natgillin/translations-raw huggingface dataset:
For severe asthma, in patients taking corticosteroids by mouth or patients who also have atopic dermatitis, the first dose is two injections of 300 mg in two different sites.
Za bolnike s hudo astmo, ki prejemajo peroralne kortikosteroide, ali bolnike, ki imajo tudi atopijski dermatitis, je začetni odmerek dve 300-miligramski injekciji zapored na dve različni mesti.
By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Dupilumab z zaviranjem teh receptorjev prepreči delovanje beljakovin IL-4 in IL-13 ter olajša simptome bolezni.
This is followed by one 200-mg injection every two weeks.
Temu sledi ena 200-miligramska injekcija vsaka dva tedna.
This is followed by one 300 mg injection every two weeks.
Temu sledi ena 300-miligramska injekcija vsak drugi teden.
How is Dupixent used?
Kako se zdravilo Dupixent uporablja?
For the full list of side effects and restrictions of Dupixent, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dupixent glejte navodilo za uporabo.
Dupixent contains the active substance dupilumab.
Zdravilo Dupixent vsebuje učinkovino dupilumab.
In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
V tej študiji je atopijski dermatitis po 16 tednih izginil ali skoraj izginil pri približno 24 % tistih, ki so zdravilo Dupixent prejemali vsak drugi teden, v primerjavi z okoli 2 % tistih, ki so prejemali placebo.
How does Dupixent work?
Kako zdravilo Dupixent deluje?
The most common side effects with Dupixent when used in treatment of atopic dermatitis are injectionsite reactions (such as redness, swelling and itching),which may affect more than 1 in 10 people, and conjunctivitis (redness and discomfort in the eye), blepharitis (inflammation of the eyelid) and cold sores, which may affect up to 1 in 10 people.
Najpogostejši neželeni učinki zdravila Dupixent pri zdravljenju atopijskega dermatitisa so reakcije na mestu injiciranja (kot so pordelost, otekanje in srbenje), ki se lahko pojavijo pri več kot 1 bolniku od
Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.
Skupni rezultati drugih dveh študij kažejo, da je atopijski dermatitis izginil ali skoraj izginil pri 37 % bolnikov, ki so se zdravili z zdravilom Dupixent vsak drugi teden, v primerjavi z 9 % bolnikov, ki so prejemali placebo.
After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo.
V prvi študiji je po 16 tednih zdravljenja atopijski dermatitis izginil ali skoraj izginil pri 39 % bolnikov, ki so se z zdravilom Dupixent zdravili vsak drugi teden, v primerjavi z 12 % bolnikov, ki so prejemali placebo.
Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease.
Zdravilo Dupixent je bilo v treh glavnih študijah pri bolnikih z zmerno do hudo boleznijo učinkovitejše od placeba (zdravila brez učinkovine).
Dupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines.
V dveh glavnih študijah pri bolnikih z astmo, ki ni bila ustrezno urejena s kombinacijo velikih odmerkov inhalacijskih kortikosteroidov in drugih zdravil, so dokazali, da zdravljenje z zdravilom Dupixent zmanjša število poslabšanj (izbruhov) astme.
Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.
V drugih dveh študijah, ki sta skupaj vključevali 1 379 bolnikov, sta se zdravilo Dupixent oziroma placebo uporabljala samostojno.
It is currently authorised in 12 European Union (EU) Member States (MS).
Trenutno je odobreno v 12 državah članicah Evropske unije (EU).
The mechanism of resistance was also harmonised.
Uskladili so tudi mehanizem odpornosti.
Section 1, 6.3 and 6.4 have only been partially harmonised as it is considered that these should be adapted nationally.
Poglavja 1, 6.3 in 6.4 so bila usklajena samo delno, saj je treba besedilo v njih sprejeti na nacionalni ravni.
Furthermore the committee considered the advice of the Infectious Diseases Working Party.
Poleg tega je odbor upošteval nasvet Delovne skupine za infekcijske bolezni;
Overall summary of the scientific evaluation of Amoxil and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Amoxil in povezanih imen(glejte Prilogo I)
However, when considering the different sites of infection, insufficient data is available to support these potential indications.
Vendar so glede na različna mesta okužbe razpoložljivi podatki nezadostni, da bi podprli te morebitne indikacije.
