natgillin/translations-raw huggingface dataset:
Bulgaria - Augmentin Germany - Augmentan Lithuania - Augm entin 
Estonija - Augmentin Francija - Augmentin IV Nemčija - Augmentan IV Grčija - Augmentin
125 mg/31.25 mg, 250 mg/62.5 mg powder for oral suspension in sachets 50 mg/12.5 mg/ml, 125 mg/31.25 mg/5 ml, 250 mg/62.5 mg/5 ml powder for oral suspension Diarrhoea 
125 mg/31,25 mg, 250 mg/62,5 mg prašek za peroralno suspenzijo v vrečkah 50 mg/12,5 mg/ml, 125 mg/31,25 mg/5 ml, 250 mg/62,5 mg/5 ml prašek za peroralno suspenzijo
Augmentin and associated names (see Annex I) 200 mg/28.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 200 mg/28,5 mg/5 ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
tin heck with their doctor or pharmacist before giving your child this medicine if they: 
Bodite posebno pozorni pri jemanju zdravila Augmentin Posvetujte se z zdravnikom ali s farmacevtom, preden boste dali to zdravilo vašemu otroku:
Clavulanic acid is a beta-lactam structurally related to penicillins. 
Klavulanska kislina je betalaktam, po zgradbi podoben penicilinu.
If your child is taking allopurinol (used for gout) with Augmentin, it may be more likely that they will you Augm If medicines to help stop blood clots (such as warfarin) are taken with Augmentin then extra blood sts may be needed. 
Če otrok hkrati z zdravilom Augmentin jemlje zdravila za preprečevanje krvnih strdkov (npr. varfarin), so lahko potrebne dodatne preiskave krvi.
HOW TO TAKE AUGMENTIN 
Kako jemati zdravilo Augmentin
Add water in 2 portions up to the mark on the bottle label (60 ml) Add 74 ml of water (or add water in 2 portions up to the mark) (80 ml) Add 92 ml of water (or add water in 2 portions up to the mark) (100 ml) Invert and shake well 
Dodajte 74 ml vode (ali dodajte vodo v dveh delih do oznake) (80 ml).
If your child who is about to take this medicine is pregnant or breast-feeding, please tell your doctor or arm sk your doctor or pharmacist for advice before taking any medicine. 
Če vaš otrok, ki jemlje zdravilo Augmentin, noseč ali doji, morate to povedati zdravniku ali farmacevtu.
2000 mg/200 mg powder for solution for infusion Powder for solution for infusion. 
2000 mg/200 mg prašek za raztopino za infundiranje prašek za raztopino za infundiranje [Izpolni država članica]
NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/125 mg film-coated tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid 
IME ZDRAVILA Augmentin in povezana imena (glejte Dodatek I) 500 mg/125 mg filmsko obložene tablete [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Au entin. 
- Navodilo shranite.
{Augmentin and associated names (see Annex I) 125 mg/31.25 mg powder for oral suspension in sachet} {Augmentin and associated names (see Annex I) 250 mg/62.5 mg powder for oral suspension in sachet} {Augmentin and associated names (see Annex I) 500 mg/125 mg powder for oral suspension in sachet} 
{Augmentin in povezana imena (glejte Dodatek I) 125 mg/31,25 mg prašek za peroralno suspenzijo v vrečki} {Augmentin in povezana imena (glejte Dodatek I) 250 mg/62,5 mg prašek za peroralno suspenzijo v vrečki} {Augmentin in povezana imena (glejte Dodatek I) 500 mg/125 mg prašek za peroralno suspenzijo v vrečki}
For adults and children  40 kg, this formulation of Augmentin provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. 
Če je ta oblika zdravila Augmentin uporabljena, kot je priporočeno spodaj, zagotavlja odraslim in otrokom s telesno maso  40 kg celoten dnevni odmerek 1500 mg amoksicilina/375 mg klavulanske kisline.
500 mg/125 mg dispersible tablets: 
500 mg/125 mg disperzibilne tablete
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or beta-lactam agents (see sections 4.3 and 4.8). 
