FrancophonIA/ELRC3.0 huggingface dataset:
English: Having considered the totality of the data submitted by the MAHs related to the use of suppositories containing terpenic derivatives in children less than 30 months and taking into account the data identified during the 2010 French safety review, the CHMP was of the opinion that suppositories containing terpenic derivatives can induce neurological disorders, especially convulsions, in children less than 30 months, due to the immaturity of the central nervous system which results in a higher susceptibility to neurological toxicity.
Slovenian: Ob upoštevanju skupnih podatkov, ki so jih predložili imetniki dovoljenja za promet z zdravilom v zvezi z uporabo svečk, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev, in ob upoštevanju podatkov, pridobljenih med francoskim varnostnim pregledom leta 2010, je CHMP menil, da lahko svečke, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev, povzročajo nevrološke bolezni, zlasti krče, in sicer zaradi nezrelosti osrednjega živčnega sistema pri navedeni populaciji, kar povzroča večjo občutljivost za nevrološko toksičnost.
English: The CHMP also noted that underreporting due to the non-prescription status can be assumed.
Slovenian: CHMP je tudi ugotovil, da je zaradi statusa zdravila brez recepta mogoče domnevati, da so poročila pomanjkljiva.
English: In addition, the suppositories can also be associated with the risk of rectal burning.
Slovenian: Poleg tega pa so svečke lahko povezane tudi s tveganjem za pekočo bolečino v danki.
English: The CHMP therefore concluded that the use of suppositories containing terpenic derivatives should be contraindicated in children less than 30 months, as well as in children with a history of epilepsy or febrile convulsion and in children with a recent history of anorectal lesion.
Slovenian: CHMP je zato sklenil, da mora biti uporaba svečk, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev, kontraindicirana, prav tako pa tudi pri otrocih z anamnezo epilepsije ali vročinskih krčev in pri otrocih z nedavno anamnezo anorektalnih lezij.
English: The main changes, agreed by the CHMP and to be included as relevant in the PI of all suppositories containing terpenic derivatives, according to the intended age range of the product, were the introduction in Section 4.3 of contraindications in children less than 30 months due to the risk of neurological disorders, especially convulsions, as well as in children with a history of febrile convulsion or epilepsy and in children with a recent history of anorectal lesion.
Slovenian: Glavna sprememba, ki jo je potrdil CHMP in ki se ustrezno vključi v informacije o zdravilu za vse svečke, ki vsebujejo derivate terpena, kakor je ustrezno ob upoštevanju načrtovanega starostnega razpona za uporabo zdravila, je bila vključitev kontraindikacij za otroke, mlajše od 30 mesecev, zaradi tveganja za pojavljanje nevroloških bolezni, še posebej krčev, ter za otroke z anamnezo vročinskih krčev ali epilepsije in za otroke z nedavno anamnezo anorektalnih lezij v poglavje 4.3.
English: The amendments to the relevant sections of the Summary of Product Characteristics, Labelling and Package Leaflet are set out in Annex III
Slovenian: Dopolnila ustreznih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so navedena v Dodatku III.
English: the CHMP has recommended the revocation or the variation, as applicable taking into consideration the age range of the approved population, of the Marketing Authorisations for suppositories containing terpenic derivatives (see Annex I).
Slovenian: CHMP je priporočil preklic oz. spremembo dovoljenj za promet z zdravili v obliki svečk, ki vsebujejo derivate terpena, kakor je ustrezno glede na starostni razpon odobrene populacije (glejte Dodatek I).
English: Grounds for the revocation or for the amendment of relevant sections of the summaries of product characteristics, labelling and package leaflet of the marketing authorisations, as applicable taking into consideration the age range of the approved population.
Slovenian: Podlaga za preklic oz. dopolnilo ustreznih poglavij povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo v dovoljenjih za promet z zdravilom, kakor je ustrezno glede na starostni razpon odobrene populacije
English: • The overall efficacy data is scarce in the paediatric population and absent in children less than 30 months.
Slovenian: • Skupni podatki o učinkovitosti pri pediatrični populaciji so skromni, pri otrocih, mlajših od 30 mesecev, pa jih ni. Celokupne terapevtske koristi so bile ocenjene kot omejene;
English: • The CHMP concluded that the benefit-risk balance of suppositories containing terpenic derivatives in children less than 30 months is not positive under normal conditions of use and that their use should therefore be contraindicated in this age population as well as in children with a history of epilepsy or febrile convulsion and in children with a recent history of anorectal lesion;
Slovenian: pri otrocih, mlajših od 30 mesecev, pod normalnimi pogoji uporabe ni pozitivno ter da mora biti njihova uporaba v tej starostni skupini kontraindicirana, prav tako pa tudi pri otrocih z anamnezo epilepsije ali vročinskih krčev in pri otrocih z nedavno anamnezo anorektalnih lezij.
