FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH01.
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, Inhibitorji dipeptidil peptidaze 4 (DPP-4), oznaka ATC: A10BH01
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Januvia za vse skupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
Slovenian: Ker prilagoditev odmerka temelji na ledvični funkciji, pred začetkom zdravljenja z zdravilom Januvia in periodično tekom zdravljenja priporočamo oceno ledvične funkcije.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Januvia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Slovenian: Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila Januvia kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
English: If you forget to take Januvia
Slovenian: Če ste pozabili vzeti zdravilo Januvia
English: If you stop taking Januvia
Slovenian: Če ste prenehali jemati zdravilo Januvia
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Slovenian: Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo Januvia lahko jemlje s hrano ali brez nje.
English: Method of administration Januvia can be taken with or without food.
Slovenian: Način uporabe Zdravilo Januvia lahko bolnik jemlje skupaj s hrano ali brez nje.
English: In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Slovenian: Poleg tega sta bili po 12 tednih povprečni zmanjšanji vrednosti HbA1c (sitagliptin -0,59 %, placebo -0.18 %) in vrednosti glukoze v plazmi na tešče (sitagliptin -25,5 mg/dl, placebo -3.0 mg/dl) na splošno podobni kot v drugih študijah s samostojnim zdravilom pri bolnikih z normalno ledvično funkcijo (glejte poglavje 5.2).
English: If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik izpusti odmerek zdravila Januvia, ga mora vzeti takoj, ko se spomni.
English: What Januvia looks like and contents of the pack
Slovenian: Izgled zdravila Januvia in vsebina pakiranja
English: Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Slovenian: Zdravilo Januvia je indicirano tudi kot dodatno zdravljenje k insulinu (z metforminom ali brez), če z dieto in s telesno aktivnostjo ter stabilnim odmerkom insulina urejenost glikemije ni zadostna.
English: Some patients have experienced the following side effects while taking sitagliptin and pioglitazone: Common: flatulence, swelling of the hands or legs
Slovenian: Pri nekaterih bolnikih, ki so jemali sitagliptin in pioglitazon, so se pojavili naslednji neželeni učinki: Pogosti: napenjanje, otekanje dlani ali nog
English: Januvia has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Januvia nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Pri uporabi zdravila Januvia v kombinaciji s sulfonilsečnino ali z insulinom lahko po potrebi zmanjšate odmerek sulfonilsečnine ali insulina, da se tako zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily.
Slovenian: Pri bolnikih s hudo ledvično okvaro (GFR ≥ 15 do < 30 ml/min) ali bolnikih s končno ledvično odpovedjo (ESRD - end-stage renal disease) (GFR < 15 ml/min), vključno s tistimi, ki potrebujejo hemodializo ali peritonealno dializo, je odmerek zdravila Januvia 25 mg enkrat na dan.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Januvia is 50 mg once daily.
Slovenian: Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je odmerek zdravila Januvia 50 mg enkrat na dan.
English: How to take Januvia
Slovenian: Kako jemati zdravilo Januvia
English: The usual recommended dose is: one 100 mg film-coated tablet once a day by mouth
Slovenian: Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta,
English: Januvia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Slovenian: Pri bolnikih s hudo jetrno okvaro uporaba zdravila Januvia ni raziskana, zato je potrebna previdnost (glejte poglavje 5.2).
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia (see section 4).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Januvia, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
English: It is important to stay on the diet and exercise recommended by your doctor while taking Januvia.
Slovenian: Med jemanjem zdravila Januvia je pomembno, da se držite diete in telesne aktivnosti, ki vam ju je priporočil zdravnik.
English: What Januvia contains
Slovenian: Kaj vsebuje zdravilo Januvia
English: Skin and subcutaneous tissue disorders pruritus
Slovenian: Bolezni kože in podkožja pruritus občasni
English: Januvia should not be used during breast-feeding.
Slovenian: Med dojenjem se zdravila Januvia ne sme jemati.
English: Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Slovenian: Zdravilo Januvia spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).
English: If a hypersensitivity reaction is suspected, Januvia should be discontinued.
Slovenian: Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom Januvia.
English: The level of digoxin in your blood may need to be checked if taking with Januvia.
