natgillin/translations-raw huggingface dataset:
Do not use vials exhibiting foreign particles or discoloration.
Ne smiju se upotrijebiti bočice koje sadrže vidljive čestice ili u kojima je otopina promijenila boju.
Sixty-three percent of Q4- and 81% of Q2treated patients met the composite endpoint at Month 24; the difference was not statistically significant based on the 95% CI (-0.357, 0.058).
Razlika nije bila statistički značajna na temelju 95% CI (-0,357, 0,058).
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Lijek razrijeđen u 0,9%tnoj otopini natrijevog klorida za intravensku primjenu zadržava kemijsku stabilnost ako se čuva do 24
Cerezyme 200 Units Powder for concentrate for solution for infusion imiglucerase
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju imigluceraza
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Ovaj lijek sadrži natrij i primjenjuje se u otopini natrijevog klorida od 9 mg/ml (0,9%) za intravensku primjenu (vidjeti dio 6.6).
Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease.
4.2 Doziranje i način primjene Liječenje bolesti mora voditi liječnik s iskustvom u liječenju Gaucherove bolesti.
It is supplied as a powder which will be mixed with sterile water before it is given.
Dolazi u obliku praška koji se prije primjene miješa sa sterilnom vodom.
Cerezyme 400 Units Powder for concentrate for solution for infusion imiglucerase
Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju imigluceraza
Anaphylactoid reactions
Anafilaktoidne reakcije
Cerezyme 200 Units powder for concentrate for solution for infusion To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 ml.
Kako bi se osigurao dovoljan volumen lijeka za točno doziranje, svaka bočica sadrži višak od 0,3 ml.
Cerezyme 400 Units powder for concentrate for solution for infusion To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.6 ml.
Kako bi se osigurao dovoljan volumen lijeka za točno doziranje, svaka bočica sadrži višak od 0,6 ml.
After reconstitution, the solution contains 40 units of imiglucerase per ml.
Nakon pripreme za primjenu otopina sadrži 40 jedinica imigluceraze po mililitru.
Cerezyme 200 Units powder for concentrate for solution for infusion Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju Rekonstituirajte jednu bočicu s 5,1 ml vode za injekcije.
Uncommon ( may affect up to 1 in 100 people): - dizziness - headache - a sensation of tingling, pricking, burning or numbness of the skin - increased heart rate - bluish skin - flushing - fall in blood pressure - vomiting - nausea - abdominal cramping - diarrhoea - pain in the joints - infusion site discomfort - infusion site burning - infusion site swelling - injection site sterile abscess - chest discomfort - fever - rigors - fatigue - backache
- proljev - bol u zglobovima - nelagoda na mjestu primjene infuzije - žarenje na mjestu primjene infuzije - oticanje na mjestu primjene infuzije - sterilna gnojna upala na mjestu injekcije - nelagoda u prsnom košu
Cerezyme 400 Units powder for concentrate for solution for infusion Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju Rekonstituirajte jednu bočicu s 10,2 ml vode za injekcije.
MARKETING AUTHORIZATION NUMBERS
PUŠTANJE SERIJE LIJEKA U PROMET
Dilution
Dojenje
Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Izbjegavajte naglo izlijevanje vode za injekcije na prašak, a otopinu miješajte polako da se ne zapjeni.
Eesti sanofi-aventis Estonia OÜ Tel. +372 6 273 488
Hrvatska sanofi-aventis Croatia d.o.o. Tel: +385 1 600 3 4 00
Common ( may affect up to 1 in 10 people): - breathlessness - coughing - hives/ localised swelling of the skin or lining of the mouth or throat - itching - rash
- koprivnjača/lokalizirano oticanje kože ili sluznice usta ili grla
EU/1/08/494/005 STELARA 130 mg Concentrate for solution for infusion
EU/1/08/494/005 STELARA 130 mg Koncentrat za otopinu za infuziju
Content (concentration)
Sastav (koncentracija) Veličina pakovanja
CAPSULE
KAPSULE
Pfizer Corporation Austria Gesellschaft M.B.H.
Pfizer Corporation Austrija Gesellschaft M.B.H.
Teva Pharma Belgium N.V.-S.A
Teva Pharma Belgija N.V.-S.A
CAPSULE, HARD ORAL USE
KAPSULE, TVRDE ORALNA PRIMJENA
Fresenius Kabi Hungary Kft.
Fresenius Kabi Mađarska Kft.
Pfizer Healthcare Ireland
Pfizer Healthcare Irska
Pfizer Luxembourg Sarl
Pfizer Luksemburg Sarl
United Kingdom Nrim Limited
Nrim Limited
Vancomycin Pfizer Healthcare Ireland
Vancomycin Pfizer Healthcare Irska
INFUSION
INFUZIJU
POWDER FOR CONCENTRATE FOR
PRAŠAK ZA KONCENTRAT ZA
United Kingdom Co-Pharma Limited Vancomycin CoPharma
Co-Pharma Limited Vancomycin CoPharma
Teva Denmark A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE
Teva Danska A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE
Mip Pharma Austria Gmbh
Mip Pharma Austrija Gmbh
Fresenius Kabi Romania S.R.L.
Fresenius Kabi Rumunjska S.R.L.
Labesfal Laboratorios Almiro, S.A.
Laboratorios Almiro, S.A.
1.025G VIAL
1.025G BOČICA
Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd
WockTVRDEt Uk Ltd Vancomycin WockTVRDEt Uk Ltd
CUTANEOUS USE
CUTANEOUS
VANCOMYCIN 500MG POWDER FOR
VANCOMYCIN 500MG PRAŠAK ZA
United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 1000MG VIAL
Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 1000MG BOČICA
1000 mg
and 1000MG
Actavis Group Ptc Vankomicin Actavis VANCOMYCIN
Actavis Group Ptc Vancomycin Actavis VANCOMYCIN PRAŠAK ZA
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, POWDER FOR ORAL SOLUTION
PRAŠAK ZA KONCENTRAT ZA OTOPINU ZA INFUZIJU, POWDER FOR ORAL SOLUTION
United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 500MG VIAL
Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 500MG BOČICA
POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION
PRAŠAK ZA OTOPINU ZA INFUZIJU / POWDER FOR ORAL SOLUTION
Voxin® 500mg/Vial
Voxin® 500mg/BOČICA
VANCOMYCIN HYDROCHLORIDE 128.15MG CAPSULE
VANCOMYCIN HYDROCHLORIDE 128.15MG KAPSULE
Fresenius Kabi France S.A.S.
Fresenius Kabi Francuska S.A.S.
Vancomicina Kern Pharma
Kern Pharma, S.L. Vancomicina Kern Pharma
Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG VIAL
Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG BOČICA
1020MG VIAL
1020MG BOČICA
United Kingdom Actavis Group Ptc Ehf.
Češka Republika Actavis Group Ptc Ehf.
Hospira Uk Ltd Vanmicira
Češka Republika Hospira Uk Ltd Vanmicira
1026MG Vial
1026MG BOČICA
VANCOMYCIN 250MG CAPSULE
VANCOMYCIN 250MG KAPSULE
Vancomycin Actavis VANCOMYCIN 125MG CAPSULE
Vancomycin Actavis VANCOMYCIN 125MG KAPSULE
VANCOMYCIN 125MG CAPSULE
VANCOMYCIN 125MG KAPSULE
United Kingdom Hikma Farmacêutica (Portugal), S.A.
Češka Republika Hikma Farmacêutica (Portugal), S.A.
