natgillin/translations-raw huggingface dataset:
Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Nakon toga injekcije treba primjenjivati svaka tri mjeseca, brojeći od dana posljednje primljene injekcije.
In vivo, ibandronic acid prevents bone destruction experimentally induced by cessation of gonadal function, retinoids, tumours or tumour extracts.
In vivo ibandronatna kiselina sprječava eksperimentalno inducirano uništavanje kosti uzrokovano zaustavljanjem gonadnih funkcija, retinoidima, tumorima ili ekstraktima tumora.
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.
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.
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).
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.
Klinički značajno smanjene razina kalcija, fosfora i magnezija u serumu potrebno je liječiti intravenskom primjenom kalcijeva glukonata, kalijeva ili natrijeva fosfata odnosno magnezijeva sulfata.
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.
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6 mg/6 ml
5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 6mg/6 ml
Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Bubrežni klirens (oko 60 ml/min u zdravih žena u postmenopauzi) doprinosi s 50-60% ukupnom klirensu i povezan je s klirensom kreatinina.
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.
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.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Atipične subtrohanteričke dijafizealne frakture femura zabilježene su kod liječenja bisfosfonatima, prvenstveno u bolesnika koji su dugotrajno primali lijekove protiv osteoporoze.
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.
Možete upravljati vozilima i strojevima jer se očekuje da Ibandronic acid Accord ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†
Poremećaji imunološkog sustava preosjetljivos t†, bronhospaza m†, angioedem† anafilaktička reakcija/šok†
DATE OF FIRST AUTHORISATION Date of first authorisation: 19 November 2012 Date of latest renewal: 18 September 2017
Datum prvog odobrenja: 19. studenog 2012.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Osteonekroza vanjskog slušnog hodnika prijavljena je kod primjene bisfosfonata, uglavnom u vezi s dugoročnim liječenjem.
For patients with breast cancer and bone metastases, Ibandronic acid Accord infusion should be administered every 3-4 weeks.
U bolesnika s rakom dojke i koštanim metastazama, infuziju Ibandronic acid Accorda treba primjenjivati svaka 3 - 4 tjedna.
Paediatric population (see section 4.2 and section 5.1)
Pedijatrijska populacija (vidjeti dio 4.2 i dio 5.1)
• new pain, weakness or discomfort in your thigh, hip or groin.
• nova bol, slabost ili neugoda u bedru, kuku ili preponama.
Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.
Količinu Ibandronic acid Accorda koju primate odredit će liječnik u ovisnosti o Vašoj bolesti.
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 1530 seconds, every three months.
Preporučena doza ibandronatne kiseline iznosi 3 mg, primijenjena putem intravenske injekcije u trajanju od 15 do 30 sekundi svaka tri mjeseca.
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.
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.
• fluid build up and swelling (‘“lymphoedema”')
• nakupljanje tekućine i naticanje (“limfedem”)
Prior to treatment with ibandronic acid the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Prije liječenja ibandronatnom kiselinom bolesnika treba odgovarajuće rehidrirati s 9 mg/ml (0,9%) otopine natrijevog klorida.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6.
5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 6. DRUGO
• your body temperature getting too low (hypothermia)
• preniska tjelesna temperatura (hipotermija)
Talk to your doctor before receiving Ibandronic acid Accord:
Obratite se svom liječniku prije nego primite lijek Ibandronic acid Accord:
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.
Jetra nema bitnu ulogu u klirensu ibandronatne kiseline, koja se ne metabolizira nego se uklanja putem renalne ekskrecije i unosom u kosti.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Slučajevi anafilaktičke reakcije/šoka, uključujući smrtonosne događaje, primijećeni su u bolesnika koji su intravenski liječeni ibandronatnom kiselinom.
Osteonecrosis of the external auditory canal
Osteonekroza vanjskog slušnog hodnika
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.
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.
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.
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.
Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Ibandronic acid Accord djeluje tako što smanjuje gubitak kalcija iz kostiju.
Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Pakiranje sadrži 1 napunjenu štrcaljku i 1 injekcijsku iglu ili 4 napunjene štrcaljke i 4 injekcijske igle.
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.
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.
Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with 9 mg/ml (0.9 %) sodium chloride.
