FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor, pharmacist or nurse if you notice any side effects.
Latvian: Pastāstiet savam ārstam,farmaceitam vai medmāsai, ja novērojat jebkādas augstākminētās blakusparādības.
English: Magyarország UCB Magyarország Kft. Tel.: +36-(1) 391 0060
Latvian: Tel.: +36-(1)391 0060
English: • feeling weak (fatigue)
Latvian: • vājuma sajūta (nogurums)
English: Description of selected adverse reactions
Latvian: Sagaidāmo blakusparādību reakciju apraksts
English: 7 transdermal patches of Leganto 8 mg/24 h
Latvian: 7 transdermālos plāksterus Leganto 8 mg/24 h
English: At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001).
Latvian: 6 mg/24 h. 20% uzlabošanās tika novērota 48% pacientu, kuri saņēma rotigotīnu, un 19% pacientu, kuri saņēma placebo (starpība 29%, CI95% 18%; 39%, p<0,0001).
English: Leganto 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 6 mg/24 h'.
Latvian: Leganto 6 mg/24 h transdermāls plāksteris Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 6 mg/24 h`.
English: What Leganto looks like and contents of the pack Leganto is a transdermal patch.
Latvian: Iepakojuma saturs un cita informācija Ko Leganto satur Aktīvā viela ir rotigotīns.
English: Leganto 8 mg/24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Latvian: Leganto 8 mg/24 h transdermāls plāksteris Katrs plāksteris 24 stundu laikā izdala 8 mg rotigotīna (rotigotine).
English: • abnormal heart beat
Latvian: • neregulāra sirdsdarbība
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)
Latvian: (ieskaitot eritēmu, niezi, kairinājumu, izsitumus, dermatītu, vezīkulas, sāpes, ekzēmu, iekaisumu, pietūkumu, krāsas izmaiņas, pāpulas, nobrāzumus, nātreni, paaugstinātu jutību)
English: Leganto 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 4 mg/24 h'.
Latvian: Leganto 4 mg/24 h transdermāls plāksteris Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 4 mg/24 h`.
English: • 8 mg/24 h: Each patch releases 8 mg of rotigotine per 24 hours.
Latvian: • 8 mg/24 h Katrs plāksteris 24 stundu laikā izdala 8 mg rotigotīna.
English: • 6 mg/24 h: Each patch releases 6 mg of rotigotine per 24 hours.
Latvian: • 6 mg/24 h: Katrs plāksteris 24 stundu laikā izdala 6 mg rotigotīna.
English: • delusion
Latvian: • apjukums
English: 7 transdermal patches of Leganto 6 mg/24 h
Latvian: 7 transdermālos plāksterus Leganto 6 mg/24 h
English: Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below.
Latvian: Pastāstiet ārstam, ja Jūs novērojat jebkādas zemāk norādītās izmaiņas uzvedībā, domāšanā vai abos.
English: Dopamine dysregulation syndrome c, perception disturbances e
Latvian: Dopamīna disregulācijas sindroms c,
English: Leganto 1 mg/24 h transdermal patch Leganto 3 mg/24 h transdermal patch
Latvian: Leganto 1 mg/24 h transdermāls plāksteris Leganto 3 mg/24 h transdermāls plāksteris
English: BOX OF 7 PATCHES - WEEK 1
Latvian: 7 transdermālie plāksteri 1. nedēļa
English: • weight increase
Latvian: • ķermeņa masas pieaugums
English: 7 transdermal patches of Leganto 4 mg/24 h
Latvian: 7 transdermālos plāksterus Leganto 4 mg/24 h
English: pruritus generalised e, skin irritation e,
Latvian: ģeneralizēta nieze e, ādas kairinājums e,
English: Restless Legs Syndrome
Latvian: Nemierīgo Kāju Sindroms
English: • 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Latvian: • 4 mg/24 h: Katrs plāksteris 24 stundu laikā izdala 4 mg rotigotīna.
English: Talk to your doctor or pharmacist if you notice any of the side effects listed above.
Latvian: Sazinieties ar savu ārstu vai farmaceitu, ja Jūs novērojat jebkuru no augstākminētajām blakusparādībām.
English: • redness, increased sweating
Latvian: • apsārtums, pastiprināta svīšana
English: The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks.
Latvian: Deva tika titrēta līdz optimālajai rotigotīna devai, veicot iknedēļas devas palielinājumu par 2 mg/24 h, sākot ar devu 2 mg/24 h līdz maksimālai devai 8 mg/24 h 4 nedēļu laikā.
English: dizziness postural e, lethargy e, convulsion e
Latvian: Nav zināmi posturāls reibonis e, letarģija e,
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Latvian: Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h vai 8 mg/24 h`.
English: Leganto 8 mg/24 h transdermal patch EU/1/11/695/046
Latvian: Leganto 8 mg/24 h transdermāls plāksteris EU/1/11/695/046
English: BOX OF 7 PATCHES - WEEK 3
Latvian: 7 transdermālie plāksteri 3. nedēļa
English: For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.
Latvian: Dažiem pacientiem efektīvā deva var būt 4 mg/24 h vai 6 mg/24 h. Lielākajai daļai pacientu efektīvā deva tiek sasniegta 3 līdz 7 nedēļu laikā, izmantojot devas no 8 mg/24 h, kas nepārsniedz maksimālo devu - 16 mg/24 h.
English: Each patch releases 1 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 h laikā izdala 1 mg rotigotīna.
English: Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment.
Latvian: Pacientiem ar viegliem līdz vidēji smagiem aknu darbības traucējumiem nav nepieciešama devas pielāgošana.
English: BOX OF 7 PATCHES - WEEK 2
Latvian: 7 transdermālie plāksteri 2. nedēļa
English: Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed above.
Latvian: Pastāstiet ārstam, ja Jūs novērojat jebkādas augstākminētās izmaiņas uzvedībā, domāšanā vai abos.
English: Name and address of the manufacturer responsible for batch release
Latvian: A. RAŽOTĀJS(-I), KAS ATBILD PAR SĒRIJAS IZLAIDI Ražotāja, kas atbild par sērijas izlaidi, nosaukums un adrese UCB Pharma S.A.
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Latvian: Ja attīstās šādi simptomi, jāapsver devas samazināšana vai pakāpeniska zāļu lietošanas pārtraukšana.
English: The outside is tan-coloured and is imprinted with Leganto 4 mg/24 h Leganto 6 mg/24 h or Leganto 8 mg/24 h.
Latvian: Ārējā puse ir dzeltenbrūnā krāsā ar uzdrukātu Leganto 2 mg/24 h, Leganto 4 mg/24 h Leganto 6 mg/24 h vai Leganto 8 mg/24 h.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation,
Latvian: (ieskaitot eritēmu, niezi, kairinājumu, izsitumus, dermatītu, vezīkulas, sāpes, ekzēmu, iekaisumu,
English: Leganto 6 mg/24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Latvian: Leganto 6 mg/24 h transdermāls plāksteris Katrs plāksteris 24 stundu laikā izdala 6 mg rotigotīna (rotigotine).
English: • Each patch releases 2 mg of rotigotine per 24 hours.
Latvian: • Katrs plāksteris 24 stundu laikā izdala 2 mg rotigotīna.
English: BOX OF 7 PATCHES - WEEK 4
Latvian: 7 transdermālie plāksteri 4. nedēļa
English: Each patch releases 8 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 stundu laikā izdala 8 mg rotigotīna (rotigotine).
English: Each patch releases 6 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 stundu laikā izdala 6 mg rotigotīna (rotigotine).
English: Peripheral oedema has been observed in clinical trials conducted in patients with RLS.
Latvian: Klīniskajos pētījumos pacientiem ar NKS tika novērota perifērā tūska.
English: Leganto 1 mg/24 h transdermal patch EU/1/11/695/001
Latvian: Leganto 1 mg/24 h transdermāls plāksteris EU/1/11/695/001
English: • headache
Latvian: • maldi
English: Leganto 3 mg/24 h transdermal patch Each patch releases 3 mg of rotigotine per 24 hours.