Vancomycin Actavis VANCOMYCIN 250MG CAPSULE
Vancomycin Actavis VANCOMYCIN 250MG KAPSULE
Vancomycin Xellia VANCOMYCIN 250MG CAPSULE
Vancomycin Xellia VANCOMYCIN 250MG KAPSULE
Orion Corporation Vancomycin Orion VANCOMYCIN 500MG VIAL
Orion Corporation Vancomycin Orion VANCOMYCIN 500MG BOČICA
Vancomycin Xellia VANCOMYCIN 125MG CAPSULE
Vancomycin Xellia VANCOMYCIN 125MG KAPSULE
Orion Corporation Vancomycin Orion VANCOMYCIN 1000MG VIAL
Orion Corporation Vancomycin Orion VANCOMYCIN 1000MG BOČICA
VANCOMYCIN 1000 mg per vial
VANCOMYCIN 1000 mg per BOČICA
Vancomicina Axelia Vancomycin hydrochloride 500 vial
Vancomicina Axelia Vancomycin hydrochloride 500
VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE
VANCOMYCIN HYDROCHLORIDE 250MG KAPSULE
POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION
PRAŠAK ZA ORALNU OTOPINU, POWDER FOR SOLUTION FOR INJECTION
Fresenius Kabi Bulgaria Eood ванкомицин каби VANCOMYCIN 1000MG VIAL
Fresenius Kabi Bugarska Eood ванкомицин каби VANCOMYCIN 1000MG BOČICA
VANCOMYCIN HYDROCHLORIDE 1025MG/1025 MG
HYDROCHLORIDE 1025MG/1025 MG
VANCOMYCIN HYDROCHLORIDE 256MG CAPSULE
VANCOMYCIN HYDROCHLORIDE 256MG KAPSULE
Mylan Hospital As Vancomycin Mylan VANCOMYCIN 1000MG VIAL
Mylan Hospital As Vancomycin Mylan VANCOMYCIN 1000MG BOČICA
Vancomicina Axelia Vancomycin hydrochloride 1000 vial
Vancomicina Axelia Vancomycin hydrochloride 1000
POWDER FOR
OTOPINU ZA
Fresenius Kabi Bulgaria Eood ванкомицин каби VANCOMYCIN 500MG VIAL
Fresenius Kabi Bugarska Eood ванкомицин каби VANCOMYCIN 500MG BOČICA
Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 500MG VIAL
Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 500MG BOČICA
Vancomycin Sandoz VANCOMYCIN 1000MG VIAL
Vancomycin Sandoz VANCOMYCIN 1000MG BOČICA
VANCOMYCIN HYDROCHLORIDE 1000000 I.U.
VANCOMYCIN HYDROCHLORIDE 1000000 I.U. G
VANCOMYCIN HYDROCHLORIDE 125MG CAPSULE
VANCOMYCIN HYDROCHLORIDE 125MG KAPSULE
Vancomicina Sala VANCOMYCIN 500MG VIAL
Vancomicina Sala VANCOMYCIN 500MG BOČICA
Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 1000MG VIAL
Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 1000MG BOČICA
Vancomicina Normon VANCOMYCIN 500MG VIAL
Vancomicina Normon VANCOMYCIN 500MG BOČICA
Vancomycin Xellia VANCOMYCIN 1000MG VIAL
Vancomycin Xellia VANCOMYCIN 1000MG BOČICA
Mylan Hospital As Vancomycin Mylan VANCOMYCIN 500MG VIAL
Mylan Hospital As Vancomycin Mylan VANCOMYCIN 500MG PRAŠAK ZA
ORAL USE
USE
Vancomicina Hospira VANCOMYCIN 500MG VIAL
Vancomicina Hospira VANCOMYCIN 500MG BOČICA
Vancomycin Vocate VANCOMYCIN 500MG VIAL
Vancomycin Vocate VANCOMYCIN 500MG BOČICA
Fresenius Kabi ванкомицин каби VANCOMYCIN 500MG POWDER FOR
Fresenius Kabi Bugarska Eood ванкомицин каби VANCOMYCIN 500MG PRAŠAK ZA KONCENTRAT ZA
VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL
VANCOMYCIN HYDROCHLORIDE 1025.14MG BOČICA
Vancomycin Vocate VANCOMYCIN 1000MG VIAL
Vancomycin Vocate VANCOMYCIN 1000MG BOČICA
United Kingdom Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh
Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh
Vancomycine Teva VANCOMYCIN 500MG VIAL
Vancomycine Teva VANCOMYCIN 500MG BOČICA
HYDROCHLORIDE 513MG VIAL
