natgillin/translations-raw huggingface dataset:
• Peel open the packaging of the syringe and safety needle to make it easier to pick up each item as you prepare for your injection.
• Odprite zunanja ovoja injekcijske brizge in igle z varovalom, da vam bosta oba predmeta med pripravo na injiciranje pri roki.
30 pre-filled syringes of solvent 30 injection needles
30 napolnjenih injekcijskih brizg z vehiklom 30 injekcijskih igel
PHARMACEUTICAL FORM Powder and solvent for solution for injection (powder for injection).
prašek in vehikel za raztopino za injiciranje (prašek za injiciranje)
Pegvisomant treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
Komercialni testi za določanje koncentracije rastnega hormona posledično dajejo napačne rezultate in zato se zdravljenja s pegvisomantom ne sme nadzirati ali prilagajati glede na serumsko koncentracijo rastnega hormona, izmerjeno s takšnimi testi.
• A vial of Somavert powder.
• vialo s praškom zdravila Somavert,
• Carefully pull the needle cover straight off.
• Z ravnim potegom previdno odstranite pokrovček igle.
• Gently swirl the liquid, sliding the vial in a circular motion on a flat surface.
• Previdno zmešajte tekočino, tako da z vialo krožite po ravni površini.
In the event of either being observed, discard the medicinal product..
Če opazite kaj od naštetega, zdravilo zavrzite.
Powder:
Trebuh:
Administration of pegvisomant should be discontinued if signs of liver disease persist.
Če znaki bolezni jeter vztrajajo, je treba uporabo pegvisomanta prekiniti.
Store the pre-filled syringe(s) below 30C or store in a refrigerator.
Napolnjene injekcijske brizge shranjujte pri temperaturi do 30 °C ali v hladilniku.
Note: You will hear a click when the needle guard has been locked.
• Opomba: Ko se varovalni nastavek za iglo zaskoči, boste zaslišali klik.
The solvent should be emptied into the vial slowly to avoid the possibility of a foam forming.
Vehikel izpraznite v vialo počasi, da se izognete penjenju, ki naredi zdravilo neuporabno.
QUESTIONS & ANSWERS What should I do if anything has accidentally touched the vial stopper?
Kaj naj storim, če se z zamaškom viale pomotoma nečesa dotaknem?
• Dizziness, sleepiness, uncontrolled trembling, decreased sense of touch.
• omotica, bolezenska zaspanost, nehotno tresenje, zmanjšana občutljivost na dotik
• Sweating, itching, rash, tendency to bruise.
• znojenje, srbenje, izpuščaj, nagnjenost k podplutbam
SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 25 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 30 mg prašek in vehikel za raztopino za injiciranje
SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 25 mg prašek in vehikel za raztopino za injiciranje SOMAVERT 30 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Respiratory, thoracic and mediastinal disorders dyspnoea laryngospasmb
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja laringospazem
Store the pre-filled syringe(s) below 30C or store in a refrigerator (2C - 8C).
Napolnjene injekcijske brizge shranjujte pri temperaturi do 30 C ali v hladilniku (2 C - 8 C).
• Eyestrain, inner ear problems.
• naprezanje oči, težave z notranjim ušesom
Pegvisomant has significant structural similarity to growth hormone which causes it to cross-react in commercially available growth hormone assays.
Pegvisomant je po strukturi močno podoben rastnemu hormonu, zato navzkrižno reagira s komercialnimi testi za določanje tega hormona.
The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been established.
Okvara jeter ali ledvic Pri bolnikih z okvaro ledvic ali jeter varnost in učinkovitost zdravila SOMAVERT nista bili dokazani.
Remove syringe cap
Odstranite pokrovček brizge
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Remove needle cover
Odstranite pokrovček igle
1 pre-filled syringe of solvent 1 injection needle
1 napolnjena injekcijska brizga z vehiklom 1 injekcijska igla
After reconstitution, the product should be used immediately.