Pred uvedbo zdravljenja z amoksicilin/klavulansko kislino je treba natančno poizvedeti glede predhodnih preobčutljivostnih reakcij na peniciline, cefalosporine ali betalaktame (glejte poglavji 4.3 in 4.8).
250 mg/125 mg film-coated tablets Film-coated tablet. 
250 mg/125 mg filmsko obložene tablete filmsko obložena tableta [Izpolni država članica]
If you have any further questions about how this product is given, ask your doctor, pharmacist or nurse. 
Če mislte, da ste dobili večji odmerek zdravila Augmentin, kot bi smeli, to nemudoma povejte medicinski sestro, zdravniku ali farmacevtu.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8). 
Pred uvedbo zdravljenja z amoksicilin/klavulansko kislino je treba natančno poizvedeti glede predhodnih preobčutljivostnih reakcij na peniciline, cefalosporine ali druge betalaktame (glejte poglavje 4.3 in 4.8).
Inflammation of large intestine 
Vnetje debelega črevesa
regnancy and breast-feeding you are pregnant, you think you might be pregnant or if you are breast-feeding, please tell your using machines e symptoms may make you unfit to drive. 
Nosečnost in dojenje Če ste noseči, če domnevate, da ste noseči, ali če dojite, morate to povedati zdravniku ali farmacevtu.
Uncommon side effects These may affect up to 1 
Občasni neželeni učinki Pojavijo se lahko pri do 1 od 100 oseb.
Augmentin and associated names (see Annex I) 600 mg/42.9 mg/5 ml powder for oral suspension (strawberry flavour) [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 600 mg/42,9 mg/5 ml prašek za peroralno suspenzijo (aroma jagode) [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
125 mg/62.5 mg/5 ml powder for oral suspension Powder for oral suspension. 
125 mg/62,5 mg/5 ml prašek za peroralno suspenzijo prašek za peroralno suspenzijo [Izpolni država članica]
Augmentin and associated names (see Annex I) 125 mg/31.25 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 125 mg/31,25 mg/5 ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
This medicinal product contains 62.9 mg (2.7 mmol) of sodium per per vial or bottle. 
To zdravilo vsebuje 125,9 mg (5,5 mmol) natrija na vialo ali stekleničko.
Augmentin 1000 mg/125 mg sachets are not recommended. 
Augmentin 1000 mg/125 mg prašek za peroralno suspenzijo v vrečkah ni priporočljiv.
Augmentin 2000 mg/200 mg should be administered by intravenous infusion over 30 to 40 min. Augmentin is not suitable for intramuscular administration. 
2000 mg/200 mg prašek za raztopino za infundiranje Zdravilo Augmentin 2000 mg/200 mg je treba dati v intravenski infuziji, ki traja od 30 do 40 minut.
6.1 List of excipients [To be completed nationally] 
6.1 Seznam pomožnih snovi [Izpolni država članica]
Augmentin and associated names (see Annex I) 100 mg/12.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 100 mg/12,5 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
If your child still feels unwell they doctor ugmentin than you should hild too much Augmentin, signs might include an upset stomach (feeling sick, being edicine carton to ve Augmentin ou remember. 
Če ste dali večji odmerek zdravila Augmentin, kot bi smeli Če ste dali otroku preveč zdravila Augmentin, so med znaki lahko prebavne motnje (siljenje na bruhanje, bruhanje ali driska) ali konvulzije.
Augmentin and associated names (see Annex I) 125 mg/62.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 125 mg/62,5 mg/5 ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
500 mg/100 mg powder for solution for injection or infusion Water for Injection Ph.Eur. 
500 mg/100 mg prašek za raztopino za injiciranje ali infundiranje Običajno topilo je voda za injekcije, Ph. Eur.
125 mg/31.25 mg, 250 mg/62.5 mg, 500 mg/125 mg powder for oral suspension in sachets; 50 mg/12.5 mg/ml, 125 mg/31.25 mg/5 ml, 250 mg/62.5 mg/5 ml powder for oral suspensions Powder for oral suspension. 
