FrancophonIA/ELRC3.0 huggingface dataset:
English: An increase in thyroidal weight and thyroidal follicular cell hyperplasia, due to an increase in thyroxine clearance, was seen in rats treated with indinavir at doses  160 mg/kg/day.
Latvian: Žurkām, kuras saņēma indinavīru devās ≥ 160 mg/kg/dienā, paaugstināta tiroksīna klīrensa dēļ novēroja palielinātu vairogdziedzera svaru un vairogdziedzera folikulāro šūnu hiperplāziju.
English: In HIV infected paediatric patients, a dose regimen of indinavir hard capsules, 500 mg/m every
Latvian: HIV inficētiem bērniem indinavīra cietās kapsulas ordinēšana 500 mg/m2 ik pēc 8 stundām izraisīja
English: Coadministration of CRIXIVAN with vardenafil is likely to result in an increase of vardenafil by competitive inhibition of metabolism.
Latvian: CRIXIVAN vienlaikus lietošana ar vardenafilu iespējams dēļ metabolisma konkurējošās inhibīcijas var paaugstināt vardenafila līmeni serumā.
English: ANTIHISTAMINES Fexofenadine
Latvian: PRETKRAMPJU LĪDZEKĻI Karbamazepīns
English: This means you will take a total of four 200 mg capsules (800 mg) each day.
Latvian: Tas nozīmē, ka Jūs kopumā lietosiet četras 200 mg kapsulas (800 mg) katru dienu.
English: Indinavir must not be given with ritonavir to patients with decompensated liver disease as ritonavir is principally metabolized and eliminated by the liver (see section 4.4).
Latvian: Tā kā ritonavīrs galvenokārt tiek metabolizēts un izvadīts caur aknām, ritonavīru kopā ar indinavīru nedrīkst lietot pacienti ar dekompensētu aknu slimību (skatīt 4.4. apakšpunktu).
English: The interaction of indinavir or indinavir/ritonavir with pravastatin or fluvastatin is not known (see section 4.5).
Latvian: Indinavīra vai indinavīra/ritonavīra mijiedarbība ar pravastatīnu vai fluvastatīnu nav zināma.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Latvian: AUGU IZCELSMES PREPARĀTI
English: Indinavir AUC24hr:220 % Indinavir Cmin:↑ 24-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
Latvian: Indinavīra AUC24hr:220 % Indinavīra Cmin:↑ 24- reizes (Attiecībā pret indinavīru 800 mg TID vienu pašu *)
English: CRIXIVAN 200 mg hard capsules
Latvian: CRIXIVAN 200 mg cietās kapsulas
English: If signs and symptoms of nephrolithiasis, including flank pain with or without haematuria
Latvian: Ja novēro nefrolitiāzes pazīmes un simptomus, ieskaitot sānu sāpes ar vai bez hematūrijas (ieskaitot mikroskopisko hematūriju), jāapsver pagaidu terapijas pārtraukšanas (piemēram, no 1 līdz 3 dienām)
English: Anhydrous lactose.
Latvian: Bezūdens laktoze.
English: CRIXIVAN 400 mg hard capsules
Latvian: CRIXIVAN 400 mg cietās kapsulas
English: Indinavir and isoniazid can be co-administered without dose adjustment.
Latvian: Indinavīru un izoniazīdu var lietot vienlaikus, nepielāgojot devu.
English: CRIXIVAN 400 mg - packs of 90 and 180 capsules - Outer carton
Latvian: CRIXIVAN 400 mg - iepakojumā 90 un 180 - kastīte
English: Rifabutin 150 mg QD (Indinavir 800 mg TID)
Latvian: Rifabutīns 150 mg QD (Indinavīrs 800 mg TID)
English: Saquinavir 1,200 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID)
Latvian: Sakvinavīrs 1200 mg SD (mīkstās kapsulas) (Indinavīrs 800 mg TID)
English: Didanosine enteric-coated 400 mg SD (Indinavir 800 mg SD)
Latvian: Didanozīna zarnās šķīstošās kapsulas 400 mg SD (Indinavīrs 800 mg SD)
English: Fluconazole 400 mg QD (Indinavir 1,000 mg TID)
Latvian: Pretsēnīšu preparāti Flukonazols 400 mg QD (Indinavīrs 1000 mg TID)
English: CRIXIVAN with ritonavir and oral midazolam should not be coadministered (see section 4.3).
Latvian: CRIXIVAN ar ritonavīru un midazolāmu iekšķīgai lietošanai nedrīkst lietot vienlaikus (skatīt 4.3. apakšpunktu).
English: Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition.
Latvian: CYP3A4 inhibīcijas rezultātā ritonavīrs paaugstina amprenavīra līmeni serumā.
English: ANTIASTHMATIC Theophylline 250 mg SD (Indinavir 800 mg TID)
Latvian: PRETASTMAS LĪDZEKĻI Teofilīns 250 mg SD (Indinavīrs 800 mg TID)
English: Saquinavir 800 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID)
Latvian: Sakvinavīrs 800 mg SD (mīkstās kapsulas) (Indinavīrs 800 mg TID)
English: Caution should be used with coadministration of CRIXIVAN with ritonavir and parenteral midazolam.
Latvian: Vienlaikus lietojot CRIXIVAN ar ritonavīru un midazolāmu parenterālai lietošanai, jāievēro piesardzība.
English: A boosted dose of 800 mg indinavir/100 mg ritonavir twice daily results in increased risk of adverse events.
Latvian: Blakusparādību risks palielinājās divreiz dienā lietojot 800 mg indinavīra/100 mg ritonavīra devu.
English: Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot eritromicīnu vai itrakonazolu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Antibiotics
Latvian: ANTIARITMISKIE LĪDZEKĻI
English: Caution is warranted and therapeutic concentration monitoring is recommended for quinidine when coadministered with CRIXIVAN.
Latvian: Lietojot kvinidīnu vienlaikus ar CRIXIVAN, jāievēro piesardzība un ieteicams kontrolēt koncentrāciju serumā.
English: The following adverse reactions have been reported during clinical studies in adults and/or postmarketing use for CRIXIVAN monotherapy and/or CRIXIVAN with combination antiretroviral therapy (CART).
Latvian: Zemāk uzskaitītas CRIXIVAN monoterapijas un/vai CRIXIVAN lietošanas kopā ar pretretrovīrusu terapiju izraisītās blakusparādības, par ko ziņots klīnisko pētījumu laikā pieaugušajiem un/vai pēcreģistrācijas periodā.
English: Dose modification of calcium channel blockers should be considered when coadministered with indinavir/ritonavir as it may result in an increased response.
Latvian: Lietojot vienlaikus ar indinavīru/ritonavīru, sakarā ar iespējamu pastiprinātu terapeitisko iedarbību, jāapsver kalcija kanālu blokatoru devas maiņa.
English: Ritonavir 100 mg BID (Indinavir 400 mg BID)
Latvian: Ritonavīrs 100 mg BID (Indinavīrs 400 mg BID)
English: Ritonavir 200 mg BID (Indinavir 800 mg BID)
Latvian: Ritonavīrs 200 mg BID (Indinavīrs 800 mg BID)
English: CRIXIVAN and oral midazolam should not be coadministered (see section 4.3).
Latvian: CRIXIVAN un midazolāmu iekšķīgai lietošanai nedrīkst lietot vienlaikus (skatīt 4.3. apakšpunktu).
English: Indinavir AUC24hr: 178 % Indinavir Cmin:11-fold; (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC:  72 % Ritonavir Cmin:  62 %
Latvian: Indinavīra AUC24hr: 178 % Indinavīra Cmin:11-reizes; (Attiecībā pret indinavīru 800 mg TID vienu pašu *)
English: Anti-Mycobacterial Isoniazid 300 mg QD (Indinavir 800 mg TID)
Latvian: Prettuberkolozes līdzekļi Izoniazīds 300 mg QD (Indinavīrs 800 mg TID)
English: • muscle pain
Latvian: • muskuļu sāpes,
English: Indinavir AUC24hr:68 % Indinavir Cmin: ↑ 10-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
Latvian: Indinavīra AUC24hr:68 % Indinavīra Cmin: ↑ 10- reizes (Attiecībā pret indinavīŗu 800 mg TID vienu pašu *)
English: • indigestion or diarrhoea
Latvian: • gremošanas traucējumi vai caureja,
English: Ritonavir 400 mg BID (Indinavir 400 mg BID)
Latvian: Ritonavīrs 400 mg BID (Indinavīrs 400 mg BID)
English: Dizziness and blurred vision have been reported during treatment with CRIXIVAN.
Latvian: Transportlīdzekļu vadīšana un mehānismu apkalpošana Ziņots par reiboņiem un redzes traucējumiem CRIXIVAN lietošanas laikā.
