natgillin/translations-raw huggingface dataset:
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 tabletti EU/1/15/1029/016 14 tabletti EU/1/15/1029/017 16 tabletti EU/1/15/1029/018 28 tabletti EU/1/15/1029/019 30 tabletti EU/1/15/1029/020 35 tabletti EU/1/15/1029/021 56 tabletti EU/1/15/1029/022 70 tabletti EU/1/15/1029/023 14 x 1 tabletti EU/1/15/1029/024 28 x 1 tabletti EU/1/15/1029/025 49 x 1 tabletti EU/1/15/1029/026 56 x 1 tabletti EU/1/15/1029/027 98 x 1 tabletti
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 5 mg tabletid aripiprasool
Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch
Aripiprazole Sandoz 30 mg tabletid Laktoosmonohüdraat Maisitärklis
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)
Aripiprazole Sandoz 30 mg tabletid EU/1/15/1029/048 (10 tabletti) EU/1/15/1029/049 (14 tabletti) EU/1/15/1029/050 (16 tabletti) EU/1/15/1029/051 (28 tabletti) EU/1/15/1029/052 (30 tabletti) EU/1/15/1029/053 (35 tabletti) EU/1/15/1029/054 (56 tabletti) EU/1/15/1029/055 (70 tabletti) EU/1/15/1029/056 (14 x 1 tabletti) EU/1/15/1029/057 (28 x 1 tabletti) EU/1/15/1029/058 (49 x 1 tabletti) EU/1/15/1029/059 (56 x 1 tabletti) EU/1/15/1029/060 (98 x 1 tabletti) EU/1/15/1029/061 (100 tabletti)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/014
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 15 mg tabletid aripiprasool
Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch
Aripiprazole Sandoz 10 mg tabletid Laktoosmonohüdraat Maisitärklis
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)
Aripiprazole Sandoz 15 mg tabletid EU/1/15/1029/029 (10 tabletti) EU/1/15/1029/030 (14 tabletti) EU/1/15/1029/031 (16 tabletti) EU/1/15/1029/032 (28 tabletti) EU/1/15/1029/033 (30 tabletti) EU/1/15/1029/034 (35 tabletti) EU/1/15/1029/035 (56 tabletti) EU/1/15/1029/036 (70 tabletti) EU/1/15/1029/037 (14 x 1 tabletti) EU/1/15/1029/038 (28 x 1 tabletti) EU/1/15/1029/039 (49 x 1 tabletti) EU/1/15/1029/040 (56 x 1 tabletti) EU/1/15/1029/041 (98 x 1 tabletti) EU/1/15/1029/042 (100 tabletti)
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/1/15/1029/00110 tabletti EU/1/15/1029/002 14 tabletti EU/1/15/1029/003 16 tabletti EU/1/15/1029/004 28 tabletti EU/1/15/1029/005 30 tabletti EU/1/15/1029/006 35 tabletti EU/1/15/1029/007 56 tabletti EU/1/15/1029/008 70 tabletti EU/1/15/1029/009 14 x 1 tabletti EU/1/15/1029/010 28 x 1 tabletti EU/1/15/1029/011 49 x 1 tabletti EU/1/15/1029/012 56 x 1 tabletti EU/1/15/1029/013 98 x 1 tabletti
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Väliskarp: Aripiprazole Sandoz 15 mg
How to store Aripiprazole Sandoz tablets
Kuidas Aripiprazole Sandozt säilitada
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 10 mg tabletid aripiprasool
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
hüdroksüpropüültselluloos, magneesiumstearaat, kollane raudoksiid.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease,
• kardiovaskulaarsed haigused (südame ja veresoonkonna haigused), kardiovaskulaarhaigus lähisugulastel, insult või „mikroinsult”, liiga kõrge või madal vererõhk;
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 tabletti EU/1/15/1029/030 14 tabletti EU/1/15/1029/031 16 tabletti EU/1/15/1029/032 28 tabletti EU/1/15/1029/033 30 tabletti EU/1/15/1029/034 35 tabletti EU/1/15/1029/035 56 tabletti EU/1/15/1029/036 70 tabletti EU/1/15/1029/037 14 x 1 tabletti EU/1/15/1029/038 28 x 1 tabletti EU/1/15/1029/039 49 x 1 tabletti EU/1/15/1029/040 56 x 1 tabletti EU/1/15/1029/041 98 x 1 tabletti
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Aripiprazole Sandoz 5 mg tabletid Laktoosmonohüdraat Maisitärklis
Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch
Aripiprazole Sandoz 15 mg tabletid Laktoosmonohüdraat Maisitärklis
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 tabletti EU/1/15/1029/049 14 tabletti EU/1/15/1029/050 16 tabletti EU/1/15/1029/051 28 tabletti EU/1/15/1029/052 30 tabletti EU/1/15/1029/053 35 tabletti EU/1/15/1029/054 56 tabletti EU/1/15/1029/055 70 tabletti EU/1/15/1029/056 14 x 1 tabletti EU/1/15/1029/057 28 x 1 tabletti EU/1/15/1029/058 49 x 1 tabletti EU/1/15/1029/059 56 x 1 tabletti EU/1/15/1029/060 98 x 1 tabletti
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
hüdroksüpropüültselluloos, magneesiumstearaat, punane raudoksiid (E172).
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 25.6% and 45.0%, respectively.
72 kuud oli madala prolaktiini taseme esinemissagedus naistel (< 3 ng/ml) ja meestel (<2 ng/ml) vastavalt 25,6 % ja 45,0 %.
Magnesium stearate
Liigne süljeeritus
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/015-027
Pancreatitis Dysphagia Diarrhoea
Diabeetiline ketoatsidoos
The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst PegIntroni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Täiskasvanuil on PegIntroni kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) viirusnakkused, farüngiit (neelupõletik), aneemia (vere punaliblede vähesus), neutropeenia (neutrofiilide ehk vere teatud valgeliblede vähesus), isutus, depressioon (masendus), ärevus, emotsionaalne labiilsus (meeleolu kõikuvus), keskendumisraskused, unetus, peavalu, peapööritus, düspnoe (hingamisraskused), köha, oksendamine, iiveldus, kõhuvalu, kõhulahtisus, suukuivus, alopeetsia (juuste väljalangemine), pruritus (kihelus), nahakuivus, nahalööve, müalgia (lihasevalu), artralgia (liigesevalu), luu-lihaskonna valu, süstekoha reaktsioonid, süstekoha põletik, väsimus, asteenia (nõrkus), ärrituvus, külmavärinad, palavik, gripilaadsed sümptomid ja kehakaalu kaotus.
The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Euroopa Komisjon andis PegIntroni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. mail
Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Et PegIntroniga seonduvad sellised kõrvalnähud nagu depressioon, peab patsiente ravi ajal tähelepanelikult jälgima.
The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et PegIntroni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
See on ravimi PegIntron Euroopa avaliku hindamisaruande kokkuvõte.
Other information about PegIntron:
Muu teave PegIntroni kohta
For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate PegIntroniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Lastel ja noorukitel, kes said PegIntroni koos ribaviriiniga, olid kõrvalnähud samasugused kui täiskasvanutel, kuigi ka kasvupeetust esines enam kui 1 patsiendil 10st.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
PegIntroni tohib kasutada täiskasvanud (vähemalt 18-aastastel) patsientidel, keda varem ei ole ravitud või kelle varasem ravi on ebaõnnestunud.
The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
PegIntroni ja ribaviriini kombinatsiooni uuriti ka uuringus, kus osales 1354 täiskasvanut, kelle varasem ravi oli ebaõnnestunud, ja uuringus, kus osales 107 varem ravimata 3-17-aastast last ja noorukit.
PegIntron is also linked to weight loss and reduced growth in children and adolescents.