Latvian: Leganto 3 mg/24 h transdermāls plāksteris Katrs plāksteris 24 stundu laikā izdala 3 mg rotigotīna (rotigotine).
English: • Press the patch down firmly with the palm of your hand.
Latvian: • Stingri piespiediet plāksteri ar plaukstu .
English: Leganto 3 mg/24 h transdermal patch
Latvian: Leganto 3 mg/24 h transdermāls plāksteris
English: EU/1/11/695/046 [7 transdermal patches] EU/1/11/695/048 [28 transdermal patches] EU/1/11/695/049 [30 transdermal patches]
Latvian: EU/1/11/695/046 [7 transdermālie plāksteri] EU/1/11/695/048 [28 transdermālie plāksteri] EU/1/11/695/049 [30 transdermālie plāksteri]
English: • vomiting, heartburn
Latvian: • vemšana, dedzināšana pakrūtē
English: Leganto 6 mg/24 h transdermal patch EU/1/11/695/037
Latvian: Leganto 6 mg/24 h transdermāls plāksteris EU/1/11/695/037
English: Leganto 4 mg/24 h transdermal patch Leganto 6 mg/24 h transdermal patch Leganto 8 mg/24 h transdermal patch
Latvian: Leganto 4 mg/24 h transdermāls plāksteris Leganto 6 mg/24 h transdermāls plāksteris Leganto 8 mg/24 h transdermāls plāksteris
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 1 mg/24 h'.
Latvian: Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 1 mg/24 h`.
English: Leganto 1 mg/24 h transdermal patch
Latvian: Leganto 1 mg/24 h transdermāls plāksteris
English: EU/1/11/695/007 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/007 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: photopsia e
Latvian: krampji e
English: Each patch releases 4 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 stundu laikā izdala 4 mg rotigotīna (rotigotine).
English: The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h.
Latvian: Ārējā puse ir dzeltenbrūnā krāsā ar uzdrukātu Leganto 2 mg/24 h.
English: EU/1/11/695/019 [7 transdermal patches] EU/1/11/695/021 [28 transdermal patches] EU/1/11/695/022 [30 transdermal patches]
Latvian: EU/1/11/695/019 [7 transdermālie plāksteri] EU/1/11/695/021 [28 transdermālie plāksteri] EU/1/11/695/022 [30 transdermālie plāksteri]
English: EU/1/11/695/037 [7 transdermal patches] EU/1/11/695/039 [28 transdermal patches] EU/1/11/695/040 [30 transdermal patches]
Latvian: EU/1/11/695/037 [7 transdermālie plāksteri] EU/1/11/695/039 [28 transdermālie plāksteri] EU/1/11/695/040 [30 transdermālie plāksteri]
English: • Your starting daily dose will be one 4 mg/24 h patch each day.
Latvian: • Jūsu sākotnējā deva būs viens 4 mg/24 h plāksteris dienā.
English: Leganto 8 mg/24 h transdermal patch rotigotine
Latvian: Leganto 8 mg/24 h transdermāls plāksteris Rotigotine
English: Leganto is available in different strength patches which release the medicine over 24 hours.The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Latvian: 1 mg/24 h, 2 mg/24 h un 3 mg/24 h stiprumi ir paredzēti nemierīgo kāju sindroma ārstēšanai.
English: EU/1/11/695/001 [7 transdermal patches] EU/1/11/695/003 [28 transdermal patches] EU/1/11/695/004 [30 transdermal patches]
Latvian: EU/1/11/695/001 [7 transdermālie plāksteri] EU/1/11/695/003 [28 transdermālie plāksteri] EU/1/11/695/004 [30 transdermālie plāksteri]
English: Leganto 3 mg/24 h transdermal patch EU/1/11/695/019
Latvian: Leganto 3 mg/24 h transdermāls plāksteris EU/1/11/695/019
English: atrial fibrillation e, supraventricular tachycardia e
Latvian: supraventrikul āra tahikardija e
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 3 mg/24 h'.