English: Ritonavir 100 mg BID (Indinavir 800 mg BID)
Latvian: Ritonavīrs 100 mg BID (Indinavīrs 800 mg BID)
English: Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot morfīnu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: NNRTIs
Latvian: Nierakmeņi
English: Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot šīs zāles vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt līmeni serumā vai terapeitisko iedarbību.
English: CRIXIVAN 200 mg hard capsules Indinavir
Latvian: CRIXIVAN 200 mg cietās kapsulas Indinavir
English: CRIXIVAN 200 mg hard capsules indinavir
Latvian: CRIXIVAN 200 mg cietās kapsulas indinavir
English: Rosuvastatin
Latvian: Ritonavīrs
English: Batch
Latvian: TM
English: Ritonavir 400 mg BID (Indinavir 800 mg BID)
Latvian: Ritonavīrs 400 mg BID (Indinavīrs 800 mg BID)
English: CRIXIVAN 400 mg hard capsules indinavir
Latvian: CRIXIVAN 400 mg cietās kapsulas Indinavir
English: CRIXIVAN 400 mg hard capsules Indinavir
Latvian: CRIXIVAN 400 mg cietās kapsulas indinavir
English: Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with indinavir.
Latvian: Lietojot šīs zāles vienlaikus ar indinavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Indinavir AUC: ↓ 20 % Indinavir Cmin: ↑ 29 % (Relative to Indinavir 800 mg TID alone) Indinavir AUC ↓ 56 % Indinavir Cmin ↓ 27 % (Relative to Indinavir 800 mg TID alone)
Latvian: Indinavīra AUC ↓ 56 % Indinavīra Cmin ↓ 27 % (Attiecībā pret indinavīru 800 mg TID vienu pašu)
English: Rifabutin 300 mg QD (Indinavir 800 mg TID)
Latvian: Rifabutīns 300 mg QD (Indinavīrs 800 mg TID)
English: • ‘haemophilia' - CRIXIVAN may make you more likely to bleed.
Latvian: - CRIXIVAN var veicināt asiņošanu.
English: Interaction with indinavir/ritonavir not studied Decreased indinavir concentrations and increased rifabutin concentrations are expected.
Latvian: Jāparedz indinavīra koncentrācijas pazemināšanos un rifabutīna koncentrācijas paaugstināšanos.
English: ANTI-INFECTIVES Antiretrovirals NRTIs
Latvian: Ne-nukleozīdu reversās transkriptāzes inhibitoriNNRTIs)
English: Efavirenz AUC and Cmin : ↔
Latvian: Efavirenza AUC un Cmin : ↔
English: Indinavir AUC24hr:266 % Indinavir Cmin:24-fold; (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC:  96 % Ritonavir Cmin:  371 %
Latvian: Indinavīra AUC24hr:266 % Indinavīra Cmin:24- reizes; (Attiecībā pret indinavīru 800 mg TID vienu pašu *)
English: Erythromycin, Itraconazole Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4, tāpēc paredzama eritromicīna un itrakonazola koncentrācijas paaugstināšanās plazmā.
English: Indinavir AUC and Cmin: ↔ (Relative to Indinavir 800 mg TID alone) Isoniazid AUC and Cmin: 
Latvian: Indinavīra AUC un Cmin: ↔ (Attiecībā pret indinavīru 800 mg TID vienu pašu)
English: Indinavir AUC:  46 % Indinavir Cmin:  57 % (Relative to Indinavir 800 mg TID alone) An increased dose (1,000 mg TID) of indinavir does not compensate for the inducing effect of efavirenz.
Latvian: Indinavīra AUC:  46 % Indinavīra Cmin:  57 % (Attiecībā pret indinavīru 800 mg TID vienu pašu)
English: Other Anti-infectives Atovaquone
Latvian: Citas zāles pret infekcijas slimībām
English: • diarrhoea
Latvian: • ‘hemofīlija'
English: Indinavir and NRTIs can be co-administered without dose adjustment.
Latvian: Indinavīru un NRTIs var lietot vienlaikus bez devas pielāgošanas.
English: Saquinavir 600 mg SD (hard gel capsule formulation) (Indinavir 800 mg TID)
Latvian: Sakvinavīrs 600 mg SD (cietās kapsulas) (Indinavīrs 800 mg TID)
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4 un tāpēc paredzama loratidīna koncentrācijas paaugstināšanās plazmā.
English: Indinavir and cimetidine can be co-administered without dose adjustment.
Latvian: Indinavīru un cimetidīnu var lietot vienlaikus, nepielāgojot devu.
English: ANTI-INFECTIVES Antiretrovirals Amprenavir
Latvian: ZĀLES PRET INFEKCIJU SLIMĪBĀM Pretretrovīrusa preparāti
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4, tāpēc paredzama fentanila koncentrācijas paaugstināšanās plazmā.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4, tāpēc paredzama ketokonazola koncentrācijas paaugstināšanās plazmā.
English: Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot buspironu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot karbamazepīnu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: liver function abnormalities
Latvian: Aknu funkcijas traucējumi
English: Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot fentanilu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4, tāpēc paredzama karbamazepīna koncentrācijas paaugstināšanās plazmā.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4 un tāpēc paredzama buspirona koncentrācijas paaugstināšanās plazmā.
English: Indinavir AUC:  28 % (Relative to Indinavir 800 mg SD alone) Venlafaxine and active metabolite Odesmethyl-venlafaxine: 
Latvian: Indinavīra AUC:  28 % (Attiecībā pret indinavīru 800 mg SD vienu pašu)
English: Antifungals
Latvian: Vardenafils
English: Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot deksametazonu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot ketokonazolu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: • acid reflux
Latvian: • skābes atvilnis,
English: Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir.
Latvian: Lietojot deksametazonu kopā ar indinavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: Interaction with indinavir/ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
Latvian: Ritonavīrs inducē glikuronidizāciju, tāpēc paredzama atovakvona koncentrācijas pazemināšanās plazmā.
English: Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ritonavir.
Latvian: Lietojot takrolīmu vienlaikus ar indinavīru/ritonavīru, ieteicams rūpīgi kontrolēt terapeitisko iedarbību un blakusparādības.
English: B. PACKAGE LEAFLET
Latvian: Atsvišķu blakusparādību apraksts
English: Indinavir AUC and Cmin:  (Relative to Indinavir 400 mg QID alone) Sulphamethoxazole AUC and Cmin: 
Latvian: Indinavīra AUC un Cmin:  (Attiecībā pret indinavīru 400 mg QID vienu pašu)
English: • having a numb mouth
Latvian: • mutes nejutīgums,
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Latvian: Indinavīrs un ritonavīrs inhibē CYP3A4 un tāpēc paredzama takrolīma koncentrācijas paaugstināšanās plazmā.
English: European Medicines Agency
Latvian: The European Medicines Agency
English: International Non-proprietary Name (INN): anecortave
Latvian: Starptautiskais neaizsargātais nosaukums (SNN): anekortāvs
English: What is Retaane?
Latvian: Kas ir Retaane?
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.
Latvian: Saskaņā ar CHMP viedokli Eiropas Komisijai licences izsniegšanai parasti ir nepieciešami 2 mēneši.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Latvian: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The two main clinical studies were carried out in patients aged between 51 and 96 years of age, and lasted up to two years.
Latvian: Tika veikti divi klīniskie pamatpētījumi, kuros piedalījās pacienti vecumā no 51 līdz 96 gadiem.
English: What were the main concerns of the CHMP?
Latvian: Kādas bija CHMP visbūtiskākās bažas?
English: The Company has informed the CHMP that there are clinical trials currently running in Europe.
Latvian: Uzņēmums CHMP informēja, ka šobrīd Eiropā risinās klīniskie pētījumi.
English: A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
Latvian: Eksperimentālās lietošanas programma ir programma, kas ļauj ārstiem pieprasīt zāles specifiskai kāda pacienta slimības ārstēšanai, pirms šīs zāles ir pilnīgi apstiprinātas.
English: The letter from the Company notifying the EMEA of the withdrawal of Retaane is available here.
Latvian: Vēstule, kurā uzņēmums informē EMEA par Retaane atsaukšanu, ir pieejama šeit.
English: The CHMP had concerns that the effectiveness of Retaane was less than what they expected to see: Compared to placebo, Retaane has some effectiveness, but many patients were ‘lost' (exited the study) before the end of the study; and this affects the reliability of the results.
Latvian: CHMP bija aizdomas, ka Retaane efektivitāte ir mazāka par gaidīto: salīdzinot ar placebo, Retaane piemita zināms iedarbīgums, tomēr daudzi pacienti tika “pazaudēti” (izstājās no pētījuma) pirms pētījuma beigām; un tas mazina rezultātu uzticamību.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Latvian: Ja jūs piedalāties klīniskajā pētījumā vai eksperimentālas lietošanas programmā un vēlaties saņemt vairāk informācijas par terapiju, jautājiet ārstam, kas jums to nodrošina.
English: Retaane was expected to be used to stop or slow down the development of these new blood vessels (neovascularisation) in the eye.
