natgillin/translations-raw huggingface dataset:
Viani Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Viani Evohaler in povezana imena (Glejte Dodatek I) 25/ 125 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I – Izpolni država članica]
EMEA/ CHMP/ 123448/ 2006/ EN 8.
8.
Viani Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Viani Evohaler in povezana imena (Glejte Dodatek I) 25/ 250 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I – Izpolni država članica]
Viani Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension Viani Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension Viani Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Viani Evohaler in povezana imena (glejte Dodatek I) 25/ 50 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom Viani Evohaler in povezana imena (glejte Dodatek I) 25/ 125 mikrogramov / odmerek, inhalacijska suspenzija pod tlakom Viani Evohaler in povezana imena (glejte Dodatek I) 25/ 250 mikrogramov / odmerek, inhalacijska suspenzija pod tlakom
Before you take Viani 3.
Kaj morate vedeti, preden boste vzeli zdravilo Viani 3.
How to take Viani 4.
Kako jemati zdravilo Viani 4.
How to store Viani 6.
Shranjevanje zdravila Viani 6.
Viani does not work in controlling sudden attacks of breathlessness and wheezing where you would need to use your fast acting ‘ rescue’ medication.
Vendar pa Viani ne more obvladati nenadnih napadov težkega in piskajočega dihanja: v takšnem primeru morate uporabiti hitrodelujoče "olajševalno" zdravilo.
Do not take Viani If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient Norflurane (HFA 134a).
Ne uporabljajte zdravila Viani Če ste alergični na (preobčutljivi za) salmeterolijev ksinafoat, flutikazonijev propionata ali norfluran (HFA 134a), ki je pomožna snov v zdravilu).
Take special care with Viani Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Viani may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
Bodite posebno pozorni pri uporabi zdravila Viani Zdravnik bo vaše zdravljenje spremljal natančneje, če imate kakšno zdravstveno težavo, npr. bolezen srca (vključno z nerednim ali hitrim srčnim utripom), čezmerno dejavno ščitnico, visok krvni tlak, diabetes mellitus (Viani lahko zviša krvni sladkor), nizek kalij v krvi ali se zdravite oz. ste se zdravili zaradi tuberkuloze.
Viani should not be taken with medicines called β -blockers (such as atenolol, propranolol, sotalol), unless your doctor tells you to do so.
Vianija ne smete jemati z zdravili, ki jih imenujemo zaviralci β (takšni so npr. atenolol, propranolol, sotalol), razen če tako naroči zdravnik.
Pregnancy and breast-feeding You should ask your doctor for advice before taking Viani whilst you are pregnant or breastfeeding.
Nosečnost in dojenje Če ste noseči ali dojite, se pred uporabo Vianija posvetujte z zdravnikom.
Driving and using machines The possible side effects associated with Viani are unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi možni neželeni učinki, povezani z Vianijem, neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
Dosage It is very important that you take your Viani every day as directed, until you are advised to stop by your doctor.
Odmerjanje Zelo važno je, da Viani uporabljate vsak dan, kot vam je predpisal zdravnik, dokler vam ne naroči, da ga nehajte uporabljati.
Viani Evohaler is for inhalation by mouth only.
Viani Evohaler je namenjen le za peroralno vdihavanje.
If your asthma gets worse or is not well controlled (you will feel wheezy and need more of your fast acting ‘ rescue’ medicine), do not increase the number of puffs of Viani you take.
Če se vam astma poslabša ali ni dobro obvladana (kar pomeni, da ste pogosteje zasopli in morate pogosteje uporabljati hitrodelujoče "olajševalno" zdravilo), ne povečujte števila vdihov Vianija.
Do not
Dajte ustnik v usta, med zobe, in ustnice dobro stisnite okrog njega.
bite it.
Ustnika ne držite z zobmi.
- Replace the mouthpiece cover.
- Znova namestite pokrovček ustnika.
EMEA/ CHMP/ 123448/ 2006/ EN
EMEA/ CHMP/ 123448/ 2006/ SL Če ste pozabili vzeti zdravilo Viani
If you forget to take Viani If you forget to take your medicine, take your next dose when it is due.
Če ste pozabili vzeti zdravilo, vzemite naslednji odmerek, ko je čas zanj.
Do not stop taking Viani suddenly as this could make your asthma worse and could cause problems with the body’ s hormones.
Vianija ne nehajte jemati nenadoma, ker to lahko poslabša astmo in povzroči težave s hormoni v telesu.
