natgillin/translations-raw huggingface dataset:
The patients received either 13 doses of placebo or reslizumab 3 mg/kg administered once every 4 weeks.
Bolniki so prejemali bodisi 13 odmerkov placeba ali reslizumaba 3 mg/kg enkrat na 4 tedne.
In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids.
Biotransformacija Kot za druga monoklonska protitelesa prevladuje mnenje tudi za reslizumab, da se z encimsko proteolizo razgrajuje v majhne peptide in aminokisline.
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
En ml koncentrata vsebuje 10 mg reslizumaba (10 mg/ml).
Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections.
Pomožne snovi: natrijev acetat trihidrat, ledocet, saharoza, voda za injekcije.
d The percentage of patients with refractory asthma (based on the American Thoracic Society
d Odstotek bolnikov z neodzivno astmo (na podlagi opredelitve neodzivne astme delavnice
- The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections.
- Druge sestavine zdravila so natrijev acetat, ledocet, saharoza in voda za injekcije.
CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL.
Zdravilo CINQAERO je na voljo v steklenih vialah, ki vsebujejo 2,5 ml ali 10 ml.
Reslizumab has a long half-life (see section 5.2).
Reslizumab ima dolg razpolovni čas (glejte poglavje 5.2).
Reslizumab total dose (mg)
Celotni odmerek reslizumaba (mg)
Based on population pharmacokinetic analysis, systemic exposure to reslizumab appears to be unaffected by circulating anti-reslizumab antibodies.
Na podlagi analize populacijske farmakokinetike kaže, da protitelesa proti reslizumabu v obtoku ne vplivajo na sistemsko izpostavljenost reslizumabu.
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial.
Zdravilo CINQAERO je na voljo kot koncentrat za raztopino za infundiranje v viali za enkratno uporabo.
Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
Kaže, da protitelesa proti reslizumabu ne vplivajo na sistemsko izpostavljenost reslizumabu.
What CINQAERO looks like and contents of the pack
Izgled zdravila CINQAERO in vsebina pakiranja
The maximum dose is 3 mg per kg of body weight.
Največji priporočeni odmerek je 3 mg na kg telesne mase.
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.
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 %)
What CINQAERO is and what it is used for What CINQAERO is
Kaj je zdravilo CINQAERO in za kaj ga uporabljamo Kaj je zdravilo CINQAERO
Study II (n=464)
Študija II (n = 464)
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.
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.
A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
Za izvlek potrebne količine koncentrata iz vial(e) je treba uporabiti primerno injekcijsko brizgo (glejte poglavje 4.2).
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.
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.
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).
Z infundiranjem je treba takoj prenehati, če bolnik doživi preobčutljivostno reakcijo na reslizumab ali katero koli pomožno snov (glejte poglavje 4.4).
1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL
Velikosti pakiranja: 1 viala z 2,5 ml 2 viali z 2,5 ml 1 viala z 10 ml 2 viali z 10 ml
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).
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.
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:
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.
Blood creatine phosphokinase increased
Zvečana vrednost kreatin fosfokinaze v krvi
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.
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.
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).
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,
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.
Ustrezno količino zdravila CINQAERO je treba dati v infuzijsko vrečico, ki vsebuje 50 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
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).
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).
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.
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.
Serum reslizumab concentrations generally decline from peak in a biphasic manner.
Na splošno koncentracije reslizumaba v serumu od največje vrednosti upadejo na dvofazni način.
Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
Preglednica 3: Demografske in izhodiščne značilnosti študij astme I do III
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.
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
CINQAERO contains sodium
Zdravilo CINQAERO vsebuje natrij
CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters.
Zdravilo CINQAERO je združljivo z linijskimi infuzijskimi filtri z majhno vezavo beljakovin iz polietersulfona (PES), poliviniliden fluorida (PVDF), najlona in celuloznega acetata (CA).
Effect on blood eosinophils
Učinek na eozinofilce v krvi
Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not significantly different between ethnic groups (white, black and Asian).
Analize populacijske farmakokinetike kažejo, da med etničnimi skupinami (belci, temnopoltimi in Azijci) ni značilnih razlik v farmakokinetiki reslizumaba.
GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Bolniki s 5. korakom po GINA so prejeli vzdrževalni PKS kod dodatno, dopolnilno zdravilo.
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.
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.
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).
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).
No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Omembe vrednih razlik v farmakokinetiki reslizumaba med temi skupinami delovanja ledvic niso opazili.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija*
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4).
Zdravilo CINQAERO mora dati zdravstveni delavec, ki je pripravljen na obvladovanje preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4.4).
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%).
Reslizumab je povzročil pomembno zmanjšanje poslabšanj astme glede na placebo pri neodzivni populaciji (59 %) in odzivni populaciji (49 %).
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product Characteristics).
