natgillin/translations-raw huggingface dataset:
Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)
pankreatitis
Nervous system disorders
Bolezni jeter,
Convulsion
povečane
Cardiac disorders
povečane
Cardiomyopathy, Tachycardia, Palpitation
žolčnika in
Vascular disorders
vrednosti alanin
Hypertension
vrednosti
Respiratrory, thoracic and mediastinal disorders
žolčevodov
Bronchospasm, Dyspnea
aminotransferaze,
Vomiting, Nausea
bilirubina v krvi,
Pancreatitis
povečane
Hepatobiliary disorders
povečane
Alanine amino- transferase increased, Aspartate amino- transferase increased
vrednosti aspartat aminotransferaze
Blood bilirubin increased, Gamma-glutamyl- transferase increased, Hepatitis
vrednosti gamaglutamil - transferaze, hepatitis
Urticaria, Rash, Pruritus, Alopecia
urtikarija,
Skin discolouration
sprememba barve
Musculoskeletal, connective tissue and bone disorders
podkožja Bolezni mišično - skeletnega sistema, vezivnega tkiva in kosti
Myalgia, Hypertonia
izpuščaj, pruritus, alopecija mialgija, hipertonija
Menstrual disorder
kože
Flu-like symptoms*, Chills*, Fever *, Injection site reaction*, Injection site inflammation*, Injection site pain
menstruacijske motnje
Injection site necrosis*
Splošne težave in
Chest pain, Malaise, Sweating
znaki, podobni
Investigations
nekroza na mestu
Weight decrease
bolečine v prsnem
* frequencies based on clinical trials
injiciranja *
Interferon beta-1b has been given without serious adverse events compromising vital functions to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week.
Interferon beta- 1b so brez resnih neželenih učinkov, ki bi ogrozili vitalne funkcije, dajali odraslim bolnikom z rakom v individualnih odmerkih do 5. 500 mikrogramov (176 milijonov i. e.) intravensko trikrat na teden.
Cytokines, Interferons, ATC Code:
Farmakoterapevtska skupina: citokini, interferoni; oznaka ATC:
Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Njihova molekulska masa je od 15. 000 do 21. 000 daltonov.
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
Delovanje interferona beta- 1b je omejeno na vrsto, zato najbolj ustrezni podatki o farmakologiji interferona beta- 1b izhajajo iz študij človeških celic v kulturah in iz in vivo študij pri ljudeh.
Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
Dokazano je, da interferon beta- 1b deluje protivirusno in imunoregulacijsko.
However, it is known that the biologic response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Znano pa je, da se tiste lastnosti interferona beta- 1b, ki spreminjajo biološki odziv, posredujejo prek njegovih interakcij s specifičnimi celičnimi receptorji na površini človeških celic.
The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Vezava interferona beta- 1b na te receptorje izzove ekspresijo številnih genskih produktov, ki veljajo za mediatorje biološkega delovanja interferona beta- 1b.
A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Številne takšne produkte so izmerili v serumski in celični frakciji krvi bolnikov, zdravljenih z interferonom beta- 1b.
Interferon beta-1b both decreases the binding affinity and enhances the internalisation and degradation of the interferon-gamma receptor.
Interferon beta- 1b zmanjša vezavno afiniteto receptorja interferona gama in povečuje njegovo internalizacijo in degradacijo.
Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Poleg tega interferon beta- 1b okrepi zaviralno (supresorsko) delovanje mononuklearnih celic v periferni krvi.
12 Clinical trials:
12 Posebnih študij o vplivu zdravila Betaferon na srce in ožilje, dihala in delovanje endokrinih organov niso izvedli.
RR-MS:
Klinična preskušanja
One controlled clinical trial with Betaferon in patients with relapsing remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5) was performed.
RR- MS Opravljeno je bilo eno kontrolirano klinično preskušanje z zdravilom Betaferon pri bolnikih z recidivno- remitentno multiplo sklerozo, ki so lahko hodili brez pomoči (izhodiščni EDSS 0 do 5, 5).