Infections of the female genital tract are both aetiologically and clinically diverse.
Okužbe ženskih spolovil so etiološko in klinično raznolike.
As a result of this harmonisation procedure, the Module 3 was substantially updated and revised to include data which has become available during the years since the first marketing authorisation.
Kot posledica tega usklajevalnega postopka je bil Modul 3 obsežno posodobljen in revidiran, tako da vključuje podatke, ki so postali na voljo v letih po prvi izdaji dovoljenja za promet z zdravilom.
The treatment of acute skin infections was effective in about 60-90% of patients depending on the study.
Zdravljenje akutnih kožnih okužb je bilo učinkovito pri približno 60-90 % bolnikov, kar je bilo odvisno od študije.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information and thus to harmonise its divergent product information across the EU.
Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila (in povezanih imen), je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom razrešitve razhajanj med nacionalno odobrenimi informacijami o zdravilu in uskladitve razhajajočih se informacij po vsej EU.
Therefore, these two possible regimens have been reflected in order for the prescriber to tailor the dosing regimen to the needs of the patient and to improve patient compliance.
Zato sta bila vključena oba mogoča režima, saj predpisovalcu omogočata prilagajanje režima odmerjanja potrebam bolnika in izboljšanje bolnikovega upoštevanja zdravljenja.
The few studies presented include different conditions, which further decreases the evidence in support for each condition.
Nekaj predloženih študij vključuje različne pogoje, kar še dodatno zmanjša dokaze, ki bi podprli zdravljenje pri posameznih stanjih.
Available data in animal and human do not suggest a reproductive toxicity.
Razpoložljivi podatki pri živalih in človeku ne kažejo vpliva na sposobnost razmnoževanja.
The quality of the product is considered satisfactory.
Kakovost zdravila velja za sprejemljivo.
Generally, cure rates were lower than in other indications with a high incidence of relapse and recurrence.
Navadno so bili deleži ozdravitve manjši kot pri drugih indikacijah z veliko incidenco relapsov in ponovitev bolezni.
The wording on the pharmacotherapeutic group, mechanism of action and ATC code was harmonised.
Besedilo o farmakoterapevtski skupini, mehanizmu delovanja in oznaki ATC je bilo usklajeno.
However, in some patient groups (especially in infants and children) drug administration every 8 hours may give rise to some problems of compliance.
Vendar lahko uporaba vsakih 8 ur pri nekaterih bolnikih (predvsem pri dojenčkih in otrocih) povzroči določene težave pri upoštevanju režima.
The efficacy rates for amoxicillin were around 80%, which is comparable to the different active controls used in the studies presented.
Delež učinkovitosti amoksicilina je bil približno 80-odstoten, kar je primerljivo z različnimi aktivnimi kontrolami, ki so bile uporabljene v predstavljenih študijah.
The breakpoint table was updated based on EUCAST (version 4) dated 01 January 2014.
Preglednica z mejnimi vrednostmi je bila posodobljena skladno z ugotovitvami združenja EUCAST (različico 4) z dne 1. januarja 2014.
The content of this section was the same across MSs, however the wording used varied slightly.
Vsebina tega poglavja je bila enaka v vseh državah članicah, vendar se je uporabljeno besedilo rahlo razlikovalo.
A harmonised wording of the warning around the potential interference with diagnostic tests already present in 5 member states was also proposed to be implemented across all MS, which was accepted.
Predlagali so tudi, naj se usklajeno besedilo opozorila glede morebitnih motenj pri diagnostičnih preiskavah, ki je že prisotno v petih državah članicah, vključi v vseh državah članicah, kar je bilo sprejeto.
However higher cure rates were observed with longer treatment duration (7-10 days) and when the causative organisms were susceptible to amoxicillin.
Vendar so večje deleže ozdravitve opazili pri daljšem zdravljenju (7-10 dni) in kadar so bili povzročitelji občutljivi za amoksicilin.
For all indications, to encourage the responsible use of antibacterial agents and to direct prescribers to take note of any existing national or local guidance and opinions on how antibacterial agents should be used the following sentence will be included in this section: “Consideration should be given to official guidance on the appropriate use of antibacterial agents”.
