natgillin/translations-raw huggingface dataset:
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Če se pojavijo neželeni učinki, je treba zdravljenje ukiniti in se posvetovati z veterinarjem.
It is recommended to administer the second injection at a different site since local tolerance has been assessed after single injection only.
Priporočljivo je, da se druga injekcija injicira na drugo mesto, prenašanje zdravila glede na mesto cepljenja je bilo namreč ugotovljeno le za eno samo injiciranje.
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAID) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
For the relief of post operative pain associated with minor soft tissue surgery such as castration.
Za lajšanje postoperativnih bolečin, povezanih z manjšimi operacijami mehkega tkiva, na primer s kastracijo.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
(EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
150 mg For the full list of excipients, see section 6.1.
50 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Do not use this veterinary medicinal product after the expiry date (EXP) stated on the carton and bottle.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), navedenega na zunanji ovojnini in viali.
Once broached, use within 28 days.
Načeto zdravilo uporabite v 28 dneh.
Cattle: subcutaneous use Pigs: intramuscular use Read the package leaflet before use.
Govedo: Subkutana uporaba Prašiči: Intramuskularna uporaba Pred uporabo preberite navodilo za uporabo.
ADVICE ON CORRECT ADMINISTRATION Avoid introduction of contamination during use.
NASVET O PRAVILNI UPORABI ZDRAVILA Pazite, da med uporabo ne bi prišlo do okužbe.
Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.
Bodite posebej pozorni na natančno odmerjanje, vključno z uporabo primerne priprave za odmerjanje,
Cattle: Subcutaneous or intravenous use Pigs: Intramuscular use Horses: Intravenous use Read the package leaflet before use.
Govedo: Subkutana ali intravenska uporaba Prašiči: Intramuskularna uporaba Konji: Intravenska uporaba Pred uporabo preberite navodilo za uporabo.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Za pomožžno zdravljenje pri zdravljenju akutnega mastitisa, v kombinaciji z antibiotičnim zdravljenjem.
In the case of overdosage symptomatic treatment should be initiated.
Pri prevelikem odmerjanju uvedemo simptomatsko zdravljenje.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritisagalactia syndrome) with appropriate antibiotic therapy.
Za pomožno zdravljenje pri zdravljenju puerperalne septikemije in toksemije (sindroma mastitisa, metritisa in agalakcije) ob ustreznem antibiotičnem zdravljenju.
Hydrochloric acid/sodium hydroxide Macrogol 300
Klorovodikova kislina/natrijev hidroksid Makrogol 300
Benzyl alcohol 20 mg
Benzilalkohol 20 mg
Hydrochloric acid/sodium hydroxide Macrogol 1500
Klorovodikova kislina/natrijev hidroksid Makrogol 1500
Clear, greenish yellow solution.
Prozorna, zelenkasto rumena raztopina.
Cattle and pigs
Govedo in prašiči
Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Izločanje Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladem govedu 26 ur.
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo:
Treatment of piglets with Melovem before castration reduces post operative pain.
Zdravljenje pujskov z zdravilom Melovem pred kastracijo blaži postoperativno bolečino.
Overdose (symptoms, emergency procedures, antidotes) In the case of overdose, symptomatic treatment should be initiated.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri prevelikem odmerjanju je treba uvesti simptomatsko zdravljenje.
The active substance in Melovem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije
TARGET SPECIES Cattle (calves and young cattle) and pigs
CILJNE ŽIVALSKE VRSTE Govedo (teleta in mlado govedo) in prašiči
Pigs: Intramuscular use
Prašiči: intramuskularna injekcija
Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs.
V kliničnih študijah, ki so bile opravljene pri prašičih, so po intramuskularnem injiciranju opazili prehodne otekline.
In pigs, after intramuscular administration, the mean plasma biological elimination half-life is approximately 2.5 hours.
Pri prašičih je srednja razpolovna doba izločanja po intramuskularnem dajanju približno 2,5 ure.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, If APPLICABLE
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Pogostost neželenih učinkov je opredeljena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se med enim ciklom zdravljenja pokažejo pri več kot 1 od 10 živali) - pogosti (več kot 1, a manj kot 10 od 100 živali) - občasni (več kot 1, a manj kot 10 od 1.000 živali) - redki (več kot 1, a manj kot 10 od 10.000 živali) - zelo redki (manj kot 1 od 10.000 živali, vključno s posameznimi poročili)
Cattle: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days
Govedo: meso in organi: 15 dni; mleko: 5 dni Prašiči, konji: meso in organi: 5 dni
EXPIRY DATE EXP {month/year} Once broached use by…
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Avoid introduction of contamination during use.
Pazite, da med uporabo ne bi prišlo do okužbe.
Keep injection vial in the outer carton in order to protect from light.
Za zaščito pred svetlobo hranite injekcijsko vialo v zunanji ovojnini.
