natgillin/translations-raw huggingface dataset:
The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ml on day 1 and 8.79 ng/ml on day 7, and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ml.
Geometrijska srednja vrednost Cmax v plazmi je bila po nanosu na 200 cm2 veliko površino poškodovane kože na 1. dan 9,75 ng/ml, na 7. dan pa 8,79 ng/ml.
A thin layer of ointment should be applied to the affected area twice daily for five days.
Na prizadeti predel kože je treba nanesti tanko plast mazila dvakrat na dan. Zdravljenje traja pet dni.
Retapamulin ointment must be kept away from the eyes and mucous membranes.
Mazilo z retapamulinom ne sme priti v stik z očmi ali s sluznicami.
Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20 ng/mL).
Po lokalni uporabi 10 mg/g mazila pri odraslih bolnikih in pediatričnih bolnikih, starih 2 leti ali več, je bila sistemska izpostavljenost retapamulinu majhna (največja koncentracija v plazmi < 20 ng/ml).
There were no treatment
Zdravljenje vseh okužb je bilo
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg retapamulin (1% w/w).
En gram mazila vsebuje 10 mg retapamulina (1 % m/m).
NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment
IME ZDRAVILA Altargo 10 mg/g mazilo
Methicillin-resistant Staphylococcus aureus (MRSA) Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
Proti meticilinu odporni Staphylococcus aureus (MRSA) Retapamulin se ne sme uporabljati za zdravljenje okužb, ki so ali bi lahko bile posledica okužbe z MRSA (glejte poglavje 5.1).
Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin antibacterial agents that interact with the ribosome.
Retapamulin selektivno zavira sintezo bakterijskih proteinov z učinkovanjem na edinstveno mesto 50S
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Altargo 10 mg/g ointment
IME ZDRAVILA IN POT(I) UPORABE Altargo 10 mg/g mazilo
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24. maj 2007
In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/kg/day
Pri študijah embriotoksičnoti na podganah so pri peroralnih odmerkih ≥ 150 mg/kg/dan (kar ustreza ≥ 3-kratni pričakovani izpostavljenosti človeka (glejte zgoraj)) opazili škodljiv vpliv na razvoj (manjša telesna masa plodov in zakasnela osifikacija skeleta) in škodljiv vpliv na matere.
Elderly (aged 65 and older)
Starejši bolniki (stari 65 let in starejši) Odmerka ni treba prilagajati.
However, there were no systemic effects on juvenile rats with topical application of retapamulin ointment.
Pri mladih podganah pri lokalni uporabi retapamulina v obliki mazila niso opazili sistemskih učinkov.
Immune system disorders
Protibakterijski spekter
NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment Retapamulin
IME ZDRAVILA Altargo 10 mg/g mazilo retapamulin
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy adult males.
Pri sočasni peroralni uporabi ketokonazola v odmerku 200 mg dvakrat na dan in lokalni uporabi retapamulin 10 mg/g mazila na poškodovani koži sta se pri zdravih odraslih moških srednji vrednosti
Pruritus Erythema
Srbenje Eritem
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
Breje kunčje samice so prejemale retapamulin v obliki kontinuirane intravenske infuzije od 7. do
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1%
V kliničnih študijah je zdravilo Altargo uporabljalo 2.150 bolnikov s povrhnjimi okužbami kože.
Systemic exposure following topical application of retapamulin through intact skin was very low.
Pri lokalni uporabi retapamulina na zdravi koži je bila sistemska izpostavljenost zelo majhna.
Talk to your doctor or pharmacist before using Altargo.
Pred začetkom jemanja zdravila Altargo se posvetujte z zdravnikom ali farmacevtom.
Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects with S. aureus and S. pyogenes
Deleži klinične uspešnosti med spremljanjem pri preizkušancih s sekundarnimi okužbami odprtih ran s S. aureus in S. pyogenes, ki so jih nameravali zdraviti in pri katerih je bila mogoča
There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin: AUC 238 ng.h/ml).
