FrancophonIA/ELRC3.0 huggingface dataset:
English: Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C Yellow No. 10 aluminium lake Opacode Black S-1-8115
Slovenian: Črni železov oksid Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C rumeno št. 10 aluminium lake Opacode črno S-1-8115
English: Adverse reactions typical of the tetracycline class of medicinal products are less likely to occur during medication with ORACEA, due to the reduced dosage and the relatively low plasma levels involved.
Slovenian: Neželeni učinki, ki so značilni za tetraciklinska zdravila se veliko redkeje pojavljajo med zdravljenjem z zdravilom ORACEA zaradi manjšega odmerka in relativno nizke koncentracije v plazmi.
English: Doxycycline is not eliminated to any great extent during haemodialysis.
Slovenian: Doksiciklin se v veliki meri ne izloča med hemodializo.
English: Dialysis does not alter serum doxycycline half-life and thus would not be of benefit in treating cases of overdose.
Slovenian: Z dializo se razpolovna doba doksiciklina v serumu ne spremeni, zato ni učinkovita pri zdravljenju prekoračenega odmerka.
English: Caution should be observed in the treatment of patients with myasthenia gravis who may be at risk of worsening of the condition.
Slovenian: Pri zdravljenju bolnikov z miastenijo gravis je potrebna previdnost, saj se lahko bolezensko stanje poslabša.
English: ORACEA must not be used during pregnancy since it may cause permanent discolouration of the teeth in the unborn child.
Slovenian: Zdravila ORACEA ne smete uporabljati med nosečnostjo, saj lahko povzroči trajno obarvanje zob pri nerojenem otroku.
English: The CHMP proposed the amendment of section 4.4 of the SPC, in order to minimise the risk for withholding treatment from patients with ocular rosacea.
Slovenian: Odbor je predlagal dopolnitev poglavja 4.4 povzetka glavnih značilnosti zdravila, da se čimbolj zmanjša tveganje odrekanja zdravljenja v primeru očesne rozacee.
English: Very rare: Glossitis, dysphagia, enterocolitis.
Slovenian: Zelo redki: Glositis, disfagija, enterokolitis.
English: • Pain in the upper part of the abdomen
Slovenian: • Bolečina v zgornjem delu trebuha
English: Doxycycline has been shown to potentiate the hypoglycaemic effect of sulphonylurea oral antidiabetic agents.
Slovenian: Doksiciklin poveča hipoglikemični učinek sulfonilsečninskih peroralnih antidiabetikov.
English: As a consequence, doxycycline is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Slovenian: Zdravilo ORACEA je kontraindicirano v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: - The CHMP considers that the benefits of marketing a systemic drug such as Oracea in the present indication outweigh the risk for potential harmful effects related to resistance development and therefore considers the benefit-risk ratio to be positive,
Slovenian: - Odbor CHMP meni, da so koristi trženja sistemskega zdravila, kot je Oracea, za trenutno indikacijo večje od tveganja možnih neželenih učinkov, povezanih z razvojem odpornosti, ter da je razmerje med koristmi in tveganjem pozitivno,
English: Tetracyclines and methoxyflurane used in combination have been reported to result in fatal renal toxicity.
Slovenian: Poročali so, da lahko uporaba tetraciklinov v kombinaciji z metoksifluranom povzroči usodno ledvično toksičnost.
English: Black iron oxide Red iron oxide Yellow iron oxide Titanium dioxide
Slovenian: Črni železov oksid Rdeči železov oksid Rumen železov oksid Titanov dioksid
English: Always take ORACEA with an adequate amount of water to wash down the capsule, since this reduces the risk of irritation or ulcer in the throat or gullet.
Slovenian: Uporaba zdravila ORACEA skupaj s hrano in pijačo Zdravilo ORACEA vedno vzemite z ustrezno količino vode, da sperete kapsulo, saj to zmanjšuje tveganje draženja ali razjede v grlu ali požiralniku.
English: • Liver damage
Slovenian: • Jetrna poškodba
English: [See Annex I - To be completed nationally]
Slovenian: [Glejte dodatek I - izpolniti na nacionalni ravni]
English: ORACEA contains doxycycline in a formulation designed to yield plasma levels below the antimicrobial threshold.
Slovenian: Zdravilo ORACEA vsebuje doksiciklin v farmacevtski obliki, ki omogoča nivo plazme pod antimikrobno mejo.
English: ORACEA is a medicine for use in adults to reduce the pimples or red bumps on the face caused by a condition called rosacea.
