FrancophonIA/ELRC3.0 huggingface dataset:
English: Belgium triggered a referral procedure on 14 September 2007 and requested the CHMP to give its opinion on whether the marketing authorisations for oral formulations of products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the reassessment of norfloxacin benefit/risk balance.
Slovenian: Belgija je 14. septembra 2007 sprožila napotitveni postopek in zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP), da poda svoje mnenje, ali je treba dovoljenja za promet z zdravilom za peroralne pripravke zdravil, ki vsebujejo norfloksacin, pri zdravljenju akutnega ali kronično zapletenega ali nezapletenega pielonefritisa, ohraniti, spremeniti, preklicati ali umakniti v Evropski uniji zaradi ponovne ocene razmerja med koristmi in tveganji pri uporabi norfloksacina.
English: Arrow Generiques 26 av Tony Garnier 69007 Lyon France
Slovenian: Arrow Generiques 26 av Tony Garnier 69007 Lyon Francija
English: via Felice Casati, 16 - 20124 Milano Italy
Slovenian: via Felice Casati, 16 - 20124 Milano Italija
English: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Slovenian: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, Nizozemska
English: However the CHMP welcomed the idea to update the MIC breakpoints in section 5.1 of the SPC to include the clinical MIC breakpoints as defined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) in section 5.1 of the SPC as these breakpoints are not only related to the pathogens found in complicated pyelonephritis, but to common urinary pathogens found in other urinary indications.
Slovenian: Kljub temu pa je Odbor za zdravila za uporabo v humani medicini pozdravil zamisel o posodobitvi mejne vrednosti najmanjše inhibicijske koncentracije (MIK) v poglavju 5.1 Povzetka glavnih značilnosti zdravila, ki naj vključuje mejne vrednosti najmanjše inhibicijske koncentracije, kot jih je določil Evropski odbor za testiranje občutljivosti za protimokrobna zdravila (EUCAST), v poglavju 5.1 Povzetka glavnih značilnosti zdravila, ker te mejne vrednosti niso povezane samo s patogeni, prisotnimi v zapletenem pielonofritisu, ampak z običajnimi sečnimi patogeni, prisotnimi v drugih sečnih indikacijah.
English: Ruhrpharm AG Heidsieker Heide 114 D-33739 Bielefeld Germany
Slovenian: Ruhrpharm AG Heidsieker Heide 114 D-33739 Bielefeld Nemčija
English: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, The Netherlands
Slovenian: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, Nizozemska
English: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, România
Slovenian: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, Romunija
English: D-40789 Monheim Germany
Slovenian: D-40789 Monheim Nemčija
English: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Spain
Slovenian: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Španija
English: As a response to CHMP, most of the MAHs proposed to withdraw the indication in question, while some MAHs chose to submit bibliographic data, because no unpublished data from clinical trials were available to them.
Slovenian: V odgovor Odboru za zdravila za uporabo v humani medicini je večina imetnikov dovoljenj za promet z zdravilom predlagala umik zadevne indikacije, nekateri imetniki dovoljenj za promet z zdravilom pa so se zaradi pomanjkanja razpoložljivih neobjavljenih podatkov o kliničnih preskusih odločili za predložitev bibliografskih podatkov.
English: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Spain
Slovenian: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Španija
English: Via G. Fabbroni, 6 - 00191 Roma Italy
Slovenian: Via G. Fabbroni, 6 - 00191 Roma Italija
English: Eurogenerics Heizel Esplanade B22 1020 Brussel Belgium
Slovenian: Eurogenerics Heizel Esplanade B22 1020 Brussel Belgija
English: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL United Kingdom
Slovenian: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL Velika Britanija
English: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Spain
Slovenian: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Španija
English: 1, cours du Triangle 92936 Paris la Défense Cedex France
Slovenian: 1, cours du Triangle 92936 Paris la Défense Cedex Francija
English: Norfloxacin containing medicinal products, which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Slovenian: Zdravila, ki vsebujejo norfloksacin in so na voljo samo kot peroralni pripravki, ne zagotavljajo zadostne serumske koncentracije za zdravljenje sočasne bakteremije;
English: 92936 Paris la Défense cedex France
Slovenian: 92936 Paris la Défense cedex Francija
English: Further to the discussion held in May 2008, the CHMP agreed that the second generation of fluoroquinolones result in higher serum concentrations than norfloxacin.
Slovenian: Po razpravi maja 2008 se je Odbor za zdravila za uporabo v humani medicini strinjal, da druga generacija fluorokinolonov zagotavlja višje serumske koncentracije kot norfloksacin.