Pri samcih in samicah podgan, ki so peroralno prejemali odmerke 50, 150 ali 450 mg/kg/dan, kar predstavlja do 5-krat večjo mejno izpostavljenost od največje pričakovane izpostavljenosti človeka
PHARMACEUTICAL PARTICULARS 6.1 List of excipients White soft paraffin
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi beli vazelin butilhidroksitoluen (E321) 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
• contact your doctor or pharmacist immediately.
• zdravilo Altargo prenehajte uporabljati; • nemudoma se posvetujte s svojim zdravnikom ali farmacevtom.
Cephalexin n/N Success
Cefaleksin n/N Delež uspešnosti natančen IZ
See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Za pomembne informacije o klinični učinkovitosti retapamulina proti različnim tipom
See package leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
Distribution
Absorpcija
No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of <2 µg/ml.
Pri vseh kliničnih izolatih je bila inhibicija dosežena pri koncentraciji retapamulina ≤ 2 µg/ml.
Package leaflet: Information for the patient Altargo 10 mg/g ointment Retapamulin
Navodilo za uporabo Altargo 10 mg/g mazilo retapamulin
The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients
Pri odraslih je bila največja izmerjena koncentracija retapamulina v plazmi 10,7 ng/ml, pri otrocih, starih od 2 do 17 let, pa 18,5 ng/ml.
Clinical Success Rates at Follow up for SIOW patients with S. aureus Phenotype/PFGE type
Deleži klinične uspešnosti pri spremljanju bolnikov s sekundarnimi okužbami odprtih ran s S. aureus
Retapamulin MICs of 2-64 µg/ml have been reported for clinical isolates of S. aureus possessing either the efflux or cfr resistance mechanisms described above.
V kliničnih izolatih S. aureus, ki so imeli zgoraj opisana mehanizma iztočne odpornosti ali odpornosti
Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were measurable in 32% (16/50) of samples.
Pri otrocih v starosti od 9 mesecev do 2 let je bila koncentracija retapamulina v plazmi merljiva v
Each gram of ointment contains 10 milligrams of - The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
- Pomožni snovi sta beli vazelin in konzervans butilhidroksitoluen (E321).
- If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
GlaxoSmithKline Pharmaceuticals s.a./n.v.
GlaxoSmithKline - Produtos Farmacêuticos, Lda
What Altargo looks like and contents of the pack Altargo is a smooth, off-white ointment.
Izgled zdravila Altargo in vsebina pakiranja
- The active substance is retapamulin.
Kaj vsebuje zdravilo Altargo - Zdravilna učinkovina je retapamulin.
Epistaxis has been reported with use of Altargo on nasal mucosa.
Ob uporabi zdravila Altargo na nosni sluznici so poročali o epistaksi.
If you use more Altargo than you should
Če ste uporabili večji odmerek zdravila Altargo, kot bi smeli Preveliko količino mazila previdno obrišite.
No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Pri in vitro ugotavljanju učinkovitosti retapamulina proti meticilinu občutljivim in proti meticilinu odpornim sevom S. aureus
• Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
Pri naslednjih stanjih varnosti in učinkovitosti niso dokazali: • impetiginizirane spremembe, katerih število je večje od 10, in skupaj presegajo 100 cm2
− early recognition and intervention may improve outcome
− zgodnje prepoznavanje in ukrepanje lahko izboljša izid.
Currently available data are described in sections 4.8 and 5.1
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1.
Date of first authorisation: 27th June 2006 Date of latest renewal: 18th April 2016
Datum prve odobritve: 27. junij 2006 Datum zadnjega podaljšanja: 18. april 2016
Effects on laboratory tests
Učinki na laboratorijske teste
Median age was 37 years, with a median disease duration of 5 years.
Povprečna starost je bila 37 let, povprečno trajanje bolezni pa 5 let.
