natgillin/translations-raw huggingface dataset:
Leganto 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 4 mg/24 h'.
Leganto 4 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Leganto 4 mg/24 h'.
Dizziness e, disturbances in consciousness NEC
Bolezni živčevja glavobol somnolenca omotica e, motnje zavesti NEC
Leganto 6 mg/24 h transdermal patch EU/1/11/695/037
Leganto 6 mg/24 h transdermalni obliž EU/1/11/695/037
syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
(vključno s sinkopo, vazovagalno sinkopo, izgubo zavesti) diskinezija, posturalna omotica, letargija konvulzija sindrom padajoče glave c
• From the second week, your daily dose may be increased by 1 mg each week - until you get to the right maintenance dose for you.
• Od drugega tedna dalje se vam lahko dnevni odmerek zvišuje po 1 mg vsak teden - dokler se ne bo dosegel za vas ustrezen vzdrževalni odmerek.
Leganto 1 mg/24 h transdermal patch Leganto 3 mg/24 h transdermal patch
Leganto 1 mg/24 h transdermalni obliž Leganto 3 mg/24 h transdermalni obliž
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above.
Povejte svojemu zdravniku, če se pri vas pojavijo kakršne koli spremembe v vedenju, mišljenju ali obeh, kot je navedeno zgoraj.
• From the second week your daily dose may be increased by 2 mg each week - until you get to the right maintenance dose for you.
• Od drugega tedna dalje se vam lahko dnevni odmerek zvišuje po 2 mg vsak teden - dokler se ne bo dosegel za vas ustrezen vzdrževalni odmerek.
Each patch releases 6 mg of rotigotine per 24 hours.
En obliž sprosti 6 mg rotigotina v 24 urah.
B. PACKAGE LEAFLET
• zamegljen vid
With rotigotine, the mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
Pri rotigotinu je bila srednja vrednost zmanjšanja časa »izklop« 2,7 ure pri skupini, ki je prejemala 8 mg rotigotina/24 h, in 2,1 ure pri skupini, ki je prejemala 12 mg rotigotina/24 h. Pri skupini, ki je prejemala placebo, je bilo zmanjšanje 0,9 ure.
190 patients received rotigotine, and 97 placebo.
81,5 % bolnikov se je sočasno zdravilo z L-dopo.190 bolnikov je prejemalo rotigotin in 97 placebo.
Leganto 3 mg/24 h transdermal patch EU/1/11/695/019
Leganto 3 mg/24 h transdermalni obliž EU/1/11/695/019
Augmentation may occur in Restless Legs Syndrome patients.
Pri bolnikih s sindromom nemirnih nog se lahko pojavi avgmentacija.
Leganto 6 mg/24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Leganto 6 mg/24 h transdermalni obliž En obliž sprosti 6 mg rotigotina v 24 urah.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Pri nenadni prekinitvi dopaminergičnega zdravljenja so poročali o simptomih, ki kažejo na maligni nevroleptični sindrom.
Leganto 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Leganto 4 mg/24 h transdermalni obliž En obliž sprosti 4 mg rotigotina v 24 urah.
7 transdermal patches.
7 transdermalnih obližev 2. teden
EU/1/11/695/046 [7 transdermal patches] EU/1/11/695/048 [28 transdermal patches] EU/1/11/695/049 [30 transdermal patches]
EU/1/11/695/046 [7 transdermalnih obližev] EU/1/11/695/048 [28 transdermalnih obližev] EU/1/11/695/049 [30 transdermalnih obližev]
SACHET LABEL - WEEK 1
7 transdermalnih obližev 1. teden
Weight decreased e, hepatic enzyme increased e
Poškodbe in zastrupitve padci a
• feeling sleepy or dizzy
• občutek zaspanosti ali omotice
Leganto is available in different strength patches which release the medicine over 24 hours.The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Jakosti 1 mg/24 h, 2 mg/24 h in 3 mg/24 h so za zdravljenje sindroma nemirnih nog.
The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h.
Zunanja stran je rumenorjave barve, z natisnjenim napisom Leganto 2 mg/24 h.
Leganto 3 mg/24 h transdermal patch Each patch releases 3 mg of rotigotine per 24 hours.
Leganto 3 mg/24 h transdermalni obliž En obliž sprosti 3 mg rotigotina v 24 urah.
