natgillin/translations-raw huggingface dataset:
Mepsevii must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique according to the steps described below.
Zdravilo Mepsevii je treba razredčiti z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za injiciranje z uporabo aseptične tehnike in ob upoštevanju spodaj opisanih korakov.
For the clinical (secondary) endpoints, beneficial responses were observed although not in all patients.
Ključni sekundarni opazovani dogodek: Večdomenski indeks kliničnega odziva (MDRI) V okviru kliničnih (sekundarnih) opazovanih dogodkov so opazili koristne odzive, vendar ne pri vseh bolnikih.
The total diluted volume of the solution for infusion should be administered with a rate titration regimen over approximately 4 hours.
Skupni razredčeni volumen raztopine za infundiranje je treba dajati v režimu s postopnim večanjem odmerka, pri čemer infundiranje traja približno 4 ure.
Animal studies with vestronidase alfa do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3).
Študije vestronidaze alfa, opravljene pri živalih, niso pokazale neposrednih ali posrednih škodljivih učinkov na gestacijo in razvoj zarodka/plodu (glejte poglavje 5.3).
The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment.
Bolnik je pozneje ponovno prejemal vestronidazo alfa in nadaljeval zdravljenje brez ponovitve.
Genotoxicity studies and carcinogenicity studies have not been performed with vestronidase alfa.
Z vestronidazo alfa niso izvedli študij genotoksičnosti in kancerogenosti.
This medicine contains 17.8 mg sodium (main component of cooking/table salt) in each 5-mL vial, and is administered with sodium chloride 9 mg/mL as a diluent.
To zdravilo vsebuje 17,8 mg natrija (glavna sestavina namizne soli) v vsaki 5 ml viali in se daje z natrijevim kloridom 9 mg/ml kot razredčilom.
Patient Weight Range (kg)
Razpon telesne mase bolnika (kg)
It should be considered that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Upoštevati je treba, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin) Rentschler Biopharma SE
In a multi-centre, randomized, placebo-controlled, Blind-Start, single-crossover Phase 3 trial (Study UX003-CL301, referred to as Study 301), 12 patients with MPS VII received vestronidase alfa 4 mg/kg every two weeks for 24 to 48 weeks.
V večcentričnem, randomiziranem, s placebom nadzorovanem preskušanju faze 3 s slepim začetkom in enim prehodom (študija UX003-CL301, imenovana študija 301) je 12 bolnikov z MPS VII od 24 do 48 tednov prejemalo 4 mg/kg vestronidaze alfa na vsaka dva tedna.
The recommended dose of vestronidase alfa is 4 mg/kg of body weight administered by intravenous infusion every two weeks.
Priporočeni odmerek vestronidaze alfa je 4 mg/kg telesne mase bolnika in se daje kot intravenska infuzija na vsaka dva tedna.
Pack size: 1 vial of 5 mL
Velikost pakiranja: 1 viala po 5 ml
Very common side effects (may affect more than 1 in 10 people): - Severe allergic reaction (anaphylactoid reaction) - Symptoms of severe allergic reaction may include shortness of breath, wheezing, difficulty breathing, and swelling of the face and tongue.
- Huda alergijska reakcija (anafilaktoidna reakcija) - med simptomi hude alergijske reakcije so lahko zasoplost, piskanje v pljučih, težko dihanje ter oteklost obraza in jezika.
One patient receiving a vestronidase alfa dose of 4 mg/kg experienced a febrile convulsion during treatment at the week 66, within 3 days of diphtheria, tetanus, pertussis vaccination.
En bolnik, ki je prejemal vestronidazo alfa v odmerku 4 mg/kg, je v 66. tednu zdravljenja doživel vročinski krč v treh dneh po cepljenju proti davici, tetanusu in oslovskemu kašlju.
It is supplied in a clear glass vial with a rubber stopper and an aluminium seal with a plastic cap.
