natgillin/translations-raw huggingface dataset:
Clinically meaningful reductions in serum CTX levels were observed at all time points measured.
Klinično pomembno zmanjšanje serumskih vrednosti CTX so opazili ob merjenju v vseh časovnih obdobjih.
Talk to a nurse or a doctor straight away if you notice any of the following serious side effectsyou may need urgent medical treatment:
Nemudoma se obrnite na medicinsko sestro ali zdravnika, če opazite katerega koli od spodaj naštetih resnih neželenih učinkov - morda boste potrebovali nujno medicinsko pomoč:
While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Med zdravljenjem morate vzdrževati dobro ustno higieno (vključno z rednim ščetkanjem zob) in opravljati redne zobozdravniške preglede.
• pain in your nerves, damaged nerve root
• bolečine v živcih, poškodbe živčnih korenov;
Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Po tem morajo biti injekcije načrtovane vsake 3 mesece od dneva zadnje injekcije.
Treatment of tumour-induced hypercalcaemia with or without metastases.
zdravljenje tumorsko povzročene hiperkalciemije z metastazami ali brez njih.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
• a family history of osteoporosis
• družinska obremenjenost z osteoporozo.
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• ste predhodno dobivali zdravilo iz skupine difosfonatov (uporabljajo se za zdravljenje ali preprečevanje kostnih bolezni),
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
- Dokazano je bilo zmanjšanje tveganja za vretenčne zlome, učinkovitosti pri zlomih stegneničnega vratu pa niso ugotovili.
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• jemljete zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon),
• itching or tingling skin around your mouth
• srbenje ali ščemenje kože okoli ust;
You should also take calcium and vitamin-D supplements, as recommended by your doctor.
Jemati morate dodatke kalcija in vitamina D, kot vam jih je priporočal zdravnik.
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.
Ibandronska kislina se odstrani iz obtoka s kostno absorpcijo (ocenjeno na 40 do 50 % pri ženskah v postmenopavzi), ostanek pa se izloči skozi ledvice v nespremenjeni obliki.
• asthma attacks
• napadi astme.
These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (please see paragraph “Influenza like illness”).
Ti simptomi so značilno povezani s prvim odmerkom, ponavadi so kratkotrajni, blagi do zmerno močni in ponavadi izginejo z nadaljevanjem zdravljenja brez posegov v samo zdravljenje (glejte odstavek »Bolezen, podobna gripi«).
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg ibandronic acid (154 patients).
Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so prejemale placebo (158 bolnic) ali 6 mg ibandronske kisline (154 bolnic).
No statistically significant difference was attained after 1 year of treatment (p=0.056).
Po 1 letu zdravljenja niso opazili statistično značilne razlike (p = 0,056).
In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘“aminoglycoside”' such as gentamicin.
Še posebej obvestite svojega zdravnika ali farmacevta, če v obliki injekcije prejemate antibiotik iz skupine aminoglikozidov, kot je gentamicin.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Pomembno si je prizadevati, da bi preprečili nastanek osteonekroze čeljustnice, ker gre za stanje, ki lahko boli in ga je težko zdraviti.
Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Ibandronske kisline pri pediatričnih bolnikih niso proučevali, zato za to skupino bolnikov ni na voljo podatkov o učinkovitosti in varnosti.
All patients received 500 mg calcium and 400 IU vitamin D daily.
Vse bolnice so prejemale 500 mg kalcija in 400 i.e. vitamina D na dan.
• tooth problems.
• težave z zobmi.
This reduction in fractures was shown for the spine but not for the hip.
Zmanjšanje zlomov je bilo dokazano za hrbtenico, ne pa za kolke.
Adequate intake of calcium and vitamin D is important in all patients.
Primeren vnos kalcija in vitamina D je pomemben pri vseh bolnikih.
• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• imate kakšne težave v ustih ali z zobmi, kot na primer slabo zdravje zob, bolezen dlesni ali predvideno izdrtje zob,
Ibandronic acid intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Intravenske injekcije ibandronske kisline so zmanjšale vrednosti serumskih C-telopeptidov alfa verige kolagena tipa I (CTX) v 3 do 7 dneh po začetku zdravljenja in vrednosti osteokalcina v 3 mesecih.
• If you have heart problems and the doctor recommended to limit your daily fluid intake.
• če imate težave s srcem in vam je zdravnik priporočil, da omejite dnevni vnos tekočin.
Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Obrnite se na medicinsko sestro ali zdravnika, če simptomi postanejo moteči ali trajajo več kot nekaj dni;
A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Klinično pomembno 50-% zmanjšanje biokemičnih označevalcev kostne resorpcije so opazili že en mesec po začetku zdravljenja z 2,5 mg ibandronske kisline.
Bone resorption due to malignant disease is characterised by excessive bone resorption that is not balanced with appropriate bone formation.
Za resorpcijo kosti zaradi maligne bolezni je značilna čezmerna resorpcija kosti, ki ni uravnotežena z ustrezno gradnjo kosti.
Temporary interruption of ibandronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Razmisliti je treba o začasnem prenehanju zdravljenja z ibandronsko kislino, dokler se to stanje ne razreši in se sovpleteni dejavniki tveganja ublažijo, če je mogoče.
There was no indication of a waning of the effect over time.
Znakov upadanja tega učinka v tem času ni bilo.
Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity.
Živalski modeli potrjujejo, da je ibandronska kislina visoko učinkovit zaviralec osteoklastne aktivnosti.
In a study in 130 patients with metastatic breast cancer the safety of ibandronic acid infused over 1 hour or 15 minutes was compared.
V študiji so pri 130 bolnikih z metastatskim rakom dojke primerjali varnost dajanja infuzije ibandronske kisline v času več kot 1 uro z dajanjem v času 15 minut.
Some patients need to be especially careful when using Ibandronic acid Accord.
Nekateri bolniki morajo biti pri prejemanju zdravila Ibandronska kislina Accord še posebno previdni.
• a condition affecting the blood vessels in your brain called ‘“cerebrovascular disorder”' (stroke or brain bleeding)
• stanje, ki prizadene žile v možganih, imenovano cerebrovaskularna bolezen (kap ali krvavitev iz možganov),
Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI)
Preglednica 3: Rezultati 3-letne študije zlomov MF 4411 (%, 95-% interval zaupanja).
• persistent eye pain and inflammation (if prolonged)
• vztrajna bolečina in vnetje oči (če traja dlje),
If you have raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2 mg or 4 mg, depending on the severity of your illness.
Če imate zvišano koncentracijo kalcija v krvi zaradi tumorja, je priporočeni odmerek 2 mg ali 4 mg v enkratnem odmerku, odvisno od resnosti bolezni.
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo nazadnje revidirano dne {MM/YYYY}
In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
V tej študiji so proučevali ibandronsko kislino v peroralnem odmerku 2,5 mg na dan in 20 mg intermitentno kot raziskovalno odmerjanje.
In subjects with severe renal impairment (mean estimated CLcr=21.2 ml/min), doseadjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Pri ljudeh s hudo ledvično okvaro (ocenjeno povprečje CLcr = 21,2 ml/min) se je povprečna vrednost AUC0-24 glede na odmerek povečala za 110 % v primerjavi z zdravimi prostovoljci.
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na ibandronsko kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Zdravilo Ibandronska kislina Accord uporabljamo pri odraslih in vam ga bodo predpisali, če imate raka dojke, ki se je razširil na kosti (metastaze v kosteh).
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
V prvotni triletni randomizirani, dvojno slepi, s placebom primerjani študiji zlomov (MF 4411) so ugotovili statistično značilno in klinično pomembno zmanjšanje incidence novih zlomov vretenc, določeno radiografsko, morfometrično ali klinično (preglednica 3).
For storage conditions of the diluted medicinal product, see section 6.3.
Za pogoje za stranjevanje razredčenega zdravila glejte poglavje 6.3.
If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Če imate raka dojke, ki se je razširil na kosti, je priporočeni odmerek 6 mg vsake 3-4 tedne, kot vsaj 15-minutna infuzija v veno.
If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.
Če se trenutno zdravite pri zobozdravniku ali imate predviden kirurški poseg v ustni votlini (npr. izdrtje zob), obvestite svojega zdravnika o zobnem zdravljenju, svojemu zobozdravniku pa povejte, da se zdravite z ibandronsko kislino.
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the 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 po menopavzi 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.
• eating a balanced diet rich in calcium and vitamin D
• uravnoteženo prehrano, bogato s kalcijem in vitaminom D,
The incidence of clinical vertebral fractures was also significantly reduced by 49 % after 3 years (p=0.011).
Incidenca kliničnih zlomov vretenc je bila značilno zmanjšana za 49 % (p = 0,011) po 3 letih.
After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.
Po petih letih uporabe zdravila Ibandronska kislina Accord se prosimo posvetujte z zdravnikom glede nadaljevanja jemanja zdravila Ibandronska kislina Accord.
Do not administer the injection to yourself.
Ne dajajte si jih sami.
1 vial (2 mg/2 ml)
1 viala (2 mg/2 ml)
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF 4411).
Varnost peroralnega zdravljenja z 2,5 mg ibandronske kisline na dan so proučevali v 4 s placebom kontroliranih kliničnih študijah pri 1.251 bolnikih; velika večina bolnikov je sodelovala v ključni triletni študiji zlomov (MF 4411).
Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Biokemični označevalci kostne premene (kot so urinarni CTX in serumski osteokalcin) so pokazali pričakovan vzorec supresije do vrednosti pred menopavzo, največjo supresijo pa so dosegli po 3 do 6 mesecih uporabe 2,5 mg ibandronske kisline enkrat na dan.
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
V celotni populaciji bolnikov v študiji MF4411 niso opazili zmanjšanja nevretenčnih zlomov, ugotovili pa so, da je bila ibandronska kislina enkrat na dan učinkovita pri podskupini bolnikov z visokim tveganjem (T-vrednost MKG stegneničnega vratu pod -3,0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69 %.
• a skin growth called a ‘“benign skin neoplasm”'
• rast kože, imenovana benigna neoplazma kože;
As renal function decreases with age, renal function is the only factor to take into consideration (see renal impairment section).
Ker se ledvična funkcija z leti zmanjšuje, je ledvična funkcija edini dejavnik, ki ga je treba upoštevati (glejte odstavek ledvična okvara).
• your body temperature getting too low (hypothermia)
• prenizka telesna temperatura (hipotermija);
In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
V hudih primerih bo morda potrebna intravenska infuzija ustreznih odmerkov kalcijevega glukonata, kalijevega ali natrijevega fosfata in magnezijevega sulfata.
It is supplied as packs containing 1, 5 or 10 vials with 6 ml of concentrate.
Na voljo je v škatlah, v katerih je 1, 5 ali 10 vial s 6 ml koncentrata.
If you use more Ibandronic acid Accord than you should You may develop low levels of calcium, phosphorus or magnesium in the blood.
Če ste vzeli večji odmerek zdravila Ibandronska kislina Accord, kot bi smeli To lahko povzroči nizke koncentracije kalcija, fosforja ali magnezija v krvi.
Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Osteoporoza je bolezen, zaradi katere postanejo kosti tanjše in šibkejše, kar se najpogosteje pojavlja pri ženskah po menopavzi.
Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Previdnost je potrebna pri bolnikih z znano preobčutljivostjo na druge difosfonate.
BATCH NUMBER<, DONATION AND PRODUCT CODES>
ŠTEVILKA SERIJE<,OZNAKE DAROVANJA IN IZDELKOV > Lot
It is supplied as packs containing 1, 5 or 10 vials.
Na voljo je v škatlah, v katerih je 1, 5 ali 10 vial.
• stomach problems such as ‘“gastroenteritis”' or ‘“gastritis”'
• težave z želodcem, kot sta gastroenteritis in gastritis;
They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Vključujejo zmanjšano število vsaditvenih mest, motnje naravnega poroda (distocija) in zvečano število visceralnih sprememb (ledvični pieloureterni sindrom).
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.
Toksične učinke, na primer znake poškodbe ledvic, so opazili pri psih samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p<0.0001).
Močan vpliv na zlome vretenc se je kazal tudi z značilno manjšo izgubo telesne višine v primerjavi s placebom (p < 0,0001).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C unless dilution has taken place in controlled and validated aseptic condition.
V normalnih razmerah naj zdravila ne bi shranjevali dlje kot 24 ur pri 2 °C do 8 °C, razen če je bila razredčitev opravljena v nadzorovanih in validiranih aseptičnih pogojih.
Ibandronic acid 6 mg n=154
Ibandronska kislina 6 mg n = 154
ONJ can also occur after stopping treatment.
Osteonekroza čeljustnice se lahko pojavi tudi po končanju zdravljenja.
The deterioration in Quality of Life was significantly less in ibandronic acid treated patients compared with placebo.
Poslabšanje kakovosti življenja je bilo pri bolnikih, zdravljenih z ibandronsko kislino, v primerjavi s placebom značilno manjše.
= serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
= koncentracija kalcija v serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
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 16550.
Preglednica 2: Povprečna relativna sprememba od izhodiščne vrednosti MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra po enem letu (primarna analiza) in dveh letih zdravljenja (populacija po protokolu) v študiji BM 16550.
Mean relative changes from baseline % [95% CI]
Povprečna relativna sprememba od izhodiščne vrednosti % [95-% interval zaupanja]
Do not take Ibandronic acid Accord if you are pregnant or breast-feeding.
Ne jemljite zdravila Ibandronska kislina Accord, če ste noseči ali dojite.
Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Porast MKG ledvene hrbtenice je po 3 letih v primerjavi s placebom znašal 5,3 %, v primerjavi z izhodiščno vrednostjo pa 6,5 %.
• memory loss
• izguba spomina;
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
preprečevanje z okostjem povezanih dogodkov (patološke frakture; zapleti, pri katerih je potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in metastazami v kosteh;
• if you are allergic to any other bisphosphonates.
• če ste alergični (preobčutljivi) na druge difosfonate,
Also, some other medicines can affect the way Ibandronic acid Accord works.
Prav tako lahko druga zdravila vplivajo na delovanje zdravila Ibandronska kislina Accord.
In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Poleg tega je bilo 64,8 % bolnikov, ki so prejemali 3-mg injekcijo vsake 3 mesece, odzivnih (odzivnost so definirali kot ≥ 50-% zmanjšanje od izhodišča) v primerjavi s 64,9 % bolnikov, ki so prejemali 2,5 mg na dan peroralno.
• if you have kidney problems.
• če imate težave z ledvicami,
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 dnevnega in tudi 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.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Accord Healthcare S.L.U.
• a high level of alkaline phosphatase in your blood
• visoka koncentracija alkalne fosfataze v krvi;
Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Klinične študije hiperkalciemije zaradi malignosti so pokazale, da je za zaviralni učinek ibandronske kisline na tumorsko povzročeno osteolizo in še posebno na hiperkalciemijo, povzročeno s tumorjem, značilno znižanje serumskega kalcija in zmanjšano izločanje kalcija z urinom.
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Načrt vodenja bolnikov, ki se jim pojavi osteonekroza čeljustnice, je treba oblikovati na podlagi tesnega sodelovanja med lečečim zdravnikom in zobozdravnikom ali ustnim kirurgom, ki ima izkušnje z osteonekrozo čeljustnice.
A tabular summary of these secondary efficacy results is presented in Table 3.
Preglednica 3 nudi tabelaričen pregled sekundarnih rezultatov učinkovitosti.
Mutagenicity/Carcinogenicity:
Mutagenost/kancerogenost:
Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh z ibandronsko kislino 6 mg, dano intravensko, so raziskovali v randomiziranem s placebom kontroliranem preskušanju faze III, ki je potekala 96 tednov.
The following risk factors should be considered when evaluating a patient's risk of developing ONJ: Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy
Pri ocenjevanju bolnikovega tveganja za nastanek osteonekroze čeljustnice je treba upoštevati naslednje dejavnike tveganja: moč zdravila, ki zavira resorpcijo kosti (tveganje je večje z zelo močnimi spojinami), pot uporabe (tveganje je večje v primeru parenteralne uporabe) in kumulativni odmerek zdravila, uporabljenega za zdravljenje resorpcije kosti,
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na ibandronsko kislino ali katerokoli drugo sestavino tega zdravila, navedeno v poglavju 6
PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless solution.
FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina.
• sleep problems, feeling anxious, emotional instability, or mood swings
• težave s spanjem, občutek zaskrbljenosti, čustvena nestabilnost ali menjava razpoloženja;