Very fast heart rate (tachycardia).
- Zelo hitro bitje srca (tahikardija)
- Uneven heartbeat or heart gives an extra beat (arrhythmias).
- Zvišanje sladkorja (glukoze) v krvi (hiperglikemija).
Tell your doctor, but do not stop
Če imate diabetes, bodo morda potrebne
taking Viani unless they tell you to do so.
razdražljivost (predvsem pri otrocih).
irritable (mainly in children).
Boleči, otekli sklepi in bolečine v mišicah.
What Viani contains
Kaj vsebuje zdravilo Viani
What Viani looks like and contents of the pack
Izgled zdravila Viani in vsebina pakiranja
EMEA/ CHMP/ 123448/ 2006/ EN Manufacturer:
EMEA/ CHMP/ 123448/ 2006/ SL
Viani Dosieraerosol Viani Viani Evohaler Viani Viani Viani Evohaler Aliflus Viani Veraspir Inalador Brisair Viani Evohaler Viani Evohaler
Viani Dosieraerosol Viani Viani Evohaler Viani Viani Viani Evohaler Aliflus Viani Vesaspir Inalador Brisair Viani Evohaler Viani Evohaler
BACKGROUND INFORMATION Viani Evohaler and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β -agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
OSNOVNE INFORMACIJE Zdravilo Viani Evohaler in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β- agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega beta- 2- agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in » po potrebi « z inhalacijskim kratko delujočim beta- 2- agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta- 2- agonistom vzpostaviti zadosten nadzor bolezni.
London, 29 May 2007 Doc. Ref.
London, 29. maj 2007 Dok. ref.
EMEA/ 144030/ 2007
EMEA/ CHMP/ 274921/ 2007
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Xefo and associated names International Non-Proprietary Name (INN): lornoxicam
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Xefo in z njim povezana imena Mednarodno nelastniško ime (INN): lornoxicam
On 16 May 2006 Nycomed Denmark Aps presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Package Leaflets and Labelling of the medicinal product Xefo and associated names.
Družba Nycomed Danmark Aps je dne 16. maja 2006 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/ 83/ ES, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), navodila za uporabo ter označevanje zdravila Xefo in z njim povezanih imen.
The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Znanstveni zaključki so na voljo v Dodatku II, dopolnjeni Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo pa v Dodatku III.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Germany
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Nemčija
100 LD50 units
100 enot LD50
Powder for solution for injection
prašek za raztopino injiciranje
For intramuscular use
za za intramuskularno uporabo
Luxembourg
Norveška
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Nemčija
2 Germany Norway
Poljska
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Germany
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main
Powder for solution For intramuscular use for injection
za za intramuskularno uporabo
Poland
2 Nemčija Portugalska
Powder for solution For intramuscular use for injection
prašek za raztopino za injiciranje
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEOMIN< (see Annex I) >
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA XEOMIN (glejte Dodatek I)
- Quality issues
- Vidiki kakovosti
From a quality point of view, Xeomin is highly purified and differs from the drug substance in Botox® and Dysport® in that it is free of complexing proteins (haemagglutinins).
Z vidika kakovosti je zdravilo Xeomin visoko prečiščeno ter se od zdravilne učinkovine v zdravilih Botox® in Dysport® loči po tem, da ne vsebuje kompleksirajočih beljakovin (hemaglutininov).
The submitted clinical trial programme consisted of: • Two Phase I studies MRZ/ BTC-9901 and MRZ/ BTC-0113, of which the latter was performed after completion of the Phase III studies • One Phase II study (MRZ/ BTC-9801) • Two Phase III studies (one study in each of the intended indication, spasmodic torticollis (MRZ/ BTC-0013) and blepharospasm (MRZ/ BTC-0003) respectively)
Seznam kliničnih študij Preizkušanje Faza, populacija, načrt Države ZAKLJUČENE ŠTUDIJE
In addition, at present there are three ongoing clinical studies with Xeomin: • In the upper limb spasticity study (MRZ 0410) 144 patients entered the second injection cycle, in which doses up to 400 U of Xeomin are administered. • In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 31 patients entered the second injection cycle. • In the blepharospasmus study (MRZ 0433) one patient has entered the second injection cycle.
načinov zdravljenja, pri čemer so preučevali razmerje med odmerkom in odzivom, sistemsko difuzijo in trajanje učinka
5 Posology The applicant submitted three non-clinical, two Phase I, one Phase II and one Phase III studies to demonstrate that a safe posology has been established for Xeomin.
