natgillin/translations-raw huggingface dataset:
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed
Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
HOW TO USE NAGLAZYME
KAKO UPORABLJATI ZDRAVILO NAGLAZYME
The concentrate for solution for infusion has to be diluted prior to administration by intravenous infusion.
Koncentrat za raztopino za infundiranje mora biti pred intravensko aplikacijo razredčen.
Dosage The recommended dosage regimen of galsulfase is 1 mg/ kg body weight administered once every week as an intravenous infusion.
Odmerjanje Priporočena režim odmerjanja za galsulfazo je 1 mg/ kg telesne mase enkrat tedensko v obliki intravenske infuzije.
If you use more Naglazyme than you should No case of overdose of Naglazyme has been reported.
Če ste uporabili večji odmerek zdravila Naglazyme, kot bi smeli Ni poročil o primerih prevelikega odmerjanja Naglazyma.
If you forget to take Naglazyme If you forget to take Naglazyme, please contact your doctor.
Če ste pozabili vzeti zdravilo Naglazyme Če ste pozabili vzeti zdravilo Naglazyme, se posvetujte s svojim zdravnikom.
If a dose is partially administered or missed, the next dose will not be increased to make up for this.
Če je bil odmerek uporabljen le delno ali če je bil izpuščen, naslednji odmerek zato naj ne bo zvišan.
Like all medicines, Naglazyme can cause side effects, although not everybody gets them.
Kakor vsa zdravila ima tudi Naglazyme lahko neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following side effects were reported as being related to Naglazyme:
V povezavi z Naglazymom so poročali o naslednjihis neželenih učinkih:
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.
Zelo pogosto (prizadetih več kot 1 od 10 bolnikov) o: bolečinah v trebuhu, bolečinah v ušesih, bolečinah, pordelih očeh, težki sapi, mrzlici, bolečini v prsih, bolečem grlu, bolečinah v trebuhu, počasnih refleksih, motnih očeh, otečenem obrazu, vnetju želodčne sluznice, zvišanem krvnem tlaku, utrujenosti, nosni kongestiji, izbočenem popku, vročini, glavobolu, izpuščaju, slabosti, bruhanju in bolečinah v sklepih.
Hives, swelling of the tongue and throat, low blood pressure, difficulty breathing and apnoea.
21 Pogosto (prizadetih več kot 1 od 100 bolnikov) o: izpuščaju, otekanju jezika in žrela, nizkem krvnem tlaku, težavah pri dihanju in začasnem prenehanju dihanja (apneja).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE NAGLAZYME
SHRANJEVANJE ZDRAVILA NAGLAZYME
Do not use Naglazyme after the expiry date which is stated on the vial after EXP.
Zdravila Naglazyme ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali poleg oznake Upor. do:
Do not use after the expiry date stated on the labelling after the letters EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23°C - 27°C).
Dokazano je bilo, da je pripravljena raztopina pri sobni temperaturi (23 °C – 27 °C) kemijsko in fizikalno stabilna do 4 dni.
From a microbiological safety point of view, the product is to be used immediately.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pripravljene raztopine odgovoren uporabnik.
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.
Praviloma shranjevanje ne sme presegati 24 ur pri temperaturi 2° C - 8° C in nadaljnjih 24 ur pri sobni temperaturi (23 °C – 27 °C) v fazi dajanja zdravila.
Do not use Naglazyme if it contains visible particles.
Ne uporabljajte zdravila Naglazyme, če opazite vidne delce.
What Naglazyme contains
Kaj vsebuje zdravilo Naglazyme
One vial of
Vsaka 5 ml
5 ml contains 5 mg galsulfase.
viala vsebuje 5 mg galsulfaze.
Galsulfase is recombinant human N-acetylgalactosamine 4- sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Galsulfaza je rekombinantna oblika humane N - acetilgalaktozamin- 4- sulfataze, ki jo pridobijo iz gensko spremenjenih ovarijskih celic kitajskega hrčka (CHO).
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate,
- Pomožne snovi so: natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat
sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
heptahidrat, polisorbat 80, voda za injekcije.
What Naglazyme looks like and contents of the pack Naglazyme is supplied as a concentrate for solution for infusion.
Izgled zdravila Naglazyme in vsebina pakiranja Naglazyme je na razpolago kot koncentrat za raztopino za infundiranje.
Package sizes:
Škatlica vsebuje:
1 and 6 vials.
