natgillin/translations-raw huggingface dataset:
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Teva in association with levodopa (see section 4.4).
Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Entakapon Teva v povezavi z levodopo, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
Each film-coated tablet contains 200 mg entacapone.
Vsaka filmsko obložena tableta vsebuje 200 mg entakapona.
In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Če ste vzeli večji odmerek zdravila Entakapon Teva, kot bi smeli Če ste vzeli prevelik odmerek, se takoj posvetujte s svojim zdravnikom, farmacevtom ali najbližjo bolnišnico.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL (60, 100 or 175 film-coated tablets)
PODATKI NA PRIMARNI OVOJNINI NALEPKA (60, 100 ali 175 filmsko obloženih tablet)
Daily ON time (Mean ±SD) Study I: Daily On time (h)
Preglednica 2: Dnevno obdobje ‘ON' (povprečje ± S.D.)
Entacapone therapy should be administered cautiously to patients with ischemic heart disease.
Pri zdravljenju bolnikov z ishemično boleznijo srca je treba entakapon uporabljati previdno.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Teva in association with levodopa.
Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Entakopon Teva v povezavi z levodopo, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prenajedanje.
Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
driska, bolečine v trebuhu, suha usta, zapeka, bruhanje zelo redki:
The substance is subject to extensive first-pass metabolism.
Pri prvem prehodu skozi jetra se učinkovina obsežno presnavlja.
Rare (may affect up to 1 in 1,000 people): - Rashes; - abnormal results in liver function test.
Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): • izpuščaji;
methyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine,dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
• rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopo,
In study I, daily ON time (hours) was measured from home diaries and in study II, the proportion of daily ON time.
V študiji II je bil merjen delež dneva, ko je bil pri bolnikih izražen učinek zdravil (obdobje ‘ON').
Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
poslabšanje parkinsonizma, omotičnost, distonija,
5.2 Pharmacokinetic properties
5.2 Farmakokinetične lastnosti Splošne značilnosti zdravilne učinkovine
Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Prav tako niso opazili medsebojnega delovanja med entakaponom in selegilinom pri bolnikih s
Characteristics in patients
Starejši bolniki
See Section 2 Warnings and precautions.
Opozorila in previdnostni ukrepi.
Experience with Entacapone Teva in patients under 18 years is limited.
Izkušenj z uporabo zdravila Entakapon Teva pri bolnikih, ki so stari manj kot 18 let, je malo, zato uporabe zdravila Entakapon Teva pri otrocih ni mogoče priporočati.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja redki:
• The other ingredients in the tablet core are cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate and in the film-coating are poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).
Filmska obloga vsebuje polivinil alkohol, smukec, titanov dioksid (E171),
Titanium dioxide (E171) Macrogol
Filmska obloga polivinil alkohol smukec titanov dioksid (E171) makrogol rumeni železov oksid (E172) lecitin (soja)
- If you get any side effects, talk to your doctor or pharmacist.
− Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
- Hepatic impairment.
- Jetrna okvara.
No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule.
Pri priporočeni shemi zdravljenja niso opazili medsebojnega delovanja entakapona in karbidope.
Entacapone Teva 200 mg film-coated tablets
Entakapon Teva 200 mg filmsko obložene tablete
Common (may affect up to 1 in 10 people): - Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
• čezmerni gibi (hiperkinezije), poslabšanje simptomov Parkinsonove bolezni, dolgotrajni mišični krči (distonija);
The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
Ob uvedbi zdravljenja z entakaponom je morda potrebno prilagoditi odmerke drugih antiparkinsonskih zdravil.
• The active substance is entacapone.
- Zdravilna učinkovina je entakapon.
Erythematous or maculopapular rash
eritematozen ali makulopapularen izpuščaj zelo redki:
It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate and unstable blood pressure; - a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
zmedenost, koma, zvišana telesna temperatura, pospešen utrip srca in nestabilen krvni tlak;
Do not drive or operate machinery if you experience these side effects.
Če pri vas prihaja do teh neželenih učinkov, ne vozite in ne upravljajte strojev.
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Iz kontroliranih preskušanj, v katerih so nenadoma prekinili dajanje entakapona, niso poročali niti o NMS niti o rabdomiolizi v zvezi z zdravljenjem z entakaponom.
