FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti, većinom u bolesnika oboljelih od raka liječenih lijekovima koji inhibiraju resorpciju kostiju, kao što je ibandronatna kiselina (vidjeti dio 4.4).
English: Patients with concomitant diseases, or who use medicinal products which have potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Croatian: Bolesnike s pratećim bolestima ili one koji koriste lijekove koji mogu imati štetne učinke na bubrege, potrebno je tijekom liječenja redovito kontrolirati u skladu s načelima dobre medicinske prakse.
English: The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Croatian: Primarna analiza podataka iz ispitivanja BM 16550 nakon jedne godine i potvrdna analiza nakon dvije godine pokazale su da režim primjene injekcije od 3 mg svaka tri mjeseca nije inferioran peroralnoj primjeni od 2,5 mg dnevno, u pogledu prosječnog povećanja BMD lumbalne kralježnice, cijelog kuka, vrata bedrene kosti i trohantera (Tablica 2).
English: Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis.
Croatian: Nakon završetka liječenja ponovno su se pojavile patološke vrijednosti povišene razgradnje kostiju koje su postojale prije liječenja, povezane s osteoporozom u postmenopauzi.
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Croatian: In vivo, ibandronatna kiselina sprječava eksperimentalno induciranu razgradnju kosti uzrokovanu zaustavljanjem gonadne funkcije, retinoidima, tumorima ili ekstraktima tumora.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Croatian: Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem ibandronatne kiseline a u dozi od 6 mg intravenski, ocijenjena je u jednom randomiziranom, placebom kontroliranom ispitivanju faze III u trajanju od 96 tjedana.
English: For treatment of tumour induced hypercalcaemia, Ibandronic acid Accord concentrate for solution for infusion is generally given as a single infusion.
Croatian: Za liječenje hiperkalcijemije uzrokovane tumorom, Ibandronic acid Accord koncentrat za otopinu za infuziju obično se daje kao jednokratna infuzija.
English: Ibandronic acid, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Croatian: Ibandronatna kiselina, poput ostalih bisfosfonata koji se primjenjuju intravenski, može izazvati prolazno smanjenje razine kalcija u serumu.
English: Total clearance of ibandronic acid is low with average values in the range 84 - 160 ml/min.
Croatian: Ukupni klirens ibandronatne kiseline je nizak, s prosječnim vrijednostima u rasponu od 84 do 160 ml/min.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i štrcaljki iza „Rok valjanosti“ ili kratice „EXP“.
English: ONJ can also occur after stopping treatment.
Croatian: Osteonekroza čeljusti može se javiti i nakon prestanka liječenja.
English: Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.
Croatian: Liječnik može zatražiti od vas da obavite stomatološki pregled prije počeka liječenja ibandronatnom kiselinom.
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Croatian: Atipične suptrohanteri čne i dijafizealne frakture femura†
English: Incidence of clinical vertebral fracture
Croatian: Incidencija kliničkih prijeloma kralježaka
English: Chemical and physical in-use stability after dilution in 0.9 % sodium chloride or 5% glucose solution has been demonstrated for 36 hours at 25°C and 2°C to 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost otopine nakon razrjeđivanja u 0,9%-tnoj otopini natrijevog klorida ili 5% -tnoj otopini glukoze iznosi 36 sati pri 25°C i 2°C - 8°C.
English: radiotherapy to bone for treatment of fractures/impending fractures surgery to bone for treatment of fractures vertebral fractures non-vertebral fractures.
Croatian: radioterapija kostiju radi liječenja prijeloma/mogućih prijeloma operacija kostiju zbog liječenja prijeloma prijelomi kralježnice drugi prijelomi osim kralježnice.
English: 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.
Croatian: Plan liječenja bolesnika koji razviju osteonekrozu čeljusti potrebno je uspostaviti u uskoj suradnji između liječnika i stomatologa ili oralnog kirurga sa iskustvom u liječenju ostenekroze čeljusti.
English: What Ibandronic acid Accord looks like and contents of the pack Ibandronic acid Accord is a concentrate for solution for infusion (sterile concentrate).
Croatian: Kako Ibandronic acid Accord izgleda i sadržaj pakiranja Ibandronic acid Accord je koncentrat za otopinu za infuziju (sterilni koncentrat).
English: Early plasma levels fall quickly, reaching 10 % of the peak values within 3 and 8 hours after intravenous or oral administration, respectively.
Croatian: Početne vrijednosti u plazmi brzo padaju, dostižući 10% vršnih vrijednosti u vremenu od 3 do 8 sati nakon intravenske odnosno peroralne primjene.
English: Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Croatian: Nakon toga injekcije treba primjenjivati svaka tri mjeseca, brojeći od dana posljednje primljene injekcije.
English: In vivo, ibandronic acid prevents bone destruction experimentally induced by cessation of gonadal function, retinoids, tumours or tumour extracts.
Croatian: In vivo ibandronatna kiselina sprječava eksperimentalno inducirano uništavanje kosti uzrokovano zaustavljanjem gonadnih funkcija, retinoidima, tumorima ili ekstraktima tumora.
English: Chemical and physical in-use stability after dilution in 9 mg/ml (0.9 %) sodium chloride solution or 5% glucose solution has been demonstrated for 36 hours at 25°C and 2°C to 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost otopine nakon razrjeđivanja u 9 mg/ml (0,9%-tnoj) otopini natrijevog klorida ili 5% -tnoj otopini glukoze iznosi 36 sati pri 25°C i 2°C - 8°C.
English: 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).
Croatian: 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).
English: Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
Croatian: Klinički značajno smanjene razina kalcija, fosfora i magnezija u serumu potrebno je liječiti intravenskom primjenom kalcijeva glukonata, kalijeva ili natrijeva fosfata odnosno magnezijeva sulfata.
English: Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products.
Croatian: Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki ne smije se miješati s otopinama koje sadrže kalcij (kao što je Ringerova otopina s laktatom i heparinkalcij) kao ni s drugim lijekovima koji se primjenjuju intravenski.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6 mg/6 ml
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 6mg/6 ml
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Croatian: Bubrežni klirens (oko 60 ml/min u zdravih žena u postmenopauzi) doprinosi s 50-60% ukupnom klirensu i povezan je s klirensom kreatinina.
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Croatian: U reproduktivnim ispitivanjima na štakorima koji su lijek primali intravenski, ibandronat je smanjio broj spermija pri dozama od 0,3 i 1 mg/kg na dan te smanjio plodnost u mužjaka pri dozi od 1 mg/kg na dan, a u ženki pri dozi od 1,2 mg/kg na dan.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Croatian: Atipične subtrohanteričke dijafizealne frakture femura zabilježene su kod liječenja bisfosfonatima, prvenstveno u bolesnika koji su dugotrajno primali lijekove protiv osteoporoze.
English: You can drive and use machines as it's expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines.
Croatian: Možete upravljati vozilima i strojevima jer se očekuje da Ibandronic acid Accord ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
English: Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†
Croatian: Poremećaji imunološkog sustava preosjetljivos t†, bronhospaza m†, angioedem† anafilaktička reakcija/šok†
English: DATE OF FIRST AUTHORISATION Date of first authorisation: 19 November 2012 Date of latest renewal: 18 September 2017
Croatian: Datum prvog odobrenja: 19. studenog 2012.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Croatian: Osteonekroza vanjskog slušnog hodnika prijavljena je kod primjene bisfosfonata, uglavnom u vezi s dugoročnim liječenjem.
English: For patients with breast cancer and bone metastases, Ibandronic acid Accord infusion should be administered every 3-4 weeks.
Croatian: U bolesnika s rakom dojke i koštanim metastazama, infuziju Ibandronic acid Accorda treba primjenjivati svaka 3 - 4 tjedna.
English: Paediatric population (see section 4.2 and section 5.1)
Croatian: Pedijatrijska populacija (vidjeti dio 4.2 i dio 5.1)
English: • new pain, weakness or discomfort in your thigh, hip or groin.
Croatian: • nova bol, slabost ili neugoda u bedru, kuku ili preponama.
English: Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.
Croatian: Količinu Ibandronic acid Accorda koju primate odredit će liječnik u ovisnosti o Vašoj bolesti.
English: The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 1530 seconds, every three months.
Croatian: Preporučena doza ibandronatne kiseline iznosi 3 mg, primijenjena putem intravenske injekcije u trajanju od 15 do 30 sekundi svaka tri mjeseca.
English: 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.
Croatian: Tijekom liječenja ibandronatnom kiselinom sve bolesnike se mora poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke kontrole i odmah prijave sve oralne simptome kao što su pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
English: • fluid build up and swelling (‘“lymphoedema”')
Croatian: • nakupljanje tekućine i naticanje (“limfedem”)
English: Prior to treatment with ibandronic acid the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Croatian: Prije liječenja ibandronatnom kiselinom bolesnika treba odgovarajuće rehidrirati s 9 mg/ml (0,9%) otopine natrijevog klorida.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6.
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 6. DRUGO
English: • your body temperature getting too low (hypothermia)
Croatian: • preniska tjelesna temperatura (hipotermija)
English: Talk to your doctor before receiving Ibandronic acid Accord:
Croatian: Obratite se svom liječniku prije nego primite lijek Ibandronic acid Accord:
English: The liver has no significant role in the clearance of ibandronic acid, which is not metabolised but is cleared by renal excretion and by uptake into bone.
Croatian: Jetra nema bitnu ulogu u klirensu ibandronatne kiseline, koja se ne metabolizira nego se uklanja putem renalne ekskrecije i unosom u kosti.
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Croatian: Slučajevi anafilaktičke reakcije/šoka, uključujući smrtonosne događaje, primijećeni su u bolesnika koji su intravenski liječeni ibandronatnom kiselinom.
English: Osteonecrosis of the external auditory canal
Croatian: Osteonekroza vanjskog slušnog hodnika
English: Based on the results of study BM 16550, ibandronic acid 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Croatian: Na temelju rezultata ispitivanja BM 16550 procjenjuje se da će intravenska injekcija ibandronatne kiseline od 3 mg koja se daje svaka tri mjeseca biti barem jednako djelotvorna u sprječavanju prijeloma kao peroralna doza ibandronatne kiseline od 2,5 mg koja se uzima jedanput dnevno.
English: At 12 months median relative changes from baseline were -58.6 % for the intravenous injection of 3 mg every 3 months regimen and -62.6 % for oral 2.5 mg daily regimen.
Croatian: Nakon 12. mjeseca medijan relativne vrijednosti promjena u odnosu na početne vrijednosti iznosio je -58,6% za liječenje intravenskom injekcijom od 3 mg svaka tri mjeseca i -62,6% za peroralno liječenje dozom od 2,5 mg jedanput dnevno.
English: Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Croatian: Ibandronic acid Accord djeluje tako što smanjuje gubitak kalcija iz kostiju.
English: Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Croatian: Pakiranje sadrži 1 napunjenu štrcaljku i 1 injekcijsku iglu ili 4 napunjene štrcaljke i 4 injekcijske igle.
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Croatian: Dvogodišnje pivotalno ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16550) pokazalo je sličnu sveukupnu sigurnost primjene intravenske injekcije ibandronatne kiseline od 3 mg svaka tri mjeseca i peroralno primijenjene ibandronatne kiseline 2,5 mg jedanput dnevno.
English: Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with 9 mg/ml (0.9 %) sodium chloride.
Croatian: Prije liječenja Ibandronic acid Accordom bolesnika treba odgovarajuće rehidrirati s 9 mg/ml (0,9%) otopine natrijevog klorida.
English: Due to limited clinical experience, ibandronic acid injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Croatian: Zbog ograničenih kliničkih iskustava injekcija ibandronatne kiseline ne preporučuje se bolesnicima čija je razina kreatinina u serumu veća od 200 μmol/l (2,3 mg/dl) ili je klirens kreatinina manji od 30 ml/min (vidjeti poglavlja 4.2 i 5.2).
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Ibandronic acid Accord infusion is repeated at 3-4 week intervals.
Croatian: Za sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama, infuzija Ibandronic acid Accorda ponavlja se u intervalima od 3 - 4 tjedna.
English: Ibandronic acid injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2)
Croatian: Injekcija ibandronatne kiseline ne preporučuje se za primjenu u bolesnika u kojih je kreatinin u serumu veći od 200 μmol/l (2,3 mg/dl) ili u kojih je klirens kreatinina (mjeren ili procijenjen) manji od 30 ml/min jer su dostupni ograničeni klinički podaci dobiveni u ispitivanjima takvih bolesnika (vidjeti poglavlja 4.4 i 5.2).
