijolična (150 mg)
English: 150 mg solution for injection in pre-filled syringe (6 x 1)
Slovenian: 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (6 x 1)
English: Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 x 1); 6 (6 x 1) or 10 (10 x 1) prefilled syringes.
Slovenian: Pakiranje vsebuje 1 napolnjeno injekcijsko brizgo, skupna pakiranja pa vsebuejo 4 (4 x 1) napolnjene injekcijske brizge ter 6 (6 x 1) ali 10 (10 x 1) napolnjenih injekcijskih brizg.
English: Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab.
Slovenian: Ena napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 75 mg omalizumaba.
English: Laryngoedema
Slovenian: Trombociti
English: 4 purple (150 mg)
Slovenian: 4 vijolične (150 mg)
English: 75 mg solution for injection in pre-filled syringe
Slovenian: 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: One syringe of 1 ml solution contains 150 mg omalizumab.
Slovenian: Ena injekcijska brizga z 1 ml raztopine vsebuje 150 mg omalizumaba.
English: Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.
Slovenian: Pakiranje vsebuje 1 napolnjeno injekcijsko brizgo, skupna pakiranja pa vsebuejo 4 (4 x 1) napolnjene injekcijske brizge ali 10 (10 x 1) napolnjenih injekcijskih brizg.
English: 2 purple (150 mg)
Slovenian: 2 vijolični (150 mg)
English: Xolair 75 mg solution for injection in pre-filled syringe omalizumab
Slovenian: Xolair 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi omalizumab
English: Your Xolair 75 mg pre-filled syringe
Slovenian: Xolair 75 mg napolnjena injekcijska brizga
English: 150 mg solution for injection in pre-filled syringe (10 x 1)
Slovenian: 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (10 x 1)
English: 3 purple (150 mg)
Slovenian: 3 vijolične (150 mg)
English: Symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), windpipe or other parts of the body, fast heartbeat, dizziness and light-headedness, confusion, shortness of breath, wheezing or trouble breathing, blue skin or lips, collapsing and losing consciousness.
Slovenian: Če opazite znake naslednjih neželenih učinkov, takoj poiščite zdravniško pomoč: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) - hude alergijske reakcije (vključno z anafilaksijo): simptomi lahko vključujejo izpuščaj, srbenje kože ali urtikarijo, otekanje obraza, ustnic, jezika, grla, sapnika ali drugih delov telesa, hitro bitje srca, vrtoglavost in občutek, da boste izgubili zavest, zmedenost, kratko sapo, piskanje pri dihanju ali oteženo dihanje, pomodrelo kožo ali ustnice, omotičnost in izgubo zavesti.
English: Xolair 150 mg solution for injection in pre-filled syringe omalizumab
Slovenian: Xolair 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi omalizumab
English: 150 mg solution for injection in pre-filled syringe (4 x 1)
Slovenian: 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (4 x 1)
English: Xolair 75 mg solution for injection in pre-filled syringe
Slovenian: Xolair 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Xolair 150 mg powder and solvent for solution for injection omalizumab
Slovenian: Xolair 150 mg prašek in vehikel za raztopino za injiciranje omalizumab
English: • Sharps disposal container.
Slovenian: • zbiralnik za ostre predmete
English: Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab.
Slovenian: Ena napolnjena injekcijska brizga z 1 ml raztopine vsebuje 150 mg omalizumaba.
English: Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Slovenian: Izbrizgajte zrak, velike mehurčke in morebitno odvečno tekočino, da boste dobili potrebni odmerek 0,6 ml. Na površini raztopine v brizgi sme ostati tenka plast majhnih mehurčkov.
English: Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose.
Slovenian: Izbrizgajte zrak, velike mehurčke in morebitno odvečno tekočino, da boste dobili potrebni odmerek 1,2 ml. Na površini raztopine v brizgi sme ostati tenka plast majhnih mehurčkov.
English: Xolair 75 mg powder and solvent for solution for injection omalizumab
Slovenian: Xolair 75 mg prašek in vehikel za raztopino za injiciranje omalizumab
English: Xolair 150 mg powder and solvent for solution for injection
Slovenian: Xolair 150 mg prašek in vehikel za raztopino za injiciranje
English: Xolair 75 mg powder and solvent for solution for injection
Slovenian: Xolair 75 mg prašek in vehikel za raztopino za injiciranje
English: Xolair 150 mg solution for injection in pre-filled syringe
Slovenian: Xolair 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: You must look out for signs of these conditions while you use Xolair.
Slovenian: V času uporabe zdravila Xolair morate biti pozorni na znake teh neželenih učinkov.
English: Your Xolair 150 mg pre-filled syringe
Slovenian: Xolair 150 mg napolnjena injekcijska brizga
English: Clear to slightly opalescent, colourless to pale brownish-yellow solution.
Slovenian: bistra do rahlo opalescentna in brezbarvna do bledo rjavorumeno obarvana raztopina
English: Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 75 mg omalizumaba*.
English: Storage of the Xolair pre-filled syringe
Slovenian: Shranjevanje zdravila Xolair v napolnjeni injekcijski brizgi
English: Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab.
Slovenian: Časovno spreminjanje koncentracije omalizumaba v serumu po aplikaciji zdravila Xolair poteka približno enako ne glede na to, ali je bilo zdravilo izdelano v liofilizirani ali v tekoči obliki.
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Slovenian: NALEPKA (Z “BLUE BOX” PODATKI) NA OVITKU SKUPNEGA PAKIRANJA Z VMESNIMI PAKIRANJI ZAVITIMI V FOLIJO
English: Xolair 150 mg powder for solution for injection omalizumab
Slovenian: Xolair 150 mg prašek za raztopino za injiciranje omalizumab subkutana uporaba
English: Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.
Slovenian: Medtem ko previdno vlečete iglo naravnost iz kože na mestu injiciranja, držite bat pritisnjen do konca.
English: One vial contains 75 mg of omalizumab*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 mg omalizumaba*.
English: The liquid should be clear to slightly cloudy.
Slovenian: Tekočina mora biti bistra do rahlo motna, barva tekočine pa lahko variira od brezbarvne do bledo rjavorumene.
English: Xolair 75 mg powder for solution for injection omalizumab
Slovenian: Xolair 75 mg prašek za raztopino za injiciranje omalizumab subkutana uporaba
English: Study 2
Slovenian: DRUGI PODATKI
English: Children (6 to less than 12 years of age) are not expected to inject Xolair themselves, however, if deemed appropriate by their doctor, a caregiver may give them their Xolair injection after proper training.
Slovenian: Pri otrocih (ki so stari od 6 do manj kot 12 let) ni predvideno, da bi si zdravilo Xolair dajali sami.
English: 1 x 75 mg vial 1 x 2 ml solvent ampoule
Slovenian: prašek in vehikel za raztopino za injiciranje 1 x 75 mg viala
English: Injection site reactions such as swelling, erythema, pain, pruritus
Slovenian: občasni znaki in simptomi dispepsije, driska, navzea
English: Keep taking your current medicine for CSU during Xolair treatment.
Slovenian: Med zdravljenjem z zdravilom Xolair nadaljujte z uporabo zdravil, ki ste jih že prej uporabljali za zdravljenje kronične spontane urtikarije.
English: L-arginine hydrochloride L-histidine hydrochloride L-histidine
Slovenian: L-argininijev klorid L-histidinijev klorid L-histidin polisorbat 20 voda za injekcije
English: 1 x 150 mg vial 1 x 2 ml solvent ampoule
Slovenian: prašek in vehikel za raztopino za injiciranje 1 x 150 mg viala
English: For subcutaneous administration only.
Slovenian: Zdravilo je namenjeno samo za subkutano uporabo.
English: Omalizumab 300 mg
Slovenian: placebo omalizumab 300 mg študija 1
English: It's important that you do this.
Slovenian: Pomembno je, da to storite.
English: The reason is unclear.
Slovenian: Razlog za to ni jasen.
English: You can take it with or without food.
Slovenian: Vzamete ga lahko s hrano ali brez nje.
English: • when you first start treatment
Slovenian: • ko prvič začnete zdravljenje
English: - The CHMP concluded that the data are supportive of the following indications:
Slovenian: - CHMP je zaključil, da podatki podpirajo naslednje indikacije:
English: The dose you take will depend on:
Slovenian: Odmerek, ki ga boste jemali, bo odvisen od:
English: However, based on interaction studies with other medicinal products, the following recommendations can be made:
Slovenian: Vendar je mogoče na podlagi študij interakcij z drugimi zdravili podati naslednja priporočila: