natgillin/translations-raw huggingface dataset:
Therefore, patients should fast overnight (at least 6 hours) before taking Ibandronic Acid Teva and continue fasting for 1 hour following intake of Ibandronic Acid Teva (see section 4.2).
Zato morajo bolniki jemati zdravilo Ibandronska kislina Teva zjutraj na prazen želodec (po vsaj 6 urah brez obroka), po zaužitju zdravila pa morajo biti še eno uro tešči (glejte poglavje 4.2).
• flu-like symptoms, feeling generally unwell or in pain
- gripi podobni simptomi, občutek slabega počutja ali bolečine,
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih zdravljenih z intravensko ibandronsko kislino so poročali o primerih anafilaktične reakcije/šoku, vključno z dogodki s smrtnim izidom.
Hepatic impairment
Atipičen zlom stegnenice
• heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having, diarrhoea (loose bowels) muscle cramps, stiffness of your joints and limbs
• zgaga, neugodje pri požiranju, bolečina v želodcu ali trebuhu (lahko zaradi vnetja želodca),
No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Po intravenskem ali peroralnem zdravljenju z ibandronsko kislino pri podganah in kuncih niso opazili neposrednih škodljivih vplivov na plod ali teratogenih učinkov.
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Absorpcija Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu prebavil hitra.
In the overall patient population of the study MF 4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
ugotovili pa so, da je bila ibandronska kislina v dnevnih odmerkih učinkovita pri podskupini bolnikov z velikim tveganjem (T-vrednost MKG stegneničnega vratu pod -3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
White, biconvex, capsule-shaped film-coated tablets, engraved “50” on one side and plain on the other.
Bela, bikonveksna, filmsko obložena tableta v obliki kapsule, z vtisnjeno oznako »50« na eni strani in gladka na drugi.
Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost (glejte poglavje 4.4).
- Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
- acetilsalicilno kislino in druga nesteroidna protivnetna zdravila (vključno z ibuprofenom,
Taking your monthly tablet
Jemanje tablete enkrat mesečno
- Take one Ibandronic Acid Teva 150 mg tablet once a month.
- Enkrat mesečno vzemite eno 150 mg tableto Ibandronska kislina Teva.
Common (may affect up to 1 in 10 people):
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
Hepatic impairment No dose adjustment is required (see section 5.2).
Okvara jeter Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
Chest pain, influenza-like illness, malaise, pain
Splošne težave in spremembe na mestu aplikacije astenija bolečina v prsih, bolezen podobna gripi, splošno slabo počutje, bolečine
Nervous system disorders
Bolezni živčevja glavobol omotica
White, biconvex, capsule-shaped film-coated tablets, engraved “I150” on one side and plain on the other.
Bela, bikonveksna, filmsko obložena tableta v obliki kapsule, z vtisnjeno oznako »I150« na eni strani in gladka na drugi.
Paediatric population (see section 4.2 and section 5.2) Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Ibandronske kisline pri pediatričnih bolnikih niso proučevali, zato za to skupino bolnikov ni na voljo podatkov o učinkovitosti in varnosti.
Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Zato bolnik po peroralnem jemanju zdravila najmanj 30 minut ne sme zaužiti takih pripravkov oziroma hrane.
Asthenia
ZDRAVILA
At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je 87,1 % (p < 0,001) bolnikov, ki so prejemali 150 mg enkrat mesečno, in 70,5 % bolnikov, ki so prejemali 2,5 mg dnevno, zadostilo kriterijem za odzivnost.
- Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
- Bolnik tablete ne sme žvečiti ali sesati, ker obstaja nevarnost za nastanek razjede v ustih in žrelu.
Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • huda bolečina v prsnem košu, huda bolečina po požiranju hrane ali pijače, huda slabost ali bruhanje, težave pri požiranju.
Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones.
Zdravilo Ibandronska kislina Teva zavira izločanje kalcija iz kosti.
Talk to your doctor first if you want to drive, use machine or tools.
Če želite voziti ali upravljati s stroji, se prej posvetujte s svojim zdravnikom.
Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Če zaužijemo hrano ali pijačo, preden je minilo 60 minut od jemanja ibandronske kisline,
This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
vnetje ali razjedo v požiralniku (ezofagusu).
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Razlik v incidenci neželenih učinkov v zgornjem delu prebavil pri teh bolnikih ni bilo, čeprav so nekateri jemali 150 mg enkrat mesečno in drugi 2,5 mg enkrat dnevno.
Ibandronic acid 2.5 mg daily (N=977)
ibandronska kislina 2,5 mg dnevno (n = 977)
You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
- Če ste pozabili vzeti tableto na vaš izbrani dan in je vaš načrtovani odmerek čez več kot 7 dni… vzemite eno tableto naslednje jutro, potem, ko se spomnite, nato jemanje tablet nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.
Ibandronic acid 2.5 mg daily (N=575)
ibandronska kislina 2,5 mg dnevno (n = 575)
Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Bolezni imunskega sistema poslabšanje astme preobčutljivostna reakcija anafilaktična reakcija/šok*
Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID) Ker acetilsalicilno kislino, nesteroidna protivnetna zdravila (NSAID) in difosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem jemanju teh zdravil potrebna previdnost.
Ibandronic Acid Teva should not be used during pregnancy.
Ibandronska kislina Teva se ne sme uporabljati med nosečnostjo.
Do not chew, suck or crush the tablet.
Tablete ne smete sesati, žvečiti ali drobiti.
Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
bolečine v trebuhu, dispepsija, navzea krvavitev, razjeda na dvanajstniku, gastritis, disfagija, suha usta
At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Po dveh letih je bilo odzivnih 93,5 % bolnikov (p = 0,004), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 86,4 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established.
Varnost in učinkovitost zdravila Ibandronska kislina Teva pri otrocih in mladostnikih, starih manj kot
Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic Acid Teva and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Zdravniki morajo biti pozorni na znake ali simptome, ki opozarjajo na možno reakcijo v požiralniku,bolnikom pa je treba naročiti, da naj v primeru če se pri njih pojavijo disfagija,
At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
78,7 % bolnikov (p = 0,002), ki so prejemali 150 mg enkrat mesečno, in 65,6 % bolnikov, ki so jemali 2,5 mg dnevno.
- Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
- sočasno zdravljenje: kortikosteroidi, kemoterapija, zaviralci angiogeneze, obsevanje glave in vratu; - slaba ustna higiena, parodontalna bolezen, slabo prileganje proteze, zobozdravstvene bolezni v anamnezi, invazivni zobozdravstveni poseg, npr. izdrtje zoba.
The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Razpon opaženih navideznih razpolovnih časov je širok ter odvisen od odmerka in občutljivosti metode.
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for oncology indications (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za indikacije v onkologiji, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Pri bolnikih s hudo ledvično okvaro se je celokupni očistek ibandronske kisline zmanjšal na 44 ml/min, v primerjavi z 129 ml/min pri bolnikih z normalnim delovanjem ledvic.
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Pri bolnikih z okvaro jeter ni farmakokinetičnih podatkov za ibandronsko kislino.
At one year, 83.5 % (p= 0.006) of patients receiving ibandronic acid 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50% from baseline).
Po enem letu je bilo odzivnih 83,5 % bolnikov (p = 0,006), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 73,9 % bolnikov, ki so jemali 2,5 mg ibandronske kisline dnevno
Therefore, Ibandronic Acid Teva should not be used during pregnancy.
Zato se zdravila Ibandronska kislina Teva med nosečnostjo ne sme uporabljati.
There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
O klinično pomembnih medetničnih razlikah v biološki uporabnosti ibandronske kisline med Azijci in
In particular, products containing calcium, including milk and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Ibandronic Acid Teva, which is consistent with findings in animal studies.
Zlasti pripravki, ki vsebujejo kalcij, vključno z mlekom in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom, lahko vplivajo na absorpcijo zdravila Ibandronska kislina
Osteonecrosis of the jaw
Osteonekroza čeljustnic
Cases of ONJ have been reported in the post-marketing setting for ibandronic acid.
Pri zdravljenju z ibandronsko kislino so poročali o primerih osteonekroze čeljustnic v obdobju po prihodu zdravila na trg.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis.
Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Za bolnike z blago ali zmerno okvaro ledvic (očistek kreatinina (CLcr) enak ali večji kot 30 ml/min)
There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Če vzamemo ibandronsko kislino 60 minut pred prvim obrokom, biološka uporabnost ni pomembno zmanjšana.
• The active substance is ibandronic acid.
- Zdravilna učinkovina je ibandronska kislina.
Ibandronic Acid Teva 150 mg film-coated tablets Ibandronic acid
Ibandronska kislina Teva 150 mg filmsko obložene tablete ibandronska kislina
Ibandronic acid 150 mg once monthly (N=291)
ibandronska kislina 150 mg enkrat mesečno (n =
Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Ibandronska kislina Teva 50 mg filmsko obložene tablete ibandronska kislina
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).
Ena filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega monohidrata).
There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Če se ibandronska kislina vzame 60 minut pred obrokom, biološka uporabnost ni pomembno zmanjšana.
Milk or antacids should be given to bind Ibandronic Acid Teva.
Za vezavo zdravila Ibandronska kislina Teva je treba zaužiti mleko ali antacide.
What Ibandronic Acid Teva looks like and contents of the pack The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “50” on one side and plain on the other.
Ibandronska kislina Teva filmsko obložene tablete so bele, bikonveksne, v obliki kapsul, z vtisnjeno oznako »50« na eni strani in gladke na drugi.
Ibandronic Acid Teva should not be used during breast-feeding.
Ibandronska kislina Teva se ne sme uporabljati med dojenjem.
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Ibandronska kislina Teva za zdravljenje osteoporoze, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
INFORMATION IN BRAILLE Ibandronic Acid Teva 150 mg film-coated tablets
PODATKI V BRAILLOVI PISAVI Ibandronska kislina Teva 150 mg filmsko obložene tablete
INFORMATION IN BRAILLE Ibandronic Acid Teva 50 mg film-coated tablets
PODATKI V BRAILLOVI PISAVI Ibandronska kislina Teva 50 mg filmsko obložene tablete
Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet, - smoking, or drinking too much alcohol, - not enough walking or other weight-bearing exercise, - a family history of osteoporosis.
Drugi dejavniki, ki lahko povečajo tveganje za zlome, so: - premajhen vnos kalcija in vitamina D s hrano,
There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Pri ekstrapolaciji izpostavljenosti, ki je 35-krat presegala izpostavljenost pri ljudeh, niso opazili škodljivih vplivov na razvoj podganjih potomcev F1.
Ocular inflammation*†
Očesne bolezni očesno vnetje*†
NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 50 mg film-coated tablets
IME ZDRAVILA Ibandronska kislina Teva 50 mg filmsko obložene tablete
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Ti selektivno delujejo na kostno tkivo in specifično zavirajo osteoklastno aktivnost brez neposrednega vpliva na proces tvorbe kosti.
Azotaemia (uraemia)
Bolezni sečil azotemija (uremija)
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Vnetje oči Pri zdravljenju z difosfonati, vključno z ibandronsko kislino, so poročali o vnetnih stanjih oči, kot so uveitis, episkleritis, skleritis.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid Teva.
Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione (kot so aluminij, magnezij, železo), lahko vplivajo na absorpcijo zdravila Ibandronska kislina Teva, zato bolniki najmanj 6 ur pred zaužitjem zdravila Ibandronska kislina Teva in še eno uro po njem ne smejo jemati drugih peroralnih zdravil.
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
da zdravilo Ibandronska kislina Teva nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Ocular inflammation†
Očesne bolezni očesno vnetje†*
Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Kaj je zdravilo Ibandronska kislina Teva in za kaj ga uporabljamo Ibandronska kislina Teva spada v skupino zdravil, ki jih imenujemo difosfonati.
Before receiving treatment, tell your doctor/nurse (health care professional) if: - you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned tooth extraction.
