natgillin/translations-raw huggingface dataset:
Treatment of osteoporosis with combination and sequential therapy The PaTH study was a 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.
Šlo je za dveletno, randomizirano, s placebom nadzorovano, multicentrično, dvojno slepo preskušanje zdravila Preotact in alendronata za zdravljenje pomenopavzne osteoporoze v monoterapiji ali v kombinaciji.
Inclusion criterias were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Vključitveni kriteriji so bili ženske med 55. in 85. letom starosti s T- točkovanjem BMD pod - 2, 5 oziroma pod - 2 in najmanj enim dodatnim dejavnikom tveganja za zlom.
A ll women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
Vse ženske so prejemale dodatke kalcija (400- 500 mg) in vitamina D (400 i. e.).
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.
Skupno 238 žensk po menopavzi so naključno razporedili v skupine tako, da so prejemale bodisi Preotact (100 µg obščitničnega hormona) bodisi alendronat (10 mg) bodisi kombinacijo navedenega, ter jih spremljali 12 mesecev.
In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
V drugem letu študije so ženske, ki so prvotno prejemale Preotact, naključno razporedili v skupini, ki sta prejemali bodisi alendronat bodisi placebo, ženske iz drugih dveh skupin pa so prejemale alendronat.
At baseline a total of 165 women (69%) had a T-score below –2.5, and 112 (47%) reported at least one fracture after menopause.
V izhodišču je skupno 165 žensk (69%) imelo vrednost T pod - 2, 5 in 112 žensk (74%) je navedlo najmanj en zlom po menopavzi.
One year of therapy, showed the following results:
Eno leto zdravljenja je dalo naslednje rezultate:
The increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Povečki BMD ledvenega predela hrbtenice nad izhodiščnimi vrednostmi so bili podobni v skupini, ki je prejemala Preotact (6, 3%), in v skupini, ki je prejemala kombinacijsko zdravljenje (6, 1%), ampak nekoliko manjši v skupini, ki je prejemala alendronat (4, 6%).
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
Povečki BMD celotnega kolka so bili 1, 9% v prvi omenjeni skupini, 0, 3% v drugi omenjeni skupini in 2, 8% v zadnji omenjeni skupini.
At the end of year 2 (12 months after Preotact was discontinued), there was a 12.1% mean increase in dual energy X-ray absorptiometry (DXA) spine BMD for patients who received alendronate for the second year.
Ob koncu drugega leta (12 mesecev po prekinitvi dajanja zdravila Preotact) je bilo pri bolnicah, ki so drugo leto prejemale alendronat, povprečno povečanje BMD hrbtenice 12%, izmerjeno z dvoenergijsko rentgensko absorpciometrijo (DXA - "dual energy X- ray absorptiometry").
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.
Pri bolnicah, ki so drugo leto prejemale placebo, je bilo povprečno povečanje 4, 1% glede na izhodišče, vendar se je nekoliko zmanjšalo, če primerjamo z zaključkom 12- mesečnega zdravljenja z zdravilom Preotact.
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.
Povprečna sprememba BMD kolka je bila v primerjavi z izhodiščem 4, 5% po enem letu prejemanja alendronata in 0, 1% po enem letu prejemanja placeba.
1.1%, p < 0.001).
Pri 180 ženskah po menopavzi so dokazali, da Preotact v kombinaciji s hormonskim nadomestnim zdravljenjem v 12 mesecih statistično značilno poveča BMD ledvenega predela hrbtenice v primerjavi s samim hormonskim nadomestnim zdravljenjem (7, 1% proti 1, 1%, p < 0, 001).
Absorption Subcutaneous administration of 100 micrograms of parathyroid hormone into the abdomen produces a rapid increase in plasma parathyroid hormone levels and achieves a peak at 1 to 2 hours after dosing.
Povprečna
8 The average half-life is of about 1.5 hours.
8 razpolovna doba je približno 1, 5 ure.
Distribution The volume of distribution at steady-state following intravenous administration is approximately 5.4 l.
Porazdelitev Volumen porazdelitve v stanju dinamičnega ravnovesja po intravenskem dajanju je približno 5, 41.
Intersubject variability in the volume of distribution of parathyroid hormone is about 40%.
Variabilnost volumna porazdelitve obščitničnega hormona med preiskovanci je približno 40%.
Biotransformation Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Biotransformacija Obščitnični hormon se v jetrih učinkovito odstranjuje iz krvi s procesi, ki jih posredujejo receptorji, nato pa se cepi v manjše peptidne fragmente.
The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Fragmenti, ki izhajajo iz karboksi- konca, pa se sproščajo nazaj v kri in se očistijo v ledvicah.
These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Ti fragmenti s karboksi- koncem naj bi imeli vlogo pri uravnavanju aktivnosti obščitničnega hormona.
Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
V normalnih fizioloških pogojih obščitnični hormon popolne dolžine (1- 84) predstavlja le 5- 30% krožečih oblik molekule, 70- 95% ostalih oblik pa so fragmenti s karboksi- koncem.
Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Po podkožnem odmerjanju zdravila Preotact C- terminalni fragmenti predstavljajo 60- 90% krožečih oblik molekule.
Systemic clearance of parathyroid hormone (45.3 l/hour) following an intravenous dose is close to normal liver plasma flow and is consistent with extensive hepatic metabolism of the active substance.
Sistemski očistek obščitničnega hormona (45, 3 l/ uro) po intravenskem odmerku je podoben običajnemu jetrnemu plazemskemu toku in skladen z obsežno presnovo zdravilne učinkovine v jetrih.
Intersubject variability in systemic clearance is about 15%.
Variabilnost sistemskega očistka med preiskovanci je približno 15%.
Elimination Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Izločanje Obščitnični hormon se presnovi v jetrih, v manjšem obsegu tudi v ledvicah.
Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Krožeče fragmente s karboksi- konci filtrirajo ledvice, vendar se kasneje med ponovnim privzemom v tubulih razcepijo v še manjše fragmente.
Hepatic impairment There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Okvara jeter V študiji pri 6 moških in 6 ženskah z zmerno okvaro jeter so odkrili manjše (približno 20 -%) zvišanje za povprečno osnovnico popravljene izpostavitve (AUC) obščitničnemu hormonu v primerjavi z ujemajočo se skupino 12 preiskovancev z normalno jetrno funkcijo.
Renal impairment 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.
Okvara ledvic Celokupna izpostavitev obščitničnemu hormonu in Cmax obščitničnega hormona sta bila v skupini 8 moških in 8 žensk z blago do zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/ min) rahlo zvišana (celokupna izpostavitev za 22% in Cmax za 56%) v primerjavi z ujemajočo se skupino 16 preiskovancev z normalno ledvično funkcijo.
The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Farmakokinetika obščitničnega hormona pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/ min) ni raziskana.
Elderly No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Starostniki Niso odkrili razlik v farmakokinetiki zdravila Preotact glede na starost (obseg 47- 88 let).
Gender The medicinal product has only been studied in postmenopausal women.
Spol Zdravilo je bilo preučeno le pri ženskah po menopavzi.
9 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.
9 kosti med podganami in človekom, je klinični pomen teh odkritij verjetno manjši.
Powder Mannitol Citric acid monohydrate Sodium chloride Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide 1N (for pH adjustment)
Prašek Manitol Citronska kislina monohidrat Natrijev klorid Klorovodikova kislina, razredčena (za uravnavanje pH) Natrijev hidroksid 1N (za uravnavanje pH)
Solvent Metacresol Water for injections
Vehikel Metakrezol Voda za injekcije
Mixed solution: chemical and physical in-use stability has been demonstrated for 28 days at 2-8°C.
Pripravljena raztopina: kemijska in fizikalna obstojnost je dokazana za 28 dni pri 2 °C - 8 °C.
During the 28-day period the mixed solution can be stored for up to 7 days at temperatures below 25°C.
V 28 - dnevnem časovnem obdobju se lahko pripravljena raztopina shranjuje do 7 dni pri temperaturi do 25 °C.
Keep the cartridge in the outer carton in order to protect from light.
Vložek shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
Mixed solution:
Pripravljena raztopina:
Store in a refrigerator (2-8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
Once the cartridge is mixed it can be stored outside the refrigerator at temperatures below 25°C for up to 7 days during the 28 day use period.(see section 6.3).
(glejte poglavje 6. 3).
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.
Zaprti sistem vsebnika je sestavljen iz vložka z dvema komorama, osrednjega zamaška, objemne zaporke (ki vsebuje zamašek iz kavčuka), ki zapira prvo komoro z liofiliziranim praškom, in končnega zamaška, ki zapira drugo komoro z vehiklom za pripravo.
Cartridge:
Vložek:
The glass of the dual-chamber cartridge is made of glass Type I.
Steklo vložka z dvema komorama je steklo tipa I.
Stopper (center and end):
Zamašek (osrednji in končni):
The stopper is made of bromobutyl rubber, grey.
Zamašek je izdelan iz bromobutilnega kavčuka, sivega.
Crimp cap (containing a rubber seal):
Objemna zaporka (ki vsebuje zamašek iz kavčuka):
The crimp cap is made of aluminium and the rubber seal is made of bromobutyl rubber.
Objemna zaporka je izdelana iz aluminija, zamašek iz kavčuka pa je izdelan iz bromobutilnega kavčuka.
10 Each dual-chamber cartridge contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses).
Vsak vložek z dvema komorama vsebuje po 1, 61 mg obščitničnega hormona in 1, 13 ml vehikla (14 odmerkov).
Preotact is available in packs of 2 and 6 cartridges.
10 Zdravilo je na voljo v pakiranju z 2 ali 6 vložki.
The Preotact pen and needles are not included.
Injekcijsko pero Preotact in igle niso priložene.
Preotact is injected using the re-usable pen, Preotact pen.
Zdravilo Preotact se injicira z peresom (pero Preotact), ki je za ponovno uporabo.
The contents of the dual-chamber cartridge is mixed in the Preotact pen.
Vsebina vložka z dvema komorama se zmeša v peresu Preotact.
After mixing the liquid should be clear and colourless.
Po mešanju mora nastati tekočina, ki je bistra in brez barve.
If the mixed solution is cloudy, coloured or contains particles the cartridge should be removed from the Preotact pen and a new cartridge inserted.
Če je pripravljena raztopina motna, obarvana ali vsebuje vidne delce, je treba vložek izvleči iz peresa Preotact in vstaviti nov vložek.
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Nycomed Danmark ApS Langebjerg 1 DK- 4000 Roskilde Danska
Boehringer Gasse 5-11 1211 Vienna Austria
Boehringer Gasse 5- 11 1211 Vienna Avstrija
The Marketing Authorisation Holder commits to performing the study and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se obveže, da bo izvedel študije in aktivnosti v zvezi s farmakovigilanco, ki so opredeljene v načrt farmakovigilance.
Outer Carton (2 and 6 dual-chamber cartridges)
Zunanja škatla (2 vložka z dvema komorama in 6 vložkov z dvema komorama)
Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone
Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje obščitnični hormon
Each dual-chamber cartridge contains 1.61 mg of parathyroid hormone..
Vsak vložek z dvema komorama vsebuje 1, 61 mg obščitničnega hormona.
When the powder and the solvent have been mixed, each dose of 71.4 microliter contains 100 micrograms parathyroid hormone.
Ko se prašek in vehikel zmešata vsak odmerek z 71, 4 mikrolitra vsebuje 100 mikrogramov obščitničnega hormona.
Sodium chloride 0.4%, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Natrijev klorid 0, 4%, manitol, citronska kislina monohidrat, klorovodikova kislina, metakrezol, natrijev hidroksid, voda za injekcije.
Each dual-chamber cartridge contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent.
Vsak vložek z dvema komorama vsebuje 1, 61 mg obščitničničnega hormona v obliki praška in 1, 13 ml vehikla.
2 dual-chamber cartridges per pack.
Škatla z 2 vložkoma z dvema komorama -.
6 dual-chamber cartridges per pack.
Škatla s 6 vložki z dvema komorama.
Subcutaneous use Do not shake the reconstituted solution Read the package leaflet before use
Pred uporabo preberite priloženo navodilo
16 EXP MM/YYYY Reconstituted solution:
EXP MM/ LLLL Pripravljena raztopina:
Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Ko je raztopina v vložku pripravljena, lahko vložek shranjujete pri temperaturi do 25 °C do 7 dni v 28 - dnevnem obdobju uporabnosti.
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark
Nycomed Danmark Aps, Langebjerg 1, 4000 Roskilde, Danska
EU/ 1/ 06/ 339/001 2 dual-chamber cartridges per pack.
EU/ 1/ 06/ 339/ 001 škatla z 2 vložkoma z dvema komorama..
EU/1/06/339/002 6 dual-chamber cartridges per pack.
EU/ 1/ 06/ 339/ 002 škatla s 6 vložki z dvema komorama.
Dual chamber cartridge
Vložek z dvema komorama
Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone Subcutaneous use
Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje obščitnični hormon Subkutana uporaba
1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
1, 61 mg obščitničnega hormona in 1, 13 ml vehikla (14 odmerkov)
What Preotact is and what it is used for 2.
Kaj je zdravilo Preotact in za kaj ga uporabljamo 2.
Before you use Preotact 3.
Kaj morate vedeti, preden boste uporabili zdravilo Preotact 3.
How to use Preotact 4.
Kako uporabljati zdravilo Preotact 4.
Possible side effects 5 How to store Preotact 6.
Možni neželeni učinki 5 Shranjevanje zdravila Preotact 6.
WHAT PREOTACT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PREOTACT IN ZA KAJ GA UPORABLJAMO
BEFORE YOU USE PREOTACT
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PREOTACT
Do not use Preotact: • if you are allergic (hypersensitive) to parathyroid hormone or any of the other ingredients of Preotact; • if you have had radiation therapy to the skeleton; • if you suffer from high calcium levels and other disturbances in the calcium-phosphor metabolism; • if you have other bone disease (including hyperparathyroidism or Paget’s disease); • if you have high levels of alkaline phosphatase; • if you suffer from severe kidney problems; • if you suffer from severe liver disease;
Ne uporabljajte zdravila Preotact: • če ste alergični na (preobčutljivi za) obščitnični hormon ali katerokoli drugo sestavino zdravila Preotact; • če ste se kdaj zdravili z obsevanjem okostja; • če imate visoke ravni kalcija in druge motnje fosfokalcijeve presnove; • če imate druge bolezni kosti (vključno s hiperparatiroidizmom in Pagetovo boleznijo); • če imate visoke ravni alkalne fosfataze; • če imate hude težave z ledvicami; • če imate hude težave z jetri.
Measuring of the calcium levels in the blood and/or urine
Določanje ravni kalcija v krvi in/ ali urinu
Your doctor will check your response to treatment at regular intervals.
Vaš zdravnik bo v rednih časovnih presledkih preverjal odziv na zdravljenje.
He or she must perform blood and/or urine tests at month 1, 3 and 6 after starting your treatment with Preotact.
Po enem mesecu, treh in šestih mesecih od začetka zdravljenja z zdravilom Preotact vam morajo opraviti preiskave krvi in/ ali urina.
Take special care with Preotact:
Bodite posebno pozorni pri uporabi zdravila Preotact:
Preotact should be used with caution if you suffer from kidney stones or have had kidney stones.
Če imate ledvične kamne ali ste jih imeli v preteklosti, je treba zdravilo Preotact uporabljati previdno.
Specific populations:
Specifične populacije:
20 Children and adolescents
20 Otroci in mladostniki
Preotact should not be used in children or adolescents.
Otroci ali mladostniki ne smejo uporabljati zdravila Preotact.
No special precautions.
Ni posebnih varnostnih ukrepov.
Preotact should be used with caution if you receive heart medicine.
Zdravilo Preotact je treba uporabljati previdno, če jemljete zdravila za srce.
Taking Preotact with food and drink
Uporaba zdravila Preotact skupaj s hrano in pijačo
Food and drink have no influence on the effect of Preotact.
Hrana in pijača ne vplivata na učinek zdravila Preotact.
Do not use Preotact if you are pregnant or breast-feeding.
Če ste noseči ali če dojite, ne uporabljajte zdravila Preotact.
No studies on the ability to drive or operate machines have been performed.
Študije vpliva na sposobnost vožnje in upravljanja s stroji niso bile opravljene.
Important information about some of the ingredients of Preotact:
Pomembne informacije o nekaterih sestavinah zdravila Preotact
This means that it is essentially “sodium-free”.
To pomeni, da je v bistvu „ brez natrija “.
HOW TO USE PREOTACT
KAKO UPORABLJATI ZDRAVILO PREOTACT
Always use Preotact exactly as your doctor has told you.
Pri uporabi zdravila Preotact natančno upoštevajte zdravnikova navodila.
The usual dose of Preotact is 100 micrograms given once a day.
Običajen odmerek zdravila Preotact je 100 mikrogramov dnevno.
Your doctor may advise you to take supplementary calcium and vitamin D.
Zdravnik vam bo morda svetoval, da jemljete dopolnila kalcija in vitamina D.
Your doctor will tell you how much you should take each day.
Zdravnik vam bo povedal, kakšen odmerek morate vzeti dnevno.
Preotact should be used with the Preotact pen.
Zdravilo Preotact se uporablja z injekcijskim peresom Preotact.
When you place the cartridge in the Preotact pen, the solvent and the powder mix.
Ko vložek vstavite v injekcijsko pero Preotact, se vehikel in prašek zmešata.
The solution is then ready to be injected into the abdomen (under the skin).
Nato je raztopina pripravljena za injiciranje v trebuh (pod kožo).
When not in use put the Preotact pen into the refrigerator.
Ko injekcijskega peresa Preotact ne uporabljate, ga shranite v hladilniku.
Important information when using Preotact • Inject yourself with Preotact shortly after you have taken the Preotact pen out of the refrigerator
Pomembni podatki o uporabi zdravila Preotact • Zdravilo Preotact si injicirajte kmalu potem, ko pero Preotact vzamete iz hladilnika. • Pero Preotact po uporabi nemudoma znova shranite v hladilniku.
Never remove a cartridge in use from the pen. • DO NOT SHAKE the Preotact pen (neither before nor after injection) as it may destroy the effect of the active substance • Use a new injection needle for each injection and throw it away after each use. • Never store your Preotact pen with the needle attached. • Never share your Preotact pen with anyone.
21 • NE STRESAJTE peresa Preotact (bodisi pred injiciranjem bodisi po injiciranju), saj se lahko izniči delovanje zdravilne učinkovine. • Za vsako uporabo uporabite novo injekcijsko iglo, ki jo po injiciranju zavrzite. • Peresa Preotact nikoli ne shranjujte z nameščeno iglo. • Peresa Preotact ne smete dajati drugim.
For instructions on how to use the Preotact pen, please read the User Manual of the Preotact pen.
Za informacije o uporabi peresa Preotact preberite Navodila za uporabo peresa Preotact.
Keep using Preotact for as long as your doctor prescribes it for you – normally no longer than 24 months.
Zdravilo Preotact uporabljajte tako dolgo, kakor vam ga predpisuje zdravnik – običajno ne dlje kot 24 mesecev.
If you use more Preotact than you should:
Če ste uporabili večji odmerek zdravila Preotact, kot bi smeli
If, by accident, you inject more than one dose of Preotact in a day, contact your doctor or pharmacist.
Če ste si pomotoma injicirali več kot en odmerek zdravila Preotact na dan, se obrnite na svojega zdravnika ali farmacevta.
If you forget to use Preotact:
Če ste pozabili uporabiti zdravilo Preotact
Never take more than one injection in the same day.
Nikoli si ne injicirajte več kot en odmerek v enem dnevu.
Do not take a double dose to make up for forgotten doses.
Ne uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you stop taking Preotact:
Če ste prenehali uporabljati zdravilo Preotact
If you stop taking Preotact before finishing the treatment please inform you doctor.
Če ste prenehali uporabljati zdravilo Preotact pred zaključkom zdravljenja, obvestite svojega zdravnika.
Like all medicines, Preotact can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Preotact neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common side effects (in more than 10% of patients) are: increased level of calcium in the blood, increased level of calcium in the urine, and nausea.
Najpogostejši neželeni učinki (pri več kot 10% bolnic) so: zvišane ravni kalcija v krvi, zvišane ravni kalcija v urinu in slabost.
Common side effects (in 1 to 10% of patients) are: back pain, constipation, decreased muscle strength, diarrhoea, dizziness, erythema at injection site, fast or irregular heart beats, headache, muscle cramps, pain in extremity, stomach upset, tiredness, and vomiting.
Pogosti neželeni učinki (pri od 1 do 10% bolnic) so: bolečine v križu, zaprtost, zmanjšana mišična moč, driska, omotica, rdečina na mestu injiciranja, hiter ali nepravilen srčni utrip, glavobol, mišični krči, bolečine v okončinah, razdražen želodec, utrujenost in bruhanje.
Uncommon side effects (in 0.1% to 1% of patients) are: abdominal pain, flu, increased level of uric acid in the blood, irritation of the skin at the injection site, loss of appetite, smell disturbance, and taste disturbance.
Občasni neželeni učinki (pri od 0, 1 do 1% bolnic) so: trebušne bolečine, gripa, zvišane ravni sečne kisline v krvi, draženje kože na mestih injiciranja, izguba apetita, motnje vonjanja in motnje okušanja.
HOW TO STORE PREOTACT
SHRANJEVANJE ZDRAVILA PREOTACT