FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose.
Slovenian: Po tretjem in četrtem odmerku je bila mediana maksimalne inhibicije 6 dni po odmerku 74 % z zmanjšanjem na mediano inhibicije 56 % 28 dni po četrtem odmerku.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Medsebojno delovanje s hrano
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Slovenian: Ti prečni ali kratki poševni zlomi se lahko pojavljajo kjer koli na stegnenici, od mesta tik pod malim trohanterjem do tik nad suprakondilarno grčo.
English: The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Slovenian: Inhibicijo endogene resorpcije kosti so dokazali tudi s kinetičnimi študijami 45Ca in sproščanjem radioaktivnega tetraciklina, predhodno vgrajenega v okostje.
English: Drink a full glass of milk before you go. Do not make yourself sick.
Slovenian: Pred odhodom popijte poln kozarec mleka.
English: *See further information below †Identified in post-marketing experience.
Slovenian: *Glejte nadaljnje informacije spodaj † ugotovljeni po prihodu zdravila na trg
English: • asthma attacks
Slovenian: • napad astme
English: - Swallow your tablet with a full glass of water (at least 180 ml).
Slovenian: - Pogoltnite tableto in popijte poln kozarec vode (vsaj 180 ml).
English: A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Slovenian: Dokazano je bilo zmanjšanje tveganja za vretenčne zlome, učinkovitosti pri zlomih stegneničnega vratu pa niso ugotovili.
English: This helps to stop your bones from getting weaker.
Slovenian: To pomaga zaustaviti napredovanje krhkosti vaših kosti.
English: After taking your tablet, wait at least 30 minutes.
Slovenian: Potem, ko vzamete tableto, počakajte vsaj 30 minut.
English: If you forget to take Ibandronic Acid Teva - If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Slovenian: Če ste pozabili vzeti zdravilo Ibandronska kislina Teva - Če ste pozabili vzeti tableto na jutro izbranega dne, ne vzemite tablete pozneje v istem dnevu.
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i.e. months 3, 6, 12 and 24.
Slovenian: Biokemični označevalci kostne premene Klinično pomembno zmanjšanje serumskih vrednosti CTX so opazili ob merjenju v vseh časovnih obdobjih, to je po 3, 6, 12 in 24 mesecih.
English: As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
Slovenian: Ker so izračunane vrednosti precej odvisne od trajanja študije, uporabljenega odmerka in občutljivosti metode, je pravi končni razpolovni čas verjetno precej daljši,
English: Fasting should be continued for at least 30 minutes after taking the tablet.
Slovenian: Bolnik se mora postiti še vsaj 30 minut po tem, ko vzame tableto.
English: Inability to stand or sit upright for at least 60 minutes
Slovenian: - Nesposobnost stanja ali vzravnanega sedenja vsaj 60 minut.
English: Then you can have your first food and drink, and take any medicines or supplements (see section 3).
Slovenian: Nato lahko zaužijete prvo hrano, pijačo in druga zdravila ali dodatke (glejte poglavje 3).
English: No statistically significant difference was attained after 1 year of treatment (p=0.056).
Slovenian: Po enem letu zdravljenja niso opazili statistično pomembne razlike (p = 0,056).
English: The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
Slovenian: Optimalno trajanje zdravljenja osteoporoze z difosfonati še ni določeno.
English: • After taking your tablet, wait at least 30 minutes.
Slovenian: • Ko vzamete tableto, počakajte vsaj 30 minut.
English: Month 2
Slovenian: Mesec 2
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Ibandronic Acid Teva on an individual patient basis, particularly after 5 or more years of use.
Slovenian: Potrebo po nadaljevanju zdravljenja z zdravilom Ibandronska kislina Teva je treba periodično ponovno oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
English: This belongs to a group of medicines called bisphosphonates.
Slovenian: Spada v skupino zdravil imenovano difosfonati.
English: A tabular summary of the secondary efficacy results is presented in Table 3.
Slovenian: V preglednici 3 je povzetek sekundarnih rezultatov učinkovitosti.
English: These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (see paragraph “Influenza like illness”).
Slovenian: Ti simptomi so značilno povezani s prvim odmerkom, ponavadi so kratkotrajni, blagi do zmerno močni in ponavadi izginejo z nadaljevanjem zdravljenja brez posegov v samo zdravljenje (glejte odstavek »Bolezen, podobna gripi«).