English: Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Spain
Slovenian: Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Španija
English: None of the answer submitted in June 2008 could demonstrate the efficacy of the oral formulation of medicinal products containing norfloxacine in the treatment of acute and chronic complicated pyelonephritis.
Slovenian: Noben v juniju 2008 predloženi odgovor pa ni mogel dokazati učinkovitosti peroralnih pripravkov zdravil, ki vsebujejo norfloksacin, pri zdravljenju akutnega in kronično zapletenega pielonefritisa.
English: Having considered the overall data provided in February and June 2008, the CHMP concluded that the marketing authorisations for the oral formulations of medicinal products containing norfloxacin, when used in the treatment of acute or chronic complicated pyelonephritis, should be withdrawn because the efficacy can no longer be demonstrated in this indication.
Slovenian: Ob upoštevanju vseh podatkov, predloženih februarja in junija 2008, je Odbor za zdravila za uporabo v humani medicini sklenil, da je treba dovoljenja za promet s peroralnimi pripravki zdravil, ki vsebujejo norfloksacin, kadar se uporabijo pri zdravljenju akutnega ali kroničnega zapletenega pielonefritis, umakniti, saj učinkovitosti za to indikacijo ni več mogoče ustrezno dokazati.
English: Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Belgium
Slovenian: Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Belgija
English: Only 3 MAHs answered to this List of outstanding issues adopted in May 2008.
Slovenian: Na vprašanja s seznama odprtih vprašanj, sprejetega maja 2008, so odgovorili le trije imetniki dovoljenj za promet z zdravilom.
English: Laboratoire Qualimed 34, rue Saint-Romain 69008 Lyon France
Slovenian: Laboratoire Qualimed 34, rue Saint-Romain 69008 Lyon Francija
English: Merck Generiques 34, rue Saint-Romain 69359 Lyon Cedex 08 France
Slovenian: Merck Generiques 34, rue Saint-Romain 69359 Lyon Cedex 08 Francija
English: The data submitted did not demonstrate that serum levels after oral treatment with norfloxacin are adequate for eradicating pathogens involved in bacteraemia associated with complicated pyelonephritis.
Slovenian: Predloženi podatki niso potrdili ustreznosti serumskih koncentracij po peroralnem zdravljenju z norfloksacinom za zatiranje patogenov, vpletenih v bakteremijo, povezano z zapletenim pielonefritisom.
English: Neopharmed S.p.A Via G. Fabbroni, 6 - 00191 Roma Italy
Slovenian: Neopharmed S.p.A Via G. Fabbroni, 6 - 00191 Roma Italija
English: Pliva Pharma S.p.A via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italy
Slovenian: Pliva Pharma S.p.A via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italija
English: Additionally, the relationship between the Pharmacokinetic and the Pharmacodynamic of orally administered norfloxacin in the treatment of complicated pyelonephritis was been established.
Slovenian: Poleg tega je bilo dokazano tudi razmerje med farmakokinetiko in farmakodinamiko peroralne uporabe norfloksacina pri zdravljenju zapletenega pielonefritisa.
English: The MAHs did not provide any relevant information showing comparison of tissue concentrations after oral treatment with norfloxacin, ciprofloxacin, ofloxacin and levofloxacin.
Slovenian: Imetniki dovoljenj za promet z zdravilom niso predložili nobenih ustreznih podatkov o primerjavi koncentracije v tkivu po peroralnem zdravljenju z norfloksacinom, ciprofloksacinom, ofloksacinom in levofloksacinom.
English: Medochemie Ltd, Limassol Constantinoupoleos St. 1-10, P.O.Box 51409, CY-3505 Limassol Cyprus
Slovenian: Medochemie Ltd, Limassol Constantinoupoleos St. 1-10, P.O.Box 51409, CY-3505 Limassol Ciper
English: Merck, Sharp et Dohme Chaussée de Waterloo 1135, 1180 Bruxelles Belgium
Slovenian: Merck, Sharp et Dohme Chaussée de Waterloo 1135, 1180 Bruxelles Belgija
English: The CHMP therefore concluded on 24 July 2008 that for oral norfloxacin containing medicinal products the benefit does not outweigh the risk in complicated pyelonephritis.
Slovenian: Odbor za zdravila za uporabo v humani medicini je 24. julija 2008 zaključil, da pri zdravilih za peroralno uporabo, ki vsebujejo norfloksacin, koristi uporabe pri zdravljenju zapletenega pielonefritisa ne odtehtajo tveganja.
English: Farmaceutici Caber S.p.A. Viale Città d'Europa 681 - 00144 Roma Italy
Slovenian: Viale Città d'Europa 681 - 00144 Roma Italija
English: Remedica Ltd, P.O Box 51706 Lemesos Cyprus
Slovenian: Remedica Ltd, P.O Box 51706 Lemesos Ciper
English: Merck Sharp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Belgium
Slovenian: Merck Sharp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Belgija
English: It is though known that the second generation fluoroquinolones (ciprofloxacin, ofloxacin and levofloxacin) show higher serum concentrations and a more favourable tissue distribution than norfloxacin.
Slovenian: Vendar pa je znano, da druga generacija fluorokinolonov (ciprofloksacin, ofloksacin in levofloksacin) kaže višje serumske koncentracije in boljšo porazdelitev po tkivih kot norfloksacin.
English: GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS”
Slovenian: PODLAGA ZA IZBRIS TERAPEVTSKE INDIKACIJE „AKUTNI IN KRONIČNI ZAPLETENI PIELONEFRITIS“
English: • The Committee concluded that the oral use of norfloxacin containing medicinal products in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms could no longer be supported;
Slovenian: • je Odbor za zdravila za uporabo v humani medicini sklenil, da peroralne uporabe zdravil, ki vsebujejo norfloksacin, pri zdravljenju akutnega ali kroničnega zapletenega pielonefritisa, zaradi dovzetnih organizmov ni več mogoče podpreti;
English: Therefore, the CHMP recommended the removal of the therapeutic indication “acute and chronic complicated pyelonephritis” for products containing norfloxacin throughout Europe.
Slovenian: Zato je Odbor za zdravila za uporabo v humani medicini priporočil izbris terapevtske indikacije „akutni in kronični zapleteni pielonefritis“ za zdravila, ki vsebujejo norfloksacin, v vsej Evropi.
English: Centrafarm Services B.V. Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
Slovenian: Nieuwe Donk 9, 4879 AC Etten-Leur, Nizozemska
English: The CHMP has recommended the removal of the therapeutic indication “acute and chronic complicated pyelonephritis” for the medicinal products containing norfloxacin taken orally (referred to medicinal products listed in Annex I).
Slovenian: Odbor za zdravila za uporabo v humani medicini je priporočil izbris terapevtske indikacije „akutni in kronični zapleteni pielonefritis“ za zdravila za peroralno uporabo, ki vsebujejo norfloksacin (navedena v seznamu zdravil v Dodatku I).
English: Ozone Laboratories Ltd, 38 Princes Court 88 Brompton Road, Knightsbridge, SW3 1ES London United Kingdom
Slovenian: Ozone Laboratories Ltd, 38 Princes Court 88 Brompton Road, Knightsbridge, SW3 1ES London Velika Britanija
English: Ozone Laboratories Ltd, 38 Princes Court, 88 Brompton Road, Knightsbridge, SW3 1ES London United Kingdom
Slovenian: Ozone Laboratories Ltd, 38 Princes Court, 88 Brompton Road, Knightsbridge, SW3 1ES London Velika Britanija
English: • The Committee considered that Marketing Authorisation Holders did not present data demonstrating that norfloxacin taken orally presents efficacy in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms;
Slovenian: • je Odbor za zdravila za uporabo v humani medicini menil, da imetniki dovoljenj za promet z zdravilom niso predložili nobenih podatkov, ki bi potrdili učinkovitost peroralne uporabe norfloksacina pri zdravljenju akutnega ali kronično zapletenega pielonefritisa zaradi dovzetnih organizmov;
English: Second generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
Slovenian: Druga generacija fluorokinolonov, kot so na primer ciprofloksacin, ofloksacin in levofloksacin, kažejo višje serumske koncentracije in boljšo porazdelitev po tkivih kot norfloksacin;
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS” PRESENTED BY THE EMEA
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA IZBRIS TERAPEVTSKE INDIKACIJE „AKUTNI IN KRONIČNO ZAPLETENI PIELONEFRITIS“, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Box 56 4745-457 S. Mamede do Coronado,
Slovenian: Bialfar - Produtos Farmacêuticos, S.A., Av. da Siderurgia Nacional, P.O. Box 56 4745-457 S. Mamede do Coronado,
English: 100ml contains 5,4g of Norfloxacin pivaloil-oxymethyl-ester as 4,0g of Norfloxacin
Slovenian: 100ml vsebuje 5,4g norfloksacina v obliki pivaloil-oksimetilnega estra, kar ustreza 4,0g norfloskacina
English: th
Slovenian: H
English: • The Committee, as a consequence, concluded that the benefit/risk balance of oral norfloxacin containing medicinal products is negative in the above indication.
