natgillin/translations-raw huggingface dataset:
The German medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of these medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Nemška agencija za zdravila je odbor CHMP zaprosila, da celovito oceni razmerje med tveganji in koristmi teh zdravil ter izda mnenje o tem, ali naj se dovoljenja za promet z njima v EU ohranijo, spremenijo, začasno umaknejo ali ukinejo.
The review of the topical estradiol-containing medicines Linoladiol N and Linoladiol HN was triggered on 24 May 2012 by Germany, under Article 31 of Directive 2001/83/EC.
Pregled zdravil za topično uporabo Linoladiol N in Linoladiol HN, ki vsebujeta estradiol, je 24. maja 2012 sprožila Nemčija v skladu s členom 31 Direktive 2001/83/ES.
The CHMP's recommendations were sent to the European Commission which endorsed them and issued a final, legally binding decision valid throughout the EU on 19 August 2014.
Odbor CHMP je priporočila poslal Evropski komisiji, ta pa jih je potrdila in 19. avgusta 2014 izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
The Linoladiol N cream (0.01 %w/w) contains 100 microgram of estradiol per gram, while Linoladiol HN (0.005 %w/w, 0.4 %w/w) contains 50 microgram of estradiol and 4 mg of the corticosteroid prednisolone per gram.
Krema Linoladiol N (0,01 % m/m) vsebuje 100 mikrogramov estradiola na gram, medtem ko krema Linoladiol HN (0,005 % m/m, 0,4 % m/m) vsebuje 50 mikrogramov estradiola in 4 mg kortikosteroida prednizolona na gram.
In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use.1 Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have been updated, taking into account new measures to manage the potential risk of side effects.
Odbor CHMP je decembra 2013 zaključil pregled koristi in tveganj, povezanih z obema kremama, in podal priporočila za njuno uporabo.1 Potem ko je farmacevtska družba zahtevala ponoven pregled zdravila Linoladiol N, so bila priporočila za to kremo posodobljena ob upoštevanju novih ukrepov za obvladovanje možnega tveganja za neželene učinke.
The CHMP reiterated the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body).
Odbor CHMP je ponovno izpostavil, da je treba zdravljenje z obema kremama omejiti na štiri tedne, ker vsebujeta sorazmerno veliko količino estradiola in ker obstajajo možna tveganja za neželene učinke zaradi sistemske absorpcije estradiola (po celem telesu).
Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer.
Sistemska absorpcija estradiola bi lahko bila povezana s podobnimi tveganji, kot jih opažajo pri sistemskem hormonskem nadomestnem zdravljenju (HNZ) in vključujejo krvne strdke, možgansko kap in raka endometrija (maternice).
In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.
Poleg tega je odbor CHMP za kremo Linoladiol N, ki vsebuje večjo količino estradiola, zahteval, da farmacevtska družba omeji količino kreme, ki je na voljo v pakiranju, da se prepreči, da bi bolnice kremo uporabljale dlje časa, kot je priporočeno.
The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.
Informacije o zdravilu za kremi Linoladiol N in Linoladiol HN so bile posodobljene tako, da bodo bolnice in zdravstveni delavci seznanjeni s temi možnimi tveganji.
If you have been using Linoladiol HN for this condition, contact your doctor to discuss alternative treatments.
Če ste kremo Linoladiol HN uporabljali za to bolezen, se posvetujte z zdravnikom o drugih možnostih zdravljenja;
Linoladiol N and Linoladiol HN are a type of local ‘hormone replacement therapy': they contain a female hormone, estradiol, used to replace the estradiol hormone the body no longer makes after menopause.
Kremi Linoladiol N in Linoladiol HN sta vrsta lokalnega „hormonskega nadomestnega zdravljenja“: vsebujeta ženski hormon estradiol, ki se uporablja za nadomeščanje hormona estradiola, ki ga telo po menopavzi ne proizvaja več.
• Linoladiol HN should no longer be prescribed for lichen sclerosus.
• krema Linoladiol HN se ne sme več predpisovati za lichen sclerosus;
This is because the creams contain the hormone estradiol which can be absorbed into the bloodstream and may increase your risks of side effects such as blood clots and strokes if the creams are used for extended periods.
