natgillin/translations-raw huggingface dataset:
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone. 
Ibandronska kislina spada v skupino difosfonatov, ki specifično delujejo na kosti.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2). 
Pri bolnikih z zmerno (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) se priporoča prilagoditev odmerka (glejte poglavje 4.2).
Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see sections 4.2 and 4.4). 
Zaradi omejenih kliničnih izkušenj se jemanje ibandronske kisline pri bolnikih s hudo okvaro ledvic ne priporoča (glejte poglavji 4.2 in 4.4).
In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day. 
V študijah vplivov na sposobnost razmnoževanja pri podganah z intravenskim dajanjem pa je ibandronska kislina zmanjšala število semenčic pri odmerkih 0,3 in 1 mg/kg/dan in zmanjšala plodnost samcev pri odmerku 1 mg/kg/dan in samic pri 1,2 mg/kg/dan.
MARKETING AUTHORISATION HOLDER 
DOVOLJENJA ZA PROMET
Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo. 
Koncentracije označevalca resorpcije kosti CTx (C-terminalni telopeptid, ki se sprosti s kolagena tipa I) v seču so bile v skupini, zdravljeni z ibandronsko kislino, pomembno manjše kot v skupini, zdravljeni s placebom.
Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance. 
Ledvični očistek ibandronske kisline pri bolnikih z različnimi stopnjami okvare ledvic je v linearni odvisnosti od kreatininskega očistka.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). 
• Med jemanjem tablete in še naslednjo uro (60 minut), ostanite v pokončnem položaju (stoje ali sede).
EU/1/10/642/001 28 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes EU/1/10/642/002 84 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes 
EU/1/10/642/001 28 filmsko obloženih tablet v PVC/Aclar/PVC - aluminijasti pretisni omoti v kartonastih škatlah EU/1/10/642/002 84 filmsko obloženih tablet v PVC/Aclar/PVC - aluminijasti pretisni omoti v kartonastih škatlah
The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for ibandronic acid 150 mg once monthly after one and two years, respectively. 
Celoten delež bolnikov, ki so imeli neželeni učinek, je bil 22,7 % za 150 mg ibandronske kisline enkrat mesečno po enem letu in 25,0 % po dveh letih.
Adequate intake of calcium and vitamin D is important in all patients. 
Za vse bolnike je pomemben zadosten vnos kalcija in vitamina D.
In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity. 
Pri zdravih moških prostovoljcih in ženskah po menopavzi je intravensko apliciran ranitidin povečal biološko uporabnost ibandronske kisline za približno 20 %, kar je verjetno posledica zmanjšane kislosti želodca.
Asthma exacerbation 
poslabšanje astme
The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who at baseline had a lumbar spine BMD T-score below -2.5. 
Učinek zdravljenja z ibandronsko kislino so nadalje preučevali v analizi podskupine bolnikov, katerih T-vrednost MKG ledvene hrbtenice je bila na začetku zdravljenja pod -2,5.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic Acid Teva administration. 
Invazivne zobozdravstvene posege se lahko med zdravljenjem opravi le po temeljitem razmisleku, zlasti se jim je treba izogibati v času blizu termina prejema zdravila Ibandronska kislina
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano dne: MM/LLLL.
Anaphylactic reaction/shock 
Anafilaktična reakcija/šok
Month 3 __/__/__ 
Mesec 3 __/__/__
Then carry on as usual the next day. 
Naslednji dan nadaljujte jemanje ene tablete na dan, kot običajno.
- Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking. 
- sočasna prisotnost raka ali drugih bolezni (na primer anemije, koagulopatije, okužbe), kajenje;
Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy. 
Klinične študije niso pokazale poslabšanja delovanja ledvic med dolgotrajnim zdravljenjem z ibandronsko kislino.
Ibandronic Acid Teva may help lower the chances of breaking bones (fractures). 
Ibandronska kislina Teva pomaga zmanjšati možnost zloma kosti.
Bone mineral density (BMD) 
Mineralna kostna gostota (MKG)
• The other ingredients are: tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80. 
- Pomožne snovi so: jedro tablete: mikrokristalna celuloza, povidon K-30, krospovidon (tipa A), koloidni brezvodni silicijev dioksid, stearinska kislina; obloga tablete: titanov dioksid (E171), hipromeloza, makrogol 400, polisorbat 80.
