natgillin/translations-raw huggingface dataset:
Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Ezofagitis, gastritis, gastroezofagealni refluks, dispepsija, proljev, bol u abdomenu, mučnina
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.
Osobito proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo), uključujući mlijeko, često mogu utjecati na apsorpciju Ibandronatne kiseline Teva, što je u skladu s podacima iz ispitivanja provedenih u životinja.
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.
Dvogodišnje ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16549) pokazalo je sličnu sveukupnu sigurnost primjene ibandronatne kiseline 150 mg jednom mjesečno i ibandronatne kiseline 2,5 mg jednom dnevno.
Biochemical markers of bone turn-over
Biokemijski biljezi koštane pregradnje
Ibandronic Acid Teva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Ibandronatna kiselina Teva je namijenjena isključivo za žene u postmenopauzi i ne smiju je uzimati žene reproduktivne dobi.
Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Stoga nije potrebna prilagodba doze u bolesnika s oštećenjem jetre.
So be especially careful if you take painkillers or anti-inflammatories while you're taking Ibandronic Acid Teva.
Stoga budite osobito oprezni ako tijekom uzimanja Ibandronatne kiseline Teva uzimate i lijekove protiv boli ili upale.
Anaphylactic reaction/shock*
Anafilaktička reakcija/šok*†
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.
U tih bolesnika nije uočena razlika u incidenciji nuspojava vezanih uz gornji dio gastrointestinalnog trakta primjenom 150 mg jedanput mjesečno u usporedbi s primjenom 2,5 mg jedanput dnevno.
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic Acid
Tablica 1 Nuspojave prijavljene uz peroralnu primjenu Ibandronatne kiseline Organski sustav
Biotransformation There is no evidence that ibandronic acid is metabolized in animals or humans.
Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
In reproductive studies in rats by the oral route, ibandronic acid decreased fertility.
U reproduktivnim ispitivanjima peroralne primjene na štakorima, ibandronatna kiselina je smanjila njihovu plodnost.
• tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
Pomoćne tvari su: ˗ jezgra tablete: mikrokristalična celuloza, povidon K-30, krospovidon (vrste A), koloidni bezvodni silicijev dioksid, stearatna kiselina.
Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Prijelomi su često bilateralni; stoga u bolesnika koji primaju bisfosfonate i koji su imali prijelom trupa bedrene kosti treba pregledati i bedrenu kost na suprotnoj nozi.
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Ne postoje farmakokinetički podaci za ibandronatnu kiselinu u bolesnika s oštećenjem jetre.
EU/1/10/642/002 84 film-coated tablets
EU/1/10/642/004 3 filmom obložene tablete
However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Na temelju poznavanja ove skupine spojeva, predoziranje peroralnim putem može rezultirati nuspojavama gornjeg dijela gastrointestinalnog trakta (npr. iritacijom želuca, dispepsijom, ezofagitisom, gastritisom ili ulkusom) ili hipokalcijemijom.
If you forget to take Ibandronic Acid Teva
Ako ste zaboravili uzeti Ibandronatnu kiselinu Teva
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.
Kako Ibandronatna kiselina Teva izgleda i sadržaj pakovanja Ibandronatna kiselina Teva filmom obložene tablete su bijele, bikonveksne tablete oblika kapsule s utisnutom oznakom „50“ na jednoj strani i bez oznake na drugoj strani.
NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
Keep taking Ibandronic Acid Teva for as long as your doctor tells you.
Uvijek uzimajte Ibandronatnu kiselinu Teva točno onako kako Vam je rekao liječnik.
Atypical subtrochanteri c and diaphyseal femoral fractures†
Atipične suptrohanteričke i dijafizealne frakture femura†
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Događaji povezani s upalom oka poput uveitisa, episkleritisa i skleritisa zabilježeni su uz primjenu ibandronatne kiseline.
Ibandronic acid 150 mg once monthly
Ibandronatna kiselina 150 mg jedanput mjesečno
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).
