natgillin/translations-raw huggingface dataset:
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.
Oštećenje funkcije bubrega zapaženo je nakon primjene zoledronatne kiseline, 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 tjedna, no zapaženo je i u bolesnika nakon jednokratne primjene.
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Prijavljeni su slučajevi osteonekroze čeljusti, pretežito u bolesnika s rakom liječenih lijekovima koji inhibiraju resorpciju kosti, uključujući zoledronatnu kiselinu (vidjeti dio 4.4).
Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Manje često Dispepsija, bol u gornjem dijelu abdomena, bol u abdomenu, gastroezofagealna refluksna bolest, konstipacija, suha usta, ezofagitis,
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% i 10,2%.
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.
U objedinjenim rezultatima zapaženo je slično sniženje u težini boli i zbrojevima interferencije boli nakon 6 mjeseci u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients.
Stopa prijeloma kuka iznosila je 1,44% u bolesnika koji su liječeni zoledronatnom kiselinom u odnosu na 2,49% u onih koji su primali placebo.
At least one new vertebral fracture (0-1 year)
Najmanje jedan novi vertebralni prijelom (0-1 godina)
Uncommon Blood creatinine increased, pollakiuria, proteinuria
Manje često Povišen kreatinin u krvi, polakizurija, proteinurija
• Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
• Potrebno je uzimati primjerenu nadoknadu kalcija i vitamina D, baviti se primjerenom fizičkom aktivnošću, izbjegavati pušenje i zdravo se hraniti
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zoledronic acid Teva Pharma (see section 4.3).
Postojeća se hipokalcijemija mora prije uvođenja terapije Zoledronatnom kiselinom Teva Pharma liječiti odgovarajućim unosom kalcija i vitamina D (vidjeti dio 4.3).
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i Zoledronatna kiselina Teva Pharma Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
• Zoledronic acid Teva Pharma 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 Pharma primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
At least one new vertebral fracture (0-3 year)
Najmanje jedan novi vertebralni prijelom (0-3 godine)
• Contraindication in pregnancy and in breast-feeding women
• Kontraindicirana je u trudnica i dojilja
What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Što Zoledronatna kiselina Teva Pharma sadrži - Djelatna tvar je zoledronatna kiselina.
Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Bolest nalik gripi, zimica, umor, astenija, bol, malaksalost, reakcija na mjestu primjene infuzije
Osteonecrosis of the external auditory canal† (bisphosphonate class adverse reaction)
Vrlo rijetko Osteonekroza vanjskog slušnog kanala† (nuspojava skupine bisfosfonata).
At least one new vertebral fracture (0-2 year)
Najmanje jedan novi vertebralni prijelom (0-2 godine)
Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Manje često Bol u vratu, mišićno-koštana ukočenost, oticanje zgloba, spazam mišića, bol u ramenima, mišićno-koštana bol u prsištu, mišićno-koštana bol, ukočenost zgloba, artritis, slabost mišića
• Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
• Ključni znakovi i simptomi ozbiljnih štetnih događaja
In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.4).
U bolesnika s Pagetovom bolešću, snažno se preporučuje osigurati uzimanje odgovarajućeg nadomjestka kalcija, koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput dnevno, tijekom najmanje 10 dana nakon primjene Zoledronatne kiseline Teva Pharma (vidjeti dio 4.4).
- Zoledronic acid Teva Pharma 5 mg solution for infusion is ready for use.
- Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju je spremna za uporabu.
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 skupine)
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.2).
Osim toga, u bolesnika s Pagetovom bolešću posebno se savjetuje osigurati uzimanje kalcija u obliku odgovarajućeg dodatka prehrani koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput na dan, najmanje tijekom 10 dana nakon primjene Zoledronatne kiseline Teva Pharma (vidjeti dio 4.2).
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 sadrže kalcij.
Zoledronic acid Teva Pharma is contraindicated during breast-feeding (see section 4.3).
Zoledronatna kiselina Teva Pharma is contraindicated during breast-feeding (see section 4.3).
Zoledronic acid Teva Pharma is contraindicated during pregnancy (see section 4.3).
Zoledronatna kiselina Teva Pharma je kontraindicirana tijekom trudnoće (vidjeti dio 4.3).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU VREĆICA
Solution for infusion 1 bag of 100 ml.
OBLIK I SADRŽAJ Otopina za infuziju 1 vrećica od 100 ml.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po 100 ml, tj. zanemarive količine natrija.
Very rare (may affect up to 1 in 10,000 people)
Vrlo rijetko (može se javiti u do 1 na 10 000 osoba):
Solution for infusion 1 bottle of 100 ml.
