natgillin/translations-raw huggingface dataset:
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
"trombotična trombocitopenična purpura" ili "TTP") sa simptomima koji uključuju vrućicu i potkožne modrice koje se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (vidjeti dio 4. "Moguće nuspojave").
If you experience prolonged bleeding when taking Clopidogrel HCS
Ako pri uzimanju lijeka Klopidogrel HCS imate produljeno krvarenje
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Broj bolesnika koji su doživjeli primarni ishod [kardiovaskularna smrt, infarkt miokarda ili moždani udar] bio je 582 (9,3%) u skupini koja je primala klopidogrel i 719 (11,4%) u skupini koja je primala placebo, uz 20%-tno smanjenje relativnog rizika (95% CI od 10% do 28%; p=0,00009) u skupini koja se liječila klopidogrelom (17% smanjenje relativnoga rizika u bolesnika koji su liječeni konzervativno,
As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4).
Stoga se zbog opreza, ne preporučuje istodobna primjena s omeprazolom ili esomeprazolom (vidjeti dio 4.4).
This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Na taj učinak najviše je utjecalo statistički značajno smanjenje incidencije infarkta miokarda [287 (4,6%) u skupini koja je primala klopidogrel i
Plavix 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg.
U bolesnika s fibrilacijom atrija, klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
- carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
- moklobemid, lijek za liječenje depresije, - repaglinid, lijek za liječenje dijabetesa, - paklitaksel, lijek za liječenje raka.
Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelklorida ).
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU
As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Zbog opreza, ne preporučuje se istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori CYP2C19 (vidjeti dio 4.4. i 5.2.).
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Stoga se ne može se isključiti izravni (slaba toksičnost) ili neizravni (loš okus) učinak.
• if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
- medicinskih stanja kod kojih postoji opasnost od unutrašnjeg krvarenja (kao što je čir želuca),
(listed in section 6).
(vidjeti dio 4.8).
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Kod bolesnika treba procijeniti prethodnu preosjetljivost na tienopiridine u povijesti bolesti (kao što su klopidogrel, tiklopidin, prasugrel) budući da je zabilježena ukrižena reaktivnost među tienopiridinima
- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
- oticanje u ustima ili kožne poremećaje kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
How to store Clopidogrel HCS
Kako čuvati Klopidogrel HCS
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
(najprije udarnu dozu od 300 mg, a nakon toga dozu od 75 mg na dan, n=1752) ili placebo (n=1739), oboje u kombinaciji s ASK (150 do 325 mg kao udarna doza nakon čega je slijedila doza od 75 do
Glomerulonephritis, blood creatinine increased
granulocitopenija, anemija
Clopidogrel HCS 75 mg film-coated tablets clopidogrel
Klopidogrel HCS 75 mg filmom obložene tablete klopidogrel
• Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil.
Drugi sastojci su (vidjeti dio 2. "Klopidogrel HCS sadrži hidrogenirano ricinusovo ulje"): Jezgra tablete: mikrokristalična celuloza, koloidni, bezvodni silicijev dioksid, krospovidon (tip A), makrogol 6000 i hidrogenirano ricinusovo ulje.
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
kolitis (uključujući ulcerozni ili limfocitni kolitis), stomatitis
What Plavix contains
HCS sadrži
A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
umjereni i slabi), procijenjen je farmakokinetički i antitrombocitni odgovor primjenom doze od 300 mg, nakon čega je slijedila doza od 75 mg/dan te primjenom doze od 600 mg, nakon čega je uslijedila doza od 150 mg/dan, u trajanju od ukupno 5 dana (stanje dinamičke ravnoteže).
Clopidogrel HCS 75 mg film-coated tablets
Klopidogrel HCS 75 mg filmom obložene tablete
It is preferable not to take this product during pregnancy.
Ne preporučuje se uzimanje lijeka Klopidogrel HCS za vrijeme trudnoće.
Vascular disorders
bulozni dermatitis
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
75 mg na dan, iznosi između 40% i 60%.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Plavix in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Klopidogrel HCS u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain.
Nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka):
Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
(kombinirani ishod infarkta miokarda, ishemijskog moždanog udara i vaskularne smrti).
ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
ASK nije promijenila klopidogrelom posredovanu inhibiciju agregacije trombocita koju inducira ADP,
Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
nakon 3 mjeseca, zabilježena korist liječenja kombinacijom klopidogrela + ASK nije dalje povećavala,
Atrial fibrillation
Prevencija aterotrombotičkih i tromboembolijskih događaja kod fibrilacije atrija
These may be due to rare decrease of some blood cells.
- vrućicu, znakove infekcije ili izrazitog umora; ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica;
Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Poremećaji probavnog sustava gastrointestinalno krvarenje, proljev, bol u trbuhu, dispepsija ulkus želuca i dvanaesnika, gastritis,
EU/1/10/651/013 Cartons of 84x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/013 Kutije sa 84x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
EU/1/10/651/014 Cartons of 90x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/014 Kutije sa 90x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jediniče doze
EU/1/10/651/012 Cartons of 56x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/012 Kutije sa 56x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
Acute liver failure, hepatitis, abnormal liver function test
hepatitis, poremećene vrijednosti jetrenih enzima
EU/1/10/651/011 Cartons of 50x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/011 Kutije sa 50x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix:
Ako se na Vas odnosi bilo koje od stanja navedenih u daljnjem tekstu, morate obavijestiti liječnika prije nego što uzmete Klopidogrel HCS:
Acquired haemophilia has been reported following use of clopidogrel.
Stečena hemofilija Nakon primjene klopidogrela prijavljena je stečena hemofilija.
EU/1/98/069/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/069/012 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
EU/1/10/651/009 Kutije sa 28x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze (kalendarsko pakovanje) EU/1/10/651/010 Kutije sa 30x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
EU/1/10/651/015 Cartons of 100x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/015 Kutije sa 100x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 3488
Pliva Hrvatska d.o.o. Tel:+ 385 1 37 20 000
MI before coronary angiography.
Coronary Artery Bypass Graft).
Reproductive systems and breast disorders
Poremećaji reproduktivnog sustava i dojki ginekomastija
Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
konstipacija, flatulencija retroperitonealno krvarenje gastrointestinalno i retroperitonealno krvarenje s fatalnim ishodom, pankreatitis,
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
U odraslih bolesnika s fibrilacijom atrija koji imaju najmanje jedan faktor rizika za krvožilne događaje,
SSRIs: since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Selektivni inhibitori ponovne pohrane serotonina (SSRI) Budući da lijekovi iz skupine SSRI utječu na aktivaciju trombocita i povećavaju rizik od krvarenja,
INSTRUCTIONS ON USE
Način primjene
The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
COMMIT ispitivanje faktorskog dizajna 2x2, uključivalo je 45 852 bolesnika koji su unutar posljednja
NMS can cause death.
MNS može uzrokovati smrt.
Hold Breath.
Zadrži dah.
No significant inhibition was observed.
Nije opažena značajna inhibicija.
• recreational (illegal) drugs
• rekreacijske (ilegalne) droge
• are an older person with dementia (loss of memory and other mental abilities).
• ste osoba starije dobi s demencijom (gubitak pamćenja i drugih mentalnih sposobnosti).
The device exterior may become warm during use.
Vanjski dijelovi uređaja se mogu zagrijati za vrijeme upotrebe.
For the main results, see the table below.
Za glavne rezultate, vidjeti donju tablicu.
The treatment of overdosage is essentially symptomatic and supportive.
Liječenje predoziranja je u osnovi simptomatsko i suportivno.
08028- Barcelona España
08028- Barcelona
• Mention of contra-indications and related warnings
• Navode o kontraindikacijama i povezanim upozorenjima
Treatment N
Liječenje N
Additional measures include oxygen and intravenous fluids.
Dodatne mjere uključuju kisik i intravenske tekućine.
Always use this medicine exactly as your doctor or nurse has told you.
Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili medicinska sestra.
Do not use ADASUVE again if NMS occurs.
Nemojte ponovno uzimati ADASUVE ako se pojavi MNS.
• have or had low or high blood pressure
• imate ili ste imali visok ili nizak krvni tlak
Very common: sedation/somnolence
Vrlo često: sedacija/somnolencija
Common: dry mouth
Često: suha usta
• medicines to treat Parkinson's disease
• lijekove za liječenje Parkinsonove bolesti
Tell your doctor if you are using or have recently used or might use any other medicines, including:
Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući:
Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.
Ocjena populacijskih podskupina (dob, rasa i spol) nije ukazala na bilo kakve razlike u odgovoru temeljene na ovim podskupinama.
Other medicines and ADASUVE
Drugi lijekovi i ADASUVE
Key elements to be included in the educational materials:
Ključni elementi koji se moraju uključiti u edukacijski materijal: Općenito:
These symptoms can temporally worsen or can even arise after discontinuation of treatment.
Ti se simptomi mogu pogoršati ili čak pojaviti nakon prekida liječenja.
Such medicinal products may modify efficacy and safety of ADASUVE in an irregular manner.
Takvi lijekovi mogu izmijeniti djelotvornost i sigurnost lijeka ADASUVE na nepravilan način.
Instruct the patient to:
Dajte bolesniku upute da:
Demographics
Demografija
Higher doses of lorazepam have not been studied.
Veće doze lorazepama nisu proučavane.
Also talk to your doctor if you have any of the following side effects that could also happen with other forms of this medicine:
Također se obratite svom liječniku ako imate bilo koju od ovih nuspojava koje se isto tako mogu pojaviti s drugim oblicima ovog lijeka:
Patients should receive regular treatment immediately after control of acute agitation symptoms.
Bolesnici bi trebali primiti redovito liječenje odmah nakon kontrole akutnih simptoma agitacije.
• worsening agitation or confusion, especially combined with fever or muscle stiffness (rare occurrence).
• pogoršanje uznemirenosti ili zbunjenost, naročito u kombinaciji s vrućicom ili ukočenošću mišića (rijetka pojava).
No more than two doses should be administered.
Ne smiju se dati više od dvije doze.
No dosage adjustment is recommended based on smoking status.
Ne preporučuje se prilagođavanje doze na osnovu pušačkog statusa.
People with this condition may also feel depressed, guilty, anxious or tense.
Osobe u takvim stanjima također mogu biti depresivne, imati osjećaj krivnje, tjeskobe ili napetosti.
Pharmacotherapeutic group: psycholeptics, antipsychotics; ATC code: N05AH01
Farmakoterapijska skupina: psiholeptici, antipsihotici; ATK oznaka: N05AH01
Risk of bronchospasm:
Rizik od bronhospazma:
In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance.
Kod slučajnog predoziranja, znakovi i simptomi će ovisiti o broju primljenih jedinica kao i o individualnoj toleranciji bolesnika.
ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
ADASUVE se može uzimati u trudnoći samo ako potencijalna korist uzimanja opravdava potencijalni rizik po plod.
Intoxication or physical disease (delirium)
Intoksikacija ili fizička bolest (delirij)
• The indicator light automatically turns off again when the medicine is inhaled.
• Svjetlo indikatora se automatski ponovno gasi kad se lijek udahne.
The medicinal product has been delivered when the green light turns off.
Lijek je isporučen kad se ugasi zeleno svjetlo.
• Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE.
• Maligni neuroleptički sindrom (MNS) je skup simptoma koji se mogu pojaviti ako uzimate antipsihotičke lijekove, uključujući i ADASUVE.
Inclusion in Study 004-301 required a diagnosis of schizophrenia.
Uključenje u Ispitivanje 004-301 je zahtijevalo dijagnozu shizofrenije.
• if you are allergic to loxapine or amoxapine;
• ako ste alergični na loksapin ili amoksapin;
The adverse reactions listed below are categorized using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Dolje navedene nuspojave su kategorizirane prema sljedećim pravilima: Vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko
You will use ADASUVE under the supervision of a doctor or nurse.
Upotrijebit ćete ADASUVE pod nadzorom liječnika ili medicinske sestre.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja će dogovoriti program edukacije zajedno s nadležnim nacionalnim tijelom.
White device with a mouthpiece on one end and a pull-tab protruding from the other end.
Bijeli uređaj s nastavkom za usta na jednom kraju i trakicom za povlačenje na drugom.
Not all pack-sized may be marketed.
Na tržištu se ne moraju nalaziti sve veličine pakiranja.
If you use more ADASUVE than you should
Ako uzmete više ADASUVE nego što ste trebali
These are diseases characterised by symptoms such as:
Te bolesti karakteriziraju sljedeći simptomi:
It is known that in humans, long-term treatment with antipsychotics may lead to loss of libido and amenorrhoea.
Poznato je da dugotrajno liječenje kod ljudi može uzrokovati gubitak libida i amenoreju.
Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited.
Prema tome, rizik metaboličkih interakcija uzrokovanih djelovanjem pojedinih izoformi je ograničen.
