natgillin/translations-raw huggingface dataset:
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4).
Najozbiljnije prijavljene nuspojave su anafilaktička reakcija/šok, atipični prijelomi bedrene kosti, osteonekroza čeljusti i upala oka (vidjeti odlomak „Opis odabranih nuspojava“ i dio 4.4).
• aching joints, arthritis, or other joint problems
• tupi bolovi u zglobovima, artritis ili drugi problemi sa zglobovima
Rare (may affect up to 1 in 1,000 people)
Rijetke (mogu se javiti kod do 1 na 1000 osoba)
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta ibandronata od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja, u fazi III, u trajanju od 96 tjedana.
Your doctor may do regular blood tests while you are receiving Iasibon.
Za vrijeme liječenja lijekom Iasibon, liječnik će Vam vjerojatno provoditi redovite krvne pretrage kako bi provjerio primate li odgovarajuću dozu ovog lijeka.
Iasibon contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Iasibon sadrži manje od 1 mmol natrija (23 mg) po dozi, odnosno zanemarive količine natrija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
• After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a refrigerator).
• Nakon razrjeđivanja infuzijska otopina stabilna je 24 sata na temperaturi od 2-8 °C (u hladnjaku).
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary.
Bolesnicima s blagim oštećenjem bubrega (CLcr ≥50 i <80 ml/min) nije potrebna prilagodba doze.
Very rare (may affect up to 1 in 10,000 people)
Vrlo rijetke (mogu se javiti kod do 1 na 10 000 osoba)
They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora bili su očekivani za ovu skupinu lijekova (bisfosfonati) i uključivale su smanjeni broj mjesta implantacije, poremećaj prirodnog poroda (distocija), povećanje visceralnih varijacija (sindrom bubrega, zdjelice i mokraćovoda) te abnormalnosti zubi u F1 potomstvu štakora.
that is bleeding, or that your stomach is inflamed (gastritis)
To može biti znak krvarenja čira u početnom dijelu crijeva (dvanaesniku) ili upale želuca (gastritis)
What you need to know before you receive Iasibon
Što morate znati prije nego počnete primati Iasibon
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva poremećaj kože,
Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth
mučnina krvarenje, vrijed na dvanaesniku, gastritis, otežano gutanje, suha usta
Acetylsalicylic acid and NSAIDs
Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi
INFORMATION IN BRAILLE Iasibon 50 mg
16. PODACI NA BRAILLEOVOM PISMU Iasibon 50 mg
Iasibon should not be used during breast-feeding.
Iasibon se ne smije koristiti za vrijeme dojenja.
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Iasibon tablets.
Interakcije lijeka i hrane Proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo),
How to take Iasibon
Kako uzimati Iasibon
If you have breast cancer that has spread to your bones, then the recommended dose is 3 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 3 ampule (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
• skin rash
• osip kože
Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule).
Iasibon 1 mg je dostupan u pakiranju od 1 ampule (ampula od 2 ml, staklo tipa I).
Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Ukupni klirens ibandronatne kiseline bio je smanjen na 44 ml/min u bolesnika s teškim oštećenjima bubrega u usporedbi sa 129 ml/min kod osoba s normalnom funkcijom bubrega.
If you have breast cancer that has spread to your bones, then the recommended dose is 6 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 6 ampula (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Nakon razrjeđivanja otopina za infuziju je stabilna 24 sata na 2 °C - 8 °C (u hladnjaku)
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
To možete spriječiti tako da se pridržavate sljedećih uputa: • Uzmite tabletu ujutro odmah nakon ustajanja, prije uzimanja prvog jutarnjeg obroka, pića,
• stomach and tummy pain, indigestion, being sick vomiting or having diarrhoea (loose bowels)
• bol u želucu i trbuhu, probavne smetnje, mučnina, povraćanje ili proljev (rijetka stolica)
Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
Iasibon 2 mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule).
Iasibon 2 mg je dostupan u pakiranju od 1 ampule (ampula od 4 ml, staklo tipa I).
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne k lik ij ozljeda, bol na mjestu injiciranja
Blood alkaline phosphatase increase, weight decrease
Pretrage povišena razina gama GT-a, povišena razina kreatinina povišene razine alkalne fosfataze u krvi, smanjenje tjelesne težine
Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.
Iasibonkoncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju.
If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Ako imate rak dojke koji se proširio na kosti, preporučena doza je 1 bočica (6 mg) svaka 3-4 tjedna, u obliku infuzije u venu, u trajanju od najmanje 15 minuta.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Nema podataka o tome smanjuje li prekid liječenja bisfosfonatima rizik od osteonekroze čeljusti u bolesnika kojima su potrebni zubarski zahvati.
Care must be taken not to administer Iasibon concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage..