Latvian: Retaane vajadzēja pārtraukt vai palēnināt šo jauno asinsvadu attīstību (neovaskularizāciju) acī.
English: The studies measured visual acuity (the results of an eye test) to see how the patients had responded to treatment.
Latvian: Pētījumos noteica redzes asumu (acu pārbaudes rezultāti), lai konstatētu, kā pacients ir reaģējis uz terapiju.
English: It is able to stop or slow down the development of new blood vessels by interfering with the production of the proteins needed to build the vessels, and of the growth factors needed for the blood vessels to spread.
Latvian: Tas spēj pārtraukt vai palēnināt jaunu asinsvadu rašanos, jo neļauj veidoties asinsvadu attīstībai nepieciešamajiem proteīniem, kā arī asinsvadu izplatībai nepieciešamajiem augšanas faktoriem.
English: Compared to photodynamic therapy, Retaane was not as effective.
Latvian: Salīdzinot ar fotodinamisko terapiju, Retaane ir mazāk efektīvs.
English: Retaane was to be injected every 6 months directly into the space behind the eye, as a ‘depot' injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly).
Latvian: Retaane bija paredzēts injicēt reizi 6 mēnešos tieši aiz acs kā “depo” injekciju (injicējamais medikaments ir sagatavots tā, lai organisms to absorbētu ļoti lēni).
English: The application was at Day 180 when the Company withdrew.
Latvian: Uzņēmums pieteikumu atsauca 180 dienas pēc tā iesniegšanas.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Latvian: Tādēļ atsaukšanas brīdī CHMP uzskatīja, ka zāļu efektivitāte nav pietiekami pierādīta, un tā neatsver identificētos apdraudējumus.
English: Anecortave, the active substance in Retaane, is similar in structure to cortisol, a natural hormone in the body.
Latvian: Anekortava, Retaane aktīvās vielas, struktūra ir līdzīga kortizola, ķermeņa dabiskā hormona, struktūrai.
English: This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Latvian: Šī slimība skar tīklenes centrālo daļu (tā saukto makulu) un izraisa redzes zudumu.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for RETAANE
Latvian: JAUTĀJUMI UN ATBILDES PAR RETAANE REĢISTRĀCIJAS APLIECĪBAS ATSAUKUMU
English: It contains 30 mg/ml of the active substance anecortave acetate.
Latvian: Tā satur 30 mg/ml aktīvās vielas anekortava acetāta.
English: The Company also plans to continue their compassionate use programme on a case-by-case basis.
Latvian: Turklāt uzņēmums plāno turpināt eksperimentālās lietošanas programmu, rūpīgi izvērtējot katru dalībnieku.
English: The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Latvian: Slimības mitro formu rada zem tīklenes un makulas esoši anormāli asinsvadi, kas var asiņot un izdalīt šķidrumu.
English: The effects of Retaane were first tested in experimental models before being studied in humans.
Latvian: Pirms pētījumiem ar cilvēkiem Retaane tika pārbaudīts eksperimentālos modeļos.
English: Retaane is a suspension for injection onto the outer part of the eye ball.
Latvian: Retaane ir suspensija injekcijām uz acs ābola ārējās virsmas.
English: The Company plans to continue the two clinical trials in wet AMD patients, as well as the clinical trial in dry AMD patients at risk of developing wet AMD.
Latvian: Uzņēmums ir iecerējis turpināt divus klīniskos pētījumus, kuros tiks apsekoti mitrās AMD pacienti, kā arī klīnisko pētījumu, kurā apsekos sausās AMD pacientus, kuriem var attīstīties mitrā AMD.
English: One compared Retaane at various strengths (3 mg, 15 mg or 30 mg) with a dummy treatment (placebo) in 128 patients.
Latvian: Vienā pētījumā, kurā piedalījās 128 pacienti, dažāda stipruma Retaane (3 mg, 15 mg vai 30 mg) salīdzināja ar indiferentas vielas terapiju (placebo).
English: Based on the review of the data submitted and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Retaane could not be approved for the treatment of subfoveal choroidal neovascularisation with classic component due to age-related macular degeneration.
Latvian: Izskatījusi saņemto informāciju un uzņēmuma atbildes uz CHMP saraksta jautājumiem, atsaukšanas brīdī komiteja bija neapmierināta un izteica pagaidu viedokli, ka nav iespējams Retaane apstiprināt tādu pacientu ārstēšanai, kuri cieš no makulas deģenerācijas radītas subfoveālas horoīdas neovaskularizācijas ar klasisku komponentu.