natgillin/translations-raw huggingface dataset:
Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 plus bevacizumab 15 mg/kg IV on Day 1 (q3w)
2. dan (na 3 tedne), ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko
Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Randomizirani bolniki so na dan 1 vsakega tritedenskega cikla do skupno 6 ciklov prejeli kemoterapijo na osnovi platine (paklitaksel 200 mg/m2 in karboplatin AUC = 6,0, oboje z i.v.
Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Zdravilo Avastin lahko poškoduje nerojenega otroka,
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with Avastin.
O propadanju kostnega tkiva (osteonekrozi) v drugih kosteh, ne v čeljustnici, so poročali pri bolnikih,
Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see Section 5.1).
Bevacizumab je indiciran za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino (glejte poglavje 5.1).
Gastrointestinal ulcera
supraventrikularna tahikardija
Gastrointestinal perforationb,d,
bolečine v trebuhu perforacija prebavilb,d,
• CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent Avastin (15 mg/kg) every 3 weeks for 6 and up to 8 cycles, followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
Avastin (15 mg/kg) vsake 3 tedne, od 6 do največ 8 ciklov, ki jim je sledilo samo zdravilo Avastin (15 mg/kg vsake 3 tedne) do napredovanja bolezni ali nesprejemljive toksičnosti.
Objective Response Rate (ORR) Patients included in analysis Rate
Število bolnikov, vključenih v analizo delež
• Gastrointestinal perforations (see section 4.4).
· perforacije prebavil (glejte poglavje 4.4),
AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment.
Shemo prejemajo bolniki, ki niso bili najprimernejši za prvo linijo zdravljenja z irinotekanom, in sicer skupaj 6 tednov v 8-tedenskih ciklih (shema Roswell Park).
Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
epistaksa, dispneja, hipoksija pljučna hipertenzijac, perforacija nosnega pretinac
Immune system disorders
Bolezni imunskega sistema preobčutljivost,
• abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
· nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot navadno, · predrtje nosnega pretina (stena iz hrustanca, ki ločuje nosnici), · luknja v želodcu ali črevesju, · odprta rana ali luknja v sluznici želodca ali tankega črevesa (znaki so lahko bolečina v trebuhu,
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Če so bevacizumab razredčili s 5-% raztopino glukoze, so opazili od koncentracije odvisen razpad tega zdravila.
Cisplatin+ Paclitaxel
Cisplatin + paklitaksel
Wound healing complicationsb,d,
d, krvavitev b,d,
Secondary Endpoints
Rezultati za vse sekundarne cilje
Objective response rate Rate
Objektivni odgovor na zdravljenje Delež
Avastin should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Avastin therapy (NCI-CTCAE v.3) (see section 4.8).
Zdravilo Avastin je treba pri bolnikih z življenjsko ogrožajočimi tromboemboličnimi neželenimi učinki, vključno s pljučno embolijo (stopnja 4, NCI-CTCAE v.3) ukiniti, bolnike s tromboemboličnimi neželenimi učinki stopnje ≤ 3 (NCI-CTCAE v.3) pa skrbno spremljati.
b 10 mg/kg every 2 weeks.
a 10 mg/kg vsaka 2 tedna b glede na kontrolno skupino
Renal thrombotic microangiopathy b,c
globoka venska tromboza renalna trombotična mikroangiopatijab,c, anevrizme in disekcije arterij
Progression-free survival Median time (months) Hazard ratio p-value
mediana preživetja brez napredovanja bolezni (meseci) razmerje ogroženosti (95-% interval zaupanja) p-vrednost
Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients.
Po neodobreni intravitrealni uporabi vial zdravila Avastin, ki so odobrene za intravensko uporabo pri rakavih bolnikih, so poročali o posameznih primerih in o skupini resnih neželenih učinkov, povezanih z očmi.
Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Zdravilo Avastin uporabljamo za zdravljenje odraslih bolnikov z napredovalim rakom debelega črevesa in danke.
Patients older than 65 years have an increased risk of experiencing the following side effects :
Pri bolnikih, starejših od 65 let, je večje tveganje za naslednje neželene učinke: · krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada,
Pulmonary embolism, Hypoxia, Dysphoniaa
Presnovne in prehranske motnje anoreksija, hipomagneziemija hiponatriemija dehidracija
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Učinkovitost in varnost zdravila Avastin v kombinaciji z interferonom alfa-2a v primerjavi s samim interferonom alfa-2a v prvi liniji zdravljenja metastatskega raka ledvičnih celic sta bili ovrednoteni v randomiziranem, dvojno slepem kliničnem preskušanju faze III.
• lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
občutek napihnjenosti, črna stolica ali kri v stolici ali kri v bruhanju), · krvavitev iz spodnjega dela debelega črevesa, · lezije v dlesnih z izpostavljeno čeljustnico, ki se ne pozdravijo in so lahko povezane z bolečino in vnetjem okoliških tkiv (za nadaljnja priporočila glejte spodaj), · luknja v žolčniku (simptomi in znaki lahko vključujejo bolečino v trebuhu, povišano telesno temperaturo in slabost/bruhanje).
Progression-free survival - Primary analysis6 Median PFS (months)1
Sekundarni opazovani dogodki Preživetje brez napredovanja bolezni - primarna analiza6 Mediana preživetja brez napredovanja (meseci) Razmerje ogroženosti [95-% IZ]
Non-GI Fistulae (see section 4.8)
Fistule izven prebavil (glejte poglavje 4.8)
Common (affects 1 to 10 users in 100) side effects, which were not severe, include: • voice changes and hoarseness.
Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov), ki pa niso bili hudi,
Please talk to your doctor since blood clots can lead to heart attack and stroke.
Posvetujte se s svojim zdravnikom, saj lahko krvni strdki privedejo do srčnega napada in kapi; · zdravilo Avastin lahko prav tako poveča tveganje za pojav krvnih strdkov v venah (tip krvnih žil);
HR (95% CI) p-value
Razmerje ogroženosti (95-% interval zaupanja) p-vrednost
Hazard ratio
razmerje ogroženosti
Febrile neutropenia, Leucopenia, Neutropeniab, Thrombo-cytopenia
Bolezni krvi in limfatičnega sistema febrilna nevtropenija, levkopenija, nevtropenijaa, trombocitopenija anemija, limfopenija
No trials have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z okvaro ledvic niso opravili,
15 mg/kg q 3 weeks
5 mg/kg i.v.
Foetal abnormalitiesa,b
(venska) trombembolijaa,b,
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below) In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving Avastin in combination with chemotherapy than with chemotherapy alone.
V nekaterih kliničnih preskušanjih so o anafilaktičnih in anafilaktoidnih reakcijah pogosteje poročali pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo, kot pri bolnikih na sami kemoterapiji.
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Pred začetkom zdravljenja in med njim je priporočljivo spremljanje proteinurije z urinskimi testnimi lističi.
The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in three phase III trials (AVF4095g , MO22224 and GOG-0213) with different patient populations and chemotherapy regimens.
III (AVF4095g, MO22224 in GOG-0213) pri različni populaciji bolnic in shemah kemoterapije.
CT+BV (n=142)
kemoterapija + bevacizumab (n = 142)
The median age was 46.0 years (range: 20−83) in the Chemo alone group and 48.0 years
Mediana starost bolnic je bila v skupini s samo kemoterapijo 46,0 let (razpon: od 20 do 83), v skupini s kemoterapijo in zdravilom Avastin pa 48,0 let (razpon: od 22 do 85); v skupini s samo kemoterapijo je bilo starejših od 65 let 9,3 % bolnic, v skupini s kemoterapijo in zdravilom Avastin pa 7,5 % bolnic.
EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens No interaction studies have been performed.
Monoklonska protitelesa z delovanjem na EGFR, v kombinaciji s kemoterapevtskimi shemami, ki vključujejo bevacizumab
Proteinuria a,b
Bolezni sečil proteinurijaa,b
Hypersensitivity reactions/infusion reactions (see section 4.8) Patients may be at risk of developing infusion/hypersensitivity reactions.
Preobčutljivostne reakcije/reakcije pri infundiranju (glejte poglavje 4.4 ter podnaslov Izkušnje po prihodu zdravila na trg, spodaj)
Osteonecrosis of the jaw b,c
bolečine v hrbtu osteonekroza čeljustnicb,c
Venous thromboembolism (see section 4.8)
CTCAE v.3) (glejte poglavje 4.8).