Faza 2 za določitev odmerka 53 bolnikov s cervikalno distonijo z rotacijo glave Odprto, randomizirano preizkušanje s primerjalno učinkovino
• Non-clinical data In non-clinical studies, the pharmacological effect (i. e. degree of the paralytic activity, effect on motility, effect on paralysis over time, duration) of Xeomin was compared to Botox:
Dvojno slepo, randomizirano, kontrolirano (Botox) preizkušanje
- The paralytic activity of Xeomin and Botox was assessed in the mouse regional paralysis test, after 3
Faza 3
repeated intramuscular injections at 6 and 13 week intervals up to a dose of 0.64 Lethal Dose Unit (LDU)/ animal for Xeomin and Botox (approx.
Dvojno slepo, randomizirano, kontrolirano (Botox) preizkušanje
32 LDU/ kg).
32 LDU/ kg);
- The influence of Xeomin and Botox on motility (static and active movements) was assessed within
- vpliv zdravil Xeomin in Botox na motiliteto (statične in aktivne gibe) je bil ocenjen v okviru študije
an acute intravenous toxicity study in mice up to 68 LDU/ kg.
akutne intravenske toksičnosti pri miših z odmerki do 68 LDU/ kg;
- The paralytic efficacy of Xeomin and Botox was analysed by electromyography (EMG) in vivo in
- paralitična učinkovitost zdravil Xeomin in Botox je bila analizirana z elektromiografijo (EMG) in
male monkeys after a single intramuscular injection of 16 LDU/ kg in the left gluteus medius muscle.
vivo na samcih opic po enkratni intramuskularni injekciji 16 LDU/ kg v levo srednjo glutealno mišico.
• Clinical data Both Phase I studies showed equal doses of Xeomin to be as effective as Botox in the EMG measurements; it was clearly demonstrated that the paralytic effects of Xeomin and Botox increased with ascending doses and a comparable trend was seen in a Phase II study.
Nedvoumno je bilo prikazano, da se paralitični učinek zdravil Xeomin in Botox pri naraščajočem odmerku povečuje, podoben trend pa je bil ugotovljen tudi pri študiji II. faze.
In Phase II dose finding trial, the efficacy in patients with rotational cervical dystonia at three doses (10, 20 and 30 U) of Xeomin was compared to the optimal dose of Botox (30 U).
V študiji II. faze za določitev odmerka so pri bolnikih s cervikalno distonijo z rotacijo glave primerjali učinkovitost zdravila Xeomin v treh odmerkih (10, 20 in 30 e) z optimalnim odmerkom zdravila Botox (30 e).
The primary efficacy variable was the decrease from baseline of the most relevant (i. e. highest amplitude) surface electromyography (EMG) level in the dystonic sternocleidomastoid muscle during maximal voluntary activation 14 days post-injection.
Primarna spremenljivka učinkovitosti je bilo znižanje najpomembnejše (tj. z najvišjo amplitudo) ravni površinske elektromiografske meritve (EMG) glede na izhodiščno vrednost v distonični sternokleidomastoidni mišici med maksimalno prostovoljno aktivacijo 14 dni po injiciranju.
Considering the data from the non-clinical studies, the early Phase I study and its conclusions, and the Phase II study - although limited conclusions could be drawn from it, the dosage of Xeomin in both Phase III studies was based on the established dose of Botox.
Ta pristop se
This approach is considered acceptable.
6 smatra kot sprejemljiv.
During a Scientific Advice procedure in 2000, the EMEA did not require or recommend that further Phase II studies be conducted before the Phase III studies were performed.
Med postopkom znanstvenega svetovanja v letu 2000 EMEA ni zahtevala ali priporočila, da se pred izvedbo študij III. faze izvedejo nadaljnje študije II. faze.
This study showed the non-inferiority of Xeomin (70-300 U) compared to Botox (70-300 U).
Ta študija je pokazala, da zdravilo Xeomin (70- 300 enot) ni slabše od zdravila Botox (70- 300 enot).
Taken altogether, the data from the non-clinical and clinical development program, which has been designed with support of Scientific Advice, provided sufficient evidence that a 1:1 dose ratio between Xeomin and Botox with respect to efficacy and safety can be concluded and the adoption of the dosage which has been established for Botox is adequately justified.
