natgillin/translations-raw huggingface dataset:
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and male fertility.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnih in ponavljajočih se odmerkih ter vpliva na plodnost samcev ne kažejo posebnega tveganja za človeka.
No reproductive toxicity studies in female animals have been performed.
Študij reprodukcijske toksičnosti na samicah živali niso opravili.
Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Water for Injections
Polisorbat 20 Natrijev klorid Natrijev hidrogenfosfat, heptahidrat Natrijev dihidrogenfosfat, monohidrat Voda za injekcije
6.2 Incompatibilities
7 6. 2 Inkompatibilnosti
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6. 6.
7 6.3 Shelf life
6. 3 Rok uporabnosti
2 years Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Raztopina ostane kemično in fizično stabilna osem ur, če jo hranimo pri temperaturi do 25 °C.
Do not freeze.
Shranjujte v hladilniku (2 °C - 8 °C). > Ne zamrzujte.
3 ml of concentrate for solution for infusion in a 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flip-off cap.
3 ml koncentrata za raztopino za infundiranje v 5- mililitrski viali (steklo vrste I) z zamaškom (butilna guma, obložena s fluorovo smolo), enodelno tesnilo in modra zaporka „ flip- off “.
Pack sizes of 1, 4 and 10 vials.
1, 4 in 10 vial.
Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ ml (0.9%) solution for infusion prior to use.
Zdravilo Elaprase je namenjeno intravenskemu infundiranju in ga je treba pred uporabo razredčiti v 0, 9- odstotni raztopini (9 mg/ ml) natrijevega klorida za infundiranje.
recommended dose of 0.5 mg/ kg.
- Glede na bolnikovo telesno maso in priporočeni odmerek 0, 5 mg/ ml določite število vial, ki jih
- Do not use if the solution in the vials is discoloured or if particulate matter is present.
- Ne uporabljajte, če je raztopina v vialah spremenila barvo ali če so v njej prisotni delci.
Do not
Ne
shake.
pretresajte.
- Withdraw the calculated volume of Elaprase from the appropriate number of vials.
- Vzemite izračunan volumen zdravila Elaprase iz ustreznega števila vial.
- Dilute the total volume required of Elaprase in 100 ml of 9 mg/ ml (0.9%) sodium chloride solution
- Razredčite skupen potreben volumen zdravila Elaprase v 100 ml 0, 9- odstotne raztopine
for infusion.
natrijevega klorida za infundiranje (9 mg/ ml).
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Švedska
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Shire (TK3) 205 Alewife Brook Parkway Cambridge, MA 02138 USA
Shire (TK3) 205 Alewife Brook Parkway Cambridge, MA 02138 ZDA
Shire Human Genetic Therapies AB Åldermansgatan 2, Box 1117, 221 04 Lund Sweden
Shire Human Genetic Therapies AB Åldermansgatan 2, Box 1117, 221 04 Lund Švedska
Summary of Product Characteristics, 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4. 2)
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 03 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 03, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, postavljen in delujoč pred lansiranjem na trg in med prodajo zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 02, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne aktivnosti farmakovigilance, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 02 načrta za obvladovanje tveganja (RMP), predstavljeni v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti (PSUR).
In addition, an updated RMP should be submitted * When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities * Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached ''. * At the request of the EMEA.
Poleg tega je treba posodobljen RMP predložiti: * kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na veljavne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; * v 60 dneh po tem, ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja); * na zahtevo Evropske agencije za zdravila (EMEA).
To carry out the planned Immunogenicity and Specific Sub-Population (Under 5 years) studies with the following proposed timelines.
Opraviti načrtovane študije imunogenosti in specifičnih podpopulacij (do 5 let) po navedenem načrtu.