English: The CHMP assessed the revised PI proposals submitted by the MAHs.
Slovenian: CHMP je ocenil predloge za spremenjene informacije o zdravilu, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
English: • Serious adverse drug reactions including neurological events, mainly convulsions, have been associated with the use of suppositories containing terpenic derivatives in children less than 30 months;
Slovenian: • Z uporabo svečk, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev, so povezani hudi neželeni učinki, vključno z nevrološkimi dogodki, predvsem krči.
English: Date of first authorisation: 19th November 2014 Date of latest renewal:
Slovenian: Datum prve pridobitve: 19. november 2014 Datum zadnjega podaljšanja:
English: Lactose is a type of sugar found in milk.
Slovenian: Laktoza je vrsta sladkorja, ki jo najdemo v mleku.
English: Special populations: Elderly patients (≥65 years old)
Slovenian: Starejši bolniki (≥ 65 let)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updatespublished on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Slovenian: Obstajajo določeni dokazi, da se tveganje za pljučnico povečuje s povečevanjem odmerka steroida, vendar to ni bilo dokončno dokazano v vseh študijah.
English: • Disturbance of the heart's electrical system (prolongation of the QTc-interval).
Slovenian: • motnje električnega sistema srca (podaljšanje intervala QTc),
English: OTHER SPECIAL WARNING(S), IF NECESSARY Front panel: Not for use in children and adolescents.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Sprednja ploskev: Ni za uporabo pri otrocih in mladostnikih.
English: Median FEV1 at inclusion in the trials was 36% of predicted normal.
Slovenian: Mediana FEV1 ob vključitvi v preskušanja je bila 36 % predvidene normalne FEV1.
English: It is important that you take your dose as advised by your doctor.
Slovenian: Pomembno je, da vzamete takšen odmerek, kot vam ga je določil zdravnik.
English: 120 doses
Slovenian: 120 odmerkov
English: • Budesonide belongs to a group of medicines called ‘corticosteroids' also known as ‘steroids'.
Slovenian: • Budezonid spada v skupino zdravil, imenovanih »kortikosteroidi«, ki so poznani tudi kot »steroidi«.
English: Every time you need to take an inhalation, follow the instructions below.
Slovenian: Vsakokrat, ko morate vdihniti zdravilo, upoštevajte spodnja navodila.
English: Adults (18 years and older)
Slovenian: Odrasli (18 let in več)
English: 60 doses
Slovenian: 60 odmerkov
English: These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Slovenian: Ti znaki lahko pomenijo, da astma ali KOPB ni dobro obvladana in morda boste morali takoj dobiti drugačna ali dodatna zdravila.
English: • Changes in your blood pressure.
Slovenian: • spremembe krvnega tlaka.
English: After opening the foil wrap: 6 months.
Slovenian: Po odprtju ovoja iz folije: 6 mesecev.
English: • It is important to use Budesonide/Formoterol Teva every day, even if you have no asthma or COPD symptoms at the time.
Slovenian: • Pomembno je, da zdravilo Budezonid/formoterol Teva uporabite vsak dan, tudi če trenutno nimate simptomov astme ali KOPB.
English: • Chest pain or tightness in the chest (angina pectoris).
Slovenian: • bolečina ali tiščanje v prsih (angina pektoris),
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Slovenian: če ste alergični na budezonid, formoterolijev fumarat dihidrat, ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: (budesonide/formoterol fumarate dihydrate)
Slovenian: (budezonid/formoterolijev fumarat dihidrat)
English: Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The use of Budesonide/Formoterol Teva follows three simple steps: open, breathe and close which are outlined below.
Slovenian: Uporaba zdravila Budezonid/formoterol Teva zajema tri preproste korake: odprite, vdihnite in zaprite, ki so opisani spodaj.
English: • Increased cough or increased breathing difficulties
Slovenian: • močnejši kašelj ali več težav z dihanjem.
English: • Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness.
Slovenian: • otekanje obraza, zlasti okrog ust (jezik in/ali žrelo in/ali težave s požiranjem) ali koprivnica, skupaj s težkim dihanjem (angioedem) in/ali nenadnim občutkom omedlevice.
English: Oral infections
Slovenian: Oralne okužbe
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol Teva, medical attention must be sought (see section 4.2).
Slovenian: Če bolnik ugotavlja, da je zdravljenje neučinkovito, ali če preseže največji priporočeni odmerek zdravila Budezonid/formoterol Teva, mora poiskati zdravniško pomoč (glejte poglavje 4.2).
English: If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva.
Slovenian: Če se ti učinki pojavijo, so po navadi blagi in po navadi izginejo med nadaljevanjem zdravljenja z zdravilom Budezonid/formoterol Teva.