Zdravilo je treba uporabiti takoj po pripravi.
Caution: Do not let the end of the syringe touch anything when the syringe cap is off.
Pozor: Ko je pokrovček brizge odstranjen, se s konico injekcijske brizge ne dotikajte ničesar.
Administration of SOMAVERT should be discontinued if signs of liver disease persist.
Če znaki bolezni jeter trajajo, je treba zdravljenje z zdravilom SOMAVERT prekiniti.
Store the pre-filled syringe(s) below 30C or store in a refrigerator (2ºC - 8°C).
Napolnjene injekcijske brizge shranjujte pri temperaturi do 30 °C ali v hladilniku (2 °C - 8 °C).
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue.
Pri bolnikih z zvečanimi vrednostmi ALT in AST oz. bolnikih, ki so se že zdravili s kakšnim analogom somatostatina, je treba izključiti obstruktivno bolezen biliarnega trakta.
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.
Akromegalija je hormonska motnja, ki nastane zaradi zvečanega izločanja rastnega hormona in IGF-I (insulinu podobnih rastnih dejavnikov).
Eye disorders eye pain asthenopia
Očesne bolezni bolečina v očeh astenopija
• Keeping the needle in the vial, look carefully at the medicine.
• Previdno preglejte zdravilo, medtem pa naj igla ostane v viali.
• Remove the cap from the vial.
• Z viale odstranite zaporko.
The metabolism of pegvisomant has not been studied.
Presnova pegvisomanta ni raziskana.
SOMAVERT contains sodium
Kaj vsebuje zdravilo SOMAVERT
SOMAVERT 20 mg, 25 mg and 30 mg Pack sizes of 1 and 30 vial(s), pre-filled syringe(s) and safety needle(s) Not all pack sizes may be marketed.
SOMAVERT 20 mg, 25 mg in 30 mg Velikost pakiranja po 1 in 30 vial, napolnjenih injekcijskih brizg in igel z varovalom.
The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder.
Ena viala zdravila z jakostjo 25 mg vsebuje 0,5 mg natrija.
Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
- SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant.
SOMAVERT 20 mg: Ena viala s praškom vsebuje 20 mg pegvisomanta.
Skin and subcutaneous tissue disorders hyperhidrosis, contusion, pruritusb, rashb face oedema, dry skin, increased tendency to bruise, night sweats, erythema b, urticaria b angioedemab
izpuščaj edem obraza, suha koža, nagnjenost k podplutbam, nočno znojenje, eritem b,
Growth hormone-secreting tumours
Tumorji, ki izločajo rastni hormon
- SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant.
SOMAVERT 25 mg: Ena viala s praškom vsebuje 25 mg pegvisomanta.
Fertility, pregnancy and lactation Women of childbearing potential
4.6 Plodnost, nosečnost in dojenje
Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Water for Injections
glicin manitol (E421) brezvodni natrijev hidrogenfosfat natrijev dihidrogenfosfat monohidrat voda za injekcije
Fatty tissue of the skin can build-up at the site of injection.
Na mestu injiciranja se lahko poveča količina maščobnega tkiva.
- SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant.
SOMAVERT 30 mg: Ena viala s praškom vsebuje 30 mg pegvisomanta.
Warnings and precautions Talk to your doctor, pharmacist or nurse before using SOMAVERT.
Pred začetkom jemanja zdravila SOMAVERT se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The site of injection should be rotated daily to help prevent lipohypertrophy.
Za preprečitev lipohipertrofije je treba zdravilo vsak dan injicirati na drugo mesto.
• Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site, swelling of the extremities, weakness, fever.
• podplutba ali krvavitev na mestu injiciranja, bolečina ali oteklina na mestu injiciranja,
Always inject this medicine exactly as your doctor or pharmacist has told you.
Pri injiciranju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Ena viala zdravila z jakostjo 15 mg vsebuje 0,4 mg natrija.