HOS Final Protocol Available Patient Enrolment Analysis of Data Immunogenicity Sub-study
Preiskava izida Hunterjevega sindroma (Hunter Outcome Survey – HOS):
Complete Underway At annual reassessment
Končano V teku Ob letni ponovni oceni
Final Protocol Available Patient Enrolment Final analysis of Data Under 5 years Sub-Study
Končni protokol na voljo Nabor bolnikov Končna analiza podatkov Podštudija do 5 let:
Complete 31.10.2008 30.09.2012
Končano 31. 10. 2008 30. 09. 2012
Final Protocol Available Patient Enrolment Final analysis of Data
Končni protokol na voljo Nabor bolnikov Končna analiza podatkov
Complete Underway 30.11.2010
Končano V teku 30. 11. 2010
To submit data regarding immunogenicity after re-exposure to idursulfase within the Annual PSURs.
Predložiti podatke o imunogenosti po ponovni izpostavljenosti idursulfazi ob letnih poročilih PSUR.
To evaluate the following long term clinical endpoints primarily through the HOS.
Oceniti naslednje dolgoročne končne točke kliničnih preiskav, predvsem s preiskavami izida Hunterjevega sindroma (HOS).
These data will be re-evaluated annually and outcomes reported and discussed within the Annual Reassessments.
Podatki se bodo letno ponovno ocenili, o izidih se pa bo poročalo in o njih razpravljalo v letni ponovni oceni.
- Assessment of long term pulmonary morbidity (e. g., incidence of infections, pulmonary function
- Ocena dolgotrajne pljučne obolevnosti (npr. incidenca okužb, status pljučne funkcije) in
status) and mortality
umrljivosti.
- Assessment of long term cardiovascular morbidity (e. g., incidence of events, and
- Ocena dolgoročne kardiovaskularne obolevnosti (npr. incidenca dogodkov in ehokardiografski
echocardiography data, where available) and mortality
podatki, kjer so na voljo) in umrljivosti.
- Assessment of long term urinary GAG excretion patterns
- Ocena vzorcev dolgoročnega izločanja GAG z urinom.
- Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
- Ocena dolgoročnih ravni protiteles, izotopov in korelacije z drugimi terapevtskimi parametri.
OUTER CARTON / 1, 4, 10 VIAL
ZUNANJA ŠKATLA/ 1, 4, 10 VIAL
Elaprase 2 mg/ ml concentrate for solution for infusion Idursulfase
Elaprase 2 mg/ ml, koncentrat za raztopino za infundiranje Idursulfaza
Each vial contains 6 mg of idursulfase Each ml contains 2 mg of idursulfase
Vsak ml vsebuje 2 mg idursulfaze.
1 vial [4, 10 vials] of 3 ml concentrate for solution for infusion
1 viala [4, 10 vial] 3 ml koncentrata za raztopino za infundiranje
Intravenous use For single use only Read the enclosed package leaflet before use
Pred uporabo preberite priloženo navodilo za uporabo.
{MMM/ YYYY}
{MMM/ LLLL}
Store in a refrigerator Do not freeze
Ne zamrzujte.
Any unused product or waste material should be disposed of in accordance with local requirements 15 11.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
In accordance with the Guidance concerning the Braille requirements for labelling and the package leaflet; there is no need to put Braille on the packaging of products which are only intended for administration by healthcare professionals, as is the case for Elaprase.
V skladu s smernicami za podatke v Braillovi pisavi za označevanje in navodila za uporabo na ovojnini zdravil, kot je zdravilo Elaprase, ki jih dajejo zdravstveni delavci, ni treba navesti podatkov v Braillovi pisavi.
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Elaprase 2 mg/ ml sterile concentrate Idursulfase Intravenous use
Elaprase 2 mg/ ml sterilni koncentrat Idursulfaza Intravenska uporaba.
Read the enclosed package leaflet before use
Pred uporabo preberite priloženo navodilo za uporabo.
Lot
Serija {številka}
Read all of this leaflet carefully before you start having this medicine.
Pred začetkom jemanja natančno preberite navodilo!
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni
What Elaprase is and what it is used for 2.
Kaj je zdravilo Elaprase in za kaj ga uporabljamo 2.
