natgillin/translations-raw huggingface dataset:
After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.
Nakon 5 godina primjene Ibandronatne kiseline Teva posavjetujte se sa svojim liječnikom o tome trebate li ga nastaviti uzimati.
Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).
Ne uzimajte Ibandronatnu kiselinu Teva s hranom ili nekim drugim pićem osim vodom jer hrana ili druga pića smanjuju djelotvornost lijeka (vidjeti dio 3).
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Kategorije učestalosti definirane su na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Do not take this medicine if any of the above apply to you.
Ukoliko se bilo što od gore navedenog odnosi na Vas, ne smijete uzimati ovaj lijek.
Temporary interruption of Ibandronic Acid Teva treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Ako je moguće, treba razmotriti privremen prekid liječenja lijekom Ibandronatna kiselina Teva dok se ovo stanje ne povuče i ublaže faktori rizika koji su pridonijeli njegovu razvoju.
Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronatna kiselina Teva indicirana je u odraslih za sprječavanje koštanih poremećaja (patološki prijelomi, komplikacije na kostima koje zahtijevaju radioterapiju ili operaciju) u bolesnika s rakom dojke i koštanim metastazama.
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Tablica 2 Rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
United Kingdom
Velika Britanija
Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Ezofagitis uključujući ulceracije ili strikture jednjaka i disfagiju, povraćanje, flatulencija
• pain or sore in your mouth or jaw.
• bol ili rana u ustima ili čeljusti.
Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).
Ibandronatna kiselina Teva je namijenjena liječenju odraslih bolesnika i biti će Vam propisana ako imate rak dojke koji se proširio na Vaše kosti (što se naziva koštane „metastaze“).
Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water.
Uzmite tabletu najmanje 6 sati nakon što ste posljednji puta uzeli hranu, piće ili bilo koje druge lijekove ili nadomjeske, osim vode.
Adverse reactions are listed according to MedDRA system organ class and frequency category.
Nuspojave su popisane prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
Chest pain, influenza-like illness, malaise, pain
Bolovi u prsima, bolest slična gripi, slabost, bol
Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with ibandronic acid 50 mg administered orally), and from post-marketing experience.
Tablici 1 popisane su nuspojave iz 2 pivotalna ispitivanja faze III (Sprječavanje koštanih događaja u bolesnika s rakom dojke i koštanim metastazama: 286 bolesnika liječena ibandronatnom kiselinom od 50 mg primijenjenom peroralno) i iz iskustva nakon stavljanja lijeka na tržište.
Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Koncentracije biljega resorpcije kostiju CTx (Cterminalni telopeptid otpušten iz kolagena tipa I) u urinu bile su znatno smanjene u grupi koja je primala ibandronatnu kiselinu u usporedbi s placebo grupom.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Ibandronatna kiselina je visoko potentan bisfosfonat iz skupine bisfosfonata koji sadrže dušik, koji selektivno djeluje na koštano tkivo i ciljano inhibira aktivnost osteoklasta bez izravnog učinka na formiranje kosti.
For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Za bolesnike s teškim oštećenjem bubrega (CLcr <30 ml/min) preporučena doza je jedna 50 mg filmom obložena tableta jedanput tjedno.
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Raspon prividnog poluvijeka je širok, a prividni terminalni poluvijek u načelu ima raspon od 10 do 72 sata.
This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood.
To je važno stoga što - aminoglikozidi i Ibandronatna kiselina Teva mogu smanjiti razine kalcija u krvi.
They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Uključuju smanjeni broj mjesta implantacije, poremećaje prirodnog poroda (distocija) i povećanje visceralnih varijacija (sindrom bubrega, zdjelice i mokraćovoda).
Month 3 __/__/__
Mjesec 3 __ /__ /__
Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Tablica 3 Sekundarni rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
However, no dosage adjustment is required when Ibandronic Acid Teva is administered with H2-antagonists or medicinal products that increase gastric pH.
No nije potrebna prilagodba doze kad se Ibandronatna kiselina Teva primjenjuje s H2-antagonistima ili drugim lijekovima koji povećavaju pH želučane kiseline.
Furthermore, ibandronic acid 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.
Nadalje, ibandronatna kiselina 150 mg jedanput mjesečno dokazano je bolja od ibandronatne kiseline 2,5 mg jedanput dnevno u povećavanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine, p=0,002, i nakon dvije godine, p<0,001.
