natgillin/translations-raw huggingface dataset:
EU/1/10/651/001 28 film-coated tablets EU/1/10/651/002 30 film-coated tablets EU/1/10/651/003 50 film-coated tablets EU/1/10/651/004 56 film-coated tablets EU/1/10/651/005 84 film-coated tablets EU/1/10/651/006 90 film-coated tablets EU/1/10/651/007 100 film-coated tablets EU/1/10/651/008 28x1 film-coated tablets EU/1/10/651/009 28x1 film-coated tablets (calendar pack) EU/1/10/651/010 30x1 film-coated tablets EU/1/10/651/011 50x1 film-coated tablets EU/1/10/651/012 56x1 film-coated tablets EU/1/10/651/013 84x1 film-coated tablets EU/1/10/651/014 90x1 film-coated tablets EU/1/10/651/015 100x1 film-coated tablets
EU/1/10/651/001 28 filmsko obloženih tablet EU/1/10/651/002 30 filmsko obloženih tablet EU/1/10/651/003 50 filmsko obloženih tablet EU/1/10/651/004 56 filmsko obloženih tablet EU/1/10/651/005 84 filmsko obloženih tablet EU/1/10/651/006 90 filmsko obloženih tablet EU/1/10/651/007 100 filmsko obloženih tablet EU/1/10/651/008 28x1 filmsko obloženih tablet EU/1/10/651/009 28x1 filmsko obloženih tablet (koledarsko pakiranje) EU/1/10/651/010 30x1 filmsko obloženih tablet EU/1/10/651/011 50x1 filmsko obloženih tablet EU/1/10/651/012 56x1 filmsko obloženih tablet EU/1/10/651/013 84x1 filmsko obloženih tablet EU/1/10/651/014 90x1 filmsko obloženih tablet EU/1/10/651/015 100x1 filmsko obloženih tablet
For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel HCS by referring to the calendar printed on the blister.
Če uporabljate pakiranje 28 x 1 tableta, lahko dan, ko ste nazadnje vzeli tabletozdravila Klopidogrel
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Koristi, ki so jih opazili s klopidogrelom, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin /nizkomolekularni heparin, antagonisti glikoproteina IIb/IIIa,
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4»Možni neželeni učinki«);
Paediatric population
• Pediatrična uporaba
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.
Pri odraslih bolnikih z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke in ki niso primerni za zdravljenje z antagonisti vitamina K (VKA) ter imajo majhno tveganje za krvavitev,
Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Hujše krvavitve so bile v obeh skupinah večinoma ekstrakranialne (5,3 % v skupini s klopidogrelom + ASA, 3,5 % v skupini s placebom + ASA),
While you are taking Clopidogrel HCS:
Ko jemljete zdravilo Klopidogrel HCS:
Clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Klopidogrel previdno dajemo bolnikom, ki sočasnega jemljejo zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
(intention to treat analysis) so v skupini, ki je jemala klopidogrel, opazili 939 dogodkov, v skupini, ki je jemala ASA, pa 1.020 dogodkov (zmanjšanje relativnega tveganja /RT/: 8,7%%, 95-odstotni interval zaupanja /IZ/: 0,2 do 16,4; p = 0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, dodatnim 10 (IZ: 0 do 20) bolnikom.
How to take Clopidogrel HCS
Kako jemati zdravilo Klopidogrel HCS
OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister (OPA/Al/PVC-Al) containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton.
OPA/Al/PVC-Al pretisni omoti , ki vsebujejo po 28, 30, 50, 56, 84, 90 in 100 filmsko obloženih tablet ali perforirani, enoodmerni pretisni omoti (OPA/Al/PVC-Al), ki vsebujejo po 28x1, 28x1 (koledarsko pakiranje), 30x1, 50x1, 56x1, 84x1, 90x1 in 100x1 filmsko obloženo tableto v škatli.
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1.035 (16,5%) v skupini zdravljeni s klopidogrelom in 1.187 (18,8%) v skupini s placebom, to je 14% zmanjšanje relativnega tveganja (95% IZ od 6% -21%, p=0,0005) za skupino,
EU/1/10/651/001 Cartons of 28 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/002 Cartons of 30 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/003 Cartons of 50 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/004 Cartons of 56 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/005 Cartons of 84 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/006 Cartons of 90 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/007 Cartons of 100 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/008 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/001 škatla z 28 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/002 škatla s 30 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/003 škatla s 50 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/004 škatla s 56 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/005 škatla s 84 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/006 škatla z 90 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/007 škatla s 100 filmsko obloženimi tabletami v OPA/Al/PVC - Al pretisnih omotih EU/1/10/651/008 škatla z 28x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Peroralni antikoagulanti Sočasno jemanje klopidogrela in peroralnih antikoagulantov ni priporočljivo, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).
Rash, pruritus, skin bleeding (purpura)
kožne krvavitve (purpura)
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
(sindrom DIHS, Drug-Induced Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozni ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel HCS.
Med jemanjem zdravila Klopidogrel HCS ne smete dojiti.
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.
ASA ni spremenila s klopidogrelom dosežene inhibicije z ADP-jem sprožene agregacije trombocitov,
Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Zaviralci protonske črpalke (PPI): Če sta bila klopidogrel in omeprazol uporabljena skupaj istočasno ali v presledku 12 ur, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (začetni odmerek) oz. 40 % (vzdrževalni odmerek).
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
5.3 Predklinični podatki o varnosti V predkliničnih študijah na podganah in pavijanih so bile najpogosteje opaženi učinek jetrne spremembe.
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).
Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in ASA, ni nadalje povečevala,
Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Podatki študije CAPRIE kažejo, da je sočasno jemanje fenitoina in tolbutamida, ki se presnavljata s
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek , se posvetujte z zdravnikom ali farmacevtom.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
V študiji CAPRIE so primerjali klopidogrel in ASA, v študijah CURE, CLARITY, COMMIT in ACTIVE_A pa klopidogrel in placebo; bolniki so oboje dobivali v kombinaciji z ASA in drugo standardno terapijo.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Izdelovalec: KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
• otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži kar so lahko znaki alergijske reakcije.
Posology • Adults and elderly
• Odrasli in starejši (več kot 65 let)
Patients were treated for up to 5 years.
bolnikov v starosti ≥ 65 let.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets-calendar pack)
PRETISNI OMOT (28x1 filmsko obložena tableta - koledarsko pakiranje) IME ZDRAVILA
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, pridobljena hemofilija A, granulocitopenija, anemija
You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin, or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach,
o nesteroidna protivnetna zdravila, običajno za lajšanje bolečih in/ali vnetih sklepov ali mišic, o heparin ali katero koli drugo zdravilo za preprečevanje strjevanja krvi, o tiklopidin, druga antiagregacijska zdravila, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem,
Glomerulonephritis, blood creatinine increased
Bolezni sečil hematurija glomerulonefritis,
Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
Filmska obloga: polivinilalkohol titanov dioksid (E171)
Clopidogrel HCS 75 mg film-coated tablets clopidogrel
Klopidogrel HCS 75 mg filmsko obložene tablete klopidogrel
Clopidogrel HCS 75 mg film-coated tablets
Klopidogrel HCS 75 mg filmsko obložene tablete
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Vendar pa so bolniki, ki so bili vključeni v klinično preizkušanje klopidogrela, brez dokazov o klinično pomembnih neželenih interakcijah sočasno jemali različna zdravila, tudi diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce angiotenzinske konvertaze (ACE), kalcijeve antagoniste, učinkovine za zniževanje holesterola,
− Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
- če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času;
The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
bolnikov in v skupini s placebom + ASA 924 (24,4 %) bolnikov (relativno zmanjšanje tveganja 11,1 %, 95 % IZ: od 2,4 % do 19,1 %, p = 0,013), predvsem kot posledica velikega zmanjšanja incidence možganskih kapi.
Plavix contains lactose
Okvara ledvic
Plavix is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Proces je znan kot aterotromboza in lahko povzroči aterotrombotične dogodke (kot so kap, srčni napad ali smrt).
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 zaviralci privzema serotonina (SSRI; Selective serotonin re-uptake inhibitors) Selektivni zaviralci privzema serotonina vplivajo na aktivacijo trombocitov in povečajo nevarnost krvavitve, zato je ob sočasnem jemanju selektivnih zaviralcev privzema serotonina in klopidogrela potrebna previdnost.
• Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil.
• Pomožne snovi so (glejte poglavj 2 »Zdravilo Klopidogrel HSC vsebuje hidrogenirano ricinusovo olje«) : - Jedro tablete: mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, krospovidon (vrsta A), makrogol 6000, hidrogenirano ricinusovo olje
Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
rumeni železov oksid (E172)
If you take more Plavix than you should
Če ste vzeli večji odmerek zdravila Klopidogrel HCS, kot bi smeli
- a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- zdravstveno stanje s tveganjem za notranjo krvavitev (rana na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa), - nedavna huda poškodba, - nedavni kirurški poseg (tudi na zobeh),
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 škatla s 84x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
Thu
VKA.
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 šklatla s 56x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
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 škatla s 50x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
These may be due to rare decrease of some blood cells.
• zvišana telesna temperatura, znaki okužbe ali huda utrujenost, kar so znaki redkega zmanjšanja števila določenih krvnih celic;
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel HCS per day to be taken orally with or without food, and at the same time each day.
(nepravilen srčni utrip), je ena 75 mg tableta zdravila Klopidogrel HCS na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
(listed in section 6).
ali v poglavju 6.1.
Clopidogrel HCS is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Zdravilo Klopidogrel HCS jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah).
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Aktivni presnovek nastane predvsem z delovanjem CYP2C19, k nastanku pa pripomorejo tudi drugi encimi
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
- ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen ali
How to store Clopidogrel HCS
Shranjevanje zdravila Klopidogrel HCS
The most common side effect reported with Clopidogrel HCS is bleeding.