• Information about any registry or other monitoring system set up in the Member State and how to enter patients
• Informacije o kateremkoli registru ali drugem sistemu spremljanja, ki je bil uveden v državi članici, in o načinu vključevanja bolnikov.
The diagnosis and management of IRIS is a controversial issue and there is no consensus concerning its treatment.
Diagnoza in obvladovanje IRIS sta sporni temi in ni soglasja glede zdravljenja.
Mean EDSS scores remained stable over 5 years.
Srednji rezultati EDSS so ostali stabilni 5 let.
Combination with other DMTs.
Kombinacija z drugimi DMT.
Teriflunomide is eliminated slowly from the plasma.
Teriflunomid se počasi izloča iz plazme.
Serious cases of ARN, either affecting one or both eyes, led to blindness in some patients.
Resni primeri ARN, bodisi na enem bodisi na obeh očesih, so pri nekaterih bolnikih povzročili slepoto.
• If your doctor tells you that you have a serious problem with your immune system (due to disease for example, HIV or due to a medicine you are taking or have previously taken
• če vam je zdravnik povedal, da imate resne težave s svojim imunskim sistemom (zaradi bolezni, npr. HIV, ali zaradi zdravil, ki jih jemljete ali ste jih jemali).
It is important that you keep this Alert Card and show it to your partner or caregivers.
Pomembno je, da to opozorilno kartico za bolnika shranite in jo pokažete svojemu partnerju ali negovalcu.
The treatment initiation form should contain the following elements:
Obrazec za uvedbo zdravljenja naj vsebuje naslednje elemente:
Prophylactic steroid treatment is currently not recommended.
Profilaktično zdravljenje s steroidi trenutno ni priporočljivo.
No prospective clinical studies have been completed to validate these findings.
Za potrditev teh ugotovitev niso bile opravljene nobene prospektivne klinične študije.
To switch from some MS medicines, your doctor may advise you to wait for a certain time to ensure that most of the previous medicine has left your body.
Pri prehodu z nekaterih zdravil za MS vam bo zdravnik mogoče svetoval, da določen čas počakate, da bo večina predhodnega zdravila odstranjena iz vašega telesa.
• Possibility of other opportunistic infections
• Možnost drugih oportunističnih okužb.
Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Brez pospešenega postopka izločanja lahko očistek teriflunomida iz plazme traja od več mesecev do 2 leti.
• The need to inform the National Competent Authority about any cases of PML
• Potreba po obveščanju pristojnih nacionalnih organov o vseh primerih PML.
Within the limitations of these data, there were no new safety signals identified in this patient population.
Upoštevajoč omejitve teh podatkov v tej skupini bolnikov niso ugotovili nobenih novih varnostnih signalov.
• Switching usually occurred after 1 year (median of 25 standard interval doses) in the secondary definition
• Do zamenjave je običajno prišlo po enem letu (mediana 25 standardnih intervalov odmerjanja) v sekundarni opredelitvi.
Alemtuzumab has profound prolonged immunosuppressive effects.
Alemtuzumab ima močne dolgotrajne imunosupresivne učinke.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The safety and efficacy of TYSABRI in children and adolescents up to 18 years have not been established.
Varnost in učinkovitost zdravila TYSABRI pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
• If you are taking medicines that suppress or modulate the immune system including other medicines used to treat MS disease.
• če jemljete zdravila, ki zavirajo ali uravnavajo imunski sistem, vključno z drugimi zdravili, ki se uporabljajo za zdravljenje MS.
However, it has recently been suggested that corticosteroids may be useful to treat IRIS, particularly in patients with severe to life-threatening IRIS (Tan et al., 2009, Clifford et al., 2010).
Kljub temu se je nedavno pojavilo mnenje, da so lahko pri zdravljenju IRIS koristni kortikosteroidi, zlasti pri bolnikih s hudo do življenje ogrožajočo obliko IRIS (Tan et al., 2009, Clifford et al., 2010).