Potreban je oprez kako se Iasibon koncentrat za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
INFORMATION IN BRAILLE Iasibon 1 mg
16. PODACI NA BRAILLEOVOM PISMU Iasibon 1 mg
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronate
Tablica 1 Nuspojave prijavljene uz peroralnu primjenu ibandronata Organsk i sustav
INFORMATION IN BRAILLE Iasibon 6 mg
16. PODACI NA BRAILLEOVOM PISMU Iasibon 6 mg
All Skeletal Related Events (SREs) Placebo n=277
Placebo n=277
Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid
Tablica 1 Nuspojave prijavljene kod intravenske primjene ibandronatne kiseline Organski sustav Često
Not known anaphylactic reaction/shock†
anafilaktička reakcija/šok†**
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with a duration of 96 weeks.
Prevencija koštanih događaja u bolesnika s rakom dojke i koštanim metastazama davanjem ibandronata u dozi od 6 mg intravenski ocijenjena je u jednom randomiziranom, placebom kontroliranom ispitivanju, u fazi III, u trajanju od 96 tjedana.
Marketing Authorisation Holder Pharmathen S.A.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A.
Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
vrijedovi jednjaka i erozije jednjaka koji su u nekim slučajevima bili teški i zahtijevali su bolničko liječenje, rijetko s krvarenjem ili strikturom jednjaka ili perforacijom.
Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) =serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
kalcij u serumu korigiran albuminom (mmol/l) = kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
You may have early signs of severe jaw problems (necrosis
To mogu biti rani znakovi teških problema čeljusne kosti (nekroze, tj. odumiranja koštanog kiva).
- Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
- Nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su striktura ili ahalazija.
Do not take Iasibon - if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6 - if you have problems with your food pipe /gullet (oesophagus) such as narrowing or difficulty swallowing - if you cannot stand or sit upright for at least one hour (60 minutes) at a time - if you have or ever had low calcium in your blood.
• ako ste alergični na ibandronatnu kiselinu ili neki sastojak ovog lijeka naveden u dijelu 6 • ako imate probleme s jednjakom (ezofagusom), kao što su suženje ili teškoće prilikom gutanja
Chest pain, influenzalike illness, malaise, pain
Opći poremećaj i i reakcije na mjestu primjene astenija bolovi u prsima, bolest nalik gripi, malaksalost, bol
Talk to your doctor or pharmacist before taking Iasibon:
obratite se svom liječniku ili ljekarniku prije nego uzmete Iasibon.
What Iasibon looks like and contents of the pack Iasibon is a colourless, clear solution.
Kako Iasibon izgleda i sadržaj pakiranja
Read the package leaflet before use Intravenous use, for infusion after dilution
Primjena u venu infuzijom, nakon razrjeđivanja
INFORMATION IN BRAILLE Iasibon 2 mg
16. PODACI NA BRAILLEOVOM PISMU Iasibon 2 mg
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dose adjustment is necessary.
Za bolesnike s blagim oštećenjem bubrega (klirens kreatinina ≥50 i <80 ml/min) nije potrebna prilagodba doze.
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).
Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi prevencije koštanih događaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min) preporučuje se prilagodba doze (vidjeti dio 4.2).
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A
Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
6.1 Popis pomoćnih tvari natrijev klorid acetatna kiselina, ledena natrijev acetat trihidrat voda za injekcije
(see section 4.2).
(pogledajte dio 4.).
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Hypocalcaemia
- Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Iasibon').
Preporučuje se da se lijek upotrijebi odmah nakon razrjeđivanja (pogledajte dio 5. ove upute o lijeku,
Treatment of tumour-induced hypercalcaemia
Liječenje hiperkalcijemije nastale zbog tumora
Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal
Jezgra tablete: povidon celuloza, mikrokristalična krospovidon škrob, prethodno geliran gliceroldibehenat silicijev dioksid, koloidni, bezvodni
Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Iasibon 1 mg koncentrat za otopinu za infuziju ibandronatna kiselina
For patients with breast cancer and bone metastases, Iasibon infusion should be administered every 3-4 weeks.
U bolesnika s rakom dojke i koštanim metastazama, infuziju lijeka Iasibon treba primjenjivati svaka 3
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):
Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (klirens kreatinina <30 ml/min) koji se liječe radi prevencije koštanih događaja, treba slijediti sljedeće preporuke za doziranje (vidjeti dio 5.2): Klirens kreatinina (ml/min)
Hypocalcaemia
- Hipokalcijemija.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Pharmathen S.A.
Nositelj odobrenja za stavljanje gotovog lijeka u promet Pharmathen S.A.
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:
Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) koji se liječe radi prevencije koštanih događaja, treba slijediti sljedeće preporuke za doziranje:
NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion
NAZIV LIJEKA Iasibon 6 mg koncentrat za otopinu za infuziju
Hypocalcaemia*
(hipokalcijemija).
