FrancophonIA/ELRC3.0 huggingface dataset:
English: Early breast cancer is breast cancer that has not spread and has been treated by surgery.
Latvian: Krūts vēzis agrīnā stadijā ir tāds, kas nav izplatījies organismā un ir ārstēts ķirurģiski.
English: All women also received goserelin, a medicine that suppresses the activity of the ovaries.
Latvian: Visas sievietes saņēma arī goserelīnu - zāles, kas mazina olnīcu aktivitāti.
English: Zoledronic acid, the active substance in Zometa, blocks an enzyme called ‘farnesyl pyrophosphate synthase'.
Latvian: Zometa aktīvā viela zoledronskābe bloķē enzīmu ar nosaukumu farnezola-pirofosfāta sintēze.
English: It also had concerns regarding the way the study in early breast cancer had been carried out.
Latvian: CHMP bija bažas arī par veidu, kādā tika veikts vēža agrīnā stadijā pētījums.
English: Zometa was only to be used if the breast cancer was ‘hormone receptor positive' (the cancer is likely to respond to hormonal treatment), and in combination with hormonal treatment.
Latvian: Zometa bija paredzēts lietot tikai “hormonu receptoru pozitīva” krūts vēža ārstēšanai (kad vēzis, visticamāk, reaģēs uz hormonālu terapiju) kopā ar hormonālas ārstēšanas līdzekļiem.
English: The company informed the CHMP that this withdrawal does not an impact on ongoing clinical trials with Zometa.
Latvian: Uzņēmums paziņoja CHMP, ka atsaukums nekādā veidā neietekmēs šobrīd notiekošos Zometa klīniskos pētījumus.
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the adjuvant treatment of early breast cancer.
Latvian: Pamatojoties uz izskatītajiem datiem un uzņēmuma atbildēm uz CHMP jautājumiem, atsaukšanas brīdī CHMP bija daži iebildumi, un CHMP tobrīd atzina, ka Zometa nevarētu apstiprināt kā palīglīdzekli krūts vēža agrīnā stadijā ārstēšanai.
English: Zometa can also be used to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Latvian: Zometa var lietot arī audzēju izraisītas hiperkalcēmijas (augsta kalcija līmeņa asinīs) ārstēšanai.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Latvian: Tādēļ pieteikuma atsaukšanas brīdī CHMP viedoklis bija tāds, ka Zometa nevar apstiprināt, balstoties uz uzņēmuma sniegtajiem datiem.
English: The study included 1,803 women previously treated with surgery who received Zometa every six months for three years, and were followed up for five years.
Latvian: Zāles Zometa sievietes saņēma trīs gadus ik pēc sešiem mēnešiem, un viņas tika novērotas piecus gadus.
English: The way Zometa is expected to works in early breast cancer is not fully elucidated.
Latvian: Zometa paredzamās iedarbības spektrs krūts vēža agrīnā stadijā ārstēšanai nav pilnībā izskaidrots.
English: There are no consequences on the use of Zometa in its authorised indications.
Latvian: Zometa var bez bažām lietot apstiprinātajai indikācijai.
English: The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Latvian: Pieteikuma atsaukšanas brīdī CHMP novērtēja uzņēmuma atbildes uz sarakstā norādītajiem jautājumiem.
English: The Committee had concerns that the anti-tumour activity of Zometa when used as add-on had not been sufficiently supported by the data from the study.
Latvian: Komitejai bija bažas par to, ka pētījuma dati nepietiekami pamatoja Zometa pretaudzēja aktivitāti, lietojot to kā papildterapiju.
English: Zometa was expected to be used as an adjuvant (add-on) in the treatment of early breast cancer in women who have not been through the menopause.
Latvian: Zometa bija paredzēts lietot kā palīglīdzekli (papildterapiju) pirmsmenopauzes vecuma sievietēm ar krūts vēzi agrīnā stadijā.
English: How is Zometa expected to work?
Latvian: Kāda ir paredzamā Zometa iedarbība?
English: The company provided data from one main study to support the use of Zometa in early breast cancer.
Latvian: Lai pamatotu Zometa lietošanu krūts vēža agrīnā stadijā ārstēšanai, uzņēmums iesniedza viena galvenā pētījuma datus.