OBLIK I SADRŽAJ Otopina za infuziju 1 boca od 100 ml.
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.
Klinička djelotvornost u liječenju Pagetove bolesti kosti 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).
Excipients: Mannitol, sodium citrate and water for injections.
Pomoćne tvari: manitol, natrijev citrat i voda za injekcije.
It is supplied in packs sizes of 1, 5 and 10.
Dostupna su pakiranja sa 1, 5 i 10 boca.
It comes in a polyolefin/styreneethylene-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.
Uncommon Anaemia
Manje često Anemija
Not known (frequency cannot be estimated from the available data) Pain in the mouth, and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth; these could be signs of bone damage in the jaw (osteonecrosis).
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Bol u ustima, i/ili čeljusti, oticanje ili ranice u ustima ili čeljusti koje ne cijele, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Nakon otvaranja: Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
- 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 uklonjene neke ili sve paratireoidne žlijezde. - ako su Vam uklonjeni dijelovi crijeva.
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
U subpopulaciji bolesnika koji su primali glukokortikoide 3 mjeseca ili kraće prije randomizacije zoledronatna kiselina povećala je BMD lumbalne kralježnice za 2,60% u odnosu na 0,64% pri primjeni risedronata (srednja razlika: 1,96%; p<0,001).
Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Djelotvornost i sigurnost primjene zoledronatne kiseline u liječenju i prevenciji osteoporoze povezane s dugotrajnim sistemskim liječenjem glukokortikoidima bila je procijenjena u randomiziranom, multicentričnom, dvostruko slijepom, stratificiranom ispitivanju s djelatnom kontrolom u 833 muškaraca i žena u dobi od 18 do 85 godina (srednja dob za muškarce 56,4 godine, za žene 53,5 godina) liječenih sa >7,5mg/dan oralno primijenjenog prednizona (ili ekvivalenta).
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
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Nakon otvaranja boce, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
- After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Nakon otvaranja vrećice, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
How to prepare and administer Zoledronic acid Teva Pharma
Kako pripremiti i primijeniti Zoledronatnu kiselinu Teva Pharma
Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Hiperemija oka Manje često Konjunktivitis, bol u oku Uveitis, episkleritis, iritis Nepoznato** Skleritis i upala očne šupljine
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 u usporedbi sa 8,7% u onih koji su primali placebo.
Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card.
Bolesnicima koji se liječe Zoledronatnom kiselinom Teva Pharma potrebno je dati uputu o lijeku i karticu s podsjetnikom za bolesnika.
Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml
Višestruko pakiranje: 5 boca od 100 ml
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis.
Nepravilni otkucaji srca (treperenje pretklijetki) zabilježeni su u bolesnica koje su primale Zoledronatnu kiselinu Teva Pharma zbog postmenopauzalne osteoporoze.
Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome
Stope incidencije ključnih varijabli kliničkih prijeloma prikazane su u Tablici 4. Tablica 4 Usporedbe incidencije ključnih varijabli kliničkog prijeloma između liječenja Ishod
Solution for infusion Multipack: 5 bags of 100 ml Multipack: 10 bags of 100 ml
Višestruko pakiranje: 5 vrećica od 100 ml
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
EU/1/12/772/001 višestruko pakiranje s 5 boca EU/1/12/772/002 višestruko pakiranje s 10 boca EU/1/12/772/005 1 boca
Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential.
Žene reproduktivne dobi Primjena Zoledronatne kiseline Teva Pharma se ne preporučuje u žena reproduktivne dobi.
Each bottle contains 100 ml of solution.
Svaka boca sadrži 100 ml otopine.
EU/1/12/772/004
EU/1/12/772/003 EU/1/12/772/004
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors.
Prije početka liječenja Zoledronatnom kiselinom Teva Pharma, u bolesnika s istodobnim rizičnim faktorima, preporučuje se stomatološki pregled uz obavljanje preventivnih stomatoloških zahvata i procjena individualne koristi i rizika.
Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Zoledronatna kiselina Teva Pharma sadrži djelatnu tvar zoledronatnu kiselinu.