125 mg/31,25 mg, 250 mg/62,5 mg, 500 mg/125 mg prašek za peroralno suspenzijo v vrečkah; 50 mg/12,5 mg/ml, 125 mg/31,25 mg/5 ml, 250 mg/62,5 mg/5 ml prašek za peroralno suspenzijo prašek za peroralno suspenzijo [Izpolni država članica]
Augmentin and associated names (see Annex I) 200 mg/28.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 200 mg/28,5 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 1000 mg/125 mg powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 1000 mg/125 mg prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
• Give at the start of a meal or slight enly during the day 
• Zdravilo dajte otroku na začetku obroka ali malo pred obrokom.
If you are not ist before giving Augmentin. 
KAJ MORATE VEDETI, PREDEN BOSTE DALI ZDRAVILO AUGMENTIN
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Augmentin and associated names (see Annex I) 2000 mg/200 mg powder for solution for infusion [See Annex I - To be completed nationally] 
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA Augmentin in povezana imena (glejte Dodatek I) 2000 mg/200 mg prašek za raztopino za infundiranje [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina za intravensko uporabo
• 1 tablet three times a day ts are not recommended for children weighing less than 40 kg. rmacist for advice. 
Uporaba Augmentin disperzibilnih tablet običajno ni priporočljiva za otroke, lažje od 40 kg. Posvetujte se z zdravnikom ali s farmacevtom.
Ireland - Augmentin 
Irska - Augmentin
NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 250 mg/125 mg dispersible tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/125 mg disperzibilne tablete [glejte Dodatek I - Izpolni država članica] amoksicilin/klavulanska kislina
PHARMACEUTICAL FORM Prolonged release tablet. 
obliko in ga nadaljevati s peroralno obliko.
Add water in 2 portions up to the mark on the bottle label (60 ml) Add 72 ml of water (or add water in 2 portions up to the mark) (80 ml) Add 90 ml of water (or add water in 2 portions up to the mark) (100 ml) Invert and shake well 
Dodajte 72 ml vode (ali dodajte vodo v dveh delih do oznake) (80 ml).
Dose Mean peak serum conc (g/ml) 
v serumu (g/ml)
• inflammation o f tubes in th 
• vnetje cevk v ledvicah,
NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 250 mg/125 mg film-coated tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/125 mg filmsko obložene tablete [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
500 mg/125 mg film-coated tablets Film-coated tablet. 
500 mg/125 mg filmsko obložene tablete filmsko obložena tableta [Izpolni država članica]
250 mg/125 mg dispersible tablets Dispersible tablet. 
250 mg/125 mg disperzibilne tablete disperzibilna tableta [Izpolni država članica]
Lithuania - Augmentin ES Poland - Augmentin ES 
Litva - Augmentin ES
Augmentin and associated names (see Annex I) 2000 mg/200 mg powder for solution for infusion [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 2000 mg/200 mg prašek za raztopino za infundiranje [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 600 mg/42.9 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 600 mg/42,9 mg/5 ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 250 mg/25 mg powder for solution for injection or infusion [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/25 mg prašek za raztopino za injiciranje ali infundiranje [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
500 mg/125 mg dispersible tablets Dispersible tablet. 
500 mg/125 mg disperzibilne tablete disperzibilna tableta [Izpolni država članica]
NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/125 mg dispersible tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid 
Augmentin in povezana imena (glejte Dodatek I) 500 mg/125 mg disperzibilne tablete [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 250 mg/31.25 mg powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/31,25 mg prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 250 mg/25 mg powder for solution for injection/in fusion} {Augmentin and associated names (see Annex I) 500 mg/50 mg powder for solution for injection/infusion} 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/25 mg prašek za raztopino za injiciranje ali infundiranje [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina za intravensko uporabo
No adjustment in Augmentin dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min. 
Bolnikom z očistkom kreatinina (CrCl) nad 30 ml/min odmerka zdravila Augmentin ni treba prilagoditi.