1 ali 6 vial.
22 Marketing authorization Holder BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
22 Imetnik dovoljenja za promet BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL Združeno kraljestvo
Manufacturer Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX United Kingdom
Izdelovalec Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX Združeno Kraljestvo
For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
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.
Kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
24 < -------------------------------------------------------------------------------------------------------------------------- --- The following information is intended for medical or healthcare professionals only:
24 < ------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion using aseptic technique.
Koncentrat za raztopino za infundiranje mora biti po aseptičnem postopku razredčen z izotonično raztopino natrijevega klorida 0, 9% za infundiranje.
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.
Priporočljivo je, da se razredčena raztopina Naglazyma aplicira bolnikom z infuzijskim setom, ki je opremljen z 0, 2μm "in- line" filtrom.
Before dilution, each vial is to be inspected for particulate matter and discolouration.
Pred redčenjem se je treba za vsako vialo prepričati, da ne sebuje vidnih delcev in da ni razbarvana.
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.
Za bolnike, ki so občutljivi na volumsko preobremenitev in tehtajo manj kakor 20 kg, je treba uporabiti 100 ml vsebnike infuzijske raztopine natrijevega klorida in v tem primeru zmanjšati hitrost infuzije tako, da celotna infuzija ne traja manj kot 4 ure.
It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible 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.
Na voljo je v obliki 5 mg tablet, 5 mg peroralnega liofilizata (disperzibilna tableta), 2, 5 mg in 5 mg orodisperzibilnih tablet (tablete se raztopijo v ustih), 0, 5 mg/ ml sirupa in 0, 5 mg/ ml peroralne raztopine.
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).
Zdravilo Neoclarityn se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezen kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
Neoclarityn can be taken with or without food.
Zdravilo Neoclarityn se lahko jemlje s hrano ali brez nje.
It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Učinkovina zavira receptorje, na katere se običajno veže snov, imenovana histamin, ki v telesu povzroča simptome alergije.
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).
Zdravilo Neoclarityn so raziskali v osmih študijah, ki so vključevale približno 4800 odraslih in mladostnikov z alergijskim rinitisom (vključno s štirimi študijami sezonskega alergijskega rinitisa in dvema študijama pri bolnikih, ki so imeli tudi astmo).
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.
Učinkovitost zdravila Neoclarityn so merili s spremembo simptomov (nabiranje sluzi v nosu, srbenje, kihanje in zamašenost nosu), ki so jih opazovali pred zdravljenjem in dva do štiri tedne po zaključku zdravljenja.
Neoclarityn has also been studied in 416 patients with urticaria.
Zdravilo Neoclarityn so raziskali tudi pri 416 bolnikih z urtikarijo.
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
V vseh študijah so učinkovitost zdravila Neoclarityn primerjali s placebom (zdravilo brez zdravilne učinkovine).
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.
Predstavljene so bile dodatne študije, s katerimi je bilo dokazano, da sirup, peroralno raztopino in orodisperzibilne tablete telo enako prenaša kot tablete ter da se lahko varno uporabljajo pri otrocih.
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.
Dva tedna dolgo zdravljenje z zdravilom Neoclarityn v odmerku 5 mg je pri alergijskem rinitisu v vseh študijah skupaj privedlo do povprečnega zmanjšanja števila simptomov za 25– 32%, v primerjavi z 12 - do 26- odstotnim zmanjšanjem pri bolnikih, ki so prejemali 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.
V dveh študijah pri bolnikih z urtikarijo se je število simptomov po šestih tednih zdravljenja z zdravilom Neoclarityn zmanjšalo za 58 in 67% v primerjavi s 40 in 33% pri bolnikih, ki so prejemali placebo.
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%).
Pri otrocih, starih manj kot dve leti, so bili najpogostejši neželeni učinki driska (3, 7%), zvišana telesna temperatura (2, 3%) in nespečnost (težava zaspati; 2, 3%).
For the full list of all side effects reported with Neoclarityn, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neoclarityn, glejte navodilo za uporabo.
Neoclarityn should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Zdravila Neoclarityn ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, loratadin ali katero koli drugo sestavino zdravila.
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.
Odbor za uporabo zdravil v humani medicini (CHMP) je zaključil, da so koristi zdravila Neoclarityn pri lajšanju simptomov alergijskega rinitisa ali urtikarije večje od z njim povezanih tveganj.