Na voljo je v viali iz brezbarvnega stekla z gumijastim zamaškom in aluminijastim tesnilom s plastično zaporko.
No human data are available on the effect of vestronidase alfa on fertility.
Podatki o učinku vestronidaze alfa na plodnost pri ljudeh niso na voljo.
Two other patients with baseline hepatosplenomegaly had reduction in liver volume (24% and 53%) and spleen volume (28% and 47%) after 36 weeks of treatment.
36 tednih zdravljenja ugotovili zmanjšanje volumna jeter (24 % in 53 %) in volumna vranice (28 % in 47 %).
There is no definitive correlation between the antibody titre and neutralizing antibody development.
Med titrom protiteles in razvojem nevtralizirajočih protiteles ni očitne korelacije.
Package leaflet: Information for the user Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa This medicine is subject to additional monitoring.
Navodilo za uporabo Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje vestronidaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
What Mepsevii looks like and contents of the pack
Izgled zdravila Mepsevii in vsebina pakiranja
It is recommended that premedication with non-sedating antihistamines with or without antipyretics be administered 30-60 minutes prior to the start of the infusion (see section 4.2).
Od 30 do 60 minut pred začetkom infundiranja se priporoča premedikacija z nesedativnimi antihistaminiki z antipiretiki ali brez njih (glejte poglavje 4.2).
The Mepsevii concentrate solution for infusion should be colourless to slightly yellow.
Raztopina za infundiranje, pripravljena s koncentratom zdravila Mepsevii, mora biti brezbarvna do rahlo rumena.
Recommended infusion rate schedule by patient weight for administration of Mepsevii at recommended dose of 4 mg/kg Patient Weight Range (kg)
Priporočeni razpored infundiranja glede na telesno maso bolnika pri uporabi zdravila Mepsevii v priporočenem odmerku 4 mg/kg
Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap.
tip I) z gumijastim zamaškom, obloženim s fluorovo smolo, ter aluminijastim tesnilom s plastično zaporko.
Based on mechanism of action, rhGUS is not expected to be tumorigenic.
Na podlagi mehanizma delovanja ni pričakovati, da bo humana rekombinantna beta-glukuronidaza (rhGUS) tumorogena.
It should be considered by the treating physician that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Lečeči zdravnik mora upoštevati, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
The pharmacokinetics of vestronidase alfa are time independent with repeat dosing.
Pri ponavljajočem se odmerjanju je farmakokinetika vestronidaze alfa neodvisna od časa.
- The active substance is vestronidase alfa.
- Učinkovina je vestronidaza alfa.
After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation the total volume of distribution (Vss) was 0.26 ± 0.13 L/kg (range: 0.10 to 0.60 L/kg).
Po ponavljajočem se odmerjanju 4 mg/kg vsak drugi teden pri bolnikih z MPS VII je bil srednji ± standardni odklon v skupnem volumnu porazdelitve (Vss) 0,26 ± 0,13 l/kg (razpon: od 0,10 do 0,60 l/kg).
The diluted solution for infusion should be administered to patients using a low-protein binding infusion bag and set (a non di (2-ethylhexyl) phthalate [DEHP] bag could be used) and the application of an infusion set equipped with an in-line, low-protein binding 0.2 μm filter is recommended.
Razredčeno raztopino za infundiranje je treba dajati bolnikom z uporabo infuzijske vrečke in kompleta, ki malo vežeta beljakovine (uporabite lahko vrečko brez di-(2-etilheksil)ftalata [DEHP]).
Do not heat, microwave or shake vials.
Vial ne segrevajte, ne izpostavljajte mikrovalovom in ne stresajte.
Vestronidase alfa is a recombinant form of human GUS and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes and subsequent catabolism of accumulated GAGs in affected tissues.
Vestronidaza alfa je rekombinantna oblika humane beta-glukuronidaze in zagotavlja eksogeni encim beta-glukuronidazo za privzem v celične lizosome in poznejši katabolizem nakopičenih glikozaminoglikanov v prizadetih tkivih.