Slovenian: • je posledično Odbor za zdravila za uporabo v humani medicini sklenil, da je pri zadevni indikaciji razmerje med koristmi in tveganji pri peroralni uporabi zdravil, ki vsebujejo norfloksacin, negativno.
English: United Kingdom Merck Sharpe & Dohme Limted, Hertford Road, Hoddesdon,
Slovenian: Merck Sharpe & Dohme Limted, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU.
English: Smarješka cesta 6, Sl-8501 Novo mesto Slovenia
Slovenian: Smarješka cesta 6, Sl-8501 Novo mesto Slovenija
English: Sede legale: ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II, 72 Torino
Slovenian: Corso Vittorio Emanuele II, 72 Torino
English: Pliva Pharma S.p.A. via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italy
Slovenian: via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italija
English: Krka d.d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Krka d.d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenija
English: Šmarješka cesta 6 8501 Novo mesto Slovenia
Slovenian: Šmarješka cesta 6 8501 Novo mesto Slovenija
English: Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm Germany
Slovenian: Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm Nemčija
English: 540mg of Norfloxacin pivaloil-oxymethyl-ester as 400mg of Norfloxacin
Slovenian: 540mg norfloksacina v obliki pivaloil-oksimetilnega estra, kar ustreza 400mg norfloksacina
English: Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: Ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Germany
Slovenian: Ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Nemčija
English: TAD Pharm. Werk Heinz-Lohmann Str. 5 D-27472 Cuxhaven Germany
Slovenian: TAD Pharm. Werk Heinz-Lohmann Str. 5 D-27472 Cuxhaven Nemčija
English: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19
Slovenian: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19 D-89150 Laichingen Nemčija
English: Ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Slovenian: Ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Nemčija
English: Novo mesto, Šmarješka cesta 6 8501 Novo mesto Slovenia
Slovenian: Novo mesto, Šmarješka cesta 6 8501 Novo mesto Slovenja
English: Utinor Tablets 400mg 400mg
Slovenian: Utinor Tablets 400mg
English: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Slovenian: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Avstrija
English: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4.
Slovenian: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4. 28023 Aravaca Madrid
English: Sandoz GmbH Biochemiestrasse 10 AT-6250 Kundl Austria
Slovenian: Sandoz GmbH Biochemiestrasse 10 AT-6250 Kundl Avstrija
English: Xrispa Alpha Farmaceuticals S.A
Slovenian: Farmaceutici Caber S.p.A.
English: Utinor 400mg tablets 400mg
Slovenian: Utinor 400mg tablets
English: Tad Pharma GmbH Heinz-Lohmann Strasse 5, DE-27472, Cuxhaven Germany
Slovenian: Tad Pharma GmbH Heinz-Lohmann Strasse 5, DE-27472, Cuxhaven Nemčija
English: Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 27472 Cuxhaven Germany
Slovenian: Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 27472 Cuxhaven Nemčija
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Slovenian: TAD Pharma GmbH Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Nemčija
English: Km Marathonos Avenue Pallini 15344
Slovenian: Xrispa Alpha Farmaceuticals S.A 16th Km Marathonos Avenue Pallini 15344
English: Film-coated tablets
Slovenian: Filmtabletten
English: Coated tablets
Slovenian: Obložene tablete
English: United Kingdom TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472
Slovenian: TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472 Nemčija
English: H-NORFLOXACIN 400mg
Slovenian: NORFLOXACIN 400mg
English: 18 May 2018
Slovenian: 18. maj 2018
English: March, 2018 CMDh meeting
Slovenian: Zasedanje skupine CMDh marca 2018
English: • Assemble everything you need.
Slovenian: • Zberite vse, kar potrebujete.
English: It is important that your hands and the items you use be as clean as possible.
Slovenian: Pomembno je, da so vaše roke in tudi predmeti, ki jih uporabljate, čisti, kolikor je le mogoče.
English: If this happens, your doctor will need to examine you as soon as possible.
Slovenian: Če se to zgodi, vas bo moral zdravnik pregledati takoj, ko je mogoče.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Slovenian: Sprejemljivo je podaljšanje trajanja stimulacije v kateremkoli ciklusu vse do 5 tednov.
English: Your physician may decide to extend your treatment up to 5 weeks.
Slovenian: Vaš zdravnik se lahko odloči za podaljšanje zdravljenja do 5 tednov.
English: • If you have unexplained vaginal bleeding.
Slovenian: • če imate nepojasnjene vaginalne krvavitve.
English: Management Treatment is directed to symptoms.
Slovenian: Vodenje zdravljenja Zdravljenje je usmerjeno k simptomom.
English: EU/1/00/155/001 (1 vial/ 1 ampoule) EU/1/00/155/002 (3 vials/ 3 ampoules) EU/1/00/155/003 (10 vials/ 10 ampoules) EU/1/00/155/004 (1 vial/ 1 vial) EU/1/00/155/005 (3 vial/ 3 vials) EU/1/00/155/006 (10 vials/ 10 vials)
Slovenian: EU/1/00/155/001 (1 viala/ 1 ampula) EU/1/00/155/002 (3 viale/ 3 ampule) EU/1/00/155/003 (10 vial/ 10 ampul) EU/1/00/155/004 (1 viala/ 1 viala) EU/1/00/155/005 (3 viale/ 3 viale) EU/1/00/155/006 (10 vial/ 10 vial)
English: In these trials the ovulation rate per cycle was 70-75 %.
Slovenian: V teh preskušanjih je bila stopnja ovulacije na ciklus 70-75 %.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Slovenian: Večplodna nosečnost lahko privede do zdravstvenih zapletov za vas in vaše otroke.
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Slovenian: Vendar pa moramo upoštevati, da se LH meritve v posameznih laboratorijih razlikujejo.
English: Children and adolescents Luveris is not for use in children and adolescents below 18 years old.
Slovenian: Otroci in mladostniki Zdravilo Luveris ni namenjeno za otroke in mladostnike, stare manj kot 18 let.
English: The doctor might ask you to stop using Luveris.
Slovenian: Zdravnik vam bo morda naročil, da prenehate uporabljati zdravilo Luveris.
English: Mild or moderate OHSS usually resolves spontaneously.
Slovenian: Blagi ali zmerni OHSS običajno izgine spontano.
English: • malformations of sexual organs incompatible with pregnancy
Slovenian: • malformacije spolnih organov, nezdružljivih z nosečnostjo
English: Absorption Following subcutaneous administration, the absolute bioavailability is approximately 60 %.
Slovenian: Absorpcija Po subkutani uporabi je absolutna biološka razpoložljivost približno 60 %.
English: Nevertheless there is a possibility that OHSS may occur, which is further described in section 4.4.
Slovenian: Vseeno pa je možen pojav OHSS, kar je podrobno opisano v poglavju 4.4.
English: Your doctor will decide on the dose and schedule of administration, which are most appropriate for you during this course of treatment.
Slovenian: Vaš zdravnik bo določil odmerek in režim dajanja, ki je v tem obdobju zdravljenja za vas najbolj primeren.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: It should be noted however, that pregnancy itself, as well as OHSS, also carries an increased risk of thromboembolic events.
Slovenian: Vendar pa je treba opomniti, da tudi sama nosečnost, kot tudi OHSS, pomeni povečanje tveganja za trombembolične dogodke.
English: This medicine stimulates your ovaries.
Slovenian: To zdravilo spodbuja vaše jajčnike.
English: In this context, it is difficult to attribute adverse reactions to any one of the substances used.
Slovenian: V tem kontekstu je neželene učinke težko pripisati katerikoli od obeh uporabljenih učinkovin.
English: Inject under the skin, as you were taught.
Slovenian: Vbrizgajte pod kožo, kot so vas naučili.
English: Contact your doctor straight away if you notice any of the below listed side effects.
Slovenian: Takoj se posvetujte z zdravnikom, če opazite katerega od spodaj navedenih neželenih učinkov.
English: As OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event, patients should be followed for at least two weeks after hCG administration.
Slovenian: Ker lahko OHSS hitro napreduje (v roku 24 ur) ali v času več dni in se razvije v resen zaplet, je treba bolnice spremljati vsaj dva tedna po dajanju hCG.
English: No severe OHSS was reported (section 4.4).
Slovenian: Ni poročil o hudem OHSS (poglavje 4.4).
English: However this will only occur if hCG is administered (see section ‘Warnings and precautions').
Slovenian: Vendar pa se le ta pojavi samo, če se daje hCG (glejte poglavje „Opozorila in previdnostni ukrepi“).
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Slovenian: Ker so te bolnice amenoreične in imajo nizko izločanje endogenega estrogena, se zdravljenje lahko začne kadarkoli.
English: • If you have had a brain tumour diagnosed.
Slovenian: • če so pri vas ugotovili možganski tumor,
English: Self-administration of this medicinal product should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Slovenian: Sami si smejo to zdravilo dajati samo tisti bolniki, ki so dovolj motivirani, primerno usposobljeni in imajo možnost strokovnega nasveta.
English: • After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Slovenian: • Ko se prašek raztopi (kar se običajno zgodi takoj), se prepričajte, da je nastala raztopina bistra in ne vsebuje delcev.