FrancophonIA/ELRC3.0 huggingface dataset:
English: Reslizumab total dose (mg)
Slovenian: Celotni odmerek reslizumaba (mg)
English: Based on population pharmacokinetic analysis, systemic exposure to reslizumab appears to be unaffected by circulating anti-reslizumab antibodies.
Slovenian: Na podlagi analize populacijske farmakokinetike kaže, da protitelesa proti reslizumabu v obtoku ne vplivajo na sistemsko izpostavljenost reslizumabu.
English: CINQAERO is provided as a concentrate for solution for infusion in a single-use vial.
Slovenian: Zdravilo CINQAERO je na voljo kot koncentrat za raztopino za infundiranje v viali za enkratno uporabo.
English: Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
Slovenian: Kaže, da protitelesa proti reslizumabu ne vplivajo na sistemsko izpostavljenost reslizumabu.
English: What CINQAERO looks like and contents of the pack
Slovenian: Izgled zdravila CINQAERO in vsebina pakiranja
English: The maximum dose is 3 mg per kg of body weight.
Slovenian: Največji priporočeni odmerek je 3 mg na kg telesne mase.
English: In placebo-controlled clinical studies, 6 out of 1,028 patients (0.6%) receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared to 2 out of 730 patients (0.3%) in the placebo group.
Slovenian: V kliničnih študijah, nadzorovanih s placebom, so pri 6 od 1.028 bolnikov (0,6 %), ki so prejemali 3 mg/kg reslizumaba, poročali o vsaj eni maligni novotvorbi, v primerjavi z 2 od 730 bolnikov (0,3 %)
English: What CINQAERO is and what it is used for What CINQAERO is
Slovenian: Kaj je zdravilo CINQAERO in za kaj ga uporabljamo Kaj je zdravilo CINQAERO
English: Study II (n=464)
Slovenian: Študija II (n = 464)
English: In both studies, an asthma exacerbation was defined as a worsening of asthma that required the following medical intervention: 1) use of systemic corticosteroids or an increase in the use of ICS treatment for 3 or more days, and/or 2) asthma-related emergency treatment including at least one of the following: an unscheduled visit to their healthcare professional for nebuliser treatment or other urgent treatment to prevent worsening of asthma symptoms; a visit to the emergency room for asthma-related treatment; or asthma-related hospitalisation.
Slovenian: 2) z astmo povezano nujno zdravljenje, vključno z vsaj nečim od naslednjega: nenačrtovanim obiskom zdravstvenega delavca, usposobljenega za zdravljenje z nebulatorjem; drugim nujnim zdravljenjem za preprečitev poslabšanja simptomov astme; obiskom oddelka za nujno medicinsko pomoč za zdravljenje, povezano z astmo; ali zdravljenjem v bolnišnici zaradi astme.
English: A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
Slovenian: Za izvlek potrebne količine koncentrata iz vial(e) je treba uporabiti primerno injekcijsko brizgo (glejte poglavje 4.2).
English: In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to placebo.
Slovenian: V združenih študijah I in II so imeli bolniki, ki so prejemali reslizumab 3 mg/kg, značilno zmanjšanje poslabšanj astme (56 % za podskupini GINA 4 in 5) v primerjavi s placebom.
English: The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to reslizumab or to any of the excipients (see section 4.4).
Slovenian: Z infundiranjem je treba takoj prenehati, če bolnik doživi preobčutljivostno reakcijo na reslizumab ali katero koli pomožno snov (glejte poglavje 4.4).
English: 1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL
Slovenian: Velikosti pakiranja: 1 viala z 2,5 ml 2 viali z 2,5 ml 1 viala z 10 ml 2 viali z 10 ml
English: The diluted medicinal product should then be administered as a 20 - 50-minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm).
Slovenian: Razredčeno zdravilo je treba potem dati v obliki 20- do 50-minutne intravenske infuzije preko sterilnega, apirogenega filtra z majhno vezavo beljakovin (0,2 µm), za enkratno uporabo.
English: NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition:
Slovenian: Bolniki z neodzivno astmod n/rb a FEV1 = forsirani ekspiratorni volumen v 1 sekundi b n/r = ni razpoložljivo c Klasifikacija GINA temelji na opredelitvi Globalne iniciative za astmo (GINA-Global Initiative for Asthma): Bolniki s 4. korakom po GINA so prejeli srednje visok do visok odmerek IKS skupaj z drugim zdravilom za obvladovanje.