Zdravilo CINQAERO mora dati zdravstveni delavec, ki je pripravljen na obvladovanje preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4.4, Povzetek glavnih značilnosti zdravila).
Vials with 2.5 mL concentrate (25 mg reslizumab)
Viale z 2,5 ml koncentrata (25 mg reslizumaba)
Patients with severe eosinophilic asthma
Bolniki s hudo eozinofilno astmo
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.
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 %).
Hypersensitivity and administration-related reactions Acute systemic reactions, including anaphylactic reactions, have been reported in association with reslizumab (see section 4.8).
V povezavi z reslizumabom so poročali o akutnih sistemskih reakcijah, vključno z anafilaktičnimi reakcijami (glejte poglavje 4.8).
No significant difference in the pharmacokinetics of reslizumab was observed across these groups.
Značilnih razlik v farmakokinetiki reslizumaba med temi skupinami niso opazili.
Effect on sputum eosinophils
Učinek na eozinofilce v sputumu
Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
Ena viala z 2,5 ml vsebuje 25 mg reslizumaba in ena viala z 10 ml vsebuje 100 mg reslizumaba.
ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Srednja razlika (95-% IZ) (vrednost p) AQLQ
Exacerbation history
Poslabšanja v preteklosti
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).
0,3 mg/kg, reslizumab 3 mg/kg ali placebo kot del dveh 52-tedenskih študij poslabšanja (študiji I in II)
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.
Vsebino brizg(e) počasi dajte v infuzijsko vrečico, ki vsebuje 50 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Pri bolnikih z ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
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.
Za infundiranje je treba uporabiti infuzijski set z linijskim, sterilnim, apirogenim filtrom z majhno vezavo beljakovin (velikost por 0,2 µm).
How CINQAERO works
Kako deluje zdravilo CINQAERO
One vial of 10 mL contains 100 mg reslizumab.
Ena viala z 10 ml vsebuje 100 mg reslizumaba.
Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5.
koncentrat za raztopino za infundiranje (sterilen koncentrat) Bistra do rahlo motna, opalescentna, brezbarvna do rahlo rumena raztopina s pH 5,5.
CINQAERO 10 mg/mL sterile concentrate reslizumab
CINQAERO 10 mg/ml sterilen koncentrat reslizumab
Baseline mean blood eosinophil count, µL-1
Izhodiščno povprečno število eozinofilcev v krvi, µl-1
Eosinophil counts
Število eozinofilcev
Fertility There are no fertility data in humans.
Podatkov o vplivu na plodnost pri ljudeh ni. Razpoložljivi predklinični podatki ne kažejo na vpliv na plodnost.
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%).
90 ml/min/1,73 m2; n = 294, približno 37 %), blago ledvično okvaro (eGFR 60 do 89 ml/min/1,73 m2;
One vial of 2.5 mL contains 25 mg reslizumab.
Ena viala z 2,5 ml vsebuje 25 mg reslizumaba.
Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Jetrna okvara Pri bolnikih z jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
How CINQAERO is given
Kako se daje zdravilo CINQAERO
Patients should be monitored during and for an appropriate time after administration of reslizumab.
Bolnike je treba spremljati med dajanjem reslizumaba in še ustrezen čas po tem.
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.
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.
Over 16 weeks
Čez 16 tednov Čez 52 tednov Čez 16 tednov Čez 52 tednov
Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
Kazale so se v spremembah na koži in sluznicah, kot dispneja, zasoplost, prebavni simptomi in mrzlica.
CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab
CINQAERO 10 mg/ml koncentrat za raztopino za infundiranje reslizumab
Reslizumab has not been studied in patients with severe renal impairment or end stage renal disease.
Reslizumaba pri bolnikih s hudo ledvično okvaro ali boleznijo ledvic v zadnjem stadiju niso preučili.
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).
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).
CINQAERO 10 mg/mL concentrate for solution for infusion
CINQAERO 10 mg/ml koncentrat za raztopino za infundiranje
● Periodic safety update reports (PSURs)
● Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU
Overall population Reslizumab 3 mg/kg (n=477)
Celotna populacija Reslizumab 3 mg/kg (n = 477)
Each mL of concentrate contains 10 mg of reslizumab.
En ml koncentrata vsebuje 10 mg reslizumaba.
Contents of the pack and other information
Shranjevanje zdravila CINQAERO Vsebina pakiranja in dodatne informacije
The concentrate is clear to slightly hazy opalescent, colourless to slightly yellow.
opalescenten, brezbarven do rahlo rumen.
What CINQAERO is used for
Za kaj uporabljamo zdravilo CINQAERO
Blood creatine phosphokinase increased*
Preiskave pogosti zvečana vrednost kreatin fosfokinaze v krvi*
Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
pri kateri imajo bolniki v krvi ali pljučih preveč eozinofilncev.
Gender The pharmacokinetics of reslizumab was not significantly different between males and females.
V farmakokinetiki reslizumaba med moškimi in ženskami ni bilo značilnih razlik.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC,
Hepatic Impairment
Maligna obolenja
Sodium acetate trihydrate Acetic acid glacial Sucrose
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev acetat trihidrat ledocet saharoza voda za injekcije
Pre-bronchodilator FEV1a, mean % predicted
FEV1a pred bronhodilatatorjem,
Anaphylactic reaction*
Bolezni imunskega sistema občasni anafilaktična reakcija*
How to store CINQAERO
Shranjevanje zdravila CINQAERO
The recommended dose is achieved using the vial-based dosing scheme in Table 1 below.
Bolniki med 35 kg in 199 kg Priporočeni odmerek se doseže z uporabo režima odmerjanja na osnovi vial v spodnji preglednici 1.
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.
18 let in več), pri katerih bolezen ni urejena kljub prejemanju zdravljenja z visokimi odmerki inhalacijskih kortikosteroidov skupaj s še enim zdravilom za astmo.
Table 2: Adverse reactions System organ class
Preglednica 2: Neželeni učinki
Missed dose
Jetrna okvara
Malignancies
Zdravila
Reslizumab has not been studied in patients with hepatic impairment.
Pri bolnikih z jetrno okvaro reslizumaba niso preučevali.
Pregnancy
Spol
It is therefore difficult to recommend an optimum method.
Zato je težko priporočiti najboljšo metodo.
The significance of these changes is unknown.
Pomembnost teh sprememb ni znana.
Date of first authorisation: 06 February 2009 Date of latest renewal: 13 November 2013
Datum prve odobritve: 06. februar 2009 Datum zadnjega podaljšanja: 13. november 2013
These can be taken from you or from a donor.
Odvzamejo se lahko vam ali drugemu darovalcu.
It is important to tell your doctor if you:
Pomembno je, da zdravniku poveste, če:
Period of Study
Obdobje študije
These changes all reversed after discontinuation of treatment.
Te spremembe so bile reverzibilne po prekinitvi zdravljenja.
Meta-Analysis
Meta-analiza
You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Vi ali vaši negovalci se lahko naučite dajanja podkožnih injekcij, da lahko nadaljujete z zdravljenjem doma.
The choice of route should depend on the individual clinical circumstance.
Izbira poti uporabe je odvisna od individualnih kliničnih okoliščin.
This medicine may cause dizziness.
To zdravilo lahko povzroča omotico.
Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Rastni faktorji so beljakovine, ki v človeškem telesu naravno nastajajo, vendar jih je mogoče tvoriti tudi s pomočjo biotehnologije za uporabo kot zdravilo.
The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Edini neželeni učinek, o katerem so poročali dosledno, je bila mišično-skeletna bolečina‚ ki se ne razlikuje od izkušenj v odrasli populaciji.
The volume of distribution in blood is approximately 150 ml/kg.
Volumen porazdelitve v krvi je približno 150 ml/kg.
When the response has been obtained, the minimal effective dose to maintain this level should be established.
Ko je takšen odziv dosežen, je treba določiti najmanjši učinkoviti odmerek za vzdrževanje te ravni.
• think you may be pregnant; or
• menite, da bi lahko bili noseči, • ali načrtujete zanositev.
Dose adjustment is not required in these circumstances.
V teh okoliščinah prilagajanje odmerka ni potrebno.
• unusual change in the urine
• neobičajna sprememba urina
Your healthcare professional should always record the exact product you are using.
Vaše medicinsko osebje mora vedno zabeležiti v vašo zdravstveno kartoteko točno ime zdravila, ki ga uporabljate.
After 1 - 2 weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Po enem do dveh tednih zdravljenja je mogoče začetni odmerek podvojiti ali prepoloviti, odvisno od bolnikovega odziva.
The solution should be visually inspected prior to use.
Raztopino je treba pred uporabo vizualno pregledati.
10 6336 Langkampfen Austria
10 6336 Langkampfen Avstrija
Idiopathic or cyclic neutropenia
Idiopatska ali ciklična nevtropenija
> 1.0 x 109/l for 3 consecutive days
> 1,0 x 109/l v obdobju treh zaporednih dni
The usual dose varies depending on your illness and weight.
Običajni odmerek se razlikuje glede na vašo bolezen in telesno maso.
Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Zdi se, da deleži, ki so večji od tega, korelirajo s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
Please tell your doctor immediately during treatment:
Takoj med zdravljenjem povejte svojemu zdravniku:
Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Vaš zdravnik vas bo morda skrbno spremljal, glejte poglavje 4 navodila za uporabo.
Geriatric use
Geriatrična uporaba
Overall, reports were more common after IV administration.
Na splošno so bila ta poročila pogostejša po intravenskem dajanju.