Slovenian: KAJ JE ZDRAVILO ORACEA IN ZA KAJ GA UPORABLJAMO ORACEA je zdravilo za uporabo pri odraslih za zmanjšanje gnojnih mehurčkov ali rdečih oteklin na obrazu, ki jih povzroča bolezen, imenovana rozacea.
English: Use of sunscreen or sunblock should be considered.
Slovenian: Potrebna je uporaba sredstva za zaščito pred UV-žarki ali kreme za sončenje.
English: The capsule should be taken in the morning with adequate amounts of water in order to reduce the risk of oesophageal irritation and ulceration (see section 4.4).
Slovenian: Kapsulo je treba vzeti zjutraj s primerno količino vode, da zmanjšamo tveganje draženja požiralnika in ulceracije.
English: Methacrylic acid-ethyl acrylate copolymer (1:1)
Slovenian: Hipromeloza kopolimer metakrilna kislina-etil akrilat (1:1) Trietilcitrat
English: Long term use of doxycycline may result in significant absorption by the suckling infant and is therefore not recommended because of a theoretical risk of dental discolouration and decreased bone growth of the suckling child.
Slovenian: Pri dolgotrajni uporabi doksiciklina med dojenjem lahko pride do pomembne absorpcije pri dojenčku, zato ga zaradi teoretičnega tveganja obarvanja zob in upočasnitve rasti kosti pri dojenčku odsvetujemo .
English: Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no. 10 aluminium lake, Opacode black S-1-8115, Opacode black S-1-8114.
Slovenian: Tiskarsko črnilo: šelak, propilenglikol, črn železov oksid, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C rumen št. 10 aluminium lake, Opacode črn S-1-8115, Opacode črn S-1-8114.
English: In a rat carcinogenicity study increases in benign tumours of the mammary gland (fibroadenoma), uterus (polyp) and thyroid (C-cell adenoma) were noted in females.
Slovenian: Pri študiji karcinogenosti pri podganah se je pokazala porast benignih tumorjev v mlečnih žlezah (fibroadenom), maternici (polip) in ščitnici (C-celični adenom) samic.
English: INSTRUCTIONS ON USE [To be completed nationally]
Slovenian: NAVODILA ZA UPORABO [Izpolniti na nacionalni ravni]
English: • Fungal infection
Slovenian: • Glivična infekcija
English: Provided that the proposed indication mirrors the primary endpoint in the pivotal studies, as currently suggested, the CHMP considered that efficacy could be regarded as sufficiently demonstrated in the presently studied populations in the submitted phase 3 studies.
Slovenian: Odbor CHMP meni, da učinkovitost lahko štejemo za zadostno dokazano v populacijah, preučenih v predloženih študijah III. faze, če predlagana indikacija odraža primarni kazalnik izida ključnih študij, kar je trenutno predlagano.
English: Treatment should cease at the first sign of photosensitivity.
Slovenian: Ob prvem znaku fotoobčutljivosti je treba nemudoma prenehati z zdravljenjem.
English: The following side effects may occur commonly (affects 1 to 10 users in 100) during treatment with ORACEA:
Slovenian: Občasni neželeni učinki, ki se lahko pojavijo (prizadenejo 1 do 10 uporabnikov na 100 uporabnikov) med zdravljenjem z zdravilom ORACEA:
English: Blood and lymphatic system disorders: Rare:
Slovenian: Bolezni krvi in limfatičnega sistema: Redki:
English: INFORMATION IN BRAILLE [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI [Izpolniti na nacionalni ravni]
English: Whilst no overgrowth by opportunistic microorganisms such as yeasts were noted during the clinical studies with ORACEA, therapy with tetracyclines at higher doses may result in overgrowth of nonsusceptible microorganisms including fungi.
Slovenian: Med kliničnimi preskušanji z zdravilom ORACEA niso zaznali prekomerne rasti oportunističnih mikroorganizmov, kot so kvasovke, vendar se lahko pri višjih odmerkih zdravljenja s tetraciklini pojavi prekomerna rast neobčutljivih mikroorganizmov, vključno gliv.
English: Do not use ORACEA after the expiry date which is stated on the outer pack and blister after Batch No.
Slovenian: Zdravila ORACEA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in pretisnem omotu za št. serije.
English: Leave 2 to 3 hours after your daily dose of ORACEA before drinking or eating dairy products.
Slovenian: Mlečne izdelke lahko zaužijete 2 do 3 ure po vašem dnevnega odmerka zdravila ORACEA.
English: Do not take ORACEA if you are allergic (hypersensitive) to any medicinal product in the tetracycline family, including doxycycline or minocycline, or to any of the other ingredients of ORACEA (see section 6.)