Kombinirani podatki iz nekliničnega in kliničnega razvojnega programa, ki je bil oblikovan ob podpori oddelka za znanstveno svetovanje, so prispevali zadosten dokaz, da je mogoče z ozirom na učinkovitost in varnost potrditi odmerjanje v razmerju 1: 1 med zdraviloma Xeomin in Botox ter da je uporaba odmerjanja, določenega za zdravilo Botox, zadostno utemeljena.
6 • Safety data The numbers of adverse events in Phase II study and in Phase III dystonia Study are submitted in the following Table:
7 • Podatki o varnosti Števila neželenih dogodkov v študiji II. faze in študiji III. faze za distonijo so podana v naslednji tabeli:
Due to the very low number in each group, results of this Phase II study were not considered to be useful from a safety point a view.
Povzetek neželenih dogodkov v študiji II. faze (BTC 9801) in študiji III. faze za cervikalno distonijo (MRZ 0013)
It should be noted that some adverse events have only been reported in patients who received Xeomin, such as dysphagia (reported in one patient in each of the Xeomin groups versus no patients in the Botox group).
Študija II. faze za cervikalno distonijo (ITT) (BTC - 9801)
In addition, two adverse events have been assessed as related to study medication, versus none in the Botox group.
(ITT) (MRZ- 0013) Skupno št. oseb Osebe z neželenimi dogodki
The two related adverse events were reported in the same patient who received 30/ 60 U of Xeomin (one injection site pain and one dysphagia).
Botox 30/ 60 e
The fact that the Phase III studies were performed in patients pretreated with Botox is adequately addressed in the SPC, which now states that ‘ there is limited experience in treatment-naïve patients’.
Dejstvo, da je bila študija III. faze izvedena z bolniki, ki so bili predhodno zdravljeni z zdravilom Botox, je v povzetku glavnih značilnosti zdravila ustrezno upoštevano, saj ta sedaj navaja, da "obstaja le malo izkušenj z uporabo pri predhodno nezdravljenih bolnikih".
Lack of data on repeated administration and the need for data on immunogenicity • Non-clinical data Two non-clinical studies, LPT10929 and LPT12444 with repeated high dose administration of Xeomin (25 LDU/ animal in LPT10929 and 16-40LDU/ animal in LPT12444) at very short injection intervals were performed in rabbits:
Pomanjkanje podatkov o ponovljeni uporabi in potreba po podatkih o imunogenosti • Neklinični podatki Dve neklinični študiji, LPT10929 in LPT12444, sta bili izvedeni s ponovljeno uporabo velikega odmerka zdravila Xeomin (25 LDU/ žival pri LPT10929 in 16- 40 LDU/ žival pri LPT12444) v zelo kratkih intervalih injiciranja, in sicer na zajcih:
- In LPT10929, in study week 12, two weeks after the last administration, Botulinum neurotoxin type
- Pri LPT10929 so v 12. tednu študije, dva tedna po zadnjem dajanju, našli nevtralizirajoča protitelesa
A neutralising antibodies were found in 4 of 8 surviving rabbits treated with Botox, but in none of the 10 surviving rabbits treated with Xeomin.
za nevrotoksin botulin tipa A pri 4 od 8 preživelih zajcih, ki so prejemali zdravilo Botox, toda pri nobenem izmed 10 preživelih zajcev, ki so prejemali zdravilo Xeomin.
- In LPT12444, in week 36, three weeks after the final injection, the ELISA test (indicating the
- Pri LPT12444 je v 36. tednu študije, tri tedne po končnem injiciranju, test ELISA (izkazujoč
presence of antibodies against Botulinum neurotoxin type A) revealed that seven of the 20 rabbits treated with Botox showed a positive response and four of these rabbits displayed BoNT/ A neutralising activity in the hemidiaphragm assay (HDA indicating if antibodies are neutralising or non-neutralising).
prisotnost protiteles proti nevrotoksinu botulinu tipa A) pokazal, da je sedem od 20 zajcev, ki so prejemali zdravilo Botox, izkazovalo pozitiven odziv, štirje od teh zajcev pa so izkazovali nevtralizirajočo aktivnost proti BoNT/ A pri testu HDA (hemidiaphragm assay) (pri čemer HDA pokaže, ali so protitelesa nevtralizirajoča ali nenevtralizirajoča).
• Clinical data Botox and Xeomin are different drug substances in terms of clostridial protein content, although both contain the same 150 kDa neurotoxin, which is the actual active substance.
• Klinični podatki Botox in Xeomin sta z vidika vsebnosti proteinov Clostridium različni zdravili, čeprav obe vsebujeta isti 150 kDa nevrotoksin, ki predstavlja dejansko zdravilno učinkovino.
