natgillin/translations-raw huggingface dataset:
In a second study (n=310), which used a weight-adjusted dose (100 microgramsg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
V drugi študiji (n=310), v kateri so uporabljali za telesno maso popravljen odmerek (100 mikrogramov/kg), je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,7 dni, v skupini s filgrastimom pa 1,8 dni (razlika 0,03 dneva, 95-odstotni interval zaupanja -0,36, 0,30).
Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neupopeg.
Zelo redko (verjetno je, da se bo pojavil pri manj kot 1 od 10.000 bolnikov) je pri bolnikih, ki so prejemali Neupopeg, prišlo do kožnega vaskulitisa (vnetja krvnih žil v koži).
Do not use Neupopeg after the expiry date which is stated on the box and on the pen label (EXP).
Neupopega ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in na nalepki injekcijskega peresnika poleg oznake »Uporabno do«.
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Običajni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija) z uporabo napolnjene injekcijske brizge, ki jo morate prejeti približno 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
If you notice a spot of blood at the injection site dab away with a cotton ball or tissues.
Če se na mestu injiciranja pojavi kapljica krvi, jo popivnajte s kosmom vate ali zložencem gaze.
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p<0.001; and 2% versus 10%, p<0.001)
Med prejemnicami pegfilgrastima je bila tudi manjša incidenca hospitalizacij in intravensko uporabljene antiinfektivne terapije, povezanih s klinično diagnozo febrilne nevtropenije, kot med prejemnicami placeba (1 % v primerjavi s 14 %, p < 0,001, ter 2 % v primerjavi z 10 %, p <
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Common (≥ 1/100 to <1/10) but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.4).
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/100 do < 1/10), a v splošnem asimptomatskih primerih splenomegalije, zelo redko pa o primerih rupture vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4).
You must stop breast feeding if you use Neupopeg.
Če uporabljate Neupopeg, morate prenehati dojiti.
Pegfilgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Bolnikom, pri katerih je prišlo do resne alergijske reakcije, je treba pegfilgrastim dokončno ukiniti.
What Neupopeg contains
Kaj vsebuje Neupopeg
See leaflet for further information.
Za podrobnosti glejte navodila za uporabo.
A. Centre the pre-filled pen in the area of the pinched skin at a right angle (90 degrees) and push firmly against the skin.
A. Napolnjeni injekcijski peresnik prislonite pravokotno na sredino kožne gube (pod kotom 90 stopinj), nato ga čvrsto pritisnite na kožo in zadržite.
Pack size of one, in either blistered or non-blistered packaging.
Pakiranje po 1 s pretisnimi omoti ali brez pretisnih omotov.
Remove from the refrigerator.
Vzemite napolnjeno injekcijsko brizgo Neupopega iz hladilnika.
Your platelet count may become low which might result in bruising.
Morda se bo znižala vaša koncentracija krvnih ploščic, kar lahko povzroči nastajanje modric.
Allergic-type reactions to Neupopeg, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
Redko so poročali o alergijskih reakcijah zaradi Neupopega (verjetno je, da se bodo pojavile pri manj kot 1 od 1000 bolnikov), vključno s pordelostjo in zardevanjem, izpuščajem na koži, dvignjenimi in srbečimi predeli kože in anafilaksijo (slabost, padec krvnega pritiska, težave z dihanjem, otekanje obraza).
Press the pre-filled pen firmly enough against the skin so that the safety cover is fully retracted (see picture 3).
Pomembne informacije za korak A v postopku injiciranja Napolnjeni injekcijski peresnik pritisnite na kožo dovolj močno, da se varnostni pokrovček popolnoma umakne (glejte sliko 3).
Excipients known to have a recognised action: sorbitol (E420), sodium acetate.
Pomožne snovi z znanim delovanjem: sorbitol (E420), natrijev acetat.
A small (n=83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
faze pri bolnikih, ki so dobivali kemoterapijo zaradi de novo akutne mieloične levkemije, je primerjala pegfilgrastim (enkraten odmerek 6 mg) s filgrastimom ob aplikaciji med indukcijsko kemoterapijo.
Common (≥ 1/100 to < 1/10) but generally asymptomatic cases of splenomegaly and very rare (< 1/10,000) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/100 do < 1/10), a v splošnem asimptomatskih primerih splenomegalije, zelo redko (< 1/10.000) pa o primerih rupture vranice, vključno z nekaterimi smrtnimi primeri.
Before you inject Neupopeg you must do the following: Hold the syringe barrel and gently take the cover from the needle without twisting.