Slovenian: Med sočasnim jemanjem z zdravilom Januvia vam bodo morda morali preveriti vrednosti digoksina v krvi.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Slovenian: Pri psih so pri izpostavljenosti, ki je bila približno 23-krat večja od izpostavljenosti pri klinični uporabi, opazili z zdravljenjem povezane prehodne fizične znake, med katerimi so nekateri kazali na škodljive učinke na živčevje, npr. dihanje z odprtimi usti, slinjenje, bruhanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ali zgrbljena drža.
English: Placebo-corrected mean change in HbA1c (%) (95 % CI)
Slovenian: Srednja sprememba vrednosti HbA1c od izhodišča (%)
English: If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted.
Slovenian: Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Januvia in drugih zdravil, ki bi lahko povzročila pankreatitis.
English: Paediatric No studies with Januvia have been performed in paediatric patients.
Slovenian: Otroci Pri otrocih študij z zdravilom Januvia niso izvedli.
English: How to store Januvia
Slovenian: Shranjevanje zdravila Januvia
English: Januvia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Slovenian: Zdravilo Januvia vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
English: - type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
Slovenian: - sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo Januvia (glejte poglavje 4)
English: Januvia 25 mg tablets Sitagliptin
Slovenian: Januvia 25 mg tablete sitagliptin
English: In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with a sulphonylurea or with insulin.
Slovenian: Poleg tega je treba bolnike, ki jemljejo zdravilo Januvia skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
English: Januvia 100 mg tablets Sitagliptin
Slovenian: Januvia 100 mg tablete sitagliptin
English: No dose adjustment for Januvia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
English: Januvia 50 mg tablets Sitagliptin
Slovenian: Januvia 50 mg tablete sitagliptin
English: If bullous pemphigoid is suspected, Januvia should be discontinued.
Slovenian: Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Januvia prekiniti.
English: EU/1/07/383/013 14 film-coated tablets EU/1/07/383/014 28 film-coated tablets EU/1/07/383/023 30 film-coated tablets EU/1/07/383/015 56 film-coated tablets EU/1/07/383/016 84 film-coated tablets EU/1/07/383/024 90 film-coated tablets EU/1/07/383/017 98 film-coated tablets EU/1/07/383/018 50 x 1 film-coated tablets
Slovenian: EU/1/07/383/013 14 filmsko obloženih tablet EU/1/07/383/014 28 filmsko obloženih tablet EU/1/07/383/023 30 filmsko obloženih tablet EU/1/07/383/015 56 filmsko obloženih tablet EU/1/07/383/016 84 filmsko obloženih tablet EU/1/07/383/024 90 filmsko obloženih tablet EU/1/07/383/017 98 filmsko obloženih tablet EU/1/07/383/018 50 x 1 filmsko obložena tableta
English: EU/1/07/383/007 14 film-coated tablets EU/1/07/383/008 28 film-coated tablets EU/1/07/383/021 30 film-coated tablets EU/1/07/383/009 56 film-coated tablets EU/1/07/383/010 84 film-coated tablets EU/1/07/383/022 90 film-coated tablets EU/1/07/383/011 98 film-coated tablets EU/1/07/383/012 50 x 1 film-coated tablets
Slovenian: EU/1/07/383/007 14 filmsko obloženih tablet EU/1/07/383/008 28 filmsko obloženih tablet EU/1/07/383/021 30 filmsko obloženih tablet EU/1/07/383/009 56 filmsko obloženih tablet EU/1/07/383/010 84 filmsko obloženih tablet EU/1/07/383/022 90 filmsko obloženih tablet EU/1/07/383/011 98 filmsko obloženih tablet EU/1/07/383/012 50 x 1 filmsko obložena tableta
English: EU/1/07/383/001 14 film-coated tablets EU/1/07/383/002 28 film-coated tablets EU/1/07/383/019 30 film-coated tablets EU/1/07/383/003 56 film-coated tablets EU/1/07/383/004 84 film-coated tablets EU/1/07/383/020 90 film-coated tablets EU/1/07/383/005 98 film-coated tablets EU/1/07/383/006 50 x 1 film-coated tablets
Slovenian: EU/1/07/383/001 14 filmsko obloženih tablet EU/1/07/383/002 28 filmsko obloženih tablet EU/1/07/383/019 30 filmsko obloženih tablet EU/1/07/383/003 56 filmsko obloženih tablet EU/1/07/383/004 84 filmsko obloženih tablet EU/1/07/383/020 90 filmsko obloženih tablet EU/1/07/383/005 98 filmsko obloženih tablet EU/1/07/383/006 50 x 1 filmsko obložena tableta
English: Januvia 100 mg film-coated tablets
Slovenian: Januvia 100 mg filmsko obložene tablete
English: Januvia 25 mg film-coated tablets
Slovenian: Januvia 25 mg filmsko obložene tablete
English: Januvia 50 mg film-coated tablets
Slovenian: Januvia 50 mg filmsko obložene tablete
English: Januvia 100 mg film-coated tablets Sitagliptin
Slovenian: Januvia 100 mg filmsko obložene tablete sitagliptin
English: Januvia 50 mg film-coated tablets Sitagliptin
Slovenian: Januvia 50 mg filmsko obložene tablete sitagliptin
English: Januvia 25 mg film-coated tablets Sitagliptin
Slovenian: Januvia 25 mg filmsko obložene tablete sitagliptin
English: p<0.001 compared to placebo or placebo + combination treatment.
Slovenian: 0,7 % med tistimi, ki so prejemali placebo.
English: Least squares mean adjusted for metformin use at Visit 1 (yes/no), insulin use at Visit 1 (pre-mixed vs. non-pre-mixed [intermediate- or long-acting]), and baseline value.
Slovenian: * Vsi zdravljeni bolniki (“intention-to-treat” analiza) Povprečje najmanjših kvadratov, prilagojeno predhodnemu statusu zdravljenja sladkorne bolezni in začetni vrednosti p < 0,001 v primerjavi s placebom ali placebom + kombiniranim zdravljenjem HbA1c (%) v 18. tednu HbA1c (%) v 24. tednu HbA1c (%) v 26. tednu Povprečje najmanjših kvadratov, prilagojeno glede na uporabo metformina pri 1. obisku (da/ne), glede na uporabo insulina pri 1. obisku (dvofazni oz. srednje ali dolgo delujoči) in glede na začetno vrednost.
English: The physician educational programme should contain the following key elements:
Slovenian: Izobraževalni program za zdravnike mora vsebovati naslednje ključne elemente:
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment
Slovenian: Države članice morajo zagotoviti, da bo imetnik dovoljenja za promet z zdravilom uvedel izobraževalni program za zdravnike, ki bo namenjeno zagotavljanju izbire primernega mesta za injiciranje zdravila za čimmanjšo pojavnost neželenih učinkov, ki so povezani z injiciranjem, ter informiranju o pričakovanih in možnih tveganjih, ki so povezani z zdravljenjem, preden da zdravilo v promet.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY MEMBER STATES
Slovenian: Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
English: • The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider.
Slovenian: • potreba po informiranju bolnikov o znakih in simptomih, ki so povezani z zdravljenjem, ter o tem, kdaj morajo poiskati pomoč zdravstvenega osebja,
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the Member States
Slovenian: DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
English: • Reminder of the need to report adverse events, including medication errors.
Slovenian: • opomnik, da je potrebno poročanje o neželenih učinkih, vključno z napakami pri zdravljenju,
English: • Injection technique and dosing interval.
Slovenian: • tehnika injiciranja in interval med posameznimi odmerki,
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Slovenian: • informacije o možnem tveganju navzkrižnih reakcij matričnih metaloproteinaz (MMP), vključno z razvojem mišično-skeletnega sindroma in poslabšanjem/pojavom avtoimunih obolenj,
English: • Information on bleeding risk in patients with coagulation disorders including those on concurrent anti-coagulation therapy.
Slovenian: • informacije o tveganju za krvavitev pri bolnikih z motnjami koagulacije, vključno s tistimi, ki sočasno prejemajo antikoagulacijsko zdravljenje,
English: • Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints.
Slovenian: • ustrezne količine rekonstitucijske tekočine in tekočine za injiciranje, ki so različne za metakarpofalangealne (MP) in proksimalne interfalagealne (PIP) sklepe,
English: • Recognition and treatment of severe immune-mediated reaction, including anaphylaxis.
