FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment
Croatian: NAZIV LIJEKA Altargo 10 mg/g mast
English: The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients
Croatian: Najveća izmjerena koncentracija retapamulina u plazmi bila je 10,7 ng/ml u odraslih i 18,5 ng/ml u pedijatrijskih ispitanika (starosti od 2-17 godina).
English: Apply to the affected area as directed by your doctor
Croatian: Primijenite na zahvaćeno područje prema uputama svog liječnika Prije uporabe pročitajte Uputu o lijeku
English: GlaxoSmithKline d.o.o.
Croatian: GlaxoSmithKline A.E.B.E.
English: However, there were no systemic effects on juvenile rats with topical application of retapamulin ointment.
Croatian: Međutim, nakon topikalne primjene retapamulin masti nije bilo sistemskih učinaka na mlade jedinke štakora.
English: The excretion of retapamulin in milk has not been studied in animals.
Croatian: Na životinjama nisu provedena ispitivanja o izlučivanju retapamulina u mlijeko.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients White soft paraffin
Croatian: 6.1 Popis pomoćnih tvari
English: Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects with S. aureus and S. pyogenes
Croatian: Stope kliničke uspješnosti na kontrolnom pregledu bolesnika sa SIOR uzrokovanog S. aureus i
English: Simi: + 354 535 7000
Croatian: Tel.: + 36 1 225 5300
English: 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.
Croatian: Za kliničke izolate S. aureus koji su imali gore opisane bilo mehanizam istjecanja ili mehanizam cfr rezistencije, prijavljene su vrijednosti MIK za retapamulin od 2-64 µg/ml.
English: What Altargo looks like and contents of the pack Altargo is a smooth, off-white ointment.
Croatian: Kako Altargo izgleda i sadržaj pakiranja
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Senzibilizacija ili teška lokalna iritacija
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Altargo 10 mg/g ointment
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Altargo 10 mg/g mast retapamulin
English: Sverige
Croatian: Danmark
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment Retapamulin
Croatian: NAZIV LIJEKA Altargo 10 mg/g mast retapamulin
English: Application site irritation (including burning sensation)
Croatian: uključujući angioedem kontaktni dermatitis reakcije na mjestu eritem iritacija na mjestu primjene (uključujući osjećaj peckanja)
English: Ísland
Croatian: Deutschland
English: General disorders and administration site conditions
Croatian: Upravljanje vozilima i strojevima
English: Each gram of ointment contains 10 milligrams of - The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
Croatian: - Drugi sastojci su bijeli vazelin i butilhidroksitoluen (E321), konzervans.
English: If you use more Altargo than you should
Croatian: Ako primijenite više lijeka Altargo nego što ste trebali Pažljivo obrišite višak masti.
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Croatian: GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 (0)10 85 52 00
English: EXP
Croatian: Apsces
English: Vistor hf.
Croatian: transporter vgaAv).
English: Irritation
Croatian: Plodnost
English: Sensitisation or severe local irritation
Croatian: Nepoznato preosjetljivost,
English: Skin and subcutaneous tissue disorders
Croatian: Karcinogeneza, mutageneza, reproduktivna toksičnost
English: Retapamulin should not be used to treat infections known or thought likely to be due to MRSA.
Croatian: Međutim, za kliničku djelotvornost protiv MRSA vidjeti dio 4.4. retapamulin se ne smije koristiti za liječenje infekcija za koje se zna ili se pretpostavlja da su uzrokovane MRSA-om.
English: - If you get any side effects talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Currently available data are described in sections 4.8 and 5.1
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1.
English: − early recognition and intervention may improve outcome
Croatian: - rano otkrivanje i intervencija mogu poboljšati ishod
English: A group of symptoms caused by a serious infection of the brain including:
Croatian: Skupinu simptoma uzrokovanu ozbiljnom infekcijom mozga uključujući:
English: Prophylactic steroid treatment is currently not recommended.
Croatian: Profilaktično liječenje steroidima trenutačno se ne preporučuje.
English: • Switching usually occurred after 1 year (median of 25 standard interval doses) in the secondary definition
Croatian: • Do promjene intervala je obično došlo nakon 1 godine (medijan od 25 standardnih intervalnih doza) u sekundarnoj definiciji
English: Within the limitations of these data, there were no new safety signals identified in this patient population.
Croatian: Uzimajući u obzir ograničenja tih podataka, u ovoj populaciji bolesnika nisu ustanovljeni novi sigurnosni signali.
English: For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Croatian: Za one s nižim rizikom od PML-a, Vaš liječnik može redovito ponavljati test za provjeru da li se išta promijenilo:
English: The diagnosis and management of IRIS is a controversial issue and there is no consensus concerning its treatment.