English: Blood creatine phosphokinase increased
Slovenian: Zvečana vrednost kreatin fosfokinaze v krvi
English: 2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.
Slovenian: 2,5 ml koncentrata v viali iz prozornega stekla tipa I, zaprti z zamaškom iz butilne gume, prevlečena s poli(etilen-ko-tetrafluoroetilenom) in zapečatena z aluminijastim obročkom in belo plastično snemljivo zaporko.
English: Also, talk to your doctor or nurse when you are given CINQAERO: - if your asthma remains uncontrolled or worsens during treatment with this medicine; - if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Slovenian: Prav tako se posvetujte zdravnikom ali medicinsko sestro, ko vam dajo zdravilo CINQAERO: - če astma med zdravljenjem s tem zdravilom ostane neurejena ali se poslabša; - če imate katerega od simptomov alergijske reakcije (srbenje, težave z dihanjem, sopenje,
English: The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL sodium chloride 9 mg/mL (0.9%) solution for infusion.
Slovenian: Ustrezno količino zdravila CINQAERO je treba dati v infuzijsko vrečico, ki vsebuje 50 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
English: A reduction in asthma exacerbations resulting in hospitalisation or an emergency room visit was observed with reslizumab 3 mg/kg that was not statistically significant (34% [p=0.2572] and 31% [p=0.4020] in Study I and Study II, respectively).
Slovenian: Z reslizumabom 3 mg/kg so opazili statistično nepomembno zmanjšanje poslabšanj astme, zaradi katere je bilo potrebno zdravljenje v bolnišnici ali obisk oddelka za nujno medicinsko pomoč (34 % [p = 0,2572] v študiji I oz. 31 % [p = 0,4020] v študiji II).
English: 10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.
Slovenian: 10 ml koncentrata v viali iz prozornega stekla tipa I, zaprti z zamaškom iz butilne gume, prevlečena s poli(etilen-ko-tetrafluoroetilenom) in zapečatena z aluminijastim obročkom in modro plastično snemljivo zaporko.
English: Serum reslizumab concentrations generally decline from peak in a biphasic manner.
Slovenian: Na splošno koncentracije reslizumaba v serumu od največje vrednosti upadejo na dvofazni način.
English: Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
Slovenian: Preglednica 3: Demografske in izhodiščne značilnosti študij astme I do III
English: Upon completion of the infusion, flush the infusion set with sterile sodium chloride 9 mg/mL (0.9%) solution for infusion to ensure that all of the CINQAERO solution for infusion has been administered.
Slovenian: Po končanju infuzije izperite infuzijski set s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje, da zagotovite, da je bila uporabljena celotna količina zdravila
English: CINQAERO contains sodium
Slovenian: Zdravilo CINQAERO vsebuje natrij
English: CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters.
Slovenian: Zdravilo CINQAERO je združljivo z linijskimi infuzijskimi filtri z majhno vezavo beljakovin iz polietersulfona (PES), poliviniliden fluorida (PVDF), najlona in celuloznega acetata (CA).
English: Effect on blood eosinophils
Slovenian: Učinek na eozinofilce v krvi
English: Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not significantly different between ethnic groups (white, black and Asian).
Slovenian: Analize populacijske farmakokinetike kažejo, da med etničnimi skupinami (belci, temnopoltimi in Azijci) ni značilnih razlik v farmakokinetiki reslizumaba.
English: GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Slovenian: Bolniki s 5. korakom po GINA so prejeli vzdrževalni PKS kod dodatno, dopolnilno zdravilo.
English: In phase 3 placebo-controlled studies with a duration of 16 to 52 weeks, low-titre, frequently transient anti-reslizumab antibodies were detected in 53 out of 983 asthma patients (5%) receiving reslizumab at 3 mg/kg.
Slovenian: V študijah 3. faze, nadzorovanih s placebom, ki so trajale 16 do 52 tednov, so pri 53 od 983 bolnikov z astmo (5 %), ki so prejemali odmerek reslizumaba 3 mg/kg, pogosto odkrili prehodno prisotnost nizkih titrov protiteles proti reslizumabu.