Vestronidase alfa is not expected to be eliminated through renal or faecal excretion.
Ni pričakovati, da se bo vestronidaza alfa izločala po ledvični ali fekalni poti.
The above calculated dose diluted 1:1 in sodium chloride 9 mg/mL (0.9%) solution for injection should be added to a new empty infusion bag.
Zgornji izračunani odmerek, razredčen v razmerju 1 : 1 z 0,9-odstotno raztopino (9 mg/ml) za injiciranje je treba dodati v novo prazno infuzijsko vrečko.
For the management of adverse reactions, see sections 4.4 and 4.8.
Izkušenj s prevelikim odmerjanjem vestronidaze alfa ni. Za obvladovanje neželenih učinkov glejte poglavji 4.4 in 4.8.
Mepsevii contains sodium
Zdravilo Mepsevii vsebuje natrij
Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia.
Razmislite o hitrem infundiranju 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), če ima bolnik znižan krvni tlak, in o dovajanju kisika pri hipoksiji.
Due to the low infusion rate, additional sodium chloride 9 mg/mL (0.9%) solution for infusion may be added through a separate line (piggyback or Y tube) to maintain sufficient intravenous flow.
Zaradi nizke hitrosti infundiranja se lahko po ločeni liniji dodaja 0,9-odstotna raztopina natrijevega klorida (9 mg/ml) (sekundarna infuzija (»komplementarna infuzija«) ali cev Y), da se ohrani zadosten pretok infuzijske tekočine.
The key secondary endpoint was the multi-domain clinical responder index (MDRI) score consisting of six domains [six-minute walk test (6MWT), forced vital capacity (FVC), shoulder flexion, visual acuity, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) fine motor and gross motor function] after 24 weeks of treatment and fatigue total score as measured by the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL).
[6-minutni test hoje (6MWT), forsirana vitalna kapaciteta (FVC), fleksija ramen, ostrina vida, test Bruininks-Oseretsky (BOT-2) finih in grobih motoričnih spretnosti] po 24 tednih zdravljenja in skupna ocena utrujenosti, merjena z večdimenzionalno lestvico utrujenosti in kakovosti življenja pri pediatričnih bolnikih (PedsQL).
Total Mepsevii Volume (rounded) (mL)
Celotni volumen zdravila Mepsevii (zaokrožen) (ml)
Study UX003-CL201 (referred to as Study 201) was a single arm, open-label, dose exploration trial that enrolled three MPS VII patients, ranging in age from 5 years to 25 years.
Druge študije Študija UX003-CL201 (imenovana študija 201) je bila odprto preskušanje za raziskavo odmerjanja z eno skupino, ki je vključevala tri bolnike z MPS VII, stare od 5 let do 25 let.
Total Mepsevii Dose Range (mg)
Celotni razpon odmerkov zdravila Mepsevii (mg)
a. Volume (mL) of calculated dose = Total dose (mg) divided by the 2 mg/mL concentration
a. Volumen (ml) izračunanega odmerka = celotni odmerek (mg), deljen s koncentracijo
Each vial contains 17.8 mg sodium.
Pomožne snovi z znanim učinkom Ena viala vsebuje 17,8 mg natrija.
The assessment of adverse reactions was based on the exposure of 23 patients from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Ocena neželenih učinkov je temeljila na izpostavljenosti 23 bolnikov v 4 kliničnih preskušanjih, starih od 5 mesecev do 25 let, ki so do 132 tednov prejemali vestronidazo alfa v odmerkih do 4 mg/kg enkrat na dva tedna.
The infusion was stopped, the patient received anticonvulsants, antipyretics and antibiotics, and the febrile convulsion resolved.
Vročinski krči so ponehali po ustavitvi infundiranja ter dajanju antikonvulzivov, antipiretikov in antibiotikov.
Discuss with your doctor if the benefits of using Mepsevii are greater than the potential risk to your baby while breast-feeding.
