natgillin/translations-raw huggingface dataset:
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.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic Acid Teva.
Vsem bolnikom je treba naročiti, naj med zdravljenjem z zdravilom Ibandronska kislina Teva skrbijo za dobro ustno higieno in redno opravljajo preglede pri zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečina, oteklina, slabo celjenje ali izcedek iz ran, pa naj takoj obvestijo zdravnika.
Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Bolezni prebavil* ezofagitis, gastritis, gastroezofagealna refluksna bolezen, dispepsija, driska, abdominalna bolečina, navzea ezofagitis,
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu prebavil hitra, koncentracije v plazmi naraščajo v odvisnosti od odmerka do peroralnega vnosa 50 mg, pri večjih vnosih pa so opazili večje poraste koncentracij v plazmi od sorazmernih z odmerkom.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Hipokalciemija
Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Zato bolnikom z okvaro jeter ni treba prilagoditi odmerkov.
Clinical efficacy
UČINKOVITO UPORABO ZDRAVILA
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Za bolnike, pri katerih se razvije osteonekroza čeljustnic, morata načrt zdravljenja v tesnem sodelovanju pripraviti lečeči zdravnik in zobozdravnik oziroma oralni kirurg, ki ima izkušnje z zdravljenjem osteonekroze čeljustnic.
Subjects with severe renal impairment (CLcr ≤ 30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Bolniki s hudo ledvično okvaro (CLcr ≤ 30 ml/min), ki so peroralno prejemali 10 mg ibandronske kisline dnevno 21 dni, so imeli 2-3- krat večje plazemske koncentracije kot bolniki z normalnim delovanjem ledvic (CLcr ≥ 80 ml/min).
- If you are allergic to ibandronic acid or any of the other ingredients of this medicine listed in section 6.
- če ste alergični na ibandronsko kislino ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
Fri.
• izpuščaj.
At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je bila mediana relativne spremembe -68 % za mesečno odmerjanje 150 mg in -62 % za dnevno odmerjanje 2,5 mg.
Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
vključno z ezofagealnimi ulceracijami ali zožitvami ter disfagijo, bruhanje, flatulenca duodenitis
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
FARMACEVTSKA OBLIKA filmsko obložena tableta
Do not take Ibandronic Acid Teva if you are pregnant or breast feeding.
Ne jemljite zdravila Ibandronska kislina Teva, če ste noseči ali dojite.
In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Dodatno ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450.
This could be a sign of an ulcer of the first section of the bowel
Te so lahko znak, da razjeda v začetnem delu črevesa (dvanajstniku)
SMPR (per patient year)
vrednost p stopnja hitrosti obolevnosti okostja (na bolnikova leta)
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Pri zdravljenju z difosfonati so poročali o osteonekrozi zunanjega sluhovoda, predvsem v povezavi z dolgotrajnim zdravljenjem.
Studies in rats have shown some reproductive toxicity (see section 5.3).
Študije na podganah so pokazale, da zdravilo nekoliko vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
osteonekroza zunanjega sluhovoda (neželeni učinek skupine difosfonatov)
After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Po intravenskem dajanju odmerka 0,5 mg se je pri bolnikih s hudo okvaro ledvic skupni očistek zmanjšal za 67 %, ledvični očistek za 77 %, neledvični očistek pa za 50 %.
The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Jetra niso pomembna za očistek ibandronske kisline, ker se ta ne presnavlja, ampak izloča skozi ledvice in prevzema v kostno tkivo.
Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Zaradi malo kliničnih izkušenj zdravila Ibandronska kislina Teva ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/min (glejte poglavje 5.2).
Talk to your doctor before taking Ibandronic Acid Teva: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
- Če imate kakršne koli motnje presnove mineralov (kot je pomanjkanje vitamina D).
• new pain, weakness or discomfort in your thigh, hip or groin.
• nova bolečina, šibkost ali nelagodje v stegnu, kolku ali dimljah.
Studies in rats have shown reproductive toxicity (see section 5.3).
Študije na podganah so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).