Entacapone Teva 200 mg film-coated tablets entacapone oral use
Entakapon Teva 200 mg filmsko obložene tablete entakapon peroralna uporaba
Very common: Dyskinesia Common:
urtikarija pogostnost neznana:
Not known (frequency cannot be estimated from the available data): - Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes; - discolouration of skin, hair, beard and nails.
• vnetje debelega črevesa (kolitis), vnetje jeter (hepatitis) z rumeno obarvanostjo kože in beločnic;
Common:
pogosti:
Adverse drug reactions* Psychiatric disorders
Preglednica 1* Neželeni učinki zdravila Psihiatrične motnje pogosti:
For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
• če pride do driske, je priporočljivo spremljanje telesne mase, da ne bi prišlo do prevelike izgube telesne mase;
Entacapone Teva is available in HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Vsebniki za tablete HDPE, s polipropilenskimi navojnimi pokrovčki s sušilom, v katerih je po 30, 60,
How to store Entacapone Teva
Shranjevanje zdravila Entakapon Teva
Entacapone Teva 200 mg film-coated tablets entacapone
Entakapon Teva 200 mg filmsko obložene tablete entakapon
Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Na začetku zdravljenja z entakaponom je zato včasih treba bolnikom, ki jemljejo standardne pripravke levodope/benserazida,
You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences; - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; - uncontrollable excessive shopping or spending; - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
• prenajedanje (uživanje velikih količin hrane v kratkem času) ali kompulzivno prenajedanje (uživanje večjih količin hrane kot običajno oziroma več, kot je potrebno za potešitev lakote).
Table 2.
Glejte Poglavje 2
Entacapone Teva aids levodopa in relieving the symptoms of Parkinson's disease.
Zdravilo Entakapon Teva pomaga levodopi pri lajšanju simptomov
prolonged muscle cramps (dystonia); - being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth; - dizziness, tiredness, increased sweating, fall; - hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
• halucinacije (pri halucinacijah bolnik vidi/sliši/čuti/voha stvari, ki jih v resnici ni), nespečnost,
Each tablet contains 200 mg of entacapone
Ena tableta vsebuje 200 mg entakapona.
NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g. agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
avtonomna disfunkcija (tahikardija, labilen krvni tlak) in povečana aktivnost serumske kreatinske fosfokinaze.
However, a longer dosing interval may be considered for patients who are receiving dialysis therapy.
Vendar je pri bolnikih na dializi lahko potrebno podaljšanje časovnega presledka med posameznimi odmerki.
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Teva.
Najvišji priporočeni odmerek je 10 tablet na dan, t.j.
Difference
Odmerjanje
- A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
in/ali netravmatske rabdomiolize.
Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Teva and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Do nje lahko pride zlasti pri nenadni prekinitvi zdravljenja z zdravilom Entakapon Teva in drugimi zdravili za zdravljenje Parkinsonove bolezni oziroma pri nenadnem znižanju odmerka teh zdravil.
Package leaflet: information for the user Entacapone Teva 200 mg film-coated tablets entacapone
Navodilo za uporabo Entakapon Teva 200 mg filmsko obložene tablete entakapon
Hepatobiliary disorders
hiperkinezija
The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Entacapone Teva.
Morda bo ob uvedbi zdravila Entakapon Teva potrebno prilagoditi odmerke drugih zdravil za zdravljenje Parkinsonove bolezni.
- Entacapone Teva taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
postanete čez dan izredno zaspani, lahko tudi povzroči, da nenadoma zaspite;
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (30 film-coated tablets)
OVOJNINAH NALEPKA (30 filmsko obloženih tablet)
Gastrointestinal disorders
Bolniki z okvaro jeter
Very common (may affect more than 1 in 10 people): - Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias); - feeling sick (nausea); - harmless reddish-brown discoloration of urine.
• nehoteni gibi z oteženim izvajanjem hotenih gibov (diskinezije); • slabost s siljenjem na bruhanje (navzea);
blister (PVC/alu) 3 x 28 tablets (24 active + 4 placebo)
3 x 28 tablet (24 z zdravilnima učinkovinama + 4 placebo)
Package size blister (PVC/alu) 28 tablets (24 active + 4 placebo)
28 tablet (24 z zdravilnima učinkovinama + 4 placebo)
Packaging
o ā
The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Izobraževalno gradivo za zdravstvene delavce je bilten, ki vključuje informacije o naslednjih bistvenih elementih:
Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
pred začetkom dajanja zdravila v promet v državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva;
The Marketing Authorisation Holder (MAH) should ensure that at launch all Healthcare Professionals who are expected to use and/or prescribe Bronchitol are provided with an educational pack.
imetnik dovoljenja za promet z zdravilom mora zagotoviti, da ob začetku dajanja zdravila v promet vsi zdravstveni delavci, ki naj bi predpisovali zdravilo Bronchitol, prejmejo izobraževalni paket.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique.
morebitno tveganje posledic med zdravljenjem, povezanih s kašljem; o potreba po tem, da se bolnik nauči čim bolj zmanjšati kašelj med odmerjanjem in da uporablja pravilno tehniko inhaliranja.
The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Tveganje za hemoptizo med zdravljenjem: o da zdravilo Bronchitol ni bilo raziskano pri bolnikih z anamnezo resnejše hemoptize (> 60 ml) v preteklih treh mesecih; o potreba po spremljanju in ugotavljanju, kdaj zdravljenje prekiniti.
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
PRILOGA 127A POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Izobraževalni paket mora vsebovati naslednje: povzetek glavnih značilnosti zdravila in navodilo za uporabo; izobraževalno gradivo za zdravstvene delavce.
The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
tveganje za bronhospazem med zdravljenjem; o treba je oceniti začetni odmerek zdravila Bronchitol, da se odkrijejo bolniki, ki se prekomerno bronhialno odzivajo na inhalirani manitol, z merjenjem stopnje bronhokonstrikcije, ki se pojavi po zaporednem dajanju manitola; o kako varno oceniti začetni odmerek zdravila Bronchitol in kako dolgo spremljati bolnika; o kako interpretirati izide ocene začetnega odmerka zdravila Bronchitol kot pozitivne, negativne ali nepopolne; o terapevtske odmerke zdravila Bronchitol je treba predpisati le, če je bolnik opravil oceno začetnega odmerka zdravila; o potreba po predhodni terapiji z bronhodilatornem 5-15 minut pred oceno začetnega odmerka zdravila Bronchitol in pred vsakim terapevtskim odmerjanjem zdravila Bronchitol; o treba je preveriti, ali bolnik zna pravilno uporabljati bronhodilatator; o bolnika je treba pregledati po približno šestih tednih, da se ocenijo znaki in simptomi bronhospazma; o tveganje za bronhospazem med dolgoročnim zdravljenjem, tudi če je bila ocena začetnega odmerka zdravila Bronchitol prvotno pozitivna, in potreba po ponovni oceni, če se pojavi dvom;
Commission decision date: 22/03/2017.
Datum sklepa Komisije: 22/03/2017.
They have been authorised for up to 20 years as Valette and other trade names via national procedures in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Odobrena so bila po nacionalnih postopkih za obdobje do 20 let pod imenom Valette in drugimi trgovskimi imeni v naslednjih državah članicah EU: Avstrija, Belgija, Bolgarija, Češka republika, Estonija, Nemčija, Madžarska, Latvija, Litva, Luksemburg, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija.
• The currently available safety data do not raise any new safety concerns.
• Trenutno razpoložljivi podatki o varnosti ne vzbujajo novih pomislekov o varnosti.
• If you have any questions or concerns, speak with your doctor, pharmacist or nurse.
• Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU.
The prescribing information for these medicines will be updated in line with the above recommendations.
Podatki o predpisovanju teh zdravil bodo posodobljeni v skladu z zgornjimi priporočili.
If you develop any of these signs and symptoms you should seek medical advice immediately.
Če se pojavi kateri izmed navedenih znakov in simptomov, takoj poiščite zdravniško pomoč.
They work by blocking the effects of a class of hormones called androgens.
Delujeta tako, da zavirata učinke razreda hormonov, imenovanih androgeni.
This alters the production of oils in the skin and also suppresses ovulation.
S tem spremenita nastajanje maščob v koži in zavreta ovulacijo.
Dienogest and ethinylestradiol are two types of hormones, a progestogen and an oestrogen.
Dienogest in etinilestradiol sta dve vrsti hormonov, progestogen in estrogen.
• When taking dienogest/ethinylestradiol, you should be alert to the signs and symptoms of blood clots in veins, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arms or legs.
• Pri jemanju dienogesta/etinilestradiola morate biti pozorni na znake in simptome krvnih strdkov v venah, ki lahko vključujejo hudo bolečino ali otekanje nog, nenadno nepojasnjeno zasoplost, hitro dihanje ali kašelj, bolečino v prsnem košu ter šibkost ali odrevenelost obraza, rok ali nog.
