natgillin/translations-raw huggingface dataset:
Sikkerheden og effekten af Naglazyme hos patienter med nedsat nyre - eller leverfunktion er ikke blevet undersøgt.
The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated.
Brug af anden medicin Der er ingen kendte interaktioner med andre lægemidler.
Using other medicines There are no known interactions with other medicinal products.
Brug af Naglazyme sammen med mad og drikke Naglazyme gives som en intravenøs infusion, og derfor forventes der ingen interaktion med mad og drikke.
Using Naglazyme with food and drink Naglazyme is given via intravenous infusion, therefore no interaction with food and drink is expected.
Graviditet Naglazyme bør ikke anvendes under graviditet, medmindre det er tvingende nødvendigt.
Pregnancy Naglazyme should not be used during pregnancy unless clearly necessary.
Spørg Deres/ din læge eller apotek til råds, før De/ du bruger nogen form for medicin.
Ask your doctor or pharmacist for advice before taking any medicine.
Amning Det vides ikke, hvorvidt galsulfase udskilles i modermælk, og derfor bør amning ophøre under behandling med Naglazyme.
Breast-feeding It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Spørg Deres/ din læge eller apotek til råds, inden De/ du tager nogen form for medicin.
Ask your doctor or pharmacist for advice before taking any medicine.
Trafik - og arbejdssikkerhed Der er ikke foretaget undersøgelser af virkningen på evnen til at køre bil eller arbejde med værktøj eller maskiner.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed
SÅDAN SKAL DE/ DU BRUGE NAGLAZYME
HOW TO USE NAGLAZYME
Koncentratet til infusionsopløsningen skal fortyndes inden det indgives som intravenøs infusion.
The concentrate for solution for infusion has to be diluted prior to administration by intravenous infusion.
Dosering Det anbefalede doseringsregimen for galsulfase er 1 mg/ kg legemsvægt administreret én gang om ugen som en intravenøs infusion.
Dosage The recommended dosage regimen of galsulfase is 1 mg/ kg body weight administered once every week as an intravenous infusion.
Den første infusionshastighed justeres således, at cirka 2, 5% af den totale opløsning infunderes i løbet af den første time, mens det resterende volumen (cirka 97, 5%) infunderes i løbet af de næste 3 timer.
The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (approximately 97.5%) over the next 3 hours.
Hvis De/ du har taget for meget Naglazyme Der er ikke rapporteret tilfælde af overdosering.
If you use more Naglazyme than you should No case of overdose of Naglazyme has been reported.
Hvis De/ du har glemt at tage Naglazyme Hvis De/ du glemmer at tage Naglazyme, bedes De/ du kontakte Deres/ din læge.
If you forget to take Naglazyme If you forget to take Naglazyme, please contact your doctor.
Hvis en dosis glemmes delvist eller helt, må De/ du ikke øge den næste dosis som erstatning for den glemte dosis.
If a dose is partially administered or missed, the next dose will not be increased to make up for this.
Spørg lægen eller apoteket, hvis der er noget, De/ du er i tvivl om eller følger Dem/ dig usikker på.
If you have any further questions on the use of this product, ask your doctor.
Naglazyme kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Naglazyme can cause side effects, although not everybody gets them.
Følgende bivirkninger er rapporteret som relateret til Naglazyme:
The following side effects were reported as being related to Naglazyme:
Meget almindelig (flere end 1 ud af 10 patienter):
Very common (greater than 1 out of 10 patients):
Abdominal smerte, øresmerte, smerte, røde øjne, kortåndethed, kulderystelser, smerte i brystet, ondt i halsen, ondt i maven, dårlige reflekser, uklare
Abdominal pain, ear pain, pain, reddened eye, shortness of breath, chills, chest pain, sore throat, stomach pain, poor reflexes, cloudy eyes, swollen face, gastroenteritis, high blood pressure, malaise, nasal congestion, bulging belly button, fever, headache, rash, nausea, vomiting and joint pain.
Almindelig (flere end 1 ud af 100 patienter):
21 Common (greater than 1 out of 100 patients):
Nældefeber, hævet tunge og hals, lavt blodtryk, åndedrætsbesvær og apnø.
Hives, swelling of the tongue and throat, low blood pressure, difficulty breathing and apnoea.
