natgillin/translations-raw huggingface dataset:
Proportion of patients with SREs (%) p-value
Udio bolesnika s koštanim događajem (%)
In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
U trećem randomiziranom, dvostruko slijepom ispitivanju faze III uspoređivala se zoledronatna kiselina u dozi od 4 mg s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili karcinomom dojke i najmanje jednom koštanom lezijom.
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Stopa fibrilacije atrija kao ozbiljna štetnog događaja bila je 1,3% (51 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) u bolesnica koje su primale placebo.
Acute phase reaction, pain
pireksija, umor reakcija akutne faze, bol
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Pogoršanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze od 4 mg zoledronatne kiseline.
Angioneurotic oedema
reakcija preosjetljivosti angioneurotski edem
Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Nemojte miješati koncentrat Zoledronatne kiseline Teva s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je Ringerova otopina s laktatom.
Caution is advised when Zoledronic Acid Teva is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Savjetuje se oprez tijekom istovremene primjene Zoledronatne kiseline Teva i antiangiogenih lijekova jer je u bolesnika koji su istovremeno liječeni tim lijekovima zabilježena povećana incidencija osteonekroze čeljusti.
In patients who show evidence of renal deterioration during treatment, Zoledronic Acid Teva should be withheld.
U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja treba prekinuti primjenu Zoledronatne kiseline Teva.
Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2.
Dodatne informacije o rukovanju Zoledronatnom kiselinom Teva, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2. Tijekom pripreme infuzije moraju se koristiti aseptičke tehnike.
- Confusion.
- Smetenost.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
U kliničkim je ispitivanjima 69 bolesnika s relapsom ili bolešću otpornom na početno liječenje (zoledronatna kiselina u dozi od 4 mg, 8 mg ili pamidronat u dozi od 90 mg) bilo liječeno
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Teva and will check your response to treatment at regular intervals.
Prije nego što počnete primati Zoledronatnu kiselinu Teva, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
Zoledronic Acid Teva must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronatnu kiselinu Teva bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
Thrombocytopenia, leukopenia
anemija trombocitopenija, leukopenija pancitopenija
Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Rezultati kliničkih ispitivanja liječenja hiperkalcemije izazvane tumorom Klinička ispitivanja liječenja hiperkalcemije izazvane tumorom pokazala su da je učinak zoledronatne kiseline obilježen smanjenjem kalcija u serumu i smanjenim izlučivanjem kalcija mokraćom.
No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu manjima od 400 μmol/l ili 4,5 mg/dl (vidjeti dio 4.4).
In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
U in vitro ispitivanu, zoledronatna kiselina je pokazala niski afinitet za humane krvne stanice, uz srednju vrijednost omjera koncentracije krvi prema plazmi od 0,59 za raspon koncentracije od
Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
hiperestezija, tremor, somnolencija konvulzije, hipoestezija i tetanija (sekundarno uz hipokalcemiju)
Diluted Solution - The readily prepared Zoledronic Acid Teva infusion solution should preferably be used immediately.
- Pripremljenu otopinu za infuziju Zoledronatne kiseline Teva treba po mogućnosti odmah primijeniti.
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
mučnina, povraćanje, smanjeni apetit proljev, zatvor, bol u abdomenu, dispepsija, stomatitis, suha usta
Other medicines and Zoledronic Acid Teva Tell your doctorif you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
astenija, periferni edemi, reakcije na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu i otvrdnuće), bol u prsištu, povećanje tjelesne težine, anafilaktična reakcija/šok, urtikarija artritis i oticanje zglobova kao simptomi reakcije akutne faze
- History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
- Bolest zuba u anamnezi, loša oralna higijena, periodontalna bolest, invazivni stomatološki zahvati (npr. vađenje zuba) i slabo pričvršćene zubne proteze.
Pam 90 mg zoledronic acid 4 mg
90 mg zoledronatna kiselina 4 mg
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Propadanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne ili jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
Zoledronic Acid Teva treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Liječenje bolesnika Zoledronatnom kiselinom Teva s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling - Painful redness and/or swelling of the eye.
- Intersticijska bolest pluća (upala tkiva oko alveola) - Simptomi nalik gripi uključujući artritis i oticanje zglobova.
Unopened Vial - Keep Zoledronic Acid Teva out of the reach and sight of children.
Kako čuvati Zoledronatnu kiselinu Teva Lijek čuvajte izvan pogleda i dohvata djece.
Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Bolesnici su bili ravnomjerno raspodijeljeni u skupinu koja je primala zoledronatnu kiselinu i skupinu koja je primala placebo.
0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
− povišenje vrijednosti kreatinina za 0,5 mg/dl ili 44 μmol/l, u bolesnika s normalnom početnom vrijednošću kreatinina u serumu (manjom od 1,4 mg/dl ili 124 μmol/l),
Uncommon: Rare:
Manje često: Rijetko:
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza "Rok valjanosti".