TARGET SPECIES Cattle, pigs and horses
CILJNE ŽIVALSKE VRSTE Govedo, prašiči in konji
Meat and offal: 15 days Milk:
Meso in organi: 15 dni Mleko:
TARGET SPECIES Cattle and pigs
CILJNE ŽIVALSKE VRSTE Govedo in prašiči
4.8 Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Izdelovalec, odgovoren za sproščanje serij
Name and address of the manufacturer responsible for batch release Dopharma B.V.
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Dopharma B.V.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Za ublažžitev ohromelosti in vnetja pri neinfekcijskih lokomotornih motnjah.
Cardboard box with 1 colourless, type I glass injection vial of 50 ml, 100 ml and 250 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Kartonska škatla z 1 brezbarvno stekleno vialo tipa I po 50 ml, 100 ml ali 250 ml, zaprto z zamaškom iz bromobutilne gume in aluminijasto zaporo.
Cardboard box with 1 colourless type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Kartonska škatla z 1 brezbarvno stekleno vialo tipa I po 100 ml, zaprto z zamaškom iz bromobutilne gume in aluminijasto zaporo.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Po enkratnem podkožnem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladih govedu in kravah v obdobju laktacije 2,1 g/ml in 2,7 g/ml po 7,7 ure in 4 urah.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Po enkratnih intramuskularnih odmerkih meloksikama po 0,4 mg/kg je Cmax pri prašičih po 1 uri znašala 1,1 do 1,5 µg/ml.
Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain.
Posebna opozorila za vsako ciljno živalsko vrsto Zdravljenje telet z zdravilom Melovem 20 minut pred odstranitvijo rogov zmanjša pooperativn bolečino.
Pregnancy and lactation Can be used during pregnancy and lactation.
Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti in laktacije.
ROUTE(S) OF ADMINISTRATION Cattle: SC
POT(I) UPORABE ZDRAVILA Govedo: s.c.
Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle.
V kliničnih študijah, ki so bile opravljene pri govedu, so po podkožnem injiciranju pogosto poročali o prehodnih oteklinah na mestu injiciranja.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladih govedu in kravah v obdobju laktacije 26 in 17,5 ure.
Cattle: SC or IV
Govedo: s.c. ali i.v.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Dopharma Research B.V.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Dopharma Research B.V.
Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
Meloxicam 5 mg
Meloksikam 5 mg/ml
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Po dveh intramuskularnih odmerkih meloksikama po 0,4 mg/kg je znašala Cmax pri prašičih po 1 uri
ROUTE(S) OF ADMINISTRATION Cattle: SC or IV
POT(I) UPORABE ZDRAVILA Govedo: s.c. ali i.v.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial 100 ml and 250 ml
Steklena viala 100 ml in 250 ml
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Po enkratnem podkožnem odmerku meloksikama po 0,5 mg/kg je Cmax pri mladem govedu po 7,7 ure znašala 2,1 µg/ml.
Not permitted for use in lactating animals producing milk for human consumption.
Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06.
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami)
Pigs: Meat and offal: 5 days
Prašiči: meso in organi: 5 dni
Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smete dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
20 μg/kg 65 μg/kg 65 μg/kg
20 μg/kg 65 μg/kg 65 μg/kg mišice jetra ledvice ni vnosa Protivnetna zdravila/ nesteroidna protivnetna zdravila govedo, koze
MARKETING AUTHORISATION HOLDER Dopharma Research B.V.
IMETNIK DOVOLJENJA ZA PROMET Dopharma Research B.V.
Withdrawal period:
NAVODILO ZA UPORABO:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
- pogosti (več kot 1, a manj kot 10 od 100 živali) - občasni (več kot 1, a manj kot 10 od 1.000 živali) - redki (več kot 1, a manj kot 10 od 10.000 živali)
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna podkožna injekcija odmerka po 0,5 mg meloksikama na kilogram telesne mase (to je 10,0 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
PACKAGE LEAFLET FOR Melovem 30 mg/ml solution for injection for cattle and pigs
NAVODILO ZA UPORABO Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče
Excipient(s):
INDIKACIJA(E) Govedo:
Muscle Liver Kidney
Steklena viala
Cardboard box with 1 colourless glass injection vial of 50 ml, 100 ml or 250 ml.
Kartonska škatla z 1 brezbarvno stekleno vialo tipa I po 50 ml, 100 ml ali 250 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
PACKAGE LEAFLET FOR Melovem 20 mg/ml solution for injection for cattle, pigs and horses
NAVODILO ZA UPORABO Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/006 (100 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/006 (100 ml)
Manufacturer responsible for batch release: Dopharma B.V.
Imetnik dovoljenja za promet z zdravilom: Dopharma Research B.V.
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 (50 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/005 (50 ml)
Cattle: meat and offal: 15 days.
Govedo: meso in organi: 15 dni
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje Meloksikam
Cattle: meat and offal: 15 days; milk: 5 days.
Meso in organi: 15 dni Mleko: 5 dni
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/003 (100 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/003 (100 ml)
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic properties.
Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov.
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče Meloksikam
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/001
ŠTEVILKA DOVOLJENJ(A) ZA PROMET EU/2/09/098/001
PACKAGE LEAFLET FOR: Melovem 5 mg/ml solution for injection for cattle and pigs
Melovem 5 mg/ml, raztopina za injiciranje za govedo in prašiče
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 (50 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/002 (50 ml)
Protect from frost.