English: Budesonide/Formoterol Teva should be used correctly in order to achieve effective treatment.
Slovenian: Zdravilo Budezonid/formoterol Teva je treba uporabljati pravilno, da bo doseženo učinkovito zdravljenje.
English: • Bruising of the skin.
Slovenian: • podplutbe na koži,
English: Before using your Budesonide/Formoterol Teva for the first time, you need to prepare it for use as follows:
Slovenian: Preden prvikrat uporabite nov inhalator Budezonid/formoterol Teva, ga morate pripraviti za uporabo na naslednji način:
English: • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
Slovenian: • Formoterolijev fumarat dihidrat spada v skupino zdravil, imenovanih »dolgodelujoči agonisti adrenergičnih receptorjev β2« ali »bronhodilatatorji«.
English: Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravnik vam je to zdravilo predpisal za zdravljenje astme ali kronične obstruktivne pljučne bolezni (KOPB).
English: COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.
Slovenian: KOPB je dolgotrajna bolezen dihalnih poti v pljučih, ki jo pogosto povzroči kajenje.
English: Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Slovenian: Simptomatsko zdravljenje bolnikov s hudo obliko KOPB (FEV1 < 50 % predvidenega normalnega FEV1) in s ponavljajočimi se poslabšanji v anamnezi, pri katerih se kljub zdravljenju z dolgodelujočimi bronhodilatatorji pojavljajo znatni simptomi.
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Slovenian: Zdravniki morajo biti pri bolnikih s KOPB pozorni na morebiten pojav pljučnice, kajti klinične značilnosti takšne okužbe se prekrivajo s simptomi poslabšanj KOPB.
English: Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
Slovenian: Nenadno in progresivno poslabšanje nadzora simptomov astme ali KOPB je lahko za bolnika življenjsko nevarno, zato je potreben nujen zdravniški pregled.
English: Important information about your asthma or COPD symptoms
Slovenian: Pomembne informacije o simptomih astme ali KOPB
English: Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
Slovenian: Dolgoročne študije z inhalacijskim budezonidom pri otrocih v povprečnih dnevnih odmerkih 400 mikrogramov (odmerjen odmerek) ali pri odraslih v dnevnih odmerkih 800 mikrogramov (odmerjen odmerek) niso pokazale pomembnega vpliva na kostno mineralno gostoto.
English: Hold your breath for 10 seconds or as long as you comfortably can. 6.
Slovenian: Zadržite dih za 10 sekund ali za toliko časa, kot lahko, ne da bi vam bilo ob tem neudobno.
English: • Medicines for allergies or antihistamines (such as terfenadine).
Slovenian: • zdravila proti alergijam ali antihistaminiki (kot je npr. terfenadin).
English: The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva than you should are trembling, headache or a rapid heartbeat.
Slovenian: Najpogostejši simptomi, ki se lahko pojavijo, če ste uporabili večji odmerek zdravila Budezonid/formoterol Teva, kot bi smeli, so tresenje, glavobol in hitro bitje srca.
English: It works by relaxing the muscles in your airways.
Slovenian: Deluje tako, da sprošča mišice v dihalnih poteh.
English: In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly.
Slovenian: V takih okoliščinah je treba redno spremljati delovanje osi hipotalamus-hipofiza-nadledvična žleza (HPA).
English: The dosage of Budesonide/Formoterol Teva is individual and should be adjusted to the severity of the disease.
Slovenian: Odmerjanje zdravila Budezonid/formoterol Teva je individualno in ga je treba prilagoditi stopnji resnosti bolezni.
English: This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
Slovenian: To pomaga preprečiti, da bi se pojavili simptomi astme, kot sta zasoplost in piskajoče dihanje.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Slovenian: Med dejavniki tveganja za pljučnico pri bolnikih s KOPB so trenutno kajenje, višja starost, nizek indeks telesne mase (ITM) in huda KOPB.
English: Chronic Obstructive Pulmonary Disease (COPD) Recommended dose:
Slovenian: Kronična obstruktivna pljučna bolezen (KOPB) Priporočeni odmerek:
English: For changes in lung-function parameters, such as FEV1, budesonide/formoterol was not superior to treatment with formoterol alone.
Slovenian: Pri spremembah parametrov pljučne funkcije, kot je FEV1, se kombinacija budezonid/formoterol ni izkazala za boljšo kot zdravljenje s samim formoterolom.
English: If you are regularly using up to 8 inhalations a day or you need to increase the amount of ‘reliever inhaler' you require, you should see your doctor as soon as possible.
Slovenian: Če redno uporabljate do 8 inhalacij na dan ali morate povečati odmerek »inhalatorja z olajševalcem«,ki ga potrebujete, obiščite zdravnika.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose')
Slovenian: - Pomožna snov je laktoza monohidrat (glejte poglavje 2 pod »Zdravilo Budezonid/formoterol Teva vsebuje laktozo«).