Slovenian: Ne jemljite zdravila ORACEA če ste alergični na (preobčutljivi za) katerokoli zdravilo iz družine tetraciklinov, vključno doksiciklin ali minociklin, ali katerokoli drugo sestavino zdravila ORACEA (glejte 6. poglavje) če ste noseči, zdravila ORACEA ne smete uporabljati od 4. meseca naprej, ker lahko škoduje nerojenemu otroku.
English: Thus, the CHMP considers that the benefits of marketing a systemic drug such as Oracea in the present indication outweighs the risk for potential harmful effects related to resistance development and therefore consider the benefit-risk ratio to be positive.
Slovenian: Tako Odbor meni, da so koristi trženja sistemskega zdravila, kot je Oracea, za trenutno indikacijo večje od tveganja možnih neželenih učinkov, povezanih z razvojem odpornosti, ter da je razmerje med koristmi in tveganjem pozitivno.
English: Driving and using machines ORACEA has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ORACEA ne vpliva na sposobnost vožnje ali upravljanja s stroji oz. je ta vpliv zanemarljiv.
English: Isotretinoin is prescribed to patients with a severe case of acne.
Slovenian: Izotretinoin se predpisuje bolnikom s hudo obliko aken.
English: - The CHMP considers the efficacy of Oracea to reduce papulopustular lesions in adult patients with facial rosacea to be sufficiently demonstrated,
Slovenian: - Odbor CHMP šteje, da je učinkovitost zdravila Oracea za zmanjšanje papulopustularnih lezij pri odraslih z obrazno rozaceo zadostno dokazana,
English: Nasopharyngitis Sinusitis Fungal infection
Slovenian: Infekcijske in parazitske bolezni nazofaringitis sinusitis glivična infekcija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg doxycycline (as monohydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 40 mg doksiciklina (v obliki monohidrata).
English: ORACEA should not be used for long periods by breastfeeding mothers since it may cause tooth discolouration and reduced bone growth in the suckling child.
Slovenian: Doječe matere ne smejo uporabljati zdravila ORACEA dlje časa, saj lahko povzroči obarvanje zob in zmanjša rast kosti pri dojenčku.
English: If superinfection is suspected, appropriate measures should be taken, including consideration of discontinuing ORACEA.
Slovenian: Če sumimo na superinfekcijo, je treba pri zdravljanju z zdravilom ORACEA primerno ukrepati in razmisliti o njegovem prenehanju.
English: The active substance is doxycycline.
Slovenian: Zdravilna učinkovina je doksiciklin.
English: A decrease in fibula growth has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
Slovenian: Pri prezgodaj rojenih otrocih, ki so peroralno prejemali tetracikline v odmerku 25 mg/kg vsakih 6 ur, so opazili manjšo rast mečnice.
English: What ORACEA contains
Slovenian: Kaj vsebuje zdravilo ORACEA
English: ORACEA is indicated to reduce papulopustular lesions in adult patients with facial rosacea.
Slovenian: Zdravilo ORACEA se uporablja za zmanjševanje papulopustularnih lezij pri odraslih bolnikih z rozaceo (pordelost obraza).
English: Hypromellose[piq-qrd1], methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry beige YS-1-17274-A (hypromellose 3cP/6cP, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80), sugar spheres (maize starch, sucrose).
Slovenian: Pomožne snovi so: hipromeloza[piq-qrd1], kopolimer metakrilna kislina-etil akrilat (1:1), trietilcitrat, smukec, opadry beige YS-1-17274-A (hipromeloza 3cP/6cP, titanov dioksid, makrogol 400, rumeni železov oksid, rdeči železov oksid, polisorbat 80), sladkorji (koruzni škrob, saharoza).
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte dodatek I - Izpolniti na nacionalni ravni]
English: Rosacea is a well-recognized chronic cutaneous disorder, often characterized by remissions and exacerbations, that primarily affects the face causing significant psychological problems in addition to the physical discomfort.
Slovenian: Primarno prizadene obraz in poleg telesnega nelagodja povzroči značilne psihološke težave.
English: Sub-therapeutic doxycycline concentrations may result.
Slovenian: Lahko pride do nižjih koncentracij doksiciklina.
English: In conclusion, the CHMP considers the efficacy of Oracea to reduce papulopustular lesions in adult patients with facial rosacea to be sufficiently demonstrated.
Slovenian: V zaključku odbor CHMP meni, da je učinkovitost zdravila Oracea za zmanjšanje papulopusturalnih lezij pri odraslih z obrazno rozaceo zadostno dokazana.