Pri vseh indikacijah se bo za spodbujanje odgovorne uporabe antibiotikov in usmerjanje predpisovalcev, naj upoštevajo vse nacionalne ali lokalne smernice ter mnenja o ustrezni uporabi antibiotikov, v tem poglavju uporabil naslednji stavek: „Upoštevati je treba uradne smernice za ustrezno uporabo antibiotikov“.
Peptidoglycan is an integral structural component of the bacterial cell wall and serves to maintain the shape and integrity of the cell.
Peptidoglikan je integralna strukturna sestavina stene bakterijske celice in vzdržuje obliko in neokrnjenost celice.
The use of parenteral formulation showed similar results to the oral formulation.
Pri uporabi parenteralne formulacije so ugotovili podobne rezultate kot pri peroralni formulaciji.
The CHMP concluded that the risks associated with them were considered sufficiently addressed by wording in other sections of the PI and were removed from this section.
Odbor CHMP je sklenil, da so bila tveganja, povezana z njimi, zadostno obravnavana v besedilih drugih poglavjih navodila za uporabo, zato so bila odstranjena iz tega poglavja.
Inhibition of peptidoglycan synthesis leads to weakening of the structure, usually followed by cell lysis and bacterial death.
Zaviranje sinteze peptidoglikanov povzroča oslabitev strukture, čemur navadno sledi celična liza in bakterijska smrt.
Furthermore amoxicillin is recommended in several guidelines (e.g. American College of Gastroenterology, National Institute for Health and Care Excellence) in combination with a proton pump inhibitor and clarithromycin.
Poleg tega amoksicilin v mnogih smernicah (npr. American College of Gastroenterology, National Institute for Health and Care Excellence) priporočajo v kombinaciji z zaviralcem protonske črpalke in klaritromicinom.
Furthermore amoxicillin is recommended as a treatment option in several recent clinical guidelines.
Poleg tega se amoksicilin priporoča kot možnost zdravljenja v več novih kliničnih smernicah.
The use of varying dose regimens ranging from 40 mg/kg/day to 90 mg/kg/day showed efficacy rates of around 90% in majority of the trials.
Z uporabo različnih režimov odmerjanja od 40 mg/kg/dan do 90 mg/kg/dan so v večini preskušanj pokazali približno 90-odstotne deleže učinkovitosti.
On the basis of its pharmacokinetics, the total daily recommended amount is usually given in three divided doses.
Na podlagi te farmakokinetike se skupni dnevni priporočeni odmerek navadno daje s tremi ločenimi odmerki.
In addition several guidelines recommend the use of amoxicillin as first choice in these infections.
Poleg tega več smernic priporoča uporabo amoksicilina kot prve izbire pri teh okužbah.
In addition, in some studies amoxicillin was only used as follow-on therapy after intravenous use of other antibiotics.
Poleg tega so v nekaterih študijah amoksicilin uporabili samo kot naknadno zdravljenje po intravenski uporabi drugih antibiotikov.
The CHMP as a consequence, concluded that the benefit-risk balance of Amoxil and associated names remains favourable, subject to the agreed changes to the product information.
Posledično je CHMP zaključil, da je razmerje med tveganji in koristmi zdravila Amoxil in povezana imena še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
Several statement regarding important information about excipients present in some member states (sodium, aspartame, sodium benzoate, lactose and sorbitol) were harmonised as well.
Uskladilo se je tudi več izjav glede pomembnih informacij o pomožnih snoveh, prisotnih v nekaterih državah članicah (natrij, aspartam, natrijev benzoat, laktoza in sorbitol).
Amoxil is approved for marketing in Europe in 17 different formulations: two strengths of capsules (250 mg and 500 mg), two strengths of dispersible tablets (750 mg and 1 g), four strength of powder for oral suspension (125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), four strength of powder for oral suspension in sachets (250, 500, 1g and 3g) and four strength of 125 mg/1.25 ml powder for solution for injection or infusion via intravenous or intramuscular route (IV/IM) or both (250 mg (intravenous or intramuscular, IV/IM), 500 mg (IV/IM), 1g (IV/IM and IM) and 2g (IV)).