POWDER VIAL
Odstranite zaporko viale
Posology
Predpriprava
SOMAVERT 20 mg powder and solvent for solution for injection One vial contains 20 mg of pegvisomant.
SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 20 mg pegvisomanta.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
Renal and urinary disorders haematuria proteinuria, polyuria, renal impairment
Bolezni sečil hematurija proteinurija, poliurija, okvara ledvic
• Eye pain
• bolečina v očeh
- Your doctor will conduct tests of your liver function before starting and during treatment with SOMAVERT.
Pred začetkom zdravljenja z zdravilom SOMAVERT in med njim bo zdravnik opravil teste delovanja vaših jeter.
Malignant fibrous histiocytomas associated with fibrosis and histiocytic inflammation were observed at injection sites in males in the rat carcinogenicity study at exposure levels equivalent to three times the human exposure based on mean plasma concentrations in two long-term studies at a daily dose of 30 mg.
V dveh dolgoročnih študijah kancerogenosti pri podganjih samcih so na mestih injiciranja opazili maligni fibrozni histiocitom, povezan s fibrozo in histiocitnim vnetjem.
- SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant.
SOMAVERT 10 mg: Ena viala s praškom vsebuje 10 mg pegvisomanta.
PHARMACOLOGICAL PROPERTIES 5.1.
5.1 Farmakodinamične lastnosti
- SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant.
SOMAVERT 15 mg: Ena viala s praškom vsebuje 15 mg pegvisomanta.
• Feeling abnormal, impaired healing.
• nenormalno počutje, počasnejše celjenje
where it blocks growth hormone binding, and thus interferes with intracellular growth hormone signal transduction.
Pegvisomant se veže na receptorje za rastni hormon na površini celic, s tem prepreči vezavo rastnega hormona in tako ovira znotrajcelični prenos signalov rastnega hormona.
• Gently pinch the skin at the site of injection.
• Kožo na mestu injiciranja rahlo stisnite v gubo.
Excipient with known effect The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder.
Ena viala zdravila z jakostjo 30 mg vsebuje 0,6 mg natrija.
SOMAVERT 25 mg powder and solvent for solution for injection One vial contains 25 mg of pegvisomant.
SOMAVERT 25 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 25 mg pegvisomanta.
• Discontinue SOMAVERT immediately.
• Takoj prekinite zdravljenje z zdravilom SOMAVERT.
• Tilt both the vial and syringe at an angle, as shown.
• Nagnite vialo in injekcijsko brizgo pod kotom, kot kaže slika.
SOMAVERT 30 mg powder and solvent for solution for injection One vial contains 30 mg of pegvisomant.
SOMAVERT 30 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 30 mg pegvisomanta.
Keep the vial(s) in their outer carton in order to protect from light.
Viale shranjujte v njihovi zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• Do not rub the area.
• Predela ne masirajte.
Keep out of reach of children.
Zdravilo shranjujte nedosegljivo otrokom!
SOMAVERT 15 mg powder and solvent for solution for injection One vial contains 15 mg of pegvisomant.
SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 15 mg pegvisomanta.
SOMAVERT 10 mg powder and solvent for solution for injection One vial contains 10 mg of pegvisomant.
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 10 mg pegvisomanta.
Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate
glicin manitol (E421) brezvodni natrijev hidrogenfosfat natrijev dihidrogenfosfat monohidrat
• Constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
• zaprtje, slabost, bruhanje, napihnjenost, prebavne motnje, vetrovi
After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 30 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 20 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 25 mg pegvisomanta.
Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Ena viala zdravila z jakostjo 10 mg vsebuje 0,4 mg natrija.
Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Ena viala zdravila z jakostjo 20 mg vsebuje 0,4 mg natrija.
Do not use SOMAVERT:
Ne uporabljajte zdravila Somavert, če se je spenilo.
SOMAVERT 20 mg powder for injection pegvisomant SC
SOMAVERT 20 mg prašek za injiciranje pegvisomant s.c.
After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 15 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 10 mg pegvisomanta.