Analysis of STRATIFY JCV showed the prevalence of anti-JCV antibodies to be approximately 55%.
Analiza STRATIFY JCV je pokazala, da prevalenca protiteles proti JCV znaša približno 55 %.
This active ingredient is called a monoclonal antibody.
Ta učinkovina se imenuje monoklonsko protitelo.
• A reminder regarding serious infections and the need to speak to their doctor if they have severe persistent infection
• Navodilo glede resnih okužb in potrebe po posvetovanju z zdravnikom v primeru vztrajne hude okužbe.
Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Opozorilno kartico za bolnika pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju, ne samo vašemu nevrologu.
The majority (85%) of patients dosed with EID had received the approved dosing for ≥1 year prior to switching to EID.
Večina (85 %) bolnikov, ki so prejemali PIO, je pred prehodom na PIO prejemala odobreno odmerjenje ≥ 1 leto.
Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Preden začnete z zdravljenjem z zdravilom TYSABRI, je pomembno, da se z zdravnikom pogovorite o pričakovanih koristih tega zdravljenja in o tveganjih, ki so z njim povezana.
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
• Severe allergy (hypersensitivity)
• huda alergija (preobčutljivost)
concentrate for solution for infusion 1 x 15 ml vial
koncentrat za raztopino za infundiranje 1 x 15 ml viala
In the MS population, anti-JCV antibody prevalence increased with age and was lower in women than in men in all cohorts tested.
V populaciji z MS se je prevalenca protiteles proti JCV zviševala s starostjo in je bila v vseh testiranih kohortah nižja pri ženskah kot pri moških.
In the postmarketing setting, the risk of PML has been well characterized over the first 6 years of treatment with the identification of different levels of PML risk in different patient subgroups.
V obdobju trženja je bilo tveganje za razvoj PML dobro opredeljeno za prvih 6 let zdravljenja z določitvijo različnih stopenj tveganja za PML pri različnih podskupinah bolnikov.
If utilising extended interval dosing, caution is required because the efficacy of extended interval dosing has not been established and the associated benefit risk balance is currently unknown (see section 5.1).
V primeru uporabe podaljšanega intervala odmerjanja je potrebna previdnost, saj učinkovitost podaljšanega intervala odmerjanja ni bila ugotovljena, razmerje med koristmi in tveganji pa je trenutno neznano (glejte poglavje 5.1).
The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Imetnik dovoljenja za promet z zdravilom dogovorjene ukrepe za spremljanje izpolni v časovnem okviru, določenem v dogovoru s pristojnimi nacionalnimi organi.
Proportion progressed1(12-week confirmation; primary outcome)
Prizadetosti Delež napredovanja1 (potrditev po 12 tednih; primarni izid)
• Risk management plan (RMP)
ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Varnost in učinkovitost zdravila TYSABRI v kombinaciji z drugimi imunosupresivi in antineoplastičnimi zdravili ni bila povsem ugotovljena.
Monitoring for potential signs of return of MS disease activity in patients switching dosing intervals.
Spremljanje morebitnih znakov ponovitve MS pri bolnikih, ki menjujejo intervale odmerjanja.
• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
• bolniki z zelo aktivno boleznijo, kljub celotnemu in ustreznemu poteku zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezni (DMT-disease modifying therapy) (za izjeme in podatke o vmesnih obdobjih brez zdravljenja glejte poglavji 4.4 in 5.1);
As scientific and medical knowledge, including both diagnostic criteria and management of IRIS is rapidly evolving, please contact Medical affairs in your country for the most up to date information on treatment recommendations.
vključno z diagnostični merili in obvladovanjem IRIS, hitro napredujejo, se obrnite na zdravstvene organe v svoji državi za najnovejše informacije glede priporočil za zdravljenje.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Povišanje limfocitov, monocitov, eozinofilcev in bazofilcev od izhodišča je bilo 35 % do 140 % za posamezne tipe celic, toda povprečno število celic je ostalo v normalnem razponu.