English: Particular attention should be given to indication, dosage and duration of treatment.
Latvian: Īpaša uzmanība jāpievērš indikācijai, devām un ārstēšanas ilgumam.
English: Studies and Reviews
Latvian: Pētījumi un pārskati
English: Communication
Latvian: Saziņas veidi
English: The draft DHPC should be submitted to the CHMP within one month after adoption of the Commission Decision.
Latvian: DHPC projekts jāiesniedz CHMP mēneša laikā pēc Komisijas lēmuma pieņemšanas.
English: The communication shall include comprehensive information on the safety risks associated with the use of nimesulide.
Latvian: Šajā ziņojumā jāiekļauj visaptveroša informācija par drošības apdraudējumu saistībā ar nimesulīda lietošanu.
English: This retrospective study should lead to a follow-up prospective study in transplant centres.
Latvian: Pēc šā retrospektīvā pētījuma jāveic perspektīvu pētījumu transplantācijas centros.
English: The protocol should be submitted to the CHMP by 3 months after the completion of the final study report of the retrospective study for review and agreement.
Latvian: Protokolu jāsniedz CHMP izskatīšanai un apstiprināšanai triju mēnešu laikā pēc retrospektīvā pētījuma galīgā pētījuma pārskata pabeigšanas.
English: The final study reports of the above studies should be submitted to the National Competent Authorities for assessment.
Latvian: Iepriekšminēto pētījumu galīgie pētījumu ziņojumi jāiesniedz valstu kompetentajām iestādēm novērtēšanai.
English: • The MAHs should perform a survey to clarify the modes of use of nimesulide in selected EU Member States to identify potential misuse.
Latvian: • Reģistrācijas apliecības īpašniekiem jāveic apsekojums, lai precizētu nimesulīda lietošanas veidus atlasītajās ES dalībvalstīs un lai identificētu potenciālu nepareizu lietošanu.
English: This study should address the relative risk of nimesulide in respect to other NSAIDs to cause severe hepatic reactions leading to transplants.
Latvian: Šajā pētījumā jāpievērš uzmanība relatīvajam riskam, ko var izraisīt nimesulīda lietošana salīdzinājumā ar citiem NSP līdzekļiem, izvērtējot smago ietekmi uz aknu darbību, kā rezultātā jāveic transplantācija.
English: A report should be provided to the National Competent authorities for assessment every 6 months as part of the PSUR (starting within one semester after adoption of the Commission Decision).
Latvian: Ik pēc sešiem mēnešiem PSUR ietvaros jāsagatavo ziņojums novērtēšanai valstu kompetentajām iestādēm (sešu mēnešu laikā no Komisijas lēmuma pieņemšanas brīža).
English: • The MAHs should conduct a pre-clinical study on identification of reactive metabolites and protein adduct information.
Latvian: • Reģistrācijas apliecības īpašniekam jāveic pirmsklinīsks pētījums, lai noteiktu reaktīvus metabolītus un datus par proteīnu pievilcējiem.
English: The MAHs should strengthen the medical review, refine the monitoring of reporting rates, and improve the quality of Individual Case Safety Reports of nimesulide.
Latvian: Reģistrācijas apliecības īpašniekiem jāpilnveido medicīniskais pārskats, jāuzlabo ziņojumu pārskatīšanas process un uz nimesulīdu attiecināmu individuālu gadījumu drošības ziņojumu kvalitāte.
English: Further updates of the Risk Management Plan should be submitted for assessment at national level.
Latvian: Riskvadības plāna papildinātās versijas jāsniedz novērtēšanai valsts līmenī.
English: • The MAHs should submit a revised Risk Management Plan for nimesulide, considering the comments raised during this procedure, to the CHMP.
Latvian: • Reģistrācijas apliecības īpašniekiem jāiesniedz CHMP rediģēts riskvadības plāns attiecībā uz nimesulīdu, ņemot vērā šajā procedūrā izteiktās piezīmes.
English: • The MAHs should conduct a retrospective cohort study in transplant centres.
Latvian: • Reģistrācijas apliecības īpašniekiem jāveic retrospektīvs ļaužu grupas pētījums transplantācijas centros.