SOMAVERT 25 mg powder for injection pegvisomant SC
SOMAVERT 25 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 20 mg powder for solution for injection pegvisomant
SOMAVERT 20 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 25 mg powder for solution for injection pegvisomant
SOMAVERT 25 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 30 mg powder for injection pegvisomant SC
SOMAVERT 30 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 30 mg powder for solution for injection pegvisomant
SOMAVERT 30 mg prašek za raztopino za injiciranje pegvisomant
Remove vial cap
Zavrzite klik
asthenia, pyrexia a see Description of selected adverse reactions below b ADR related to hypersensitivity reaction
gripi podobna bolezen, utrujenost, astenija, pireksija nenormalno počutje, slabše celjenje, lakota glejte »Opis izbranih neželenih učinkov«, spodaj neželeni učinki, povezani s preobčutljivostno reakcijo
SOMAVERT 10 mg powder for solution for injection pegvisomant
SOMAVERT 10 mg prašek za raztopino za injiciranje pegvisomant
Powder and solvent for solution for injection 1 vial of powder
prašek in vehikel za raztopino za injiciranje
SOMAVERT 10 mg powder for injection pegvisomant SC
SOMAVERT 10 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 15 mg powder for solution for injection pegvisomant
SOMAVERT 15 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 15 mg powder for injection pegvisomant SC
SOMAVERT 15 mg prašek za injiciranje pegvisomant s.c.
1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant.
1 ml pripravljene raztopine vsebuje 25 mg pegvisomanta.
You may need to read it again - If you have any further questions, ask your doctor, pharmacist or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant.
1 ml pripravljene raztopine vsebuje 20 mg pegvisomanta.
1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant.
1 ml pripravljene raztopine vsebuje 30 mg pegvisomanta.
1 ml of solvent, 1 ml of the solution contains 15 mg pegvisomant.
1 ml pripravljene raztopine vsebuje 15 mg pegvisomanta.
Make needle safe
Zavarujte iglo
SOMAVERT 20 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje pegvisomant
The powder is white to slightly off-white.
Prašek je bel do belkast.
1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant.
1 ml pripravljene raztopine vsebuje 10 mg pegvisomanta.
SOMAVERT 10 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje pegvisomant
SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 30 mg prašek in vehikel za raztopino za injiciranje pegvisomant
SOMAVERT 25 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 25 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Note: Make sure you keep the needle in at full depth.
• Opomba: Igla naj ostane do konca zabodena v kožo.
SOMAVERT 15 mg powder and solvent for solution for injection pegvisomant
SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Breast-feeding
urtikarija angioedem
2132NP Hoofddorp Netherlands
2132 NP Hoofddorp Nizozemska
Response in skin and blood was evaluated every 4 weeks.
Odziv kože in krvi so ovrednotili vsake 4 tedne.
Disease stage IB/II
Stadij bolezni IB/II
As with all therapeutic proteins, there is a potential for immunogenicity.
Kot pri vseh terapevtskih proteinih obstaja možnost imunogenosti.
TLS was observed most frequently during the first month of treatment.
TLS so najpogosteje opazili v prvem mesecu zdravljenja.
Each arm enrolled 186 patients.
V vsaki skupini je bilo 186 bolnikov.
The majority of patients recovered from infection.
Večina bolnikov je po okužbi okrevala.
• Each vial is for single use only.
• Vsaka viala je samo za enkratno uporabo.
- have heart problems.
- če imate težave s srcem.
100-1 Hagiwara-machi, Takasaki-shi, Gunma, 370-0013, Japan
100-1 Hagiwara-machi, Takasaki-shi Gunma, 370-0013, Japonska
This medicine should not be used in children and adolescents below 18 years of age.
To zdravilo se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Blood (n)
Kri (n)
However, the medicine can cause tiredness in some people, so take particular care when driving and using machines until you are certain that this medicine does not affect you.
