FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren hereditary angioedema angioedema without any known cause.
Slovenian: Če mislite, da bi lahko bili alergični, ne jemljite zdravila Sprimeo HCT in se posvetujte z zdravnikom, - če ste imeli katero od naslednjih oblik angioedema (težave z dihanjem ali s požiranjem ali otekanje obraza, rok, stopal, oči, ustnic in/ali jezika): angioedem v času jemanja aliskirena; prirojeni angioedem; angioedem brez znanega vzroka; - če ste noseči več kot 3 mesece.
English: In this population, Sprimeo HCT 150 mg/12.5 mg to 300 mg/25 mg provided dose-dependent systolic/diastolic blood pressure reduction from 20.6/12.4 mmHg to 24.8/14.5 mmHg, which were significantly superior to the respective monotherapies.
Slovenian: V tej populaciji je zdravilo Sprimeo HCT v odmerkih od 150 mg/12,5 mg do 300 mg/25 mg povzročilo od odmerka odvisno znižanje krvnega tlaka od 20,6/12,4 mmHg do 24,8/14,5 mmHg, kar je bilo statistično značilno boljše kot pri uporabi posameznih monoterapij.
English: Grapefruit juice should not be taken together with Sprimeo HCT.
Slovenian: Zdravila Sprimeo HCT se ne sme jemati skupaj z grenivkinim sokom.
English: Due to the hydrochlorothiazide component, Sprimeo HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zaradi vsebnosti hidroklorotiazida je zdravilo Sprimeo HCT kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 5.2).
English: Treatment with Sprimeo HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo.
Slovenian: Pri zdravljenju z zdravilom Sprimeo HCT v odmerkih do 300 mg/25 mg je bila incidenca vseh neželenih učinkov skupaj podobna kot pri placebu.
English: No initial dose adjustment of Sprimeo HCT is required in elderly patients.
Slovenian: Pri starejših bolnikih prilagajanje začetnega odmerka zdravila Sprimeo HCT ni potrebno.
English: Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium is recommended when Sprimeo HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Slovenian: Zdravila, na katera vplivajo motnje koncentracije kalija v serumu: Pri uporabi zdravila Sprimeo HCT skupaj z zdravili, na katera vplivajo motnje koncentracije kalija v serumu (na primer z glikozidi digitalisa in antiaritmiki), je priporočeno periodično spremljanje koncentracije kalija v serumu.
English: Sprimeo HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Zdravilo Sprimeo HCT je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 4.4).
English: Due to the hydrochlorothiazide component, Sprimeo HCT is contraindicated for use in patients with anuria and in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Slovenian: Zaradi vsebnosti hidroklorotiazida je zdravilo Sprimeo HCT kontraindicirano za uporabo pri bolnikih z anurijo in pri bolnikih s hudo okvaro ledvic (s hitrostjo glomerulne filtracije (GFR) < 30 ml/min/1,73 m2).
English: You should take Sprimeo HCT with a light meal once a day, preferably at the same time each day.
Slovenian: Jemanje zdravila Sprimeo HCT skupaj s hrano in pijačo Zdravilo Sprimeo HCT je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: No data are available for the use of Sprimeo HCT in patients with severe hepatic impairment.
Slovenian: O uporabi zdravila Sprimeo HCT pri bolnikih s hudo okvaro jeter ni podatkov.
English: If pregnancy is detected during therapy, Sprimeo HCT should be discontinued as soon as possible.
Slovenian: V primeru, da se med zdravljenjem z zdravilom Sprimeo HCT izkaže, da je ženska noseča, je treba zdravljenje čimprej prekiniti.
English: What Sprimeo HCT looks like and contents of the pack Sprimeo HCT 150 mg/12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with “LCI” on one side and “NVR” on the other.
Slovenian: Izgled zdravila Sprimeo HCT in vsebina pakiranja Filmsko obložene tablete Sprimeo HCT 150 mg/12,5 mg so bele ovalne filmsko obložene tablete z oznako “LCI” na eni strani in “NVR” na drugi.