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Izvučenu količinu koncentrata treba dodatno razrijediti u 100 ml sterilne otopine za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5%-tne m/V otopine glukoze.
How Zoledronic Acid Teva is given - Zoledronic Acid Teva is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
- Zoledronatna kiselina Teva daje se u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
• Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Dojenje (vidjeti dio 4.6).
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Ovaj se lijek ne smije miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je Ringerova otopina s laktatom, te ga treba primijeniti kao zasebnu intravensku otopinu putem zasebne infuzijske linije.
Zoledronic Acid Teva concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Zoledronatna kiselina Teva ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je Ringerova otopina s laktatom, i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zoledronic Acid Teva.
Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet u bolesnika koji su se liječili Zoledronatnom kiselinom Teva.
Blurred vision, scleritis and orbital inflammation
konjunktivitis zamagljen vid, skleritis i upala orbite uveitis episkleritis
Only clear solution free from particles and discolouration should be used.
Smije se primijeniti samo bistra otopina bez vidljivih čestica i promjene boje.
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
U vrlo su rijetkim slučajevima uz primjenu zoledronatne kiseline nastupile omamljenost i pospanost.
Instructions for preparing reduced doses of Zoledronic Acid Teva Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose
Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način: - 4,4 ml za dozu od 3,5 mg
How to store Zoledronic Acid Teva
Kako primjenjivati Zoledronatnu kiselinu Teva
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Teva or after stopping treatment.
Odmah obavijestite svog liječnika ako za vrijeme liječenja Zoledronatnom kiselinom Teva ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
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.
Do nalaza pregleda bolesnika u kojih postoji sumnja na atipični prijelom bedrene kosti, potrebno je razmotriti i prekid terapije bisfosfonatima na temelju procjene omjera koristi i rizika liječenja u pojedinog bolesnika.
The following properties have been demonstrated in preclinical studies: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
− in vivo: inhibicija osteoklastične resorpcije kosti, koja mijenja mikrookoliš koštane srži i čini je manje pogodnom za rast tumorskih stanica, antiangiogeno djelovanje i analgetsko djelovanje.
Figure 1: Mean changes from baseline in BPI scores.
Slika 1: Srednja vrijednost promjene rezultata na ljestvici boli (BPI) od početne vrijednosti.
Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
Tlf: +45 44 98 55 11
Blood creatinine and blood urea increased, hypocalcaemia
hipofosfatemija povišeni kreatinin i urea u krvi, hipokalcemija hipomagnezemija, hipokalemija hiperkalemija, hipernatremija
Very rare (may affect up to 1 in 10,000 people):
Vrlo često (mogu se javiti u više od 1 na 10 osoba):
To avoid potential incompatibilities, Zoledronic Acid Teva concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Kako bi se izbjegle potencijalne inkompatibilnosti, koncentrat Zoledronatne kiseline Teva mora se razrijediti otopinom za injekciju natrijeva klorida 9 mg/ml (0,9%) ili 5% m/V otopinom glukoze.
6.6 Special precautions for disposal and other handling Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Prije primjene, 5 ml koncentrata iz jedne bočice ili potreban volumen koncentrata izvučen iz jedne bočice mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (otopina natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili 5%-tna m/V otopina glukoze).
How Zoledronic Acid Teva is given
Koliko se Zoledronatne kiseline Teva daje
You must not be given Zoledronic Acid Teva if you are breast-feeding.
Ne smijete dobivati Zoledronatnu kiselinu Teva ako dojite.
One vial contains 4 mg zoledronic acid, (as monohydrate).
Jedna bočica sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
Suomi/Finland rationpharm Oy Puh/Tel: +358 20 180 5900
Puh/Tel: +358 20 180 5900
To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Da biste izbjegli moguće inkompatibilnosti, otopina za infuziju koja se koristi za razrjeđenje mora biti otopina za injekciju natrijevog klorida od 0,9 mg/ml (0,9%) ili 5%-tna m/V
Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Nepravilni otkucaji srca (srčane aritmije), napadaji, grčevi i trzanje mišića (tetanija) zabilježeni su uz jaku hipokalcemiju.
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Jedna bočica s 5 ml koncentrata sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
Zoledronic Acid Teva recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
4,0 mg zoledronatne kiseline 3,5 mg* zoledronatne kiseline 3,3 mg* zoledronatne kiseline 3,0 mg* zoledronatne kiseline
Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronatna kiselina Teva 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Ako ste trudni ili dojite, obratite se svom liječniku za savjet prije nego što uzmete bilo koji lijek.
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Prije i poslije primjene Zoledronatne kiseline Teva mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic Acid Teva therapy.