Vendar lahko to zdravilo pri nekaterih ljudeh povzroča utrujenost, zato bodite posebno previdni pri vožnji in uporabi strojev, dokler niste prepričani, da pri vas nima takšnega učinka.
- have had or plan to have a stem cell transplant, either using your own cells or a donor's.
- če ste imeli ali načrtujete presaditev matičnih celic, bodisi z uporabo lastnih celic bodisi celic darovalca;
Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
Bolnike, ki imajo dejavnike tveganja, povezane z boleznimi srca, je treba spremljati in uvesti ustrezne previdnostne ukrepe.
a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
a: Vrednost P je bila pridobljena s testom Cochran-Mantel-Haenszel, prilagojenim za tip bolezni, stadij bolezni in območje.
Note: Overall response rate is based on Global Composite Response score.
Opomba: Skupna stopnja odziva temelji na globalnem sestavljenem odzivu.
The amount of POTELIGEO you will receive is calculated by your doctor based on your body weight.
Količino zdravila POTELIGEO, ki jo boste prejeli, bo izračunal zdravnik glede na vašo telesno maso.
Although unlikely to be caused by this medicine, these may be signs of a heart disorder.
Čeprav je maloverjetno, da gre za učinek tega zdravila, so to lahko znaki bolezni srca;
Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Znano je, da se človeški IgG izločajo z materinim mlekom v prvih nekaj dneh po porodu, čeprav se kmalu zatem koncentracije zelo znižajo; v tem kratkem obdobju ni mogoče izključiti tveganja za dojenega otroka.
United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Združeno kraljestvo allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice.
Bolnike je treba pozorno spremljati z ustreznimi laboratorijskimi in kliničnimi preiskavami za stanje elektrolitov, hidracije in delovanja ledvic, zlasti v prvem mesecu zdravljenja, in jih obravnavati skladno z najboljšo medicinsko prakso.
If a compartment level response or overall response is not observed after 3 months of treatment, discontinuation of treatment should be considered.
Če po 3 mesecih zdravljenja ni opaziti odziva na ravni telesnega predela ali skupnega odziva, je treba razmisliti o prekinitvi zdravljenja.
There were no positive neutralising antibody responses.
Pozitivnih odzivov nevtralizirajočih protiteles ni bilo.
Severe reactions (Grade 3) were experienced by 4% of patients.
Hude reakcije (3. stopnje) so se pojavile pri 4 % bolnikov.
Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration.
Ne uporabljajte tega zdravila, če opazite znake deterioracije (poslabšanja), kot sta prisotnost delcev ali obarvanost.
If this happens, the infusion may need to be stopped and you may require additional treatment.
Če se to zgodi, bo morda treba ustaviti prejemanje tega zdravila in morda boste potrebovali dodatno zdravljenje.
Patients should be monitored for signs and symptoms of infection and treated promptly.
Bolnike je treba spremljati glede znakov in simptomov okužbe ter jih takoj zdraviti.
The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period.
Varnostni profil, ugotovljen v 90 dneh po zadnjem odmerku mogamulizumaba, je skladen z varnostnim profilom, opaženim med zdravljenjem v okviru študije.
Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat)
Preglednica 2: odziv med randomiziranim obdobjem zdravljenja v študiji 0761-010 (namen zdravljenja)
Linearity and accumulation
Linearnost in kopičenje
On a power model analysis, no deviation from dose proportionality was evident.
Pri analizi modela moči ni bilo opaziti nikakršnega odstopanja od sorazmernosti z odmerkom.
Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab.
Resne okužbe, vključno s sepso, pljučnico in kožnimi okužbami, so se pojavile pri 14,3 % bolnikov, ki so prejemali mogamulizumab.
Time to compartment level response in Stage IB/II patients was approximately 3 months, which is consistent with time to response for the ITT population overall (approximately 3 months).
Čas do odziva na ravni telesnega predela pri bolnikih s stadijem IB/II je bil približno 3 mesece, kar se ujema s časom do odziva pri celotni populaciji ITT (približno 3 mesece).