natgillin/translations-raw huggingface dataset:
Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention) Median time to first DE requiring substantial intervention
prilagođen za rizično razdoblje (% bolesnika bez ijednog razdoblja EB) Medijan vremena do prve EB
Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Žarenje kože, herpes simpleks, nepodnošenje alkohola (naleti crvenila u licu ili osjetljivost kože nakon uzimanja alkohola),
Vehicle Twice weekly (N=75)
Podloga Dvaput tjedno (N = 75)
1 g ointment contains: 1.0 mg tacrolimus (as monohydrate)
1 g masti sadrži: 1,0 mg takrolimusa (u obliku takrolimus hidrata)
1 g ointment contains: 0.3 mg tacrolimus (as monohydrate)
1 g masti sadrži: 0,3 mg takrolimusa (u obliku takrolimus hidrata)
White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin
POPIS POMOĆNIH TVARI bijeli vazelin, tekući parafin, propilenkarbonat, bijeli pčelinji vosak, tvrdi parafin, butilhidroksitoluen
1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
1 g Protopic 0,03% masti sadrži 0,3 mg takrolimusa u obliku takrolimus hidrata (0,03%).
Vehicle Twice weekly (N=73)
Podloga Dvaput tjedno (N = 73)
The use of Protopic at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
(npr. kortizonom) ili lijekovima koji utječu na imunološki sustav nije ispitana.
white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321), all-rac-α-tocopherol.
6.1 Popis pomoćnih tvari bijeli vazelin tekući parafin propilenkarbonat bijeli pčelinji vosak tvrdi parafin butilhidroksitoluen (E321) sav-rac-α-tokoferol
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
1 g Protopic 0,1% masti sadrži 1,0 mg takrolimusa u obliku takrolimus hidrata (0,1%).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPIC 0.1% OINTMENT (10 g TUBE)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PROTOPIC 0,1% MAST (10 g TUBA)
Cutaneous use Read the package leaflet before use.
NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopic is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
takrolimusu iz Protopic masti približno je 30 puta manja od one opažene kod peroralnih imunosupresivnih doza u bolesnika s presađenim bubregom ili jetrom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPIC 0.03% OINTMENT (10 g TUBE)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PROTOPIC 0,03% MAST (10 g TUBA)
Transplant patients receiving immunosuppressive regimens (e.g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopic and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Bolesnici s presađenim organom koji su primali imunosupresivne režime (npr. sistemski takrolimus) imaju povećan rizik od razvoja limfoma.
One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Jedan gram Protopic 0,03% masti sadrži 0,3 mg takrolimusa (u obliku takrolimus hidrata).
One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Jedan gram Protopic 0,1% masti sadrži 1,0 mg takrolimusa (u obliku takrolimus hidrata).
Excipients warnings
Prijavljivanje nuspojava
Only Protopic 0.03 % ointment should be used in children from the age of 2 to 16 years.
U djece u dobi od 2 do 16 godina smije se primjenjivati samo Protopic 0,03% mast.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PROTOPIC 0,1% MAST (10 g, 30 g, 60 g KUTIJA)
Cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
(npr. kožni T stanični limfomi) i druge vrste limfoma i karcinome kože (vidjeti dio 4.4).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PROTOPIC 0,03% MAST (10 g, 30 g, 60 g KUTIJA)
An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 0.03% ointment if the clinical condition allows.
Potrebno je pokušati smanjiti učestalost primjene ili primjenjivati manju jačinu
The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease.
Nethertonov sindrom, lamelarna ihtioza, generalizirana eritroderma i kožni oblik bolesti presatka protiv primatelja (engl.
Hard paraffin
Killorglin
Protopic 0.1% ointment tacrolimus monohydrate
Protopic 0,1% mast takrolimus hidrat
Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment.
U djece u dobi od 2 do 16 godina potrebno je primjenjivati samo Protopic 0,03% mast.
Metabolism and nutrition disorders
Mehanizam djelovanja i farmakodinamički učinci
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU PROTOPIC 0,03% MAST (30 g, 60 g TUBA)
Flare treatment
Liječenje rasplamsane bolesti
Protopic 0.03% ointment tacrolimus monohydrate
Protopic 0,03% mast takrolimus hidrat
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.1% OINTMENT (30 g, 60 g TUBE)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU PROTOPIC 0,1% MAST (30 g, 60 g TUBA)
Protopic 0.1% ointment
Protopic 0,1% mast
Tel: +48 22 244 18 40
LEO Pharma Sp. z o.o. Tel: +48 22 244 18 40
Protopic 0.03% ointment
Protopic 0,03% mast
B. PACKAGE LEAFLET
Medijan broja EB
Protopic 0.03% ointment tacrolimus monohydrate Cutaneous use
Protopic 0,03% mast takrolimus hidrat Za kožu
LIST OF EXCIPIENTS
Investigator's
Astellas Ireland Co. Ltd. Killorglin
Astellas Ireland Co.