English: You should consider using a sunscreen or sunblock to reduce the risk of sunburn and you should stop using ORACEA
Slovenian: UV-žarki ali kremo za sončenje, da zmanjšate tveganje opeklin in prenehajte uporabljati zdravilo ORACEA, če imate na koži opekline od sonca.
English: • Inflammation or ulceration of the gullet
Slovenian: • Vnetje ali razjede požiralnika
English: OTHER Store in the original package in order to protect from light.
Slovenian: DRUGI PODATKI Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: ORACEA should be used with caution in patients with a history of predisposition to candidiasis overgrowth.
Slovenian: Zdravilo ORACEA je treba pri bolnikih, pri katerih je znana nagnjenost h kandidazi, uporabljati previdno.
English: If you take an overdose of ORACEA, there is a risk of damage to the liver, kidneys or pancreas.
Slovenian: Če ste vzeli večji odmerek zdravila ORACEA, kot bi smeli Če vzamete večji odmerek zdravila ORACEA, obstaja nevarnost poškodbe jeter, ledvic in pankreasa.
English: Printing inks
Slovenian: Tiskarska črnila
English: Each capsule contains 40 mg doxycycline (as monohydrate).
Slovenian: Ena kapsula vsebuje 40 mg doksiciklina (v obliki monohidrata).
English: Pack size: 56 capsules in 4 strips of 14 each
Slovenian: Velikost ovojnine: 56 kapsul v 4 trakovih po 14 kapsul 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: Member State Marketing Authorisation Holder
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolniti na nacionalni ravni]
English: Adverse reactions reported for tetracycline antibiotics as a class are listed following the table.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi tetraciklinskih antibiotikov, so navedene v spodnji preglednici.
English: This medicine has been prescribed for you.
Slovenian: Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: HOW TO TAKE ORACEA
Slovenian: KAKO UPORABLJATI ZDRAVILO ORACEA
English: You should continue to take ORACEA until your doctor tells you to stop.
Slovenian: Če ste prenehali uporabljati zdravilo ORACEA Zdravilo ORACEA morate jemati, dokler vam zdravnik ne predpiše drugače.
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišično-skeletnega sistema, vezivnega tkiva bolečina v hrbtu
English: Doxycycline is known to cross the placenta and literature data indicate that tetracyclines can have toxic effects on the developing fetus.
Slovenian: Podatki v literaturi kažejo, da imajo lahko tetraciklini toksične učinke na razvijajoči se zarodek.
English: • Skin rashes or hives
Slovenian: • Kožni izpuščaji ali koprivnica
English: Skin and subcutaneous tissue disorders: Rare:
Slovenian: Hepatotoksičnost Bolezni kože in podkožja: Redki:
English: The following side effects may occur very rarely (affects less than 1 user in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Slovenian: Zelo redki neželeni učinki, ki se lahko pojavijo (prizadenejo manj kot 1 uporabnika na 10.000 uporabnikov) med zdravljenjem z zdravilom ORACEA:
English: 1 Name approval pending 2 Name approval pending
Slovenian: Odobritev imena v teku Odobritev imena v teku
English: Pharmacotherapeutic group: Antibacterials for systemic use, Tetracyclines.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, tetraciklini, oznaka ATC: J01AA02.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolniti na nacionalni ravni]
English: ≥ 1/10,000 to < 1/1,000
Slovenian: ≥ 1/1.000 do < 1/100
English: • Inflammation of the sinuses
Slovenian: • Vnetje sinusov
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: • Sinus headache
Slovenian: • Sinusni glavobol
English: Agents inhibiting peristalsis should not be employed in this situation.
Slovenian: V takšni situaciji ne smemo dajati sredstev, ki zavirajo peristaltiko.
English: Cardiac disorders: Rare:
Slovenian: Srčne bolezni: Redki:
English: Immune system disorders: Rare:
Slovenian: Bolezni imunskega sistema: Redki:
English: It is advisable that doxycycline and beta-lactam antibiotics should not therefore be used in combination.
Slovenian: Zato kombinacijo doksiciklina in betalaktamskih antibiotikov odsvetujemo .
English: The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Slovenian: Redki neželeni učinki, ki se lahko pojavijo (prizadenejo 1 do 10 uporabnikov na 10.000 uporabnikov) med zdravljenjem z zdravilom ORACEA:
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečina
English: MARKETING AUTHORISATION NUMBERS [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolniti na nacionalni ravni]
English: Route of administration
Slovenian: C. NAVODILO ZA UPORABO
English: LIST OF EXCIPIENTS Contains also sucrose See leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi saharozo
English: HOW TO STORE ORACEA
Slovenian: SHRANJEVANJE ZDRAVILA ORACEA
English: Nervous system disorders: Rare:
Slovenian: Bolezni živčevja: Redki:
English: No dosage adjustment is necessary in patients with renal impairment.
Slovenian: Pri bolnikih z ledvično okvaro odmerkov ni potrebno prilagajati.
English: BATCH NUMBER Batch No.:
Slovenian: ŠTEVILKA SERIJE Št. serije:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/PVC/AClAR BLISTER
Slovenian: ALUMINIJ/PVC/AClAR PRETISNI OMOT
English: The frequency categories used are:
Slovenian: Navedba pogostnosti:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTON
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare:
Slovenian: ≥ 1/10.000 do < 1/1.000 Zelo redki: < 1/10.000
English: Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
Slovenian: Antianabolno delovanje tetraciklinov lahko povzroči povečanje BUN-a. Do sedaj opravljene študije kažejo, da se to ne pojavi pri uporabi doksiciklina pri bolnikih z okvarjeno ledvično funkcijo.
English: Talc
Slovenian: Smukec
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg doxycycline (as monohydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 40 mg doksiciklina (v obliki monohidrata).
English: Invented name Strength Pharmaceutical Form
Slovenian: Izmišljeno ime name
English: NAME OF THE MEDICINAL PRODUCT ORACEA 40 mg modified-release hard capsules
Slovenian: IME ZDRAVILA ORACEA 40 mg trde kapsule s prirejenim sproščanjem
English: ORACEA 40 mg Prolonged-release capsule, hard Oral
Slovenian: ORACEA 40 mg Kapsula s podaljšanim sproščanjem, trda
English: Gastric lavage should be considered.
Slovenian: Treba je razmisliti tudi o izpiranju želodca.
English: ORACEA 40 mg Modified-release capsule, hard Oral
Slovenian: ORACEA 40 mg Kapsula s prirejenim sproščanjem, trda
English: Sinus headache
Slovenian: Jetrna okvara
English: PACKAGE LEAFLET: INFORMATION FOR THE USER ORACEA 40 mg modified release hard capsules Doxycycline
Slovenian: NAVODILO ZA UPORABO: ORACEA 40 mg trde kapsule s prirejenim sproščanjem doksiciklin
English: Psychiatric disorders
Slovenian: Psihiatrične motnje anksioznost
English: However, as there are no data to support safety in hepatic impairment at this lower dose, ORACEA should be administered with caution to patients with hepatic impairment or to those receiving potentially hepatotoxic medicinal products.
Slovenian: Bolnikom z jetrno okvaro, ali tistim, ki prejemajo potencialno hepatotoksična zdravila je potrebna previdnost pri dajanju zdravila ORACEA, ker ni na voljo podatkov, ki bi podprli varnost uporabe zdravila pri jetrni okvari v nizkih odmerkih.
English: • Pain
Slovenian: • Bolečina
English: Increased blood urea.
Slovenian: zvišana sečnina v krvi.
English: Pain
Slovenian: Peroralno
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolniti na nacionalni ravni]
English: 40 mg Modified-release capsule, hard Oral
Slovenian: 40 mg Kapsula s prirejenim sproščanjem, trda
English: 40 mg Prolonged-release capsule, hard Oral
Slovenian: 40 mg Kapsula s podaljšanim sproščanjem, trda
English: Hypertension
Slovenian: Jakost
English: • Dry mouth
Slovenian: • Vnetje črevesja
English: Back pain
Slovenian: • Bolečina v hrbtu
English: Keep this leaflet.
Slovenian: Navodilo shranite.
English: BEFORE YOU TAKE ORACEA
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ORACEA
English: Always take ORACEA exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila ORACEA natančno upoštevajte zdravnikova navodila.
English: NAME OF THE MEDICINAL PRODUCT ORACEA 40 mg modified-release hard capsules doxycycline
Slovenian: ORACEA 40 mg trde kapsule s prirejenim sproščanjem doksiciklin
English: Hepatic impairment
Slovenian: Bolezni živčevja sinusni glavobol
English: 13 February 2013
Slovenian: 13. februar 2013
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC
Slovenian: Izid postopka po členu 31 Direktive 2001/83/ES
English: They are currently marketed in most EU countries.
Slovenian: Zdravila so trenutno na tržišču v večini držav EU.
English: Questions and answers on the review of calcitonincontaining medicines
Slovenian: Vprašanja in odgovori v zvezi s pregledom zdravil, ki vsebujejo kalcitonin
English: The European Commission issued a decision on 13 February 2013.
Slovenian: Evropska komisija je sklep izdala dne 13. februarja 2013.