Botox has a protein content of 5 ng/ 100U, i. e. the 150 kDa neurotoxin and non-effective complexing proteins, and quickly dissociates into the neurotoxin and the complexing proteins after administration.
Zdravilo Botox ima vsebnost beljakovin 5 ng/ 100 e, tj.
Xeomin has a protein content of only 0,6 ng/ 100U as it only consists of the 150 kDa neurotoxin, free from complexing proteins.
150 kDa nevrotoksin in neučinkujoče kompleksirajoče beljakovine, ter po aplikaciji hitro disociira v nevrotoksin in kompleksirajoče beljakovine.
Publications of clinical studies have been mentioned
8 Zdravilo Xeomin je bilo razvito z namenom zmanjšanja tveganja za nastanek nevtralizirajočih protiteles, ki utegnejo privesti do sekundarne neuspešnosti zdravljenja.
7 (Jankovic et al, 20031, 20062, Barnes et al, 20053) to support the hypothesis that the amount of antibodies is correlated to the amount of clostridial protein load and thus, that there might be a lower risk for patients treated with Xeomin to develop secondary non-response.
V podporo hipotezi, da je količina protiteles v korelaciji s količino proteinov Clostridium, so bile navedene objavljene klinične študije (Jankovic et al, 20031, 20062, Barnes et al, 20053), odtod pa sledi, da utegne pri bolnikih, zdravljenih z zdravilom Xeomin, obstajati manjše tveganje za nastop sekundarnega neodziva.
In 2003, Jankovic compared 130 patients treated for cervical dystonia with original Botox (25ng protein/ 100 U before 1998), 42 of whom were exposed only to the original Botox and 119 treated with the current Botox (5ng protein/ 100 U since 1998).
Leta 2003 je Jankovic primerjal 130 bolnikov, zdravljenih zaradi cervikalne distonije z originalnim zdravilom Botox (25 ng beljakovin/ 100 e pred letom 1998), med katerimi je bilo 42 bolnikov izpostavljenih le originalnemu zdravilu Botox, 119 pa zdravljenih s sedanjih zdravilom Botox (5 ng beljakovin/ 100 e od leta 1998 dalje).
Blocking antibodies were detected in 4 of 42 (9.5%) patients treated only with original Botox and in none of the patients treated with only the current Botox, despite a higher mean dose of current Botox per visit than original Botox.
Blokirajoča protitelesa so bila opažena pri 4 izmed 42 (9, 5%) bolnikov, zdravljenih le z originalnim zdravilom Botox, ter pri nobenem izmed bolnikov, zdravljenih le s sedanjim zdravilom Botox, in sicer navkljub večjemu povprečnemu odmerku sedanjega zdravila Botox na obisk kot originalnega.
The immunological reactions on Xeomin were specifically investigated in the Phase III study MRZ- 0013 in patients with cervical dystonia.
Imunske reakcije na zdravilo Xeomin so namensko preučevali v študiji III. faze MRZ- 0013 pri bolnikih s cervikalno distonijo.
Data of changes in TWSTRS-Severity score in patients with hemidiaphragm assay (HAD) positive group between control visit (3 weeks after one injection) and final visit (12 weeks after one injection) were submitted.
Predloženi so bili podatki o spremembah rezultata podlestvice za resnost (TWSTRS- Severity) pri bolnikih iz skupine pozitivnih na testu HDA (hemidiaphragm assay) med kontrolnim pregledom (3 tedne po eni injekciji) in končnim pregledom (12 tednov po eni injekciji).
These data were divided into 3 subgroups: patients with HDA negative, patients with positive antibodies< 5 mU/mL and patients with positive antibodies> 5 mU/ mL.
Ti podatki so bili razdeljeni na 3 podskupine: bolniki z negativnim izvidom HDA, bolniki z < 5 me/ ml pozitivnih protiteles ter bolniki z > 5 me/ ml pozitivnih protiteles.
Of the Xeomin patients with a negative mouse hemidiaphragm assay (HDA) result at baseline, indicating that no neutralising antibodies are present, 2 individuals had a positive result (< 5 mU/ mL) at the final visit.
Izmed bolnikov, zdravljenih z zdravilom Xeomin, z negativnim izhodiščnim rezultatom testa HDA, izkazujočim, da ni prisotnih nevtralizirajočih protiteles, sta imela ob končnem pregledu pozitiven rezultat (< 5 me/ ml) dva posameznika.