Pogovorite se z zdravnikom, ali so koristi uporabe zdravila Mepsevii med dojenjem večje od možnih tveganj za vašega otroka.
Each vial of 5 mL concentrate contains 10 mg vestronidase alfa (10 mg/ 5 mL).
Ena viala s 5 ml koncentrata vsebuje 10 mg vestronidaze alfa (10 mg/5 ml).
Mepsevii 2 mg/mL sterile concentrate vestronidase alfa
Mepsevii 2 mg/ml, sterilen koncentrat vestronidaza alfa
Patients who were enrolled in Study 301 were eligible to roll over to Study UX003-CL202 (referred to as Study 202), an open-label extension trial in which patients received additional doses of vestronidase alfa at 4 mg/kg intravenously every other week for up to 144 weeks.
Bolniki, ki so sodelovali v študiji 301, so lahko prešli na odprto podaljšanje preskušanja UX003-CL202 (študija 202), v katerem so do 144 tednov vsak drugi teden prejemali dodatne intravenske odmerke vestronidaze alfa 4 mg/kg.
How Mepsevii works
Kako deluje zdravilo Mepsevii
Dilute the calculated dose 1:1 using equal volume of sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous infusion.
Izračunani odmerek razredčite v razmerju 1 : 1 z enako količino 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za intravensko infuzijo.
It is not known whether vestronidase alfa is excreted in human milk, but systemic exposure via breast-milk is not expected.
Podatkov iz študij pri doječih ženskah ni. Ni znano, ali se vestronidaza alfa izloča v materino mleko, vendar se ne pričakuje, da bo prek materinega mleka prišlo do sistemske izpostavljenosti.
Your doctor may also give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Zdravnik vam bo morda dal (ali vam je že dal) tudi druga zdravila, denimo antihistaminik ali kortikosteroid za zdravljenje alergijske reakcije ali antipiretik za znižanje zvišane telesne temperature.
Slowly withdraw Mepsevii from the appropriate number of vials using caution to avoid excessive agitation and any air or frothing.
Počasi odvzemite zdravilo Mepsevii iz ustreznega števila vial ter pazite, da vial ne stresate preveč in da se vsebina ne peni.
Key Secondary Endpoint: Multi-Domain Clinical Responder Index (MDRI)
Ključni sekundarni opazovani dogodek je bil večdomenski indeks kliničnega odziva (MDRI), sestavljen iz šestih domen
The pharmacokinetics of vestronidase alfa were evaluated in a total of 19 MPS VII patients including 15 paediatric patients and 4 adults from 3 clinical trials.
Farmakokinetiko vestronidaze alfa so ocenili pri skupaj 19 bolnikih z MPS VII, vključno s
*Vestronidase alfa is a recombinant form of human beta-glucuronidase (rhGUS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
* Vestronidaza alfa je rekombinantna oblika humane beta-glukuronidaze (rhGUS).
Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim Germany
Erwin-Rentschler-Strasse 21
Patients should be observed for a minimum of 60 minutes after completing the infusion of vestronidase alfa.
Po koncu infundiranja vestronidoze alfa je treba bolnike opazovati še najmanj 60 minut.
Other Investigations
DRUGI PODATKI
Your doctor may give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
- Zdravnik vam bo morda dal (ali vam je že dal) še druga zdravila, denimo antihistaminik ali kortikosteroid za zdravljenje alergijske reakcije ali antipiretik za znižanje zvišane telesne temperature.
Mepsevii 2 mg/mL concentrate for solution for infusion.
Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje
Do not use if the solution is discoloured or if there is particulate matter in the solution.
Raztopine ne uporabljajte, če je drugačne barve ali če vsebuje tujke.
Minimal important differences (MIDs) were pre-specified for the six MDRI domains plus fatigue, which are: 6MWT (≥23 meters and ≥10% change from baseline), FVC (5% absolute change or 10% relative change from baseline in FVC%pred), shoulder flexion (20 degree change of both shoulder range of motion), visual acuity (3 lines (corrected, both eyes), BOT-2 fine motor (fine motor precision: change of 0.72, and manual dexterity: change of 1.47), BOT-2 gross motor (balance: 0.57, and running speed and agility: 0.59), and fatigue (10 points of total score).