Tablet core: 
Obloga tablete:
What Ibandronic Acid Teva is and what it is used for What you need to know before you take Ibandronic Acid Teva How to take Ibandronic Acid Teva Possible side effects 
Kaj je zdravilo Ibandronska kislina Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ibandronska kislina Teva Kako jemati zdravilo Ibandronska kislina Teva
This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study. 
Ta shema je v triletni študiji zmanjšala pojavnost novih zlomov vretenc, določeno radiografsko, za 62 % (p = 0,0001).
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours. 
Navidezni končni razpolovni čas je na splošno v razponu od 10 do 72 ur.
Ibandronic Acid Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby. 
Zdravilo Ibandronska kislina Teva se uporablja samo pri ženskah po menopavzi, ženske, ki še lahko imajo otroka, pa ga ne smejo jemati.
EU/1/10/642/003 1 film-coated tablet in PVC/Aclar/PVC - Aluminium blister in cardboard boxes EU/1/10/642/004 3 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes 
EU/1/10/642/003 1 filmska obložena tableta v PVC/Aclar/PVC - aluminijasti pretisni omoti v kartonastih škatlah EU/1/10/642/004 3 filmsko obložene tablete v PVC/Aclar/PVC - aluminijasti pretisni omoti v kartonastih škatlah
Ibandronic Acid Teva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium). 
Zdravilo Ibandronska kislinaTeva je treba vzeti zjutraj na prazen želodec (po najmanj 6 urah brez obroka) in eno uro pred prvim dnevnim obrokom hrane ali pijače, ki ni voda (glejte poglavje 4.5), ali zaužitjem drugih peroralnih zdravil ali prehranskih dopolnil (vključno s kalcijem).
- Patients should not lie down for 60 minutes after taking Ibandronic Acid Teva. 
- Bolnik se ne sme uleči še 60 minut po tem, ko je vzel zdravilo Ibandronska kislina Teva.
After you have taken Ibandronic Acid Teva, please wait for 1 hour before you can have your first food and further drinks. 
Po tem, ko ste vzeli zdravilo Ibandronska kislina Teva, prosimo počakajte 1 uro, preden zaužijete prvo hrano in nadaljnjo pijačo (glejte poglavje 3.
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. 
Nekateri bolniki občutijo bolečino v stegnu ali dimljah, ki je pogosto povezana z značilnostmi stresnega zloma in se pojavi več tednov ali mesecev pred pojavom popolnega zloma stegnenice.
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. 
• simptomi, podobni gripi, vključno s povišano telesno temperaturo, drgetanjem in mrazenjem, občutjem neugodja, bolečino v kosteh in bolečimi mišicami ter sklepi.
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women. 
Spol Biološka uporabnost in farmakokinetika ibandronske kisline sta pri moških in ženskah podobni.
- If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing. 
- če imate težave s požiralnikom (ezofagusom), kot je zožitev ali težave s požiranjem.
The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney. 
Absorbiran delež ibandronske kisline se iz sistemskega krvnega obtoka v kostno tkivo odstrani z absorpcijo (ocenjeno na 40 do 50 % pri ženskah v postmenopavzi), ostanek pa se izloči skozi ledvice v nespremenjeni obliki.
Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. 
Vzemite vašo tableto vsaj 6 ur po vašem zadnjem zaužitem obroku, pijači, katerem koli zdravilu ali dodatku razen vodi.
What you need to know before you take Ibandronic Acid Teva 
Kaj morate vedeti, preden boste vzeli zdravilo Ibandronska kislina Teva
This is because Ibandronic Acid Teva can affect the way some other medicines work. 
Zdravilo Ibandronska kislina Teva lahko vpliva na delovanje drugih zdravil.
Do not take this medicine if any of the above apply to you. 
Če se kar koli od zgoraj naštetega nanaša na vas, tega zdravila ne smete prejeti.
Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis. 
Po prekinitvi zdravljenja so patološke vrednosti povišane kostne resorpcije, povezane s postmenopavzno osteoporozo, spet enake kot pred začetkom zdravljenja.
- radiotherapy to bone for treatment of fractures/impending fractures, - surgery to bone for treatment of fractures, - vertebral fractures, - non-vertebral fractures. 
- zdravljenje kosti z obsevanjem zaradi fzlomov/grozečih zlomov, - operacija kosti za zdravljenje zlomov, - zlomi vretenc, - nevertebralni zlomi.
The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney. 