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Slovenian: Ni dokončnih kliničnih dokazov, da se stopnja tveganja za pljučnico znotraj skupine inhalacijskih kortikosteroidnih zdravil razlikuje.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornih za sproščanje serij
English: Contains 1 inhaler.
Slovenian: Vsebuje 1 inhalator.
English: Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 micrograms).
Slovenian: Omejeni podatki o tej interakciji za visokoodmerni inhalacijski budezonid kažejo, da lahko pride do bistvenega povečanja plazemskih koncentracij (v povprečju štirikratnih), če itrakonazol, 200 mg enkrat na dan, dajemo sočasno z inhalacijskim budezonidom (enkratni odmerek 1.000 mikrogramov).
English: The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group).
Slovenian: Povprečno število poslabšanj bolezni na leto (kot je opredeljeno zgoraj) je bilo pri budezonidu/formoterolu značilno zmanjšano v primerjavi z zdravljenjem s samim formoterolom ali placebom (povprečna vrednost 1,4 v primerjavi z 1,8-1,9 v skupini s placebom/formoterolom).
English: • If you are using Budesonide/Formoterol Teva for asthma, your doctor will want to regularly check your symptoms.
Slovenian: • Če zdravilo Budezonid/formoterol Teva uporabljate za astmo, vas bo zdravnik redno nadziral glede simptomov.
English: Budesonide/Formoterol Teva is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Slovenian: Zdravilo Budezonid/formoterol Teva ni indicirano pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 4.2).
English: Budesonide/Formoterol Teva has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Budezonid/formoterol Teva nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Do not use Budesonide/Formoterol Teva to treat these asthma symptoms.
Slovenian: Ne uporabljate zdravila Budezonid/formoterol Teva za odpravljanje teh simptomov astme.
English: Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Slovenian: Simptomi in znaki, ki se lahko pojavijo pri akutni adrenalni krizi, so včasih nejasni, lahko pa vključujejo anoreksijo, bolečine v trebuhu, izgubo telesne teže, utrujenost, glavobol, navzeo, bruhanje, motnje zavesti, konvulzije, hipotenzijo in hipoglikemijo.
English: Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Slovenian: Zato je treba razmisliti o dodatni uporabi sistemskih kortikosteroidov v obdobjih stresa, kot so npr. hude okužbe ali pred neurgentnimi kirurškimi posegi.
English: A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Slovenian: Kombinacijo budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih predpisujte previdno pri bolnikih s tirotoksikozo, feokromocitomom, sladkorno boleznijo, nezdravljeno hipokaliemijo, hipertrofično obstruktivno kardiomiopatijo, idiopatsko subvalvularno aortno stenozo, hudo hipertenzijo, anevrizmo ali drugimi hudimi kardiovaskularnimi boleznimi, kot so na primer ishemična srčna bolezen, tahiaritmije ali hudo srčno popuščanje.
English: The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold.
Slovenian: Močni zaviralec CYP3A4 ketokonazol je v odmerku 200 mg enkrat na dan povečal plazemsko koncentracijo sočasno uporabljanega peroralnega budezonida (enkratni odmerek 3 mg) v povprečju za 6-krat.
English: Chronic obstructive pulmonary disease (COPD)
Slovenian: Kronična obstruktivna pljučna bolezen (KOPB)
English: If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva.
Slovenian: Če za zdravljenje astme ali KOPB jemljete steroide v obliki tablet, vam bo zdravnik morda zmanjšal število tablet, ki jih jemljete, ko boste začeli uporabljati zdravilo Budezonid/formoterol Teva.
English: • Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
Slovenian: • nenadno akutno piskajoče dihanje in/ali težko dihanje nemudoma po uporabi inhalatorja (imenovano tudi »paradoksni bronhospazem«).
English: Patients should not be initiated on Budesonide/Formoterol Teva during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Slovenian: Bolnikom se ne sme uvesti zdravila Budezonid/formoterol Teva med poslabšanjem astme ali v obdobju pomembnega oziroma akutnega poslabšanja simptomov astme.
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Slovenian: En odmerek vsebuje približno 10 miligramov laktoze (v obliki monohidrata).
English: The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Slovenian: Povprečna PIFR, ki so jo dosegli bolniki z astmo ali KOPB, je presegala 60 l/min, pri tej stopnji obe preiskovani napravi v pljuča dovedeta primerljivi količini zdravila.
English: Recommended doses:
Slovenian: Priporočeni odmerki:
English: Budesonide/Formoterol Teva contains two different active substances: budesonide and formoterol fumarate dihydrate.
Slovenian: Zdravilo Budezonid/formoterol Teva vsebuje dve različni zdravilni učinkovini: budezonid in formoterolijev fumarat dihidrat.