natgillin/translations-raw huggingface dataset:
- The active substance is rivastigmine hydrogen tartrate.
Što Nimvastid sadrži - Djelatna tvar je rivastigmin hidrogentartarat.
Nimvastid 1.5 mg (on carton label only)
Nimvastid 1,5 mg (samo na kutiji)
Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172) Gelatine
Ovojnica kapsule Titanijev dioksid (E171) Željezov oksid, žuti (E172) Željezov oksid, crveni (E172) Želatina
These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Progressive Deterioration Scale, njegovateljeva procjena svakodnevnih aktivnosti, uključujući osobnu higijenu, hranjenje, oblačenje, poslove vezane za domaćinstvo kao što su odlazak u kupovinu, očuvanje sposobnosti orijentiranja u okolini, kao i uključivanje u aktivnosti koje se odnose na financije, itd.).
Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Parkinsonova bolest (pogoršanje) Prekomjerno lučenje sline Diskinezija
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Neki su slučajevi teškog povraćanja bili povezani s rupturom jednjaka (vidjeti dio 4.4).
Fatigue and asthenia Gait disturbance Parkinson gait
Umor i astenija Poremećaj hoda Hod kod Parkinsonove bolesti
• Swallow the capsules whole with a drink.
- Kapsule progutajte cijele uz tekućinu.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Ako se u bolesnika s demencijom koja je povezana s Parkinsonovom bolešću tijekom liječenja uoče nuspojave (npr. mučnina, povraćanje, abdominalna bol ili gubitak teka), smanjenje tjelesne težine ili pogoršanje ekstrapiramidalnih simptoma (npr. tremora), oni se mogu izbjeći izostavljanjem jedne ili više doza.
14 hard capsules: EU/1/09/525/001 28 hard capsules: EU/1/09/525/002 30 hard capsules: EU/1/09/525/003 56 hard capsules: EU/1/09/525/004 60 hard capsules: EU/1/09/525/005 112 hard capsules: EU/1/09/525/006 200 hard capsules: EU/1/09/525/047 250 hard capsules: EU/1/09/525/007
14 tvrdih kapsula: EU/1/09/525/001 28 tvrdih kapsula: EU/1/09/525/002 30 tvrdih kapsula: EU/1/09/525/003 56 tvrdih kapsula: EU/1/09/525/004 60 tvrdih kapsula: EU/1/09/525/005 112 tvrdih kapsula: EU/1/09/525/006 200 tvrdih kapsula: EU/1/09/525/047 250 tvrdih kapsula: EU/1/09/525/007
Re-initiation of therapy
Ponovni početak liječenja
Metabolism and nutritional disorders Common
Poremećaji metabolizma i prehrane Često
Nimvastid 4.5 mg (on carton label only)
Nimvastid 4,5 mg (samo na kutiji)
• Tell your caregiver that you are taking Nimvastid.
Uzimanje lijeka - Recite osobi koja Vas njeguje da uzimate Nimvastid.
Microcrystalline cellulose
Celuloza, mikrokristalična
Nimvastid 1.5 mg hard capsules
Nimvastid 1,5 mg tvrde kapsule
Nimvastid 4.5 mg hard capsules
Nimvastid 4,5 mg tvrde kapsule
Vascular disorders Very rare
Krvožilni poremećaji Vrlo rijetko
14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 ili 112 x 1 tableta u perforiranim blisterima djeljivim na jedinične doze s OPA/Al/PVC filmom i PET/Al odvojivom folijom, u kutiji.
28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
28 x 1, 30 x 1, 56 x 1, 60 x 1 ili 112 x 1 tableta u perforiranim blisterima djeljivim na jedinične doze s OPA/Al/PVC filmom i PET/Al odvojivom folijom, u kutiji.
No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
U bolesnika s blagim do umjerenim oštećenjem bubrega ili jetre nije potrebna prilagodba doze.
Nimvastid 6 mg (on carton label only)
Nimvastid 6 mg (samo na kutiji)
Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Zbog toga odgovorni liječnik treba rutinski procijeniti sposobnost bolesnika s demencijom koji uzimaju rivastigmin, mogu li nastaviti upravljati vozilima ili raditi sa složenim strojevima.
Nimvastid 6 mg hard capsules
Nimvastid 6 mg tvrde kapsule
White to almost white powder in a capsule with orange cap and orange body.
Bijeli do gotovo bijeli prašak u kapsuli s narančastom kapicom i narančastim tijelom.