English: Metabolism and nutrition disorders Very common:
Slovenian: Presnovne in prehranske motnje zelo pogosti: pogosti:
English: What Sprimeo HCT contains - Each Sprimeo HCT 150 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Slovenian: Kaj vsebuje zdravilo Sprimeo HCT - Vsaka filmsko obložena tableta Sprimeo HCT 150 mg/12,5 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: The usual dose of Sprimeo HCT is one tablet a day.
Slovenian: Običajni odmerek zdravila Sprimeo HCT je ena tableta na dan. Tableto pogoltnite celo z malo vode.
English: The concomitant use of Sprimeo HCT with angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEI) is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Slovenian: Sočasna uporaba zdravila Sprimeo HCT in zaviralcev angiotenzinskih receptorjev II ali zaviralcev encima angiotenzinske konvertaze (ACE) je kontraindicirana pri bolnikih z okvaro ledvic (GFR < 60 ml/min/1,73 m2) (glejte poglavja 4.3, 4.4 in 5.2).
English: Sprimeo HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo Sprimeo HCT je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: - anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia).
Slovenian: diazoksid), - zdravila za zdravljenje protina, na primer alopurinol, - antiholinergična zdravila (zdravila za zdravljenje različnih motenj, kot so želodčne in črevesne kolike, krči sečnega mehurja, astma, potovalna bolezen, mišični krči, Parkinsonova bolezen in kot dodatek pri anesteziji), - amantadin (zdravilo za zdravljenje Parkinsonove bolezni, ki ga uporabljamo tudi pri zdravljenju ali preprečevanju določenih bolezni, ki jih povzročajo virusi),
English: Due to the hydrochlorothiazide component, Sprimeo HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Slovenian: Zaradi vsebnosti hidroklorotiazida je pri bolnikih s simptomatsko hiperurikemijo uporaba zdravila Sprimeo HCT kontraindicirana (glajte poglavje 4.3).
English: There is no clinical experience with Sprimeo HCT in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni kliničnih izkušenj z zdravilom Sprimeo HCT.
English: Very rare: Psychiatric disorders Rare: Nervous system disorders Rare: Eye disorders Rare: Not known: Cardiac disorders Rare: Vascular disorders Common: Respiratory, thoracic and mediastinal disorders Very rare:
Slovenian: hiperkalciemija, hiperglikemija, poslabšanje metaboličnega stanja pri zelo redki: Psihiatrične motnje redki: Bolezni živčevja redki: Očesne bolezni redki:
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets
Slovenian: Sprimeo HCT 300 mg/12,5 mg filmsko obložene tablete
English: No data are available on patients with severe hepatic impairment treated by Sprimeo HCT.
Slovenian: O bolnikih s hudo okvaro jeter, ki jemljejo zdravilo Sprimeo HCT, ni podatkov.
English: Sprimeo HCT 300 mg/25 mg film-coated tablets
Slovenian: Sprimeo HCT 300 mg/25 mg filmsko obložene tablete
English: - Each Sprimeo HCT 150 mg/25 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Slovenian: - Vsaka filmsko obložena tableta Sprimeo HCT 150 mg/25 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklorotiazida.
English: Sprimeo HCT 150 mg/25 mg film-coated tablets
Slovenian: Sprimeo HCT 150 mg/25 mg filmsko obložene tablete
English: Sprimeo HCT 300 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Sprimeo HCT 300 mg/12.5 mg or Sprimeo HCT 150 mg/25 mg.
Slovenian: Zdravilo Sprimeo HCT 300 mg/25 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 300 mg ali samo hidroklorotiazid v odmerku 25 mg ali če uporabljajo zdravilo Sprimeo HCT 300 mg/12,5 mg ali Sprimeo HCT 150 mg/25 mg.
English: - Each Sprimeo HCT 300 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Slovenian: - Vsaka filmsko obložena tableta Sprimeo HCT 300 mg/12,5 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: The pharmacokinetics of aliskiren are not significantly affected in patients with mild to moderate liver disease.
Slovenian: Farmakokinetične lastnosti aliskirena pri bolnikih z blago do zmerno hudo boleznijo jeter niso bistveno spremenjene, zato pri bolnikih z blago do zmerno okvaro jeter prilagajanje začetnega odmerka zdravila Sprimeo HCT ni potrebno.