Regarding the risk of side effects, the CHMP considered that the available data do not raise any new safety concern.
V zvezi s tveganjem za neželene učinke je odbor menil, da razpoložljivi podatki ne vzbujajo novih pomislekov o varnosti.
Use should be limited to women who choose oral contraception
Uporabo je treba omejiti na ženske, ki se odločijo za peroralno kontracepcijo
The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne was initiated on 25 February 2016 at the request of the UK's medicines agency (the Medicines and Healthcare products Regulatory Agency, MHRA), under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg za zdravljenje aken, se je začel 25. februarja 2016 na zahtevo agencije za zdravila Združenega kraljestva (Regulativne agencije za zdravila in zdravstvene izdelke, MHRA) v skladu s členom 31 Direktive 2001/83/ES.
Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that there is sufficient evidence to support its use in moderate acne.
Po ovrednotenju obstoječih podatkov o učinkovitosti omenjene kombinacije pri zdravljenju aken je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA zaključil, da je dovolj dokazov, ki podpirajo uporabo omenjenih zdravil pri zmernih aknah.
• It is not known how the efficacy of dienogest/ethinylestradiol compares with other acne treatments, i.e. topical treatments and systemic antibiotics.
• Ni znano, kakšna je učinkovitost dienogesta/etinilestradiola v primerjavi z drugimi načini zdravljenja aken, tj. topičnimi zdravili in sistemskimi antibiotiki.
However, these medicines, which are also approved as hormonal contraceptives, should only be used in women who choose oral contraception.
Vendar smejo ta zdravila, ki so hkrati odobrena kot hormonska kontracepcijska sredstva, uporabljati samo ženske, ki se odločijo za peroralno kontracepcijo.
• Your acne will usually improve after 3 to 6 months of treatment with dienogest/ethinylestradiol.
• Stanje aken se običajno izboljša po treh do šestih mesecih zdravljenja z dienogestom/etinilestradiolom.
The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low.
Znano tveganje za vensko trombembolijo (VTE oziroma krvne strdke v venah), ki se lahko pojavi pri vseh kombiniranih hormonskih kontracepcijskih sredstvih, velja za majhno.
• Data from two phase III trials (study no. A07062 and A28501) in a total of around 2,400 women (mostly with moderate acne) showed that dienogest/ethinylestradiol was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone at treating acne in terms of changes in inflammatory lesion count, total lesion count and improvement of facial acne according to IGA (Investigator's Global Assessment).
• Podatki iz dveh preskušanj III. faze (študiji št. A07062 in A28501) pri skupaj približno 2 400 ženskah (večinoma z zmernimi aknami) so pokazali, da je dienogest/etinilestradiol pri zdravljenju aken glede spremenjenega števila vnetnih lezij, skupnega števila lezij in izboljšanja obraznih aken po skupni oceni raziskovalca učinkovitejši od placeba ter vsaj tako učinkovit kot etinilestradiol/norgestimat in etinilestradiol/ciproteron.
• Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
• Ker izboljšanje aken običajno zahteva vsaj tri mesece zdravljenja z dienogestom/etinilestradiolom, nadaljnje izboljšanje pa je vidno po šestih mesecih, je treba ženske pregledati po treh do šestih mesecih zdravljenja in nato v rednih časovnih presledkih, da se oceni potreba po nadaljevanju zdravljenja.
• Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
• Glede na razpoložljive dokaze, in da žensk ne bi po nepotrebnem izpostavljali morebitnemu večjemu tveganju za VTE, je treba uporabo dienogesta/etinilestradiola omejiti na drugo izbiro zdravljenja in na ženske, ki se odločijo za peroralno kontracepcijo.
They should only be used when treatments applied to the skin or an antibiotic taken by mouth have not worked.
Uporabljajo se lahko le takrat, kadar so zdravila za nanos na kožo ali peroralni antibiotiki neuspešni.
On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked.
Evropska agencija za zdravila (EMA) je 26. januarja 2016 priporočila, da se zdravila, ki vsebujejo kombinacijo dienogesta 2 mg in etinilestradiola 0,03 mg, lahko še naprej uporabljajo za zdravljenje zmernih aken, ko so ustrezna zdravila za nanos na kožo ali peroralni antibiotiki neuspešni.