natgillin/translations-raw huggingface dataset:
sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
povidoon K90, naatriummetabisulfit (E223), askorbüülpalmitaat (E304) ja DL-α-tokoferool (E307).
At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2”).
Teise nädala alguses peaksite kasutama 4 mg Neuprot (pakend märgistusega “2.
hallucination, hallucination visual, hallucination auditory, illusion), nightmare e,
tajumishäirede (k.a hallutsinatsioon, visuaalne hallutsinatsioon, kuulmishallutsinatsioon, illusioon), õudusunenäode, paranoia e,
AST, ALT, GGT), weight increased e, heart rate increased e, CPK increased d,e
ASAT, ALAT, GGT), kaalutõus e, kiirenenud pulss e, kreatiniinfosfokinaasi (CPK) taseme tõus d,e
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Neupro.
Hoiatused ja ettevaatusabinõud Enne Neupro kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega.
hypersexuality, libido increased), confusional state, disorientationd, agitationd
(k.a hüperseksuaalsus, suurenenud libiido), segasusseisund, desorientatsioon d,
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Ravimiga seotud kõrvaltoimed, mida kirjeldati enam kui 10%-l transdermaalse plaastriga Neupro ravitavatel patsientidel, on iiveldus, oksendamine, manustamiskoha reaktsioonid, unisus, pearinglus ja peavalu.
Neupro 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Neupro 1 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 1 mg rotigotiini.
7 transdermal patches of Neupro 8 mg/24 h
7 transdermaalset plaastrit Neupro 8 mg/24 h
What Neupro looks like and contents of the pack Neupro is a transdermal patch.
Kuidas Neupro välja näeb ja pakendi sisu
Erythema e, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Naha ja nahaaluskoe kahjustused pruuritus erüteeme, hüperhidroos e, üldine pruurituse, nahaärrituse, kontaktdermatiite, üldine löövee
Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Neupro 1 mg/24 h transdermaalne plaaster Neupro 3 mg/24 h transdermaalne plaaster
7 transdermal patches of Neupro 6 mg/24 h
7 transdermaalset plaastrit Neupro 6 mg/24 h
Palpitationse, atrial fibrillatione, supraventricular tachycardiae
Südame häired palpitatsioonide, kodade virvenduse, supraventrikulaarne tahhükardiae
paranoia e, confusional state e, psychotic disorder e, delusione, deliriume
segasusseisund e, psühhootiline häire e, delusioone, deliirium e
The patches of 2 mg/24 h are used for the treatment of Parkinson's disease and Restless Leg Syndrome.
Parkinsoni tõve ja rahutute jalgade sündroomi raviks kasutatakse 2 mg / 24 h plaastreid.
Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Iga 15 cm2 suurune plaaster sisaldab 6,75 mg rotigotiini.
Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Iga 30 cm2 suurune plaaster sisaldab 13,5 mg rotigotiini.
Neupro 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h'.
Neupro 8 mg/24 h transdermaalne plaaster Pealiskihi välimine pool on beež ja sellel on jäljend ‘Neupro 8 mg/24 h'.
The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.
Välimine pool on beež ja sellel on jäljend Neupro 4 mg/24 h, Neupro 6 mg/24 h või Neupro 8 mg/24 h.
Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
Neupro 4 mg/24 h transdermaalne plaaster Neupro 6 mg/24 h transdermaalne plaaster Neupro 8 mg/24 h transdermaalne plaaster
In a randomized, open-label study (SP825) in patients with early stage Parkinson's disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole.
25 patsienti randomiseeriti saama rotigotiinravi ja 26 patsienti ropiniroolravi Parkinsoni tõve varajase staadiumi randomiseeritud avatud uuringus (SP825).
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, asthenic conditions and headache.
Ravimiga seotud kõrvaltoimed, mida kirjeldati enam kui 10%-l transdermaalse plaastriga Neupro ravitavatel patsientidel, on iiveldus, manustamiskoha reaktsioonid, asteenilised seisundid ja peavalu.
How to use the Neupro patches
Kuidas Neupro plaastreid kasutada
Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd
agitatsioond psühhootiline häire, obsessiivkompulsiivne häire, agressiivne käitumine/ agressioon b,
Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Iga 40 cm2 suurune plaaster sisaldab 18,0 mg rotigotiini.
7 transdermal patches of Neupro 4 mg/24 h
7 transdermaalset plaastrit Neupro 4 mg/24 h
pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)
(k.a patoloogiline hasartmängude mängimine, stereotüüpsus/ sundtegutsemine, liigsöömishoog/ söömishäire b, sundostleminec)
Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Iga 20 cm2 suurune plaaster sisaldab 9,0 mg rotigotiini.