Patients receiving Betaferon showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Bolniki, ki so prejemali zdravilo Betaferon, so imeli redkejše (30%) in manj hude klinične recidive in so bili redkeje hospitalizirani zaradi bolezni.
There is no evidence of an effect of Betaferon on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing remitting multiple sclerosis.
Pri recidivno- remitentni multipli sklerozi niso opazili nobenega pomembnega vpliva na napredovanje bolezni.
Two controlled clinical trials with Betaferon involving a total of 1657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i. e. patients were able to walk) were performed.
Narejeni sta bili dve kontrolirani klinični preskušanji z zdravilom Betaferon, ki sta skupaj zajeli 1657 bolnikov s sekundarno progresivno multiplo sklerozo (izhodiščni EDSS 3 do 6, 5, tj. bolniki so lahko hodili).
Patients with mild disease and those unable to walk were not studied.
Bolnikov z blago boleznijo in bolnikov nezmožnih hoje, niso proučevali.
The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Izsledki obeh preskušanj niso usklajeni glede na primarno končno točko do potrjenega napredovanja, ki pomeni odložitev napredovanja invalidnosti.
One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Betaferon) in patients who received Betaferon.
Prva od njiju je pri bolnikih, ki so prejemali zdravilo Betaferon, ugotovila statistično značilno odložitev do napredovanja invalidnosti (razmerje ogroženosti = 0, 69, 95% interval zaupanja (0, 55, 0, 86), p = 0, 0010, kar ustreza 31% zmanjšanju tveganja zaradi zdravila Betaferon) in do priklenjenosti na voziček (razmerje ogroženosti = 0, 61, 95% interval zaupanja (0, 44, 0, 85), p = 0, 0036, kar ustreza 39% zmanjšanju tveganja zaradi zdravila Betaferon).
This effect continued over the observation period of up to 33 months.
Ta vpliv se je nadaljeval med obdobjem spremljanja do 33 mesecev.
The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
Učinek zdravljenja se je pojavil pri bolnikih z vsemi proučevanimi stopnjami invalidnosti in neodvisno od recidivne aktivnosti.
There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Obstajajo dokazi, da so imeli bolniki v tem preskušanju v celoti manj aktivno bolezen kot v omenjenem prvem preskušanju pri sekundarno progresivni multipli sklerozi.
In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8 million IU Betaferon versus all placebo patients).
Z retrospektivno metaanalizo podatkov obeh preskušanj so ugotovili statistično značilen celotni učinek zdravljenja (p = 0, 0076; 8 milijonov i. e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).
Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28% risk reduction due to Betaferon in patients with relapses or pronounced EDSS progression, 8 million IU Betaferon versus all placebo patients).
Retrospektivne analize v podskupinah so pokazale, da je učinek zdravljenja na napredovanje invalidnosti najverjetnejši pri bolnikih, ki imajo aktivno bolezen, preden se začne zdravljenje (razmerje ogroženosti = 0, 72, 95% interval zaupanja (0, 59, 0, 88), p = 0, 0011, kar ustreza 28% zmanjšanju tveganja zaradi zdravila Betaferon pri bolnikih s poslabšanjem bolezenskih znakov ali izrazitim napredovanjem glede na EDSS, ki so dobivali 8 milijonov i. e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS > 1 point or > 0.5 point for EDSS > =6 in the previous two years) can help to identify patients with active disease.
Te retrospektivne analize podskupin so pokazale, da lahko poslabšanja in izrazito napredovanje glede na EDSS (EDSS > 1 točko ali > 0, 5 točke pri EDSS > = 6 v zadnjih dveh letih) pripomorejo k odkritju bolnikov z aktivno boleznijo.
In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
V obeh preskušanjih se je pri bolnikih s sekundarno progresivno multiplo sklerozo, ki so prejemali zdravilo Betaferon, pogostnost kliničnih recidivov zmanjšala (30%).
One controlled clinical trial with Betaferon was performed in patients with a single clinical event and MRI features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Enkratni demielinizacijski dogodek, ki nakazuje MS Pri bolnikih z enim samim kliničnim dogodkom in izvidi magnetnoresonančnega slikanja, ki kažejo na multiplo sklerozo (vsaj dve klinično tihi leziji na T2- poudarjenem magnetnoresonančnem slikanju) so opravili kontrolirano klinično preskušanje.