When observed, blood concentrations exceeding 1.0 ng/ml were transient.
Kad su opažene koncentracije u krvi iznad
Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
(Protopic 0,03% i Protopic 0,1% mast).
Protopic 0.1% ointment tacrolimus monohydrate Cutaneous use
Protopic 0,1% mast takrolimus hidrat Za kožu
It may harm them,
herpetični ekcem,
Nervous system disorders
UV zračenju.
Adults and adolescents (12 years of age and over)
Odrasli i adolescenti (u dobi od 12 godina i stariji)
The safety profile of these subjects was not different from that of the general population.
Sigurnosni profil kod ovih ispitanika se nije razlikovao od onog u općoj populaciji.
Common: the following may affect up to 1 in 10 people
Česte: sljedeće nuspojave mogu se javiti u najviše 1 na 10 osoba
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Desloratadin se umjereno veže (83 % - 87 %) na proteine plazme.
Date of latest renewal: 8 August 2016
Datum posljednje obnove odobrenja: 8. kolovoza 2016.
Desloratadine effectively controlled symptoms for 24 hours.
Desloratadin je učinkovito kontrolirao simptome tijekom 24 sata.
EU/1/11/746/001 - Cartons of 7 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/002 - Cartons of 10 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/003 - Cartons of 14 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/004 - Cartons of 15 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/005 - Cartons of 20 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/006 - Cartons of 30 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/007 - Cartons of 40 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/008 - Cartons of 50 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/009 - Cartons of 60 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/010 - Cartons of 90 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/011 - Cartons of 100 film-coated tablets in PVC/PVdC/aluminium blisters
EU/1/11/746/001 - kutije od 7 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/002 - kutije od 10 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/003 - kutije od 14 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/004 - kutije od 15 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/005 - kutije od 20 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/006 - kutije od 30 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/007 - kutije od 40 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/008 - kutije od 50 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/009 - kutije od 60 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/010 - kutije od 90 filmom obloženih tableta u PVC/PVdC/aluminij blisterima EU/1/11/746/011 - kutije od 100 filmom obloženih tableta u PVC/PVdC/aluminij blisterima
Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG United Kingdom
Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Ujedinjeno Kraljevstvo
● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to
● povećana osjetljivost kože na sunčevu svjetlost, čak i u slučaju slabog sunca, i na UV (ultraljubičastu) svjetlost, na primjer UV svjetlost solarija
● unusual weakness
● neuobičajena slabost
• if you have medical or familial history of seizures.
• ako imate napadaje u osobnoj ili obiteljskoj povijesti bolesti.
Germany info@ratiopharm.de
Njemačka info@ratiopharm.de
Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Liječenje desloratadinom također je značajno smanjilo utjecaj na spavanje i dnevne aktivnosti, što se mjerilo skalom od četiri stupnja za procjenu tih varijabli.
Talk to your doctor, pharmacist or nurse before taking Desloratadine ratiopharm:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Desloratadin ratiopharm.
● increased appetite
● povećan apetit
Desloratadine ratiopharm with food, drink and alcohol Desloratadine ratiopharm may be taken with or without a meal.
Desloratadin ratiopharm s hranom, pićem i alkoholom Desloratadin ratiopharm se može uzeti uz ili bez obroka.
• if you have poor kidney function.
• ako imate oslabljenu funkciju bubrega.
Pack sizes of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets.
Veličine pakiranja od 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 i 100 filmom obloženih tableta.
In the event of overdose, consider standard measures to remove unabsorbed active substance.
U slučaju predoziranja, primijenite standardne mjere za uklanjanje neresorbirane djelatne tvari.
The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Najčešće zabilježene nuspojave kod primjene lijeka a koje su češće u odnosu na placebo bile su umor (1,2 %), suha usta (0,8 %) i glavobolja (0,6 %).
The efficacy of desloratadine tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Djelotvornost tableta desloratadina još nije jasno dokazana u ispitivanjima na adolescentnim bolesnicima u dobi od 12 do 17 godina.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 January 2012
Datum prvog odobrenja: 13. siječnja 2012.
ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany info@ratiopharm.de
ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Njemačka info@ratiopharm.de
If you forget to take Desloratadine ratiopharm If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Ako ste zaboravili uzeti svoju dozu lijeka na vrijeme, uzmite ju što je prije moguće, a zatim nastavite lijek uzimati prema uobičajenom rasporedu.
Each tablet contains 14.25 mg of lactose (as monohydrate).
Jedna tableta sadrži 14,25 mg laktoze (u obliku laktoza hidrata).
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine ratiopharm.
Vezano za trajanje liječenja, Vaš će liječnik odrediti od kojeg tipa alergijskog rinitisa bolujete te koliko dugo trebate uzimati Desloratadin ratiopharm.
6.5 Nature and contents of container PVC/PVdC/aluminium blister:
PVC/PVdC/aluminij blisteri:
For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.
Trajanje liječenja urtikarije razlikuje se od bolesnika do bolesnika, stoga trebate slijediti upute svojeg liječnika.
7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 30 film-coated tablets 40 film-coated tablets 50 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets
7 filmom obloženih tableta 10 filmom obloženih tableta 14 filmom obloženih tableta 15 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 40 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
An improvement in pruritus of more than 50 % was observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with placebo.
Zabilježeno je smanjenje svrbeža za više od 50 % kod 55 % bolesnika liječenih desloratadinom, u usporedbi s 19 % bolesnika koji su primali placebo.
There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Ne postoji dokaz o klinički značajnoj akumulaciji lijeka nakon primjene desloratadina jednom dnevno (5 mg do 20 mg) tijekom 14 dana.
Desloratadine ratiopharm 5 mg film-coated tablets are supplied in PVC/PVdC/aluminium blister packs of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets.
Desloratadin ratiopharm 5 mg filmom obložene tablete dostupne su u PVC/PVdC/aluminij blister pakiranjima od 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 i 100 filmom obloženih tableta.
However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Međutim, češće su zabilježeni umor, suha usta i glavobolja nego kod primjene tablete placeba.
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
Preosjetljivost na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1 ili loratadin.
In clinical studies with desloratadine, the following side effects were reported as:
U kliničkim ispitivanjima s desloratadinom, sljedeće nuspojave bile su prijavljene kao:
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
U kliničkom ispitivanju s 578 ispitanika adolescenata, u dobi od 12 do 17 godina, najčešći štetni događaj bila je glavobolja koja se javljala u 5,9 % bolesnika liječenih desloratadinom i u 6,9 % bolesnika koji su primali placebo.
These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Ova svojstva uključuju ihibiciju otpuštanja proinflamatornih citokina poput IL-4, IL-6, IL-8 i IL-13 iz ljudskih mastocita/bazofila, kao i inhibiciju ekspresije adhezijske molekule P-selektina na endotelnim stanicama.
Adverse reactions seen with desloratadine
Nuspojave opažene uz desloratadin
The safety and efficacy of Desloratadine ratiopharm 5 mg film-coated tablets in children below the age of 12 years have not been established.
Sigurnost i djelotvornost Desloratadin ratiopharm 5 mg filmom obloženih tableta u djece mlađe od 12 godina nisu ustanovljene.
Very rare: the following may affect up to 1 in 10,000 people ● severe allergic reactions
Vrlo rijetke (javljaju se u manje od 1 na 10 000 osoba): ● teške alergijske reakcije ● osip
Film-coating:
Film ovojnica:
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Desloratadine ratiopharm 5 mg film-coated tablets therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Desloratadin ratiopharm 5 mg filmom obloženim tabletama uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
METHOD AND ROUTE(S) OF ADMINISTRATION Swallow the tablet whole with water.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Tabletu progutajte cijelu s vodom.
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Ako se uzme u preporučenoj dozi, ovaj lijek ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
U dva placebo-kontrolirana klinička ispitivanja u trajanju od šest tjedana kod bolesnika s kroničnom idiopatskom urtikarijom, desloratadin je učinkovito ublažavao svrbež i smanjivao veličinu i broj koprivnjača do kraja prvog intervala doziranja.
Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Desloratadin je bio učinkovit u ublažavanju simptoma sezonskog alergijskog rinitisa, što se vidi iz ukupnog rezultata upitnika o kvaliteti života ispitanika s rinokonjuktivitisom.
What Desloratadine ratiopharm looks like and contents of the pack Round, biconvex, blue film-coated tablets.
Kako Desloratadin ratiopharm izgleda i sadržaj pakiranja Okrugle, bikonveksne, plave filmom obložene tablete
In adolescents, headache was the most commonly reported side effect.