Najpogostejši neželeni učinek, o katerem so poročali med zdravljenjem z zdravilom Klopidogrel
Vistor hf.
Klopidogrel HCS, ne dojijo.
Nervous system
Organski sistem Pogosti
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja modrice izpuščaj, srbenje,
Medicinal products associated with bleeding risk:
• če pri vas obstaja tveganje za krvavitev, kot je:
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Navodilo za uporabo Klopidogrel HCS 75 mg filmsko obložene tablete klopidogrel Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Pri manjših urezninah ali poškodbah, npr.
Always take this medicine exactly as your doctor or pharmacist has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali faramecvta.
If you forget to take a dose of Plavix, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
EU/1/10/651/009 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters (calendar pack)
EU/1/10/651/009 škatla z 28x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih (koledarsko pakiranje) EU/1/10/651/010 škatla s 30x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
Recent ischaemic stroke
Kounisov sindrom
• Periodic Safety Update Reports
Nadaljnja presnova vmesnega presnovka
Renal impairment
• Jetrna okvara
NMS can cause death.
NMS lahko povzroči smrt.
These are diseases characterised by symptoms such as:
Te bolezni zaznamujejo simptomi, kot so:
Date of first authorisation: 20 February 2013 Date of latest renewal:
Datum prve odobritve: 20. februarja 2013 Datum zadnjega podaljšanja:
• recreational (illegal) drugs
• rekreativne (nezakonite) droge;
For the main results, see the table below.
Za glavne rezultate glejte spodnjo tabelo.
These symptoms can temporally worsen or can even arise after discontinuation of treatment.
Ti simptomi se lahko začasno poslabšajo ali se pojavijo celo po prekinitvi zdravljenja.
• At the request of the European Medicines Agency;
na zahtevo Evropske agencije za zdravila;
• are an older person with dementia (loss of memory and other mental abilities).
• ste starejša oseba z demenco (izguba spomina in drugih umskih sposobnosti).
Additional measures include oxygen and intravenous fluids.
Dodatni ukrepi vključujejo kisik in intravenske tekočine.
The treatment of overdosage is essentially symptomatic and supportive.
Zdravljenje prevelikega odmerjanja je v osnovi simptomatsko in podporno.
The terminal elimination half-life (T½) ranged from 6 to 8 hours.
Končni eliminacijski razpolovni čas (T½) je segal od 6 do 8 ur.
• Introductory statement on the purpose of the educational material
• uvodna izjava o namenu izobraževalnega materiala,
Inclusion in Study 004-301 required a diagnosis of schizophrenia.
Vključitev v študijo 004-301 je zahtevala diagnozo shizofrenije.
The device exterior may become warm during use.
Med uporabo se lahko zunanjost naprave segreje.
• Mention of contra-indications and related warnings
• navedba kontraindikacij in povezanih opozoril,
Key elements to be included in the educational materials:
Ključni elementi, ki morajo biti vključeni v izobraževalni material: Splošno:
• medicines to treat Parkinson's disease
• zdravila za zdravljenje Parkinsonove bolezni;
Common: dry mouth
Pogosti: suha usta
Typically, this will occur within 25 minutes of use.
Običajno do tega pride v 25 minutah po uporabi.
Such medicinal products may modify efficacy and safety of ADASUVE in an irregular manner.
Taka zdravila lahko spremenijo učinkovitost in varnost zdravila ADASUVE na nepravilen način.
Read all instructions before use.
Pred uporabo preberite vsa navodila.
No more than two doses should be administered.
Več kot dveh odmerkov se ne sme dati.
Treatment N
Zdravljenje N
Healthcare professionals should ensure the patient will use the inhaler properly.
Zdravstveni delavec mora zagotoviti, da bo bolnik pravilno uporabljal inhalator.
• have or had low or high blood pressure
• imate ali ste imeli nizek ali visok krvni tlak;
Intoxication or physical disease (delirium)
Zastrupitev ali fizična bolezen (delirij)
Loxapine is 96.6% bound to human plasma proteins.
Loksapin se 96,6 % veže na človeške plazemske beljakovine.
Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.
Pregled podskupin populacije (starost, rasa in spol) ni pokazal nikakršne diferencialne odzivnosti na podlagi razvrstitve v podskupine.
In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance.
V primeru nenamernega prevelikega odmerjanja so znaki in simptomi odvisni od števila vzetih enot in tolerance posameznega bolnika.
Instruct the patient to:
Bolniku dajte napotke, da mora:
Study Patients
Študija Bolniki
• Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE.
• Nevroleptični maligni sindrom (NMS) je niz simptomov, ki se lahko pojavijo, če jemljete antipsihotike, vključno z zdravilom ADASUVE.
Pharmacotherapeutic group: psycholeptics, antipsychotics; ATC code: N05AH01
Farmakoterapevtska skupina: psiholeptiki, antipsihotiki; oznaka ATC: N05AH01