• bruising
• modrice
QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion ibandronic acid
NAZIV LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina
QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula s 1 ml koncentrata za otopinu za infuziju sadrži 1 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Iasibon 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
Anaemia, blood dyscrasia
Poremećaji krvi i limfnog sustava anemija, krvna diskrazija
For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Za bolesnike s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) preporučena je prilagodba doze na jednu 50 mg filmom obloženu tabletu svaki drugi dan (vidjeti dio 5.2).
A statistically significant improvement in bone pain score was shown for Ibandronate 50 mg compared to placebo.
Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost ibandronata 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE,
System Organ Class
Organsk i sustav
Pruritus
Dojenje
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment
Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi sprječavanja koštanih poremećaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min)
Talk to your doctor, pharmacist or nurse before receiving Iasibon:
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Iasibon:
One ampoule with 1 ml of a concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate)
Jedna ampula sa 1 ml koncentrata za otopinu za infuziju sadrži 1 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Važno je da Iasibon uzimate u pravo vrijeme i na pravi način jer može izazvati iritaciju, upalu ili vrijed jednjaka (ezofagusa).
Concentrate for solution for infusion 1 vial
Koncentrat za otopinu za infuziju 1 ampula
• being unable to pass water (urine), cystitis (bladder inflammation)
• poteškoće s mokrenjem, upala mokraćnog mjehura (cistitis)
Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Opći poremećaji i reakcije na mjestu primjene vrućica, bolest nalik gripi**, periferni edemi,
Benign skin neoplasm
• žučni kamenci
Ocular inflammati on†**
osteonekroza čeljusti†**,
Overdose
Doza
Neoplasms benign, malignant, and unspecified
zloćudne i nespecificirane novotvorine dobroćudne novotvorine kože
One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Jedna ampula s 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion
NAZIV LIJEKA Iasibon 1 mg koncentrat za otopinu za infuziju
How to receive Iasibon
Kako ćete primati Iasibon
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ampula sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku
NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion
NAZIV LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju
How to store Iasibon
Kako čuvati Iasibon
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
U bolesnika s pridruženim faktorima rizika (npr. rak, kemoterapija, radioterapija, kortikosteroidi, loša zubna higijena) preporučuje se pregled zuba i odgovarajući preventivni zubarski zahvati prije liječenja bisfosfonatima.
What Iasibon is and what it is used for What you need to know before you receive Iasibon How to receive Iasibon
Što morate znati prije nego počnete primati Iasibon Kako ćete primati Iasibon Moguće nuspojave
Hypersensitivity bronchospasm†, angioedema†, Anaphylactic reaction/shock†
Poremećaji imunološkog sustava preosjetljivost†, bronhospazam†, angioedem†,
Patients with hepatic impairment (see section 4.2)
Pedijatrijska populacija (vidjeti dijelove 4.2 i 5.2)
Pharmathen S.A. 6, Dervenakion str 15351 Pallini, Attiki Greece
6, Dervenakion str 15351 Pallini, Attiki
• problems with your parathyroid gland
• problemi s paratireoidnom žlijezdom
Paraesthesia, dysgeusia (taste perversion)
Poremećaj i živčanog sustava parestezija, disgeuzija
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/005
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/005
NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film-coated tablets ibandronic acid
Uputa o lijeku: Informacija za bolesnika Iasibon 50 mg filmom obložene tablete ibandronatna kiselina
Atypical subtrocha nteric and diaphysea l femoral fractures†
poremećaj zglobova, bol u kostima atipične suptrohan terične i dijafizealne frakture femura†
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
U bolesnika koji primaju ibandronatnu kiselinu intravenski prijavljeni su slučajevi ozbiljnih alergijskih reakcija, ponekad sa smrtnim ishodom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 6 mg concentrate for solution for infusion ibandronic acid
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/004
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/659/003
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 1 mg concentrate for solution for infusion ibandronic acid
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 1 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
Atypical subtrochant eric and diaphyseal femoral fractures†
Poremećaj i mišićno koštano g sustava i vezivnog tkiva atipične suptrohanterične i dijafizealne frakture femura†
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata)
Pegnancy
palpitacije
Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Greece
6, Dervenakion str. 15351 Pallini, Attiki
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 2 mg concentrate for solution for infusion ibandronic acid
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Iasibon 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina i.v. primjena
At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
Nervous system disorders
Endokrini poremećaji poremećaj paratireoidnih žlijezda
Acetic acid, glacial
astenija, žeđ hipotermija
One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
TVARI Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
A statistically significant improvement in bone pain score was shown for intravenous Ibandronate 6 mg compared to placebo.
Ibandronat 6 mg dan intravenski pokazao je u usporedbi s placebom statistički značajno poboljšanje rezultata kod boli u kostima.
Store in the original package in order to protect from moisture.
6.4 Posebne mjere pri čuvanju lijeka Čuvati u originalnom pakovanju radi zaštite od vlage.