HYDROCHLORIDE 513MG BOČICA
510MG VIAL
510MG BOČICA
HYDROCHLORIDE 1025MG VIAL
HYDROCHLORIDE 1025MG BOČICA
Vancomycin Mip VANCOMYCIN 500MG VIAL
Vancomycin Mip VANCOMYCIN 500MG BOČICA
Vancomycin Xellia VANCOMYCIN 500MG VIAL
Vancomycin Xellia VANCOMYCIN 500MG BOČICA
Vancomycin Xellia VANCOMYCIN 250MG CAPSULE, HARD ORAL USE
Vancomycin Xellia VANCOMYCIN 125MG KAPSULE, TVRDE ORALNA PRIMJENA
Vancomycin Mip VANCOMYCIN 1000MG VIAL
Vancomycin Mip VANCOMYCIN 1000MG BOČICA
Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL
Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G BOČICA
Lyomark Pharma Vancomycin Lyomark VANCOMYCIN
Lyomark Pharma Vancomycin
VANCOMYCIN 500 mg per vial
VANCOMYCIN 500 mg per BOČICA
Vancomycin Noridem VANCOMYCIN 1000MG VIAL
Vancomycin Noridem VANCOMYCIN 1000MG BOČICA
Vancomycine Mylan VANCOMYCIN 1000MG VIAL
Vancomycine Mylan VANCOMYCIN 1000MG BOČICA
VANCOMYCIN HYDROCHLORIDE 500000 I.U.
VANCOMYCIN HYDROCHLORIDE 500000 I.U. BOČICA
Vancomycin hydrochloride 500 Vial
Vancomycin hydrochloride 500 BOČICA
Vancomycin Noridem VANCOMYCIN 500MG VIAL
Vancomycin Noridem VANCOMYCIN 500MG BOČICA
Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG VIAL
Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG BOČICA
Vancomycin Actavis VANCOMYCIN 1000MG VIAL
Vancomycin Actavis VANCOMYCIN 1000MG BOČICA
VANCOMYCIN 1G VIAL POWDER FOR
VANCOMYCIN POWDER FOR
Vankomicin Actavis VANCOMYCIN 500MG VIAL
Vankomicin Actavis VANCOMYCIN 500MG BOČICA
1025.2 - 1040.2MG VIAL
1025.14MG BOČICA
Vancomycin Actavis VANCOMYCIN 500MG VIAL
Vancomycin Actavis VANCOMYCIN 500MG BOČICA
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG BOČICA
Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 500 mg VIAL
Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 500 mg BOČICA
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG BOČICA
Vancomycin Hikma VANCOMYCIN 500MG VIAL
Vancomycin Hikma VANCOMYCIN 500MG BOČICA
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG BOČICA
Vancomycin Hikma VANCOMYCIN 1000MG VIAL
Vancomycin Hikma VANCOMYCIN 1000MG BOČICA
Vancomycine Hikma VANCOMYCIN 500MG VIAL
Vancomycine Hikma VANCOMYCIN 500MG BOČICA
1000MG vial
1000MG BOČICA
513MG Vial
513MG BOČICA
VANCOMYCIN HYDROCHLORIDE 512MG VIAL
VANCOMYCIN HYDROCHLORIDE 512MG BOČICA
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG BOČICA
VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL
VANCOMYCIN HYDROCHLORIDE 512.57MG BOČICA
500MG VIAL
500MG BOČICA
Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg vial
Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg BOČICA
Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 500 mg vial
Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 500 mg BOČICA
Vancomycine Hikma VANCOMYCIN 1000MG VIAL
Vancomycine Hikma VANCOMYCIN 1000MG BOČICA
Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Vancomycin Nrim VANCOMYCIN 1000MG BOČICA
Vancomycin Nrim VANCOMYCIN 500MG VIAL
Vancomycin Nrim VANCOMYCIN 500MG BOČICA
Trading
Laboratórios
Vancomycine Mylan VANCOMYCIN 500MG VIAL
Vancomycine Mylan VANCOMYCIN 500MG BOČICA
VANCOMYCIN Hydrochloride1000MG VIAL
VANCOMYCIN Hydrochloride1000MG BOČICA