Pred zdravljenjem obvestite zdravnika/medicinsko sestro (zdravstvenega delavca), če: - imate težave v ustih ali z zobmi, kot so slabo zdravstveno stanje zobovja, bolezni dlesni ali načrtujete izdrtje zoba; - nimate redne zobozdravstvene oskrbe ali že dolgo niste bili na pregledu pri zobozdravniku; - ste kadilec (ker lahko kajenje poveča tveganje za težave z zobovjem); - ste se že zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti); - jemljete zdravila, imenovana kortikosteroidi (kot sta prednizolon ali deksametazon); - imate raka.
NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 150 mg film-coated tablets
IME ZDRAVILA Ibandronska kislinaTeva 150 mg filmsko obložene tablete
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one
Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerka ni potrebno.
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva artralgija, mialgija,
Do not take Ibandronic Acid Teva
Zdravila Ibandronska kislina Teva ne smete jemati:
Do not take Ibandronic Acid Teva with food.
Zdravilo Ibandronska kislina Teva skupaj s hrano in pijačo Ne jemljite zdravila Ibandronska kislina Teva skupaj s hrano.
BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
MKG - povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po treh letih
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
At two years 93.4 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93,4 % bolnikov (p < 0,001), ki so prejemali 150 mg ibandronske kisline enkrat mesečno, in 78,4 % bolnikov, ki so prejemali 2,5 mg ibandronske kisline dnevno.
(see sections 5.1 and 5.2).
Pediatrična populacija (glejte poglavji 4.2 in 5.2)
Keep taking Ibandronic Acid Teva for as long as your doctor tells you.
Zdravilo Ibandronska kislina Teva jemljite, dokler vam je to naročil zdravnik, ker deluje samo, če ga jemljemo redno.
Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva.
Med zdravljenjem z zdravilom Ibandronska kislina Teva bo zdravnik verjetno naredil običajne preiskave krvi, da bo preveril, če prejemate pravi odmerek zdravila.
50 mg film-coated tablet every second day is recommended (see section 5.2).
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) se priporoča zmanjšanje odmerka na eno 50 mg filmsko obloženo tableto vsak drugi dan (glejte poglavje 5.2).
84 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 28 filmsko obloženih tablet 84 filmsko obloženih tablet
Angioedema, Face oedema, Urticaria
Bolezni kože in podkožja izpuščaj angioedem, edem obraza, urtikarija
Musculoskele tal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice†
Reproductive toxicity
Vpliv na sposobnost razmnoževanja
Influenza like illness*
Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Pri bolnikih, ki so prejemali peroralne difosfonate, so poročali o neželenih učinkih, kot so ezofagitis ter razjede in erozije na požiralniku, ki so bili v nekaterih primerih hudi in so zahtevali hospitalizacijo.
Furthermore, ibandronic acid 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
V prospektivno načrtovani analizi po enem letu, p = 0,002, in dveh letih, p < 0,001 se je ibandronska kislina v odmerku 150 mg enkrat mesečno izkazala za bolj učinkovito od ibandronske kisline v odmerku 2,5 mg dnevno, kar se tiče povišanja MKG ledvene hrbtenice.
Biochemical markers of bone turn-over
incidenca novih zlomov vretenc
Rash
Čet
NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 150 mg film-coated tablets ibandronic acid
Navodilo za uporabo Ibandronska kislina Teva 150 mg filmsko obložene tablete ibandronska kislina
Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
odinofagija, retrosternalna bolečina ali novonastala ali poslabšana zgaga, prekinejo zdravljenje z zdravilom Ibandronska kislina Teva in poiščejo zdravniško pomoč.
• Keep this leaflet.
*Za nadaljnje informacije glejte spodnje besedilo.
It does not interfere with osteoclast recruitment.
Ibandronska kislina ne vpliva na zbiranje osteoklastov.
Ibandronic acid 2.5 mg daily (N=294)
ibandronska kislina 2,5 mg dnevno (n =
Medicinal product-Food Interactions
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
[dead bone tissue] in the jaw bone)
(nekroza [odmrtje kostnega tkiva] čeljustnice);
Back pain
Pet Sob Ned