Razlog za to je, da kremi vsebujeta hormon estradiol, ki se lahko absorbira v krvni obtok in lahko, če se kremi uporabljata daljše obdobje, poveča tveganje za neželene učinke, kot so krvni strdki in možganska kap;
On 25 April 2014, the EMA's Committee for Medicinal Products for Human Use (CHMP) updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je 25. aprila 2014 posodobil priporočila za uporabo krem velike jakosti Linoladiol N in Linoladiol HN, ki vsebujeta estradiol.
• Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.
• kremi Linoladiol N in Linoladiol HN se zaradi tveganj, povezanih z možno sistemsko izpostavljenostjo estradiolu, ne smeta uporabljati več kot štiri tedne.
In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.
Poleg tega se krema Linoladiol HN ne sme več uporabljati za zdravljenje lichen sclerosus, bolezni kože, ki pogosto prizadene spolovila, saj ni dovolj dokazov o koristih pri tej bolezni.
Linoladiol HN also contains low-dose prednisolone, which acts as an anti-inflammatory agent.
Krema Linoladiol HN vsebuje tudi nizkoodmerni prednizolon, ki deluje protivnetno.
The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use.
Evropska agencija za zdravila je zaključila pregled krem Linoladiol N in Linoladiol HN, ki vsebujeta estradiol, in posodobila priporočila za njuno uporabo.
• Linoladiol HN was previously being used to treat a condition called lichen sclerosus.
• krema Linoladiol HN se je v preteklosti uporabljala za zdravljenje bolezni, imenovane lichen sclerosus.
The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area.
Krema Linoladiol N je namenjena samo za uporabo v nožnici za zdravljenje žensk po menopavzi, ki imajo atrofijo nožnice zaradi pomanjkanja hormona estrogena, krema Linoladiol HN pa je namenjena ženskam po menopavzi, ki imajo blago vnetno bolezen kože okoli spolovil.
• Linoladiol N should be applied into the vagina while Linoladiol HN should be applied to the external genital area.
• kremo Linoladiol N je treba nanesti v nožnico, kremo Linoladiol HN pa na zunanja spolovila;
• Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.
• krema Linoladiol HN je indicirana za kratkotrajno zdravljenje akutnih blagih vnetnih bolezni kože zunanjih spolovil pri ženskah po menopavzi;
Following a request from the company, a reexamination of the opinion for Linoladiol N was carried out and concluded in April 2014.
Na zahtevo farmacevtske družbe je bil aprila 2014 opravljen in zaključen ponoven pregled mnenja o zdravilu Linoladiol N. Končno mnenje odbora CHMP je bilo poslano Evropski komisiji, ki je 19. avgusta 2014 izdala končni sklep.
The European Medicines Agency has updated advice on how to use Linoladiol N and Linoladiol HN creams.
Evropska agencija za zdravila je posodobila priporočila o tem, kako uporabljati kremi Linoladiol N in Linoladiol HN. Bolnice, ki uporabljajo ti kremi, morajo upoštevati naslednje:
• Linoladiol N is indicated for the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women.
• krema Linoladiol N je indicirana za zdravljenje atrofije nožnice zaradi pomanjkanja estrogena pri ženskah po menopavzi;
• Linoladiol HN should only be used for treating postmenopausal women with mild, inflammatory skin conditions affecting the external genital area.
• krema Linoladiol HN se lahko uporablja samo za zdravljenje žensk po menopavzi, ki imajo blago vnetno bolezen kože, ki prizadene zunanja spolovila;
• Linoladiol N is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of estrogen.
• krema Linoladiol N se lahko uporablja samo v nožnici za zdravljenje žensk po menopavzi, ki imajo atrofijo nožnice zaradi pomanjkanja estrogena;
A reduction of 6 points is considered a clinically meaningful improvement.
Zmanjšanje za 6 točk velja za klinično pomembno izboljšanje.
You will also need:
Potrebujete tudi:
Results of the subgroup analysis were consistent with overall study results for all subjects.
Rezultati analize podskupine so bili skladni s splošnimi rezultati študije za vse preiskovance.
All antibody titres were low.
Vsi titri protiteles so bili nizki.
There are also links to other websites about rare diseases and treatments.
Tam najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Your doctor will discuss with you the risks and benefits of taking this medicine.
Zdravnik se bo z vami pogovoril o tveganjih in koristih uporabe tega zdravila.
There is no antidote available.
Antidota ni na voljo.
Interim analysis indicates that the effect was sustained up to one year of treatment.
Vmesna analiza kaže, da se je učinek v enem letu zdravljenja ohranil.
Repeat these steps until large air bubbles are removed.
Te korake ponavljajte, dokler ne odstranite velikih zračnih mehurčkov.
Important:
Pomembno:
Results of primary and secondary efficacy measures-ITT population
Rezultati primarnih in sekundarnih meril učinkovitosti - populacija ITT
Health related Quality of Life
Kakovost življenja, povezana z zdravjem
E-mail: medinfoEMEA@shire.com
E-pošta: medinfoEMEA@shire.com
Lower scores indicate lower impairment (or better health-related quality of life).
Manjše vrednosti rezultata pomenijo manjšo okvaro (oziroma boljšo kakovost življenja, povezano z zdravjem).
If symptoms should occur, symptomatic treatment is recommended.
Če se simptomi pojavijo, je priporočljivo simptomatsko zdravljenje.
Adjusted p-values for multiple testing.
Prilagojene p-vrednosti za večkratno testiranje.
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 humani IgG v prvih nekaj dneh po rojstvu izločajo v materino mleko, nato pa kmalu padejo na nizke koncentracije; posledično v tem kratkem obdobju tveganja za dojenega otroka ni mogoče izključiti.
• It is important to use different injection sites to keep skin healthy.
• Pomembno je, da uporabljate različna mesta injiciranja, da ostaja koža zdrava.
There is no available information to identify potential signs and symptoms of overdose.
Za opredelitev možnih znakov in simptomov prevelikega odmerjanja ni razpoložljivih informacij.
Important: Do not shake.
Pomembno: Ne stresajte.
Adjusted p-values d
Prilagojene p-vrednosti d
Important: Be sure to inject into a subcutaneous space which is not too shallow (skin layer) or too deep (muscle).
Pomembno: Prepričajte se, da injicirate v podkožno mesto, ki ni preplitko (kožna plast) ali pregloboko (mišica).
Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 2°C to 8°C.
Kemična in fizična stabilnost med uporabo je bila dokazana za 2 uri pri temperaturi 25 °C in za 8 ur pri temperaturi od 2 °C do 8 °C.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side affects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The anticipated time to reach steady state concentration was approximately 70 days.
Pričakovani čas do doseganja koncentracij v stanju dinamičnega ravnovesja je bil približno 70 dni.
Each pack also contains the following items:
Eno pakiranje vsebuje tudi naslednje pripomočke:
There were no differences in international normalised ratio (INR) between treatment groups.
Med skupinami zdravljenja ni bilo razlike v internacionalnem normaliziranem razmerju (INR).
This helps to reduce the amount of bradykinin in your bloodstream and prevents symptoms of HAE.
To pomaga zmanjšati količino bradikinina v krvnem obtoku in prepreči simptome HAE.
This is because it has not been studied in this age group.
Zdravila namreč v tej starostni skupini niso preučili.
Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date.
Viale lahko shranite pri temperaturi, nižji od 25 °C, za enkratno 14-dnevno obdobje, vendar ne dlje od datuma izteka roka uporabnosti zdravila.
The mean (SD) volume of distribution of lanadelumab in patients with HAE is 14.5 litres (4.53).
Povprečni (SD) volumen porazdelitve lanadelumaba pri bolnikih s HAE je 14,5 litra (4,53).
Do not touch the needle tip or allow it to touch any other surface.
Konice igle se ne dotikajte in ne pustite, da se dotakne druge površine.
% reduction relative to placebo corresponds to 100% * (1-rate ratio).
% zmanjšanje glede na placebo ustreza 100 % * (1-razmerje pojavnosti).