Zdravilo Amoxil je pridobilo dovoljenje za promet z zdravilom v Evropi s 17 različnimi formulacijami: kapsule dveh jakosti (250 mg in 500 mg), disperzibilne tablete dveh jakosti (750 mg in 1 g), prašek za peroralno suspenzijo štirih jakosti (125 mg/1,25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), prašek za peroralno suspenzijo v vrečici štirih jakosti (250 mg, 500 mg, 1 g in 3 g) in štiri jakosti 125 mg/1,25 ml prašek za raztopino za injiciranje ali infundiranje intravensko ali intramuskularno (i.v./i.m.)
The manufacture and control of both the active substance and the finished product comply with CHMP and International Conference on Harmonisation (ICH) guidelines.
Izdelava in nadzor nad zdravilno učinkovino in končnim izdelkom sta v skladu s smernicami CHMP in smernicami Mednarodne konference o usklajevanju (ICH).
These tables are preceded by general recommendations on factors to consider when selecting the dose and duration of treatment, with a cross reference to 4.4, and followed by a reference to treatment guidelines to be considered when selecting the posology.
Pred temi preglednicami morajo biti navedena splošna priporočila glede dejavnikov, ki jih je treba upoštevati pri izbiranju odmerka in trajanju zdravljenja, vključno z navzkrižno referenco na poglavje 4.4, po njih pa je treba navesti referenco na smernice za zdravljenje, ki jih je treba upoštevati pri izbiri odmerjanja.
Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) - Parenteral formulation
Hude okužbe ušesa, nosu in žrela (kot so mastoiditis, peritonzilarne okužbe, epiglotitis in sinusitis, če jih spremljajo hudi sistemski znaki ter simptomi) - parenteralna formulacija
The CHMP reviewed the totality of the data and consulted its Infectious Diseases Working Party on the proposed harmonised PI.
Odbor CHMP je pregledal vse podatke in se s svojo Delovno skupino za infekcijske bolezni posvetoval glede predlaganih usklajenih informacij o zdravilu.
Treatment with amoxicillin generally produced high clinical and bacteriological response rates (around 90%), with efficacy similar to the antibiotic comparators.
Zdravljenje z amoksicilinom je navadno vzpostavilo visoke ravni kliničnega in bakteriološkega odziva (približno 90 %), učinkovitost pa je bila podobna kot pri primerjalnih antibiotikih.
Bacteraemia that occurs in association with or is suspected to be associated with, any of the infections listed above - Parenteral formulation
Bakteriemija, ki je povezana ali domnevno povezana z katerimi koli zgoraj navedenimi okužbamiparenteralna formulacija
Recent guidelines (Public Health England guideline 2015, Infectious Diseases Society of America guidelines 2014 and Surgical Society Infections guideline 2011) recommend antibiotics other than amoxicillin for the treatment of most skin and soft tissue infections.
Novejše smernice (Public Health England 2015, Infectious Diseases Society of America 2014 in Surgical Society Infections 2011) pri zdravljenju večine okužb kože in mehkega tkiva priporočajo antibiotike, ki niso amoksicilin.
The growing resistance to amoxicillin of H. influenzae and M. catarrhalis (through β-lactamase production) and S. pneumoniae and H. influenzae (through changes in protein binding site) increased the risk of treatment failure, therefore amoxicillin should not be used as empirical treatment in these infections.
Vedno večja odpornost H. influenzae, M. catarrhalis (prek tvorbe β-laktamaze), S. pneumoniae in H. influenzae (prek sprememb na mestu vezave beljakovin) na amoksicilin je povečala tveganje neuspešnosti zdravljenja, zato se amoksicilin ne sme uporabljati kot empirično zdravljenje teh okužb.
The possible interaction with oral contraceptives through an effect on the gut flora was removed, in line with the recent Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) recommendation to remove this interaction from the PI of numerous antibiotics including amoxicillin (CMDh/326/2015, Rev.0).
Morebitna interakcija s peroralnimi kontracepcijskimi sredstvi zaradi učinka na črevesno floro je bila odstranjena skladno s priporočilom Usklajevalne skupine za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) glede odstranitve te interakcije iz informacij o zdravilu za številne antibiotike, vključno z amoksicilinom (CMDh/326/2015, Rev.0).
Several national guidelines and international societies including the World Health Organization recommend amoxicillin either as first or second line treatment for streptococcal pharyngitis.