Primite telo injekcijske brizge ter nežno in brez sukanja potegnite pokrovček z igle.
A. Place the pre-filled pen on the injection site at a right angle (90 degrees) and push firmly against the skin.
A. Napolnjeni injekcijski peresnik prislonite pravokotno na injekcijsko mesto (pod kotom 90 stopinj), nato ga čvrsto pritisnite na kožo in zadržite (glejte sliko).
Neupopeg is a solution for injection in a pre-filled pen (6 mg/0.6 ml).
Neupopeg je raztopina za injiciranje v napolnjenem injekcijskem peresniku (6 mg/0,6 ml).
NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection.
IME ZDRAVILA Neupopeg 6 mg raztopina za injiciranje
Before administration, Neupopeg solution should be inspected visually for particulate matter.
Pred uporabo morate raztopino Neupopega pregledati glede vidnih delcev.
White blood cell counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving Neupopeg.
Pri manj kot 1 % bolnikov, ki dobivajo Neupopeg, so opazili število belih krvničk, ki je enako 100 x 109/l ali višje.
Allow the pre-filled pen to reach room temperature before injecting.
Pred injiciranjem naj se napolnjen injekcijski peresnik segreje na sobno temperaturo.
Equipment that you need To give yourself a subcutaneous injection you will need:
Oprema, ki jo boste potrebovali
The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.
Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje derivat lateksa in lahko povzroča hude alergijske reakcije.
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine.
The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
Pokrovček igle pri napolnjenem injekcijskem peresniku vsebuje suho naravno gumo (derivat lateksa).
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroča alergične reakcije.
One 6 mg dose (a single pre-filled pen) of Neupopeg (SureClick) is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (en napolnjen injekcijski peresnik) Neupopega (SureClick), ki je dan v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred very rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.
Redko (verjetno je, da se bo pojavil pri manj kot 1 od 1.000 bolnikov) se je pojavil Sweetov sindrom (izbočene boleče spremembe slivove barve na okončinah in včasih tudi na obrazu in vratu s povišano telesno temperaturo), tu lahko vplivajo tudi drugi dejavniki.
Pegfilgrastim
pegfilgrastima ANC
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
Neupopeg contains the active substance pegfilgrastim.
Zdravilo Neupopeg vsebuje zdravilno učinkovino pegfilgrastim.
Very rare (< 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
Pri bolnikih, zdravljenih z Neupoegom, so zelo redko (< 1/10.000) poročali o primerih kožnega vaskulitisa.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
IME ZDRAVILA IN POT(I) UPORABE
Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Po uporabi G-CSF so opisani redki primeri (≥ 1/10.000 do < 1/1.000) neželenih učinkov na pljučih, zlasti intersticijske pljučnice.
Do not use Neupopeg if you notice it is cloudy or there are particles in it.
Če opazite, da je Neupopeg moten ali da v njem plavajo delci, ga ne smete uporabiti.
• Keep used syringes out of the reach and sight of children.
• Uporabljene injekcijske brizge shranjujte nedosegljivo otrokom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING UNBLISTERED SYRINGE OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI ŠKATLICA Z INJEKCIJSKO BRIZGO V NEPRETISNI OVOJNINI
** The concentration is 20 mg/ml if the PEG moiety is included The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class.
** Če je vključen še delež PEG, je koncentracija 20 mg/ml.
The needle cover on the pre-filled pen contains a derivative of latex and may cause severe allergic reactions.
Pokrovček igle pri napolnjenem injekcijskem peresniku vsebuje derivat lateksa in lahko povzroča hude alergijske reakcije.
The safety and efficacy of Neupopeg have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti Neupopega niso ovrednotili.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/001
One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) Neupopega, ki je dan v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
Do not lift the prefilled pen.
Ne dvigajte napolnjenega injekcijskega peresnika.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/002
• Keep used pens out of the reach and sight of children.
• Uporabljene injekcijske peresnike shranjujte nedosegljivo otrokom.
NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection in a pre-filled pen.
IME ZDRAVILA Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Neupopeg 6 mg solution for injection in a pre-filled pen pegfilgrastim
Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku pegfilgrastim
MARKETING AUTHORISATION NUMBER(S) EU/1/02/228/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/228/003
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
Neupopeg is essentially sodium-free.
Neupopeg je pravzaprav brez natrija.
Disposing of used pre-filled pens
Odlaganje rabljenih napolnjenih injekcijskih peresnikov Odlaganje rabljenih napolnjenih injekcijskih peresnikov
Rare (likely to occur in fewer than 1 in 1000 patients)cases of breathing problems have been reported after taking G-CSFs.