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that ibandronic acid has no or negligible influence on the ability to drive and use machines.
Croatian: S obzirom na farmakodinamički i farmakokinetički profil lijeka i prijavljene nuspojave, očekuje se da ibandronatna kiselina ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.
Croatian: Neiskorištenu otopinu za injekciju kao i korištenu štrcaljku i iglu potrebno je odložiti u skladu s lokalnim propisima.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Croatian: Odmah se obratite liječniku i stomatologu ako Vam se jave problemi s ustima i zubima, kao što su pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak, jer to mogu biti znakovi osteonekroze čeljusti.
English: To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you.
Croatian: Nastavljanje primjene lijeka Ibandronic acid Accord Kako biste imali najveću korist od liječenja, važno je da nastavite primati injekcije svaka tri mjeseca sve dok Vam ih liječnik propisuje.
English: • walking or other weight-bearing exercise
Croatian: • šetnje i druge aktivnosti koje uključuju podizanje tereta
English: Dosage: Treatment of Tumour-induced hypercalcaemia Ibandronic acid Accord is usually administered in a hospital setting.
Croatian: Doziranje: Liječenje hiperkalcijemije nastale zbog tumora Ibandronic acid Accord se obično primjenjuje u bolničkim uvjetima.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Croatian: Odmah se obratite liječniku i stomatologu ako vam se jave problemi s ustima i zubima, kao što su pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak, jer to mogu biti znakovi osteonekroze čeljusti.
English: Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Croatian: Peroralno liječenje ibandronatnom kiselinom 2,5 mg tabletama jedanput dnevno dovelo je do progresivnih povećanja BMD kralježaka i ostalih dijelova skeleta.
English: [Justification for not including Braille accepted]
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Croatian: U kliničkim ispitivanjima nije bilo dokaza pogoršanja bubrežne funkcije tijekom dugotrajne terapije ibandronatnom kiselinom.
English: This includes:
Croatian: Takav način obuhvaća:
English: 5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
Croatian: Koncentrat za otopinu za infuziju 1 bočica (6 mg/6 ml) 5 bočica (6 mg/6 ml) 10 bočica (6 mg/6 ml)
English: 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.
Croatian: U bolesnika liječenih ibandronatnom kiselinom došlo je do značajnog pada biljega resorpcije kostiju u urinu (piridinolin i deoksipiridinolin) koji je bio statistički značajan u usporedbi s placebo grupom.
English: What Ibandronic acid Accord is and what it is used for
Croatian: Što je Ibandronic acid Accord i za što se koristi
English: Talk to your doctor, pharmacist or nurse before receiving Ibandronic acid Accord:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Ibandronic acid Accord:
English: If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.
Croatian: Ukoliko niste sigurni, posavjetujte se sa svojim liječnikom ili ljekarnikom prije liječenja Ibandronic acid Accordom.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/min).
Croatian: Nisu potrebne prilagodbe doze za bolesnike s blagim ili umjerenim oštećenjem funkcije bubrega (klirens kreatinina jednak ili veći od 30 ml/min).
English: • if you have kidney problems.
Croatian: • ako imate problema s bubrezima.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms, including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.
Croatian: Bolest slična gripi obuhvaća nuspojave prijavljene kao akutna reakcija ili simptomi kao što su bolovi u mišićima i zglobovima, groznica, zimica, umor, mučnina, gubitak apetita, i bolovi u kostima.
English: Do not take Ibandronic acid Accord if you are pregnant or breast-feeding.
Croatian: Ne smijete primjenjivati lijek Ibandronic acid Accord ako ste trudni ili dojite.
English: 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.
Croatian: Jetra nema bitnu ulogu u klirensu ibandronatne kiseline jer se ibandronatna kiselina ne metabolizira, nego se uklanja izlučivanjem putem bubrega i apsorpcijom u kosti.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with ibandronic acid in patients with concomitant risk factors.
Croatian: U bolesnika s pridruženim faktorima rizika preporučuje se pregled zuba s preventivnim zubarskim zahvatom i individualna procjena koristi i rizika prije liječenja ibandronatnom kiselinom.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju i naljepnici iza „Rok valjanosti“ ili kratice „EXP“.