English: Hepatic reactions should be given cumulatively and for the period covered by the PSUR.
Latvian: Ietekme uz aknu darbību jāapkopo atbilstoši periodam, kas norādīts PSUR ziņojumā.
English: • The MAHs should conduct a review of epidemiological data to review the risk of hepatic damage from nimesulide in comparison with other NSAIDs
Latvian: • Reģistrācijas apliecības īpašniekiem jāveic pārskats par epidemioloģiskiem datiem, lai analizētu aknu darbības traucējumu risku, lietojot nimesulīdu, salīdzinājumā ar citiem nesteroīdiem pretiekaisuma (NSP) līdzekļiem.
English: The MAHs should expedite and submit all safety reports and case series in PSURs for nimesulide, with a six monthly periodicity.
Latvian: Reģistrācijas apliecības īpašniekam ātri jāveic un jāiesniedz visi ar nimesulīdu saistītie drošības ziņojumi un PSUR ziņojumu gadījumu pārskati ik pēc sešiem mēnešiem.
English: • The MAHs should perform a monitoring activity to evaluate the effectiveness of risk communication on nimesulide.
Latvian: • Reģistrācijas apliecības īpašniekiem jāveic uzraudzība, lai novērtētu, cik efektīva ir ziņošana par risku saistībā ar nimesulīdu.
English: • The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) to be agreed with the CHMP.
Latvian: • Reģistrācijas apliecības īpašniekiem jāinformē veselības aprūpes speciālisti par šī nimesulīda pārskata rezultātu ar „Tiešo veselības aprūpes speciālistu ziņojumu”
English: These PSURs should include a specific overview of the hepatic reactions.
Latvian: PSUR ziņojumos jāietver īpašs pārskats par šo zāļu ietekmi uz aknu darbību.
English: These PSURs should be submitted to the National Competent Authorities for assessment.
Latvian: PSUR ziņojumi jāiesniedz novērtēšanai valstu kompetentajām iestādēm.
English: The following conditions in relation to post-marketing surveillance, studies and review and communication shall be fulfilled by the Marketing Authorisation Holders of nimesulide containing medicinal products (systemic formulation).
Latvian: Nimesulīdu saturošu zāļu (sistēmisku formulāciju) reģistrācijas apliecību īpašniekiem jāievēro šādi nosacījumi saistībā ar pēcreģistrācijas uzraudzību, pētījumiem, pārskatu un saziņu.
English: Competent authorities for assessment within one year after adoption of the Commission Decision.
Latvian: Gada laikā pēc Komisijas lēmuma pieņemšanas jāizstrādā pārskats, ko iesniedz novērtēšanai valstu kompetentajām iestādēm.
English: Name Strength
Latvian: Nosaukums Stiprums Zāļu forma Ievadīšanas
English: ETHYPHARM 17/21 rue Saint-Matthieu 78550 Houdan
Latvian: ETHYPHARM 17/21 rue SaintMatthieu 78550 Houdan
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Latvian: I. PIELIKUMS ZĀĻU NOSAUKUMI, ZĀĻU FORMA(S), STIPRUMS(-I), LIETOŠANAS VEIDS(-I), PIETEIKUMA IESNIEDZĒJS(-I) UN REĢISTRĀCIJAS APLIECĪBAS(-U)
English: 1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
Latvian: 1 ml (120 mg/ml) 1 pildspalvveida pilnšļirce + 2 spirta salvetēm
English: 75014 PARIS
Latvian: 75014 Paris France
English: em., H-1036 Budapest Hungary
Latvian: H-1036 Budapest Hungary
English: 92931 PARIS LA DEFENSE FRANCE
Latvian: 92931 Paris la Defence France
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Latvian: Rua Quinta Pinheiro, 5, Outurela
English: Comprimidos
Latvian: Tabletes
English: 1800 Vilvoorde Belgium
Latvian: 1800 Vilvoorde Beļgium
English: Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
Latvian: Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Beļgium
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Latvian: Ladeepharma Pharmaceutical Limited Lajos u. 48-66
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Latvian: Osa Mayor, 4 28023 Aravaca Madrid
English: 28108 Alcobendas (Madrid) Spain
Latvian: 28108 Alcobendas Madrid
English: MAROUSSI GR-15125 ATHENS
Latvian: Athens GR-15125 Greece
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Latvian: Zāļu nosaukumi, zāļu forma, stiprumi, lietošanas veids, pieteikuma iesniedzēji un reģistrācijas apliecību īpašnieki dalībvalstīs
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Latvian: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Latvian: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta 28108 Alcobendas Madrid
English: LABORATOIRES MAJORELLE 80-82 rue Gallieni 92100 BOULOGNE BILLANCOURT FRANCE
Latvian: Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt
English: Berlifarma - Especialidades Farmaceuticas, Lda.