The injection of TAKHZYRO can be summarised in 5 steps:
Injiciranje zdravila TAKHZYRO lahko povzamemo v 5 korakih:
f) Check the solution in the vial for particles or a change in the colour (normally it is colourless to slightly yellow).
f) Preverite, ali raztopina v viali vsebuje delce oz. je spremenila barvo (običajno je brezbarvna do rahlo rumena).
If you inject TAKHZYRO yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.
Če si zdravilo TAKHZYRO injicirate sami ali vam ga injicira negovalec, morate vi ali vaš negovalec natančno prebrati in upoštevati navodila v poglavju 7, »Navodila za uporabo«.
[mild, N=98] and 30 to 59 ml/min/1.73m
[blaga, N = 98] in od 30 do 59 ml/min/1,73 m
Note: CI=confidence interval; LS=least squares.
Opomba: IZ = interval zaupanja; LS = metoda najmanjših kvadratov (least squares).
The frequency of adverse reactions listed in Table 1 is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Pogostnost spodaj naštetih neželenih učinkov, navedenih v preglednici 1, je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
It is important that you keep injecting TAKHZYRO as instructed by your doctor even if you feel better.
Pomembno je, da si zdravilo TAKHZYRO redno injicirate, kot vam je naročil zdravnik, četudi se počutite bolje.
• Inject the medicine in a different place each time.
Zdravilo si vsakič injicirajte v drugo mesto.
Long-term safety and efficacy of TAKHZYRO for prophylaxis to prevent HAE attacks was evaluated in an open-label HELP study extension.
Dolgoročno varnost in učinkovitost zdravila TAKHZYRO kot profilakse za preprečevanje napadov HAE so ocenili v odprtem podaljšku študije HELP.
e) Gently invert the vial 3 to 5 times to ensure the solution is mixed.
e) Vialo nežno 3- do 5-krat obrnite in zagotovite, da je raztopina premešana.
With this condition your blood does not have enough of a protein called ‘C1 inhibitor', or C1 inhibitor does not work properly.
Pri tej bolezni v krvi ni dovolj beljakovine, imenovane ‘zaviralec C1' ali pa zaviralec C1 ne deluje pravilno.
Afterwards, lanadelumab could be used during breast-feeding if clinically needed.
Kasneje se lanadelumab lahko uporablja med dojenjem, če je to klinično potrebno.
% Reduction relative to placebo (95% CI)
% zmanjšanje glede na placebo (95-% IZ)
If you have not had an attack for a long period, your doctor may change the dose to 300 mg every 4 weeks, especially if you have a low body weight.
Če dolgo časa niste imeli napada, lahko zdravnik odmerek spremeni na 300 mg vsake 4 tedne, zlasti, če imate majhno telesno maso.
From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately.
Z mikrobiološkega vidika je treba zdravilo porabiti takoj, razen če je bilo tveganje kontaminacije z mikrobi izključeno z načinom priprave.
It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the name and batch number of the medicine.
Zelo priporočljivo je, da vsakič, ko uporabite odmerek zdravila TAKHZYRO, zabeležite ime in številko serije zdravila.
What hereditary angioedema (HAE) is
Kaj je hereditarni angioedem (HAE)?
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja neporabljenega zdravila med uporabo odgovoren uporabnik.
Table 1 summarises adverse reactions observed in the HELP study that included 84 subjects with HAE, who received at least one dose of TAKHZYRO.
V preglednici 1 so povzeti neželeni učinki, ki so jih opazili v študiji HELP, v katero je bilo vključenih 84 preiskovancev s HAE, ki so prejeli vsaj en odmerek zdravila TAKHZYRO.
Each TAKHZYRO vial is intended for single use only (see section 6.6).
Vsaka viala zdravila TAKHZYRO je namenjena samo za enkratno uporabo (glejte poglavje 6.6).
The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
Raztopina ima pH vrednost približno 6,0 in osmolalnost približno 300 mOsm/kg.
In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
V primeru hude preobčutljivostne reakcije je treba takoj prenehati z dajanjem zdravila TAKHZYRO in uvesti ustrezno zdravljenje.
Following SC administration, the time to maximum concentration is approximately 5 days.
Po s.c. dajanju je največja koncentracija dosežena v približno 5 dneh.