Patients with monofocal or multifocal onset of the disease were included (i. e. patients with clinical evidence for a single or at least two lesions, respectively, of the central nervous system).
Vključili so bolnike z monofokalnim (bolnike s kliničnimi znaki ene lezije osrednjega živčevja) in multifokalnim (bolnike s kliničnimi znaki vsaj dveh lezij osrednjega živčevja) začetkom bolezni.
Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
13 ustrezala bolnikovim znakom in simptomom.
This study consisted of two phases, a placebo-controlled phase followed by a pre-planned follow-up phase.
Preskušanje je imelo dve obdobji, s placebom kontroliranemu obdobju je sledilo vnaprej načrtovano obdobje spremljanja.
The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple sclerosis (CDMS), whichever came first.
S placebom kontrolirano obdobje je trajalo 2 leti ali dokler se ni pri bolniku razvila klinično potrjena multipla skleroza, odvisno do česa je prišlo prej.
After the placebo-controlled phase, patient entered a pre-planned follow-up phase with Betaferon to evaluate the effects of immediate versus delayed start of Betaferon-treatment, comparing patients initially randomized to Betaferon ("immediate treatment group") or to placebo ("delayed treatment group").
Namen tega je bil ugotoviti vpliv takojšnjega in odloženega začetka zdravljenja z zdravilom Betaferon, in sicer s primerjavo bolnikov, ki so bili na začetku randomizirani v skupino, ki je prejemala zdravilo Betaferon ("skupina s takojšnjim zdravljenjem"), in bolnikov, ki so bili na začetku randomizirani v skupino, ki je prejemala placebo ("skupina z odloženim zdravljenjem").
13 In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (Hazard Ratio = 0.53, 95% confidence interval (0.39, 0.73), p < 0.0001).
Zmanjšanje tveganja je bilo 47% (razmerje ogroženosti = 0, 53, interval zaupanja = 95% (0, 39, 0, 73), p < 0, 0001).
Within the study period of two years, CDMS occurred in 45% of the placebo group compared to 28% of the Betaferon group (Kaplan-Meier estimates).
V dveletnem obdobju trajanja študije se je CDMS pojavila pri 45% bolnikov v skupini, ki je prejemala placebo, in pri 28% bolnikov, ki so prejemali zdravilo Betaferon (metoda Kaplan- Meier).
Betaferon prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Betaferon group (based on the 25th percentiles).
Zdravilo Betaferon je podaljšal čas do CDMS za 363 dni, od 255 pri bolnikih, ki so prejemali placebo, na 618 dni pri bolnikih, ki so prejemali zdravilo Betaferon (na osnovi 25. percentile).
This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p = 0.0011). Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates).
Ta učinek zdravljenja je bil po dodatnem letu spremljanja še vedno opazen; v tej fazi je bilo tveganje 41% manjše (razmerje ogroženosti = 0, 59, 95% interval zaupanja (0, 42, 0, 83), p = 0, 0011). V triletnem obdobju študije se je klinično potrjena MS razvila pri 51% bolnikov v skupini z odloženim zdravljenjem in pri 37% bolnikov v skupini s takojšnjim zdravljenjem (metoda Kaplan - Meier).
The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Betaferon in the third year of the study.
Opazno je bilo trajanje terapevtskega učinka, čeprav je večina bolnikov iz skupine s placebom v tretjem letu študije prejemala zdravilo Betaferon.
The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria.
Robustnost učinka zdravljenja je pokazala tudi upočasnitev napredovanja v multiplo sklerozo glede na merila po McDonaldu.
In two years, the risk in the placebo group was 85% and 69% in the Betaferon group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p < 0.00001).
V dveh letih je bilo zmanjšanje tveganja v skupini, ki je prejemala placebo 85% in 69% v skupini, ki je prejemala zdravilo Betaferon (razmerje ogroženosti = 0, 57, interval zaupanja = 95% (0, 46, 0, 71), p < 0, 00001).