Nimvastid 3 mg hard capsules
Nimvastid 3 mg tvrde kapsule
Nimvastid 3mg (on carton label only)
Nimvastid 3 mg (samo na kutiji)
Total patients studied Total patients with pre-defined AE(s) Tremor
Ukupan broj bolesnika s unaprijed određenim štetnim događajem (događajima)
Nimvastid 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body.
Nimvastid 3 mg tvrde kapsule, koje sadrže bijeli do gotovo bijeli prašak, imaju narančastu kapicu i narančasto tijelo.
Excipient with known effect: Each orodispersible tablet contains 21 µg sorbitol E420.
Pomoćna tvar s poznatim učinkom: Svaka raspadljiva tableta za usta sadrži 21 µg sorbitola E420.
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
- Jako povraćanje koje može dovesti do puknuća cijevi koja spaja usta sa želucem (jednjaka) - Dehidracija (gubitak previše tekućine) - Poremećaji jetre (žutilo kože, žute bjeloočnice, abnormalno tamna mokraća ili neobjašnjiva mučnina, povraćanje, umor i gubitak apetita) - Agresivnost, osjećaj nemira - Nepravilni otkucaji srca
ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Intent-To-Treat; namjera liječiti); RDO (eng.
• Aggression, feeling restless
Agresivnost, nemir
What Nimvastid looks like and contents of the pack Nimvastid 1.5 mg hard capsules, which contain a white to almost white powder, have a yellow cap and yellow body.
Nimvastid 1,5 mg tvrde kapsule, koje sadrže bijeli do gotovo bijeli prašak, imaju žutu kapicu i žuto tijelo.
Excipient with known effect: Each orodispersible tablet contains 15.75 µg sorbitol E420.
Pomoćna tvar s poznatim učinkom: Svaka raspadljiva tableta za usta sadrži 15,75 µg sorbitola E420.
Excipient with known effect: Each orodispersible tablet contains 10.5 µg sorbitol E420.
Pomoćna tvar s poznatim učinkom: Svaka raspadljiva tableta za usta sadrži 10,5 µg sorbitola E420.
112 hard capsules: EU/1/09/525/018 200 hard capsules: EU/1/09/525/049 250 hard capsules: EU/1/09/525/019
112 tvrdih kapsula: EU/1/09/525/018 200 tvrdih kapsula: EU/1/09/525/049 250 tvrdih kapsula: EU/1/09/525/019
• Accidentally falling
Opća slabost Padanje
• Feeling agitated
Noćne more Agitacija
Nimvastid 6 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and orange body.
Nimvastid 6 mg tvrde kapsule, koje sadrže bijeli do gotovo bijeli prašak, imaju smeđkastocrvenu kapicu i narančasto tijelo.
Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Bolesnici uključeni u ovo ispitivanje imali su MMSE (eng.
112 hard capsules: EU/1/09/525/012 200 hard capsules: EU/1/09/525/048 250 hard capsules: EU/1/09/525/013
112 tvrdih kapsula: EU/1/09/525/012 200 tvrdih kapsula: EU/1/09/525/048 250 tvrdih kapsula: EU/1/09/525/013
- The other ingredients for Nimvastid 3 mg, 4.5 mg and 6 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content,
- Drugi sastojci za Nimvastid 3 mg, 4,5 mg i 6 mg kapsule su mikrokristalična celuloza, hipromeloza, koloidni bezvodni silicijev dioksid i magnezijev stearat u sadržaju kapsule i titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172) i želatina u ovojnici kapsule.
Nimvastid 4.5 mg orodispersible tablets
Nimvastid 4,5 mg raspadljive tablete za usta
Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis
Bol u abdomenu i dispepsija Ulkusi želuca i dvanaesnika Gastrointestinalno krvarenjePankreatitis
Nimvastid 1.5 mg orodispersible tablets
Nimvastid 1,5 mg raspadljive tablete za usta
112 hard capsules: EU/1/09/525/024 200 hard capsules: EU/1/09/525/050 250 hard capsules: EU/1/09/525/025
112 tvrdih kapsula: EU/1/09/525/024 200 tvrdih kapsula: EU/1/09/525/050 250 tvrdih kapsula: EU/1/09/525/025
28 hard capsules: EU/1/09/525/008
28 tvrdih kapsula: EU/1/09/525/008
Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.
Svaka tvrda kapsula sadrži rivastigmin hidrogentartarat koji odgovara 1,5 mg rivastigmina.
Orodispersible tablets are round and white tablets.
Kako Nimvastid izgleda i sadržaj pakiranja Raspadlive tablete za usta su okrugle i bijele.
30 hard capsules: EU/1/09/525/009
30 tvrdih kapsula: EU/1/09/525/009
Nimvastid 3 mg orodispersible tablets
Nimvastid 3 mg raspadljive tablete za usta
Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Svaka tvrda kapsula sadrži rivastigmin hidrogentartarat koji odgovara 3 mg rivastigmina.
Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Svaka tvrda kapsula sadrži rivastigmin hidrogentartarat koji odgovara 6 mg rivastigmina.
Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Svaka tvrda kapsula sadrži rivastigmin hidrogentartarat koji odgovara 4,5 mg rivastigmina.
Excipient with known effect: Each orodispersible tablet contains 5.25 µg sorbitol E420.
Pomoćna tvar s poznatim učinkom: Svaka raspadljiva tableta za usta sadrži 5,25 µg sorbitola E420.
Nimvastid 6 mg orodispersible tablets
Nimvastid 6 mg raspadljive tablete za usta
Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Retrieved Drop Outs-slučajevi koji su ispali, a uzeti su u obzir); LOCF (eng.
Patients with dementia and Parkinson's disease These patients have some side effects more often.
Ovi bolesnici češće imaju neke nuspojave.
28 hard capsules: EU/1/09/525/014
28 tvrdih kapsula: EU/1/09/525/014
Renal impairment
Poremećaj hoda
United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0) 203 751 1888
Tel: + 44 (0) 203 751 1888
60 hard capsules: EU/1/09/525/017
60 tvrdih kapsula: EU/1/09/525/017
56 hard capsules: EU/1/09/525/016
56 tvrdih kapsula: EU/1/09/525/016
Nimvastid 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body.
Nimvastid 4,5 mg tvrde kapsule, koje sadrže bijeli do gotovo bijeli prašak, imaju smeđkastocrvenu kapicu i smeđkastocrveno tijelo.
60 hard capsules: EU/1/09/525/023
60 tvrdih kapsula: EU/1/09/525/023
56 hard capsules: EU/1/09/525/010
56 tvrdih kapsula: EU/1/09/525/010
56 hard capsules: EU/1/09/525/022
56 tvrdih kapsula: EU/1/09/525/022
30 hard capsules: EU/1/09/525/021
30 tvrdih kapsula: EU/1/09/525/021
28 hard capsules: EU/1/09/525/020
28 tvrdih kapsula: EU/1/09/525/020
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.
Svaka raspadljiva tableta za usta sadrži rivastigmin hidrogentartarat koji odgovara 1,5 mg rivastigmina.
Rivastigmine
Doziranje
60 hard capsules: EU/1/09/525/011
60 tvrdih kapsula: EU/1/09/525/011
30 hard capsules: EU/1/09/525/015
30 tvrdih kapsula: EU/1/09/525/015
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Svaka raspadljiva tableta za usta sadrži rivastigmin hidrogentartarat koji odgovara 4,5 mg rivastigmina.
Fall
Padanje
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Svaka raspadljiva tableta za usta sadrži rivastigmin hidrogentartarat koji odgovara 3 mg rivastigmina.
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Svaka raspadljiva tableta za usta sadrži rivastigmin hidrogentartarat koji odgovara 6 mg rivastigmina.
28 x 1 orodispersible tablet:EU/1/09/525/042 30 x 1 orodispersible tablet:EU/1/09/525/043 56 x 1 orodispersible tablet:EU/1/09/525/044 60 x 1 orodispersible tablet:EU/1/09/525/045 112 x 1 orodispersible tablet:EU/1/09/525/046
28 x 1 raspadljiva tableta za usta: EU/1/09/525/042 30 x 1 raspadljiva tableta za usta: EU/1/09/525/043 56 x 1 raspadljiva tableta za usta: EU/1/09/525/044 60 x 1 raspadljiva tableta za usta: EU/1/09/525/045 112 x 1 raspadljiva tableta za usta: EU/1/09/525/046
14 x 1 orodispersible tablet:EU/1/09/525/026 28 x 1 orodispersible tablet:EU/1/09/525/027 30 x 1 orodispersible tablet:EU/1/09/525/028 56 x 1 orodispersible tablet:EU/1/09/525/029 60 x 1 orodispersible tablet:EU/1/09/525/030 112 x 1 orodispersible tablet:EU/1/09/525/031
14 x 1 raspadljive tablete za usta: EU/1/09/525/026 28 x 1 raspadljiva tableta za usta: EU/1/09/525/027 30 x 1 raspadljiva tableta za usta: EU/1/09/525/028 56 x 1 raspadljiva tableta za usta: EU/1/09/525/029 60 x 1 raspadljiva tableta za usta: EU/1/09/525/030 112 x 1 raspadljiva tableta za usta: EU/1/09/525/031
28 x 1 orodispersible tablet:EU/1/09/525/037 30 x 1 orodispersible tablet:EU/1/09/525/038 56 x 1 orodispersible tablet:EU/1/09/525/039 60 x 1 orodispersible tablet:EU/1/09/525/040 112 x 1 orodispersible tablet:EU/1/09/525/041
28 x 1 raspadljiva tableta za usta: EU/1/09/525/037 30 x 1 raspadljiva tableta za usta: EU/1/09/525/038 56 x 1 raspadljiva tableta za usta: EU/1/09/525/039 60 x 1 raspadljiva tableta za usta: EU/1/09/525/040 112 x 1 raspadljiva tableta za usta: EU/1/09/525/041
28 x 1 orodispersible tablet:EU/1/09/525/032 30 x 1 orodispersible tablet:EU/1/09/525/033 56 x 1 orodispersible tablet:EU/1/09/525/034 60 x 1 orodispersible tablet:EU/1/09/525/035 112 x 1 orodispersible tablet:EU/1/09/525/036
28 x 1 raspadljiva tableta za usta: EU/1/09/525/032 30 x 1 raspadljiva tableta za usta: EU/1/09/525/033 56 x 1 raspadljiva tableta za usta: EU/1/09/525/034 60 x 1 raspadljiva tableta za usta: EU/1/09/525/035 112 x 1 raspadljiva tableta za usta: EU/1/09/525/036
A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Ispitivanje rivastigmina na zečevima ukazalo je na blagi potncijal iritacije oka/sluznice
Busuttil Ltd. Tel: +356 21 445 885
Tel: +356 21 445 885
Elderly
Distonija
Gait abnormality
Fibrilacija atrija
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
- Općenito loše osjećanje - Drhtanje ili osjećaj zbunjenosti - Smanjen apetit - Noćne more
Fatigue and asthenia Malaise
Anksioznost Nemir
КРКА България ЕООД Teл.
E.J. Busuttil Ltd.
It is used in the following groups:
Primjenjuje se u sljedećim skupinama:
This means that Eptifibatide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Integrilin.
To znači da je Eptifibatide Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Integrilin.
This reduces the risk of a blood clot forming and helps prevent heart attacks.
To smanjuje rizik od stvaranja krvnog ugruška i pomaže u sprečavanju srčanih udara.
The recommended dose is 180 micrograms per kilogram body weight given as an injection into a vein as soon as possible after diagnosis.
Preporučena je doza 180 mikrograma po kilogramu tjelesne težine, koja se daje injekcijom u venu što prije nakon postavljanja dijagnoze.
The full EPAR and risk management plan summary for Eptifibatide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) i sažetak plana upravljanja rizikom za Eptifibatide Accord nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Eptifibatide Accord is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Eptifibatide Accord daje se zajedno s aspirinom i nefrakcioniranim heparinom (drugi lijekovi koji sprečavaju krvne ugruške).
The company provided data from the published literature on eptifibatide.
Tvrtka je pružila podatke iz objavljene literature o eptifibatidu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Eptifibatide Accord has been shown to be comparable to Integrilin.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je Eptifibatide Accord usporediv s Integrilinom.
Patients who have moderately reduced kidney function should receive a lower dose during the infusion.
Bolesnicima kojima je umjereno smanjena funkcija rada bubrega trebaju primati manju dozu tijekom infuzije.
Because Eptifibatide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Eptifibatide Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of heart surgery, or until discharge from the hospital, whichever occurs first.
Nakon toga se daje kontinuirana infuzija od 2,0 mikrograma/kg u minuti, što se nastavlja do najviše 72 sata, sve do početka operacije srca ili otpuštanja iz bolnice (ovisno o tome što se prvo dogodi).
The patients most likely to benefit from a treatment with Eptifibatide Accord are those at high risk of heart attack in the three to four days after the start of acute (sudden) angina.
Bolesnici za koje postoji najveća vjerojatnost da će imati koristi od liječenja lijekom Eptifibatide Accord jesu bolesnici s visokim rizikom od srčanog udara tri do četiri dana nakon početka akutne (iznenadne) angine.
This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart).
To uključuje bolesnike koji imaju perkutanu transluminalnu koronarnu angiografiju (PTCA, vrsta operacije kojom se čiste arterije koje opskrbljuju srce).
If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), infusion of Eptifibatide Accord can be continued for up to 24 hours after the procedure, with a maximum treatment duration of 96 hours.
Ako je bolesnik podvrgnut perkutanoj koronarnoj intervenciji (PCI ili angioplastika ili kirurški zahvat koji se primjenjuje kako bi se odblokirale sužene koronarne arterije), infuzija lijeka Eptifibatide Accord može se nastaviti do najviše 24 sata nakon zahvata, pri čemu liječenje može trajati najdulje 96 sati.
Eptifibatide Accord is a ‘generic medicine'.
Eptifibatide Accord je „generički lijek”.
Eptifibatide Accord is a medicine used to prevent a heart attack in adults.
Eptifibatide Accord je lijek koji se koristi za sprečavanje srčanog udara u odraslih.
This sticking together of platelets is an important step in forming a blood clot, and when it happens in the blood vessels supplying the heart it can lead to a heart attack.
Sljepljivanje trombocita važan je element stvaranja krvnog ugruška i, ako se dogodi u krvnim žilama koje opskrbljuju srce, može dovesti do srčanog udara.
• patients who have already had a non-Q-wave myocardial infarction (a type of heart attack), with chest pain in the last 24 hours and with abnormalities on the electrocardiogram (ECG) or signs of heart problems in the blood.
• u bolesnika koji su već imali infarkt miokarda bez formiranog Q zupca (vrsta srčanog udara), s bolovima u prsima u posljednja 24 sata i s abnormalnostima na elektrokardiogramu (EKG-u) ili znakovima srčanih problema u krvi.
The active substance in Eptifibatide Accord, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky.
Djelatna tvar u lijeku Eptifibatide Accord, eptifibatid, zaustavlja sljepljivanje trombocita blokiranjem proteina glikoprotein IIb/III na njihovoj površini, koji pomaže u njihovu sljepljivanju.
No additional studies were needed as Eptifibatide Accord is a generic medicine that is given by injection and infusion into a vein and contains the same active substance as the reference medicine, Integrilin.
Nisu bila potrebna dodatna ispitivanja jer je Eptifibatide Accord generički lijek koji se daje injekcijom i infuzijom u venu i koji sadrži istu djelatnu tvar kao i referentni lijek Integrilin.
Eptifibatide Accord eptifibatide
Eptifibatide Accord eptifibatid
The Committee recommended that Eptifibatide Accord be approved for use in the EU.
Odbor je preporučio izdavanje odobrenja za primjenu lijeka Eptifibatide Accord u EU-u.
It is not intended to provide practical advice on how to use Eptifibatide Accord.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Eptifibatide Accord.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eptifibatide Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana u sažetak opisa svojstava lijeka i uputu o lijeku za Eptifibatide Accord uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
What measures are being taken to ensure the safe and effective use of Eptifibatide Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Eptifibatide Accord?
A risk management plan has been developed to ensure that Eptifibatide Accord is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Eptifibatide Accord.
It is available as solutions for infusion (drip) and injection into a vein.
Dostupan je u obliku otopine za infuziju (drip) koja se daje u venu.
This is a summary of the European public assessment report (EPAR) for Eptifibatide Accord.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Eptifibatide Accord.
Eptifibatide Accord should be given by a doctor who has experience in the management of heart attacks and angina and can only be obtained with a prescription.
Eptifibatide Accord propisuje liječnik s iskustvom u liječenju srčanih udara i angine te se izdaje samo na liječnički recept.
Other information about Eptifibatide Accord
Ostale informacije o lijeku Eptifibatide Accord
• patients who have unstable angina (chest pain caused by poor blood flow to the heart, that may occur at rest or without an obvious trigger);
• u bolesnika koji imaju nestabilnu anginu (bol u prsima uzrokovana slabim protokom krvi do srca, koja se može javiti pri mirovanju ili bez nekog očitog uzroka);
The medicine contains the active substance eptifibatide.
Lijek sadrži djelatnu tvar eptifibatid.
What is Eptifibatide Accord and what is it used for?
Što je Eptifibatide Accord i za što se koristi?
For more information about treatment with Eptifibatide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Eptifibatide Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
Eptifibatide Accord must not be used in patients with severe kidney problems.
Eptifibatide Accord ne smije se primjenjivati u bolesnika s ozbiljnim problemima u funkciji rada bubrega.
Eptifibatide Accord is an inhibitor of platelet aggregation.
Eptifibatide Accord je inhibitor agregacije trombocita.