Croatian: Dijagnoza i liječenje IRIS-a kontroverzno je pitanje i u pogledu liječenja nema konsenzusa.
English: The treatment initiation form should contain the following elements:
Croatian: Obrazac za početak liječenja treba sadržavati sljedeće elemente:
English: The safety and efficacy of TYSABRI in children and adolescents up to 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka TYSABRI u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: PML is a rare infection of the brain.
Croatian: PML je rijetka infekcija mozga
English: 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
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Speak to your doctor as soon as possible if you think you have an infection.
Croatian: Obratite se što prije svom liječniku ako mislite da imate infekciju.
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na natalizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: After dilution, immediate use is recommended.
Croatian: Nakon razrjeđivanja, preporučuje se primijeniti odmah.
English: What TYSABRI is and what it is used for
Croatian: Što je TYSABRI i za što se koristi
English: • The longer that you are on treatment especially if you have been on treatment for more than two years.
Croatian: • što se dulje liječite, osobito ako se liječite dulje od dvije godine
English: • 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
Croatian: • ako Vam liječnik kaže da imate ozbiljne probleme s imunološkim sustavom (zbog bolesti npr. HIV-a ili zbog lijeka kojeg primjenjujete ili ste prethodno primjenjivali)
English: Alemtuzumab has profound prolonged immunosuppressive effects.
Croatian: Alemtuzumab ima izrazito dugotrajne imunosupresivne učinke.
English: • A reminder regarding serious infections and the need to speak to their doctor if they have severe persistent infection
Croatian: • Podsjetnik na ozbiljne infekcije i potrebu za javljanjem liječniku ako imaju tešku infekciju koja ne prolazi
English: Mean EDSS scores remained stable over 5 years.
Croatian: Srednje vrijednosti rezultata EDSS ostale su stabilne 5 godina.
English: Always use this medicine exactly as described in this leaflet or as your doctor has told you.
Croatian: Uvijek primijenite lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik.
English: • If you have previously taken a medicine called an immunosuppressant.
Croatian: • ako ste prethodno uzimali lijek nazvan imunosupresiv.
English: Date of first authorisation: 27th June 2006 Date of latest renewal: 18th April 2016
Croatian: Datum posljednje obnove odobrenja: 18. travnja 2016.
English: • Inform about an ongoing study assessing the efficacy, tolerability and safety of switching to EID after at least 12 months on approved dosing.
Croatian: • Informirajte o ispitivanju za ocjenu djelotvornosti, podnošljivosti i sigurnosti prelaska na EID nakon najmanje 12 mjeseci na odobrenoj dozi koje traje.
English: Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Croatian: Pokažite svoju Karticu s upozorenjima za bolesnika i ovu uputu o lijeku bilo kojem liječniku koji je uključen u Vaše liječenje, a ne samo svom neurologu.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Croatian: Odmah obavijestite liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti.
English: Contents of the pack and other information What TYSABRI contains
Croatian: Sadržaj pakiranja i druge informacije Što TYSABRI sadrži
English: This active ingredient is called a monoclonal antibody.
Croatian: Ova djelatna tvar naziva se monoklonsko protutijelo.
English: The majority (85%) of patients dosed with EID had received the approved dosing for ≥1 year prior to switching to EID.
Croatian: Većina (85 %) bolesnika liječenih prema EID-u primalo je odobrene doze ≥ 1 godine prije prelaska na EID.
English: If you have all three risks described above your chance of getting PML is higher.
Croatian: Ako imate sva tri gore opisana rizika, mogućnost da dobijete PML je veća.
English: • Reminder not to start Tysabri if there is a serious problem with their immune system
Croatian: • Podsjetnik na to da se Tysabri ne daje ako postoji neki ozbiljni problem s imunosnim sustavom
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system
Croatian: • Možda nećete moći primati TYSABRI ako trenutno primate ili ste prethodno primali lijekove koji djeluju na Vaš imunološki sustav.
English: • If you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
Croatian: • ako imate aktivni tumor (osim ako se radi o vrsti tumora kože koji se zove karcinom bazalnih stanica).
English: Monitoring for potential signs of return of MS disease activity in patients switching dosing intervals.
Croatian: Praćenje potencijalnih znakova povratka aktivnosti bolesti MS-a u bolesnika koji su promijenili interval doziranja.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Croatian: Važno je da čuvate Karticu s upozorenjima za bolesnika te da je pokažete svom partneru ili skrbnicima.
English: • Possibility of other opportunistic infections
Croatian: • Mogućnost drugih oportunističkih infekcija
English: If you have any further questions on TYSABRI, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja o TYSABRIJU, obratite se liječniku.
English: 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.