Prije liječenja Ibandronic acid Accordom bolesnika treba odgovarajuće rehidrirati s 9 mg/ml (0,9%) otopine natrijevog klorida.
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).
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).
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.
Za sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama, infuzija Ibandronic acid Accorda ponavlja se u intervalima od 3 - 4 tjedna.
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)
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).
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.
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.
Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.
Neiskorištenu otopinu za injekciju kao i korištenu štrcaljku i iglu potrebno je odložiti u skladu s lokalnim propisima.
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.
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.
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.
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.
• walking or other weight-bearing exercise
• šetnje i druge aktivnosti koje uključuju podizanje tereta
Dosage: Treatment of Tumour-induced hypercalcaemia Ibandronic acid Accord is usually administered in a hospital setting.
Doziranje: Liječenje hiperkalcijemije nastale zbog tumora Ibandronic acid Accord se obično primjenjuje u bolničkim uvjetima.
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.
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.
Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Peroralno liječenje ibandronatnom kiselinom 2,5 mg tabletama jedanput dnevno dovelo je do progresivnih povećanja BMD kralježaka i ostalih dijelova skeleta.
[Justification for not including Braille accepted]
Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
U kliničkim ispitivanjima nije bilo dokaza pogoršanja bubrežne funkcije tijekom dugotrajne terapije ibandronatnom kiselinom.
This includes:
Takav način obuhvaća:
5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
Koncentrat za otopinu za infuziju 1 bočica (6 mg/6 ml) 5 bočica (6 mg/6 ml) 10 bočica (6 mg/6 ml)
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.
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.
What Ibandronic acid Accord is and what it is used for
Što je Ibandronic acid Accord i za što se koristi
Talk to your doctor, pharmacist or nurse before receiving Ibandronic acid Accord:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Ibandronic acid Accord:
If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.
Ukoliko niste sigurni, posavjetujte se sa svojim liječnikom ili ljekarnikom prije liječenja Ibandronic acid Accordom.
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/min).
Nisu potrebne prilagodbe doze za bolesnike s blagim ili umjerenim oštećenjem funkcije bubrega (klirens kreatinina jednak ili veći od 30 ml/min).
• if you have kidney problems.
• ako imate problema s bubrezima.
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.
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.
Do not take Ibandronic acid Accord if you are pregnant or breast-feeding.
Ne smijete primjenjivati lijek Ibandronic acid Accord ako ste trudni ili dojite.
The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Jetra nema bitnu ulogu u klirensu ibandronatne kiseline jer se ibandronatna kiselina ne metabolizira, nego se uklanja izlučivanjem putem bubrega i apsorpcijom u kosti.
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.
U bolesnika s pridruženim faktorima rizika preporučuje se pregled zuba s preventivnim zubarskim zahvatom i individualna procjena koristi i rizika prije liječenja ibandronatnom kiselinom.
Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju i naljepnici iza „Rok valjanosti“ ili kratice „EXP“.
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).
Pojava metaboličkih interakcija nije vjerojatna jer ibandronatna kiselina ne inhibira glavne humane jetrene izoenzime P450 i ne inducira jetreni citokromatski P450 sustav u štakora (vidjeti dio 5.2).
Children and adolescents Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.
Djeca i adolescenti Ibandronic acid Accord se ne smije davati djeci i adolescentima mlađim od 18 godina.
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.
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega u kojih je kreatinin u serumu jednak ili manji od 200 μmol/l (2,3 mg/dl) ili u kojih je klirens kreatinina (mjeren ili procijenjen) jednak ili veći od 30 ml/min.
Appropriate medical support and monitoring measures should be readily available when ibandronic acid intravenous injection is administered.
Odgovarajuća liječnička podrška i mjere praćenja trebaju biti lako dostupne tijekom intravenske primjene ibandronatne kiseline.
Where the medicinal product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Kad se lijek primjenjuje u postojeći intravenski infuzijski put, infuzijska otopina mora biti ograničena na izotoničnu otopinu natrijeva klorida ili 50 mg/ml (5%) otopinu glukoze.
Ibandronic acid is only for use in postmenopausal women and must not be taken by women of child bearing potential.
Ibandronatna kiselina je namijenjena isključivo za žene u postmenopauzi i ne smiju je primjenjivati žene reproduktivne dobi.
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).
BMD lumbalne kralježnice u 92,1% bolesnika koji primaju injekciju od 3 mg svaka tri mjeseca povećala se ili ostala ista nakon jednogodišnjeg liječenja (bolesnici koji su odgovorili na liječenje) u usporedbi s 84,9% bolesnika koji su peroralno primali 2,5 mg jedanput dnevno (p=0,002).
Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Ostale nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora jednake su očekivanima za bisfosfonate kao skupinu lijekova.
What Ibandronic acid Accord contains
Što Ibandronic acid Accord sadrži
Ibandronic acid Accord 3 mg solutionfor injection (for osteoporosos indications) Medicinal product subject to medical prescription.
Ibandronic acid Accord 3 mg otopina za injekciju (za indikacije osteoporoze) Lijek se izdaje na recept.
This medicine contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. ‘essentially sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi (3 ml), odnosno zanemarive količine natrija.
Ibandronic acid 2.5 mg daily tablets
Ibandronatna kiselina 2,5 mg tablete jedanput dnevno
See also dose section above for patients with renal impairment.
Pogledajte i poglavlje iznad o doziranju u bolesnika s oštećenjem bubrega.
Patients with cardiac impairment
Bolesnici s oštećenjem srca
After intravenous administration of 0.5 mg of ibandronic acid, 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 ibandronatne kiseline u bolesnika sa teškim oštećenjem funkcije bubrega, ukupni, bubrežni i nebubrežni klirens smanjili su se za 67%, 77% odnosno 50%.
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).
Nakon dvogodišnjeg liječenja 85,6% bolesnika koji su primali injekcije od 3 mg i 77,0% bolesnika koji su primali peroralno liječenje od 2,5 mg imalo je povećanu ili nepromijenjenu BMD cijelog kuka (p=0,004).
Where Ibandronic acid Accord is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Kada se Ibandronic acid Accord primjenjuje putem postojećeg intravenskog infuzijskog puta, infuzijska otopina mora biti ograničena na izotoničnu otopinu natrijeva klorida ili 50 mg/ml (5%) otopinu glukoze.
Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki može, poput ostalih bisfosfonata koji se primjenjuju intravenski, izazvati prolazno smanjenje vrijednosti kalcija u serumu.
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.
Da bi se primijenio, sadržaj bočice treba koristiti na sljedeći način: sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama - treba ga dodati u 100 ml izotonične otopine natrijevog klorida ili u 100 ml 5%-tne otopine glukoze i primijeniti infuzijom u trajanju od najmanje 15 minuta.
What you need to know before you receive Ibandronic acid Accord
Što morate znati prije nego počnete primjenjivati Ibandronic acid Accord
Children and adolescents Ibandronic acid Accord must not be used in children or adolescents below 18 years.
Djeca i adolescenti Ibandronic acid Accord se ne smije davati djeci ni adolescentima mlađima od 18 godina.
Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Ibandronic acid Accord injection therapy.
Hipokalcijemiju i ostale poremećaje metabolizma kostiju i minerala potrebno je procijeniti i učinkovito liječiti prije početka terapije injekcijama lijeka Ibandronic acid Accord.
Uncommon Rare
Vrlo rijetko Nepoznat o
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).
Nakon dvogodišnjeg liječenja 92,8% bolesnika koji su primali injekcije od 3 mg te 84,7% bolesnika koji su primali peroralno liječenje od 2,5 mg imalo je povećanu ili nepromijenjenu BMD lumbalne kralježnice (p=0,001).
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 procjeni stanja bolesnika i na temelju ocjene omjera koristi i rizika za svakoga pojedinog bolesnika.
• stomach pain (such as gastritis) or tummy pain, , indigestion, nausea, having diarrhoea (loose bowels) or constipation
• bol u želucu (poput gastritisa) ili bol u trbuhu, probavne smetnje, mučnina, proljev (osjetljiva crijeva) ili zatvor
Each pre-filled syringe contains 3 ml of solution.
Jedna napunjena štrcaljka sadrži 3 ml otopine.