FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir/ritonavir 300/100 mg QD 400/100 mg QD
Latvian: Atazanavīrs/ritonavīrs 300/100 mg dienā
English: Data reported in the literature from 20 HIV-infected patients suggest a steady state Cmax of 5.74 μg/ml (5.00-7.44) and Cmin of 3.73 μg/ml (3.20-5.08) with an AUC of 109.0 h*μg/ml (96.0-143.5) in patients taking 200 mg of nevirapine bid.
Latvian: Cmax ir 5,74 mikrogrami/ml (5,00-7,44) un Cmin ir 3,73 mikrogrami/ml (3,20-5,08) ar AUC
English: In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Latvian: 200 mg vienreizējas nevirapīna devas farmakokinētiskajā pētījumā, HIV-negatīviem pacientiem ar vieglu līdz vidēji smagu aknu bojājumu (Child-Pugh A, n=6, Child-Pugh B, n=4), vienam no Child
English: The risk of hepatic reactions is greatest in the first 6 weeks of therapy.
Latvian: Vislielākais aknu blakusparādību risks vērojams pirmo 6 terapijas nedēļu laikā.
English: Furthermore, combining the following compounds with Nevirapine Teva is not recommended: efavirenz, ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), atazanavir (in combination with ritonavir), boceprevir; fosamprenavir (if not co-administered with low dose ritonavir) (see section 4.5).
Latvian: ketokonazols, delavirdīns, etravirīns, rilpivirīns, elvitegravīrs (kombinācijā ar kobicistatu), atazanavīrs
English: Severe and life-threatening hepatotoxicity, including fatal fulminant hepatitis, has occurred in patients treated with nevirapine.
Latvian: Pacientiem, ko ārstēja ar nevirapīnu, novērota arī smaga un dzīvībai bīstama hepatotoksicitāte, ieskaitot fatālu zibensveida hepatītu.
English: compared with historical data where nevirapine was administered alone.
Latvian: Nevirapīns: ietekme: ↑100%, salīdzinot ar iepriekš veikto pārbaužu datiem, kad nevirapīns tika lietots viens pats.
English: Cmax ↑ 1.29 (0.98-1.68)
Latvian: Rifabutīna Cmax ↑ 1,28 (1,09
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Latvian: FARMACEITISKĀ INFORMĀCIJA 6.1. Palīgvielu saraksts Mikrokristāliskā celuloze Laktoze (monohidrāta veidā)
English: (women more than 250 cells/mm³, men more than 400 cells/mm³) - pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of nevirapine therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
Latvian: - iepriekš ārstēti pacienti ar nosakāmu HIV-1 plazmas vīrusu koncentrāciju un lielāku CD4 šūnu skaitu nevirapīna terapijas sākumā (sievietām vairāk nekā 250 šūnu/mm3, vīriešiem vairāk nekā 400 šūnu/mm3).
English: What Nevirapine Teva is and what it is used for What you need to know before you take Nevirapine Teva How to take Nevirapine Teva Possible side effects
Latvian: Kā lietot Nevirapine Teva Iespējamās blakusparādības Kā uzglabāt Nevirapine Teva
English: Dose:
Latvian: Retāk:
English: Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.92 (0.85-0.99)
Latvian: Flukonazola Cmin ↔ 0,93 Flukonazola Cmax ↔ 0,92
English: Results of in vitro studies showed a weak antagonism of nevirapine by adefovir (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Latvian: 5.1. apakšpunktu), tas nav apstiprinājies klīniskajos pētījumos un samazināta efektivitāte nav sagaidāma.
English: What Nevirapine Teva looks like and contents of the pack
Latvian: Nevirapine Teva ārējais izskats un iepakojums
English: Herbal preparations containing St. John‘s Wort and Nevirapine Teva must not be co-administered (see section 4.3).
Latvian: Augu preparātus, kas satur asinszāli, nedrīkst lietot vienlaikus ar Nevirapine Teva (skatīt 4.3 apakšpunktu).
