natgillin/translations-raw huggingface dataset:
There are no data on the use of ibandronic acid in patients less than 18 years old.
O uporabi ibandronske kisline pri bolnikih, starih manj kot 18 let, ni podatkov.
To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Da bi se izognili možnim inkompatibilnostim, lahko koncentrat ibandronske kisline za raztopino za infundiranje razredčimo le z izotonično raztopino natrijevega klorida ali 5 % raztopino glukoze.
Children and adolescents Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.
Zdravilo Ibandronska kislina Accord se ne sme uporabljati pri otrocih in mladostnikih starih manj kot 18 let.
Rare (may affect up to 1 in 1000 people): • hives
Redki (pojavijo se pri največ 1 od 1000 bolnikov): • koprivnica.
For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh, ki se zdravijo zaradi preprečevanja z okostjem povezanih dogodkov, se priporoča prilagoditev odmerka (glejte poglavje 4.2).
Sodium chloride Sodium acetate trihydrate Glacial acetic acid Water for injections
Natrijev klorid Natrijev acetat trihidrat Koncentrirana ocetna kislina Voda za injekcije
(N=974)
placebo (n = 974)
EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
EU/1/12/798/005 1 napolnjena injekcijska brizga EU/1/12/798/006 4 napolnjene injekcijske brizge
Ibandronic acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).
Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki 2,25 mg natrijevega ibandronata monohidrata).
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija, diskrazija krvi
ibandronic acid 3 mg injection every 3 months (N=365)
ibandronska kislina 3 mg v obliki injekcije vsake 3 mesece (n = 365)
Patients with cardiac impairment
Bolniki s srčno okvaro
Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck
rak, sočasne bolezni (npr. anemijo, koagulopatije, okužbo), kajenje, sočasna zdravljenja: kortikosteroide, kemoterapijo, zaviralce angiogeneze, radioterapijo glave in vratu, slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege, npr. ekstrakcijo zob.
No dose adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 μmol/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/min.
Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo serumski kreatinin enak ali manjši kot 200 µmol/l (2,3 mg/dl) ali očistek kreatinina (izmerjen ali ocenjen) enak ali večji kot 30 ml/min, prilagajanje odmerkov ni potrebno.
Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki 6,75 mg natrijevega ibandronata monohidrata).
• stomach pain (such as gastritis) or tummy pain, , indigestion, nausea, having diarrhoea (loose bowels) or constipation
• bolečina v želodcu (kot je npr. gastritis) ali trebuhu, slaba prebava, slabost, driska ali zaprtje,
Uncommon (may affect less than 1 in 100 people)
Občasni (pojavijo se lahko pri manj kot 1 od 100 bolnikov):
ibandronic acid 3 mg injection every 3 months (N=334)
ibandronska kislina 3 mg v obliki injekcije vsake 3 mesece (n = 334)
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Ena viala vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
Ibandronic acid concentrate for solution for infusion should not be mixed with calcium containing solutions.
Koncentrata ibandronske kisline za raztopino za infundiranje ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Preglednica 1: Neželeni učinki, ki so se pojavili pri postmenopavznih ženskah, ki so v študijah faze III BM16550 in MF4411 ter po prihodu zdravila na trg prejemale ibandronsko kislino 3 mg v obliki injekcije vsake 3 mesece ali ibandronsko kislino 2,5 mg na dan.
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).
Ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450, zato presnovna medsebojna delovanja niso verjetna (glejte poglavje 5.2).
Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid
Neželeni učinki o katerih so poročali pri intravenskem dajanju ibandronske kisline
Elderly (see section 4.2) In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Multivariantna analiza je pokazala, da starost za vse preizkušane farmakokinetične parametre ni neodvisen dejavnik.
Appropriate medical support and monitoring measures should be readily available when ibandronic acid intravenous injection is administered.
Pri dajanju intravenske injekcije ibandronske kisline mora biti na voljo ustrezna medicinska podpora in nadzor.
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Farmakokinetika ibandronske kisline pri bolnikih, ki niso na hemodializi, ni poznana.