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Slovenian: Ibandronska kislina se izloča le z renalno ekskrecijo in ni podvržena biotransformaciji.
English: In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased normal bone mass compared with untreated animals.
Slovenian: Pri mladih (hitro rastočih) podganah je prav tako prišlo do zaviranja endogene resorpcije kosti, kar je v primerjavi z nezdravljenimi živalmi povečalo normalno kostno maso.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Slovenian: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Velika Britanija
English: Taking this medicine
Slovenian: Jemanje zdravila
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2010
Slovenian: Datum prve pridobitve dovoljenja za promet: 17.09.2010 Datum zadnjega podaljšanja: 25.06.2015
English: See dosing instructions, above.
Slovenian: Glejte zgornja navodila za odmerjanje.
English: * Mean change from baseline to last assessment.
Slovenian: ** Mediana spremembe od izhodiščne vrednosti do zadnje ocene.
English: This reduction in fractures was shown for the spine but not for the hip.
Slovenian: Zmanjšanje zlomov je bilo dokazano za hrbtenico, vendar ne za kolke.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05-BA06
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka ATC: M05BA06.
English: If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Slovenian: Če je naslednji načrtovani odmerek v manj kot 7 dneh, naj bolnik počaka do tega odmerka in nato nadaljuje jemanje ene tablete enkrat mesečno po prvotnem načrtu.
English: Bone resorption due to malignant disease is characterized by excessive bone resorption that is not balanced with appropriate bone formation.
Slovenian: Za resorpcijo kosti zaradi maligne bolezni je značilna čezmerna resorpcija kosti, ki ni uravnotežena z ustrezno gradnjo kosti.
English: • Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.
Slovenian: • Vzemite tableto kmalu po tem, ko zjutraj vstanete, preden zaužijete prvo hrano, pijačo, katero koli zdravilo ali dodatek.
English: Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
Slovenian: Drugače lahko del nekaj zdravila preide nazaj v vaš požiralnik (ezofagus).
English: A relative risk reduction of 61 % was observed after 2 years (p=0.0006).
Slovenian: Po dveh letih so opazili zmanjšanje relativnega tveganja za 61 % (p = 0,0006).
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: • posvetujte se z zdravnikom, če imate bolečine v ušesu, izcedek iz ušesa in/ali vnetje ušesa.
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Slovenian: Swensweg 5, 2031 GA Haarlem Nizozemska
English: Never take two Ibandronic Acid Teva tablets within the same week.
Slovenian: ne vzemite dveh tablet zdravila Ibandronska kislina Teva v istem tednu.
English: In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
Slovenian: V prvotni triletni randomizirani, dvojno slepi, s placebom nadzorovani študiji (MF 4411) zlomov so ugotovili statistično in klinično pomembno zmanjšanje incidence novih zlomov vretenc, določeno radiografsko, morfometrično in klinično (preglednica 3).
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Slovenian: Skupni očistek ibandronske kisline je majhen, povprečna vrednost je od 84 do 160 ml/min.
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3-6 months.
Slovenian: Biokemični označevalci kostne premene (kot so urinarni CTX in serumski osteokalcin) so pokazali pričakovan vzorec supresije do vrednosti pred menopavzo; največjo supresijo so dosegli po 3 do 6 mesecih.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Slovenian: Najvišje koncentracije v plazmi so bile na tešče dosežene v 0,5 do 2 urah (mediana časa 1 ura), absolutna biološka uporabnost je bila okoli 0,6 %.
English: After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.
Slovenian: Po petih letih uporabe zdravila Ibandronska kislina Teva se, prosimo, posvetujte z zdravnikom glede nadaljevanja jemanja zdravila Ibandronska kislina Teva.
English: 3 film-coated tablets pack Month 1
Slovenian: pakiranje 3 filmsko obložene tablete Mesec 1
English: Analgesic use *
Slovenian: uporaba analgetikov*
English: Patients should pay particular attention and be able to comply with the dosing instructions (see section 4.2).
Slovenian: Bolniki morajo biti posebno previdni in morajo biti sposobni slediti navodilom za odmerjanje (glejte poglavje 4.2).
English: Do not make yourself vomit, and do not lie down - this could cause Ibandronic Acid Teva to irritate your oesophagus.
Slovenian: Ne izzovite bruhanja in ne lezite - tako bi zdravilo Ibandronska kislina Teva lahko dražilo vaš požiralnik.
English: Water may be taken at any time during the course of Ibandronic Acid Teva treatment (see section 4.5).