What you need to know before you have Elaprase 3.
Kaj morate vedeti, preden vam bodo dali zdravilo Elaprase 3.
How Elaprase is given to you 4.
Kako vam bodo dali zdravilo Elaprase 4.
Possible side effects 5 How Elaprase is stored 6.
Možni neželeni učinki 5 Shranjevanje zdravila Elaprase 6.
WHAT ELAPRASE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ELAPRASE IN ZA KAJ GA UPORABLJAMO
Elaprase is used as enzyme replacement therapy to treat Hunter syndrome (Mucopolysaccharidosis II) when the level of iduronate-2-sulfatase in the body is lower than normal.
Zdravilo Elaprase se uporablja kot encimsko nadomestno zdravljenje za zdravljenje Hunterjevega sindroma (mukopolisharidoze II), kadar je količina iduronat- 2- sulfataze v telesu manjša od normalne.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ELAPRASE
KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO ELAPRASE
Is there any reason for not being given Elaprase?
Ali obstaja razlog, da vam ne dajo zdravila Elaprase?
If you are allergic (hypersensitive) to idursulfase or any of the other ingredients of Elaprase.
Če ste preobčutljivi za (alergični na) idursulfazo ali katero koli sestavino zdravila Elaprase.
Take special care with Elaprase
Bodite posebno pozorni pri uporabi zdravila Elaprase
If you are treated with Elaprase you may experience reactions during or following an infusion (see section 4 Possible Side Effects).
Če se zdravite z zdravilom Elaprase, boste morda med infundiranjem ali po njem imeli reakcije (glejte poglavje 4 Možni neželeni učinki).
Most of the time you can still be given Elaprase even if these symptoms occur.
Večinoma vam bodo zdravilo Elaprase dajali tudi, če se pojavijo ti simptomi.
If you experience an allergic side effect following administration of Elaprase, you should contact your doctor immediately.
Če po dajanju zdravila Elaprase opazite tako reakcijo, takoj povejte svojemu zdravniku.
If severe allergic (anaphylactic-type) reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment.
Če se pojavijo hude alergijske (anafilaktične) reakcije, bo zdravnik prekinil infundiranje in takoj začel ustrezno zdravljenje.
There is no known interaction of Elaprase with other medicines.
Ni znanih interakcij zdravila Elaprase z drugimi zdravili.
Taking Elaprase with food and drink
Jemanje zdravila Elaprase skupaj s hrano in pijačo:
Due to the way the product is broken down by the body interactions with food and drink are unlikely.
Zaradi načina, kako telo razgradi zdravilo, medsebojno delovanje s hrano in pijačo ni verjetno.
19 Pregnancy and breast-feeding
19 Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katero koli zdravilo.
Ask your doctor or pharmacist for advice before taking any medicine.
Vpliv na sposobnost upravljanja vozil in strojev
It is not known if Elaprase will affect the ability to drive or use machines.
Ni znano, ali zdravilo Elaprase vpliva na sposobnost upravljanja vozil in strojev.
HOW ELAPRASE IS GIVEN TO YOU
KAKO VAM BODO DALI ZDRAVILO ELAPRASE
Elaprase has to be diluted in 9 mg/ ml (0.9%) sodium chloride solution for infusion before use.
Zdravilo Elaprase je treba pred uporabo razredčiti v 0, 9- odstotni raztopini natrijevega klorida za infundiranje (9 mg/ ml).
The usual dose is an infusion of 0.5 mg (half a milligramme) for every kg you weigh.
Običajni odmerek je infundiranje 0, 5 mg (pol miligrama) na kilogram vaše telesne teže.
After dilution Elaprase is given through a vein (drip feed).
Zdravilo Elaprase se po redčenju daje v veno (z infuzijo).
What will happen if I am given too much Elaprase?
Kaj se bo zgodilo, če mi dajo preveč zdravila Elaprase?