Vancomycin Mylan VANCOMYCIN 500MG VIAL
Vancomycin Mylan VANCOMYCIN 500MG BOČICA
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG BOČICA
Vankomicin Pfizer VANCOMYCIN 1000MG VIAL
Vankomicin Pfizer VANCOMYCIN 1000MG BOČICA
Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG BOČICA
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG BOČICA
POWDER FOR ORAL SOLUTION, SOLUTION FOR INFUSION
PRAŠAK ZA ORALNU OTOPINU, SOLUTION FOR INFUSION
Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE
Sandoz Gmbh Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE
Vancomicina Pfizer VANCOMYCIN 1000MG VIAL
Vancomicina Pfizer VANCOMYCIN 1000MG BOČICA
Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG BOČICA
Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG BOČICA
Vancomycine Pfizer VANCOMYCIN 500MG VIAL
Vancomycine Pfizer VANCOMYCIN 500MG BOČICA
Vancomycin Teva VANCOMYCIN 1000 I.U.
Vancomycin Teva VANCOMYCIN 1000 I.U. / MG
Vancomycin Pfizer VANCOMYCIN 1000MG VIAL
Vancomycin Pfizer VANCOMYCIN 1000MG BOČICA
Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 1000MG VIAL
Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 1000MG BOČICA
Vankomicin Pfizer VANCOMYCIN 500MG VIAL
Vankomicin Pfizer VANCOMYCIN 500MG BOČICA
Vancomicina Pfizer VANCOMYCIN 500MG VIAL
Vancomicina Pfizer VANCOMYCIN 500MG BOČICA
Vancomicina Labesfal VANCOMYCIN Hydrochloride 500MG vial
Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 500MG BOČICA
Vancomycin Norma VANCOMYCIN 500MG VIAL
Norma Hellas S.A. Vancomycin Norma VANCOMYCIN 500MG BOČICA
HYDROCHLORIDE 500MG VIAL
HYDROCHLORIDE 500MG BOČICA
512.6 - 520.1MG VIAL
512.571MG UNITS
Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 500MG VIAL
Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 500MG BOČICA
Vancomycin Pfizer VANCOMYCIN 500MG VIAL
Vancomycin Pfizer VANCOMYCIN 500MG BOČICA
VANCOMYCIN HYDROCHLORIDE 1MG VIAL
VANCOMYCIN HYDROCHLORIDE 1MG BOČICA
Vancomicina Normon VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Vancomicina Normon VANCOMYCIN 1G BOČICA
Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G
Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G BOČICA
VANCOMYCIN HYDROCHLORIDE 510MG VIAL
VANCOMYCIN HYDROCHLORIDE 510MG BOČICA
MA (EU) number (Invented) name
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
The dose in children depends on their age.
Doza u djece ovisi o njihovoj dobi.
Adults and adolescents can use any form of the medicine.
Odrasle osobe i adolescenti mogu koristiti bilo koji oblik lijeka.
The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Neoclarityn nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The side effects seen in children are similar.
Kod djece su uočene slične nuspojave.
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Neoclarityn na snazi u Europskoj uniji od 15. siječnja 2001.
Neoclarityn has also been studied in 416 patients with urticaria.
Neoclarityn je također ispitivan u 416 bolesnika s urtikarijom.
The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Preporučena doza za odrasle osobe i adolescente (u dobi od 12 godina i stariji) iznosi 5 mg jednom na dan.