EU/1/11/695/019 [7 transdermal patches] EU/1/11/695/021 [28 transdermal patches] EU/1/11/695/022 [30 transdermal patches]
EU/1/11/695/019 [7 transdermalnih obližev] EU/1/11/695/021 [28 transdermalnih obližev] EU/1/11/695/022 [30 transdermalnih obližev]
EU/1/11/695/001 [7 transdermal patches] EU/1/11/695/003 [28 transdermal patches] EU/1/11/695/004 [30 transdermal patches]
EU/1/11/695/001 [7 transdermalnih obližev] EU/1/11/695/003 [28 transdermalnih obližev] EU/1/11/695/004 [30 transdermalnih obližev]
EU/1/11/695/037 [7 transdermal patches] EU/1/11/695/039 [28 transdermal patches] EU/1/11/695/040 [30 transdermal patches]
EU/1/11/695/037 [7 transdermalnih obližev] EU/1/11/695/039 [28 transdermalnih obližev] EU/1/11/695/040 [30 transdermalnih obližev]
Leganto 8 mg/24 h transdermal patch rotigotine
Leganto 8 mg/24 h transdermalni obliž rotigotin
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Leganto.
Pred začetkom uporabe zdravila Leganto se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, saj:
Each patch releases 2 mg of rotigotine per 24 hours.
Vsak obliž sprosti 2 mg rotigotina v 24 urah.
Each patch releases 4 mg of rotigotine per 24 hours.
Vsak obliž sprosti 4 mg rotigotina v 24 urah.
Leganto 1 mg/24 h transdermal patch rotigotine
Leganto 1 mg/24 h transdermalni obliž rotigotin
• 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
• 4 mg/24 h Vsak obliž sprosti 4 mg rotigotina v 24 urah.
Leganto 2 mg/24 h transdermal patch
Leganto 2 mg/24 h transdermalni obliž
What Leganto looks like and contents of the pack Leganto is a transdermal patch.
Izgled zdravila Leganto in vsebina pakiranja
EU/1/11/695/007 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/007 [84 transdermalnih obližev (3 pakiranja po 28)]
• From the second week, your daily dose may be increased by 1 mg each week until you get to the right maintenance dose for you.
• Od drugega tedna dalje, se vam lahko dnevni odmerek po zdravnikovih navodilih zvišuje po 1 mg na teden, dokler se ne bo dosegel za vas ustrezen vzdrževalni odmerek.
The active substance is rotigotine.
Učinkovina je rotigotin.
• Your starting dose will be one 1 mg/24 h patch each day.
• Začeli boste z uporabo enega obliža 1 mg/24 h dnevno.
EU/1/11/695/016 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/016 [84 transdermalnih obližev (3 pakiranja po 28)]
Leganto 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Leganto 1 mg/24 h transdermalni obliž En obliž sprosti 1 mg rotigotina v 24 urah.
EU/1/11/695/028 [7 transdermal patches] EU/1/11/695/030 [28 transdermal patches] EU/1/11/695/031 [30 transdermal patches]
EU/1/11/695/028 [7 transdermalnih obližev] EU/1/11/695/030 [28 transdermalnih obližev] EU/1/11/695/031 [30 transdermalnih obližev]
Rotigotine
• kolcanje
What Leganto is used for
Zakaj se uporablja zdravilo Leganto
EU/1/11/695/010 [7 transdermal patches] EU/1/11/695/012 [28 transdermal patches] EU/1/11/695/013 [30 transdermal patches]
EU/1/11/695/010 [7 transdermalnih obližev] EU/1/11/695/012 [28 transdermalnih obližev] EU/1/11/695/013 [30 transdermalnih obližev]
Leganto 3 mg/24 h transdermal patch rotigotine
Leganto 3 mg/24 h transdermalni obliž rotigotin
Leganto 4 mg/24 h transdermal patch Leganto 6 mg/24 h transdermal patch Leganto 8 mg/24 h transdermal patch
Leganto 4 mg/24 h transdermalni obliž Leganto 6 mg/24 h transdermalni obliž Leganto 8 mg/24 h transdermalni obliž rotigotin
• Your starting daily dose will be one 4 mg/24 h patch each day.
• Začeli boste z uporabo enega obliža 4 mg/24 h dnevno.
Each patch releases 3 mg of rotigotine per 24 hours.