Absorbiran delež ibandronske kisline se iz sistemskega krvnega obtoka odstrani z absorpcijo v kostno tkivo (ocenjeno na 40 do 50 %), preostanek pa se nespremenjen izloči skozi ledvice.
After one year (primary analysis) the median relative change from baseline was -76 % for ibandronic acid 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily. 
Po enem letu (primarna analiza) je bila mediana relativne spremembe od izhodiščne vrednosti -76 % za ibandronsko kislino 150 mg enkrat mesečno in -67 % za ibandronsko kislino 2,5 mg dnevno.
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women. 
Biološka uporabnost in farmakokinetika ibandronske kisline sta pri moških in ženskah podobni.
You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe 
Lahko imate hudo vnetje požiralnika, morda z ranami ali zožitvijo požiralnika.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy. 
- potentnost zdravila, ki zavira resorpcijo kosti (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek zdravila, ki zavira resorpcijo kosti;
Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral. 
Selektivno delovanje difosfonatov na kostno tkivo temelji na njihovi veliki afiniteti do mineralizirane kosti.
There are no adequate data from the use of ibandronic acid in pregnant women. 
O uporabi ibandronske kisline pri nosečnicah ni zadostnih podatkov.
The other ingredients are: 
To vključuje:
Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI) 
Preglednica 3: rezultati triletne študije MF 4411 zlomov (%, 95-odstotni interval zaupanja) placebo (n = 974)
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration. 
Študije na podganah v laktaciji so pokazale, da je po intravenskem dajanju v mleku prisotna majhna količina ibandronske kisline.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/001 28 film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/642/001 28 filmsko obloženih tablet
Based on the results of study BM 16549, ibandronic acid 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily. 
Glede na rezultate BM 16549 pričakujemo, da je ibandronska kislina v odmerku 150 mg enkrat mesečno najmanj enako učinkovita v preprečevanju zlomov kakor ibandronska kislina v odmerku
Ibandronic Acid Teva tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. 
Tablete Ibandronska kislina Teva je treba vzeti zjutraj na prazen želodec (po najmanj 6 urah brez obroka) in pred prvim dnevnim obrokom hrane ali pijače.
Month 2 __/__/__ 
Mesec 2 __/__/__
In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity. 
Pri zdravih moških prostovoljcih in ženskah po menopavzi je intravensko apliciran ranitidin povečal biološko uporabnost ibandronske kisline za približno 20 % (kar je znotraj normalne variabilnosti biološke uporabnosti ibandronske kisline).
Patients with renal impairment Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr). 
Izpostavljenost bolnikov z različnimi stopnjami ledvične okvare ibandronski kislini je povezana o očistkom kreatinina (CLcr).
Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline 
Preglednica 4: rezultati triletne študije zlomov MF 4411 (%, 95-odstotni interval zaupanja) za bolnike, ki so imeli na začetku zdravljenja T-vrednost MKG ledvene hrbtenice pod -2,5
BATCH NUMBER Lot 
ŠTEVILKA SERIJE Lot:
Paediatric population (see sections 4.2 and 5.1) There are no data on the use of ibandronic acid in patients less than 18 years old. 
Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi ibandronske kisline pri bolnikih, mlajših od 18 let, ni podatkov.
Other medicines and Ibandronic Acid Teva 
Druga zdravila in zdravilo Ibandronska kislina Teva
The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. 
Farmakodinamski učinek ibandronske kisline je zaviranje resorpcije kosti.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of ibandronic acid 150 mg once monthly and ibandronic acid 2.5 mg daily was similar. 
V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549) je bila skupna varnost ibandronske kisline v odmerku 150 mg enkrat mesečno in ibandronske kisline v odmerku 2,5 mg enkrat dnevno podobna.
Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia 
- Nenormalnosti požiralnika, ki upočasnijo njegovo praznenje kot sta striktura ali ahalazija.
Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. 
Zlomi so pogosto obojestranski; zato je treba pri bolnikih, ki so utrpeli zlom srednjega dela stegnenice in se zdravijo z difosfonati, pregledati tudi kontralateralno stegnenico.
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2). 
Presnovna medsebojna delovanja niso verjetna, ker ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450 (glejte poglavje 5.2).
Marketing Authorisation Holder: Teva B.V. 
Imetnik dovoljenja za promet z zdravilom: Teva B.V.
Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures. 