English: Sprimeo HCT 150 mg/25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with “CLL” on one side and “NVR” on the other.
Slovenian: Filmsko obložene tablete Sprimeo HCT 150 mg/25 mg so bledo rumene ovalne filmsko obložene tablete z oznako “CLL” na eni strani in “NVR” na drugi.
English: Sprimeo HCT 150 mg/12.5 mg film-coated tablets
Slovenian: Sprimeo HCT 150 mg/12,5 mg filmsko obložene tablete
English: OTHER
Slovenian: Sprimeo
English: Sprimeo HCT 150 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone.
Slovenian: Zdravilo Sprimeo HCT 150 mg/12,5 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 150 mg ali samo hidroklorotiazid v odmerku 12,5 mg.
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Slovenian: Filmsko obložene tablete Sprimeo HCT 300 mg/12,5 mg so vijoličasto bele ovalne filmsko obložene tablete z oznako “CVI” na eni strani in “NVR” na drugi.
English: Side effects reported in clinical studies for patients treated with Sprimeo HCT were: Common (affecting less than 1 in 10 patients):
Slovenian: V kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Sprimeo HCT, opisali naslednje neželene učinke:
English: - Each Sprimeo HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Slovenian: - Vsaka filmsko obložena tableta Sprimeo HCT 300 mg/25 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklorotiazida.
English: Abdominal discomfort, constipation, diarrhoea
Slovenian: bolečine v trebuhu, obstipacija, diareja zelo redki:
English: Sprimeo HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “CVV” on one side and “NVR” on the other.
Slovenian: Filmsko obložene tablete Sprimeo HCT 300 mg/25 mg so svetlo rumene ovalne filmsko obložene tablete z oznako “CVV” na eni strani in “NVR” na drugi.
English: Always take Sprimeo HCT exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Sprimeo HCT natančno upoštevajte zdravnikova navodila.
English: Sprimeo HCT 150 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Sprimeo HCT 150 mg/12.5 mg.
Slovenian: Zdravilo Sprimeo HCT 150 mg/25 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 150 mg ali samo hidroklorotiazid v odmerku 25 mg ali če uporabljajo zdravilo Sprimeo HCT 150 mg/12,5 mg.
English: Sprimeo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Sprimeo HCT 300 mg/25 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Sprimeo HCT 150 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Sprimeo HCT 150 mg/25 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Sprimeo HCT 300 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Sprimeo HCT 150 mg/12.5 mg.
Slovenian: Zdravilo Sprimeo HCT 300 mg/12,5 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 300 mg ali samo hidroklorotiazid v odmerku 12,5 mg ali če uporabljajo zdravilo Sprimeo HCT 150 mg/12,5 mg.
English: HOW TO STORE SPRIMEO HCT
Slovenian: SHRANJEVANJE ZDRAVILA SPRIMEO HCT
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Sprimeo HCT 300 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Sprimeo HCT 150 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Sprimeo HCT 150 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Slovenian: Sočasna uporaba zdravila Sprimeo HCT in zaviralcev angiotenzinskih receptorjev II ali zaviralcev ACE je kontraindicirana pri bolnikih z okvaro ledvic (GFR < 60 ml/min/1,73 m2) (glejte poglavje 4.3).
English: Sprimeo HCT is contraindicated in patients with anuria or severe renal impairment (GFR < 30 ml/min/1.73 m2) and the concomitant use of Sprimeo HCT with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m
Slovenian: Pri bolnikih z okvaro ledvic (GFR < 60 ml/min/1,73 m2) je sočasna uporaba aliskirena in zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev II kontraindicirana.
English: Concomitant use of Sprimeo HCT with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Slovenian: SprimeoPri bolnikih s sladkorno boleznijo je sočasna uporaba zdravila Sprimeo HCT in zaviralcev angiotenzinskih receptorjev II ali zaviralcev ACE kontraindicirana (glejte poglavje 4.3).
