natgillin/translations-raw huggingface dataset:
Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. 
Protopic 0,03% mast se primjenjuje za liječenje umjerenog do teškog atopijskog dermatitisa (ekcema) u odraslih koji nemaju prikladan odgovor ili ne podnose konvencionalne terapije kao što su topikalni kortikosteroidi, i u djece (starosti 2 ili više godina) koja nisu imala prikladan odgovor na konvencionalne terapije kao što su topikalni kortikosteroidi.
Adults and adolescents (16 years of age and above) Adult patients should use Protopic 0.1% ointment. 
Odrasli i adolescenti (u dobi od 16 ili više godina) Odrasli bolesnici trebaju primjenjivati Protopic 0,1% mast.
• The active substance is tacrolimus monohydrate. 
• Djelatna tvar je takrolimus hidrat.
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus. 
Kod visokih supkutanih doza takrolimusa u mužjaka štakora bila je zabilježena smanjena funkcija spermija.
Butylhydroxytoluene (E321) All-rac-α-tocopherol 
(E321), sav-rac-α-tokoferol.
Tacrolimus 0.03% (N=189) 
Takrolimus 0,03% (N = 189)
defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3. 
3 mjeseca definirana kao udio bolesnika s najmanje 60% poboljšanja na modificiranom indeksu površine i težine ekcema (mEASI; engl. modified Eczema Area and Severity Index) do 3. mjeseca u odnosu na početno stanje.
Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). 
Liječenje umjerenog do teškog atopijskog dermatitisa za sprječavanje rasplamsavanja i produljenja razdoblja bez rasplamsavanja u bolesnika s visokom učestalošću egzacerbacije bolesti (tj. nastaje 4 ili više puta godišnje) koji su imali početni odgovor (lezije potpuno nestale, gotovo nestale ili blago zahvaćaju kožu) na liječenje takrolimus mašću dvaput na dan u trajanju do najviše 6 tjedana.
Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed. 
Veličine pakiranja: 10 g, 30 g i 60 g.
Tacrolimus 0.03% Twice daily (N=210) 
Takrolimus 0,03% dvaput na dan (N = 210)
Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids. 
Liječenje umjerenog do teškog atopijskog dermatitisa u djece koja nisu imala prikladan odgovor na konvencionalne terapije, kao što su topikalni kortikosteroidi.
In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated. 
U slučaju trajne limfadenopatije, potrebno je ispitati njezin uzrok.
Tacrolimus 0.03% Once daily (N=207) 
Takrolimus 0,03% jedanput na dan (N = 207)
Tacrolimus 0.1% Twice weekly (N=80) 
Takrolimus 0,1% Dvaput tjedno (N = 80)
Adults (16 years of age and older) 
Odrasli (u dobi od 16 ili više godina)
Children (2 years of age and above) 
Djeca (u dobi od 2 ili više godina)
LEO Pharma s.r.o. 
LEO Pharma S.p.A.
• skin tingling 
• trnci u koži • osip
In patients using tacrolimus ointment, cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been reported (see section 4.8). 
U bolesnika koji primjenjuju takrolimus mast zabilježeni su slučajevi zloćudnih bolesti, uključujući kožne (npr. kožni T-stanični limfomi) i druge vrste limfoma te karcinome kože (vidjeti dio 4.8).
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common. 
Nepodnošenje alkohola (naleti crvenila u licu ili nadraženost kože nakon konzumiranja alkohola) bilo je često.
In a subanalysis of a pooled population of patients with moderate to severe atopic dermatitis these differences remained statistically significant (Table 4). 
Ove su razlike ostale statistički značajne i u podanalizi objedinjene populacije bolesnika s umjerenim do teškim atopijskim dermatitisom (Tablica 4).
Median mEASI Percentage Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician's Global Evaluation § higher values = greater improvement 
Medijan mEASI stopa smanjenja (primarni ishod)§ Poboljšanje za ≥ 90% prema liječničkoj ocjeni općeg stanja
The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p<0.001; Table 1). 
Stopa odgovora u skupini koja je primala 0,1% takrolimusa (71,6%) bila je značajno viša od onog u skupini koja je primala liječenje na temelju topikalnih kortikosteroida
Ointment 30 g 
Mast 30 g 60 g
Tacrolimus 0.1% (N=186) 
Takrolimus 0,1% (N = 186)
Formal topical drug interaction studies with tacrolimus ointment have not been conducted. 
Nisu provedena službena ispitivanja interakcija topikalnih lijekova i takrolimus masti.
Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. 
Protopic 0,1% mast se primjenjuje za liječenje umjerenog do teškog atopijskog dermatitisa (ekcema) u odraslih koji nemaju prikladan odgovor ili ne podnose konvencionalne terapije kao što su topikalni kortikosteroidi.
Package leaflet: Information for the user Protopic 0.03% ointment tacrolimus monohydrate 
Uputa o lijeku: Informacije za korisnika Protopic 0,03% mast takrolimus hidrat
*The adverse reaction has been reported during post-marketing experience 
*Nuspojava je bila zabilježena nakon stavljanja lijeka u promet
Package leaflet: Information for the user Protopic 0.1% ointment tacrolimus monohydrate 
Uputa o lijeku: Informacije za korisnika Protopic 0,1% mast takrolimus hidrat
However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far. 
Međutim, dostupni dokazi do sada ne potvrđuju niti ne opovrgavaju njihovu povezanost s liječenjem Protopic mašću.
Post-marketing 
Nakon stavljanja u promet
The use of Protopic ointment under occlusion has not been studied in patients. 
U bolesnika nije ispitana primjena Protopic masti ispod okluzivnih povoja.
Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience. 
Rozacea (crvenilo lica), dermatitis sličan rozacei, lentigo (prisutnost ravnih smeđih pjegica na koži),
Tacrolimus Twice weekly (N=78) 
Takrolimus Dvaput tjedno (N = 78)
Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.1% ointment twice weekly. 
Kad se umjereni do teški atopijski dermatitis jednom potpuno povuče ili gotovo potpuno povuče nakon najviše 6 tjedana liječenja rasplamsane bolesti te ako Vam se bolest često rasplamsa (tj. 4 ili više puta godišnje), primjenom Protopic 0,1% masti dvaput tjedno može biti moguće spriječiti povratak rasplamsane bolesti ili produljiti vrijeme u kojem nemate rasplamsanu bolest.
Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly. 
Kad se umjereni do teški atopijski dermatitis jednom potpuno povuče ili gotovo potpuno povuče nakon najviše 6 tjedana liječenja rasplamsane bolesti te ako Vam se bolest često rasplamsa (tj. 4 ili više puta godišnje), primjenom Protopic 0,03% masti dvaput tjedno može biti moguće spriječiti povratak rasplamsane bolesti ili produljiti vrijeme u kojem nemate rasplamsanu bolest.
Herpes simplex, Herpes virus infection, Kaposi's varicelliform eruption* 
folikulitis, herpes simpleks, infekcija herpes virusom,
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) 
Poremećaji metabolizma i prehrane nepodnošenje alkohola (naleti crvenila u licu ili nadraženost kože nakon konzumiranja alkoholnog pića)
The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period. 
(AUC) mEASI-a kao stopa početnih vrijednosti uprosječen za razdoblje liječenja.
Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older). 
Protopic masti (Protopic 0,03% i Protopic 0,1% mast) za odrasle bolesnike
An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years. 
U djece od 2 do 11 godina starosti ispitana je interakcija s protein-konjugiranim cjepivom protiv bakterije
Tel:+385 1 3778 770 
Remedia d.o.o. Tel:+385 1 3778 770
Ointment A white to slightly yellowish ointment. 
Mast Bijela do blago žućkasta mast.
The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design, 
Djelotvornost i sigurnost takrolimus masti u terapiji održavanja kod blagog do teškog atopijskog dermatitisa bila je procijenjena u 524 bolesnika u fazi III dva multicentrična, klinička ispitivanja sličnog ustroja, jednog u odraslih bolesnika (≥ 16 godina) i jednog u pedijatrijskih bolesnika
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