En obliž sprosti 3 mg rotigotina v 24 urah.
EU/1/11/695/043 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/043 [84 transdermalnih obližev (3 pakiranja po 28)]
Leganto 6 mg/24 h transdermal patch rotigotine
Leganto 6 mg/24 h transdermalni obliž rotigotin
EU/1/11/695/025 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/025 [84 transdermalnih obližev (3 pakiranja po 28)]
Leganto 2 mg/24 h transdermal patch Rotigotine
Leganto 2 mg/24 h transdermalni obliž rotigotin
Hepatic enzyme increased (incl.
Srednja vrednost izboljšanja rezultata UPDRS (II.
• Your starting daily dose will be one 2 mg/24 h patch each day.
• Začeli boste z uporabo enega obliža 2 mg/24 h dnevno.
Leganto 4 mg/24 h transdermal patch rotigotine
Leganto 4 mg/24 h transdermalni obliž rotigotin
EU/1/11/695/052 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/052 [84 transdermalnih obližev (3 pakiranja po 28)]
Talk to your doctor if they last for a long time or if you are worried about them.
Če trajata dlje časa ali vas skrbi zaradi njiju, se posvetujte z zdravnikom.
SACHET LABEL - WEEK 4
7 transdermalnih obližev 4. teden
Vision blurred e,
Očesne bolezni zamegljen vid e,
EU/1/11/695/034 [84 transdermal patches (3 packs of 28)]
EU/1/11/695/034 [84 transdermalnih obližev (3 pakiranji po 28)]
SACHET LABEL - WEEK 3
7 transdermalnih obližev 3. teden
The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks.
Bolnikom so odmerek 4 tedne postopno povečevali do optimalnega odmerka rotigotina v tedenskih korakih po 2 mg/24 h, od 2 mg/24 h do največjega odmerka 8 mg/24 h. V skupini, ki je prejemala ropinirol, so bolnikom 13 tednov postopno povečevali odmerek do optimalnega odmerka, do največ 24 mg/dan.
A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h.
Odmerjanje pri bolnikih v napredovali fazi Parkinsonove bolezni z nihanji: Enkratni dnevni odmerek začnemo s 4 mg/24 h in ga nato povečujemo v tedenskih korakih po 2 mg/24 h do učinkovitega odmerka, do največjega odmerka 16 mg/24 h. 4 mg/24 h ali 6 mg/24 h lahko zadoščata kot učinkovita odmerka za nekatere bolnike.
Obsessivecompulsive disorder, agitation d
agitiranost d psihotične motnje, obsesivno kompulzivna motnja, nasilno vedenje/ agresivnostb, blodnja d,
Pruritus generalised, skin irritation, dermatitis contact
Bolezni kože in podkožja eritem, hiperhidroza, pruritus razširjen pruritus, draženje kože, kontaktni dermatitis razširjen izpuščaj
Hypotension e
razširjen izpuščaj e
This summary was last updated in 08-2007.©EMEA 2007
Povzetek je bil nazadnje posodobljen 08-2007.©EMEA 2007
As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 28 July 2006.
Ker je podjetje posredovalo zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 28. julija 2006.
Hypersensitivity (allergic reactions) has sometimes been seen.
V nekaterih primerih je bila opažena preobčutljivost (alergijske reakcije).
Additionally, any improvement in skin lesions was monitored.
Poleg tega so opazovali izboljšanje kožnih lezij.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Evropska komisija je dovoljenje za promet z zdravilom CEPROTIN, veljavno po vsej Evropski uniji, odobrila družbi Baxter AG dne 16. julija 2001.
The marketing authorisation was renewed on 16 July
Dovoljenje za promet z zdravilom je bilo podaljšano dne 16. julija 2006.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CEPROTIN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) CEPROTIN Povzetek EPAR za javnost
CEPROTINCEPROTINOther information about CEPROTIN:
Druge informacije o zdravilu CEPROTIN:
CEPROTIN was originally authorised under 'Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
Zdravilo CEPROTIN je bilo prvotno odobreno „v izjemnih okoliščinah“, saj zaradi majhnega števila bolnikov, pri katerih so diagnosticirali to bolezen, še ni bilo mogoče zagotoviti celovitih informacij o zdravilu.
What benefit has CEPROTIN shown during the studies?
Kakšne koristi je zdravilo CEPROTIN izkazalo med raziskavami?
The Committee recommended that CEPROTIN be given marketing authorisation.
Zato je priporočil, da se za zdravilo CEPROTIN podeli dovoljenje za promet.
The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.
Rezultati pri zdravljenju drugih vrst zapletov pri strjevanju krvi in zdravljenju bolnikov z drugimi oblikami pomanjkanja proteina C niso zadoščali, da bi v celoti ocenili uporabo zdravila CEPROTIN pri teh skupinah.
CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
Zdravilo CEPROTIN je prašek in vehikel, ki se zmešata v raztopino za injiciranje.
Protein C slows down the production of thrombin, and therefore slows down further clotting.
Protein C upočasni nastajanje trombina in tako upočasni nadaljnje strjevanje.
What is the risk associated with CEPROTIN?
Kakšna tveganja so povezana z zdravilom CEPROTIN?
CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Zdravilo CEPROTIN vsebuje humani protein C, pridobljen in prečiščen iz človeške plazme (tekoči del krvi).
Protein C is a natural substance in the blood that controls clotting.
Protein C je naravna učinkovina v krvi, ki nadzoruje njeno strjevanje.
When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.
Posebna pozornost je potrebna, kadar bolniki začnejo prejemati drugo antikoagulantno zdravilo, kot npr. varfarin, z zdravljenjem z zdravilom CEPROTIN pa je treba nadaljevati, dokler se zdravljenja z varfarinom ne prilagodi.
CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
Zdravila CEPROTIN se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) humani protein C, mišje beljakovine ali heparin, razen v primeru življenjsko nevarnih zapletov.
It contains the active substance human protein C.
Zdravilo vsebuje zdravilno učinkovino humani protein C.
In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
Pri bolnikih s hudim prirojenim pomanjkanjem proteina C je zdravilo CEPROTIN privedlo do izboljšanja v vseh 16 primerih purpure fulminans in v vseh šestih epizodah kumarinske kožne nekroze.
CEPROTIN is also used for the short-term prevention of clotting in patients with severe congenital protein C deficiency in certain situations when there is an increased risk of clotting, such as surgery or when treatment with a coumarin is not sufficient or possible.
Zdravilo CEPROTIN se uporablja tudi za kratkotrajno preprečevanje strjevanja krvi pri bolnikih s hudim prirojenim pomanjkanjem proteina C v določenih situacijah, ko obstaja povečano tveganje strjevanja, npr. pri operaciji ali kadar zdravljenje s kumarinom ne zadostuje ali ni mogoče.
CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
Zdravilo CEPROTIN se uporablja pri bolnikih s hudim prirojenim (dednim) pomanjkanjem proteina C za zdravljenje purpure fulminans (obsežnega strjevanja krvi v žilju, ki povzroča odmiranje tkiv tik pod kožo, kar pogosto privede do okvar organov in amputacij) in kumarinske kožne nekroze (zapleta pri antikoagulentnem zdravljenju z zdravili, kot je varfarin, kar povzroči odmiranje kože).
Why has CEPROTIN been approved?
Zakaj je bilo zdravilo CEPROTIN odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN's benefits are greater than its risks for patients with severe congenital protein C deficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila CEPROTIN za bolnike s hudim prirojenim pomanjkanjem proteina C večje od z njim povezanih tveganj.
CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Zdravljenje z zdravilom CEPROTIN sme uvesti le zdravnik, ki ima izkušnje s tovrstnim zdravljenjem, in le, kadar je možno meriti aktivnost proteina C. Zdravilo CEPROTIN se daje z intravensko injekcijo (injekcija v žilo) s hitrostjo injiciranja največ 2 ml na minuto, razen pri otrocih s telesno maso, manjšo od 10 kg, pri katerih hitrost injiciranja ne sme preseči 0,2 ml na kilogram telesne mase na minuto.
The full EPAR for CEPROTIN is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo CEPROTIN je na voljo tukaj.
CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Zdravilo CEPROTIN so preučevali pri 79 bolnikih, med katerimi jih je imelo 22 diagnosticirano hudo obliko prirojenega pomanjkanja proteina C. Glavna merila študije so bila normalizacija ravni proteina
An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Injekcija zdravila CEPROTIN takoj, a le za kratek čas zviša raven proteina C. Pri bolnikih s pomanjkanjem proteina C bi naj z nadomestitvijo proteina C nadzorovali ali preprečili trombotične zaplete (zaplete pri strjevanju krvi).