Latvian: Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 3 mg/24 h`.
English: • Your starting daily dose will be one 2 mg/24 h patch each day.
Latvian: • Jūsu sākotnējā deva būs viens 2 mg/24 h plāksteris dienā.
English: Leganto 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Latvian: KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS Leganto 1 mg/24 h transdermāls plāksteris Katrs plāksteris 24 stundu laikā izdala 1 mg rotigotīna (rotigotine).
English: EU/1/11/695/028 [7 transdermal patches] EU/1/11/695/030 [28 transdermal patches] EU/1/11/695/031 [30 transdermal patches]
Latvian: EU/1/11/695/028 [7 transdermālie plāksteri] EU/1/11/695/030 [28 transdermālie plāksteri] EU/1/11/695/031 [30 transdermālie plāksteri]
English: EU/1/11/695/010 [7 transdermal patches] EU/1/11/695/012 [28 transdermal patches] EU/1/11/695/013 [30 transdermal patches]
Latvian: EU/1/11/695/010 [7 transdermālie plāksteri] EU/1/11/695/012 [28 transdermālie plāksteri] EU/1/11/695/013 [30 transdermālie plāksteri]
English: Leganto 4 mg/24 h transdermal patch EU/1/11/695/028
Latvian: Leganto 4 mg/24 h transdermāls plāksteris EU/1/11/695/028
English: Leganto 1 mg/24 h transdermal patch rotigotine
Latvian: Leganto 1 mg/24 h transdermāls plāksteris rotigotine
English: EU/1/11/695/016 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/016 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h'.
Latvian: Ārējais slānis ir dzeltenbrūnā krāsā ar uzdrukātu `Leganto 2 mg/24 h`.
English: This makes the S-shaped break in the liner open up.
Latvian: Tas veido S - veida iegriezumu pārklājumā.
English: • nightmares
Latvian: • nakts murgi
English: • Thigh or hip.
Latvian: • Augšstilbs vai gūža.
English: {MM/YYYY}
Latvian: (II.
English: Pruritus
Latvian: Žagas
English: Do not breast-feed during treatment with Leganto.This is because rotigotine may pass into your breast milk and affect your baby.
Latvian: Tas ir āpēct, ka rotigotīns var nokļūt mātes pienā un ietekmēt bērnu.
English: • feeling sick (nausea)
Latvian: • nelabuma sajūta (slikta dūša)
English: • Bend the patch in half.
Latvian: • Pārlokiet plāksteri uz pusēm.
English: Leganto 6 mg/24 h transdermal patch rotigotine
Latvian: Leganto 6 mg/24 h transdermāls plāksteris rotigotine
English: EU/1/11/695/043 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/043 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: Irritability, oedema peripheral swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditions a
Latvian: Nav zināmi pietūkumu, krāsas izmaiņas, pāpulas, nobrāzumus, nātreni, paaugstinātu jutību), astēniski stāvokļi a
English: Leganto 4 mg/24 h transdermal patch rotigotine
Latvian: Leganto 4 mg/24 h transdermāls plāksteris rotigotine
English: EU/1/11/695/025 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/025 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: Leganto 3 mg/24 h transdermal patch rotigotine
Latvian: Leganto 3 mg/24 h transdermāls plāksteris rotigotine
English: SACHET LABEL - WEEK 1
Latvian: MINIMĀLĀ INFORMĀCIJA IZVIETOJAMĀ UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMĀ PACIŅAS MARĶĒJUMS - 1. NEDĒĻA
English: Each patch releases 3 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 stundu laikā izdala 3 mg rotigotīna.
English: Leganto 2 mg/24 h transdermal patch rotigotine
Latvian: Leganto 2 mg/24 h transdermāls plāksteris rotigotine
English: EU/1/11/695/052 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/052 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: • Your starting dose will be one 1 mg/24 h patch each day.
Latvian: • Jūsu sākotnējā deva būs viens Leganto 1 mg/24 h plāksteris katru dienu.
English: EU/1/11/695/034 [84 transdermal patches (3 packs of 28)]
Latvian: EU/1/11/695/034 [84 transdermālie plāksteri (3 kastītes pa 28)]
English: Each patch releases 2 mg of rotigotine per 24 hours.
Latvian: Katrs plāksteris 24 h laikā izdala 2 mg rotigotīna.
English: UCB Pharma S.A. Tel: +34-91 570 34 44
Latvian: UCB Pharma România S.R.L. Tel: +40-21 300 29 04
English: Week 3
Latvian: + III.
English: photopsiae
Latvian: • caureja
English: The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson's disease.
Latvian: Ir pieejami šādi stiprumi Parkinosona slimības ārstēšani: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h un 8 mg/24 h.
English: Leganto is available in the following pack-sizes:
Latvian: Ir pieejami šādi Leganto iepakojumi:
English: • confusion
Latvian: • aizkaitināmība
English: hallucination, hallucination visual, hallucination auditory, illusion), nightmare e,
Latvian: (ieskaitot halucinācijas, redzes halucinācijas, dzirdes halucinācijas, ilūzijas), nakts murgi e, paranoja e, apjukums e, psihotiski traucējumi e,
English: • From the second week, your daily dose may be increased by 1 mg each week until you get to the right maintenance dose for you.
Latvian: • No otrās nedēļas Jūsu dienas devu var palielināt par 1 mg katru nedēļu, līdz tiks sasniegta Jums nepieciešamā uzturošā deva, kad Jūs un ārsts piekrītat, ka simptomi tiek attiecīgi pietiekami kontrolēti un zāļu izraisītās blakusparādības ir pieņemamas.
English: UCB Pharma S.A. Tél: +33-(0)1 47 29 44 35
Latvian: Tél: +33-(0)1 47 29 44 35
English: Leganto 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Latvian: KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS Leganto 4 mg/24 h transdermāls plāksteris Katrs plāksteris 24 stundu laikā izdala 4 mg rotigotīna (rotigotine).
English: DATE OF REVISION OF THE TEXT
Latvian: 10. TEKSTA PĀRSKATĪŠANAS DATUMS {MM/GGGG}
English: System/organ classes acc. to MedDRA
Latvian: MedDRA orgānu sistēmu klasifikācijas
English: dry mouth e, abdominal pain e, diarrhoea c
Latvian: sausa mute e, sāpes vēderā e,
English: Hepatic enzyme increased (incl.
Latvian: Vidējā UPDRS summas uzlabošanās (II.
English: This summary was last updated in 08-2007.©EMEA 2007
Latvian: Šis kopsavilkums pēdējo reizi tika atjaunots 08-2007.©EMEA 2007
English: As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 28 July 2006.
Latvian: Tā kā uzņēmums iesniedza prasīto papildu informāciju, „izņēmuma” statuss beidzās 2006. gada 28. jūlijā.
English: Hypersensitivity (allergic reactions) has sometimes been seen.
Latvian: Dažreiz novēro paaugstinātu jutību (alerģiskas reakcijas).
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Latvian: Tajā ir paskaidrots, kā Cilvēkiem paredzēto zāļu komiteja (CHMP) novērtēja veiktos pētījumus, pirms sniegt ieteikumus par šo zāļu lietošanu.
English: The medicine can only be obtained with a prescription.
Latvian: Šīs zāles var iegādāties tikai pret ārsta recepti.
English: The marketing authorisation was renewed on 16 July
Latvian: Reģistrācijas apliecību atjaunināja 2006. gada 16. jūlijā.
English: Additionally, any improvement in skin lesions was monitored.
Latvian: Papildus novēroja jebkādu ādas bojājumu mazināšanos.
English: The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Latvian: Eiropas Komisija 2001. gada 16. jūlijā izsniedza CEPROTIN reģistrācijas apliecību, kas ir derīga visā Eiropas Savienībā, uzņēmumam Baxter AG.