Croatian: Budući da se znanstvene i medicinske spoznaje, uključujući dijagnostičke kriterije i liječenje IRIS-a, brzo razvijaju, najnovije informacije o preporukama za liječenje zatražite na odjelu za medicinska pitanja u svojoj zemlji.
English: In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Croatian: U kliničkim ispitivanjima TYSABRI je približno prepolovio napredovanje onesposobljujućih učinaka multiple skleroze i smanjio broj napadaja za oko dvije trećine.
English: • Do not use TYSABRI if you are pregnant unless you have discussed this with your doctor.
Croatian: • Ne primajte TYSABRI ako ste trudni, bez prethodnog razgovora sa svojim liječnikom.
English: Initiating treatment with TYSABRI after alemtuzumab is generally not recommended.
Croatian: Prijelaz na TYSABRI nakon liječenja alemtuzumabom uglavnom se ne preporučuje.
English: What TYSABRI looks like and contents of the pack
Croatian: Kako TYSABRI izgleda i sadržaj pakiranja
English: Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Croatian: Bez ubrzanog postupka uklanjanja, klirens teriflunomida iz plazme može trajati od nekoliko mjeseci do 2 godine.
English: Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS.
Croatian: Stoga nakon PLEX-a ili IA-a redovito kliničko praćenje bolesnika, uključujući praćenje MR-om, može biti korisno za rano otkrivanje IRIS-a.
English: • A reminder of where to report side effects
Croatian: • Podsjetnik gdje mogu prijaviti nuspojavu
English: Analysis of STRATIFY JCV showed the prevalence of anti-JCV antibodies to be approximately 55%.
Croatian: JCV pokazala je prevalenciju anti-JCV antitijela od približno 55 %.
English: 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).
Croatian: Ako se upotrebljava produljeni interval doziranja, potreban je oprez jer djelotvornost produljenog intervala doziranja nije utvrđena te povezani omjer koristi i rizika trenutačno nije poznat (vidjeti dio 5.1).
English: • If you are taking medicines that suppress or modulate the immune system including other medicines used to treat MS disease.
Croatian: • ako uzimate lijekove koji potiskuju ili mijenjaju djelovanje imunološkog sustava, uključujući druge lijekove kojima se liječi multipla skleroza.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Croatian: Magnetska rezonancija (0-2 godine) Medijan % promjene volumena hiperintenzivnih lezija T2
English: o Information provided regarding - In all cases where further investigation of change in neurological status or change in brain MRI is indicated, TYSABRI must be suspended and not restarted until non MS pathology has been confidently excluded.
Croatian: o Informacije dane u vezi s tim - u svim slučajevima u kojima je indicirano daljnje istraživanje promjene neurološkog statusa ili promjene MR-a mozga, liječenje lijekom TYSABRI je potrebno prekinuti i ne smije se ponovno započinjati liječenje njime dok se pouzdano ne isključi patologija nepovezana s MS-om.
English: 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.
Croatian: Iako upalna reakcija nakon imunorekonstitucije može biti nužan korak prema uklanjanju stanica zaraženih JCV-om, liječenje aktivne imunosne reakcije može postati nužno radi sprječavanja potencijalne štete koju izaziva IRIS (Talan 2009.; Elston i Thacker 2009.) i može biti opasno po život te samim time zahtijevati liječenje u jedinici intenzivnog liječenja.
English: • Reminder to show the card to patients and caregivers and provides a list of symptoms that may be associated with the development of PML
Croatian: • Podsjetnik na to da karticu pokažete bolesnicima i skrbnicima te osigurate popis simptoma koji bi mogli biti povezani s razvojem PML-a
English: When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
Croatian: Kada počnete primati TYSABRI možda nećete primijetiti poboljšanje, ali TYSABRI ipak djeluje sprječavanjem pogoršanja multiple skleroze.
English: Talk to your doctor before using TYSABRI.
Croatian: Obratite se svom liječniku prije nego primite TYSABRI.
English: In the MS population, anti-JCV antibody prevalence increased with age and was lower in women than in men in all cohorts tested.
Croatian: U populaciji bolesnika s MS-om prevalencija anti-JCV antitijela povećavala se s dobi te je bila manja u žena nego u muškaraca u svim testiranim kohortama.
English: PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown.
Croatian: PML je bolest povezana s nekontroliranim povećanjem broja JC virusa u mozgu, iako je razlog za to povećanje u nekih bolesnika liječenih TYSABRIJEM nepoznat.
English: Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that you speak to your doctor as soon as possible.
Croatian: Stoga ako smatrate da Vam se multipla skleroza pogoršava, ili ako primijetite neke nove simptome dok ste na liječenju TYSABRIJEM ili do 6 mjeseci nakon završetka liječenja TYSABRIJEM, vrlo je važno da se odmah obratite svom liječniku.