Po uporabi G-CSF so opisani redki (verjetno je, da se bodo pojavili pri manj kot 1 od 1000 bolnikov) primeri težav dihanja.
NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg injection Pegfilgrastim
Neupopeg 6 mg injekcija pegfilgrastim
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak napolnjen injekcijski peresnik vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
If there are particles in it, you must not use it. For a more comfortable injection, leave at room temperature for approximately 30 minutes.
Da bo injiciranje manj neprijetno, pustite napolnjen injekcijski peresnik stati 30 minut zunaj hladilnika.
The abdomen can be considered when the thigh and back of arm are judged by a healthcare professional to be inappropriate.
Če zdravstveni delavec oceni, da stegno ali zadnji del nadlakta nista primerni mesti, lahko injicirate v trebuh.
Water for injections
OZNAKA NAPOLNJENE INJEKCIJSKE BRIZGE
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a single use pre-filled syringe (0.6 ml).
Raztopina za injiciranje v napolnjeni injekcijski brizgi (0,6 ml) za enkratno uporabo.
NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection Pegfilgrastim
Neupopeg 6 mg raztopina za injiciranje pegfilgrastim
NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg solution for injection in a pre-filled pen Pegfilgrastim
NAVODILO ZA UPORABO Neupopeg 6 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku pegfilgrastim
Injecting Neupopeg yourself
Samoinjiciranje Neupopega
What Neupopeg looks like and contents of the pack Neupopeg is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Neupopeg je raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
PACKAGE LEAFLET: INFORMATION FOR THE USER Neupopeg 6 mg solution for injection in a pre-filled syringe pegfilgrastim
NAVODILO ZA UPORABO Neupopeg 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
Driving and Using Machines
Vpliv na sposobnost upravljanja vozil in strojev
If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
Če ste negotovi glede samoinjiciranja ali če imate kakšna vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
Proceed with the next dose immediately and continue as advised by your doctor.
Takoj nadaljujte z naslednjim odmerkom in nadaljujte, kot vam je svetoval zdravnik.
It is recommended that not more than 4 mL per minute be administered.
Priporoča se, da se ne uporabi več kot 4 mL zdravila na minuto.
OTHER Octapharma-Logo
DRUGI PODATKI Octapharma-Logo
How often you need an injection will depend on how well Nuwiq is working for you.
Kako pogosto potrebujete injekcijo, je odvisno od tega, kako dobro zdravilo Nuwiq deluje v vašem primeru.
Inject the solution into the vein at a slow speed, not faster than 4 mL per minute.
Raztopino injicirajte v veno počasi, ne hitreje kot 4 mL na minuto.
Unopened vial 2 years
6.3 Rok uporabnosti Neodprta viala 2 leti
Date of latest renewal: 26 april 2019
Datum prve odobritve: 22. julij 2014 Datum zadnjega podaljšanja: 26. april 2019
A CVAD is an external connector that allows access to the bloodstream through a catheter without injection through the skin.
CVAD je zunanji priključek, ki omogoča dostop v krvni obtok skozi kateter brez injekcije skozi kožo.
The way Nuwiq is used in children and adolescents does not differ from the way it is used in adults.
Način uporabe zdravila Nuwiq pri otrocih in mladostnikih se ne razlikuje od načina uporabe pri odraslih.
33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Pri 33 (82,5%) bolnikih ni prišlo do nobenih krvavitev, pri 36 (90,0%) bolnikih pa ni prišlo do spontanih krvavitev.
Because factor VIII products may have to be given more often in children and adolescents, a central venous access device (CVAD) may need to be fitted.
Ker je včasih pri otrocih in mladostnikih potrebno zdravila s faktorjem VIII dajati pogosteje, bo morda treba namestiti napravo za centralni venski dostop (CVAD).
Once the medicinal product has been taken out of the refrigerator, it must not be returned to the refrigerator.
Ko je zdravilo enkrat vzeto iz hladilnika, se ga ne sme več vrniti vanj.
Your doctor will calculate your dose of Nuwiq (in international units = IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Zdravnik bo izračunal velikost odmerka zdravila Nuwiq (v mednarodnih enotah = i.e.) glede na vaše stanje in telesno maso ter v skladu s tem, ali se uporablja za preprečevanje ali zdravljenje krvavitev.
Nuwiq can be used for all age groups.
Zdravilo Nuwiq se lahko uporablja za vse starostne skupine.
Do not store Nuwiq in the refrigerator again after it has been stored at room temperature.
Zdravila Nuwiq ne hranite znova v hladilniku, potem ko je že bilo shranjeno pri sobni temperaturi.