Slovenian: Voda se lahko uživa kadar koli v obdobju zdravljenja z zdravilom Ibandronska kislina Teva (glejte poglavje 4.5).
English: One year data in study BM 16549 Two year data in study BM
Slovenian: (populacija po protokolu) v študiji BM 16549. enoletni podatki študije BM 16549 dveletni podatki študije BM
English: Urinary CTx **
Slovenian: koncentracija CTx v seču**
English: 2031 GA Haarlem The Netherlands
Slovenian: 2031 GA Haarlem Nizozemska
English: The primary pharmacological effects of ibandronic acid on bone are not directly related to actual plasma concentrations, as demonstrated by various studies in animals and humans.
Slovenian: 5.2 Farmakokinetične lastnosti Primarni farmakološki učinki ibandronske kisline na kosti niso neposredno povezani z dejanskimi koncentracijami v plazmi, kar so pokazale številne študije pri živalih in ljudeh.
English: Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Slovenian: Zmanjšano renalno izločanje kalcija lahko spremlja padec koncentracije fosfata v serumu, kar pa ne zahteva zdravljenja.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: Med zdravljenjem morate skrbeti za dobro ustno higieno (ki vključuje redno umivanje zob) in opravljati redne preglede pri zobozdravniku.
English: At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
Slovenian: Pri odmerkih, ki so bili znatno večji od farmakološko učinkovitih odmerkov, ibandronska kislina ni vplivala na mineralizacijo kosti.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Slovenian: Poti izločanja ne vključujejo znanih kislinskih ali bazičnih transportnih sistemov, ki sodelujejo pri izločanju drugih zdravilnih učinkovin.
English: In case a dose is missed, patients should be instructed to take one Ibandronic Acid Teva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
Slovenian: Če bolnik odmerek izpusti, mu je treba svetovati, naj vzame eno 150 mg tableto Ibandronska kislinaTeva naslednje jutro po tem, ko se spomni, razen če je do naslednjega načrtovanega odmerka manj kot 7 dni.
English: The anti-fracture effect was consistent over the duration of the study.
Slovenian: Učinek proti zlomom se je ohranil med celotno študijo.
English: If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Slovenian: Če imate blage težave z ledvicami, bo morda vaš zdravnik zmanjšal odmerek na eno tableto vsak drugi dan.
English: In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
Slovenian: Pri živalskih modelih je ibandronska kislina povzročila biokemične spremembe, ki kažejo na od odmerka odvisno zaviranje resorpcije kosti, vključno s supresijo urinarnih biokemičnih označevalcev razgradnje kostnega kolagena (kot so deoksipiridinolin in navzkrižni N-telopeptidi kolagena tipa I (NTX)).
English: The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p<0.0001).
Slovenian: Močan vpliv na zlome vretenc se je kazal tudi s statistično pomembno manjšo izgubo telesne višine v primerjavi s placebom (p < 0,0001).
English: - Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Slovenian: - Tablete je treba pogoltniti cele in popiti poln kozarec vode (180 do 240 ml); bolnik mora pri tem stati ali vzravnano sedeti.
English: EU/1/10/642/002 84 film-coated tablets
Slovenian: EU/1/10/642/002 84 filmsko obloženih tablet
English: In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Slovenian: V tej študiji so preučevali ibandronsko kislino v peroralnem odmerku 2,5 mg dnevno in 20 mg intermitentno kot raziskovalno odmerjanje.
English: If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
Slovenian: Če imate hude težave z ledvicami, vam bo morda zdravnik zmanjšal odmerek na eno tableto enkrat na teden.
English: After swallowing your monthly Ibandronic Acid Teva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Slovenian: Po tem, ko pogoltnete svojo mesečno tableto Ibandronska kislina Teva, počakajte eno uro, preden vzamete katero koli drugo zdravilo, vključno s tabletami proti želodčnim težavam, dodatki kalcija in vitamini.
English: After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Slovenian: Po prvotni sistemski izpostavljenosti se ibandronska kislina hitro veže v kostno tkivo ali pa se izloči s sečem.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Slovenian: O možnosti za osteonekrozo zunanjega sluhovoda je treba razmisliti pri bolnikih, ki prejemajo difosfonate in imajo simptome bolezni ušes, vključno s kroničnimi vnetji ušes.
English: Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity.
Slovenian: Živalski modeli potrjujejo, da je ibandronska kislina zelo učinkovit zaviralec osteoklastne aktivnosti.
English: Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Slovenian: Klinične študije pri bolnikih z rakom dojke in metastazami v kosteh so pokazale, da je zaviralni učinek na osteolizo kosti odvisen od odmerka in izražen z označevalci resorpcije kosti ter da so dogodki, povezani z okostjem, odvisni od odmerka.
English: Patients should then return to taking their dose once a month on their originally scheduled date.
Slovenian: Nato naj nadaljuje jemanje odmerkov enkrat mesečno na prvotno izbrani datum.
English: In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses (see section 5.3).
Slovenian: V študijah pri podganah z uporabo intravenske poti je ibandronska kislina zmanjšala plodnost pri velikih dnevnih odmerkih (glejte poglavje 5.3).
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60 % of total clearance and is related to creatinine clearance.
Slovenian: Ledvični očistek (okoli 60 ml/min pri zdravih ženskah po menopavzi) predstavlja 50 do 60 % skupnega očistka in je povezan s kreatininskim očistkom.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Slovenian: Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so bile naključno razvrščene za prejemanje placeba (277 bolnic) ali 50 mg odmerkov ibandronske kisline (287 bolnic).
English: If you take more Ibandronic Acid Teva than you should If you've taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Ibandronska kislina Teva, kot bi smeli Če ste pomotoma vzeli več kot eno tableto, spijte poln kozarec mleka in se nemudoma posvetujte s svojim zdravnikom.
English: With no further dosing, there is a loss of suppression of biochemical markers of bone resorption.
Slovenian: Brez nadaljnjega odmerjanja supresija biokemičnih označevalcev resorpcije kosti izgine.
English: • severe stomach pain.
Slovenian: • hude bolečine v trebuhu.
English: The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Slovenian: Menijo, da razlika med navideznim skupnim in ledvičnim očistkom odraža prevzem v kostno tkivo.
English: Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Slovenian: Peroralna biološka uporabnost ibandronske kisline je v prisotnosti hrane večinoma zmanjšana.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Slovenian: Po treh letih je bil porast MKG ledvene hrbtenice v primerjavi s placebom 5,3 %, v primerjavi z izhodiščno vrednostjo pa 6,5 %.
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
Slovenian: Klinično pomembno 50odstotno zmanjšanje biokemičnih označevalcev kostne resorpcije so opazili že en mesec po začetku zdravljenja z 2,5 mg odmerkom ibandronske kisline.
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila vedno natančno upoštevajte navodila svojega zdravnika.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000),very rare
Slovenian: (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: • persistent eye pain and inflammation
Slovenian: • vztrajna bolečina in vnetje oči,
English: Then you can have your first food and drink, and take any medicines or supplements.
Slovenian: Nato lahko zaužijete prvo hrano, pijačo in druga zdravila ali dodatke.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Slovenian: Takoj se posvetujte z zdravnikom in zobozdravnikom, če imate kakršne koli težave v ustih ali z zobmi, kot so majavost zob, bolečina, oteklina in slabo celjenje ali izcedek iz ran, saj so to lahko znaki osteonekroze čeljustnic.
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:
Slovenian: Nemudoma se obrnite na medicinsko sestro ali zdravnika, če opazite katerega koli od spodaj naštetih resnih neželenih učinkov - morda boste potrebovali nujno medicinsko zdravljenje:
English: - For the next hour (60 minutes) after you've taken your tablet do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus do not eat anything do not drink anything (except water if you need it) do not take any other medicines
Slovenian: - Naslednjo uro (60 minut) po tem, ko ste vzeli tableto se ne ulezite; če niste v vzravnanem položaju (stoječem ali sedečem), lahko nekaj zdravila steče nazaj v požiralnik;
English: In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28 %), with median maximal inhibition (69 %) seen 6 days later.
Slovenian: V fazi I bioekvivalenčne študije pri 72 ženskah po menopavzi, ki so prejemale 150 mg peroralno vsakih 28 dni, skupno štiri odmerke, je bila inhibicija serumskega CTX po prvem odmerku opazna že 24 ur po odmerku (mediana inhibicije 28 %), z mediano maksimalne inhibicije (69 %), opaženo 6 dni pozneje.
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50 % of the circulating dose.
Slovenian: Pri ljudeh je navidezni terminalni volumen porazdelitve najmanj 90 l. Količina odmerka, ki doseže kosti, je ocenjena na 40 do 50 % odmerka, ki je v krvnem obtoku.