• heart failure,
mišična oslabelost,
The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
kar je v območju, ki so ga opisali za imunoglobuline G in druga monoklonska protitelesa.Tipična vrednost za periferni volumen (Vp), če so bevacizumab dajali sočasno z drugimi antineoplastičnimi zdravili, je pri bolnicah znašala 1,69 l, pri bolnikih pa 2,35 l. Po prilagoditvi glede na telesno maso so imeli bolniki večji volumen osrednjega prostora (+20 %) kot bolnice.
Caution should be exercised when Avastin and intravenous bisphosphonates are administered simultaneously or sequentially.
Avastin in intravenskih difosfonatov je potrebna previdnost.
Infection, Urinary tract infection
okužba sečil nekrotizirajoči fasciitisa
Tumour-associated haemorrhage (see section 4.4)
Krvavitev, povezana s tumorjem (glejte poglavje 4.4)
Median
Zdravljenje
OTHER SPECIAL WARNING(S), IF NECESSARY This medicinal product does not contain any preservative
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Take with water.
Vzemite z vodo.
{Name and address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov } <{tel}> <{faks}> <{e-mail}>
In these cases observation is recommended.
V teh primerih priporočamo opazovanje.
80339 München, Germany
80339 München, Nemčija
Infants and children up to 12 years of age.
Dojenčki in otroci do 12. leta starosti.
Most of these patients took medication just prior to going to bed.
Večina teh bolnikov je vzela zdravilo tik pred spanjem.
Adults, including the elderly:
Odrasli, vključno starostniki:
B. LABELLING
B. OZNAČEVANJE
Concomitant administration should therefore be avoided.
Zato se je treba sočasni uporabi izogibati.
You should take one capsule ORACEA each day in the morning.
Vsak dan zjutraj morate vzeti eno kapsulo zdravila ORACEA.
Opacode Black S-1-8114
Opacode črno S-1-8114
In clinical trials patients were treated for 16 weeks.
V kliničnih preskušanjih so bolnike zdravili 16 tednov.
• Changes in the number or type of certain blood cells
• Spremembe v številu ali tipu določenih krvnih celic
These effects may be symptoms of a severe allergic (hypersensitivity) reaction.
Ti učinki so lahko simptomi resne alergijske (preobčutljivostne) reakcije.
Distribution, metabolism and elimination:
Porazdelitev, metabolizem in eliminacija:
The data resulting from this study should be provided to the relevant national competent authorities for assessment.
Podatke iz omenjene študije mora posredovati ustreznim nacionalnim pristojnim organom v vrednotenje.
• Abnormal reaction of the skin to sunlight
• nenormalna reakcija kože na sončno svetlobo
Studies in animals have not demonstrated a teratogenic effect.
Študije na živalih niso pokazale teratogenega učinka.
Other interactions:
Druge interakcije:
• Allergic reaction causing swelling of the eyes, lips or tongue*
• Alergijska reakcija, ki povzroči otekanje oči, ustnic ali jezika *
Pharmacokinetics in special populations:
Farmakokinetika pri posebnih populacijah:
• Allergic (hypersensitivity) reaction throughout the body*
• Alergijska (preobčutljivostna) reakcija po vsem telesu*
• Changes in some blood tests (amount of glucose in blood or tests of liver function).
• Spremembe pri nekaterih krvnih testih (količina glukoze v krvi ali testi jetrne funkcije).
Very rare: Bulging fontanelle in infants
Zelo redki: Izbočena fontanela pri dojenčkih
Swallow the capsule whole and do not chew it.
Pogoltnite celo kapsulo in je ne žvečite.
The possibility of an increased risk of bleeding events should be borne in mind.
Treba je upoštevati možnost večjega tveganja krvavitev.
• Increased pressure in the brain
• Zvišan tlak v možganih
The clinical significance of these findings is not known.
Klinični pomen teh ugotovitev ni znan.
This reaction is more common during long-term use of the medicinal product but has been observed following repeated short-term courses.
Ta reakcija je bolj običajna med dolgotrajno uporabo zdravila, vendar je bila opažena po večkratnih kratkotrajnih odmerkih.
Thyroid function is normal.
Ščitnična funkcija je normalna.
• Damage to red blood cells (haemolytic anaemia)
• Poškodbe rdečih krvnih celic (hemolitična anemija)
Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment.