English: In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (50% and 59%, respectively) compared to placebo (see Table 4).
Slovenian: V študijah I in II so imeli bolniki, ki so prejemali reslizumab 3 mg/kg, značilno zmanjšanje poslabšanj astme (50 % oz. 59 %) v primerjavi s placebom (glejte preglednico 4).
English: No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Slovenian: Omembe vrednih razlik v farmakokinetiki reslizumaba med temi skupinami delovanja ledvic niso opazili.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija*
English: CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4).
Slovenian: Zdravilo CINQAERO mora dati zdravstveni delavec, ki je pripravljen na obvladovanje preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4.4).
English: Patients with severe refractory eosinophilic asthma Reslizumab produced significant reductions in asthma exacerbations relative to placebo in the refractory population (59%) and non-refractory population (49%).
Slovenian: Reslizumab je povzročil pomembno zmanjšanje poslabšanj astme glede na placebo pri neodzivni populaciji (59 %) in odzivni populaciji (49 %).
English: CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product Characteristics).
Slovenian: Zdravilo CINQAERO mora dati zdravstveni delavec, ki je pripravljen na obvladovanje preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4.4, Povzetek glavnih značilnosti zdravila).
English: Vials with 2.5 mL concentrate (25 mg reslizumab)
Slovenian: Viale z 2,5 ml koncentrata (25 mg reslizumaba)
English: Patients with severe eosinophilic asthma
Slovenian: Bolniki s hudo eozinofilno astmo
English: The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies.
Slovenian: O anafilaktični reakciji kot resnemu neželenemu učinku, za katerega menijo, da je povezan z reslizumabom, so v odprtih študijah astme, nadzorovanih s placebom, poročali pri 3 bolnikih (0,19 %).
English: Hypersensitivity and administration-related reactions Acute systemic reactions, including anaphylactic reactions, have been reported in association with reslizumab (see section 4.8).
Slovenian: V povezavi z reslizumabom so poročali o akutnih sistemskih reakcijah, vključno z anafilaktičnimi reakcijami (glejte poglavje 4.8).
English: No significant difference in the pharmacokinetics of reslizumab was observed across these groups.
Slovenian: Značilnih razlik v farmakokinetiki reslizumaba med temi skupinami niso opazili.
English: Effect on sputum eosinophils
Slovenian: Učinek na eozinofilce v sputumu
English: Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
Slovenian: Ena viala z 2,5 ml vsebuje 25 mg reslizumaba in ena viala z 10 ml vsebuje 100 mg reslizumaba.
English: ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Slovenian: Srednja razlika (95-% IZ) (vrednost p) AQLQ
English: Exacerbation history
Slovenian: Poslabšanja v preteklosti
English: 39 paediatric asthma patients from 12 to 17 years were randomised to reslizumab 0.3 mg/kg, reslizumab 3 mg/kg or placebo as part of two 52-week exacerbation studies (Studies I and II) and one 16-week lung function study (Study III).
Slovenian: 0,3 mg/kg, reslizumab 3 mg/kg ali placebo kot del dveh 52-tedenskih študij poslabšanja (študiji I in II)
English: Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Slovenian: Vsebino brizg(e) počasi dajte v infuzijsko vrečico, ki vsebuje 50 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
English: Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Slovenian: Pri bolnikih z ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 µm) should be used for infusion.
Slovenian: Za infundiranje je treba uporabiti infuzijski set z linijskim, sterilnim, apirogenim filtrom z majhno vezavo beljakovin (velikost por 0,2 µm).
English: How CINQAERO works
Slovenian: Kako deluje zdravilo CINQAERO
English: One vial of 10 mL contains 100 mg reslizumab.
Slovenian: Ena viala z 10 ml vsebuje 100 mg reslizumaba.
English: Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5.
Slovenian: koncentrat za raztopino za infundiranje (sterilen koncentrat) Bistra do rahlo motna, opalescentna, brezbarvna do rahlo rumena raztopina s pH 5,5.
English: CINQAERO 10 mg/mL sterile concentrate reslizumab
Slovenian: CINQAERO 10 mg/ml sterilen koncentrat reslizumab
English: Baseline mean blood eosinophil count, µL-1
Slovenian: Izhodiščno povprečno število eozinofilcev v krvi, µl-1
English: Eosinophil counts
Slovenian: Število eozinofilcev
English: Fertility There are no fertility data in humans.