Do not use the medicine in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.
Ne uporabljajte tega zdravila, če opazite vidne znake poškodbe varnostnega zapirala pakiranja, še posebej tistega na brizgi in/ali viali.
You might need a higher dose of Nuwiq or a different product to control bleedings.
Morda boste potrebovali večji odmerek zdravila Nuwiq ali drugo zdravilo za nadzor krvavitev.
There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Nuwiq.
Obstaja majhna verjetnost, da pride do anafilaktične reakcije (huda, nenadna alergijska reakcija) na zdravilo Nuwiq.
These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds.
izmed teh otrok, ki so jih nadalje zdravili v obdobju z mediano približno 30 mesecev (razpon od 9,5 do 52 mesecev); v tem obdobju 45% otrok ni imelo spontanih krvavitev.
However for patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Vendar pa je pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), tveganje občasno (pri manj kot 1 od 100 bolnikov).
Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Farmakoterapevtska skupina: Antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02.
However depending on the body weight and posology, the patient could receive more than one vial (see section 2 for information on content per vial).
Vendar pa lahko glede na telesno maso in odmerjanje bolnik prejme več kot eno vialo (glejte poglavje 2 za informacije o vsebnosti na vialo).
A non-neutralizing anti-factor VIII antibody was detected in one adult patient (see Table 1).
Nenevtralizirajoča protitelesa za faktor VIII so odkrili pri enem odraslem bolniku (glejte preglednico 1).
The dose of Nuwiq is calculated depending on your body weight and the factor VIII levels to be achieved.
Odmerek zdravila Nuwiq se izračuna glede na vašo telesno maso in raven faktorja VIII, ki jo je treba doseči.
One mL of reconstituted solution contains 7.35 mg sodium (18.4 mg sodium per vial).
En mL rekonstituirane raztopine vsebuje 7,35 mg natrija (18,4 mg natrija na vialo).
Frequency of adverse drug reactions (ADRs) in clinical trials
Pogostnost pojava neželenih učinkov zdravila (NUZ) v kliničnih preskušanjih
Nuwiq is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Zdravilo Nuwiq je izdelano s tehnologijo rekombinantne DNK v gensko spremenjenih humanih embrionalnih ledvičnih celicah (HEK) 293F.
See section 2, “Nuwiq contains sodium”.
Glejte poglavje 2, "Zdravilo Nuwiq vsebuje natrij".
Frequency, type and severity of adverse reactions in children and adolescents are assumed to be the same as in adults.
Domneva se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enaki kot pri odraslih in mladostnikih.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
One International Unit (IU) of factor VIII activity is equivalent to the quantity of factor VIII in one mL of normal human plasma.
Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne humane plazme.
AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life,
AUC = Površina pod krivuljo (FVIII:C), T1/2 = Končna razpolovna doba,
The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
The mean ± SD annualised bleeding rate was 1.2 ± 3.9 and the mean ± SD dose were 52.2 ± 12.2 IU/kg per injection and 99.7 ± 25.6 IU/kg per week.
Povprečna ± SD stopnja krvavitve, normalizirane na eno leto, je bila 1,2 ± 3,9, povprečni ± SD odmerek pa je bil 52,2 ± 12,2 i.e./kg na injiciranje in 99,7 ± 25,6 i.e./kg na teden.
If severe, sudden allergic reactions (anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped immediately.
(anafilaktične) reakcije (zelo redko, lahko se pojavijo pri največ 1 na 10.000 ljudi), morate injiciranje zdravila takoj ustaviti.
Do not increase the total dose of Nuwiq to control your bleeding without consulting your doctor.
Ne povečujte skupnega odmerka zdravila Nuwiq za nadzor vaše krvavitve, ne da bi se posvetovali z zdravnikom.
Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Infuzijo ponavljajte na vsakih 8-24 h, dokler se rana zadostno ne zaceli, nato nadaljujte s terapijo še najmanj naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII med 30 in 60 % (i.e./dL).
If this happens, your or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Če pride do tega, zdravilo pri vas ali vašem otroku ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
The specific activity of Nuwiq is approximately 9500 IU/mg protein.
Specifična aktivnost zdravila Nuwiq znaša približno 9500 i.e./mg beljakovin.
The posology is the same in adults and children and adolescents, however, shorter dose intervals or higher doses may be necessary for children and adolescents.
Odmerjanje je pri odraslih, otrocih in mladostnikih enako, vendar pa so pri otrocih in mladostnikih lahko potrebni krajši intervali med odmerki ali višji odmerki.