Following discontinuation of fingolimod, lymphocyte count progressively returns to normal range within 1 to 2 months after stopping therapy.
Po ukinitvi fingolimoda se število limfocitov postopoma vrne v normalno območje v 1 do 2 mesecih po prekinitvi zdravljenja.
No information on the severity of the relapses before inclusion of patients in the study is available.
Informacije o resnosti recidivov, pred vključitvijo bolnikov v študijo,
• You will also find this information in the Patient Alert Card you have been given by your doctor.
• Te informacije najdete tudi v opozorilni kartici za bolnika, ki vam jo je dal vaš zdravnik.
The Marketing Authorisation Holder must, following discussions and agreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora, po dogovoru in soglasju s pristojnimi organi v vsaki državi članici, v kateri se trži zdravilo TYSABRI, zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo TYSABRI, dobili informacije, ki bodo vključevale naslednje elemente:
• A description of PML, potential symptoms and management of PML
• Opis PML, morebitni simptomi in obvladovanje PML.
Use of plasmapheresis (PLEX) or intravenous immunoglobulin (IVIg) can affect meaningful interpretation of serum antiJCV antibody testing.
Uporaba plazmafereze (PLEX) ali intravenskega imunoglobulina (IVIg) lahko vpliva na smiselno razlago testov za serumska protitelesa proti JCV.
The treatment reported in these cases included anti-viral therapy and in some cases, surgery (see section 4.4).
Zdravljenje, o katerem so poročali pri teh primerih, je vključevalo protivirusno zdravljenje in v nekaterih primerih operacijo (glejte poglavje 4.4).
A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Analiza populacijske farmakokinetike se je izvajala na vzorcih več kot 1100 bolnikov z MS, ki so prejemali odmerke od 3 mg/kg do 6 mg/kg natalizumaba.
Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest an effect of TYSABRI exposure on pregnancy outcomes.
Podatki iz kliničnih preskušanj, prospektivnega registra nosečnosti, primerov v obdobju trženja zdravila in iz razpoložljive literature ne kažejo, da bi izpostavljenost zdravilu TYSABRI vplivala na izide nosečnosti.
As the actual duration of these effects is unknown, initiating treatment with TYSABRI after alemtuzumab is not recommended unless the benefits clearly outweigh the risks for the individual patient.
Ker dejansko trajanje teh učinkov ni znano, po alemtuzumabu ni priporočljivo začeti zdravljenja z zdravilom TYSABRI, razen če koristi očitno odtehtajo tveganja za posameznega bolnika.
Patients presenting with eye symptoms such as decreased visual acuity, redness and painful eye should be referred for retinal screening for ARN.
Bolnike, ki pridejo na pregled z očesnimi simptomi, kot so zmanjšana ostrina vida, rdečina in bolečine v očesu, je treba napotiti na retinalni presejalni pregled za ARN.
Although the inflammatory reaction following immune reconstitution may be a necessary step to remove JCV-infected cells, it may become necessary to treat the active immune reaction to prevent potential damage caused by IRIS (Talan 2009; Elston and Thacker 2009) and can be life-threatening and may therefore require management in an intensive care unit.
Čeprav je lahko vnetna reakcija, ki sledi imunski rekonstituciji, nujen korak pri odstranjevanju celic, okuženih z JCV, bo aktivno imunsko reakcijo morda treba zdraviti zaradi preprečevanja morebitnih posledic IRIS (Talan 2009; Elston in Thacker 2009), saj je lahko življenje ogrožajoča in zahteva zdravljenje na oddelku za intenzivno nego.
When switching patients from another DMT to TYSABRI, the half-life and mode of action of the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Pri prehajanju bolnikov z druge DMT na zdravilo TYSABRI je treba upoštevati razpolovni čas in način delovanja drugega zdravljenja, da se izognemo aditivnemu imunskemu učinku, hkrati pa kar najbolj zmanjšamo tveganje za reaktivacijo bolezni.