natgillin/translations-raw huggingface dataset:
No oral antipsychotic supplementation was allowed.
Dodajanje peroralnih antipsihotikov ni bilo dovoljeno.
Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 2025 °C.
Suspenzija je kemijsko in fizikalno stabilna v viali 24 ur pri 20-25 °C.
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
NAVODILA ZA ZDRAVSTVENO OSEBJE
In a study of oral olanzapine given to Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
V študiji peroralnega olanzapina, ki so ga dali belcem, Japoncem in Kitajcem ni bilo razlik v farmakokinetičnih parametrih med temi tremi populacijami.
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPADHERA and regularly during treatment.
Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila ZYPADHERA in redno tekom zdravljenja.
Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Potrebna je posebna previdnost glede uporabe ustrezne tehnike injiciranja v izogib nenamernega intravaskularnega ali subkutanega injiciranja (glejte poglavje 6.6).
Final volume to inject (ml)
Končni volumen za injiciranje (ml)
If you are already taking antidepressants, medicines for anxiety or to help you sleep (tranquillisers), you may feel drowsy if ZYPADHERA is given.
Če že jemljete antidepresive, zdravila proti anksioznosti ali zdravila, ki vam pomagajo spati (pomirjevala), se boste po dajanju zdravila ZYPADHERA morda počutili zaspane.
Fertility Effects on fertility are unknown (see section 5.3 for preclinical information)
Plodnost Učinki na plodnost niso znani (glejte poglavje 5.3 za predklinične podatke).
Reactions occurred rarely (<1 in 1,000 injections) between 1 and 3 hours, and very rarely (<1 in 10,000 injections) after 3 hours.
Učinki so se redko pojavili (< 1 od 1.000 injiciranj) med 1 in 3 urami in zelo redko (< 1 od 10.000 injiciranj) po 3 urah.
− Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines
Podpirati pomen ustreznega spremljanja presnove z razdeljevanjem koristnih, objavljenih antipsihotičnih smernic.
Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Klorovodikova kislina (za prilagoditev pH) Natrijev hidroksid (za prilagoditev pH)
The vial is for single use only.
Viala je samo za enkratno uporabo.
These results support efficacy for ZYPADHERA over 8 weeks of treatment and a drug effect that was observed as early as 1 week after starting treatment with ZYPADHERA.
Ti rezultati podpirajo učinkovitost zdravila ZYPADHERA preko 8 tednov zdravljenja in učinkovitost zdravila, ki so ga opazili že 1 teden po začetku zdravljenja z zdravilom ZYPADHERA.
2) Recommendations for monitoring of patients for glucose, lipids, and weight
2) Priporočila za spremljanje bolnikov glede glukoze, lipidov in telesne mase.
ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Zdravila ZYPADHERA niso sistemsko preučevali pri starejših bolnikih (> 65 let).
As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.
Kot običajen previdnostni ukrep vam lahko vaš zdravnik nadzoruje krvni tlak, če ste stari več kot 65 let.
Oral olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Olanzapin so uporabljali kot prilagodljiv odmerek, ki so ga začeli z 2,5 mg in zviševali do 20 mg/dan.
Discard the vials, syringe, used needles, extra needle and any unused solvent in accordance with appropriate clinical procedures.
Zavrzite viale, injekcijsko brizgo, uporabljene igle, dodatno iglo in kakršenkoli neuporabljen vehikel v skladu z ustreznimi kliničnimi postopki.
Withdraw the pre-determined solvent volume (Step 2) into the syringe.
Izvlecite predhodno določen volumen vehikla (Korak 2) v injekcijsko brizgo.
• been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
• če so vam v preteklosti ugotovili težave z očmi, kot je določena vrsta glavkoma (povišan tlak v očesu).
Vial of suspension after reconstitution: 24 hours.
Viala s suspenzijo po rekonstituciji: 24 ur.
Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Olanzapin ni bil mutagen ali klastogen v širokem razponu standardnih testov, ki je vključeval teste mutiranja bakterij ter in vitro in in vivo teste na sesalcih.
In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
Withdraw air to equalize the pressure in the vial.
Za izenačitev tlaka v viali spustite zrak.
The most commonly reported injection site related adverse reaction was pain.
Najpogosteje poročani neželeni učinek na mestu injiciranja je bila bolečina.
The plasma protein binding of olanzapine is about 93% over the concentration range of 7 to about 1000 ng/mL.
Vezava olanzapina na plazemske beljakovine je bila okoli 93 % v razponu koncentracij od približno 7 do približno 1000 ng/ml.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu
As olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Ker olanzapin lahko povzroči zaspanost in omotičnost, je treba bolnike opozoriti na previdnost glede upravljanja s stroji, vključno z motornimi vozili.
Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Zelo redki neželeni učinki vključujejo resne alergijske reakcije, kot je npr. reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).
Similar pharmacokinetic differences between males and females and smokers and non-smokers were observed in ZYPADHERA clinical trials.
Podobno so opazovali farmakokinetične razlike med moškimi in ženskimi ter kadilci in nekadilci pri kliničnih preskušanjih z zdravilom ZYPADHERA.
• The use of ZYPADHERA in elderly patients with dementia (confusion and memory loss) is not recommended as it may have serious side effects.
• Uporaba zdravila ZYPADHERA ni priporočljiva pri starejših bolnikih z demenco (zmedenost in izguba spomina), saj lahko povzroči resne neželene učinke.
However, systemic concentrations in these studies were generally less than that seen at effect levels in the oral studies; thus the information on oral olanzapine is provided below for reference.
Vendar so bile sistemske koncentracije v teh študijah na splošno nižje kot tiste, ki so jih opazili na nivojih učinkovanja pri peroralnih študijah; zato kot referenco spodaj navajamo podatke za peroralni olanzapin.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
Ob navzočnosti več kot enega dejavnika, ki bi lahko prispeval k počasnejši presnovi (ženski spol, starostnik, nekadilec), je treba pretehtati znižanje odmerka.
Three Hypodermic safety needles.
Tri podkožne varnostne igle.
In a review of safety data from clinical trials and spontaneous postmarketing reports, injection site abscess was rarely (≥ 1/10,000 to < 1/1,000) reported.
Pri pregledu podatkov o varnosti iz kliničnih študij in spontanih poročil v obdobju trženja so o abcesu na mestu injiciranja poročali redko (≥ 1/10.000 do < 1/1.000).
Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
ZYPADHERA ostane v viali stabilno še do 24 ur.
Plasma concentrations remain measurable for several months after each ZYPADHERA injection.
Plazemske koncentracije ostanejo merljive še nekaj mesecev po vsakem injiciranju zdravila ZYPADHERA.
16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
16 O zvišanih plazemskih koncentracijah prolaktina so poročali pri 47,4 % mladostnikov.
After reconstitution in the vial: 24 hours.
Po rekonstituciji viale: 24 ur.
• Parkinson's disease
• Parkinsonova bolezen
Only remove the device with the engaged needle from the syringe when required by a specific medical procedure.
Z injekcijske brizge odstranite pripomoček z nameščeno iglo samo, ko je to zahtevano po določenem zdravstvenem postopku.
Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Bolnike je potrebno opozoriti glede tega možnega tveganja in jih je potrebno po vsakem dajanju zdravila ZYPADHERA 3 ure opazovati v zdravstvenih ustanovah.
If this happens, you may have the symptoms listed below after your injection.
Če se to zgodi, imate lahko po injiciranju simptome, ki so navedeni spodaj.
• carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
• karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo potrebno spremeniti vaš odmerek zdravila ZYPADHERA.
After each injection you will be observed in your healthcare facility for at least 3 hours for the symptoms listed above.
Po vsakem injiciranju vas bodo v vaši zdravstveni ustanovi najmanj 3 ure opazovali za pojav simptomov, naštetih zgoraj.
If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately.
Če se vam to zgodi potem, ko ste prejeli zdravilo ZYPADHERA, nemudoma povejte svojemu zdravniku ali medicinski sestri.
Tap the vial firmly and repeatedly on a hard surface until no powder is visible.
Vialo dobro stresite ob trdo površino in ponavljajte, dokler ni vidnega nič praška.
You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
Ko dojite, injekcij ne smete dobivati, ker lahko majhne količine olanzapina prehajajo v materino mleko.
In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Pri psih z izraženo citopenijo ni bilo neželenih učinkov na progenitorne in proliferirajoče celice v kostnem mozgu.
Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term oral olanzapine studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Nadzorovani podatki o učinkovitosti pri mladostnikih (starih 13 do 17 let) so omejeni na kratkoročne študije peroralnega olanzapina pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Tik pred odhodom iz zdravstvene ustanove mora biti potrjeno, da je bolnik buden, orientiran in da nima znakov in simptomov prevelikega odmerjanja.