Nakon početka terapije Zoledronatnom kiselinom Teva potrebno je pažljivo pratiti standardne metaboličke parametre hiperkalcemije, kao što su razine kalcija, fosfata i magnezija u serumu.
Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg.
Zoledronatna kiselina primijenjena supkutano u dozama ≥ 0,2 mg/kg u štakora pokazala je teratogeno djelovanje.
- Low level of magnesium and potassium in the blood.
- Niska razina fosfata u krvi.
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Rijetko (mogu se javiti u do 1 na 1000 osoba): - Kao posljedica niskih razina kalcija: nepravilni otkucaji srca (srčana artimija, uslijed hipokalcemije).
5.1 Pharmacodynamic properties
5. FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
Hypophosphataemia
hipokalcemija hipofosfatemija
In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu većima od 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
4 x 5 ml vials
4 x 5 ml bočice 10 x 5 ml bočica
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
vrućica, sindrom nalik gripi (uključujući umor,
10 x 5 ml vials
1 x 5 ml bočica
The refrigerated solution should then be equilibrated to room temperature before administration.
Prije primjene rashlađenu otopinu treba pustiti da dosegne sobnu temperaturu.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Važne informacije o nekim sastojcima Zoledronatne kiseline Teva Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
Excipients
Pamidronat
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu većom od 265 μmol/l ili 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
Zoledronic Acid Teva treatment should be resumed at the same dose as that given prior to treatment interruption.
Teva smije se nastaviti istom dozom koja se davala prije prekida liječenja.
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including;
Nadalje, postoje dokazi o povezanosti hipokalcemije i sekundardnih neuroloških nuspojava prijavljenih u tim slučajevima, uključujući konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4) Prijavljivanje sumnji na nuspojavu
For instructions of the dilution of the medicinal product before administration, see section 6.6.
- 3,8 ml za dozu od 3,0 mg Za uputu o otapanju lijeka prije primjene, vidjeti dio 6.6.
Teva Pharmaceuticals Ireland Tel: +353 51 321 740
Tel: +353 51 321 740
Important information about some of the ingredients in Zoledronic Acid Teva
Sadržaj pakiranja i druge informacije Što Zoledronatna kiselina Teva sadrži
Very rare:
Vrlo rijetko.
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
< 3% primijenjene doze otkrilo se u fecesu, što pokazuje da funkcija jetre nema važnu ulogu u farmakokinetici zoledronatne kiseline.
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion
Zoledronatna kiselina Teva 4 mg/5 ml koncentrat za otopinu za infuziju
PLIVA Croatia Ltd
Pliva Hrvatska d.o.o
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
glavobolja omaglica, parestezija, disgeuzija, hipoestezija,
If you get any side effects, talk to your doctor pharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
UAB "Sicor Biotech" Tel: +370 5 266 02 03
Tel: +370 5 266 02 03
Batch
tahikardija
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
*p-vrijednosti u usporedbi s pamidronatom.
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly people
Sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti
NA Not Applicable
NP Nije primjenjivo.
METHOD OF ADMINISTRATION Dilute before use.
Razrijediti prije primjene.
The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Ta se reakcija još zove simptomi “nalik gripi” ili simptomi “nakon doziranja”.
METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Renal impairment
Razrijeđena otopina
UAB "Sicor Biotech" filiāle Latvijā Tel: +371 67 323 666
Latvija UAB "Sicor Biotech" filiāle Latvijā
- Chest pain.
otopina glukoze.
In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
zoledronatna kiselina u dozi od 4 mg značajno je smanjila udio bolesnika s koštanim događajima, produljila medijan vremena do prvog koštanog događaja za više od 2 mjeseca i smanjila stopu koštanog pobola.
You should not be given Zoledronic Acid Teva: - if you are breast-feeding.
Ne smijete primiti Zoledronatnu kiselinu Teva:
Sodium citrate Water for injections
6. FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol natrijev citrat voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Teva 4 mg/5 ml sterile concentrate zoledronic acid
Uputa o lijeku: Informacije za korisnika Zoledronatna kiselina Teva 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
- Rijetko može nastati neuobičajen prijelom bedrene kosti osobito u bolesnika koji se dugotrajno liječe zbog osteoporoze; osjetite li bol, slabost ili nelagodu u bedru, kuku ili preponama, odmah se javite liječniku, jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti.
Gastrointestinal disorders Very common:
Poremećaji probavnog sustava Često:
During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate class adverse reaction).
atipični suptrohanterični prijelomi i prijelomi dijafize bedrene kosti (nuspojava razreda bisfosfonata).
United Kingdom Teva UK Limited Tel: +44 1977 628 500 This leaflet was last revised in {MM/YYYY} Other sources of information 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 internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
Episcleritis
OBLIK
UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
UAB "Sicor Biotech" Eesti filiaal
Contents of the pack and other information
OBLIK I SADRŽAJ