Tal med lægen, hvis en bivirkning bliver værre, eller De/ du får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
SÅDAN OPBEVARER DE/ DU NAGLAZYME
HOW TO STORE NAGLAZYME
Brug ikke Naglazyme efter den udløbsdato, der står på hætteglasset.
Do not use Naglazyme after the expiry date which is stated on the vial after EXP.
Brug ikke Naglazyme efter den udløbsdato, der står på etiketten.
Do not use after the expiry date stated on the labelling after the letters EXP.
Hvis det ikke anvendes omgående, er brugsopbevaringstid og – forhold brugerens ansvar, og det bør normalt ikke strække sig ud over 24 timer ved 2°C - 8°C efterfulgt af op til 24 timer ved stuetemperatur (23°C - 27°C) under administration.
If not used immediately, in-use storage times and conditions are the responsibility of the user and must normally not be longer than 24 hours at 2°C - 8°C followed by up to 24 hours at room temperature (23°C - 27°C) during administration.
Brug ikke Naglazyme, hvis De/ du ser partikler i opløsningen.
Do not use Naglazyme if it contains visible particles.
Af hensyn til miljøet må De/ du ikke smide medicinrester i afløbet, toilettet eller skraldespanden
These measures will help to protect the environment.
Galsulfase.
- The active substance is galsulfase.
Ét hætteglas af 5 ml indeholder 5 mg galsulfase.
5 ml contains 5 mg galsulfase.
Galsulfase er en rekombinant form af human N- acetylgalactosamine 4- sulfatase og er fremstillet af genetisk udviklede celler fra ovarier fra kinesiske hamstre (Chinese Hamster Ovary - CHO).
Galsulfase is recombinant human N-acetylgalactosamine 4- sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Natriumklorid, natriumfosfat monobasisk monohydrat, natriumfosfat
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate,
dibasisk heptahydrat, polysorbat 80, vand til injektioner.
sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
Naglazymes udseende og pakningsstørrelse Naglazyme leveres som et koncentrat til infusionsopløsning.
What Naglazyme looks like and contents of the pack Naglazyme is supplied as a concentrate for solution for infusion.
22 Indehaveren af markedsføringstilladelsen BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL Storbritannien
22 Marketing authorization Holder BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
Fremstiller Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX Storbritannien
Manufacturer Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX United Kingdom
Hvis De/ du vil have yderligere oplysninger om Naglazyme, skal De/ du henvende Dem/ dig til den lokale repræsentant:
For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder:
Naglazyme er godkendt under ” særlige omstændigheder ”.
This medicine has been authorised under “ exceptional circumstances”.
Det europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende Naglazyme, og denne indlægsseddel vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Der er også links til websites om sjældne sygdomme og hvordan de behandles.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. There are also links to other websites about rare diseases and treatments.
< -------------------------------------------------------------------------------------------------------------------------
24 < -------------------------------------------------------------------------------------------------------------------------- --- The following information is intended for medical or healthcare professionals only:
Det
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion using aseptic technique.
24 anbefales, at den fortyndede Naglazyme opløsning administreres til patienterne ved brug af et infusionssæt, der er udstyret med et 0, 2 µm in- line filter.
It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
I sådanne tilfælde bør infusionshastigheden (ml/ min) nedsættes således, at den totale varighed ikke bliver mindre end 4 timer.
100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/ min) should be decreased so that the total duration remains no less than 4 hours.
Neoclarityn anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f. eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
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 kan tages med eller uden et måltid.
Neoclarityn can be taken with or without food.
Neoclarityn blev undersøgt i 8 undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
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).
Effekten af Neoclarityn blev målt ved at se på ændringen i symptomerne (næseflåd, kløe, nysen, tilstopning) før og efter 2 eller 4 ugers behandling.
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.
I alle undersøgelserne blev Neoclarityns effekt sammenlignet med virkningen af placebo (uvirksom behandling).
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Til allergisk rhinitis førte en 2- ugers behandling med Neoclarityn 5 mg, hvis man ser på resultaterne af alle undersøgelserne taget under et, til et gennemsnitligt fald i symptomscoren på mellem - 25 til - 32% sammenlignet med et fald på 12 til 26% hos patienter, som fik placebo.
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.
I de to undersøgelser af urticaria var faldet i symptomscoren efter 6 ugers behandling med Neoclarityn 58% og 67% sammenlignet med 40% og 33% for patienter behandlet med placebo.
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.