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
• simptomi nalik gripi, uključujući vrućicu, tresavicu i drhtanje, osjećaj nelagode, bol u kostima, mišićima i zglobovima.
The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Raspon opaženih prividnih poluživota širok je te ovisi o dozi i osjetljivosti metode, no prividni krajnji poluživot u načelu ima raspon od 10 do 60 sati.
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.
Učinak liječenja ibandronatnom kiselinom dodatno je procijenjen analizom populacijske podskupine bolesnika čija je početna T-vrijednost BMD lumbalne kralježnice bila manja od -2,5.
Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Liječenje s 2,5 mg dnevno dovelo je do progresivnih povećanja BMD kralježaka i ostalih dijelova skeleta.
The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Farmakodinamički učinak ibandronatne kiseline je inhibicija resorpcije kosti.
Anaphylactic reaction/shock
Anafilaktička reakcija/šok
Pharmacokinetics in special populations
Farmakokinetika u posebnim skupinama
Month 1 __/__/__
Mjesec 1 __ /__ /__
The pharmacokinetics of ibandronic acid in these patients is unknown, and ibandronic acid should not be used under these circumstances.
Nisu poznata farmakokinetska svojstva ibandronatne kiseline u ovih bolesnika te se ibandronatna kiselina ne bi smjela koristiti u takvim slučajevima.
The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Apsorbirani udio ibandronatne kiseline uklanja se iz cirkulacije koštanom apsorpcijom (procijenjeno na 40-50% u žena u postmenopauzi), a ostatak se nepromijenjen eliminira putem bubrega.
If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).
Ako se jave ti simptomi, prestanite uzimati Ibandronatnu kiselinu Teva i odmah se javite svom liječniku (vidjeti dio 3).
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Prijavljeni su slučajevi osteonekroze čeljusti, pretežno u bolesnika oboljelih od raka liječenih lijekovima koji inhibiraju resorpciju kosti, kao što je ibandronatna kiselina (vidjeti dio 4.4).
In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
U zdravih muških ispitanika i žena u postmenopauzi, intravenski ranitidin uzrokovao je povećanje bioraspoloživosti ibandronatne kiseline za otprilike 20% (što je u okviru normalne varijabilnosti bioraspoloživosti ibandronatne kiseline), vjerojatno kao rezultat smanjene kiselosti želuca.
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Početne vrijednosti u plazmi, međutim, brzo padaju, dostižući 10% vršnih vrijednosti u roku od 3 do 8 sati nakon intravenske ili peroralne primjene.
Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis.
Nakon prekida liječenja došlo je do vraćanja na patološke vrijednosti povećane resorpcije kosti koje su postojale prije liječenja, koje su povezane s osteoporozom u postmenopauzi.
Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Ibandronatna kiselina Teva pripada skupini lijekova koji se nazivaju bisfosfonati.
Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
U nekliničkim ispitivanjima učinci su zamijećeni samo pri izloženosti lijeku znatno višoj od maksimalne izloženosti kod ljudi, što ukazuje na malu važnost za kliničku primjenu.
The extent of absorption is impaired when taken together with food or beverages (other than water).
Apsorpcija je smanjena ako se lijek uzima s hranom ili pićem (osim s vodom).
- Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
˗ acetilsalicilnu kiselinu i druge nesteroidne protuupalne lijekove (NSAIL) (uključujući ibuprofen, natrij-diklofenak i naproksen) koji mogu nadražiti želudac i crijeva.
Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
U suprotnom, dio lijeka vam se može vratiti u jednjak (ezofagus).
The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Apsorbirana frakcija ibandronatne kiseline se iz cirkulacije uklanja putem koštane apsorpcije (procijenjeno na 40-50%), a ostatak se nepromijenjen izlučuje putem bubrega.
The deterioration in Quality of Life and WHO performance status was significantly less in ibandronic acid treated patients compared with placebo.
Pogoršanje kvalitete života i općeg stanja prema WHO, bilo je znatno manje u bolesnika liječenih ibandronatnom kiselinom nego u bolesnika koji su primali placebo.
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).
Najozbiljnije prijavljene nuspojave su anafilaktička reakcija/šok, atipični prijelomi bedrene kosti, osteonekroza čeljusti, gastrointestinalna iritacija i upala oka (vidjeti odlomak „Opis odabranih nuspojava“ i dio 4.4).