English: Reproductive system and breast disorders Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: Impotence General disorders and administration site conditions Not known:
Slovenian: Splošne težave in spremembe na mestu aplikacije občasni:
English: Sprimeo HCT should be discontinued if hypercalcaemia develops during treatment.
Slovenian: Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Sprimeo HCT prekiniti.
English: - alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures).
Slovenian: - holestiramin, holestipol ali druge izmenjevalne smole (snovi, ki jih uporabljamo predvsem za zdravljenje visokih ravni lipidov v krvi), - citotoksična zdravila (za zdravljenje raka), kot sta metotreksat ali ciklofosfamid, - mišičnih relaksantov (zdravil za sproščanje mišic, ki jih uporabljajo med operacijami), - alkohol, uspavalne tablete in anestetike (zdravila, ki omogočajo bolnikom, da prestanejo operacije in druge posege), - jodirana kontrastna sredstva (sredstva, ki jih uporabljajo pri slikovnih preiskavah), - zdravila za artritis.
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Slovenian: Zdravilo Sprimeo HCT kontraindicirano pri bolnikih z anurijo in pri bolnikih s hudo okvaro ledvic (s GFR < 30 ml/min/1,73 m2).
English: Immune system disorders Rare:
Slovenian: Srčne bolezni redki:
English: Renal dysfunction, acute renal failure
Slovenian: akutni glavkom zaprtega zakotja
English: (It is also better to avoid Sprimeo HCT in early pregnancy - see Pregnancy section.)
Slovenian: Uporaba zdravila Sprimeo HCT ni priporočljiva v zgodnjem obdobju nosečnosti.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: DODATEK POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI NAJ JIH UVELJAVIJO DRŽAVE ČLANICE
English: • 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
Slovenian: • Pred uvedbo zdravila na trg v državi članici mora nacionalni pristojni organ uskladiti vsebino in obliko izobraževalnega gradiva z imetnikom dovoljenja za promet z zdravilom.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Cinryze are provided with an Educational pack.
Slovenian: • Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da bodo ob uvedbi zdravila na trg vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Cinryze, prejeli izobraževalni paket.
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented in their national territory:
Slovenian: Države članice morajo zagotoviti, da bodo na njihovem nacionalnem ozemlju uveljavljeni vsi pogoji ali omejitve glede varne in učinkovite uporabe zdravila, opisane v nadaljevanju:
English: The existence of a post marketing registry in which health care professionals are encouraged to enter patients
Slovenian: Obstoj postmarketinškega registra, v katerega zdravstveni delavci vpisujejo bolnike, k čemur jih spodbujamo.
English: • Educational material for Healthcare Professionals
Slovenian: • Izobraževalno gradivo za zdravstvene delavce;
English: The educational pack should contain the following:
Slovenian: Izobraževalni paket naj vsebuje naslednje:
English: • Summary of Product Characteristics and Patient Information Leaflet for Cinryze
Slovenian: • Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Cinryze;
English: Their prescribing physician will provide training on the following elements: Precaution for storage
Slovenian: Njihov zdravnik, ki predpisuje zdravilo, bo poskrbel za izobraževanje o naslednjih elementih: Navodila za shranjevanje,
English: • Educational materials for non Healthcare Professionals
Slovenian: • Izobraževalna gradiva za osebe, ki niso zdravstveni delavci.
English: The educational material for non Healthcare Professionals should include information on the following key elements:
Slovenian: Izobraževalno gradivo za osebe, ki niso zdravstveni delavci, naj obsega informacije o naslednjih ključnih elementih:
English: Necessary skills have to be acquired by non-healthcare professionals before Cinryze may be safely and effectively administered at home.
Slovenian: Osebe, ki niso zdravstveni delavci, si morajo pridobiti potrebno znanje, preden se lahko zdravilo Cinryze varno in učinkovito uporablja doma.
English: A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Slovenian: Navodilo s podrobnostmi ključnih elementov izobraževanja, ki naj ga bolnik hrani doma zaradi nadaljnjih napotkov.
English: The educational material for Healthcare Professionals should include information on the following key elements:
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vključevati informacije o naslednjih ključnih elementih:
English: For some patients the prescribing physician may decide that Cinryze may be administered at home by a non Healthcare Professional such as a family member or by self-administration.
Slovenian: Zdravnik, ki predpisuje zdravilo, se lahko odloči, da nekaterim bolnikom lahko daje zdravilo Cinryze doma oseba, ki ni zdravstveni delavec, na primer družinski član, ali da si lahko dajejo zdravilo bolniki sami.
English: London, 23 January 2008 EMEA/CHMP/350278/2007
Slovenian: London, 23. januar 2008 EMEA/CHMP/350278/2007
English: The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden.
Slovenian: Referenčna država članica je bilo Združeno kraljestvo, zadevne države članice pa so bile Danska, Finska, Norveška in Švedska.
English: Article 29(4) of Directive 2001/83/EC, as amended.
Slovenian: Člen 29 (4) direktive 2001/83/ES, z vsemi spremembami.
English: The Mutual Recognition Procedure started on 15 November 2005.
Slovenian: Postopek medsebojnega priznavanja se je začel 15. novembra 2005.
English: These issues were considered to be of serious public health concern.
Slovenian: Menili so, da ta sporna vprašanja predstavljajo resen zadržek glede javnega zdravja.
English: The Rapporteur was Dr Hudson and Co-Rapporteur(s) was Dr Ljungberg.
Slovenian: Poročevalec je bil dr. Hudson, soporočevalec pa dr. Ljungberg.
English: The final opinion was converted into a Decision by the European Commission on 18 January 2008.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 18. januarja 2008.
English: International Non-Proprietary Name (INN): Ciprofloxacin
Slovenian: Mednarodno nelastniško ime (INN): Ciprofloxacin
English: The arbitration procedure started on 1 June 2006 with the adoption of a list of questions.
Slovenian: Arbitražni postopek se je začel 1. junija 2006 s sprejemom seznama vprašanj.
English: These Member States were not able to reach an agreement with respect to the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Omenjene države članice niso mogle doseči soglasja glede skupnega priznavanja dovoljenja za promet, ki ga je izdala referenčna država članica.
English: United Kingdom referred the reasons for disagreement to the EMEA on 5 May 2006.
Slovenian: Združeno kraljestvo je dne 5. maja 2006 agenciji EMEA podalo razloge za nesoglasje.
English: Ciprofloxacin Nycomed and associated names
Slovenian: Ciprofloxacin Nycomed in z njim povezana imena
English: The Marketing Authorisation Holder provided written explanations on 21 September 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 21. septembra 2006.
English: A positive opinion was adopted by consensus on 16 November 2006.
Slovenian: Odbor je dne 16. novembra 2006 soglasno sprejel pozitivno mnenje.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je podan v dodatku I. Znanstveni zaključki so na voljo v dodatku II, povzetek glavnih značilnosti zdravila pa v dodatku III.
English: Ciprofloxacin Nycomed and associated names, 2 mg/ml Solution for Infusion, is an antibiotic belonging to the quinolone family effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Slovenian: Ciprofloxacin Nycomed in z njim povezana imena, 2 mg/ml raztopina za infundiranje, je antibiotik iz družine kinolonov, ki so in vitro učinkoviti proti mnogim po Gramu negativnim aerobnim bakterijam kot tudi nekaterim po Gramu pozitivnim organizmom.
English: The proposed dosage regimen for complicated urinary tract infections (100 mg bid) was considered too low and should be changed to 200-400 mg twice daily.
Slovenian: Predlagani režim odmerjanja pri zapletenih okužbah sečil (100 mg bid) je domnevno prenizek in bi ga bilo treba spremeniti v 200-400 mg dvakrat dnevno.
English: Further, as patients referred to parenteral treatment often are seriously ill, it was felt of importance that a maximum dosage of 1200 mg (400 mg three times daily) instead of 800 mg be permitted.
Slovenian: Prav tako bi moral zaradi resnosti bolezni tistih bolnikov, ki se zdravijo s parenteralnim načinom zdravljenja, najvišji dovoljeni odmerek zdravila znašati 1200 mg (400 mg trikrat dnevno) namesto 800 mg.