(sprememba območja gibanja obeh ramen za 20 stopinj), ostrina vida (3 linije (korigirano za obe očesi)), fine motorične spretnosti BOT-2 (natančnost fine motorike: sprememba za 0,72; ročna spretnost: sprememba za 1,47), grobe motorične spretnosti BOT 2 (ravnotežje: 0,57; hitrost in gibljivost pri teku: 0,59) ter utrujenost (celotni rezultat 10 točk).
The primary endpoint was the percent reduction in urinary GAG excretion (Dermatan Sulfate, DS) before and after 24 weeks of treatment with vestronidase alfa.
Primarni opazovani dogodek je bil odstotek zmanjšanja izločanja GAG z urinom (dermatansulfat, DS)
This event was assessed as possibly related to vestronidase alfa due to the temporal association with the infusion.
Zaradi časovne povezave z infuzijo je ta dogodek ocenjen kot morebiti povezan z vestronidazo alfa.
Serious hypersensitivity reactions, including anaphylaxis, have been reported with vestronidase alfa; therefore, appropriate medical support should be readily available when vestronidase alfa is administered.
Preobčutljivostne reakcije, vključno z anafilaksijo Pri uporabi vestronidaze alfa so poročali o resnih preobčutljivostnih reakcijah, vključno z anafilaksijo;
MedDRA Preferred Term
Prednostni izraz (MedDRA)
- You may have side effects while you are being given Mepsevii or for up to a day afterwards.
- Med prejemanjem zdravila Mepsevii ali v enem dnevu po njem se lahko pri vas pojavijo neželeni učinki.
After 24 weeks of treatment with vestronidase alfa, a rapid and sustained, highly significant reduction in uGAG (DS) excretion was achieved with a LS mean (±SE) percentage change of -64.82% (±2.468%) (p<0.0001).
Po 24 tednih zdravljenja z vestronidazo alfa je bilo doseženo hitro, trajno in zelo pomembno zmanjšanje izločanja uGAG (DS) z odstotno spremembo v mediani najmanjših kvadratov
Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa
Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje vestronidaza alfa
Urticaria Rash Pruritus
- koprivnica (urtikarija)
Total Number of Mepsevii Vials
Celotno število vial zdravila Mepsevii
After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation of the total clearance (CL) was 0.079 ± 0.045 L/h/kg (range: 0.038 to 0.20 L/h/kg); the mean ± standard deviation of the elimination half-life (t1/2) was 2.6 ± 0.6 hours (range: 0.9 to 3.6 hours).
Po ponavljajočem se odmerjanju 4 mg/kg vsak drugi teden pri bolnikih z MPS VII je bil srednji ± standardni odklon v skupnem očistku (CL) 0,079 ± 0,045 l/h/kg (razpon: od 0,038 do 0,20 l/h/kg);
Table 1 Adverse reactions reported in patients treated with Mepsevii MedDRA System Organ Class
Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z zdravilom
Common *Refer to description of selected adverse reactions for details on the febrile convulsion reported in 1 of 23 trial patients.
* Glejte opis izbranih neželenih učinkov za podrobnosti o vročinskih krčih, o katerih so poročali pri
Description of selected adverse reactions
Opis izbranih neželenih učinkov Vročinski krči
IV use after dilution
Za IV uporabo po razredčitvi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, but should normally not be longer than 36 hours at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C.
Zdravilo se praviloma sme shraniti za največ 36 ur pri temperaturi 2-8 °C in nato za največ 6 ur pri sobni temperaturi, ki ne sme presegati 25 °C.
How to store Mepsevii
Kako boste dobili zdravilo Mepsevii
Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.