Latvian: BerlifarmaEspecialidades Farmaceuticas, Lda.
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Latvian: Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Latvian: Viale Certosa, 130 20156 Milano (MI) Italy
English: EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
Latvian: LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 Boulogne Billancourt Cedex France
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Latvian: 25 rue des Peupliers 92000 Nanterre France
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Latvian: Teva UK Limited Brampton Road Hampden Park Eastbourne
English: CYPROTERONE/ETHIN YLESTRADIOL BAYER 35 µg
Latvian: CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Latvian: Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA, United Kingdom
English: 220, avenue de la Recherche 59120 Loos
Latvian: Bayer Santé 220, avenue de la Recherche 59120 Loos France
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Latvian: Stragen UK Limited Castle Court 41
English: 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium
Latvian: Diestersteenweg 349 3510 Hasselt Beļgium
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Latvian: Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E-28108 Spain
English: Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
Latvian: 2 Grigori Afxentiou Street Larnaca 6023
English: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
Latvian: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Latvian: 92593 Levallois Perret Cedex
English: London SW5 9JL
Latvian: Kramer Mews London SW5 9JL United Kingdom
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Latvian: FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A
English: Marszałka J.Piłsudskiego 5 95-200 Pabianice Poland
Latvian: 95-200 Pabianice Poland
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Latvian: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Latvian: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: Chloe 35 micrograms/2 mg film-coated tablets
Latvian: Chloe 35 micrograms/2 mg filmcoated tablets
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Latvian: Diane 2000 micrograms/35 micrograms film-coated tablets
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Latvian: Rue Saint Georges 5 4000 Liège
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Latvian: Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Kent NN8 6GT United Kingdom
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Latvian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: Bayer Pharma
Latvian: Bayer plc
English: BAYER ΕΛΛΑΣ ΑΒΕΕ SOROU 18-20
Latvian: Bayer Hellas ABEE Sorou 18-20
English: Camberley, Surrey GU16 7SR UK
Latvian: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance 92100 BOULOGNE FRANCE
Latvian: Luksemburga Pierre Fabre Dermatologie 45, place Abel Gance
English: Fannin UK CoCyprindiol 2000/35 Tablets
Latvian: Fannin UK Co-Cyprindiol 2000/35 Tablets
English: Stragen UK Ltd.
Latvian: Medico Uno Worldwide Ltd.
English: Bellgyn "ratiopharm" 2 mg/ 0,035 mgüberzogene Tabletten
Latvian: Bellgyn "ratiopharm" 2 mg/ 0,035 mg - überzogene Tabletten
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Latvian: 92800 Puteaux France
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Latvian: Strandhaven Limited 600 High Road Seven Kings, Ilford Essex IG3 8BS United Kingdom
English: LABORATORIOS EFFIK, S.A. San Rafael, 3
Latvian: Laboratorios EFFIK, S.A.