The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Pealiskihi välimine pool on beež ja sellel on jäljend ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h või 8 mg/24 h'.
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Iga 5 cm2 suurune plaaster sisaldab 2,25 mg rotigotiini.
Palpitationse, atrial fibrillatione, supraventricular tachycardia e
kodade virvendus e, supraventrikulaarne tahhükardia e
Vertigo e
suukuivus e,
Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Neupro 6 mg/24 h transdermaalne plaaster Pealiskihi välimine pool on beež ja sellel on jäljend ‘Neupro 6 mg/24 h'.
Each patch of 10 cm2 contains 4.5 mg of rotigotine.
Iga 10 cm2 suurune plaaster sisaldab 4,5 mg rotigotiini.
Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Naha ja nahaaluskoe kahjustused erüteem, hüperhidroos, pruuritus üldine pruuritus, nahaärritus, kontaktdermatiit üldine lööve
Neupro 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 4 mg rotigotiini.
On the first day of treatment, start with Neupro 2 mg (package marked “Week 1”), and use one Neupro 2 mg transdermal patch daily.
nädal”) ja kasutage iga päev ära üks Neupro 2 mg transdermaalne plaaster.
Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Neupro 4 mg/24 h transdermaalne plaaster Pealiskihi välimine pool on beež ja sellel on jäljend ‘Neupro 4 mg/24 h'.
The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h'.
Pealiskihi välimine pool on beež ja sellel on jäljend ‘Neupro 2 mg/24 h'.
Disturbances in consciousness NEC
Psühhiaatrilised häired tajumishäired a
Fall e a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson's disease
Täheldati turuletulekujärgsel perioodil d Topeltpimedate platseebokontrollitud kliiniliste uuringute ühendandmed (2011)
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
Välimine pool on beež ja sellel on jäljend Neupro 2 mg/24 h.
Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
Neupro 1 mg/24 h transdermaalne plaaster EU/1/05/331/038
Dopamine dysregulation syndromec, perception disturbancese
deliirium d dopamiini düsregulatsiooni sündroom c
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90,
Polü(dimetüülsiloksaan, trimetüülsilüülsilikaat)-kopolümerisaat,
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Välimine pool on beež ja sellel on jäljend Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h või 8 mg/24 h.
Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Neupro 8 mg/24 h transdermaalne plaaster EU/1/05/331/010
Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Neupro 6 mg/24 h transdermaalne plaaster EU/1/05/331/007
Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Neupro 4 mg/24 h transdermaalne plaaster EU/1/05/331/004
Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Neupro 3 mg/24 h transdermaalne plaaster EU/1/05/331/047
EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
EU/1/05/331/047 [7 transdermaalset plaastrit] EU/1/05/331/049 [28 transdermaalset plaastrit] EU/1/05/331/050 [30 transdermaalset plaastrit] EU/1/05/331/058 [14 transdermaalset plaastrit]
EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
EU/1/05/331/038 [7 transdermaalset plaastrit] EU/1/05/331/040 [28 transdermaalset plaastrit] EU/1/05/331/041 [30 transdermaalset plaastrit] EU/1/05/331/056 [14 transdermaalset plaastrit]
Neupro 8 mg/24 h transdermal patch rotigotine
Neupro 8 mg/24 h transdermaalne plaaster rotigotiin
EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
EU/1/05/331/010 [7 transdermaalset plaastrit] EU/1/05/331/011 [28 transdermaalset plaastrit] EU/1/05/331/033 [30 transdermaalset plaastrit] EU/1/05/331/061 [14 transdermaalset plaastrit]
Neupro 2 mg/24 h transdermal patch
Neupro 2 mg/24 h transdermaalne plaaster
Neupro 1 mg/24 h transdermal patch rotigotine
Neupro 1 mg/24 h transdermaalne plaaster rotigotiin
The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Tugevused rahutute jalgade sündroomi raviks on 1 mg/24 h, 2 mg/24 h ja 3 mg/24 h.
EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
EU/1/05/331/004 [7 transdermaalset plaastrit] EU/1/05/331/005 [28 transdermaalset plaastrit] EU/1/05/331/021 [30 transdermaalset plaastrit] EU/1/05/331/059 [14 transdermaalset plaastrit]
EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
EU/1/05/331/001 [7 transdermaalset plaastrit] EU/1/05/331/002 [28 transdermaalset plaastrit] EU/1/05/331/015 [30 transdermaalset plaastrit] EU/1/05/331/057 [14 transdermaalset plaastrit]
EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
EU/1/05/331/007 [7 transdermaalset plaastrit] EU/1/05/331/008 [28 transdermaalset plaastrit] EU/1/05/331/027 [30 transdermaalset plaastrit] EU/1/05/331/060 [14 transdermaalset plaastrit]
Neupro 6 mg/24 h transdermal patch rotigotine
Neupro 6 mg/24 h transdermaalne plaaster rotigotiin
Vomiting, dyspepsia
letargiae, krambide
AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd
ASAT, ALAT, GGT), kaalutõuse, kiirenenud pulss e, kreatiniinfosfokinaasi (CPK) taseme tõus d,e (vt
Component of a multipack, can't be sold separately
42 transdermaalset plaastrit, hulgipakendi osa (ei müüda eraldi).
EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/053 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/044 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/036 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/018 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/024 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsion e
(k.a sünkoop, vasovagaalne sünkoop, teadvusekaotus), düskineesia, posturaalne pearinglus, letargia krambid langetatud pea sündroom c,e
Application and instillation site reactionsa (incl.
Üldised häired ja manustamiskoha reaktsioo-* nid reaktsioonid kasutamis- ja manustamiskohal a
Neupro 4 mg/24 h transdermal patch Rotigotine
Neupro 4 mg/24 h transdermaalne plaaster rotigotiin
Oedema peripheral, asthenic conditionsa (incl.
perifeerne turse, asteenilised seisundid a
Neupro 3 mg/24 h transdermal patch rotigotine
Neupro 3 mg/24 h transdermaalne plaaster rotigotiin
Neupro 2 mg/24 h transdermal patch Rotigotine
Neupro 2 mg/24 h transdermaalne plaaster rotigotiin
EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
EU/1/05/331/030 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsione
(k.a sünkoop, vasovagaalne sünkoop, teadvusekaotus), düskineesia, posturaalne pearinglus, letargia krambid langetatud pea sündroom c
• itching
• pearinglus
syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
(k.a sünkoop, vasovagaalne sünkoop, teadvusekaotus), düskineesia e,
Ref.: EMEA/356088/2009 EMEA/H/C/1053
Viide: EMEA/484207/2009 EMEA/H/C/1053
It is available as pink tablets (75 mg).
Seda turustatakse roosade tablettidena (75 mg).
The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food.
Clopidogrel Teva tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Akuutse koronaarsündroomi korral kasutatakse Clopidogrel Tevat koos aspiriiniga; ravi algab üldiselt küllastusannusega, kus võetakse neli 75 mg tabletti.
Clopidogrel Teva can be started between seven days and six months after the stroke;
Clopidogrel Teva manustamist võib alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
Clopidogrel Teva can be given to the following groups of patients:
Clopidogrel Tevat võib kasutada järgmiste patsiendirühmade korral:
The Committee recommended that Clopidogrel Teva be given marketing authorisation.
Komitee soovitas anda Clopidogrel Tevale müügiloa.
Clopidogrel Teva clopidogrel EPAR summary for the public
Clopidogrel Teva klopidogreel Kokkuvõte üldsusele
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
Euroopa Komisjon andis Clopidogrel Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Teva Pharma B.V.28.
The full EPAR for Clopidogrel Teva can be found here.
Euroopa avaliku hindamisaruande täisteksti Clopidogrel Teva kohta leiate siit.
Clopidogrel Teva is a ‘generic medicine'.
Clopidogrel Teva on geneeriline ravim.
Because Clopidogrel Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Et Clopidogrel Teva on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
This means that Clopidogrel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
See tähendab, et Clopidogrel Teva on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
Clopidogrel Teva can be started between a few days and 35 days after the attack;
Clopidogrel Teva manustamist võib alustada mõne kuni 35 päeva jooksul pärast infarkti;
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Teva võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Clopidogrel Tevat võib manustada ka patsientidele, kellel on ST-segmendi elevatsiooniga (elektrokardiogrammi ehk EKG teatud ebanormaalne näit) südameinfarkt, kui arst arvab, et ravimist on patsiendile kasu.
Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Clopidogrel Teva on ravim, mis sisaldab toimeainena klopidogreeli.
Other information about Clopidogrel Teva:
Muu teave Clopidogrel Teva kohta
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Seetõttu arvas inimravimite komitee, et nagu ka Plavixi puhul, ületab Clopidogrel Teva kasulikkus sellega kaasnevad riskid.