Date of first authorisation: 20 February 2013 Date of latest renewal:
Datum prvog odobrenja: 20. veljače 2013.
Do not use ADASUVE
Nemojte uzimati ADASUVE
Do not open pouch until ready to use.
Ne otvarajte vrećicu dok niste spremni za primjenu lijeka.
Very common: dysgeusia
Vrlo često: disgeuzija
PEC Change
PEC promjena
In female rats, reproductive effects have been observed (see section 5.3).
Kod ženki štakora je opažen utjecaj na reprodukciju (vidjeti dio 5.3).
Similar changes, e.g., gynecomastia, are known in humans, but only after long-term administration of medicines causing hyperprolactinaemia.
Slične promjene (npr. ginekomastija) su poznate kod ljudi, ali samo nakon dugotrajne primjene lijekova koji uzrokuju hiperprolaktinemiju.
• When ADASUVE is removed from the pouch, the indicator light is off.
• Kad se ADASUVE izvadi iz vrećice, svjetlo indikatora je ugašeno.
Neuroleptic malignant syndrome (NMS)
Maligni neuroleptički sindrom (MNS)
• Observation of patients for 1 hour after each dose of ADASUVE
• Zapažanja o bolesnicima 1 sat nakon davanja svake doze lijeka ADASUVE
Use within 15 minutes after removing the tab (or until the green light turns off) to prevent automatic deactivation of the inhaler.
Upotrijebite u roku od 15 minuta nakon uklanjanja trakice (ili dok se ne ugasi zeleno svjetlo) kako biste spriječili automatsku deaktivaciju inhalatora.
Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors, and its interaction with these systems may influence the spectrum of its pharmacological effects.
Loksapin se veže na noradrenergičke, histaminergičke i kolinergičke receptore i njegove interakcije s ovim sustavima mogu utjecati na široki spektar njegovih farmakoloških učinaka.
The terminal elimination half-life (T½) ranged from 6 to 8 hours.
Konačno vrijeme poluživota eliminacije (T½) iznosilo je između 6 i 8 sati.
Loxapine excretion occurs mainly in the first 24 hours.
Loksapin se u najvećoj mjeri izlučuje tijekom prva 24 sata.
• Addtional risk minimisation measures
• Dodatne mjere minimizacije rizika
• adrenaline
• adrenalin
The inhaler is then ready for use.
Inhalator je tada spreman za upotrebu.
Healthcare professionals should ensure the patient will use the inhaler properly.
Zdravstveni radnici trebaju osigurati da bolesnik ispravno koristi inhalator.
Before treatment with ADASUVE, tell your doctor or nurse if you:
Prije liječenja lijekom ADASUVE, obratite se svom liječniku ili medicinskoj sestri ako:
• have or had urinary retention (incomplete emptying of the bladder)
• imate ili ste imali urinarnu retenciju (nepotpuno pražnjenje mokraćnog mjehura)
Rescue medication (intramuscular lorazepam) was given if medically required.
Simptomatski lijek (lorazepam intramuskularno) je primijenjen po potrebi.
About 35% of the patients with schizophrenia were taking concomitant antipsychotics at the time of dosing while approximately 13% of the patients with bipolar disorder were taking these drugs.
Oko 35% bolesnika oboljelih od shizofrenije su istodobno uzimali antipsihotike u vrijeme uzimanja lijeka, dok je otprilike 13% bolesnika oboljelih od bipolarnog poremećaja uzimalo ove lijekove.
• (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
• (Shizofrenija) Osluškivanje, viđenje ili osjećanje stvari koje se stvarno ne događaju, sumnjičavost, pogrešne predodžbe, nepovezan govor i ponašanje i emocionalna ravnodušnost.
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:
Nositelj odobrenja će osigurati da, nakon rasprave i dogovora s nadležnim nacionalnim tijelom u svakoj državi članici gdje se ADASUVE stavlja u promet, za vrijeme stavljanje lijeka u promet i nakon toga, svi zdravstveni djelatnici za koje se očekuje da će koristiti ADASUVE, dobiju informativni paket koji sadrži sljedeće:
Pharmacokinetics in special patient populations
Farmakokinetika kod posebnih populacije bolesnika
• if you have symptoms of wheezing or shortness of breath;
• ako imate simptome piskanja ili nedostatka zraka;