natgillin/translations-raw huggingface dataset:
Based on the results of study BM 16549, Bondenza 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Glede na rezultate študije BM 16549 pričakujemo, da je zdravilo Bondenza 150 mg enkrat na mesec najmanj enako učinkovito v preprečevanju zlomov kakor ibandronska kislina 2,5 mg enkrat na dan.
Planning when to take Bondenza with peel-off stickers for your personal calendar What Bondenza is and what it is used for What you need to know before you take Bondenza How to take Bondenza
Kaj vsebuje navodilo Načrtovanje jemanja zdravila Bondenza z nalepkami za vaš osebni koledar Kaj je zdravilo Bondenza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Bondenza Kako jemati zdravilo Bondenza Možni neželeni učinki 5 Shranjevanje zdravila Bondenza Vsebina pakiranja in dodatne informacije
Bondenza is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Bondenza je na voljo v pakiranju po 1 napolnjeno injekcijsko brizgo in 1 injekcijsko iglo ali po 4 napolnjene injekcijske brizge in 4 injekcijske igle.
ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Dajanje 2,5 mg ibandronske kisline na dan je povzročilo statistično značilno in klinično pomembno zmanjšanje incidence novih zlomov vretenc.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Če je do naslednjega načrtovanega odmerka manj kot 7 dni, naj bolnik počaka do tega odmerka in nadaljuje jemanje ene tablete enkrat na mesec po prvotnem načrtu.
Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16549.
Preglednica 2: Povprečna relativna sprememba od izhodiščne vrednosti MKG ledvene hrbtenice, kolka, femoralnega vratu in trohantra po enem letu (primarna analiza) in dveh letih zdravljenja (populacija po protokolu) v študiji BM 16549.
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu gastrontestinalnega trakta hitra, plazemske koncentracije naraščajo do peroralnega vnosa 50 mg v odvisnosti od odmerka, pri večjih vnosih pa so opazili večje poraste plazemskih koncentracij od sorazmernih z odmerkom.
Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4) .
Zaradi omejenih kliničnih izkušenj jemanje zdravila Bondenza pri bolnikih s hudo okvaro ledvic ni priporočljivo (glejte poglavje 4.2 in poglavje 4.4).
Bondenza 3 mg injection every 3 months (N=365)
Bondenza 3 mg v obliki injekcije vsake 3 mesece (n = 365)
If you are breast-feeding, you will need to stop breast-feeding in order to receive Bondenza.
Če dojite, boste morali z dojenjem prenehati, da bi lahko prejemali zdravilo Bondenza.
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Študija je vključevala ženske, stare od 55 do 80 let, ki so bile vsaj 5 let v postmenopavzi in ki so imele MKG ledvene hrbtenice 2 do 5 SD pod povprečno vrednostjo pred menopavzo (T-vrednost) pri vsaj enem vretencu (L1-L4) ter so imele enega do štiri predhodnih zlomov vretenc.
Existing hypocalcaemia must be corrected before starting Bondenza injection therapy.
Obstoječo hipokalcemijo je treba popraviti pred začetkom zdravljenja z zdravilom Bondenza v obliki injekcije.
Trochanter BMD
MKG trohantra
Appropriate medical support and monitoring measures should be readily available when Bondenza intravenous injection is administered.
Pri dajanju intravenske injekcije zdravila Bondenza mora biti na voljo ustrezna medicinska podpora in nadzor.
Bondenza 3 mg solution for injection in pre-filled syringes is a solution for intravenous injection by a health care professional.
Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi je raztopina za intravensko injiciranje, ki jo daje zdravstveno osebje.
Physicians should be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue Bondenza and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Zdravniki morajo biti pozorni na znake ali simptome, ki opozarjajo na možno reakcijo v požiralniku, bolnikom pa je treba naročiti, da naj v primeru če se pri njih pojavijo disfagija, odinofagija,
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bondenza is administered with H2antagonists or other active substances which increase gastric pH.
Ker je to zvečanje v mejah normalne variabilnosti biološke uporabnosti ibandronske kisline, pri sočasnem jemanju zdravila Bondenza z antagonisti histaminskih receptorjev H2 ali drugimi zdravili, ki zvečajo pH želodca, prilagajanje odmerkov ni potrebno.