U adolescenata, najčešće zabilježena nuspojava bila je glavobolja.
The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Stupanj nakupljanja desloratadina bio je u skladu s njegovim poluvijekom (približno 27 sati) i s učestalosti doziranja jednom dnevno.
Teva Operations Poland Sp. Z o.o.
Teva Operations Poland Sp. Z o.o. ul.
Round, biconvex, blue film-coated tablets.
Okrugle, bikonveksne, plave filmom obložene tablete
Pharmacotherapeutic group: antihistamines - H1 antagonist, ATC code: R06A X27
Farmakoterapijska skupina: Ostali antihistaminici za sustavnu primjenu, ATK oznaka: R06AX27
Use caution when taking Desloratadine ratiopharm with alcohol.
Potreban je oprez kada se Desloratadin ratiopharm uzima s alkoholom.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of desloratadine.
U farmakokinetičkom ispitivanju u kojem su demografski podaci ispitanika bili usporedivi s podacima opće populacije koja je imala sezonski alergijski rinitis, 4 % ispitanika imalo je višu koncentraciju desloratadina.
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Desloratadin je dugodjelujući antagonist histamina bez sedativnog učinka, sa selektivnim antagonističkim djelovanjem na periferne H1-receptore.
Maximum desloratadine concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Maksimalna koncentracija desloratadina bila je oko 3 puta veća od uobičajene nakon približno 7 sati od primjene, s poluvijekom u terminalnoj fazi od oko 89 sati.
Desloratadine ratiopharm 5 mg film-coated tablets is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Desloratadin ratiopharm 5 mg filmom obložene tablete indicirane su u odraslih i adolescenata u dobi od 12 ili više godina za ublažavanje simptoma povezanih s: - alergijskim rinitisom (vidjeti dio 5.1), - urtikarijom (vidjeti dio 5.1).
During the marketing of Desloratadine ratiopharm, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Nakon stavljanja u promet lijeka Desloratadin ratiopharm, slučajevi teških alergijskih reakcija (otežano disanje, zviždanje pri disanju, svrbež, koprivnjača i oticanje) bili su prijavljeni vrlo rijetko.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg desloratadine.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 5 mg desloratadina.
How to store Desloratadine ratiopharm Contents of the pack and other information
Kako čuvati Desloratadin ratiopharm Sadržaj pakiranja i druge informacije
In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
U kontroliranim kliničkim ispitivanjima, kod preporučene doze od 5 mg dnevno, nije bila povećana incidencija somnolencije u usporedbi s placebom.
Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Desloratadin primijenjen u jednokratnoj dnevnoj dozi od 7,5 mg nije imao učinak na psihomotorne sposobnosti u kliničkim ispitivanjima.
España ratiopharm España, S.A. Tel: +34 91 567 29 70
Polska ratiopharm España, S.A. Tel: +34 91 567 29 70
What Desloratadine ratiopharm is and what it is used for
Što je Desloratadin ratiopharm i za što se koristi
In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
U kliničkom ispitivanju višestrukih doza, u kojem se primjenjivalo do 20 mg desloratadina dnevno tijekom 14 dana, nije uočen klinički ili statistički značajan kardiovaskularni učinak.
Film-coating: polyvinyl alcohol (part. hydrolysed), titanium dioxide (E171), macrogol/PEG 3350, talc and indigo carmine aluminium lake (E132).
- Film ovojnica: poli(vinilni alkohol) (djelomično hidroliziran), titanijev dioksid (E171),makrogol/PEG3350, talk i indigo carmine aluminium lake (E132).
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 desloratadine were reported in 3 % of patients in excess of those treated with placebo.
U kliničkim ispitivanjima kod različitih indikacija, uključujući alergijski rinitis i kroničnu idiopatsku urtikariju, pri preporučenoj dozi od 5 mg dnevno, kod primjene desloratadina zabilježene su nuspojave u 3 % više bolesnika nego u onih koji su primali placebo.
In the case of severe renal insufficiency, Desloratadine ratiopharm 5 mg film-coated tablets should be used with caution (see section 5.2).
U slučaju teške insuficijencije bubrega, Desloratadin ratiopharm 5 mg filmom obložene tablete treba oprezno primjenjivati (vidjeti dio 5.2).
Adults During the marketing of Desloratadine ratiopharm, the following side effects were reported as:
Odrasli Nakon stavljanja u promet lijeka Desloratadin ratiopharm, sljedeće su nuspojave prijavljene kao: