natgillin/translations-raw huggingface dataset:
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Aripiprazol Sandoz 15 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
16. PODACI NA BRAILLEOVOM PISMU Aripiprazol Sandoz 5 mg
Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Pomoćna(e) tvar(i) s poznatim učinkom 97,75 mg laktoze hidrata po tableti.
Excipient(s) with known effect 196.50 mg lactose monohydrate per tablet.
Pomoćna(e) tvar(i) s poznatim učinkom 196,50 mg laktoze hidrata po tableti.
Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Pomoćna(e) tvar(i) s poznatim učinkom 65,97 mg laktoze hidrata po tableti.
Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Sandoz is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Sandoz je 15 mg i primjenjuje se jedanput dnevno neovisno o obrocima u obliku monoterapije ili kombinirane terapije (vidjeti dio 5.1).
What Aripiprazole Sandoz tablets look like and contents of the pack´
Sandoz izgleda i sadržaj pakiranja
Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Somnolencija/sedacija i ekstrapiramidni poremećaji bili su prijavljeni vrlo često (≥ 1/10), dok su često bili prijavljeni suha usta, pojačan apetit i ortostatska hipotenzija (≥ 1/100, < 1/10).
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section
Aripiprazol može izazvati reakcije preosjetljivosti, čije su značajke alergijski simptomi (vidjeti dio 4.8).
White coloured, round shaped tablet, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side.
Bijela, okrugla tableta, približnog promjera 7,8 mm, s utisnutom oznakom “SZ” na jednoj strani i “448” na drugoj strani.
Aripiprazole Sandoz20mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8mm, debossed with “SZ” on one side and “448” on the other side.
Aripiprazol Sandoz 20 mg tablete su bijele, okrugle tablete, približnog promjera 7,8 mm, s utisnutom oznakom “SZ“ na jednoj strani i “448“ na drugoj strani.
How to take Aripiprazole Sandoz
Kako uzimati Aripiprazol
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 28.0% and 53.3%, respectively.
U pedijatrijskoj populaciji s bipolarnim poremećajem (10-17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 29.5% and 48.3%, respectively.
U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease,
• srčanih i krvožilnih bolesti, srčanih ili krvožilnih bolesti u obitelji, moždanog udara,
Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.
Žuta, prošarana, okrugla tableta, približnog promjera 7,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “447” na drugoj strani.
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.
Ružičasta, prošarana, okrugla tableta, približnog promjera 9,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “449” na drugoj strani.
Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Red iron oxide (E172)
hidroksipropilceluloza, magnezijev stearat, crveni željezov oksid (E172).
Each tablet contains 20 mg of aripiprazole.
Jedna tableta sadrži 20 mg aripiprazola.
Aripiprazole Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side.
Aripiprazol Sandoz 15 mg tablete su žute, prošarane, okrugle tablete, približnog promjera 7,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “447“ na drugoj strani.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
• Drugi sastojci su laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza,
Aripiprazole Sandoz 20 mg tablets
Aripiprazol Sandoz 20 mg tablete
Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Aripiprazol Sandoz 5 mg tablete su plave, prošarane, okrugle tablete, približnog promjera 6,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “444“ na drugoj strani.
Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Plava, prošarana, okrugla tableta, približnog promjera 6,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “444” na drugoj strani.
•• feeling aggressive,
• agresivnost,
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.
Ružičasta, prošarana, okrugla tableta, približnog promjera 6,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “446” na drugoj strani.
obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
generalizirani anksiozni poremećaj, opsesivno kompulzivni poremećaj (OKP) i socijalnu fobiju,
Aripiprazole Sandoz30mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0mm, debossed with “SZ” on one side and “449” on the other side.
Sandoz 30 mg tablete su ružičaste, prošarane, okrugle tablete, približnog promjera 9,0 mm, s oznakama “SZ“ na jednoj strani i “449“ na drugoj strani.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva osip fotosenzitivna reakcija alopecija hiperhidroza
Grand mal convulsion Serotonin syndrome Speech disorder
Serotoninski sindrom
Aripiprazole Sandoz 15 mg tablets
Aripiprazol Sandoz 15 mg tablete
Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side.
Sandoz 10 mg tablete su ružičaste, prošarane, okrugle tablete, približnog promjera 6,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “446“ na drugoj strani.
Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Aripiprazol Sandoz 5 mg tablete EU/1/15/1029/001 (10 tableta) EU/1/15/1029/002 (14 tableta) EU/1/15/1029/003 (16 tableta) EU/1/15/1029/004 (28 tableta) EU/1/15/1029/005 (30 tableta) EU/1/15/1029/006 (35 tableta) EU/1/15/1029/007 (56 tableta) EU/1/15/1029/008 (70 tableta) EU/1/15/1029/009 (14 x 1 tableta) EU/1/15/1029/010 (28 x 1 tableta) EU/1/15/1029/011 (49 x 1 tableta) EU/1/15/1029/012 (56 x 1 tableta) EU/1/15/1029/013 (98 x 1 tableta) EU/1/15/1029/014 (100 tableta)
Aripiprazole Sandoz 5 mg tablets
Aripiprazol Sandoz 5 mg tablete
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Sandoz 30 mg tablete aripiprazol
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/042
Schizophrenia in adolescents aged 15 years and older
Shizofrenija u adolescenata u dobi od 15 i više godina: preporučena doza za Aripiprazol
Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172)
Aripiprazol Sandoz 15 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat žuti željezov oksid (E172)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/061
If you get any side effects, talk to your doctor or pharmacist.
• Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Sandoz 20 mg tablete aripiprazol
Salivary hypersecretion Vomiting
Nepoznato duboku vensku trombozu) hipertenzija sinkopa
Pancreatitis Dysphagia Diarrhoea
abnormalnog krvnog tlaka
Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Aripiprazol Sandoz 15 mg tablete EU/1/15/1029/029 (10 tableta) EU/1/15/1029/030 (14 tableta) EU/1/15/1029/031 (16 tableta) EU/1/15/1029/032 (28 tableta) EU/1/15/1029/033 (30 tableta) EU/1/15/1029/034 (35 tableta) EU/1/15/1029/035 (56 tableta) EU/1/15/1029/036 (70 tableta) EU/1/15/1029/037 (14 x 1 tableta) EU/1/15/1029/038 (28 x 1 tableta) EU/1/15/1029/039 (49 x 1 tableta) EU/1/15/1029/040 (56 x 1 tableta) EU/1/15/1029/041 (98 x 1 tableta) EU/1/15/1029/042 (100 tableta)
The safety and efficacy of Aripiprazole Sandoz in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Sandoz u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Sandoz 10 mg tablete aripiprazol
EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
EU/1/15/1029/015 10 tableta EU/1/15/1029/016 14 tableta EU/1/15/1029/017 16 tableta EU/1/15/1029/018 28 tableta EU/1/15/1029/019 30 tableta EU/1/15/1029/020 35 tableta EU/1/15/1029/021 56 tableta EU/1/15/1029/022 70 tableta EU/1/15/1029/023 14x1 tableta EU/1/15/1029/024 28x1 tableta EU/1/15/1029/025 49x1 tableta EU/1/15/1029/026 56x1 tableta EU/1/15/1029/027 98x1 tableta
Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Sandoz 30 mg tablete EU/1/15/1029/048 (10 tableta) EU/1/15/1029/049 (14 tableta) EU/1/15/1029/050 (16 tableta) EU/1/15/1029/051 (28 tableta) EU/1/15/1029/052 (30 tableta) EU/1/15/1029/053 (35 tableta) EU/1/15/1029/054 (56 tableta) EU/1/15/1029/055 (70 tableta) EU/1/15/1029/056 (14 x 1 tableta) EU/1/15/1029/057 (28 x 1 tableta) EU/1/15/1029/058 (49 x 1 tableta) EU/1/15/1029/059 (56 x 1 tableta) EU/1/15/1029/060 (98 x 1 tableta) EU/1/15/1029/061 (100 tableta)
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Sandoz 5 mg tablete aripiprazol
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/028
EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
EU/1/15/1029/048 10 tableta EU/1/15/1029/049 14 tableta EU/1/15/1029/050 16 tableta EU/1/15/1029/051 28 tableta EU/1/15/1029/052 30 tableta EU/1/15/1029/053 35 tableta EU/1/15/1029/054 56 tableta EU/1/15/1029/055 70 tableta EU/1/15/1029/056 14 x 1 tableta EU/1/15/1029/057 28 x 1 tableta EU/1/15/1029/058 49 x 1 tableta EU/1/15/1029/059 56 x 1 tableta EU/1/15/1029/060 98 x 1 tableta
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Aripiprazol Sandoz 5 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat boja
EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
EU/1/15/1029/001 10 tableta EU/1/15/1029/002 14 tableta EU/1/15/1029/003 16 tableta EU/1/15/1029/004 28 tableta EU/1/15/1029/005 30 tableta EU/1/15/1029/006 35 tableta EU/1/15/1029/007 56 tableta EU/1/15/1029/008 70 tableta EU/1/15/1029/009 14x1 tableta EU/1/15/1029/010 28x1 tableta EU/1/15/1029/011 49x1 tableta EU/1/15/1029/012 56x1 tableta EU/1/15/1029/013 98x1 tableta
UNIQUE IDENTIFIER - HUMAN READABLE DATA
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM (Samo kutija za bocu:)
EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
EU/1/15/1029/029 10 tableta EU/1/15/1029/030 14 tableta EU/1/15/1029/031 16 tableta EU/1/15/1029/032 28 tableta EU/1/15/1029/033 30 tableta EU/1/15/1029/034 35 tableta EU/1/15/1029/035 56 tableta EU/1/15/1029/036 70 tableta EU/1/15/1029/037 14x1 tableta EU/1/15/1029/038 28x1 tableta EU/1/15/1029/039 49x1 tableta EU/1/15/1029/040 56x1 tableta EU/1/15/1029/041 98x1 tableta
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazol Sandoz 15 mg tablete aripiprazol
Hydroxypropyl cellulose
hidroksipropilceluloza, magnezijev stearat.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/014
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
• nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi Vama ili drugima, što može uključivati: - snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj, - promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani seksualni poriv, - pretjerano kupovanje ili trošenje koje se ne može kontrolirati, - prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi), - sklonost da se odluta.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
hidroksipropilceluloza, magnezijev stearat, žuti željezov oksid.
Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Aripiprazol Sandoz 20 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat
Aripiprazole Sandoz 30 mg tablets
Sandoz 30 mg tablete
Aripiprazole Sandoz 30mg tablets
Sandoz 30 mg tablete aripiprazol
Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Sandoz tablets for patients who have difficulty swallowing Aripiprazole Sandoz tablets (see section 5.2).
Sandoz tablete u bolesnika kojima je teško progutati Aripiprazol
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Sandoz 30 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat crveni željezov oksid (E172)
Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
EU/1/15/1029/021 (56 tableta) EU/1/15/1029/022 (70 tableta) EU/1/15/1029/023 (14 x 1 tableta) EU/1/15/1029/024 (28 x 1 tableta) EU/1/15/1029/025 (49 x 1 tableta) EU/1/15/1029/026 (56 x 1 tableta) EU/1/15/1029/027 (98 x 1 tableta) EU/1/15/1029/028 (100 tableta)
The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Liječnik može odlučiti da bolesnici ili njegovi njegovatelj mogu sami injicirati lijek nakon što su prošli odgovarajuću obuku.
This compared with 2 attacks per month for patients on placebo (a dummy treatment).
To je uspoređeno s dva napadaja mjesečno za bolesnike koji su uzimali placebo (prividno liječenje).
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu3151551
The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Preporučena početna doza lijeka Takhzyro iznosi 300 mg svaka dva tjedna.
Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Više informacija o lijeku Takhzyro nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Bolesnici su imali u prosjeku 0,3 napadaja mjesečno kada su dobivali injekcije lijeka Takhzyro svaka dva tjedna i 0,5 napadaja kada su dobivali injekcije svaka četiri tjedna.
If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Ako bolesnik nema napadaje pri dozi koja se uzima jednom svaka dva tjedna, liječnik može smanjiti učestalost uzimanja lijeka na jednom svaka četiri tjedna.
Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Nasljedni angioedem rijetka je bolest, a Takhzyro je dobio status „lijeka za rijetku bolest” 9. listopada 2015.
Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
U bolesnika s angioedemom dolazi do brzog oticanja tkiva ispod kože, u područjima kao što su lice, grlo, ruke i noge.
What measures are being taken to ensure the safe and effective use of Takhzyro?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Takhzyro?
Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Takhzyro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Takhzyro have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Takhzyro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
The European Medicines Agency therefore decided that Takhzyro's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Takhzyro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Other information about Takhzyro
Ostale informacije o lijeku Takhzyro
Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.
Napadaji nasljednog angioedema mogu biti opasni po život ako oteklina oko grla pritišće dišne puteve.
The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.
Najčešće nuspojave lijeka Takhzyro (koje se mogu pojaviti u više od 1 na 10 bolesnika) su reakcije na mjestu injiciranja, uključujući eritem (crvenilo), modrice i bol.
By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.
Inhibiranjem djelovanja kalikreina, lanadelumab pomaže u sprječavanju oticanja i povezanih simptoma angioedema.
As for all medicines, data on the use of Takhzyro are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Takhzyro kontinuirano se prate.
What is Takhzyro and what is it used for?
Što je Takhzyro i za što se primjenjuje?
An overview of Takhzyro and why it is authorised in the EU
Pregled informacija o lijeku Takhzyro i zašto je odobren u EU-u
For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Takhzyro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.
Bolesnici s nasljednim angioedemom imaju visoke razine tvari koja se naziva bradikinin i koja uzrokuje proširenje krvnih žila i propuštanje tekućine u okolna tkiva, što uzrokuje napadaje oticanja, koje nalazimo pri pojavi angioedema.
Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Lijek Takhzyro izdaje se samo na liječnički recept, a liječenje se mora započeti pod nadzorom liječnika s iskustvom u liječenju nasljednog angioedema.
Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.
Takhzyro je lijek za sprječavanje napadaja nasljednog angioedema u bolesnika u dobi od 12 godina i starijih.
What are the risks associated with Takhzyro?
Koji su rizici povezani s lijekom Takhzyro?
Why is Takhzyro authorised in the EU?
Zašto je lijek Takhzyro odobren u EU-u?
Overall, the safety profile was considered acceptable.
Sigurnosni profil lijeka Takhzyro smatra se prihvatljivim.