The Committee recommended that Neoclarityn be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Neoclarityn odobri dovoljenje za promet.
Other information about Neoclarityn:
Druge informacije o zdravilu Neoclarityn:
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn to SP Europe on 15 January 2001.
Evropska komisija je dovoljenje za promet z zdravilom Neoclarityn, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 15. januarja 2001.
The full EPAR for Neoclarityn is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neoclarityn je na voljo tukaj.
EU Number
Številka EU EU/ 1/ 00/ 161/ 001
Strength
20 tablet
Packaging
30 tablet
Content
50 table
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
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 EU/ 1/ 00/ 161/ 033 EU/ 1/ 00/ 161/ 034 EU/ 1/ 00/ 161/ 0035
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 Neoclarityn
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
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 2, 5 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Peroralni liofilizat Orodisperzibilna tableta
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
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu)
pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ Alu) pretisni omot (PVC/ OPA/ alu)
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 100 tablets
1 2 3 5 7 10 14 15 20 21 30 50 100 5 tablet
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
Orodisperzibilna tableta
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Peroralna uporaba
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
pretisni omot (PVC/ OPA/ alu)
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
2, 5 mg
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
Orodisperzibilna tableta
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)
Peroralna uporaba
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
pretisni omot (PVC/ OPA/ alu)
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
10 tablet
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
EU/ 1/ 00/ 161/ 0038
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
Orodisperzibilna tableta
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
Peroralna uporaba
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)
pretisni omot (PVC/ OPA/ alu)
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
12 tablet
EU/ 1/ 00/ 161/ 059
EU/ 1/ 00/ 161/ 0039
0.5 mg/ ml
18 tablet
EU/ 1/ 00/ 161/ 060
EU/ 1/ 00/ 161/ 0043
EU/ 1/ 00/ 161/ 061
EU/ 1/ 00/ 161/ 0054
1 bottle
0, 5 mg/ ml
EU/ 1/ 00/ 161/ 062
EU/ 1/ 00/ 161/ 0060
Oral solution
1 steklenička
2/ 3 EU/ 1/ 00/ 161/ 063
EU/ 1/ 00/ 161/ 0063
EU/ 1/ 00/ 161/ 064
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EU/ 1/ 00/ 161/ 065
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EU/ 1/ 00/ 161/ 066
EU/ 1/ 00/ 161/ 0066
EU/ 1/ 00/ 161/ 067
EU/ 1/ 00/ 161/ 0067
Neoclarityn is indicated for the relief of symptoms associated with:
Neoclarityn je indiciran za lajšanje simptomov:
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
Pri otrocih, mlajših od 12 let, še niso ugotovili učinkovitosti in varnosti Neoclarityn tablet.
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
V primeru hude ledvične insuficience morate zdravilo Neoclarityn uporabljati previdno (glejte poglavje 5. 2).
2 4.5 Interaction with other medicinal products and other forms of interaction
2 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih, v katerih so bolniki sočasno s tabletami desloratadina jemali tudi eritromicin ali ketokonazol, niso opažali klinično pomembnih interakcij med zdravili (glejte poglavje 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).
(glejte poglavje 5. 1).
The use of Neoclarityn during pregnancy is therefore not recommended.
Varnost zdravila Neoclarityn v času nosečnosti še ni bila ugotovljena, zato ne priporočamo njegove uporabe v času nosečnosti.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breast-feeding women.
Desloratadin se izloča v materino mleko, zato ne priporočamo uporabe zdravila Neoclarityn pri doječih materah.
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.
V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo so pri priporočenem odmerku 5 mg na dan o neželenih učinkih zdravila Neoclarityn poročali pri 3% bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
Hepatobiliary disorders
Bolezni živčevja Srčne bolezni
Elevations of liver enzymes, increased bilirubin, hepatitis
Omotica, zaspanost, nespečnost, psihomotorična hiperaktivnost, epileptični napadi Tahikardija, palpitacije
Musculoskeletal and connective tissue disorders General disorders
Bolezni porebavil Bolezni jeter, žolčnika in žolčevodov Bolezni mišično- skeletnega sistema in vezivnega tkiva Splošne težave
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Trebušne bolečine, navzeja, bruhanje, dispepsija, driska Povečane vrednosti jetrnih encimov in bilirubina, hepatitis Mialgija Preobčutljivostne reakcije (kot so. anafilaksija, angioedem, dispneja, pruritus, izpuščaj in urtikarija)