natgillin/translations-raw huggingface dataset:
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Nositelj odobrenja će provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom , kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2 odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane Povjerenstva za humane lijekove (CHMP).
Based on two placebo-controlled studies involving 2642 postmenopausal osteoporotic women, hypercalcemia was reported in 25.3% of patients treated with Preotact compared to 4.3% of placebotreated patients.
Temeljem dva placebom kontrolirana ispitivanja koja su uključivala 2642 žene u postmenopauzi sa osteoporozom, hiperkaciemija je prijavljena kod 25,3% bolesnica liječenih Preotactom u usporedbi sa 4,3% bolesnica koje su uzimale placebo.
The most relevant fracture reduction was observed among patients at high risk of fractures such as patients with previous fractures and in patients with a lumbar spine T-score of < - 3.
Najvažnije smanjenje rizika prijeloma primijećeno je u bolesnica sa visokim rizikom prijeloma, kao što su bolesnice s prethodnim prijelomima i bolesnice s T-vrijednošću lumbalne kralježnice ≤ -3.
No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem jetre (ukupna vrijednost 7-9 na Child-Pugh ljestvici).
Wash your hands with soap and water before you handle the pre-filled pen.
Prije rukovanja napunjenom brizgalicom operite ruke vodom i sapunom.
Pull both needle covers off. Save the outer needle cover as you will need it to remove the needle after the injection.
Sačuvajte vanjski poklopac, jer će Vam trebati kad budete uklanjali iglu nakon korištenja.
Patients with urolithiasis
Bolesnika s urolitijazom
In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria.
Kod ovih bolesnika je veća vjerojatnost da će liječenje Preotactom pogoršati podležeću hiperkalciuriju.
In a large phase III clinical study, antibodies to parathyroid hormone were detected in 3% of women receiving Preotact compared to 0.2% of women receiving placebo.
U velikom kliničkom ispitivanju faze III, antitijela na paratiroidni hormon otkrivena su kod 3% žena koje su primale Preotact u usporedbi sa 0,2% žena koje su primale placebo.
The overall exposure and Cmax of parathyroid hormone were slightly increased (22% and 56%, respectively) in a group of 8 male and 8 female subjects with mild-to-moderate renal impairment (creatinine clearances of 30 to 80 ml/min) compared with a matched group of 16 subjects with normal renal function.
Ukupna izloženost i Cmax paratireoidnog hormona bila je blago povećana (22%, odnosno 56%) u grupi od 8 žena i 8 muškaraca sa blagim do umjerenim oštećenjem bubrega (klirens kreatinina od 30-80 ml/min) u odnosu na odgovarajuću grupu od 16 osoba sa normalnom bubrežnom funkcijom.
• If you have just mixed a new pre-filled pen you can use the needle already on.
• Ako ste upravo pomiješali novu napunjenu brizgalicu,
5.3 Preclinical safety data
5.3 Pretklinički podaci o sigurnosti primjene
Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Ispitivanja na miševima ukazuju na povećanu incidenciju osteosarkoma kod dugotrajne primjene Preotacta (vidjeti dio 5.3).
• if you shall have or previously have had radiation therapy to the skeleton;
• ako ste bili ili trebate ići na terapiju zračenjem koštanog sustava;
Effects on serum calcium concentrations
Učinak na koncentraciju kalcija u serumu
Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
U kliničkom ispitivanju faze III uključeno je relativno malo bolesnica koje su u postmenopauzi manje od 5 godina i imaju 45-54 godina (2-3%).
Preotact increases serum uric acid concentrations.
Preotact povećava koncentraciju urične kiseline u serumu.
Treatment with Preotact reduced volumetric cortical bone BMD (measured at the distal radius and mid-shaft tibia), while periosteal circumference or indices of cortical bone strength were maintained.
Terapija Preotactom smanjila je volumetrijski BMD kortikalne kosti (mjereno na distalnom promjeru i srednjem dršku tibie), dok je periostealna cirkumferencija i indeks snage kortikalne kosti bio održan.
No osteosarcomas have been observed in clinical trials.
U kliničkim ispitivanjima nije primjećen razvoj osteosarkoma.
These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Za dijelove koji na krajevima imaju karboksilnu skupinu smatra se da igraju ulogu u regulaciji djelovanja paratireoidnog hormona.
From the knowledge of the mechanism of action, combined use of Preotact and cardiac glucosides may predispose patients to digitalis toxicity if hypercalcemia develops (see section 4.4).
Iz saznanja o mehanizmu djelovanja, istodobno uzimanje Preotacta i srčanih glikozida može izložiti bolesnika toksičnosti digitalisa ako se pojavi hiperkalciemija (vidjeti dio 4.4).
A user manual is included in the box to instruct patients on the correct use of the pen.
Priručnik za korisnika s uputama o pravilnoj uporabi brizgalice uključen je u sadržaj kutije.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU • UVJETI ILI OGRANIČENJA VEZANI UZ DOSTUPNOST I UPORABU PREMA
Put the cap back on the pre-filled pen and place it in the refrigerator.
Vratite poklopac natrag napunjenu brizgalicu i spremite je u hladnjak.
It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3, 4.4, and 5.1).
Tijekom kliničkog programa kontrolirana je praćenjem laboratorijskih vrijednosti i korištenjem prethodno detaljiziranog algoritma praćenja (vidjeti dio 4.3, 4.4, i 5.1).
• Put the outer needle cover on.
• Nataknite vanjski poklopac na iglu.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Međutim, ako patite od osteoporoze, veća je vjerojatnost da ćete slomiti kost, bilo u kralježnici,
• You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
• Nakon pripreme za primjenu, napunjenu brizgalicu čuvajte najviše 28 dana u hladnjaku.
• suffer from kidney stones;
• patite od bubrežnih kamenaca;
Parathyroid hormone should not be used in women of childbearing potential, during pregnancy or breast-feeding.
Paratireoidni hormon se ne smije koristiti u žena rerproduktivne dobi, tijekom trudnoće ili dojenja.
For the mean change in hip BMD, there was a 4.5% increase from baseline with one year of alendronate compared to a 0.1% decrease after one year of placebo.
Za srednju promjenu u BMD kuka zabilježeno je povećanje od 4,5% u odnosu na početnu vrijednost nakon jednogodišnjeg liječenja alendronatom u usporedbi sa 0,1%-tnim smanjenjem nakon jedne godine na placebu.
Preotact has not been studied in patients with active urolithiasis.
Preotact nije ispitan u bolesnika s aktivnom urolitijazom.
Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Nastavno na liječenje Preotactom bolesnici se mogu liječiti bifosfonatom kako bi se dodatno povećala mineralna gustoća kostiju (vidjeti dio 5.1).
Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
PaTH ispitivanje bilo je randomizirano, placebom kontrolirano, dvogodišnje, multicentrično, dvostruko-slijepo ispitivanje sponzorirano od Nacionalnog Instituta za zdravlje (NIH) sa Preotactom i alendronatom kao monoterapijom, te njihovom kombinacijom u liječenju postmenopauzalne osteoporoze.
Patients with pre-existing hypercalciuria
Bolesnika s postojećom hiperkalciurijom
Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Dijelovi koji na krajevima imaju karboksilnu skupinu filtriraju se bubrezima i kasnije kidaju na još manje dijelove tijekom tubularne reapsorpcije.
Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Preotact je indiciran za liječenje osteoporoze kod žena u postmenopauzi koje imaju visoki rizik prijeloma kosti (vidjeti dio 5.1)
The recommended dose of Preotact is 100 micrograms per day.
Preotacta je 100 mikrograma na dan.
For the patients who received placebo during the second year, the mean percent increase was 4.1% compared to baseline, but had decreased slightly compared to the end of 12 months of Preotact treatment.
U bolesnica koje su tijekom druge godine primale placebo, srednje postotno povećanje bilo je 4,1% u odnosu na početne vrijednosti, ali se lagano smanjilo u odnosu na vrijednosti s kraja 12-mjesečnog liječenja Preotactom.
Physiological actions of parathyroid hormone include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular reabsorption of calcium and excretion of phosphate by the kidney.
Fiziološka funkcija paratireoidnog hormona uključuje stimulaciju izgradnje kostiju direktnim utjecajem na stanice koje grade kost (osteoblaste) posrednim povećavanjem apsorpcije kalcija u crijevima, te povećavanjem tubularne reapsorpcije kalcija i izlučivanja fosfata bubrezima.
Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Nakon šest mjeseci praćenje nije potrebno za one bolesnike koji su u tijekom tog razdoblja imali normalne vrijednosti ukupnog kalcija u serumu.
• Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
• Primijenite Preotact neposredno nakon što ste napunjenu brizgalicu izvadili iz hladnjaka.
It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3 and 4.4).
Tijekom kliničkog programa kontrolirana je praćenjem laboratorijskih vrijednosti i korištenjem prethodno detaljiziranog algoritma postupanja (vidjeti dijelove 4.3 i 4.4).
Hypercalciuria
Hiperkalciuria
Preotact has been studied in patients with pre-existing hypercalciuria.
Preotact je ispitan u bolesnika s postojećom hiperkalciurijom.
There is no relevant use of Preotact in paediatric patients for the treatment of osteoporosis at high risk of fractures
Nema relevantne primjene Preotacta u pedijatrijskoj populaciji za liječenje osteoporoze s visokim rizikom prijeloma.
The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
Tablica u nastavku daje pregled nuspojava čija je incidencija najmanje 0,5% veća u skupini na paratireoidnom hormonu u odnosu na placebo.
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
u cijeloj bedrenoj kosti bilo je 0,3%, 1,9% odnosno 3,0% u tri grupe istim redoslijedom.
Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za upute o rekonstituciji lijeka prije uporabe, vidjeti dio 6.6.
There are no data available from the use of parathyroid hormone in women of childbearing potential, during pregnancy and breast feeding.
Nema dostupnih podataka o primjeni paratireoidnog hormona u žena reproduktivne dobi, tijekom trudnoće i dojenja.
The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone.
Sljedeći podaci o nuspojavama zasnivaju se na dva placebom kontrolirana ispitivanja u kojima su sudjelovale 2642 žene s osteoporozom u postmenopauzi, od kojih je 1341 primala paratireoidni hormon.
• nausea.
• umor.
Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001).
Na kraju ispitivanja opaženo je značajno povećanje BMD u kuku (ukupno, u vratu femura i trohanteru) 1,0; 1,8; i 1% za Preotact u odnosu na1,1; -0,7; i -0,6% za placebo (p<0,001).
Blood alkaline phosphatase increased Anorexia
Povećanje serumske alkalne fosfataze Anoreksija
Uncommon (may affect up to 1 in 100 people):
Manje česte (mogu zahvatiti do jednog od ukupno 100 ljudi):
Preotact is available in a pack with 2 pre-filled pens.
Preotact je dostupan u pakovanju sa dvije napunjene brizgalice.
Preotact is available in packs of 2 pre-filled pens.
Preotact je dostupan u pakovanju od 2 brizgalice.
Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
natrijev hidroksid (za prilagodbu pH)
The content of the cartridge is reconstituted in the pen.
Sadržaj komore se rekonstituira unutar brizgalice.
• Screw the pre-filled pen together until the clear front part and the pen body meet.
• Zavijanjem sklopite napunjenu brizgalicu dok se prozirni prednji dio i tijelo brizgalice ne dodirnu.
No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem bubrega (klirens kreatinina 30-80 ml/min).
• Do not store the pre-filled pen with the needle on.
• Ne čuvajte napunjenu brizgalicu s postavljenom iglom.
2 pre-filled pens per pack.
2 napunjene brizgalice u pakovanju
Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Kod sumnje na predoziranje potrebno je privremeno prekinuti primjenu Preotacta, nadzirati razinu kalcija u serumu i primijeniti neophodne dodatne mjere, kao što je nadoknadu volumena.
• smell disturbance, taste disturbance.
• poremećaji osjeta mirisa i okusa.
• Screw the needle off.
• Odvijte iglu.
Point the needle straight up and press the blue injection button until it is fully depressed.
Držite iglu uspravno i pritisnite do kraja plavo dugme za injektiranje.
• increased level of calcium in the blood,
• povećanje razine kalcija u krvi,
Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Paratireoidni hormon se uspješno eliminira iz krvi preko receptorima posredovnog procesa u jetri i kidanjem u manje proteinske dijelove.
The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Kombinacija se pokazala djelotvorna bez obzira na dob, stopu pregradnje kostiju ili početnu vrijednost mineralne gustoće kostiju.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Ukoliko imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili ljekarniku.
This will release most of the air in the pre-filled pen and is called ‘priming'.
Time ćete osloboditi većinu zraka iz napunjene brizgalice.
• increased level of calcium in the urine,
• povećanje razine kalcija u urinu,
Keep the product protected from light.
Čuvati zaštićeno od svjetlosti.
• Never store your pre-filled pen with the needle attached.
• Nikad ne čuvajte napunjenu brizgalicu s nataknutom iglom.
• sodium hydroxide.
• natrijev hidroksid.
Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium.
Preotactom potrebno je nadzirati u prvom, trećem i šestom mjesecu liječenja, zbog povećanja kalcija u serumu i/ili mokraći.
In the Preotact clinical program, accidental overdose has been reported.
U kliničkom ispitivanju Preotacta zabilježeno je nenamjerno predoziranje.
The dose counter
Brojač doza
- If you have any further questions, ask your doctor or your pharmacist.
Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku
Press the yellow release button to release the blue injection button.
Pritisnite žuto dugme kako bi se oslobodilo plavo dugme za injektiranje.
Common (may affect up to 1 in 10 people):
Česte (mogu se javiti kod do 1 od 10 korisnika):
Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
Preotact se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na napunjenoj brizgalici kao EXP i pakovanju kao Rok valjanosti.
• if you suffer from severe kidney problems;
• ako patite od ozbiljnih bubrežnih problema;
Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Bolesnika koji uzimaju srčane glikozide Potreban je oprez u bolesnika koji uzimaju srčane glikozide zbog rizika od toksičnosti digitalisa ako se razvije hiperkalciemija (vidi dio 4.5)
• You can store the unmixed pre-filled pen at temperatures between 2-25°C.
• Napunjenu brizgalicu u kojoj lijek nije izmiješan možete čuvati na temperaturi između 2 i 25oC.
During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Tijekom tog 28-dnevnog razdoblja, rekonstituirana otopina se do 7 dana može čuvati na temperaturi do 25oC.
• Take the daily injection • Store the pre-filled pen
• Primijenite jednu injekciju na dan • Spremite napunjenu brizgalicu
• Press the yellow release button to release the blue injection button.
• Pritisnite žuto dugme kako biste oslobodili plavo dugme za injektiranje.
The needle pre-filled pen is full number of index outer needle cover needle inner needle cover
igla vanjski poklopac igle unutrašnji poklopac igle
• if you suffer from high calcium levels in your blood or other disturbances in the calcium
• ako imate visoku razinu kalcija u krvi ili patite od drugih poremećaja metabolizma kalcija i fosfora;
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled pen
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE Napunjena brizgalica
Do not shake the pre-filled pen
Ne tresite napunjenu brizgalicu.
• who are receiving or who has previously received radiation therapy to the skeleton
• koji primaju ili koji su prethodno primali terapiju zračenjem koštanog sustava • sa zloćudnim bolestima koštanog sustava ili metastazama kostiju
Pre-filled pen(after reconstitution): Store in a refrigerator (2-8°C).
Napunjena brizgalica (nakon pripreme za primjenu): Čuvati u hladnjaku (2-8oC).
Hypercalcemia
Hiperkalciemija
Pull the cap straight off from the front end of the pre-filled pen.
Povlačenjem uklonite poklopac s prednjeg dijela napunjene brizgalice.
Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
U bolesnica liječenih Preotactom relativni rizik novih prijeloma kralježaka u 18 mjesecu terapije bio je smanjen za 61% u odnosu na skupinu koja je primala placebo.
Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House 1 Grand Canal Street Upper Dublin 4
Nositelj odobrenja za stavljanje gotovog lijeka u promet NPS Pharma Holdings Limited Grand Canal House
A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Preotact (100 mikrograma paratireoidnog hormona), alendronat (10 mg), ili kombinacija oba lijeka, te praćeno tijekom 12 mjeseci.
For all subjects who received parathyroid hormone 100 micrograms blood uric acid increase was reported for 8 subjects (0.6%) and hyperuricemia was reported for 5 subjects (0.4%).
Od svih ispitanica koje su primale 100 mikrograma paratireoidnog hormona, povećanje urične kiseline zabilježeno je kod 8 ispitanica (0,6%),
Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Preotact se koristi za liječenje osteoporoze kod žena u postmenopauzi koje imaju visoki rizik prijeloma kosti.
The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.
Pivotalno ispitivanje bilo je 18-mjesečno dvostruko slijepo, placebom kontrolirano ispitivanje faze III (TOP) o utjecaju
• Add a needle
• Dodajte iglu
Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Držeći napunjenu brizgalicu za prozirni prednji dio, zakretanjem navijte iglu sve do prozirnog prednjeg dijela napunjene brizgalice.
Reconstituted solution: Store in a refrigerator (2-8°C).
Rekonstituirana otopina: Čuvati u hladnjaku (2-8oC).
Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Navojni zatvarač (sadrži gumeni čep): Aluminij.
After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Nakon rekonstitucije, svaka doza od 71,4 mikrolitara sadrži 100 mikrograma paratireoidnog hormona.
• Calcium and vitamin D supplementation should be withdrawn
• Nadomjeske kalcija i vitamina
Rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
Štakorima koji su gotovo tijekom cijelog životnog vijeka primali dnevnu injekciju, vjerojatno zbog epigenetskog mehanizma, razvijali su o dozi ovisne koštane formacije i imali povećanu incidenciju koštanih tumora, uključujući osteosarkom.
Preotact should therefore not be used in patients with severe hepatic impairment (see section 4.3).
Preotact se stoga ne smije koristiti u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
Powder and solvent for solution for injection.
Prašak i otapalo za injekcijsku otopinu.
Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.
Liječnik će Vam reći koliku dozu morate uzimati svaki dan.
The container closure system is comprised of a dual-chamber cartridge, a center stopper, a crimp cap (containing a rubber seal) sealing the first chamber containing lyophilised powder and an end stopper sealing the second chamber containing the solvent for mixing.
(sadrži gumeni čep) koji brtvi prvu komoru s liofiliziranim praškom i zadnjeg čepa koji brtvi drugu komoru s otapalom za miješanje.
• sodium chloride,
• natrijev klorid,
• reddening of the skin (erythema) at injection site,
• crvenilo kože (eritem) na mjestu uboda,
Preotact is supplied in a pre-filled pen containing a cartridge.
Preotact dolazi u obliku napunjene brizgalice koja sadrži uložak.
• irritation of the skin at the injection site,
• iritacija kože na mjestu uboda, • gubitak teka,
Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Preotact se stoga ne smije koristiti u bolesnika s teškim oštećenjem bubrega (vidjeti dio 4.3).
• decreased muscle strength, muscle cramps, dizziness,
• gubitak mišićne snage, mišićni grčevi, omaglica,
Caution should be exercised in
Potreban je oprez kod
Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
u cijelom kuku povećao se za 9%, 6%, odnosno, 2%, u te 3 grupe.