Very rare (may affect up to 1 in 10000 people):
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
For total hip BMD, 82.3 % of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1 % of patients receiving 2.5 mg daily orally (p=0.02).
Po enem letu je bilo na MKG kolka odzivnih 82,3 % bolnikov, ki so prejemali 3-mg injekcijo vsake 3 mesece, in 75,1 % bolnikov, ki so jemali 2,5 mg na dan peroralno (p = 0,02).
Blood alkaline phosphatase increase, weight decrease
Preiskave zvišana γGT, zvišan kreatinin zvišane koncentracije alkalne fosfataze v krvi, znižanje telesne mase
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Oznaka ATC: M05BA06
Deafness
Odmerek
Ibandronic acid Accord 6 mg concentrate for solution for infusion Each vial contains 6 ml of concentrate.
Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 6 ml koncentrata.
Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
O primerih osteonekroze čeljustnice so poročali v obdobju po začetku trženja za ibandronsko kislino.
There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with ibandronic acid that was statistically significant compared to placebo.
V primerjavi s placebom se je pri bolnikih, zdravljenih z ibandronsko kislino, v urinu pojavilo statistično značilno izrazito zmanjšanje označevalcev kostne resorpcije (piridinolina in deoksipiridinolina).
Prevention of skeletal events in patients with breast cancer and bone metastases
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
Prescribers should consult the section Patients with Renal Impairment below for recommendations on dosing and administration in this patient group.
Pri tej skupini bolnikov morajo predpisovalci upoštevati navodila za odmerjanje in način uporabe iz poglavja Bolniki z ledvično okvaro spodaj.
• fluid build up and swelling (‘“lymphoedema”')
• zastajanje tekočin in otekanje (limfni edem);
For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh je treba upoštevati naslednja priporočila za odmerjanje, da se prepreči z okostjem povezane dogodke:
Relative Risk Reduction New morphometric vertebral fractures
Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
For lumbar spine BMD, 92.1 % of patients receiving 3 mg injection every 3 months increased or maintained their BMD after 1 year of treatment (i.e. were responders) compared with 84.9 % of patients receiving oral 2.5 mg daily (p=0.002).
MKG ledvene hrbtenice se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 92,1 % bolnikov (t. i. odzivni bolniki), ki so prejemali 3-mg injekcijo vsake 3 mesece, in 84,9 % bolnikov, ki so prejemali 2,5 mg na dan peroralno (p = 0,002).
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.
Povzroči progresivno čisto povečanje kostne mase in zmanjša incidenco zlomov, tako da pri ženskah v postmenopavzi zmanjša povečano razmerje med razgradnjo in tvorbo kosti in ga približa razmerju pred menopavzo.
How to receive Ibandronic acid Accord 4.
Kako prejemati zdravilo Ibandronska kislina Accord 4.
• One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
• Ena napolnjena injekcijska brizga s 3 ml raztopine vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata).
Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina in voda za injekcije.
At two years, 80.1 % and 68.8 % of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Po dveh letih je tem kriterijem zadostilo 80,1 % bolnikov v skupini, ki je prejemala 3 mg vsake 3 mesece, in 68,8 % bolnikov v skupini, ki je prejemala 2,5 mg na dan (p = 0,001).
For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2):
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh je treba upoštevati naslednja priporočila za odmerjanje, da se prepreči z okostjem povezane dogodke (glejte poglavje 5.2):
It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Zdravilo je na voljo v vialah iz stekla (tipa I) z gumijastim zamaškom in aluminijastim pokrovčkom s »flip-off« zaporko.
Therefore, ibandronic acid should not be used during pregnancy.
Zato se ibandronske kisline med nosečnostjo ne sme uporabljati.
ibandronic acid 2.5 mg daily (N=575)
ibandronska kislina 2,5 mg enkrat na dan (n = 575)
An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with ibandronic acid 3 mg injection.
Tudi dveletno zdravljenje s 3-mg injekcijo ibandronske kisline je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 6 mg sterile concentrate ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Ibandronska kislina Accord 6 mg sterilni koncentrat ibandronska kislina i.v.
Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ena viala vsebuje 2 ml koncentrata.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 2 mg sterile concentrate ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Ibandronska kislina Accord 2 mg sterilni koncentrat ibandronska kislina i.v.
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih, zdravljenih z ibandronsko kislino, dano intravensko, so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Zdravilo Ibandronska kislina Accord zavira izločanje kalcija iz kosti.
Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Bolezni prebavil diareja, bruhanje, dispepsija, gastrointesti nalna bolečina, bolezen zob gastroenteritis, gastritis, ulceracija ust, disfagija, heilitis
Ibandronic acid 3 mg injection every 3 months Bone mineral density (BMD)
Ibandronska kislina 3 mg v obliki injekcije, dane vsake 3 mesece Mineralna kostna gostota (MKG)
Up to now there is no experience of acute poisoning with ibandronic acid concentrate for solution for infusion.
Ni poročil o primerih akutnega prevelikega odmerjanja s koncentratom ibandronske kisline za raztopino za infundiranje.
• Place all used needles and syringes into a sharps container (puncture-proof disposable container).
• uporabljenje injekcijske igle in injekcijske brizge odvrzite v zabojnik za ostre predmete;
Ibandronic acid should not be used during pregnancy.
Ibandronske kisline se med nosečnostjo ne sme uporabljati.
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Pri bolnikih, ki so prejemali ibandronsko kislino za onkološke indikacije, so v obdobju po začetku trženja v zelo redkih primerih poročali o osteonekrozi čeljustnice (glejte poglavje 4.8).
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/min).
Za bolnike z blago ali zmerno ledvično okvaro (CLcr enak ali večji kot 30 ml/min) prilagajanje odmerkov ni potrebno.
PRE-FILLED SYRINGE
Atipičen zlom stegnenice
Do not receive Ibandronic acid Accord
Ne prejemajte zdravila Ibandronska kislina Accord:
One year data in study BM 16550
Enoletni podatki iz študije BM
• gallstones
• žolčni kamni;
[Justification for not including Braille accepted]
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
The start of treatmentor of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Pri bolnikih, ki imajo odprte lezije mehkih tkiv v ustih, je treba začetek zdravljenja oz. nov ciklus zdravljenja odložiti.
This medicine contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. ‘essentially sodiumfree'.
Zdravilo Ibandronska kislina Accord vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek (3 ml), kar v bistvu pomeni ‛brez natrija'.
BMD - mean change relative to baseline lumbar spine at year 3
MKG - povprečna sprememba glede na izhodiščno vrednost za kolk po 3 letih
• You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord.
• Med zdravljenjem z zdravilom Ibandronska kislina Accord morate jemati dodatke kalcija in vitamina D. Obvestite svojega zdravnika, če to ni mogoče.
All patients must receive adequate supplemental calcium and vitamin D.
Vsi bolniki morajo prejemati ustrezne dodatke kalcija in vitamina D. Anafilaktična reakcija/šok
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata) v 3 ml raztopine.
Administration failures
Napake pri aplikaciji
4 mg (4 ml of concentrate for solution for infusion)
≥30 CLcr < 50 4 mg (4 ml koncentrata za raztopino za infundiranje)
Rare (may affect up to 1 in 1000 people):
Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
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 in odvisen od odmerka in občutljivosti metode.
• The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
• Pomožne snovi so natrijev klorid, ocetna kislina, natrijev acetat trihidrat in voda za injekcije.
ibandronic acid 2.5 mg daily (N=334)
ibandronska kislina 2,5 mg enkrat na dan (n = 334)
How to receive Ibandronic Acid Accord
Kako prejemati zdravilo Ibandronska kislina Accord
Paediatric population (see section 4.2 and section 5.2).
Pediatrični bolniki (glejte poglavji 4.2 in 5.2)
For this purpose the contents of the vial are to be used as follows: - Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least 15 minutes.
• preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in zasevki v kostehdodamo k 100 ml izotonične raztopine natrijevega klorida ali k 100 ml 5-% raztopine glukoze in infundiramo vsaj 15 minut.
Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje ibandronska kislina
Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje ibandronska kislina
What Ibandronic acid Accord contains
Kaj vsebuje zdravilo Ibandronska kislina Accord
If you get any side effects, talk to your doctor or pharmacist.
• Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid
Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje ibandronska kislina
NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe
IME ZDRAVILA Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Ocular inflammation*†
Očesne bolezni katarakta vnetje oči†**
Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting ibandronic acid therapy for metastatic bone disease.
Pred začetkom zdravljenja metastatične bolezni kosti z ibandronsko kislino je treba učinkovito zdraviti hipokalciemijo in druge motnje kosti in presnove mineralov.
Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati.
Total hip BMD 1.8 [1.5, 2.1]
MKG stegneničnega vratu 1,6 [1,2; 2,0] MKG trohantra
ibandronic acid 2.5 mg daily (N=377)
ibandronska kislina 2,5 mg enkrat na dan (n = 377)
After 2 years of treatment, 92.8 % of patients receiving 3 mg injections and 84.7 % of patient receiving 2.5 mg oral therapy had increased or maintained lumbar spine BMD (p=0.001).
Po dveh letih zdravljenja se je MKG ledvene hrbtenice povišala ali ostala enaka izhodiščni vrednosti pri 92,8 % bolnikov, ki so prejemali 3-mg injekcije, in 84,7 % bolnikov, ki so prejemali peroralno zdravljenje z 2,5 mg (p = 0,001).
Ibandronic acid should not be used during breastfeeding.
Ibandronske kisline se ne sme uporabljati med dojenjem.
Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe ibandronic acid
Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ibandronska kislina
Mutagenicity/Carcinogenicity
Mutagenost in kancerogeni potencial
After 2 years of treatment, 85.6 % of patients receiving 3 mg injections and 77.0 % of patient receiving 2.5 mg oral therapy had increased or maintained total hip BMD (p=0.004).
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 85,6 % bolnikov, ki so prejemali 3-mg injekcije, in 77,0 % bolnikov, ki so prejemali peroralno zdravljenje z 2,5 mg (p = 0,004).
METHOD OF ADMINISTRATION EXPIRY DATE
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP
A statistically significant improvement in bone pain score was shown for intravenous ibandronic acid 6 mg compared to placebo.
V primerjavi s placebom se je pri ibandronski kislini 6 mg, dani intravensko, pokazalo statistično značilno izboljšanje rezultata pri bolečini v kosteh.
Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Ibandronic acid therapy should only be initiated by physicians experienced in the treatment of cancer.
Zdravljenje z ibandronsko kislino lahko vpelje le zdravnik z izkušnjami pri zdravljenju raka.
• not enough walking or other weight-bearing exercise
• pomanjkanje hoje ali drugih telesnih aktivnosti,
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 for cancer-related conditions.
Pri bolnikih, ki so prejemali ibandronsko kislino za stanja, povezana z rakom, so zelo redko poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnice (odmiranje kosti v čeljusti).
• The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
• Pomožne snovi so natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina in voda za injekcije.
EXPIRY DATE
DATUM PRIDOBITVE
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Pri zdravljenju z difosfonati, vključno z ibandronsko kislino, so poročali o vnetnih stanjih oči, kot so uveitis, episkleritis, skleritis.
Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections.
Pomožne snovi: natrijev klorid, koncentrirana ocetna kislina, natrijev acetat trihidrat in voda za injekcije.
Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Bolezni dihal, prsnega koša in mediastinalnega prostora faringitis pljučni edem, stridor
Ibandronic acid concentrate for solution for infusion should be administered as an intravenous infusion.
Koncentrat ibandronske kisline za raztopino za infundiranje damo v obliki intravenske infuzije.
Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Drugi neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to skupino zdravil (difosfonati).
Talk to your doctor, pharmacist or nurse before receiving Ibandronic acid Accord:
Pred začetkom uporabe zdravila Ibandronska kislina Accord se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: