natgillin/translations-raw huggingface dataset:
Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Zoledronatna kiselina značajno je smanjila srednju vrijednost broja dana s ograničenom aktivnošću za 17,9 dana u usporedbi s placebom, odnosno srednju vrijednost broja dana s ograničenom aktivnošću zbog prijeloma za 2,9 i broja dana provedenih u krevetu zbog prijeloma za 0,5 dana u odnosu na placebo (za sve p<0,01).
The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse.
Uobičajena doza iznosi 5 mg, a daje Vam je liječnik ili medicinska sestra u obliku jedne infuzije u venu.
Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
U bolesnica u dobi od 75 godina i više koje su primale zoledronatnu kiselinu zabilježen je smanjen rizik od prijeloma za 60% u usporedbi s bolesnicama koje su primale placebo (p<0,0001).
The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Preporučena doza je jedna intravenska infuzija od 5 mg zoledronatne kiseline.
4.4 Special warnings and precautions for use
4.4 Posebna upozorenja i mjere opreza pri uporabi Bubrežna funkcija
Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Bolesnici koji su na kraju šestomjesečnog osnovnog kliničkog ispitivanja bili klasificirani kao osobe u kojih je zabilježen terapijski odgovor zadovoljili su kriterije za uključivanje u produljeno razdoblje praćenja.
Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Manje često su zabilježeni teški, a ponekad i onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji uzimaju bisfosfonate, uključujući zoledronatnu kiselinu (vidjeti dio 4.8).
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion multipack: 5 bottles x 100 ml multipack: 10 bottles x 100 ml
OBLIK I SADRŽAJ Otopina za infuziju višestruko pakiranje: 5 vrećicax 100 ml višestruko pakiranje: 10 vrećicax 100 ml
Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Liječenje godišnjom dozom od 5 mg zoledronatne kiseline značajno je smanjilo BSAP za 30% nakon 12 mjeseci u odnosu na početnu vrijednost, a to je smanjenje održano na 28% ispod početnih razina nakon 36 mjeseci.
Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo.
(μCT) pokazala je povećani volumen trabekularne kosti i očuvanje arhitekture trabekularne kosti u bolesnica liječenih zoledronatnom kiselinom u usporedbi s onima koje su primale placebo.
- Store below 30°C.
- Čuvati na temperaturi ispod 30ºC.
MARKETING AUTHORISATION HOLDER Teva B.V.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1).
U bolesnika s nedavnim prijelomom kuka nakon slabe traume preporučuje se primjena infuzije zoledronatne kiseline najmanje dva tjedna nakon oporavka prijeloma kuka (vidjeti dio 5.1).
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Generics.
Izgledi za razvoj ovih nuspojava smanjuju se sa sljedećim dozama Zoledronatne kiseline
The hip fracture event rate was 1.44% for zoledronic acid-treated patients compared to 2.49% for placebo-treated patients.
Stopa prijeloma kuka iznosila je 1,44% u bolesnika koji su liječeni zoledronatnom kiselinom u usporedbi s 2,49% u onih koji su primali placebo.
In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
U ispitivanju HORIZON - (Pivotal Fracture Trial [PFT]) (vidjeti dio 5.1), ukupna incidencija atrijske fibrilacije iznosila je 2,5% (96 od 3862) u bolesnika koji su primali zoledronatnu kiselinu i 1,9% (75
1 bottle of 100 ml
1 bočica od 100 ml
The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Pakiranja sa 5 i 10 bočica dostupna su samo kao višestruka pakiranja koja sadrže 5 ili 10
Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Manje često, zabilježeni su slučajevi osteonekroze (primarno čeljusti), pretežito u bolesnika s rakom liječenih bisfosfonatima, uključujući zoledronatnu kiselinu.
Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags.
Zoledronatna kiselina Teva Generics dostupna je u višestrukim pakiranjima sa 5 ili 10 vrećica.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
Myalgia, arthralgia, bone pain, back pain, pain in extremity
Mialgija, artralgija, bol u kostima, bol u leđima, bol u ekstremitetima
What Zoledronic acid Teva Generics contains - The active substance is zoledronic acid.
Što Zoledronatna kiselina Teva Generics sadrži - Djelatna tvar je zoledronatna kiselina.
In patients treated with zoledronic acid, no osteomalacia, marrow fibrosis or woven bone formation was detected.
U bolesnica liječenih zoledronatnom kiselinom nisu otkriveni osteomalacija, fibroza srži niti stvaranje ne lamelarne kosti.
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Nakon otvaranja bočice, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
Each bag contains 100 ml of solution.
Svaka vrećica sadrži 100 ml otopine.
Effect on hip fractures
Učinak na prijelom kuka
Flu-like symptoms, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Simptomi nalik gripi, zimica, umor, astenija, bol, malaksalost, reakcija na mjestu primjene infuzije
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Prijavljeni su rijetki slučajevi zatajenja bubrega koji iziskuju dijalizu i rijetki slučajevi sa smrtnim ishodom u bolesnika s postojećim poremećajem funkcije bubrega ili u bolesnika s drugim rizicima uključujući poodmaklu dob, istovremenu primjenu nefrotoksičnih lijekova, istovremenu primjenu diuretskog liječenja ili dehidraciju u razdoblju nakon infuzije (vidjeti dijelove 4.4 i 4.8 Učinci klase)
B-CTx was significantly reduced by 61% below baseline levels at 12 months and was sustained at 55% below baseline levels at 36 months.
B-CTx je bio značajno smanjen za 61% ispod početnih razina nakon 12 mjeseci, a to je smanjenje održano na 55% ispod početnih razina nakon 36 mjeseci.
36 months.
mjeseci).
During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Nakon stavljanja lijeka na tržište zabilježene su sljedeće nuspojave (učestalost: rijetko): atipični subtrohanterični i dijafizealni prijelomi bedrene kosti (nuspojava kod bisfosfonata).
6.5 Nature and contents of container multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Višeslojna poliolefin/stiren-etilen-butilen (SEB) vrećica sa SFC polipropilenskim infuzijskim otvorom zatvorenim gumenim čepom i kapicom.
For information on the infusion of Zoledronic acid Teva Generics, see section 6.6.
Za informacije o infuziji Zoledronatne kiseline Teva Generics vidjeti dio 6.6. 4.3 Kontraindikacije
This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
Ovaj lijek ne smije doći u dodir s otopinama koje sadrži kalcij.
The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Te nuspojave su većinom bile blage do umjereno teške, a povukle su se unutar tri dana od pojave.
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhydrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Poremećaji kože i potkožnog tkiva Manje često Osip, hiperhidroza, svrbež, eritem Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Reproduktivna ispitivanja na životinjama sa zoledronatnom kiselinom pokazala su reproduktivnu toksičnost uključujući pojavu malformacija
Treatment with zoledronic acid resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Liječenje zoledronatnom kiselinom dovelo je do porasta BMD-a lumbalne kralježnice od 6,7%, ukupnog BMD-a kuka od 6,0%, BMD-a vrata bedrene kosti od 5,1% i distalnog dijela palčane kosti od 3,2% tijekom 3 godine u usporedbi s placebom.
Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Nakon primjene zoledronatne kiseline zapaženo je oštećenje funkcije bubrega (vidjeti dio 4.8), osobito u bolesnika s prethodnim poremećajem bubrežne funkcije ili u bolesnika s drugim rizicima uključujući poodmaklu dob, istovremenu primjenu nefrotoksičnih lijekova, istovremenu primjenu diuretskog liječenja (vidjeti dio 4.5) ili dehidraciju koja se pojavljuje nakon primjene zoledronatne kiseline.
Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Nije poznato** Reakcije preosjetljivosti uključujući rijetke slučajeve bronhokonstrikcije,
† Identified in post-marketing experience.
† Identificirano poslije stavljanja lijeka u promet.
Zoledronic acid is contraindicated during breast-feeding (see section 4.3).
Zoledronatna kiselina je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months.