Slovenian: • prepoznava in zdravljenje resnih reakcij, povezanih z imunostjo, vključno z anafilaksijo,
English: • The summary of product characteristics and the patient information leaflet
Slovenian: • povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: It may harm them,
Slovenian: To so lahko znaki poškodbe ušesnih kosti;
English: These measures will help protect the environment
Slovenian: Taki ukrepi pomagajo varovati okolje.
English: • you have cancer.
Slovenian: • imate raka.
English: 79539, Germany
Slovenian: 79539, Nemčija
English: • you are a smoker (as this may increase the risk of dental problems)
Slovenian: • ste kadilec (ker lahko kajenje poveča tveganje za težave z zobovjem);
English: Bondronat is indicated in adults for
Slovenian: Bondronat je indiciran pri odraslih za:
English: You can help stop this happening by doing the following:
Slovenian: To lahko preprečite tako, da:
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Slovenian: • če ne morete stati ali sedeti pokončno vsaj eno uro (60 minut),
English: Number of events (per patient)
Slovenian: število dogodkov (na bolnika)
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Slovenian: Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): • napad astme.
English: • Do not use this medicine if you notice that the solution is not clear or contains particles
Slovenian: • Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali vsebuje vidne delce.
English: Acetic acid (99%)
Slovenian: Ocetna kislina (99 %)
English: They are available in packs of 28 and 84 tablets.
Slovenian: Na voljo so v pakiranju po 28 in 84 tablet.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimization) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: If you develop these symptoms, stop taking Bondronat and tell your doctor straight away (see sections 3 and 4).
Slovenian: Če se pojavijo ti simptomi, prenehajte z jemanjem zdravila Bondronat in takoj obvestite svojega zdravnika (glejte poglavji 3 in 4).
English: • you don't receive routine dental care or have not had a dental check up for a long time
Slovenian: • nimate redne zobozdravstvene oskrbe ali že dolgo niste bili na pregledu pri zobozdravniku;
English: The usual dose of Bondronat is one tablet each day.
Slovenian: Običajni odmerek zdravila Bondronat je ena tableta vsak dan.
English: Bondronat with food and drink
Slovenian: Zdravilo Bondronat skupaj s hrano in pijačo
English: **See further information below †Identified in post-marketing experience.
Slovenian: **Glejte nadaljne informacije spodaj † ugotovljeni po prihodu zdravila na trg
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRIDUCT
Slovenian: PRILOGA II A. IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: • rise in body temperature
Slovenian: • zvišanje telesne temperature,
English: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Slovenian: V nekaterih primerih ti dogodki niso prenehali, dokler niso ibandronske kisline ukinili.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 1996
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 25. junij 1996 Datum zadnjega podaljšanja: 25. junij 2006
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano
English: Analgesic use *
Slovenian: uporaba analgezije *
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorsation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • if you are allergic to any other bisphosphonates
Slovenian: • če ste alergični na druge difosfonate,
English: Do not take Bondronat:
Slovenian: Ne jemljite zdravila Bondronat:
English: Other medicines and Bondronat
Slovenian: Druga zdravila in zdravilo Bondronat
English: even if their signs of illness are the same as yours
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: What Bondronat is and what it is used for
Slovenian: Kaj je zdravilo Bondronat in za kaj ga uporabljamo
English: This belongs to a group of medicines called bisphosphonates.
Slovenian: Spada v skupino zdravil, imenovano difosfonati.
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Bondronat tablets.
Slovenian: Pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom in hrano, lahko vplivajo na absorpcijo tablet Bondronat.
English: Before receiving treatment, tell your doctor/nurse (health care professional) if:
Slovenian: Pred zdravljenjem obvestite zdravnika/medicinsko sestro (zdravstvenega delavca), če:
English: • dry mouth, strange taste in your mouth or difficulty swallowing
Slovenian: • suha usta, čuden okus v ustih ali težave pri požiranju,
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Children and adolescents Bondronat should not be used in children and adolescents below the age of 18 years.
Slovenian: Otroci in mladostniki Zdravilo Bondronat se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.