The safety of TAKHZYRO was evaluated in a subgroup of 23 subjects aged 12 to <18 years old.
Varnost zdravila TAKHZYRO so ocenili v podskupini s 23 preiskovanci, starimi od 12 do < 18 let.
In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication.
V primeru prebijajočega napada HAE je treba uvesti zdravljenje, prilagojeno posamezniku, z odobrenim rešilnim zdravilom.
Model-based treatment period HAE attack rate (attacks/4 weeks).
Stopnja napadov HAE v obdobju zdravljenja na podlagi modela (napadi/4 tedne).
Lanadelumab is a fully human, monoclonal antibody (IgG1/ κ-light chain).
Lanadelumab je povsem humano, monoklonsko protitelo (IgG1/κ-lahka veriga).
HAE is a condition which runs in families.
HAE je bolezen, ki se pojavlja v družini.
• A doctor, pharmacist or nurse should show you how to prepare and inject TAKHZYRO properly before you use it for the first time.
Zdravnik, farmacevt ali medicinska sestra vam bo pokazala, kako pravilno pripraviti in injicirati zdravilo TAKHZYRO, preden ga prvič uporabite.
• The area you choose for injection should be at least 5 cm away from any scars or your belly button (navel).
• Predel, ki ga izberete za injiciranje, mora biti vsaj 5 cm proč od morebitnih brazgotin in popka.
The European Medicines Agency has deferred the obligation to submit the results of studies with TAKHZYRO in one or more subsets of the paediatric population in the prevention of hereditary angioedema attacks.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom TAKHZYRO za eno ali več podskupin pediatrične populacije pri preprečevanju napadov hereditarnega angioedema.
This is so that you keep a record of the batches used.
Na tak način vodite evidenco, katere serije ste uporabili.
Interference with coagulation test
Vpliv na koagulacijske teste
If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).
če ste alergični na zdravilo TAKHZYRO ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Fear/Shame score
Rezultat za strah/sram
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja ali razvoja (glejte tudi poglavje 5.3).
The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE.
Študija HELP je bila multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija z vzporednimi skupinami s 125 (115 odraslimi in 10 mladostniki) preiskovanci s simptomatičnim HAE tipa I ali II.
Release the skin fold and gently remove the needle.
Spustite kožno gubo in nežno odstranite iglo.
Step 4: Select and prepare injection site a) Choose an injection site on your stomach
4. korak: Izberite in pripravite mesto injiciranja a) Izberite mesto injiciranja na trebuhu
Lanadelumab has a mean (SD) total body clearance of 0.0297 L/h (0.0124) and a terminal elimination half-life of approximately 14 days.
Lanadelumab ima povprečni (SD) skupni telesni očistek 0,0297 l/h (0,0124) in končno razpolovno dobo izločanja približno 14 dni.
There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.
Ni razpoložljivih kliničnih podatkov o uporabi lanadelumaba pri bolnikih s HAE z normalno aktivnostjo C1-INH.
Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.
Med temi reakcijami na mestu injiciranja jih je bilo 97 % blagih, 90 % pa jih je v 1 dnevu po nastanku izzvenelo, z mediano trajanja 6 minut.
No dedicated drug-drug interaction studies have been conducted.
Namenskih študij medsebojnega delovanja med zdravili niso izvedli.
The percentage of subjects who were attack free is provided in Table 3.
Odstotek preiskovancev, ki niso imeli napadov, je naveden v preglednici 3.
The cHMWK formation rate was maximally reduced by 53.7% with an IC50 of 5705 ng/ml.
Stopnja nastajanja cHMWK se je zmanjšala za 53,7 %, vrednost IC50 pa je bila 5705 ng/ml.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before starting to use Takhzryo.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite zdravilo TAKHZYRO.
2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.
2,4 % (2/84) preiskovancev, zdravljenih z lanadelumabom, je bilo pozitivnih na nevtralizirajoča protitelesa.
HELP study
Študija HELP
Do not use this medicine if you notice signs of deterioration such as particles in the vial or changed colour of the injection solution.
Ne uporabljajte tega zdravila, če opazite znake kvarjenja, kot so delci v viali ali spremenjena barva raztopine za injiciranje.