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
EU/1/12/772/001 višestruko pakiranje s 5 boca EU/1/12/772/002 višestruko pakiranje s 10 boca
How to store Zoledronic acid Teva Pharma
Kako čuvati Zoledronatnu kiselinu Teva Pharma
ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
U bolesnika koji su primali Zoledronatnu kiselinu Teva Pharma za osteoporozu prijavljena je ONJ nakon stavljanja lijeka u promet (vidjeti dio 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (with blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (s plavim okvirom)
How Zoledronic acid Teva Pharma is given
Kako se primjenjuje Zoledronatna kiselina Teva Pharma
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
U bolesnika koji primaju Zoledronatnu kiselinu Teva Pharma za osteoporozu prijavljena je nuspojava koja se zove osteonekroza čeljusti (ONJ) (oštećenje koštanog tkiva čeljusti) nakon stavljanja lijeka u promet.
- you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone
Prije nego počnete liječenje Zoledronatnom kiselinom Teva Pharma obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako - imate bilo kakav problem sa ustima ili zubima kao što je loše zdravlje zuba, bolesti desni ili planirano vađenje zuba; - ne dobivate rutinsku stomatološku skrb ili duže vrijeme niste obavili pregled kod zubara; - ste pušač (jer to može povećati rizik problema sa zubima); - ste se prije liječili bifosfonatima (u svrhu liječenja ili prevencije poremećaja kostiju); - uzimate lijekove koji se zovu kortikosteroidi (kao što su prednizolon ili deksametazon); - imate rak.
See section 4.
Tablica 1.
Not known** Renal impairment.
Nepoznato** Oštećenje funkcije bubrega.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Tijekom liječenja bisfosfonatima bolesnici se moraju uputiti da prijave svaku pojavu boli u bedrima, kukovima ili preponama.
Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma.
Prijavljeni su slučajevi ONJ za Zoledronatnu kiselinu Teva Pharma nakon stavljanja lijeka u promet.
You can also report side effects directly 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 nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Svaka boca sa 100 ml otopine sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.
U bolesnika s Pagetovom bolešću preporučuje se određivanje kalcija u serumu prije infuzije Zoledronatne kiseline Teva Pharma.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OVERPOUCH
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA VREĆICA
One bottle contains 5 mg zoledronic acid (as monohydrate).
Jedna boca sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Zoledronic acid
Razine vitamina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA (s plavim okvirom )
Each bottle contains 5 mg zoledronic acid (as monohydrate).
Svaka boca sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (bez plavog okvira)
proteinuria
Doziranje
Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.
Uz primjenu Zoledronatne kiseline Teva Pharma, preporučuje se odgovarajući unos kalcija i vitamina D.
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma.
Na dan kad ćete primiti Zoledronatnu kiselinu Teva Pharma možete normalno jesti.
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Ne smijete primati Zoledronatnu kiselinu Teva Pharma: - ako ste alergični na zoledronatnu kiselinu, druge bisfosfonate ili neki drugi sastojak ovog lijeka
Each bag contains 5 mg zoledronic acid (as monohydrate).
Svaka vrećica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u bocama zoledronatna kiselina
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza „Rok valjanosti“.
1 bottle of 100 ml.
Jedna boca sadrži 100 ml otopine.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u vrećicama
Zoledronic acid Teva Pharma 5 mg solution for infusion in bags zoledronic acid
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u vrećicama zoledronatna kiselina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (s plavim okvirom)
EU/1/12/772/003
EU/1/12/772/005 1 boca
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju zoledronatna kiselina
- Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza „Rok valjanosti“.
• Creatinine clearance should be calculated based on actual body weight using the
• Prije svake doze Zoledronatne kiseline Teva Pharma treba izračunati klirens kreatinina na temelju stvarne tjelesne težine koristeći Cockcroft-Gaultovu formulu.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles
Zoledronatna kiselina Teva Pharma 5 mg otopina za infuziju u bocama
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Manje često Osip, hiperhidroza, svrbež, eritem
Absolute reduction in fracture event rate (CI)
Apsolutno smanjenje stope događaja za prijelome % (CI)
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma.
Prije svake doze Zoledronatne kiseline Teva Pharma liječnik Vam mora napraviti krvnu pretragu kako bi provjerio Vašu bubrežnu funkciju (razine kreatinina).
The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks.
Preporučena doza je 210 mg jednom tjedno prva 3 tjedna, a zatim svaka 2 tjedna.
The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks.
Liječnik može odlučiti prekinuti liječenje ako se stanje ne popravi nakon 12 do 16 tjedana.
The full EPAR for Kyntheum can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Kyntheum nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Kyntheum
Ostale informacije o lijeku Kyntheum
There have been some reports of suicidal behaviour in patients taking the medicine.
Postoje slučajevi suicidalnog ponašanja u bolesnika koji uzimaju lijek.
What measures are being taken to ensure the safe and effective use of Kyntheum?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kyntheum?