Več nacionalnih smernic in mednarodnih združenj, vključno s Svetovno zdravstveno organizacijo, priporoča amoksicilin kot zdravljenje prve ali druge izbire proti streptokoknemu faringitisu.
Information in this section consistently reflects across MSs that amoxicillin does not affect the ability to drive or use machines.
Informacije v tem poglavju so skladne v vseh državah članicah in navajajo, da amoksicilin nima vpliva na sposobnost vožnje in upravljanja strojev.
Treatment and prophylaxis of endocarditis- all formulations
Zdravljenje in profilaksa pri endokarditisu - vse formulacije
The CHMP considered that the parenteral route was adequate for the more severe infections of the ear nose and throat.
Odbor CHMP je menil, da je parenteralna pot uporabe ustrezna za hujše okužbe ušesa, nosu in žrela.
Sulfasalazine plasma concentration may be reduced with aminopenicillins, however studies do not support this effect for amoxicillin and no relevant reports were identified in the safety database of the MAH; therefore it was considered acceptable to remove this statement.
Pri aminopenicilinih lahko pride do zmanjšanja koncentracije sulfasalazina v plazmi, vendar študije ne podpirajo tega učinka pri amoksicilinu in v varnostni podatkovni zbirki imetnika dovoljenja za promet z zdravilom ni pomembnih poročil, zato je odbor menil, da je odstranitev te izjave sprejemljiva.
Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, vendar je večino poglavij treba dopolniti na nacionalni ravni.
The MAH proposed to harmonise the paediatric dosing recommendations using the most commonly approved mg/kg dose (40 - 90 mg/kg/day in divided doses).
Imetnik dovoljenja za promet z zdravilom je priporočil uskladitev priporočil za odmerjanje pri pediatrični populaciji, tako da bi se uporabil najpogosteje odobreni odmerek v mg/kg (40-90 mg/kg/dan v razdeljenih odmerkih).
The MAH presented two small clinical trials and five retrospective case studies as well as reviews and guidelines.
Imetnik dovoljenja za promet z zdravilom je predstavil dve majhni klinični preskušanji, pet retrospektivnih študij primerov, preglede in smernice.
Many national and European guidelines recommend amoxicillin as one of several treatment options for AECB in adults patients with increased dyspnoea, sputum volume and sputum purulence or in case of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD).
Mnoge nacionalne in evropske smernice priporočajo amoksicilin kot eno od mnogih možnostih zdravljenja AEKB pri odraslih bolnikih s povečano dispnejo, prostornino sputuma in gnojnim sputumom ali v primerih eksacerbacij pri bolnikih s hudo kronično obstruktivno pljučno boleznijo (KOPB).
In addition a cross reference to section 4.2, 4.4 and 5.1 is included at the beginning of the section, in particular to highlight that “amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin”.
Poleg tega bo na začetek tega poglavja vključena navzkrižna referenca na poglavja 4.2, 4.4 in 5.1, ki bo poudarila predvsem, »da amoksicilin ni primeren za zdravljenje nekaterih vrst okužb, razen če je bil patogen že dokumentiran in poznan kot občutljiv ali obstaja zelo velika verjetnost, da bo patogen primeren za zdravljenje z amoksicilinom«.
In addition the MAH provided data from recognised animal models to support the prophylaxis and treatment indication.
Poleg tega je imetnik dovoljenja za promet z zdravilom predložil podatke iz priznanih živalskih modelov, ki so podprli indikacijo profilakse in zdravljenja.
Furthermore, recent guidelines do not support the use of amoxicillin for genital infections such as pelvic inflammatory disease or vaginosis, other antibiotics are recommended.
Poleg tega nove smernice ne podpirajo uporabe amoksicilina pri okužbah spolovil, kot so vnetna bolezen medenice ali vaginoza, pri katerih so priporočeni drugi antibiotiki.
These included bronchitis, acute lung disease, urethritis, gonococcal infection, male genital infections, gonorrhoea, enteritis with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, serious infections caused by haemophilus influenza.
Te so vključevale bronhitis, akutno pljučno bolezen, uretritis, gonokokno okužbo, okužbe moških spolovil, gonorejo, enteritis z bakteriemijo in okužbami v trebušni votlini, kot so peritonitis, holecistitis ter akutni holangitis, in resne okužbe, ki jih povzroča haemophilus influenzae.