P1NP je bio značajno smanjen za 61% ispod početnih razina nakon 12 mjeseci, a to je smanjenje održano na 52% ispod početnih razina nakon 36 mjeseci.
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, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene).
Prije liječenja bisfosfonatima u bolesnika s istovremeno prisutnim rizičnim faktorima (primjerice rak, kemoterapija, antiangiogeni lijekovi,
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
To je dalje dovelo do peripartalne hipokalcijemije, što je poznati učinak lijekova iz skupine bisfosfonata, te zatim distocije i prijevremenog prekida ispitivanja.
The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Ukupan postotak bolesnika koji su imali nuspojave nakon prve, druge, odnosno treće infuzije iznosio je 44,7%, 16,7% odnosno 10,2%.
Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
bolesnika s relapsom ponovno se liječenje se sastoji od primjene dodatne intravenske infuzije od 5 mg zoledronatne kiseline nakon intervala od godinu dana ili dulje nakon početnog liječenja.
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Ako je otopina u bila hladnjaku, pustite da se prije primjene zagrije na sobnu temperaturu.
Paget's disease of the bone
Pagetova bolest kosti
Uncommon Blood creatinine increased, pollakiuria, proteinuria
Manje često Povišen kreatinin u krvi, polakizurija,
All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Svi su bolesnici dobili 1000 do 1500 mg elementarnog kalcija plus 800 do 1200 IU nadomjestka vitamina
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
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 dostupnih podataka koji bi upućivali na to bi li prestanak liječenja bisfosfonatima smanjio rizik od osteonekroze čeljusti u bolesnika kojima su potrebni stomatološki zahvati.
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Kada su rezultati bili objedinjeni, nakon 6 mjeseci zapaženo je slično sniženje u težini boli i zbrojeva interferencije boli u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections.
Pomoćne tvari: mannitol, natrijev citrat i voda za injekcije.
The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Razlika u plazmatskom klirensu zoledronatne kiseline između ispitanika iznosila je 36%, a u pojedinačnog ispitanika 34%.
Zoledronic acid is eliminated by renal excretion.
Zoledronatna kiselina se eliminira putem bubrega.
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
zatvor, suha usta, žgaravica, kožni osip, pojačano znojenje, svrbež, crvenilo kože, bol u vratu, ukočenost mišića, kostiju i/ili zglobova, oticanje zgloba, grčevi mišića, bol u ramenu, bol u prsnim mišićima i rebrima, upala zgloba, mišićna slabost, poremećene vrijednosti bubrežnih pretraga, neuobičajeno često mokrenje, oticanje šaka, gležnjeva ili stopala, žeđ, zubobolja, poremećaji okusa.
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03).
Porast BMD-a lumbalne kralježnice i vrata bedrene kosti bio je nakon 12 mjeseci značajno veći u skupini liječenoj zoledronatnom kiselinom u usporedbi s onom liječenom risedronatom (za sve p<0,03).
Atrial fibrillation Uncommon Palpitations
Fibrilacija atrija
Any clinical fracture (1) Clinical vertebral fracture
Bilo koji klinički prijelom (1) Klinički vertebralni prijelom (2)
Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Zoledronatna kiselina ispitivana je u bolesnika oba spola koji su bili stariji od 30 godina i u kojih je radiološki potvrđena primarno blaga do umjerena Pagetova bolest kosti (u vrijeme ulaska u kliničko ispitivanje medijan razine alkalne fosfataze u serumu (SAP) bio je 2,6-3,0 puta veći od gornje granice normalnog referentnog raspona specifičnog za tu dob).
Each bottle contains 100 ml of solution.
Svaka bočica sadrži 100 ml otopine.
For information on the infusion of zoledronic acid, see section 6.6.
Za informacije o infuziji zoledronatne kiseline, vidjeti dio 6.6. 4.3 Kontraindikacije
Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Uz najnižu dozu (0,01 mg/kg tjelesne težine) koja je ispitivana u štakora zapažena je distocija.
Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Teške alergijske reakcije uključujući omaglicu i otežano disanje, oticanje uglavnom lica i vrata, pad krvnog tlaka, dehidracija uz simptome kao što su vrućica, povraćanje i proljev nakon primjene lijeka.
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
osobito u bolesnika s otprije ugroženom bubrežnom funkcijom ili dodatnim rizičnim faktorima (npr. poodmakla dob, onkološki bolesnici na kemoterapiji, istovremena primjena nefrotoksičnih lijekova, istovremena diuretska terapija, teška dehidracija), od kojih je većina primala dozu od 4 mg svaka 3-4
It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Lijek je dostupan u vrećicama od poliolefin/stiren-etilen-butilena (SEB), koje se nalaze u vanjskoj vrećici.
Zoledronic acid Teva Generics with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Generics, as directed by your doctor.
Pazite da popijete dovoljno tekućine (najmanje jednu ili dvije čaše) prije i nakon liječenja Zoledronatnom kiselinom Teava Pharma, prema uputama liječnika.
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
bol u prsištu koja nije vezana uz srce Nije poznato** Dehidracija dodatno uz simptome nakon primjene kao što su vrućica, povraćanje i proljev
All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.
Sve su žene primale 1000 do 1500 mg elementarnog kalcija uz dodatke prehrani s 400 do 1200 IU vitamina
In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
U bolesnika s nedavnim prijelomom kuka nakon manje traume, preporučuje se prije prve infuzije zoledronatne kiseline dati udarnu dozu od 50 000 do 125 000 IU vitamina
Observed in patients taking concomitant glucocorticosteroids.
Zapaženo u bolesnika koji istovremeno uzimaju glukokortikoide.
Women of childbearing potential Zoledronic acid is not recommended in women of childbearing potential.
Žene reproduktivne dobi Zoledronatna kiselina ne preporučuje se ženama reproduktivne dobi.
• Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
• Potreban je oprez kad se zoledronatna kiselina primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
- if you have had some or all of the parathyroid glands in your neck surgically removed.
- ako ne možete svaki dan uzimati nadomjestke kalcija. - ako su Vam iz vrata operacijom uklonjene neke ili sve paratireoidne žlijezde. - ako su Vam uklonjeni dijelovi crijeva.
Elevated bone turnover is a characteristic of Paget's disease of the bone.
Za Pagetovu bolest kosti karakteristična je povećana pregradnja kosti.
• Zoledronic acid Teva Generics should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
• Potreban je oprez kad se Zoledronatna kiselina Teva Generics primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with zoledronic acid versus 8.7% for placebo.
Incidencija kliničkih prijeloma bila je 7,5% u muškaraca liječenih zoledronatnom kiselinom naspram 8,7% u onih koji su primali placebo.
(cannot be estimated from the available data).
(<1/10 000) nije poznato (ne može se procijeniti na osnovi dostupnih podataka).
Bone histology
Histologija kosti
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
U subpopulaciji bolesnika koji su primali glukokortikoide dulje od 3 mjeseca prije randomizacije zoledronatna kiselina povisila je BMD lumbalne kralježnice za 4,06% u usporedbi sa 2,71% pri primjeni risedronata (srednja vrijednost razlike: 1,36%; p<0,001).
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
- Preosjetljivost na djelatnu tvar, bilo koji bisfosfonat ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1. - Bolesnici s hipokalcijemijom (vidjeti dio 4.4).
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.
U bolesnika s klirensom kreatinina ≥ 35 ml/min nije potrebno prilagođavati dozu.
Patients were randomised to either zoledronic acid 5 mg single infusion or to oral risedronate 5 mg daily for one year.
Bolesnici su randomizirani ili u skupinu koja je primila jednokratnu infuziju zoledronatne kiseline u dozi od 5 mg ili u skupinu koja je oralno dobivala risedronat u dozi od 5 mg na dan tijekom godine dana.
1 bag of 100 ml
1 vrećica od 100 ml
Zoledronic acid (N = 1,065) event rate (%)
Zoledronatna kiselina (N=3875)
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalanog sustava za prijavu nuspojava navedenog u Dodatku V.