Bolesnici bi stoga Ibandronatnu kiselinu Teva trebali uzimati nakon noćnog gladovanja (barem 6 sati) i trebali bi gladovati još 1 sat nakon uzimanja Ibandronatne kiseline Teva (vidjeti dio 4.2).
- If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.
- Ako imate probleme s jednjakom (cijev koja povezuje usta sa želucem), kao što su suženje ili teškoće prilikom gutanja.
They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it's less likely to cause irritation.
One Vam pomažu u pravilnom uzimanju tableta Ibandronatne kiseline Teva i njihovu brzom dolasku u želudac, čime je smanjena mogućnost pojave nadražaja.
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.
Nakon jedne godine (primarna analiza) medijan relativne vrijednosti promjene u odnosu na početne vrijednosti iznosio je -76% za ibandronatnu kiselinu 150 mg jedanput mjesečno, odnosno -67% za ibandronatnu kiselinu 2,5 mg jedanput dnevno.
The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost Ibandronatne kiseline Teva u djece i adolescenata mlađih od 18 godina nije ustanovljena.
It is not known whether ibandronic acid is excreted in human milk.
Nije poznato izlučuje li se ibandronatna kiselina u majčino mlijeko.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
- Budite u uspravnom položaju (sjedeći ili stojeći) dok uzimate tabletu te još jedan sat (60 minuta) nakon uzimanja tablete.
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).
Bolesnici s teškim oštećenjima bubrega (CLcr ≤30 ml/min) koji su peroralno uzimali 10 mg ibandronatne kiseline svakodnevno u razdoblju od 21 dan, imali su dvostruko do trostruko više koncentracije u plazmi od osoba s normalnom funkcijom bubrega (CLcr ≥80 ml/min).
Ostravska 29/305
Teva Czech Industries s.r.o. Ostravska 29/305
Read the package leaflet before use.
Prije uporabe pročitati uputu o lijeku.
Common Uncommon Rare
Manje često Rijetko Vrlo rijetko Nepozna to
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic Acid Teva tablets.
Proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo), uključujući mlijeko i hranu, mogu utjecati na apsorpciju tableta Ibandronatne kiseline Teva.
Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
Često (mogu se javiti kod manje od 1 na 10 osoba): • mučnina, žgaravica i nelagoda pri gutanju (upala jednjaka)
Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Bioraspoloživost je smanjena za otprilike 90% kada se ibandronatna kiselina primjenjuje uz standardni doručak, u usporedbi s bioraspoloživosti opaženom u ispitanika koji su je primijenili natašte.
There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Nema dokaza klinički značajnih međuetničkih razlika između azijata i bijelaca u izloženosti ibandronatnoj kiselini.
Relative risk reduction of clinical vertebral fracture
Smanjenje relativnog rizika za kliničke prijelome kralježaka
Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
U postmenopauzalnih žena ibandronatna kiselina dovodi do progresivnog neto povećanja koštane mase i smanjuje incidenciju prijeloma smanjujući povećanu koštanu pregradnju na premenopauzalne vrijednosti.
Tel: +39 02 89 17 98 1
Teva Italia S.r.l. Tel: +39 02 89 17 98 1
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Ibandronatna kiselina Teva ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na blister pakovanju i kutiji iza oznake „EXP“ ili „Rok valjanosti“.
Ocular inflammation*†
Upala oka*†*
Ibandronic acid 150 mg once monthly (N=291)
Ibandronatna kiselina 150 mg jedanput mjesečno (n=291)
Secondary efficacy endpoints
Sekundarne mjere ishoda djelotvornosti
METHOD AND ROUTE OF ADMINISTRATION Do not suck, chew or crush the tablets.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne otapajte u ustima, ne žvačite i ne drobite tablete.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili ljekarniku.
Tablet coating:
Ovojnica tablete:
Subjects with severe renal failure (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Ispitanici s teškim zatajenjem bubrega (CLcr manji od 30 ml/min) koji su peroralno uzimali 10 mg ibandronatne kiseline svakodnevno u razdoblju od 21 dan, imali su 2 do 3 puta više koncentracije u plazmi od ispitanika s normalnom funkcijom bubrega, dok je ukupni klirens ibandronatne kiseline iznosio 44 ml/min.
Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati još barem 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
U bolesnika kod kojih se sumnja na atipičan prijelom bedrene kosti treba razmotriti obustavljanje liječenja bisfosfonatima nakon procjene stanja bolesnika i na temelju ocjene omjera koristi i rizika za svakoga pojedinog bolesnika.
Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia
Nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su strikture ili ahalazija.
How to take Ibandronic Acid Teva).
Kako uzimati ibandronatnu kiselinu Teva).
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
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).
Nakon jedne godine odgovorilo je 83,5% (p= 0,006) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 73,9% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno (definirano kao smanjenje od ≥50% od početne vrijednosti).
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora jednake su očekivanima za bisfosfonate kao skupinu lijekova.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Među ovim bolesnicima, incidencija nuspojava u obliku poremećaja gornjeg dijela gastrointestinalnog trakta u bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno bila je slična onoj u bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
You may have early signs of a possible unusual fracture of the thigh bone.
To mogu biti rani znakovi mogućeg neubičajenog prijeloma bedrene kosti.
Adequate intake of calcium and vitamin D is important in all patients.
Za sve je bolesnike važno da uzimaju odgovarajuće količine kalcija i vitamina D.
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.
Nadomjesci kalcija, antacidi i neki peroralni lijekovi koji sadrže multivalentne katione (kao što su aluminij, magnezij i željezo) mogu utjecati na apsorpciju Ibandronatne kiseline Teva.
Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance.
Bubrežni klirens ibandronatne kiseline u bolesnika s različitim stupnjevima oštećenja funkcije bubrega linearno je povezan s klirensom kreatinina.
Month 2
Mjesec 1 Mjesec 2 Mjesec 3
Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati najmanje još sljedećih 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Krvarenje, vrijed na dvanaesniku, gastritis, disfagija, suha usta
At one year (primary analysis), 91.3 % (p=0.005) of patients receiving ibandronic acid 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Nakon jedne godine (primarna analiza) u 91,3% (p=0,005) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno došlo je do povećanja BMD lumbalne kralježnice više ili jednako početnoj vrijednosti (BMD responderi) u usporedbi s 84% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
It contains the active substance ibandronic acid.
Sadrži djelatnu tvar ibandronatnu kiselinu.
Ibandronic acid 150 mg once monthly (N=320)
Ibandronatna kiselina 150 mg jedanput mjesečno (n=320)
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic Acid Teva in patients with concomitant risk factors.
U bolesnika s istodobno prisutnim faktorima rizika preporučuje se prije liječenja lijekom Ibandronatna kiselina Teva provesti pregled zuba i preventivne stomatološke zahvate te ocijeniti omjer koristi i rizika za svakog pojedinog bolesnika.
Children and adolescents Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Djeca i adolescenti Ibandronatna kiselina Teva ne se smije davati djeci i adolescentima mlađima od 18 godina.
Back pain
Bol u leđima
Children and adolescents Do not give Ibandronic Acid Teva to children or adolescents below 18 years.
Djeca i adolescenti Ibandronatnu kiselinu Teva nemojte davati djeci i adolecentima mlađim od 18 godina.
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.
Ako zaboravite uzeti tabletu ujutro na odabrani dan, nemojte je uzimati kasnije toga istog dana.
No specific information is available on the treatment of overdose with Ibandronic Acid Teva.
Nisu dostupne specifične informacije o liječenju u slučaju predoziranja Ibandronatnom kiselinom Teva.
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.
Pri ocjenjivanju bolesnikova rizika za razvoj osteonekroze čeljusti potrebno je razmotriti sljedeće faktore rizika: - potentnost lijeka koji inhibira koštanu resorpciju (veći rizik kod primjene visoko potentnih spojeva), put primjene (veći rizik kod parenteralne primjene) i kumulativnu dozu inhibitora koštane resorpcije - rak, popratna stanja (npr. anemija, koagulopatije, infekcija), pušenje - istodobno primijenjene terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze,
Do not take a double dose to make up for a forgotten dose.