If you forget to have Elaprase
Če ste pozabili jemati zdravilo Elaprase
If you have missed an Elaprase infusion, please contact your doctor.
Če ste izpustili infuzijo zdravil Elaprase, se obrnite na svojega zdravnika.
Like all medicines, Elaprase can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Elaprase neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Over time the number of these infusion-associated reactions decreases.
Sčasoma se število teh reakcij, povezanih z infundiranjem, zmanjšuje.
Very common side effects (more than 1 per 10) are: • Headache • Increased blood pressure • Chest pain • Hives, rash, itching • Fever, and infusion site swelling
Zelo pogosti neželeni učinki (več kot 1 od 10) so: glavobol • povišan krvni tlak • bolečine v prsnem košu • koprivnica, izpuščaj, srbenje • zvišana telesna temperatura, otekanje na mestu infundiranja •
Common side effects (more than 1 per 100) are: • Dizziness, tremor • Teary eyes • Changes in the way your heart beats, bluish skin • Decreased blood pressure, flushing (redness) • Difficulty breathing, wheezing, blood clot in the lung artery, cough, quickened breathing • Abdominal pain, nausea, diarrhoea, swollen tongue • Facial swelling, skin lesions (redness, eczema) • Pain in the joints • Swelling of the extremities
Pogosti neželeni učinki (več kot 1 od 100) so: vrtoglavica, tresenje • solzenje • spremembe srčnega utripa, modrikasta koža • znižanje krvnega tlaka, vročinski oblivi (rdečica) • težave pri dihanju, sopenje, strjevanje krvi v pljučni arteriji, kašelj, pospešeno dihanje • bolečine v trebuhu, slabost, driska, otečen jezik • otekanje obraza, poškodbe na koži (rdečica, ekcem) • bolečina v sklepih • otekanje okončin •
If you have problems breathing, with or without bluish skin, tell your doctor immediately.
Če imate težave pri dihanju, tudi če nimate modrikaste kože, takoj povejte zdravniku.
If any of the side effects gets serious, or if your notice any side effects not listed in this leaflet, please tell your doctor.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW ELAPRASE IS STORED
SHRANJEVANJE ZDRAVILA ELAPRASE
Keep out of reach and sight of children.
20 Zdravilo shranjujte nedosegljivo otrokom!
Do not use Elaprase after the expiry date which is stated on the label after the letters EXP.
Zdravila Elaprase ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake „ Uporabno do “.
Store in a refrigerator (2°C – 8°C) Do not freeze
Ne zamrzujte.
Do not use Elaprase if you notice that there is discolouration or presence of foreign particles.
Ne uporabljajte zdravila Elaprase, če opazite, da je raztopina spremenila barvo ali so v njej delci.
The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Zdravilna učinkovina je idursulfaza, ki ima obliko humanega encima iduronat- 2- sulfataze.
Idursulfase is produced in a human cell line by genetic engineering technology.
Idursulfaza se proizvaja v humani celični liniji s tehnologijo genskega inženiringa.
The other ingredients are Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Water for injections
Pomožne snovi so polisorbat 20 natrijev klorid natrijev dihidrogenfosfat, heptahidrat natrijev hidrogenfosfat, monohidrat voda za injekcije
Elaprase is a concentrate for solution for infusion.
Zdravilo Elaprase je koncentrat za raztopino za infundiranje.
Each vial contains 3 ml of concentrate for solution for infusion.
Vsaka viala vsebuje 3 ml koncentrata za raztopino za infundiranje.
Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Marketing Authorisation Holder Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Švedska
Shire Human Genetic Therapies AB, Åldermansgatan 2, PO Box 1117, SE 221 04 Lund, Sweden
Shire Human Genetic Therapies AB, Åldermansgatan 2, PO Box 1117, SE 221 04 Lund, Švedska
This medicine has been authorised under “ exceptional circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „ izjemnih okoliščinah “.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za vrednotenje zdravil (EMEA) bo vsako leto ponovno pregledala vse nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
More detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za vrednotenje zdravil (EMEA) http: // www. emea. europa. eu /.