What is CEPROTIN used for?
Za kaj se zdravilo CEPROTIN uporablja?
The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation.
C in drugih pokazateljev aktivacije koagulacije (strjevanja).
How does CEPROTIN work?
Kako zdravilo CEPROTIN deluje?
How has CEPROTIN been studied?
Kako je bilo zdravilo CEPROTIN raziskano?
What is CEPROTIN?
Kaj je zdravilo CEPROTIN?
How is CEPROTIN used?
Kako se zdravilo CEPROTIN uporablja?
If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Če se zdravilo CEPROTIN uporablja pri bolnikih s hudim prirojenim pomanjkanjem proteina C, se lahko razvijejo protitelesa, ki zavirajo protein C. Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila CEPROTIN, glejte Navodilo za uporabo.
In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting.
V telesu protein C nadzoruje tvorbo trombina, t.j.
EU/1/15/1069/001 Episalvan
EU/1/15/1069/001 Episalvan gel
as well as hybrids of both species (equivalent to 0.5 - 1.0 g birch bark), corresponding to 72-88 mg betulin.
ter tudi hibridov obeh vrst (enakovrednega 0,5-1,0 g skorje breze), kar ustreza 72-88 mg betulina.
Cutaneous use Tube (alu)
Dermalna uporaba tuba (alu)
Extraction solvent: n-Heptane
Ekstrakcijsko topilo: n-heptan
1g of gel contains: 100 mg extract (as dry extract) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
--1 1g gela vsebuje: 100 mg prečiščenega suhega ekstrakta skorje breze vrst Betula pendula Roth in Betula pubescens Ehrh.
MA (EU) number (Invented) name
(Izmišljeno) ime Jakost
Further information on Esperoct can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/esperoct.
Nadaljnje informacije o zdravilu Esperoct so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/esperoct.
What measures are being taken to ensure the safe and effective use of Esperoct?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Esperoct?
The European Medicines Agency decided that Esperoct's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Esperoct večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Esperoct
Druge informacije o zdravilu Esperoct
Since this could potentially cause problems especially in children below 12 years of age, Esperoct is only approved for use in adults and children from 12 years of age.
Ker lahko to povzroči težave, zlasti pri otrocih, mlajših od 12 let, je zdravilo Esperoct odobreno le za uporabo pri odraslih in otrocih, starejših od 12 let.
As for all medicines, data on the use of Esperoct are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Esperoct stalno spremljajo.
When bleeding episodes occurred, they were successfully treated with one or two further injections in 94% of cases.
Ko so se epizode krvavitve pojavile, so bile v 94 % primerov uspešno zdravljene z eno ali dvema dodatnima injekcijama.
These include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest, tingling and wheezing.
Te vključujejo: oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, siljenje na bruhanje in bruhanje, nemir, hiter srčni utrip, tiščanje v prsih, mravljinčenje in piskajoče dihanje.
Patients or their carers may be able to inject Esperoct themselves at home once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Esperoct injicirajo sami doma.
Twelve further patients in this study did not receive preventive treatment but were given Esperoct for treating bleeding ‘on demand'.
Dvanajst dodatnih bolnikov v tej študiji ni prejelo preventivnega zdravljenja, ampak so zdravilo Esperoct za zdravljenje krvavitev prejeli „na zahtevo“.
The dose, frequency and duration of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Odmerek, pogostnost in trajanje zdravljenja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev, ter od resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
Esperoct can be used in adults and children from 12 years of age.
Zdravilo Esperoct se lahko uporablja pri odraslih in otrocih, starih 12 let in več.
What benefits of Esperoct have been shown in studies?
Kakšne koristi zdravila Esperoct so se pokazale v študijah?
Side effects reported with Esperoct are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Esperoct, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Esperoct authorised in the EU?
Zakaj je bilo zdravilo Esperoct odobreno v EU?
The company that markets Esperoct will carry out a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues and organs.
Podjetje , ki trži zdravilo Esperoct, bo izvedlo študijo za proučitev morebitnega učinka kopičenja PEG v horoidnem pletežu možganov in drugih tkivih in organih.