Bondenza 3 mg injection every 3 months (N=334)
Bondenza 3 mg v obliki injekcije vsake 3 mesece (n = 334)
Incidence of new morphometric vertebral fractures Relative risk reduction of clinical vertebral fracture Incidence of clinical vertebral fracture
Incidenca novih zlomov vretenc (določeno morfometrično) Zmanjšanje relativnega tveganja za klinične zlome vretenc Incidenca kliničnih zlomov vretenc
Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14 % and 18 % of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke Od več kot 1.500 bolnikov, vključenih v študijo BM 16549, ki je primerjala mesečno jemanje ibandronske kisline z dnevnim, je po enem letu 14 % bolnikov uporabljalo antagoniste histaminskih receptorjev H2 ali zaviralce protonske črpalke, po dveh letih pa 18 % bolnikov.
Bondenza 3 mg solution for injection ibandronic acid
Bondenza 3 mg raztopina za injiciranje ibandronska kislina
If a dose of Bondenza is missed
Če ste pozabili odmerek zdravila Bondenza
What Bondenza contains
Kaj vsebuje navodilo
Where Bondenza 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.
Kjer zdravilo Bondenza dajemo skozi obstoječi intravenski infuzijski kanal, je intravenski infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ml (5-%) raztopina glukoze.
Bondenza 3 mg injection every 3 months
Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece
The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for Bondenza 3 mg injection every 3 months after one year and two years, respectively.
Celoten delež bolnikov, ki so imeli neželeni učinek, je bil 26,0 % za zdravilo Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece, po enem letu in 28,6 % po dveh letih.
Bondenza is essentially sodium free.
Zdravilo Bondenza je praktično brez natrija.
If you're breast feeding, you may need to stop in order to take Bondenza.
Če dojite, boste morda morali z dojenjem prenehati, da bi lahko jemali zdravilo Bondenza.
In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9 - 10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Pri ljudeh je bila učinkovitost tako dnevnega kot intermitentnega dajanja ibandronske kisline z 9- do 10-tedenskim premorom brez odmerka potrjena v kliničnem preskušanju (MF 4411), v katerem je ibandronska kislina dokazala učinkovitost proti zlomom.
Furthermore, Bondenza 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Zdravilo Bondenza 150 mg enkrat na mesec se je izkazalo za boljše kakor ibandronska kislina 2,5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p = 0,002, in dveh letih, p < 0,001.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bondenza.
Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione (kot so aluminij, magnezij, železo), lahko vplivajo na absorpcijo zdravila Bondenza, zato bolniki najmanj 6 ur pred zaužitjem zdravila Bondenza ter še 1 uro po ne smejo jemati drugih peroralnih zdravil.
Do not use this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do in na brizgi poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Bondenza 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Zdravilo Bondenza 150 mg enkrat na mesec se je v povišanju MKG izkazalo za najmanj enako učinkovito kakor ibandronska kislina 2,5 mg enkrat na dan v dveletni dvojno slepi, multicentrični študiji (BM 16549) pri ženskah z osteoporozo v postmenopavzi (izhodiščna T-vrednost MKG ledvene hrbtenice pod -2,5 SD).
Bondenza 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi lahko kot drugi intravensko dajani difosfonati povzroči prehodno zmanjšanje koncentracije kalcija v serumu.
EU/1/03/266/006
EU/1/03/266/005 EU/1/03/266/006
Subjects with severe renal failure (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Bolniki s hudo motnjo ledvičnega delovanja (CLcr manjši kot 30 ml/min), ki so prejemali peroralno 10 mg ibandronske kisline na dan 21 dni, so imeli 2- do 3-krat višje plazemske koncentracije kot osebe z normalno ledvično funkcijo.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549) je bila celokupna varnost zdravila Bondenza 150 mg enkrat na mesec in ibandronske kisline 2,5 mg enkrat na dan podobna.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
FARMACEVTSKA OBLIKA filmsko obložena tableta
Acetylsalicylic acid and NSAIDs In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking acetylsalicylic acid or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
Acetilsalicilna kislina in nesteroidna protivnetna zdravila V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549), ki so sočasno jemale acetilsalicilno kislino ali nesteroidna protivnetna zdravila, je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so jemale ibandronsko kislino 2,5 mg vsak dan ali 150 mg enkrat na mesec eno ali dve leti.
Also contains sodium chloride, glacial acetic acid, sodium acetate trihydrate, water for injections.
Zdravilo vsebuje tudi natrijev klorid, koncentrirano ocetno kislino (ledocet), natrijev acetat trihidrat in vodo za injekcije.
Talk to your doctor before taking Bondenza: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Pred začetkom jemanja zdravila Bondenza se posvetujte s svojim zdravnikom: - če imate kakršnekoli motnje presnove mineralov (kot je pomanjkanje vitamina D), - če vaše ledvice ne delujejo normalno, - če imate težave s požiranjem ali prebavo.
Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Zdravljenje z 2,5 mg na dan je povzročilo progresivno zvečanje MKG vretenc in nevretenčnih delov skeleta.
This includes: - eating a balanced diet rich in calcium and vitamin D - walking or other weight-bearing exercise - not smoking and not drinking too much alcohol
To vključuje - uravnoteženo prehrano, bogato s kalcijem in vitaminom D, - hojo ali druge telesne aktivnosti z vplivom na telesno maso, - opustitev kajenja in zmerno pitje alkohola.
NAME OF THE MEDICINAL PRODUCT Bondenza 3 mg solution for injection
IME ZDRAVILA Bondenza 3 mg raztopina za injiciranje
Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Zaradi malo kliničnih izkušenj zdravila Bondenza ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/min (glejte poglavje 5.2).
Bondenza may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
S tem kostno maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike.
However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Glede na podatke o tej skupini zdravil lahko preveliko peroralno odmerjanje povzroči neželene učinke v zgornjem delu prebavil (kot so razdražen želodec, dispepsija, ezofagitis, gastritis ali razjeda) ali hipokalcemijo.
Due to limited clinical experience, Bondenza 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).
Zaradi omejenih kliničnih izkušenj zdravila Bondenza v obliki injekcije ne priporočamo bolnikom, ki imajo serumski kreatinin nad 200 µmol/l (2,3 mg/dl) ali kreatininski očistek, manjši kot 30 ml/min (glejte poglavje 4.2 in poglavje 5.2).
Cellulose, microcrystalline Crospovidone Stearic acid
Jedro tablete laktoza monohidrat povidon mikrokristalna celuloza krospovidon stearinska kislina brezvoden koloidni silicijev dioksid
What Bondenza contains - The active substance is ibandronic acid.
Kaj vsebuje zdravilo Bondenza - Zdravilna učinkovina je ibandronska kislina.
Bondenza 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Bondenza 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi je bistra, brezbarvna raztopina.
Bondenza 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).
Uporaba zdravila Bondenza v obliki injekcije pri bolnikih s serumskim kreatininom nad 200 µmol/l (2,3 mg/dl) ali s kreatininskim očistkom (izmerjenim ali ocenjenim) pod 30 ml/min zaradi malo kliničnih podatkov iz študij, ki so vključevale take bolnike, ni priporočljiva (glejte poglavji 4.4 in 5.2).
Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Zato morajo bolniki jemati zdravilo Bondenza zjutraj na prazen želodec (vsaj 6 ur brez obroka), po zaužitju zdravila Bondenza pa morajo biti še 1 uro tešči (glejte poglavje
• new pain, weakness or discomfort in your thigh, hip or groin.
• na novo nastala bolečina, šibkost ali neugodje v stegnih, kolku ali dimljah.
• Place all used needles and syringes into a sharps container (puncture-proof disposable container).
• uporabljenje igle in injekcijske brizge odvrzite v zabojnik za ostre predmete;
The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who at baseline had a lumbar spine BMD T-score below -2.5.
Učinek zdravljenja z ibandronsko kislino so nadalje proučevali v analizi podskupine bolnikov, katerih T-vrednost MKG ledvene hrbtenice je bila na začetku zdravljenja pod -2,5.
- Patients should not lie down for 1 hour after taking Bondenza.
- Po zaužitju zdravila Bondenza bolniki 1 uro ne smejo leči.
- Take your Bondenza tablet after you first get up for the day, and before you have anything to eat or drink (on an empty stomach) - Swallow your tablet with a full glass of water (at least 180 ml).
- Vzemite tableto zdravila Bondenza ko zjutraj vstanete in preden karkoli pojeste ali popijete (na prazen želodec).
• heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having diarrhoea (loose bowels)
• zgaga, neugodje pri požiranju, bolečina v želodcu ali trebuhu (lahko zaradi vnetja želodca),
Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Pri bolnikih, ki so prejemali peroralne difosfonate, so poročali o neželenih učinkih, kot so ezofagitis, razjede požiralnika in erozije požiralnika; le-ti so bili v nekaterih primerih hudi in so zahtevali hospitalizacijo, redko so jih spremljale krvavitve ali posledična striktura ali perforacija požiralnika.
Do not pass it on to others.
Ne dajajte si jih sami.
Relative risk reduction New morphometric vertebral fractures
Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
Rare (may affect up to 1 in 1000 people): • hives
Redki (pojavijo se pri največ 1 od 1.000 bolnikov): • koprivnica.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Pri teh bolnikih je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so se zdravili z zdravilom Bondenza 150 mg enkrat na mesec ali ibandronsko kislino 2,5 mg vsak dan.
Each prefilled syringe contains 3 ml of solution.
Ena napolnjena injekcijska brizga vsebuje 3 ml raztopine.
Furthermore, Bondenza 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Zdravilo Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece, se je izkazalo za boljše kakor peroralno dana ibandronska kislina 2,5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p < 0,001, in dveh letih, p < 0,001.
At one year, 83.5 % (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Po enem letu je bilo odzivnih 83,5 % bolnikov (p = 0,006), ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 73,9 % bolnikov, ki so jemali ibandronsko kislino 2,5 mg enkrat na dan, odzivnost so definirali kot ≥ 50 % zmanjšanje od izhodišča.
- The active substance is ibandronic acid.
- Zdravilna učinkovina je ibandronska kislina.
Posology
BESEDILO NALEPK
At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bondenza 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Po enem letu (primarna analiza) se je 91,3 % (p = 0,005) bolnikom, ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, MKG lumbalne hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84,0 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Če zaužijemo hrano ali pijačo, preden je minilo 60 minut od jemanja ibandronske kisline, sta zmanjšana biološka uporabnost in porast MKG.
Angioedema, Facial swelling/oedema, Urticaria
Bolezni kože in podkožja angioedem, otekanje obraza/edem, urtikarija
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550) je bila celokupna varnost zdravila Bondenza 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2,5 mg, dane peroralno enkrat na dan, podobna.
Based on the results of study BM 16550, Bondenza 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.
Glede na rezultate študije BM 16550 pričakujemo, da je zdravilo Bondenza 3 mg v obliki intravenske injekcije, ki jo dajemo vsake 3 mesece, najmanj enako učinkovito v preprečevanju zlomov kakor peroralno odmerjena ibandronska kislina 2,5 mg enkrat na dan.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/266/003 1 filmsko obložena tableta
Continuing to receive Bondenza
Nadaljevanje jemanja zdravila Bondenza
Therefore dose adjustment is not necessary in patients with hepatic impairment.
Za bolnike z jetrno okvaro prilagajanje odmerkov ni potrebno.
The pharmacokinetics of ibandronic acid was not assessed in patients with end-stage renal disease managed by other than hemodialysis.
Farmakokinetike ibandronske kisline pri bolnikih s končno ledvično odpovedjo, ki jih niso zdravili s hemodializo, niso proučevali.
Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Uporaba zdravila Bondenza pri bolnikih s kreatininskim očistkom pod 30 ml/min zaradi malo kliničnih izkušenj ni priporočljiva (glejte poglavji 4.4 in 5.2).
There is no relevant use of Bondenza in children below 18 years, and Bondenza was not studied in this population.
Uporaba zdravila Bondenza pri otrocih, mlajših od 18 let, ni smotrna.
When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Če upoštevamo strožji kriterij, ki združuje MKG ledvene hrbtenice in kolka, je bilo po enem letu odzivnih 83,9 % (p < 0,001) bolnikov, ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec, in 65,7 % bolnikov, ki so prejemali ibandronsko kislino 2,5 mg na dan.
You should not be given Bondenza if you are pregnant, or if there is a possibility you may become pregnant.
Če ste noseči ali če obstaja možnost, da bi lahko zanosili, ne smete prejemati zdravila Bondenza.
Absorption Not applicable
Napake pri aplikaciji