Ena viala s 5 ml koncentrata vsebuje 10 mg vestronidaze alfa.
Slowly add Mepsevii to the infusion bag using care to avoid agitation, ensuring liquid to liquid contact without generating bubbles or turbulence.
Tekočini se morata zmešati, ne da bi prišlo do mehurčkov ali turbulence.
Mepsevii is considered high in sodium.
Zdravilo Mepsevii velja za zdravilo z visoko vsebnostjo natrija.
Each mL of concentrate contains 2 mg vestronidase alfa*.
En ml koncentrata vsebuje 2 mg vestronidaze alfa*.
Posology
Koprivnica
The clinical program for vestronidase alfa included 23 treatment naïve patients with MPS VII from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
starih od 5 mesecev do 25 let, z MPS VII v 4 kliničnih preskušanjih, ki so do 132 tednov prejemali vestronidazo alfa v odmerkih do 4 mg/kg enkrat na dva tedna.
This medicinal product contains 17.8 mg sodium per vial and is administered in sodium chloride 9 mg/mL (0.9%) solution for infusion (see section 6.6).
Dieta z omejitvijo natrija To zdravilo vsebuje 17,8 mg natrija na vialo in se daje v 0,9-odstotni raztopini natrijevega klorida
Each mL of sterile concentrate contains 2 mg vestronidase alfa.
En ml sterilnega koncentrata vsebuje 2 mg vestronidaze alfa.
Each mL of concentrate contains 2 mg vestronidase alfa.
En ml koncentrata vsebuje 2 mg vestronidaze alfa.
Common side effects (may affect up to 1 in 10 people): - Itching of the skin (pruritus) - Loose stools (diarrhoea) - Rash - Fever with involuntary contractions of muscles of face or limbs (febrile convulsion)
- izpuščaj - zvišana telesna temperatura z nehotenim krčenjem mišic obraza ali okončin (vročinski krči)
Study UX003-CL203 (referred to as Study 203) is an ongoing open-label, uncontrolled single arm study that enrolled eight patients less than 5 years of age at a dose of 4 mg/kg vestronidase alfa every two weeks for 48 weeks of treatment period and additional weeks during optional continuation period to evaluate reduction of urinary GAG excretion, growth velocity and hepatosplenomegaly.
V njej sodeluje 8 bolnikov, mlajših od 5 let, ki so v obdobju zdravljenja 48 tednov dobivali vestronidazo alfa v odmerku 4 mg/kg na vsaka dva tedna in imajo možnost dodatnih tednov izbirnega podaljšanja zdravljenja.
The risks and benefits of readministering vestronidase alfa should be considered following a severe hypersensitivity reaction.
Po hudi preobčutljivostni reakciji je treba pretehtati tveganja in koristi ponovnega zdravljenja z vestronidazo alfa.
Colourless to slightly yellow solution.
koncentrat za raztopino za infundiranje (sterilen koncentrat) Brezbarvna do rahlo rumena raztopina.
Talk to your doctor before you are given Mepsevii.
Preden dobite zdravilo Mepsevii, se posvetujte z zdravnikom.
Febrile Convulsion
Bolezni živčevja
Special populations
Posebne skupine bolnikov Starejši bolniki
Clinical efficacy and safety
KLINIČNI PODATKI
After the injection, the pressure within the eye should be checked.
Po injiciranju je treba preveriti tlak v očesu.
Further information on Eylea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Eylea so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The diseases cause the gradual loss of the central part of a person's vision.
Bolezen povzroči postopno izgubo osrednjega dela vida.
Eylea received a marketing authorisation valid throughout the EU on 22 November 2012.
Za zdravilo Eylea je bilo 22. novembra 2012 izdano dovoljenje za promet, veljavno po vsej EU.
It can also attach to other proteins such as placental growth factor (PlGF).
Veže se lahko tudi na druge beljakovine, kot je placentni rastni dejavnik (PlGF).
What measures are being taken to ensure the safe and effective use of Eylea?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eylea?