Doc.
juulil 2009.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or ‘non-Q-wave' myocardial infarction.
Samuti võib Clopidogrel Tevat kasutada patsientidel, kellel seda ebanormaalset EKG-näitu ei ole, kui neil on ebastabiilne rinnaangiin (tugevad valud rindkeres) või on Q-sakita südameinfarkt.
Because Clopidogrel Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Et Clopidogrel Teva on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Clopidogrel Teva bioekvivalentsust võrdlusravimiga Plavix.
Clopidogrel Teva is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel Tevat kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
Why has Clopidogrel Teva been approved?
Miks Clopidogrel Teva heaks kiideti?
What are the benefit and risk of Clopidogrel Teva?
Milles seisneb Clopidogrel Teva kasulikkus ja mis riskid ravimiga kaasnevad?
How has Clopidogrel Teva been studied?
Kuidas Clopidogrel Tevat uuriti?
• patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Sel juhul tuleb Clopidogrel Tevat manustada koos aspiriiniga (samuti antikoagulant), sealhulgas patsientidele, kellele on paigaldatud stent (ahenenud arterit avardav väike toru).
What is Clopidogrel Teva used for?
Milleks Clopidogrel Tevat kasutatakse?
How is Clopidogrel Teva used?
Kuidas Clopidogrel Tevat kasutatakse?
The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation.
Clopidogrel Teva toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada trombide (soonesiseste verehüüvete) teket.
How does Clopidogrel Teva work?
Kuidas Clopidogrel Teva toimib?
Neutropenia lasted on average 1.6 days with both medicines.
Mõlema ravimiga kestis neutropeenia keskmiselt 1,6 päeva.
Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lisateave Pelgrazi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Pelgraz?
Mis meetmed võetakse, et tagada Pelgrazi ohutu ja efektiivne kasutamine?
Pelgraz (pegfilgrastim)
Pelgraz (pegfilgrastiim)
This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
See tähendab, et Pelgraz on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
What is Pelgraz and what is it used for?
Mis on Pelgraz ja milleks seda kasutatakse?
As for all medicines, data on the use of Pelgraz are continuously monitored.
Nagu kõigi ravimite puhul, teostatakse Pelgrazi kasutamise kohta pidevat järelevalvet.
Other information about Pelgraz
Muu teave Pelgrazi kohta
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelgraz have been included in the summary of product characteristics and the package leaflet.
Pelgrazi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist.
Lisateavet Pelgrazi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Euroopa Ravimiamet otsustas, et vastavalt ELi nõuetele bioloogiliselt sarnaste ravimite kohta sarnaneb Pelgraz struktuuri, puhtuse ja bioloogilise toime poolest Neulastaga ning et Pelgraz jaotub organismis samamoodi.
The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Pelgrazi toimeaine pegfilgrastiim sisaldab filgrastiimi, mis on väga sarnane inimvalguga, mida nimetatakse granulotsüütide kolooniaid stimuleerivaks faktoriks (G-CSF).
Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU.
Seetõttu on amet arvamusel, et nagu ka Neulasta korral, ületab Pelgrazi kasulikkus sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiite.
Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz.
Et Pelgraz on bioloogiliselt sarnane ravim, ei pea Neulastaga tehtud pegfilgrastiimi efektiivsus- ja ohutusuuringuid Pelgraziga kordama.
Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients.
Pelgrazi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones.
Pelgrazi kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on luuvalu.
The reference medicine for Pelgraz is Neulasta.
Pelgrazi võrdlusravim on Neulasta.
Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Pelgrazi manustatakse annuses 6 mg ühekordse nahaaluse süstena vähemalt 24 tundi pärast iga keemiaravitsükli (vähi ravimravi) lõppu.
What are the risks associated with Pelgraz?
Mis riskid Pelgraziga kaasnevad?
How does Pelgraz work?
Kuidas Pelgraz toimib?
For the full list of side effects and restrictions with Pelgraz, see the package leaflet.
Pelgrazi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Pelgraz ei ole ette nähtud kasutamiseks kroonilise müeloidleukeemia (teatud verevähi) või müelodüsplastiliste sündroomidega (haigusseisundid, mille korral patsiendi organismis tekib suurel hulgal ebanormaalseid vererakke, mille tagajärjel võib välja kujuneda leukeemia) patsientidel.
Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta.
Uuringud on samuti tõendanud, et Pelgraz tekitab organismis sarnase toimeainesisalduse kui Neulasta.