English: CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Latvian: CEPROTIN ievada ar intravenozu injekciju (injicējot vēnā) ar maksimālo injicēšanas ātrumu 2 ml minūtē, izņemot bērniem ar ķermeņa svaru, kas mazāks par 10 kg, kad injicēšanas ātrums nedrīkst pārsniegt 0,2 ml uz kilogramu ķermeņa svara minūtē.
English: CEPROTIN was originally authorised under 'Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
Latvian: CEPROTIN sākotnēji reģistrēja “izņēmuma kārtā”, jo tobrīd sakarā ar mazo pacientu skaitu, kam diagnosticēta šī slimība, nebija iespējams iegūt pietiekamu informāciju par šīm zālēm.
English: It contains the active substance human protein C.
Latvian: Tas satur aktīvo vielu cilvēka C proteīnu.
English: The Committee recommended that CEPROTIN be given marketing authorisation.
Latvian: Komiteja ieteica izsniegt CEPROTIN reģistrācijas apliecību.
English: CEPROTINCEPROTINOther information about CEPROTIN:
Latvian: Cita informācija par CEPROTIN:
English: CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Latvian: Ārstēšanu ar CEPROTIN drīkst uzsākt tikai ārsts, kam ir pieredze šāda veida ārstēšanā un kad ir iespējams izmērīt C proteīna aktivitāti.
English: When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.
Latvian: Kad pacienti sāk saņemt citus antikoagulantus, piemēram, varfarīnu, ir jābūt sevišķi uzmanīgiem, un ārstēšana ar CEPROTIN jāturpina, līdz tiek noregulēta ārstēšana ar varfarīnu.
English: The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation.
Latvian: Pētījumā vērtēja galvenokārt C proteīna līmeņa normalizēšanos un citus koagulācijas (recēšanas) aktivēšanas rādītājus.
English: Why has CEPROTIN been approved?
Latvian: Kāpēc CEPROTIN tika apstiprināts?
English: The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.
Latvian: Rezultāti cita veida recēšanas traucējumu, kā arī pacientu ar cita veida C proteīna deficītu ārstēšanā nebija pietiekami, lai pilnībā novērtētu CEPROTIN lietošanu šīm pacientu grupām.
English: The full EPAR for CEPROTIN is available here.
Latvian: Pilns CEPROTIN EPAR teksts ir atrodams šeit.
English: CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
Latvian: CEPROTIN ir pulveris un šķīdinātājs, ko sajauc, lai pagatavotu šķīdumu injekcijai.
English: CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Latvian: CEPROTIN pētījumā kopā bija iesaistīti 79 pacienti, no kuriem 22 bija diagnozētas smagākas C proteīna deficīta formas.
English: Protein C slows down the production of thrombin, and therefore slows down further clotting.
Latvian: C proteīns palēnina trombīna veidošanos, tādā veidā palēninot turpmāku recekļu veidošanos.
English: In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
Latvian: Pacientiem ar smagu iedzimtu C proteīna deficītu CEPROTIN deva uzlabojumu visos 16 purpura fulminans gadījumos un visās sešās kumarīna izraisītajās ādas nekrozes epizodēs.
English: CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
Latvian: CEPROTIN nedrīkst lietot cilvēki, kam var būt paaugstināta jutība (alerģija) pret cilvēka C proteīnu, peļu proteīnu vai heparīnu, izņemot gadījumus, kad jānovērš dzīvību apdraudošas komplikācijas.
English: CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
Latvian: CEPROTIN lieto pacientiem ar smagu iedzimtu (ģenētisku) C proteīna trūkumu, lai ārstētu purpura fulminans (plašu asins recekļu veidošanos asinsvados, kas izraisa audu atmiršanu zem ādas un bieži noved pie orgānu darbības traucējumiem un amputācijas) un kumarīna izraisītu ādas nekrozi (komplikācijas, kas rodas, ārstējot ar antikoagulantiem, piemēram, varfarīnu, un izraisa ādas atmiršanu).