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Latvian: Chatfield Pharmaceuticals Limited
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Latvian: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: United Kingdom Cipla (EU) Limited, Millbrow House, Millbrow Road, Esher, Surrey KT10 9NW
Latvian: Cipla (EU) Limited Hillbrow House Hillbrow Road Esher
English: 21465 Reinbek Germany
Latvian: 61352 Bad Homburg Germany
English: BN22 9AG
Latvian: East Sussex BN22 9AG United Kingdom
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Latvian: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Latvian: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Latvian: Diane-35 0,035mg/2mg überzogene Tablette
English: Camilette CoCyprindiol 2000/35 Tablets
Latvian: Camilette Co-Cyprindiol 2000/35 Tablets
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Latvian: DK-4230 Skælskør Denmark
English: Strandhaven CoCyprindiol 2000/35 Tablets
Latvian: Strandhaven Co-Cyprindiol 2000/35 Tablets
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Latvian: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Latvian: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Latvian: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: Clevia 2 mg/0,035 mg Filmtabletten
Latvian: Cyprotomin 2 mg/0,035 mg Filmtabletten
English: CYPROTERONE/ETHIN YLESTRADIOL DCI PHARMA 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RATIOPHARM 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg
English: Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
Latvian: DK-5260 Odense S. Denmark
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Latvian: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Latvian: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: Jan Emiel Mommaertslaan 14 1831 Machelen Belgium
Latvian: 1831 Machelen Beļgium
English: CYPROTERONE/ETHIN YLESTRADIOL SANDOZ 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Latvian: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL ZENTIVA 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Latvian: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL TEVA 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZYDUS 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg
English: Aragoneses, 15
Latvian: Piłsudskiego 5
English: HEATON a.s. Na Pankráci 14 Praha 4
Latvian: Na Pankráci 332/14 14000 Praha 4
English: CYPROTERONE/ETHIN YLESTRADIOL EG 2 mg/0,035 mg
Latvian: CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg
English: RATIOPHARM GMBH Keilaranta 10
Latvian: Taurus Pharma GmbH Benzstr. 11
English: DE-89079 Ulm Germany
Latvian: 10 40789 Monheim Germany
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Latvian: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Latvian: Orifarm Generics A/S Postbox 69
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Latvian: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Latvian: Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: Reigate, Surrey RH2 9RJ
Latvian: Surrey KT10 9NW United Kingdom
English: Cyproderm
Latvian: Cyproterone
English: STRAGEN
Latvian: Beļgium
English: Etterstad 0601, OSLO
Latvian: Etterstad 0601, OSLO Norway
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien,
Latvian: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria
English: AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens,
Latvian: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens, Greece
English: AstraZeneca Kft. 1113 Budapest, Bocskai ut 134
Latvian: 1113 Budapest, Bocskai ut 134146 Hungary
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire
Latvian: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire
English: S-15185 Södertälje, Sweden
Latvian: AstraZeneca Pharmaceuticals AB, S-15185 Södertälje, Sweden
English: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
Latvian: AstraZeneca BV Louis Pasteurlaan 5
English: AstraZeneca UK Limited 2 Kingdom Street, London
Latvian: AstraZeneca UK Limited, 2 Kingdom Street, London W2 6BD, United Kingdom
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund, Denmark
Latvian: 2620 Albertslund, Denmark
English: W2 6BD,
Latvian: 2 Kingdom Street, London W2 6BD, United Kingdom
English: LU1 3LU
Latvian: SK10 2NA
English: AstraZeneca UK Ltd. 2 Kingdom Street, London
Latvian: AstraZeneca UK Ltd.
English: Tell your doctor immediately if you experience:
Latvian: Nekavējoties pastāstiet savam ārstam, ja Jums ir:
English: • every two weeks during the first six months of treatment, and
Latvian: • ik pēc divām nedēļām pirmos sešus ārstēšanas mēnešus un
English: Folate supplementation was optional and only used in 10 % of patients.
Latvian: Folātu papildu lietošana nebija obligāta, to izmantoja tikai 10 % pacientu.
English: • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Latvian: • ja Jums kādreiz ir bijusi tuberkuloze vai esat bijis ciešā saskarē ar kādu, kam ir tuberkuloze vai kādreiz tā ir bijusi.
English: The tablets are packed in bottles.
Latvian: Tabletes iepakotas pudelēs.
English: For more information on these, please read section 4 (Possible Side Effects).
Latvian: Vairāk informācijas par to, lūdzu, lasiet 4. punktā (Iespējamās blakusparādības).
English: C study indicated that at least about 82 to 95 % of the dose is absorbed.
Latvian: C apstiprināja, ka absorbējas vismaz ne mazāk kā 82 % - 95 % zāļu devas.