- radiotherapy to bone for treatment of fractures/impending fractures, - surgery to bone for treatment of fractures, - vertebral fractures, - non-vertebral fractures.
- radioterapija kostiju radi liječenja prijeloma/mogućih prijeloma, - operacija kostiju zbog liječenja prijeloma, - prijelomi kralježnice, - drugi prijelomi osim kralježnice.
Osteonecrosis of the external auditory canal
Osteonekroza vanjskog slušnog kanala
The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Rizik od teških štetnih događaja jednjaka čini se veći u bolesnika koji se ne pridržavaju uputa o doziranju i/ili koji nastavljaju peroralno primjenjivati bisfosfonate nakon pojave simptoma koji upućuju na iritaciju jednjaka.
No dose adjustment is required (see section 5.2).
Nije potrebna prilagodba doze (vidjeti dio 5.2).
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
U ljudi, prividni terminalni volumen distribucije iznosi najmanje 90 l, dok se količina doze koja dospijeva do kosti procjenjuje na 40-50% cirkulirajuće doze.
- Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva.
˗ dodatke koji sadrže kalcij, magnezij, željezo ili aluminij jer mogu utjecati na učinke Ibandronatne kiseline Teva.
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.
14% od više od 1500 bolesnika uključenih u ispitivanje BM 16549 u kojem su se uspoređivali mjesečni i dnevni režimi doziranja ibandronatne kiseline nakon jedne godine koristilo je histaminske (H2) blokatore ili inhibitore protonske pumpe, odnosno 18% nakon dvije godine.
A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
Klinički značajno smanjenje biokemijskih biljega koštane resorpcije od 50 % primijećeno je već mjesec dana nakon početka liječenja ibandronatnom kiselinom u dozi od 2,5 mg.
You can drive and use machines as it's expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.
Možete upravljati vozilima i strojevima jer se očekuje da Ibandronatna kiselina Teva ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i strojevima.
In some cases, these events did not resolve until the ibandronic acid was discontinued.
U nekim slučajevima ovi simptomi se nisu povukli sve do prekida primjene ibandronatne kiseline.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Osteonekroza vanjskog slušnog kanala prijavljena je s bisfosfonatima, uglavnom povezana s dugoročnom terapijom.
Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
Bolesnici koji su imali gastrointestinalne bolesti u anamnezi, uključujući bolesnike s peptičkim ulkusom u kojih nije došlo do nedavnog krvarenja ili hospitalizacije te bolesnike s dispepsijom ili refluksom koji je kontroliran lijekovima, uključeni su u ispitivanje primjene mjesečne doze.
SMPR (per patient year)
SMPR (po bolesnik-godini)
Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Preosjetljivost† bronhospazam† angioedem†, anafilaktička reakcija/šok†*
Also some other medicines can affect the way Ibandronic Acid Teva works.
Također, drugi lijekovi mogu utjecati na djelovanje Ibandronatne kiseline Teva.
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Ibandronatna kiselina pripada u skupinu bisfosfonata, tvari koji djeluju specifično na kosti.
Marketing Authorisation Holder: Teva B.V.
Nositelj odobrenja za stavljanje u promet lijeka: Teva B.V.
Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Bolest slična gripi uključuje događaje prijavljene kao reakcija akutne faze ili simptome koji uključuju bol u mišićima, bol u zglobovima, vrućicu, zimicu, umor, mučninu, gubitak apetita ili bol u kostima.
Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic Acid Teva.
Mogu se javiti iritacija, upala ili vrijed jednjaka/cijevi koja povezuje usta sa želucem (ezofagus), često sa simptomima jake boli u prsima, jake boli nakon gutanja hrane i/ili pića, jake mučnine ili povraćanja, osobito ako ne popijete punu čašu vode i/ili ako legnete unutar jednog sata nakon uzimanja lijeka Ibandronatna kiselina Teva.
The recommended dose is one 150 mg film-coated tablet once a month.
Preporučena doza je jedna filmom obložena tableta od 150 mg jedanput mjesečno.
Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
U testovima genotoksičnosti nije bilo dokaza genetske aktivnosti ibandronatne kiseline.
Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Bioraspoloživost i povećanje BMD smanjuju se ako se hrana ili piće uzimaju prije nego prođe 60 minuta od primjene ibandronatne kiseline.
Ibandronic Acid Teva may help lower the chances of breaking bones (fractures).
Ibandronatna kiselina Teva može smanjiti rizik za prijelom kostiju (fraktura).
No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem bubrega (CLcr ≥50 i <80 ml/min).
Toxic effects, e.g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Toksični učinci, npr. znakovi oštećenja bubrega, zamijećeni su u pasa samo pri izloženosti dozama koje se smatraju znatno višima od maksimalno dopuštenih kod ljudi, što upućuje na malu važnost za kliničku primjenu.
Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Smanjeno izlučivanje kalcija putem bubrega može biti praćeno padom razine fosfata u krvi, što ne zahtjeva terapijske mjere.
• severe adverse skin reactions
• teške kožne nuspojave
Based on the results of study BM 16549, ibandronic acid 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Na temelju rezultata studije BM 16549 očekuje se da će ibandronatna kiselina 150 mg jedanput mjesečno biti barem jednako djelotvorna u sprječavanju prijeloma kao ibandronatna kiselina 2,5 mg jedanput dnevno.
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
S obzirom na farmakodinamički i farmakokinetički profil lijeka i prijavljene nuspojave, očekuje se da Ibandronatna kiselina Teva ne utječe ili zanemarivo utječe na sposobnost upravljanja motornim vozilima i rada na strojevima.
Do not make yourself vomit, and do not lie down - this could cause Ibandronic Acid Teva to irritate your oesophagus.
Nemojte izazivati povraćanje i nemojte leći jer bi Ibandronatna kiselina Teva mogla nadražiti jednjak.
Studies in rats have shown reproductive toxicity (see section 5.3).
Ispitivanja u štakora pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
Ibandronic Acid Teva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Ibandronatnu kiselinu Teva treba uzeti nakon noćnog gladovanja (barem 6 sati) i 1 sat prije uzimanja prve hrane ili pića (osim obične vode) na početku dana (vidjeti dio 4.5) te drugih oralnih lijekova ili nadomjesnih preparata (uključujući kalcij).
Opadry white YS-1-7003: Titanium dioxide (E 171) Hypromellose Macrogol 400
Opadry white YS-1-7003 titanijev dioksid (E 171) hipromeloza makrogol 400 polisorbat 80
Medicinal product-Food Interaction
Interakcije lijek - hrana
Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Bioraspoloživost se smanjuje za otprilike 75% ako se tablete ibandronatne kiseline uzimaju 2 sata nakon standardnog obroka.
In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Osim toga, ibandronatna kiselina ne inhibira glavne izoenzime citokroma P450 u ljudskoj jetri i ne inducira jetreni P450 citokromski sustav u štakora.
There is no relevant use of Ibandronic Acid Teva in children below 18 years, and Ibandronic Acid Teva was not studied in this population (see section 5.1 and section 5.2).
Ibandronatna kiselina Teva nije bila značajno primjenjivana u djece mlađe od 18 godina pa nije ispitivana u ovoj populaciji (vidjeti dijelove 5.1 i 5.2).
Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Klinička ispitivanja u bolesnika s rakom dojke i koštanim metastazama pokazala su da postoji inhibitorni učinak na osteolizu kostiju ovisan o dozi, izražen biljezima resorpcije kostiju, te učinak na koštane promjene ovisan o dozi.
Incidence of clinical vertebral fracture 6.97 % (4.67, 9.27) BMD - mean change relative to baseline lumbar spine at year 3
Incidencija kliničkih prijeloma kralježaka 6,97% (4,67; 9,27) 3,57% (1,89; 5,24) BMD - srednja promjena u odnosu na početne vrijednosti za lumbalnu kralježnicu nakon 3 godine
It's important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you.
Nastavljanje uzimanja lijeka Ibandronatna kiselina Teva Važno je uzimati Ibandronatnu kiselinu Teva svaki mjesec, dok god Vam to propisuje Vaš liječnik.
Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Zbog opasnosti od iritacije jednjaka ne smije se izazivati povraćanje, a bolesnik mora cijelo vrijeme ostati u uspravnom položaju.
* Mean change from baseline to last assessment.
* Srednja vrijednost promjene od početne vrijednosti do zadnje procjene.