Bolnike je treba po 6 tednih pregledati in če učinek ni viden, je treba razmisliti o prenehanju zdravljenja.
Each pack contains 56 capsules.
V vsaki ovojnini je 56 kapsul.
The conditions of the Marketing Authorisation are set out in Annex IV.
Pogoji dovoljenja za promet so navedeni v Dodatku IV.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTAVLIH ODPADNIH SNOVI, KADAR SO POTREBNI
Between 40% and 60% of an administered dose can be accounted for in the urine by 92 hours, and approximately 30% in the faeces.
Med 40% in 60% vnešenega odmerka lahko pričakujemo v urinu v 92 urah, in približno 30% v blatu.
The clinical relevance of these findings remains unknown.
Klinična pomembnost teh ugotovitev je še neznana.
However, the studies submitted concerning the absence of risk for selection of antibiotic resistance in the normal microbiota were not considered as fully convincing, due to limitations in the methods used.
Vendar študije, predložene v zvezi z odsotnostjo tveganja selekcije odpornosti proti antibiotikom pri normalnem mikrobiotu, niso bile štete za popolnoma prepričljive zaradi omejitev uporabljenih metod.
Interactions affecting other medicinal products:
Interakcije, ki vplivajo na druga zdravila:
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORACEA
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ORACEA
The indication rosacea as defined by the study inclusion criteria was regarded to fulfil these criteria.
Meni, da indikacija rozacee, kakor je bila opredeljena v vključitvenih kriterijih študije, izpolnjuje te pogoje.
• Inflammation of the nose and throat
• Vnetje nosu in grla
This probably leading to a higher risk for adverse reactions, such as development of resistance in the commensal microflora.
To verjetno povzroča večje tveganje neželenih učinkov, kot je razvoj odpornosti pri komenzalni mikroflori.
Do not take a double dose to make up for a forgotten capsule.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, da bi nadomestili pozabljeno kapsulo.
ORACEA and certain other medications may not work properly when taken together.
ORACEA in določena druga zdravila lahko nepravilno delujejo, če jih jemljemo skupaj.
• High or increased blood pressure
• Visok ali zvišan krvni tlak
Quinapril may reduce the absorption of doxycycline due to the high magnesium content in quinapril tablets.
Kvinapril lahko zmanjša absorpcijo doksiciklina zaradi visoke vsebnosti magnezija v tabletah kvinaprila.
• Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
• Poslabšanje bolezni imunskega sistema, ki je poznana kot sistemski eritematozni lupus (SLE)
Therefore it is recommended that patients should be assessed 4 weeks after stopping treatment.
Zato priporočamo, da bolnike po 4 tednih po prenehanju zdravljenja ponovno pregledate.
Therefore such medicinal products or foodstuffs should be taken after a period of 2 to 3 hours following ingestion of doxycycline.
Zato je treba ta zdravila ali hrano zaužiti 2 do 3 urah po prejemu doksiciklina.
The scope, design and end-points should be in line with similar trials published in the literature.
Cilj, zasnova in kazalniki izida morajo biti v skladu s podobnimi preskušanji, objavljenimi v literaturi.
The CHMP was also satisfied with the explanation on the exclusion criteria of nodule numbers, as no effect on nodules is claimed in the proposed indication.
Odbor je bil tudi zadovoljen z razlago izključitvenih kriterijev glede števila nodulov, saj v predlagani indikaciji ni naveden učinek na nodule.
The scope, design and endpoints of the study should be in line with similar trials published in the literature and the study protocol should be validated by and submitted to the National Competent Authority of the Reference Member State within three months of approval.
Cilj, zasnova in kazalniki izida študije morajo biti v skladu s podobnimi preskušanji, objavljenimi v literaturi, protokol študije pa mora prejeti in potrditi pristojni nacionalni organ referenčne države članice v treh mesecih od odobritve.
Overall it is estimated that, since authorization, more than 400,000 prescriptions for Oracea were filled at pharmacies in the USA up to November 2007 and the post-marketing experience identified no new safety concerns.
Ocenjujejo, da so od odobritve do novembra 2007 v lekarnah v ZDA izdali zdravilo Oracea na več kot 400 000 receptov, pri čemer v obdobju trženja zdravila niso odkrili nobenih novih varnostnih zadržkov.