Slovenian: Podatkov o vplivu na plodnost pri ljudeh ni. Razpoložljivi predklinični podatki ne kažejo na vpliv na plodnost.
English: Most patients in the population pharmacokinetic analysis had normal renal function (estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%).
Slovenian: 90 ml/min/1,73 m2; n = 294, približno 37 %), blago ledvično okvaro (eGFR 60 do 89 ml/min/1,73 m2;
English: One vial of 2.5 mL contains 25 mg reslizumab.
Slovenian: Ena viala z 2,5 ml vsebuje 25 mg reslizumaba.
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Slovenian: Jetrna okvara Pri bolnikih z jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: How CINQAERO is given
Slovenian: Kako se daje zdravilo CINQAERO
English: Patients should be monitored during and for an appropriate time after administration of reslizumab.
Slovenian: Bolnike je treba spremljati med dajanjem reslizumaba in še ustrezen čas po tem.
English: In an open-label phase 3 extension study, low-titre, frequently transient anti-reslizumab antibodies were detected in 49 out of 1,014 asthma patients (5%) who received 3 mg/kg reslizumab for up to 36 months.
Slovenian: V odprtem podaljšku študije 3. faze so pri 49 od 1.014 bolnikov z astmo (5 %), ki so do 36 mesecev prejemali odmerek reslizumaba 3 mg/kg, pogosto odkrili prehodno prisotnost nizkih titrov protiteles proti reslizumabu.
English: Over 16 weeks
Slovenian: Čez 16 tednov Čez 52 tednov Čez 16 tednov Čez 52 tednov
English: Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
Slovenian: Kazale so se v spremembah na koži in sluznicah, kot dispneja, zasoplost, prebavni simptomi in mrzlica.
English: CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab
Slovenian: CINQAERO 10 mg/ml koncentrat za raztopino za infundiranje reslizumab
English: Reslizumab has not been studied in patients with severe renal impairment or end stage renal disease.
Slovenian: Reslizumaba pri bolnikih s hudo ledvično okvaro ali boleznijo ledvic v zadnjem stadiju niso preučili.
English: Of these subjects, 1,006 asthma patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given intravenously (1,028 patients).
Slovenian: Med temi osebami je bilo 1.006 bolnikov z astmo izpostavljenih vsaj 6 mesecev, 759 jih je bilo izpostavljenih vsaj 1 leto in 237 jih je bilo izpostavljenih dlje kot 2 leti (do 3 leta).
English: CINQAERO 10 mg/mL concentrate for solution for infusion
Slovenian: CINQAERO 10 mg/ml koncentrat za raztopino za infundiranje
English: ● Periodic safety update reports (PSURs)
Slovenian: ● Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU
English: Overall population Reslizumab 3 mg/kg (n=477)
Slovenian: Celotna populacija Reslizumab 3 mg/kg (n = 477)
English: Each mL of concentrate contains 10 mg of reslizumab.
Slovenian: En ml koncentrata vsebuje 10 mg reslizumaba.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila CINQAERO Vsebina pakiranja in dodatne informacije
English: The concentrate is clear to slightly hazy opalescent, colourless to slightly yellow.
Slovenian: opalescenten, brezbarven do rahlo rumen.
English: What CINQAERO is used for
Slovenian: Za kaj uporabljamo zdravilo CINQAERO
English: Blood creatine phosphokinase increased*
Slovenian: Preiskave pogosti zvečana vrednost kreatin fosfokinaze v krvi*
English: Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
Slovenian: pri kateri imajo bolniki v krvi ali pljučih preveč eozinofilncev.
English: Gender The pharmacokinetics of reslizumab was not significantly different between males and females.
Slovenian: V farmakokinetiki reslizumaba med moškimi in ženskami ni bilo značilnih razlik.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC,
English: Hepatic Impairment
Slovenian: Maligna obolenja
English: Sodium acetate trihydrate Acetic acid glacial Sucrose
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev acetat trihidrat ledocet saharoza voda za injekcije
English: Pre-bronchodilator FEV1a, mean % predicted
Slovenian: FEV1a pred bronhodilatatorjem,
English: Anaphylactic reaction*
Slovenian: Bolezni imunskega sistema občasni anafilaktična reakcija*
English: How to store CINQAERO
Slovenian: Shranjevanje zdravila CINQAERO
English: The recommended dose is achieved using the vial-based dosing scheme in Table 1 below.