PegIntroni seostatakse lastel ja noorukitel ka kehakaalu kaotuse ja kasvupeetusega.
PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
PegIntroni ei tohi kasutada patsiendid, kellel on raske terviseseisund, rasked maksaprobleemid, ravile allumatu kilpnäärmehaigus või epilepsia või muud kesknärvisüsteemi häired.
PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
PegIntroni ei tohi kasutada patsiendid, kes on mis tahes interferooni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
What is PegIntron?
Mis on PegIntron?
For the full list of all side effects reported with PegIntron, see the package leaflet.
PegIntroni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Why has PegIntron been approved?
Miks PegIntron heaks kiideti?
The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
PegIntroni ja ribaviriini kombinatsioon oli efektiivne tsirroosiga ja HIVnakkusega patsientidel.
PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
PegIntroni kasutamist koos ribaviriiniga või ilma võrreldi alfa-2b-interferooniga viies põhiuuringus, milles osales kokku üle 6000 täiskasvanud patsiendi, kellel oli C-hepatiit ja keda varem ei olnud ravitud, sh 328 tsirroosiga patsienti ja 507 patsienti, kellel oli ka HIV-nakkus.
The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
PegIntronis sisalduvat alfa2b-interferooni valmistatakse rekombinant-DNA-tehnika abil: seda toodab bakter, millele on lisatud alfa-2b-interferooni teket võimaldav geen (DNA).
PegIntron peginterferon alfa-2b
PegIntron alfa-2b-peginterferoon
In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Teistele täiskasvanud patsientidele, kelle veres on C-hepatiidi viirus, sh neile, kes on nakatunud ka inimese immuunpuudulikkuse viirusega (HIV), manustatakse PegIntroni koos ribaviriiniga (ravi kahe preparaadiga) või ainsa ravimina, kui patsient ribaviriini ei talu.
What is the risk associated with PegIntron?
Mis riskid PegIntroniga kaasnevad?
PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
PegIntron on ravim, mis sisaldab toimeainena alfa-2b-peginterferooni.
Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Sõltuvalt kõrvalnähtude raskusest võib olla vaja ravi (sh ka botsepreviiri manustamine) täielikult lõpetada.
PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
PegIntroni tohib anda koos ribaviriini ja botsepreviiriga (ravi kolme preparaadiga) täiskasvanud patsientidele 1. tüüpi C-hepatiidi korral, kui patsiendi maks on kahjustatud, ent võimeline normaalselt talitlema (kompenseeritud maksahaigus).
In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Varem ravimata täiskasvanud patsientidel oli PegIntron efektiivsem kui alfa-2b-interferoon: ligikaudu veerandil patsientidest tekkis ravivastus üksnes PegIntronile ning ligikaudu pooltel PegIntroni ja ribaviriini kombinatsioonile.
PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Ravimit PegIntron kasutatakse kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viiruse nakkusest põhjustatud maksahaigus) raviks vähemalt 3-aastastel patsientidel.
Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
Ravi kolme preparaadiga suurendas ravile kiiresti reageerinud varem ravimata ja tervenenud patsientide arvu ligikaudu 30% võrra.
How does PegIntron work?
Kuidas PegIntron toimib?
What benefit has PegIntron shown during the studies?
Milles seisneb uuringute põhjal PegIntroni kasulikkus?
Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Kahes põhiuuringus (1503 täiskasvanud patsienti, kellel oli 1. tüüpi C-hepatiit ja kompenseeritud maksahaigus) hinnati koos ribaviriini ning botsepreviiriga manustatud PegIntroni toimet (ravi kolme preparaadiga) ainult PegIntroni ja ribaviriini toimega.
The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
PegIntroni toimeaine alfa-2b-peginterferoon kuulub interferoonide rühma.
The Committee noted that the dual combination with ribavirin was shown to be effective against longterm hepatitis C virus infection in adults and children.