Ako ste zaboravili uzeti Ibandronatnu kiselinu Teva Nemojte uzeti dvostruku dozu da biste nadoknadili dozu koju ste propustili.
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).
Ibandronatna kiselina Teva 50 mg: lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer.
Predoziranje peroralnim putem može rezultirati poremećajima gornjeg dijela gastrointestinalnog trakta, primjerice iritacijom želuca, žgaravicom, ezofagitisom, gastritisom ili vrijedom.
Ibandronic acid 2.5 mg daily
Ibandronatna kiselina 2,5 mg jedanput dnevno
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Headache Dizziness
Upala oka
No specific information is available on the treatment of overdosage with Ibandronic Acid Teva.
Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja Ibandronatnom kiselinom Teva.
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).
Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni (vidjeti dio 4.4).
Hypocalcaemi a*
Hipokalcijemija*
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.
Ibandronatna kiselina nije ispitivana na pedijatrijskoj populaciji, stoga nisu dostupni podaci o djelotvornosti i sigurnosti primjene u ovoj skupini bolesnika.
When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Prema strožem kriteriju, gdje se uzima u obzir BMD lumbalne kralježnice i cijelog kuka, nakon jedne godine odgovorilo je 83,9% (p<0,001) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 65,7% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
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.
Nakon dvije godine taj je kriterij zadovoljilo 87,1% (p<0,001) bolesnika u skupini 150 mg jedanput mjesečno odnosno 70,5% bolesnika u skupini 2,5 mg jedanput dnevno.
Since Nonsteroidal Anti-Inflammatory medicinal products and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Budući da su nesteroidni protuupalni lijekovi povezani s gastrointestinalnom iritacijom, potreban je oprez pri istodobnom peroralnom liječenju.
White, biconvex, capsule-shaped film-coated tablets, engraved “50” on one side and plain on the other.
Bijele, bikonveksne, filmom obložene tablete, oblika kapsule s utisnutom oznakom „50“ na jednoj strani i bez oznake na drugoj strani.
BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
BMD - srednja promjena u odnosu na početne vrijednosti za lumbalnu kralježnicu nakon 3 godine
Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 1 or 3 tablets.
Ibandronatna kiselina Teva dostupna je u pakovanju od 1 ili 3 tablete u PVC/Aclar/PVC //aluminij blisteru, u kutiji.
Patients with renal impairment
Bolesnici s oštećenjem bubrega
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva
There are no data on the effects of ibandronic acid in humans.
Nema saznanja o djelovanju ibandronatne kiseline u ljudi.
Do not chew, suck or crush the tablet.
Nemojte žvakati, otapati u ustima niti drobiti tabletu.
Do not suck, chew or crush the tablet.
Ne otapajte u ustima, ne žvačite i ne drobite tabletu.
Fatigue
Svrbež
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - supplements containing calcium, magnesium, iron or aluminium - acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Posebno, obavijestite svog liječnika ili ljekarnika ukoliko uzimate neke od sljedećih lijekova: - nadomjesne pripravke kalcija, magnezija, željeza ili aluminija
Special populations Renal impairment
Posebne populacije Oštećenje funkcije jetre
MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/003 1 film-coated tablet EU/1/10/642/004 3 film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/10/642/003 1 filmom obložena tableta
Uncommon (may affect less than 1 in 100 people):
Manje često (mogu se javiti u manje od 1 na 100 osoba):
România Teva Pharmaceuticals S.R.L
Malta Teva Pharmaceuticals Ireland, L-Irlanda
Very rare (may affect up to 1 in 10,000 people):
Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba):
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.
Nakon intravenske primjene 0,5 mg u bolesnika sa teškim oštećenjem funkcije bubrega, ukupni, bubrežni i nebubrežni klirens smanjili su se za 67%, 77% odnosno 50%.