Slovenian: Bolniki med 35 kg in 199 kg Priporočeni odmerek se doseže z uporabo režima odmerjanja na osnovi vial v spodnji preglednici 1.
English: Batch
Slovenian: ACQ
English: CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age and over) when the condition is not well controlled despite treatment with high-dose inhaled corticosteroids together with another asthma medicine.
Slovenian: 18 let in več), pri katerih bolezen ni urejena kljub prejemanju zdravljenja z visokimi odmerki inhalacijskih kortikosteroidov skupaj s še enim zdravilom za astmo.
English: Table 2: Adverse reactions System organ class
Slovenian: Preglednica 2: Neželeni učinki
English: Missed dose
Slovenian: Jetrna okvara
English: Malignancies
Slovenian: Zdravila
English: Reslizumab has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z jetrno okvaro reslizumaba niso preučevali.
English: Pregnancy
Slovenian: Spol
English: It is therefore difficult to recommend an optimum method.
Slovenian: Zato je težko priporočiti najboljšo metodo.
English: The significance of these changes is unknown.
Slovenian: Pomembnost teh sprememb ni znana.
English: Date of first authorisation: 06 February 2009 Date of latest renewal: 13 November 2013
Slovenian: Datum prve odobritve: 06. februar 2009 Datum zadnjega podaljšanja: 13. november 2013
English: These can be taken from you or from a donor.
Slovenian: Odvzamejo se lahko vam ali drugemu darovalcu.
English: It is important to tell your doctor if you:
Slovenian: Pomembno je, da zdravniku poveste, če:
English: Period of Study
Slovenian: Obdobje študije
English: These changes all reversed after discontinuation of treatment.
Slovenian: Te spremembe so bile reverzibilne po prekinitvi zdravljenja.
English: Meta-Analysis
Slovenian: Meta-analiza
English: 83607 Holzkirchen Germany
Slovenian: 83607 Holzkirchen
English: You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Slovenian: Vi ali vaši negovalci se lahko naučite dajanja podkožnih injekcij, da lahko nadaljujete z zdravljenjem doma.
English: The choice of route should depend on the individual clinical circumstance.
Slovenian: Izbira poti uporabe je odvisna od individualnih kliničnih okoliščin.
English: This medicine may cause dizziness.
Slovenian: To zdravilo lahko povzroča omotico.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Slovenian: Rastni faktorji so beljakovine, ki v človeškem telesu naravno nastajajo, vendar jih je mogoče tvoriti tudi s pomočjo biotehnologije za uporabo kot zdravilo.
English: The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Slovenian: Edini neželeni učinek, o katerem so poročali dosledno, je bila mišično-skeletna bolečina‚ ki se ne razlikuje od izkušenj v odrasli populaciji.
English: The volume of distribution in blood is approximately 150 ml/kg.
Slovenian: Volumen porazdelitve v krvi je približno 150 ml/kg.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Slovenian: Ko je takšen odziv dosežen, je treba določiti najmanjši učinkoviti odmerek za vzdrževanje te ravni.
English: • think you may be pregnant; or
Slovenian: • menite, da bi lahko bili noseči, • ali načrtujete zanositev.
English: Dose adjustment is not required in these circumstances.
Slovenian: V teh okoliščinah prilagajanje odmerka ni potrebno.
English: • unusual change in the urine
Slovenian: • neobičajna sprememba urina
English: Your healthcare professional should always record the exact product you are using.
Slovenian: Vaše medicinsko osebje mora vedno zabeležiti v vašo zdravstveno kartoteko točno ime zdravila, ki ga uporabljate.
English: After 1 - 2 weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Slovenian: Po enem do dveh tednih zdravljenja je mogoče začetni odmerek podvojiti ali prepoloviti, odvisno od bolnikovega odziva.
English: The solution should be visually inspected prior to use.
Slovenian: Raztopino je treba pred uporabo vizualno pregledati.
English: 10 6336 Langkampfen Austria
Slovenian: 10 6336 Langkampfen Avstrija