Klinična učinkovitost Pri prepoznavanju žensk s povečanim tveganjem za osteoporotični zlom je treba upoštevati neodvisne dejavnike tveganja, na primer majhno mineralno kostno gostoto, starost, obstoj predhodnih zlomov, zlome v družinski anamnezi, visoko razmerje med razgradnjo in tvorbo kosti in nizek indeks telesne mase.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation, (see paragraph “Description of selected adverse reactions” and section 4.4). 
Najbolj resni poročani neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic, draženje prebavil, vnetje oči (glejte odstavek »Opis izbranih neželenih učinkov« in poglavje 4.4).
Some people need to be especially careful while they're taking Ibandronic Acid Teva. 
Nekateri bolniki morajo biti pri uporabi zdravila Ibandronska kislina Teva še posebej previdni.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see sections 4.4 and 4.5). 
Če vnos s hrano ni zadosten, morajo bolniki prejemati dodatke kalcija oziroma vitamina D (glejte poglavji 4.4 in 4.5).
METHOD AND ROUTE OF ADMINISTRATION Do not suck, chew or crush the tablets. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablet ne smete sesati, žvečiti ali drobiti.
Osteonecrosis of jaw*†, 
osteonekroza čeljustnic†*,
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Teva. 
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Ibandronska kislina Teva opravite zobozdravstveni pregled.
The pharmacokinetics of ibandronic acid was not assessed in patients with end-stage renal disease managed by other than hemodialysis. 
Farmakokinetike ibandronske kisline pri bolnikih s končno odpovedjo ledvic, ki se niso zdravili s hemodializo, niso preučevali.
Patients with renal impairment 
Bolniki z ledvično okvaro
It's important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you. 
Nadaljevanje jemanja zdravila Ibandronska kislina Teva Pomembno je, da vzamete zdravilo Ibandronska kislina Teva vsak mesec, dokler vam ga je predpisal zdravnik.
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF 
2,5 mg ibandronske kisline dnevno so preučevali v štirih s placebom nadzorovanih kliničnih študijah pri 1251 bolnikih; velika večina bolnikov je sodelovala v ključni triletni študiji zlomov (MF 4411).
Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Ibandronic Acid Teva. 
Glede na klinično oceno posameznega bolnika pa se pri bolnikih, ki se zdravijo z zdravilom Ibandronska kislina Teva, priporoča spremljanje delovanja ledvic, serumske koncentracije kalcija, fosfata in magnezija.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4). 
Najbolj resni neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic, draženje prebavil in vnetje oči (glejte odstavek “Opis izbranih neželenih učinkov” in poglavje 4.4).
Pharmacokinetics in special populations 
Farmakokinetika pri posebnih skupinah bolnikov Spol
Paediatric population (see section 4.2 and section 5.1) There are no data on the use of ibandronic acid in these age groups. 
Pediatrična populacija (glejte poglavji 4.2 in 5.1) O uporabi ibandronske kisline pri tej skupini bolnikov ni podatkov.
This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood. 
Aminoglikozidi in zdravilo Ibandronska kislina Teva lahko znižajo koncentracijo kalcija v krvi.
Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks. 
50 mg tabletami ibandronske kisline so raziskovali v dveh randomiziranih, s placebom nadzorovanih preskušanjih faze III, ki so potekala 96 tednov.
Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright. 
Zaradi možnosti draženja požiralnika se bruhanje ne sme izzvati, bolnik pa mora ostati v povsem pokončnem položaju.
Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see sections 4.4 and 5.2). 
Zdravilo Ibandronska kislinaTeva se pri bolnikih, ki imajo kreatininski očistek pod 30 ml/min, ne priporoča zaradi pomanjkanja kliničnih izkušenj (glejte poglavji 4.4 in 5.2).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Ibandronska kislina Teva 50 mg: Predpisovanje in izdaja zdravila je pod omejenimi pogoji in na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively. 
Antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke Od več kot 1.500 bolnikov, vključenih v študijo BM 16549, ki je primerjala mesečno jemanje ibandronske kisline z dnevnim, je po enem letu 14 % bolnikov uporabljalo antagoniste histaminskih receptorjev H2 ali zaviralce protonske črpalke, po dveh letih pa 18 % bolnikov.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/003 1 film-coated tablet EU/1/10/642/004 3 film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/642/003 1 filmsko obložena tableta EU/1/10/642/004 3 filmsko obložene tablete 13.