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Predstavljena su dodatna ispitivanja kako bi se pokazalo da tijelo tretira sirup, oralnu otopinu i orodisperzibilne tablete na isti način kao tablete, te da bi se dokazalo da se mogu sigurno primjenjivati u djece.
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
U odraslih osoba i adolescenata, najčešće nuspojave bile su iscrpljenost (umor; 1,2 %), suha usta (0,8 %) i glavobolja (0,6 %).
This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Neoclarityn.
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 Neoclarityn.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Neoclarityn.
In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
U djece mlađe od dvije godine, najčešće nuspojave su proljev (3,7 %), vrućica (2,3 %) i insomnija (poteškoće sa spavanjem; 2,3 %).
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
U svim ispitivanjima, djelotvornost lijeka Neoclarityn uspoređena je s onom placeba (liječenja bez djelatne tvari).
For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Neoclarityn pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Ako su receptori inhibirani, histamin ne može djelovati, te to rezultira ublažavanjem simptoma ili alergije.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
U dva ispitivanja kod urtikarije, smanjenje u rezultatu simptoma nakon šest tjedana terapije lijekom Neoclarityn bilo je 58 do 67 %, u usporedbi sa 40 i 33 % u bolesnika liječenih placebom.
Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Neoclarityn je ispitivan u ukupno osam ispitivanja koja su obuhvatila 4 800 odraslih osoba i adolescenata s alergijskim rinitisom (uključujući ispitivanja u slučaju sezonskog alergijskog rinitisa i dva ispitivanja u bolesnika koji su također imali astmu).
It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Dostupan je kao tablete od 5 mg, orodisperzibilne tablete (tablete koje se otapaju u ustima) od 2,5 mg i 5 mg, sirup od 0,5 mg/ml i oralna otopina od 0,5 mg/ml.
Neoclarityn is a medicine containing the active substance desloratadine.
Neoclarityn je lijek koji sadrži djelatnu tvar desloratadin.
The active substance in Neoclarityn, desloratadine, is an antihistamine.
Djelatna tvar lijeka Neoclarityn, desloratadin, je antihistamin.
The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
Djelotvornost je mjerena promatranjem promjena simptoma (svrbež, broj i veličina osipa, poremećaji spavanja i dnevnih funkcija) prije i nakon šest tjedana terapije.
Other information about Neoclarityn
Ostale informacije o lijeku Neoclarityn
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
U slučaju alergijskog rinitisa, promatrajući rezultate svih ispitivanja zajedno, nakon dva tjedna terapije lijekom Neoclarityn od 5 mg došlo je do prosječnog smanjenja simptoma od 25 do 32 %, u usporedbi sa smanjenjem od 12 do 26% u bolesnika koji su primali placebo.
EPAR summary for the public desloratadine
EPAR, sažetak za javnost
Why has Neoclarityn been approved?
Zašto je Neoclarityn odobren?
Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Neoclarityn se koristi za ublažavanje simptoma alergijskog rinitisa (upale nosnih putova uzrokovane alergijom, primjerice alergijom na sijeno ili alergijom na prašinske grinje) ili urtikarije (stanje kože uzrokovano alergijom, sa simptomima koji uključuju svrbež i osip).
It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Djeluje inhibirajući receptore na koje se normalno vezuje histamin, tvar u tijelu koja uzrokuje alergijske simptome.
Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Neoclarityn se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na desloratadin ili na bilo koju drugu pomoćnu tvar.
The CHMP decided that Neoclarityn's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi lijeka Neoclarityn premašuju s njim povezane rizike za ublažavanje simptoma povezanih s alergijskim rinitisom ili urtikarijom i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
What is Neoclarityn?
Što je Neoclarityn?
What is the risk associated with Neoclarityn?
Koji su rizici povezani s lijekom Neoclarityn?
The effectiveness of Neoclarityn was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Djelotvornost lijeka Neoclarityn mjerena je promatranjem promjena simptoma (iscjedak iz nosa, svrbež, kihanje i zatvor) prije i nakon dva ili četiri tjedna terapije.