There are also links to other web sites about rare disease and treatments. ---------------------------------------------------------------------------------------------------------------------------------
Na tem spletnem mestu so tudi povezave na druge internetne strani o redkih boleznih in njihovem zdravljenju. < ------------------------------------------------------------------------------------------------------------------------------
21 Instructions for use, handling and disposal
21 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of 9 mg/ ml sodium chloride solution for infusion (0.9%w/ v).
Skupen volumen potrebnega koncentrata za raztopino za infundiranje Elaprase razredčite v 100 ml raztopine natrijevega klorida za infundiranje (9 mg/ ml; 0, 9% m/ v).
Do not infuse Elaprase concomitantly in the same intravenous line with other agents.
Zdravila Elaprase ne infundirajte skupaj v isti intravenski liniji z drugimi učinkovinami.
Emadine is a clear eye drop solution.
Zdravilo Emadine je bistra raztopina kapljic za oko.
It contains the active substance emedastine (0.5 mg/ ml).
Vsebuje zdravilno učinkovino emedastin (0, 5 mg/ ml).
Emadine is available in a bottle and in single-dose containers.
Zdravilo Emadine je na voljo v plastenki in enoodmernih vsebnikih.
Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Zdravilo Emadine se uporablja za zdravljenje simptomov sezonskega alergijskega konjunktivitisa (vnetje oči, ki ga pri bolnikih s senenim nahodom povzroča cvetni prah).
Emadine is used in adults and children aged three years and older.
Zdravilo Emadine se uporablja pri odraslih in otrocih, starih tri leta in več.
Emadine is given as one drop in the affected eye(s) twice a day.
Zdravilo Emadine se daje kot ena sama kapljica v prizadeto oko (prizadeti očesi) dvakrat na dan.
Its effects have not been studied beyond six weeks.
Učinkov zdravila niso raziskovali po preteku šestih tednov.
Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Zdravilo Emadine ni priporočljivo za bolnike nad 65. letom starosti ali za bolnike, ki imajo težave z jetri ali ledvicami.
It works by blocking the receptors that histamine normally attaches to.
Blokira receptorje, na katere se histamin navadno veže.
Histamine is a substance in the body that causes allergic symptoms.
Histamin je snov, ki v telesu povzroča simptome alergije.
When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Kadar so receptorji blokirani, histamin nima učinka, kar pripelje do ublažitve simptomov alergije.
Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Zdravilo Emadine so primerjali z levokabastinom (drugim antihistaminikom) v eni glavni študiji, ki je vključevala 222 bolnikov s sezonskim konjuktivitisom, starih štiri leta ali več.
The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Glavno merilo učinkovitosti je bila ublažitev srbenja in zmanjšanje pordelosti v trajanju največ šest tednov, kar so merili z devettočkovno lestvico.
The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘ allergen challenge’.
Družba je predstavila tudi rezultate študij, v katerih so bolniki prejemali zdravilo Emadine, levokabastin ali placebo (zdravilo brez zdravilne učinkovine), preden so bili izpostavljeni „ alergenemu izzivu ”.
This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
To je test, v katerem bolniki z alergijo, ki trenutno ne kažejo simptomov alergije, prejmejo točno določen odmerek alergena (snovi, na katero so alergični), da bi sprožili alergijsko reakcijo.
Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Zdravilo Emadine je bilo pri blaženju simptomov sezonskega konjunktivitisa vsaj tako učinkovito kot levokabastin.
In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
V obeh skupinah bolnikov so rezultati glede srbenja padli s približno 5, 1 na začetku študije na približno 3, 8 po petih minutah in približno 2, 7 po dveh urah.
Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Podobne rezultate so opazili tudi pri zmanjševanju pordelosti, in sicer so zabeležili zmanjšanje s 4, 5 na 3, 7 po petih minutah in na 2, 7 po dveh urah.