Zdravilo ne sme zmrzniti.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
NEŽELENI UČINKI Govedo in prašiči podkožno, intramuskularno in intravensko dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goved.
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention.
Najboljše možno lajšanje bolečine po operaciji boste dosegli, če boste zdravilo Melovem uporabili
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/005
In cattle and pigs, subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
NEŽELENI UČINKI Govedo in prašiči podkožno in intramuskularno dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goved.
4.8 Interaction with other medicinal products and other forms of interaction
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Benzyl alcohol Hydrochloric acid Sodium chloride Macrogol 400
6.1 Seznam pomožnih snovi benzilalkohol klorovodikova kislina natrijev klorid makrogol 400 makrogol 1500 meglumin voda za injekcije
WITHDRAWAL PERIOD Cattle:
KARENCA Govedo:
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/002
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 30 mg/ml
Meloksikam 20 mg Pomožna(e) snov(i): Etanol 150 mg
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Meloksikam je nesteroidno protivnetno zdravilo iz skupine oksikamov.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml
Meloksikam 20 mg Pomožna(pomožne) snov(i): Etanol 150 mg
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) each ml contains:
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
SPECIAL STORAGE CONDITIONS Keep the injection vial in the outer carton in order to protect from light.
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte nedosegljivo otrokom.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 30 mg/ml
Meloksikam 30 mg/ml
Immediate Packaging Pack size
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
Strength Pharmaceutical Form Route of Administration
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Date of first authorisation: 3 March 2017
Datum prve odobritve: 3. marec 2017
Assessment was undertaken by a blinded observer.
Oceno je izvedel slepi opazovalec.
The safety profile observed in elderly patients was consistent with that in the overall patient population.
Varnostni profil, opažen pri starejših bolnikih, je bil konsistenten s tistim pri celotni populaciji bolnikov.
Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.
O kožnih preobčutljivostnih reakcijah so poročali pri 2,3 % zdravljenih bolnikov.
The response criteria were the same as for CAILS.
Merila za odziv so bila enaka kot pri CAILS.
Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group.
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let, saj varnost in učinkovitost pri tej starostni skupini nista bili dokazani.
Your doctor may restart the treatment upon improvement of your symptoms.
Zdravnik bo zdravljenje morda znova uvedel po izboljšanju vaših simptomov.
- Tell your doctor if you have ever had an allergic reaction to chlormethine.
- Povejte svojemu zdravniku, če ste že kdaj imeli alergijskoreakcijo na klormetin.
The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Ledaga pri otrocih, starih 0 do 18 let, še nista bili dokazani.
In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older.
Pri nadzorovanem kliničnem preskušanju je bilo 31 % (79/255) študijske populacije starih 65 let ali starejših.
• The opening of the tube is covered with a foil safety seal.
• Odprtina tube je zaprta z varnostno tesnilno folijo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Results in other secondary endpoints (response in percentage of body surface area affected, time to first confirmed CAILS response, duration of first confirmed CAILS response and time to disease progression) were consistent with those for CAILS and SWAT.
Rezultati pri drugih sekundarnih opazovanih dogodkih (odziv glede na odstotek prizadete telesne površine, čas do prvega potrjenega odziva po CAILS, trajanje prvega potrjenega odziva po CAILS in čas do napredovanja bolezni) so bili konsistentni s tistimi iz CAILS in SWAT.
• Fire, flame, and smoking must be avoided until Ledaga has dried.
• Ognju, plamenom in kajenju se je treba izogibati, dokler se zdravilo Ledaga ne posuši.
Do not stop using your medicine until your doctor advises you to do so.
Ne prenehajte uporabljati zdravila, dokler vam tako ne naroči zdravnik.
Local skin reactions
Lokalne reakcije na koži
A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids.
Manjše število preskušancev (6,3 %, 8/128), zdravljenih z zdravilom Ledaga, je uporabljalo lokalne kortikosteroide.
Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na tubi in škatli poleg oznake »EXP«.
The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses.
Razmerje odzivov in 95-% interval zaupanja pri populaciji ITT sta bila 1,226 (0,974-1,552) za CAILS in 1,017 (0,783-1,321) za SWAT, tako da sta konsistentna s tistima pri populaciji EE za celotno vrednost odzivov po CAILS in SWAT.
Response rates (%)
Stopnja odziva (v %)
If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated.
Če bolnik nadaljevanje zdravljenja prenaša vsaj 1 teden, se lahko pogostnost nanašanja poveča na vsak drugi dan za vsaj 1 teden in nato na enkrat na dan, če bolnik to prenese.
• medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure).
• takoj je treba poiskati medicinsko pomoč (vključno s posvetom z oftalmologom v primeru izpostavljenosti očesa).
- Contact with your eyes must be avoided.
- Stiku zdravila z očmi se je treba izogniti.
- Remove the cap from the tube just before use.
- Pokrovček s tube odstranite tik pred uporabo.