Fatal outcomes have been reported for acute oral overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Poročali so o smrtnih izidih pri akutnih peroralnih prevelikih odmerjanjih tako nizkih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
Inject the solvent volume into the powder vial.
Injicirajte volumen vehikla v vialo s praškom.
The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10).
Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Prilagoditev odmerka Bolnike je v prvem enem do dveh mesecih zdravljenja potrebno skrbno spremljati za znake relapsa.
Increased total bilirubin
celokupni bilirubin
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of patients.
Dolgoročno zdravljenje z olanzapinom (do 12 mesecev) za preprečevanje ponovnega pojava bolezni pri bolnikih z bipolarno motnjo je bilo povezano s povečanjem telesne mase za ≥ 7 % z osnove pri 39,9 %
A lower starting dose (150 mg/4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant.
Nižji začetni odmerek (150 mg/4 tedne) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki.
In a study of oral olanzapine in breast-feeding, healthy women, olanzapine was excreted in breast milk.
V študiji peroralnega olanzapina pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
If any blood is drawn into the syringe, discard the syringe and the dose and begin reconstitution and administration procedure again.
Če v injekcijsko brizgo potegnete kakršnokoli količino krvi, injekcijsko brizgo in odmerek zavrzite ter ponovno začnite z rekonstitucijo in postopkom dajanja.
Preclinical safety studies were performed using olanzapine pamoate monohydrate.
Predklinične študije o varnosti so opravili z uporabo olanzapinijevega pamoat monohidrata.
If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day.
Če je peroralni olanzapin klinično indiciran, kombiniran celokupni odmerek olanzapina iz obeh oblik ne sme preseči ustreznega najvišjega odmerka peroralnega olanzapina 20 mg/dan.
• difficulty talking
• težave pri govoru
(Fig. 1 and 2) 8.
(Sliki 1 in 2)
No new toxic effect resulting from systemic exposure to olanzapine could be identified.
Niso mogli ugotoviti nobenega novega toksičnega učinka, kot posledico sistemske izpostavitve olanzapinu.
In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
V kliničnih preskušanjih z olanzapin praškom za raztopino za injiciranje ali z zdravilom ZYPADHERA, olanzapin ni bil povezan z nenehnim podaljševanjem absolutnega QT ali QTc intervalov.
All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Vsi bolniki, ki so prejemali peroralni olanzapin ali placebo in so doživeli cerebrovaskularni dogodek, so imeli prej obstoječe dejavnike tveganja.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α-1 adrenergic; and histamine H1 receptors.
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev M1-M5; adrenergičnih α1; in histaminskih H1 receptorjev.
A lower starting dose (150 mg every 4 weeks) should be considered for such patients.
Pri teh bolnikih je treba upoštevati nižji začetni odmerek (150 mg vsake 4 tedne).
The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Varnost in učinkovitost zdravila ZYPADHERA pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) jih je 89,4 % pridobilo ≥ 7 %, 55,3 % ≥ 15 % in 29,1 % ≥ 25% od njihove osnovne telesne mase.
• Two 19-gauge, 50 mm Hypodermic safety needles
• Dve 19-gauge, 50 mm podkožni varnostni igli
During treatment with oral olanzapine, adolescents gained significantly more weight compared with adults.
Med zdravljenjem z olanzapinom so mladostniki povečali signifikantno več telesne mase v primerjavi z odraslimi.
Remove the needle, holding the vial upright to prevent any loss of solvent.
Odstranite iglo in medtem držite vialo pokončno, da preprečite kakršnokoli izgubo vehikla.
In plasma, olanzapine is bound to albumin and α1-acid glycoprotein.
V plazmi se olanzapin veže predvsem na albumin in α1-kisli glikoprotein.
If parenteral benzodiazepines are essential for management of post injection adverse reactions, careful evaluation of clinical status for excessive sedation and cardiorespiratory depression is recommended (see section 4.5).
Če so parenteralni benzodiazepini nujni za uravnavanje neželenih reakcij po injiciranju, je priporočeno skrbno ovrednotiti klinično stanje pretirane sedacije in kardiorespiratorne depresije (glejte poglavje 4.5).
If this happens, contact your doctor or nurse immediately.
Če se to zgodi, nemudoma pokličite vašega zdravnika ali medicinsko sestro.
ZYPADHERA is not recommended to be started if you are over 75 years.
Uvajanje zdravila ZYPADHERA ni priporočljivo, če ste stari več kot 75 let.
When indicated, dose escalation should be performed with caution in these patients.
Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno.
SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze.
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte v hladilniku in ne zamrzujte.
No information on the use of ZYPADHERA in patients >75 years is available.
Na voljo ni podatkov o uporabi zdravila ZYPADHERA pri bolnikih starejših > 75 let.
These signs and symptoms can sometimes occur as a result of ZYPADHERA entering the bloodstream too quickly (a common side effect that may affect up to1 in10 people);
Ti znaki in simptomi se lahko občasno pojavijo kot posledica prehitrega prehajanja zdravila ZYPADHERA v krvni obtok (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10 bolnikov)
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
V času antipsihotičnega zdravljenja lahko traja nekaj dni do nekaj tednov, da pride do izboljšanja kliničnega stanja bolnika.
Patients who have been given too much olanzapine have also experienced the following symptoms:
Bolniki, ki so prejeli preveč olanzapina, kot bi smeli, so imeli naslednje simptome:
A total of 1469 patients with schizophrenia were included in 2 pivotal trials:
V 2 vodilnih preskušanjih je bilo vključenih skupaj 1469 bolnikov s shizofrenijo:
If you are given more ZYPADHERA than needed This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.
To zdravilo boste prejeli pod zdravniškim nadzorom in je zato malo verjetno, da ga boste prejeli preveč.
An education program to the health care professionals (HCP) (doctors-nurses-pharmacist) shall address,
• Dodatni ukrepi za zmanjševanje tveganj Izobraževalni program za zdravstveno osebje (zdravnike-medicinske sestre-farmacevte) bo obsegal,
• rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
• hitro bitje srca, vznemirjenost/nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Among all ZYPADHERA treated patients, sedation was reported by 4.7% of patients.
ZYPADHERA, so o sedaciji poročali pri 4,7 % bolnikov.
DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).
Sindrom DRESS se sprva kaže kot gripi podobni simptomi z izpuščajem na obrazu, nato pa z razširjenim izpuščajem, visoko telesno temperaturo, povečanimi bezgavkami, povišanimi ravnmi jetrnih encimov na izvidih krvnih testov in s povišanjem vrste belih krvničk (eozinofilija).
ZYPADHERA comes as a powder which your doctor or nurse will make into a suspension that will then be injected into the muscle in your buttock.
Zdravilo ZYPADHERA je na voljo kot prašek, ki ga bosta vaš zdravnik ali medicinska sestra pripravila kot suspenzijo, ki bo injicirana v mišico vaše zadnjice.
If signs and symptoms of overdose consistent with post injection syndrome are observed, appropriate supportive measures should be taken (see section 4.4).
Če so opaženi znaki in simptomi značilni za sindrom po injiciranju, je potrebno izvesti ustrezne podporne ukrepe (glejte poglavje 4.4).
Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom ZYPADHERA, moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Citokroma P450-CYP1A2 in P450-CYP2D6 prispevata k tvorbi N-demetilnih in 2-hidroksimetilnih metabolitov, oboji so v študijah na živalih pokazali pomembno manj farmakološke aktivnosti in vivo kot olanzapin.
In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
Pri bolnikih s Parkinsonovo boleznijo lahko peroralna oblika olanzapina poslabša simptome.
Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Olanzapin ni priporočljiv za uporabo pri bolnikih s psihozo, povezano z demenco, in/ali vedenjskimi motnjami zaradi povečane umrljivosti in tveganja za cerebrovaskularne dogodke.
Attach a syringe (if not already attached) to the Luer connection of the device with an easy twisting motion.
Pritrdite injekcijsko brizgo (če še ni pritrjena) na Luerjev spoj pripomočka z enostavnim zasukom.
• muscle stiffness or shaking
• okorelost mišic ali tresenje
The half-life of olanzapine after ZYPADHERA is 30 days compared to 30 hours following oral administration.
Razpolovni čas olanzapina po zdravilu ZYPADHERA je 30 dni v primerjavi s 30 urami po peroralnem dajanju.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 210 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 210 mg
Children and adolescents ZYPADHERA is not for patients who are under 18 years.
Otroci in mladostniki Zdravilo ZYPADHERA ni namenjeno bolnikom, mlajšim od 18 let.
STEP 3: Reconstituting ZYPADHERA 1.
KORAK 3: Rekonstitucija zdravila ZYPADHERA 1.
Loosen the powder by lightly tapping the vial.
Prašek zrahljajte z rahlim stresanjem viale.
Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Zelo pogosti: Povečanje telesne mase13, zvišane ravni trigliceridov14, povečan apetit