Important information about some of the ingredients of ORACEA ORACEA contains sugar (sucrose).
Pomembne informacije o nekaterih sestavinah zdravila ORACEA ORACEA vsebuje sladkor (saharozo).
Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, UK.
Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, VB.
Upon discontinuation, lesions tended to reappear at 4 weeks follow-up.
Po prenehanju zdravljenja so se lezije po 4 tednih ponovno pojavile.
ORACEA may make certain antibiotics, including penicillins, less effective.
Zdravilo ORACEA lahko povzroči, da so določeni antibiotiki, vključno penicilini, manj učinkoviti.
• Inflammation of the membrane surrounding the heart
• Vnetje membrane, ki obdaja srce
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco na nekatere sladkorje, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
The capsules are beige in colour and bear the marking “CGPI 40”.
Kapsule so beige barve in imajo oznako “CGPI 40”.
Do not take milk or dairy products at the same time as ORACEA since these products contain calcium which may reduce the effectiveness of ORACEA.
Ne uživajte mleka ali mlečnih izdelkov sočasno z zdravilom ORACEA, saj ti pripravki vsebujejo kalcij, ki lahko zmanjša učinkovitost zdravila ORACEA.
Since no formal dose-response studies have been conducted, Phase III data were analyzed to investigate the existence of a dose-efficacy relationship.
Ker formalne študije odmerka in odziva niso bile opravljene, so podatke študij III. faze analizirali za dokaz odvisnosti med odmerkom in učinkovitostjo.
In humans, the use of tetracyclines during a limited number of pregnancies has not revealed any specific malformation to date.
Uporaba tetraciklinov v omejenem številu nosečnosti pri ljudeh ni pokazala specifičnih malformacij.
The Applicant considered that studies against other active treatments were not practical or warranted, in the case of Oracea.
Predlagatelj je menil, da študije s primerjanjem z drugimi aktivnimi zdravljenji v primeru zdravila Oracea niso bile praktične ali utemeljene.
This leaflet was last approved in
To navodilo je bilo odobreno
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Prosimo, obvestite svojega zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Tell your doctor about medications that you are taking or plan to take whilst you are taking ORACEA .
Obvestite svojega zdravnika o zdravilih, ki jih jemljete, ali jih nameravate jemati med jemanjem zdravila ORACEA.
A. SUMMARY OF PRODUCT CHARACTERISTICS
A. POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
As for other tetracyclines, doxycycline forms a stable calcium complex in any boneforming tissue.
Tako kot drugi tetraciklini tudi doksiciklin tvori stabilen kalcijev kompleks v kateremkoli kostnem tkivu.
The CHMP also considered that the survey referred to by the Applicant, showing that papulopustular lesions are readily recognized and rated by dermatologists providing a qualitative as well as quantitative measurement, was relevant; therefore the currently proposed indication was considered clinically applicable and practical.
Odbor je tudi menil, da je pomembna raziskava, na katero se sklicuje predlagatelj in ki kaže, da dermatologi enostavno prepoznavajo in ocenjujejo papulopustularne lezije, kar omogoča kvalitativno in kvantitativno merjenje, zato se trenutno predložena indikacija šteje za klinično uporabno in praktično.
ORACEA must not be used to treat infections caused by organisms susceptible (or suspected to be susceptible) to doxycycline.
Zdravilo ORACEA se ne sme uporabljati za zdravljenje okužb, ki jih povzročajo organizmi, ki so občutljivi (ali za katere sumimo, da so občutljivi) na doksiciklin.
Post-marketing experience has not identified any new safety concerns.
V obdobju trženja zdravila niso odkrili nobenih novih varnostnih zadržkov.
Very rare: Brown-black microscopic discolouration of thyroid tissue has been reported with long term use of tetracyclines.
Zelo redki: O rjavo-črnem mikroskopskem obarvanju tkiva ščitnice so poročali po dolgotrajni uporabi tetraciklinov.
If you take more ORACEA capsules than you should, ask your doctor immediately for advice.
Če vzamete več kapsul zdravila ORACEA, kot bi jih morali, nemudoma poiščite nasvet pri svojem zdravniku.
Treatment should cease if evidence of raised intracranial pressure develops.
Z zdravljenjem je treba prenehati, če se pojavi povišan intrakranialni tlak.