After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard ratio=0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Vnaprej načrtovana vmesna analiza po 3 letih je pokazala napredovanje glede na EDSS (potrjeno povečanje ocene glede na EDSS za 1 ali več v primerjavi z izhodiščem) pri 24% bolnikov v skupini z odloženim zdravljenjem in pri 16% bolnikov v skupini s takojšnjim zdravljenjem (razmerje ogroženosti = 0, 6, 95% interval zaupanja:
There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving'immediate 'treatment.
Pri večini bolnikov, ki so bili zdravljeni takoj, niso ugotovili prednosti glede potrjenega napredovanja prizadetosti.
Follow-up of patients is continuing in order to provide additional data.
Da bi pridobili dodatne podatke, se spremljanje bolnikov nadaljuje.
No benefit, attributable to Betaferon, in quality of life (as measured by FAMS - Functional Assessment of MS:
Ugotovili niso nobene prednosti glede kakovosti življenja, ki bi jo bilo mogoče pripisati zdravilu Betaferon (merjeno s FAMS – Functional Assessment of MS:
Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event, the risk in two years for progression to CDMS in patients with monofocal onset was 47% for placebo and 24% for Betaferon, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Pomembne učinke so dosegli tudi pri bolnikih z manj diseminirano in manj aktivno boleznijo v času prvega kliničnega dogodka, tveganje do napredovanja do klinično potrjene multiple skleroze (CDMS) v dveh letih pri bolnikih z monofokalnim začetkom je bilo pri placebu 47% in 24% pri zdravilu Betaferon, brez ojačitve z gadolinijem (Gd) 41% in 20%, z manj kot 9 lezij T2 39% in 18%.
In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Ti bolniki imajo veliko tveganje za nastanek CDMS, zaradi diseminacije bolezni, za katere dajejo dokaze klinična preskušanja.
However, the long-term impact of early treatment with Betaferon is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long term evolution of the disease.
Vendar je dolgotrajen učinek zgodnjega zdravljenja z zdravilom Betaferon neznan tudi pri teh podskupinah z velikim tveganjem, kajti študija je bila namenjena ocenjevanju časa do CDMS, ne pa dolgotrajnega razvoja bolezni.
Furthermore, for the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Vendar je sprejemljivejši konzervativen pristop, to pomeni vsaj 9 hiperintenzivnih lezij T2 v prvi preiskavi in vsaj ena nova T2 ali ena nova lezija po ojačanju z Gd v naslednji preiskavi, ki je izvedena vsaj 1 mesec po prvi preiskavi.
Therapy with Betaferon was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Betaferon group).
14 Pri bolnikih z enim samim kliničnim dogodkom je bilo zdravljenje z zdravilom Betaferon dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (92, 8% v skupini, ki je prejemala zdravilo Betaferon).
To increase tolerability of Betaferon in the study of patients with a first clinical event, a dose titration was applied and non- steroidal anti-inflammatory drugs were administered at start of therapy.
Da bi povečali toleranco na zdravilo Betaferon so v študiji pri bolnikih s prvim kliničnim dogodkom odmerek titrirali, na začetku zdravljenja pa so uporabili nesteroidna protivnetna zdravila.
Betaferon was effective in all multiple sclerosis studies to reduce disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RR- MS, SP- MS in enkratni demielinizacijski dogodek, ki nakazuje MS Zdravilo Betaferon je v vseh študijah multiple skleroze učinkovito zmanjšalo aktivnost bolezni (akutno vnetje v osrednjem živčevju in trajne spremembe tkiva), merjeno z magnetnoresonančnim slikanjem (MRS).
14 5.2 Pharmacokinetic properties
Farmakokinetične lastnosti
Maximum serum levels of about 40 IU/ ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Največjo koncentracijo v serumu okrog 40 i. e. / ml so izmerili od 1 do 8 ur po subkutani injekciji 500 mikrogramov (16 milijonov i. e.) interferona beta- 1b.
From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min-1·kg-1 and 5 hours, respectively.
Na osnovi različnih študij je bil ocenjeni povprečni očistek največ 30 ml· min- 1· kg- 1, razpolovni čas faze porazdelitve iz seruma pa 5 ur.
The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately 50%.
Absolutna biološka uporabnost subkutano uporabljenega interferona beta- 1b je bila 50%.
Experience with other interferons suggest a potential for impairment of male and female fertility.
Izkušnje z drugimi interferoni nakazujejo možnost vpliva na moško in žensko plodnost.
Carcinogenicity studies have not been performed.
Študije karcinogenosti niso izvedli.
6.1 List of excipients:
6. 1 Seznam pomožnih snovi
Human albumin Mannitol
Viala (s praškom za raztopino za injiciranje) humani albumin manitol
Sodium Chloride, Water for injections.
Vehikel (raztopina natrijevega klorida 5, 4 mg/ ml (0, 54% m/ v)) natrijev klorid voda za injekcije
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in 6.6.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v 6. 6.
6.3 Shelf life
15 6. 3 Rok uporabnosti
After reconstitution an immediate use is recommended.
Zdravilo je priporočljivo uporabiti takoj po pripravi.
15 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
For storage conditions of the reconstituted product see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
3 ml clear vial (type I glass) with a butyl rubber stopper (type I) and aluminium overseal and
Viala (s praškom za raztopino za injiciranje) 3 ml prozorna viala (steklo tipa I) z zamaškom iz butilne gume (tip I) in prekrivno zaporko iz aluminija
1.2 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Vehikel (z raztopino natrijevega klorida 5, 4 mg/ ml (0, 54%)) 1, 2 ml napolnjena injekcijska brizga (steklo tipa I) z 1, 2 ml vehikla
- 5 vials with powder and 5 pre-filled syringes with solvent, or
- 5 vial s praškom in 5 napolnjenih injekcijskih brizg z vehiklom ali
- 15 vials with powder and 15 pre-filled syringes with solvent.
- 15 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom.
• Reconstitution:
• Rekonstitucija
To reconstitute lyophilised interferon beta-1b for injection, use the pre-filled syringe with solvent provided and a needle to inject the 1.2 ml of the solvent (sodium chloride solution, 5.4 mg/ ml (0.54% w/ v)) into the Betaferon vial.
Za pripravo liofiliziranega interferona beta- 1b za injiciranje je treba v vialo z zdravilom Betaferon s priloženo napolnjeno injekcijsko brizgo z vehiklom in iglo vbrizgati 1, 2 ml vehikla (raztopina natrijevega klorida, 5, 4 mg/ ml (0, 54% m/ v)).
Dissolve the powder completely without shaking.
Prašek je treba popolnoma raztopiti, brez pretresanja.
After reconstitution, draw 1.0 ml from the vial into the syringe for the administration of 250 micrograms Betaferon.
Za odmerjanje 250 mikrogramov zdravila Betaferon, je treba po rekonstituciji potegniti 1 ml raztopine iz viale v brizgo.
• Inspection prior to use
• Pregled pred uporabo
Inspect the reconstituted product visually before use.
Pripravljeno zdravilo je treba pred uporabo pregledati.
Discard the product before use if it contains particulate matter or is discoloured.
Če vsebuje delce ali je obarvano, se ga ne sme uporabiti, temveč ga je treba zavreči.
Bayer Schering Pharma AG D-13342 Berlin Germany
Bayer Schering Pharma AG D- 13342 Berlin
16 9.
16 Nemčija
Date of first authorisation:
Datum prvega dovoljenja za promet:
30 November 1995 Date of last renewal:
30. november 1995 Datum zadnjega podaljšanja dovoljenja za promet:
* produced by genetic engineering from strain of Escherichia coli.
18 Na splošno se na začetku zdravljenja priporoča titriranje odmerka.
18 Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Zdravljenje je treba začeti z odmerkom 62, 5 mikrogramov (0, 25 ml) subkutano vsak drugi dan, nato pa ga počasi povečevati do odmerka 250 mikrogramov (1 ml) vsak drugi dan (glejte preglednico A).