Den fuldstændige liste over alle de indberettede bivirkninger ved Neoclarityn fremgår af indlægssedlen.
For the full list of all side effects reported with Neoclarityn, see the Package Leaflet.
Neoclarityn må ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
Neoclarityn should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Neoclarityn er større end risiciene til lindring af de symptomer, der er forbundet med allergisk rhinitis eller urticaria.
The Committee for Medicinal Products for Human Use (CHMP) decided that Neoclarityn’ s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Neoclarityn.
The Committee recommended that Neoclarityn be given marketing authorisation.
Andre oplysninger om Neoclarityn:
Other information about Neoclarityn:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neoclarityn til SP Europe den 15. januar 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn to SP Europe on 15 January 2001.
Den fuldstændige EPAR for Neoclarityn findes her.
The full EPAR for Neoclarityn is available here.
EU/ 1/ 00/ 161/ 003
Pharmaceutical Form
5 tabletter
Content
EU/ 1/ 00/ 161/ 006
EU/ 1/ 00/ 161/ 001 EU/ 1/ 00/ 161/ 002 EU/ 1/ 00/ 161/ 003 EU/ 1/ 00/ 161/ 004 EU/ 1/ 00/ 161/ 005 EU/ 1/ 00/ 161/ 006 EU/ 1/ 00/ 161/ 007 EU/ 1/ 00/ 161/ 008 EU/ 1/ 00/ 161/ 009 EU/ 1/ 00/ 161/ 010 EU/ 1/ 00/ 161/ 011 EU/ 1/ 00/ 161/ 012 EU/ 1/ 00/ 161/ 013
Neoclarityn
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
EU/ 1/ 00/ 161/ 010
EU/ 1/ 00/ 161/ 014 EU/ 1/ 00/ 161/ 015 EU/ 1/ 00/ 161/ 016 EU/ 1/ 00/ 161/ 017 EU/ 1/ 00/ 161/ 018 EU/ 1/ 00/ 161/ 019 EU/ 1/ 00/ 161/ 020 EU/ 1/ 00/ 161/ 021 EU/ 1/ 00/ 161/ 022 EU/ 1/ 00/ 161/ 023 EU/ 1/ 00/ 161/ 024 EU/ 1/ 00/ 161/ 025 EU/ 1/ 00/ 161/ 026 EU/ 1/ 00/ 161/ 027 EU/ 1/ 00/ 161/ 028 EU/ 1/ 00/ 161/ 029 EU/ 1/ 00/ 161/ 030 EU/ 1/ 00/ 161/ 031 EU/ 1/ 00/ 161/ 032
Filmovertrukne tabletter
0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
Oral anvendelse
Syrup Syrup Syrup Syrup Syrup Syrup Syrup Syrup Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate
blister (Aclar/ PVC, alu)
bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
EU/ 1/ 00/ 161/ 012
1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 2 3 5 7 10 14 15 20 21 30
Neoclarityn
1/ 3 EU/ 1/ 00/ 161/ 033 EU/ 1/ 00/ 161/ 034 EU/ 1/ 00/ 161/ 035 EU/ 1/ 00/ 161/ 036 EU/ 1/ 00/ 161/ 037 EU/ 1/ 00/ 161/ 038 EU/ 1/ 00/ 161/ 039 EU/ 1/ 00/ 161/ 040 EU/ 1/ 00/ 161/ 041 EU/ 1/ 00/ 161/ 042 EU/ 1/ 00/ 161/ 043 EU/ 1/ 00/ 161/ 044 EU/ 1/ 00/ 161/ 045 EU/ 1/ 00/ 161/ 046 EU/ 1/ 00/ 161/ 047 EU/ 1/ 00/ 161/ 048 EU/ 1/ 00/ 161/ 049 EU/ 1/ 00/ 161/ 050 EU/ 1/ 00/ 161/ 051 EU/ 1/ 00/ 161/ 052 EU/ 1/ 00/ 161/ 053 EU/ 1/ 00/ 161/ 054 EU/ 1/ 00/ 161/ 055 EU/ 1/ 00/ 161/ 056 EU/ 1/ 00/ 161/ 057 EU/ 1/ 00/ 161/ 058
5 mg
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Filmovertrukne tabletter
5 mg 5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
Oral anvendelse
Oral lyophilisate Oral lyophilisate Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
blister (Aclar/ PVC, alu)
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
50 tabletter
blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu)
EU/ 1/ 00/ 161/ 013
50 100 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets
EU/ 1/ 00/ 161/ 014
EU/ 1/ 00/ 161/ 059
EU/ 1/ 00/ 161/ 015
EU/ 1/ 00/ 161/ 060
EU/ 1/ 00/ 161/ 016
EU/ 1/ 00/ 161/ 061
1/ 3 EU/ 1/ 00/ 161/ 017
EU/ 1/ 00/ 161/ 062
EU/ 1/ 00/ 161/ 018
2/ 3 EU/ 1/ 00/ 161/ 063
EU/ 1/ 00/ 161/ 019
EU/ 1/ 00/ 161/ 064
EU/ 1/ 00/ 161/ 020
EU/ 1/ 00/ 161/ 065
EU/ 1/ 00/ 161/ 021
EU/ 1/ 00/ 161/ 066
EU/ 1/ 00/ 161/ 066 EU/ 1/ 00/ 161/ 067
EU/ 1/ 00/ 161/ 067
Neoclarityn Neoclarityn
Neoclarityn
Neoclarityn er indiceret til symptomlindring i forbindelse med:
Neoclarityn is indicated for the relief of symptoms associated with:
Effekt og sikkerhed af Neoclarityn- tabletter til børn under 12 år er ikke undersøgt.
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
5. 2).
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
5. 1).
In a clinical pharmacology trial Neoclarityn taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Brug af Neoclarityn under graviditet kan derfor ikke anbefales.
The use of Neoclarityn during pregnancy is therefore not recommended.
Desloratadin udskilles i modermælk; anvendelse af Neoclarityn anbefales derfor ikke hos ammende kvinder.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breast-feeding women.
I kliniske undersøgelser ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Neoclarityn rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3% of patients in excess of those treated with placebo.
FARMAKOLOGISKE EGENSKABER 3 5. 1 Farmakodynamiske egenskaber
PHARMACOLOGICAL PROPERTIES
Farmakoterapeutisk klassifikation:
5.1 Pharmacodynamic properties
Neoclarityn, givet i en enkelt daglig dosis på 7, 5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske undersøgelser.
Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Hos patienter med allergisk rhinitis lindrede Neoclarityn effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
In patients with allergic rhinitis, Neoclarityn was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Effekten af Neoclarityn- tabletter er ikke blevet tydeligt vist i undersøgelser med unge patienter mellem 12 og 17 år.
The efficacy of Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Neoclarityn var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den total score i rhino- konjunktivitis livskvalitetsspørgeskemaet.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
I to placebokontrollerede seks- ugers undersøgelser hos patienter med kronisk idiopatisk urticaria var Neoclarityn effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Behandling med Neoclarityn reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire- points skala, der anvendtes for at vurdere disse parametre.
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Neoclarityn leveres i enkeltdosisblisterpakninger af formstøbt blisterfilm med folielåg.
Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
6 Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Neoclarityn 0, 5 mg/ ml syrup
Neoclarityn 0.5 mg/ ml syrup
5. 1).
Neoclarityn may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
4. 4) og at der ikke er nogen resultater, der understøtter brug af Neoclarityn til behandling af infektiøs rhinitis.
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Neoclarityn.
2, 5 ml (1, 25 mg) Neoclarityn syrup en gang daglig.
2.5 ml (1.25 mg) Neoclarityn syrup once a day.
5 ml (2, 5 mg) Neoclarityn syrup en gang daglig.
5 ml (2.5 mg) Neoclarityn syrup once a day.
10 ml (5 mg) Neoclarityn syrup en gang daglig.
10 ml (5 mg) Neoclarityn syrup once a day.
Effekt og sikkerhed af Neoclarityn syrup til børn under 1 år er ikke undersøgt.
Efficacy and safety of Neoclarityn syrup in children under 1 year of age have not been established.
Sikkerheden af Neoclarityn syrup hos børn i alderen 2 til 11 år som er dårlige til at metabolisere, er den samme som for børn som har en normal evne til at metabolisere.
The safety of Neoclarityn syrup in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Effekten af Neoclarityn syrup hos børn < 2 år, der er dårlige til at metabolisere, er ikke undersøgt.
The effects of Neoclarityn syrup in poor metabolisers < 2 years of age have not been studied.
5. 1).
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).