English: • Severe allergy (hypersensitivity)
Croatian: • teške alergija (preosjetljivost)
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Čuvati bočicu u originalnom pakiranju radi zaštite od svjetlosti.
English: Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies (see sections 4.4 and 4.8).
Croatian: Bolesnici s povećanim rizikom od oportunističkih infekcija, uključujući imunokompromitirane bolesnike (uključujući bolesnike koji trenutno primaju terapiju imunosupresivima ili koji su imunokompromitirani uslijed prethodnih terapija (vidjeti dijelove 4.4 i 4.8).
English: Other medicines and TYSABRI
Croatian: Drugi lijekovi i TYSABRI
English: 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:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora nakon rasprave i dogovora s nacionalnim regulatornim tijelom svake države članice na čijem se tržištu TYSABRI nalazi, osigurati da svi liječnici koji namjeravaju propisati TYSABRI dobiju komplet za liječnika koji sadrži sljedeće elemente: • Sažetak opisa svojstava lijeka i uputu o lijeku
English: The decision to suspend TYSABRI at any stage may be based on the initial clinical presentation, MRI findings, the evolution of symptoms or signs and/or the response to corticosteroid treatment.
Croatian: Odluka o obustavi lijeka TYSABRI u bilo kojoj fazi može se temeljiti na početnoj kliničkoj slici, nalazima MR-a, razvoju simptoma ili znakova i/ili odgovoru na liječenje kortikosteroidima.
English: • A description of PML, potential symptoms and management of PML
Croatian: • Opis PML-a, potencijalni simptomi i liječenje PML-a
English: MS causes inflammation in the brain that damages the nerve cells.
Croatian: Multipla skleroza uzrokuje upalu u mozgu koja oštećuje živčane stanice.
English: What you need to know before you use TYSABRI
Croatian: Što morate znati prije nego počnete primati TYSABRI
English: • If you do not have antibodies to the JC virus in your blood OR
Croatian: • ako nemate protutijela na JC virus u krvi ILI
English: • Reminder to keep the card with them for 6 months after the last dose of Tysabri
Croatian: • Podsjetnik na to da karticu drže uza se 6 mjeseci nakon zadnje doze lijeka Tysabri
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Croatian: • ako ste liječeni dulje od 2 godine, a imate nižu razinu protutijela na JC virus u krvi.
English: o Description of PML and incidence.
Croatian: o Opis PML-a i incidencije.
English: No recommendation on a posology can be made.
Croatian: Nije moguće dati preporuku o doziranju.
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o Opportunistic infections (other than PML):
Croatian: • Informaciju da je s TYSABRIJEM moguća pojava atipičnih/oportunističkih infekcija, posebno PML, koja uključuje: o Oportunističke infekcije (osim PML-a):
English: If further deterioration occurs during steroid taper and this is judged to be due to continuing or new inflammatory reactions a further course of higher dose steroids may be necessary.
Croatian: U slučaju daljnjeg pogoršanja tijekom postupnog smanjenja steroida i ako se procijeni da su uzrok nastavljene ili nove upalne reakcije, dodatna kura velike doze steroida može biti nužna.
English: Use of plasmapheresis (PLEX) or intravenous immunoglobulin (IVIg) can affect meaningful interpretation of serum antiJCV antibody testing.
Croatian: Primjena plazmafereze (PLEX) ili intravenskog imunoglobulina (i.v.Ig) može utjecati na valjano tumačenje testiranja anti-JCV protutijela u serumu.
English: If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if a switch to TYSABRI is appropriate for you.
Croatian: Ako ste bili liječeni alemtuzumabom, treba temeljito procijeniti i razmotriti s liječnikom je li odluka o prijelazu na TYSABRI za Vas odgovarajuća.
English: • The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes).
Croatian: • Simptomi PML-a mogu nalikovati relapsu multiple skleroze (npr. slabost ili smetnje vida).
English: 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.
Croatian: Budući da stvarno trajanje tih učinaka nije poznato, ne preporučuje se započeti primjenu lijeka TYSABRI poslije alemtuzumaba osim kad je za pojedinog bolesnika jasno da su koristi veće od rizika.
English: • 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)
Croatian: • Bolesnici u kojih je bolest visoko aktivna usprkos potpunom i odgovarajućem ciklusu liječenja barem jednom terapijom koja mijenja tijek bolesti (engl. disease modifying therapy, DMT) (iznimke i podatke o razdobljima ispiranja lijeka iz organizma vidjeti u dijelovima 4.4 i 5.1).
English: • Each vial is for single-use only.
Croatian: • Svaka bočica namijenjena je za jednokratnu uporabu.