Augmentin and associated names (see Annex I) 250 mg/62.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/62,5 mg/5 ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
250 mg/31.25 mg and 500 mg/62.5 mg powder for oral suspension in sachets 
250 mg/31,25 mg prašek za peroralno suspenzijo v vrečkah, 500 mg/62,5 mg prašek za peroralno suspenzijo v vrečkah
Augmentin and associated names (see Annex I) 50 mg/12.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 50 mg/12,5 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
250 mg/25 mg powder for solution for injection or infusion in 
250 mg/25 mg prašek za raztopino za injiciranje ali infundiranje Nemčija - Augmentan
Adults and children  40 kg CrCl: 10-30 ml/min 500 mg/125 mg twice daily CrCl < 10 ml /min 
Odrasli in otroci  40 kg CrCl 10-30 ml/min
Formulation 
Oblika
Augmentin 250 mg/125 mg dispersible tablets are not recommended in children < 40 kg. 125 mg/62.5 mg/5 ml powder for oral suspension 
250 mg/125 mg disperzibilne tablete Augmentin 250 mg/125 mg disperzibilne tablete niso priporočljive za otroke < 40 kg.
Augmentin and associated names (see Annex I) 500 mg/100 mg powder for solution for injection or infusion [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 500 mg/100 mg prašek za raztopino za injiciranje ali infundiranje [glejte Dodatek I - izpolni država članica]] amoksicilin/klavulanska kislina
• inflammation of 
• bruhanje,
Augmentin and associated names (see Annex I) 125 mg/31.25 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 125 mg/31,25 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 125 mg/62.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 125 mg/62,5 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
Augmentin and associated names (see Annex I) 500 mg/50 mg powder for solution for injection or infusion [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 500 mg/50 mg prašek za raztopino za injiciranje ali infundiranje [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
2000 mg/200 mg powder for solution for infusion This medicinal product contains 125.9 mg (5.5 mmol) of sodium per per vial or bottle. 
2000 mg/200 mg prašek za raztopino za infundiranje To zdravilo vsebuje 39,3 mg (1,0 mmol) kalija na vialo ali stekleničko.
NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 875 mg/125 mg powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 875 mg/125 mg prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
250 m 1 g/3 .25 mg powder for oral suspension in sachets Franc A e - ugmentin 
250 mg/31,25 mg prašek za peroralno suspenzijo v vrečkah Francija - Augmentin
The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (250 mg/125 mg tablets three times daily) was administered in the fasting state to groups of healthy volunteers are presented below. 
Spodaj so predstavljeni farmakokinetični rezultati študije, v kateri so amoksicilin/klavulansko kislino (250 mg/125 mg tablete) na tešče uporabili v skupinah zdravih prostovoljcev.
This should be considered if you are on a controlled sodiu m diet. 
Če ste na dieti z nadzorovanim vnosom natrija, morate to upoštevati.
Lot 
AUC
com hese may affect up to 1 in 100 people ncommon side effects that may show up in blood tests: 
če opazite katerega od teh simptomov, se morate nujno posvetovati z zdravnikom Redki neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
If you forget to give your child a dose, give it as soon as y child the next dose too soon, but wait about 4 hour 
Če ste otroku pozabili dati odmerek zdravila, mu ga dajte, čim se spomnite.
Augmentin and associated names (see Annex I) 250 mg/62.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 250 mg/62,5 mg/ml prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD mesec LLLL} [glejte Dodatek I - izpolni država članica]
Augmentin 125 mg/62.5 mg/5 ml powder for oral suspension contains 2.5 mg of aspartame (E951) per ml, a source of phenylalanine. 
125 mg/62,5 mg/5 ml prašek za peroralno suspenzijo Zdravilo Augmentin 125 mg/62,5 mg/5 ml prašek za peroralno suspenzijo vsebuje na 1 ml 2,5 mg aspartama (E951), ki je vir fenilalanina.
• Community acquired pneumonia. 
• pljučnica, dobljena v domačem okolju.
WHAT IT IS USED FOR 
Uporabno do: {MM LLLL}
If your child still feels unwell they doctor. 
Če se še vedno ne počutite dobro, ponovno obiščite zdravnika.
If you forget to give your child a dose, give it as so child the next dose too soon, but wait about 4 hours before giving the next dose. 