Inimravimite komitee märkis, et on tõendatud kahe preparaadiga ravi (PegIntron koos ribaviriiniga) efektiivsus täiskasvanutel ja lastel kroonilise C-hepatiidi nakkuse korral.
What is PegIntron used for?
Milleks PegIntroni kasutatakse?
Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Ravi PegIntroniga peab alustama üksnes C-hepatiidiga patsientide ravis kogenud arst ning ravi peab toimuma tema järelevalve all.
How is PegIntron used?
Kuidas PegIntroni kasutatakse?
In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
1. tüüpi C-hepatiidi ja kompenseeritud maksahaigusega patsientide ravi kolme preparaadiga (PegIntron kombinatsioonis ribaviriini ning botsepreviiriga) oli efektiivsem kui ravi kahe preparaadiga (PegIntron koos ribaviriiniga).
How has PegIntron been studied?
Kuidas PegIntroni uuriti?
The doses of ribavirin and PegIntron may need to be adjusted for patients who experience side effects.
Kui patsiendil tekivad kõrvalnähud, võib olla vaja ribaviriini ja PegIntroni annuseid kohandada.
Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with PegIntron and ribavirin.
PegIntroni ja ribaviriini kombinatsioonile tekkis ravivastus ligikaudu veerandil täiskasvanuist, kelle varasem ravi oli ebaõnnestunud, ning ligikaudu kahel kolmandikul lastest ja noorukitest.
In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Alfa-2b-interferoon on PegIntronis pegüleeritud (seotud polüetüleenglükooliga).
The medicine can only be obtained with a prescription.
Pärast asjakohase väljaõppe saamist võivad patsiendid endale ravimit ise süstida.
The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Liikmesriigid tagavad, et müügiloa hoidja saadab kõikidele arstidele, kes võivad hakata Tamiflu'd välja kirjutama või kasutama, tervishoiutöötajatele mõeldud kirja, mille tekst on lisatud inimravimite komitee hindamisaruandele.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Liikmesriigid peavad tagama kõikide allpool kirjeldatud ravimpreparaadi ohutu ja efektiivse kasutamise tingimuste või piirangute täitmise.
The Member States shall agree with the MAH the communication plan for the DHPC letter.
Liikmesriigid lepivad müügiloa hoidjaga kokku tervishoiutöötajatele mõeldud kirja levitamise kava.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED VÕI PIIRANGUD, MIDA TULEB RAKENDADA LIIKMESRIIKIDES
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
LISA RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED VÕI PIIRANGUD, MIDA TULEB RAKENDADA LIIKMESRIIKIDES
The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Arst võib otsustada, et patsient või tema hooldaja tohib süstida ravimit ka ise, kui nad on saanud asjakohase väljaõppe.
What measures are being taken to ensure the safe and effective use of Takhzyro?
Mis meetmed võetakse, et tagada Takhzyro ohutu ja efektiivne kasutamine?
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.
Euroopa Ravimiamet otsustas, et Takhzyro kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
Overall, the safety profile was considered acceptable.
Takhzyro ohutusprofiili peeti üldiselt vastuvõetavaks.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/medicines/human/orphandesignations/eu3151551
Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Lisateave Takhzyro kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Other information about Takhzyro
Muu teave Takhzyro kohta
The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Takhzyro soovitatav algannus on 300 mg iga 2 nädala järel.
If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Kui patsiendile ei teki haigushooge ühe annuse kasutamisel iga kahe nädala järel, võib arst sagedust vähendada ühe annuseni iga 4 nädala järel.
Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Takhzyro on efektiivne angioödeemi hoogude ennetamisel ning asjaolu, et seda on vaja manustada ainult kord 2 või 4 nädala järel, peeti eeliseks muude olemasolevate ravivõimaluste ees.
As for all medicines, data on the use of Takhzyro are continuously monitored.
Nagu kõigi ravimite puhul, teostatakse Takhzyro kasutamise kohta pidevat järelevalvet.
Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Takhzyro kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Lisateavet Takhzyro kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.