Naslednjega odmerka mu ne smete dati prezgodaj, temveč počakajte približno 4 ure, preden vzame naslednji odmerek.
Augmentin and associated names (see Annex I) 125 mg/31.25 mg powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 125 mg/31,25 mg prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
PHARMACEUTICAL FORM Powder for oral suspension. 
FARMACEVTSKA OBLIKA prašek za peroralno suspenzijo [Izpolni država članica]
Intermediate 
Uporabljeno
Augmentin and associated names (see Annex I) 500 mg/62.5 mg powder for oral suspension [See Annex I - To be completed nationally] 
Augmentin in povezana imena (glejte Dodatek I) 500 mg/62,5 mg prašek za peroralno suspenzijo [glejte Dodatek I - izpolni država članica] amoksicilin/klavulanska kislina
{MM/YYYY}. 
• prebavil,
If y ur child stops taking Augmentin 
Otrok naj neha jemati zdravilo Augmentin.
gm rks. 
Cmax tmax
6 July 2012 
6. julij 2012
This change was to be recognised in the Netherlands and all other 
To spremembo bi bilo treba odobriti na Nizozemskem in v vseh drugih zadevnih državah članicah.
Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended 
Izid postopka iz člena 6 (12) Uredbe 1084/2003/ES, kakor je bila spremenjena.
Because the Member States were not able to reach an agreement on this new indication, on 28 and 29 June 2011 the Italian and Swedish medicines regulatory agencies referred the matter to the CHMP for arbitration. 
Ker se države članice niso uspele sporazumeti o tej novi indikaciji, sta italijanska in švedska regulativna agencija za zdravila 28. in 29. junija 2011 zadevo poslali odboru CHMP v arbitražo.
The Committee reviewed the two main studies presented by the company to support the new indication. 
Odbor je pregledal dve glavni študiji, ki jih je za podporo nove indikacije predložila družba Bayer B.V.
The grounds for the referral were concerns over whether the medicines' benefits in the combined indication outweighed their risks, particularly the risk of venous thromboembolism (VTE, formation of blood clots in the veins). 
Razlog za napotitveni postopek so bili pomisleki glede tega, ali so koristi zdravil pri kombinirani indikaciji večje od tveganj, predvsem od tveganja za vensko trombembolijo (VTE, tvorbo krvnih strdkov v venah).
They contain two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone. 
Vsebujeta dve zdravilni učinkovini, etinilestradiol in drospirenon, pridobljeni iz naravnih hormonov, ki jih tvorijo jajčniki: etinilestradiol je pridobljen iz estrogena in drospirenon iz progesterona.
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to consider a proposed change to the marketing authorisations for these medicines to include a new indication for the treatment of moderate acne in women seeking oral contraception. 
Odbor za zdravila za humano uporabo (CHMP) pri Evropski agenciji za zdravila je bil naprošen, naj pregleda predlagano spremembo dovoljenja za promet s tema zdraviloma, ki vključuje novo indikacijo za zdravljenje zmernih aken pri ženskah, ki želijo uporabljati peroralno kontracepcijo.
1 Yaz is authorised in all EU Member States except Hungary, and Ethinylestradiol-Drospirenone 24+4 is authorised in the following Member States: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. 
Zdravilo Yaz je odobreno v vseh državah članicah EU, razen na Madžarskem, zdravilo Ethinylestradiol-Drospirenone 24+4 pa je odobreno v naslednjih državah članicah: v Avstriji, Bolgariji, na Cipru, Češkem, Danskem, Finskem, v Franciji,
The Committee concluded that the change to the marketing authorisations cannot be granted. 
Odbor je sklenil, da spremembe dovoljenja za promet z zdraviloma ni mogoče odobriti.
Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are authorised in several Member States of the European Union (EU)1 under a mutual recognition procedure on the basis of an initial authorisation granted by the Netherlands. 
Zdravili Yaz 24+4 in Ethinylestradiol-Drospirenone 24+4 sta po postopku medsebojnega priznavanja na podlagi prvotnega dovoljenja, odobrenega na Nizozemskem, odobreni v več državah članicah Evropske unije (EU)1.