English: (0.2 %), angioedema, urticaria
Latvian: - dzeltena āda (dzelte), - sāpes vēderā
English: Amprenavir AUC ↔ 0.89 (0.77
Latvian: Amprenavīra AUC ↔ 0,89
English: Norethindrone (NET) 1.0 mg QD
Latvian: Noretindrons (NET)
English: Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79-1.21)
Latvian: Didanozīna AUC ↔ 1,08 Didanozīna Cmin NN Didanozīna Cmax ↔ 0,98
English: Rare hepatitis fulminant (which may be fatal)
Latvian: Retāk dzelte Reti zibensveida hepatīts (kas var būt letāls) Ādas un zemādas audu bojājumi
English: Stavudine Cmin ND Stavudine Cmax ↔ 0.94 (0.86-1.03)
Latvian: Stavudīna AUC ↔ 0,96 Stavudīna Cmin NN Stavudīna Cmax ↔ 0,94
English: As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm3 with detectable HIV-1 RNA in plasma (50 or more copies/ml),
Latvian: Sakarā ar biežāk novēroto hepatotoksicitāti sievietēm ar CD4 šūnu skaitu virs 250 šūnām/mm3 un nosakāmām HIV-1 RNS plazmā (50 vai vairāk kopiju/ml), šis iemesls jāņem vērā apsverot terapijas nepieciešamību (skatīt 4.4. apakšpunktu).
English: Nevirapine Cmax ↑ 1.20
Latvian: Nevirapīna Cmax ↑ 1,25
English: Methadone-maintained patients beginning Nevirapine Teva therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
Latvian: Pacienti, kas regulāri lieto metadonu, uzsākot ārstēšanu ar Nevirapine Teva, jānovēro, vai nerodas abstinences simptomi,
English: Maraviroc AUC ↔ 1.01 (0.6 -1.55)
Latvian: Maraviroka AUC ↔ 1,01
English: It is not recommended to coadminister boceprevir and Nevirapine Teva (see section 4.4).
Latvian: Boceprevīru un Nevirapine Teva nav ieteicams lietot vienlaicīgi (skatīt 4.4. apakšpunktu).
English: Nevirapine has been evaluated in both treatment-naïve and treatment-experienced patients.
Latvian: Nevirapīns ir ticis pētīts, gan ārstējot ar to pirmo reizi, gan atkārtoti.
English: Nevirapine Teva may be taken with or without food.
Latvian: Nevirapine Teva var lietot gan ēšanas laikā, gan neatkarīgi no ēdienreizēm.
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Latvian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Abnormal liver functioning has been reported with the use of Nevirapine Teva.
Latvian: Ir ziņots, ka, lietojot Nevirapine Teva, konstatētas aknu funkcijas izmaiņas.
English: BN
Latvian: PI
English: Skin and subcutaneous tissue disorders
Latvian: Bieži galvassāpes Kuņģa-zarnu trakta traucējumi
English: Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Latvian: Sakvinavīru/ritonavīru vienlaikus ar Nevirapine Teva var lietot bez devas pielāgošanas.
English: Maraviroc and Nevirapine Teva can be co-administered without dose adjustments.
Latvian: Maraviroku un Nevirapine Teva var lietot vienlaikus bez devas pielāgošanas.
English: It is very important that you take only one Nevirapine Teva tablet a day for the first 14 days (”lead-in” period) If you have any rash during this period, do not increase the dose but consult your doctor.
Latvian: Ir ļoti svarīgi pirmajās 14 dienās (,,ievadterapijas” periodā) lietot tikai vienu Nevirapine Teva tableti dienā.
English: Amprenavir Cmin ↓ 0.81 (0.69-0.96) Amprenavir Cmax ↔ 0.97 (0.85-1.10)
Latvian: Amprenavīra Cmin ↓ 0,81 Amprenavīra Cmax ↔ 0,97
English: Results of in vitro studies showed a weak antagonism of nevirapine by ribavirin (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Latvian: In vitro pētījumu rezultāti liecina par vāju nevirapīna un ribavirīna antagonismu (skatīt
English: If co-administered with Nevirapine Teva, an adjustment in the telaprevir dose should be considered.
Latvian: Nevirapine Teva, jāapsver tā devas pielāgošana.
English: Rifabutin and Nevirapine Teva can be coadministered without dose adjustments.
Latvian: Rifabutīnu un Nevirapine Teva var lietot vienlaikus bez devas pielāgošanas.
English: Nevirapine co-administration did not alter the ovulation suppression effects of DMPA.
Latvian: Vienlaicīga nevirapīna lietošana neietekmē DMPA ovulāciju nomācošo darbību.
English: You must take the dose of Nevirapine Teva as prescribed by your doctor.
Latvian: Jums jālieto ārsta nozīmētā Nevirapine Teva deva.
English: Ketoconazole Cmax ↓ 0.56 (0.42
Latvian: Ketokonazola Cmin NN Ketokonazola Cmax ↓ 0,56
English: Ketoconazole Cmin ND
Latvian: Metadona Cmin NN
English: Dose adjustment of Nevirapine Teva is not required when co-administered with lopinavir.
Latvian: Ir maz klīnisku datu par Nevirapine Teva devas pielāgošanu, lietojot vienlaikus ar rifampicīnu.
English: Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Latvian: inhibitors nozīmīgi inhibē aknu enzīmus, tāpat kā citus metabolisma ceļus.
English: Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49-1.04)
Latvian: Zidovudīna Cmax ↓ 0,70
English: Rifabutin AUC ↑ 1.17 (0.98-1.40)
Latvian: Rifabutīna AUC ↑ 1,17
English: Telbivudine and Nevirapine Teva may be co-administered without dose adjustments.
Latvian: Telbivudīnu un Nevirapine Teva drīkst lietot vienlaikus bez devas pielāgošanas.
English: Interferons and Nevirapine Teva may be co-administered without dose adjustments.
Latvian: Interferonus un Nevirapine Teva drīkst lietot vienlaikus bez devas pielāgošanas.
English: Gastrointestinal disorders Common nausea, vomiting, abdominal pain, diarrhoea Hepatobiliary disorders Common hepatitis (including severe and life-threatening hepatotoxicity) (1.9%) Uncommon jaundice
Latvian: Bieži hepatīts (arī smaga un dzīvību apdraudoša hepatotoksicitāte) (1,9%)
English: Nevirapine concentrations in human cerebrospinal fluid
Latvian: Antitrombotiski līdzekļi Varfarīns
English: Teva Pharmaceuticals IrelandL-Irlanda Tel: +353 51 321740
Latvian: Τel: +353 51 321740
English: Nevirapine Cmin ↑ 1.34 (1.21-1.49) Nevirapine Cmax ↑ 1.25 (1.14-1.37)
Latvian: Nevirapīna AUC ↑ 1,29 Nevirapīna Cmin ↑ 1,34
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel: +372 6610801
Latvian: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
English: Serum levels of nevirapine can be reduced by concomitant use of the herbal preparation St. John's Wort (Hypericum perforatum).
Latvian: Nevirapīna koncentrācija serumā var samazināties, to lietojot vienlaikus ar augu preparātiem, kas satur asinszāli
English: Nevirapine: exposure: ↑100%
Latvian: Nevirapīns: salīdzinot ar
English: Lopinavir Cmin ↓ 0.45 (0.25-0.82) Lopinavir Cmax ↓ 0.86 (0.64-1.16)
Latvian: Lopinavīra Cmin ↓ 0,45 Lopinavīra Cmax ↓ 0,86
English: It is not recommended to coadminister efavirenz and Nevirapine Teva (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1).
Latvian: Nevirapine Teva lietošana nav ieteicama (skatīt 4.4. apakšpunktu) papildus toksicitātes dēļ.
English: Darunavir Cmin ↔ 1.02 (0.79-1.32) Darunavir Cmax ↑ 1.40 (1.14-1.73)
Latvian: Darunavīra AUC ↑ 1,24 Darunavīra Cmin ↔ 1,02 Darunavīra Cmax ↑ 1,40
English: Raltegravir and Nevirapine Teva can be co-administered without dose adjustments.
Latvian: Raltegravīru un Nevirapine Teva var lietot vienlaikus bez devas pielāgošanas.
English: It is not recommended to coadminister fosamprenavir and Nevirapine Teva if fosamprenavir is not co-administered with ritonavir (see section 4.4).
Latvian: Atazanavīra/ritonavīra kombinācija ar Nevirapine Teva nav ieteicama (skatīt 4.4. apakšpunktu).
English: Enfuvirtide and Nevirapine Teva can be co-administered without dose adjustments.
Latvian: Entekavīru un Nevirapine Teva drīkst lietot vienlaikus bez devas pielāgošanas.
English: You may experience fatigue when taking Nevirapine Teva.
Latvian: Transportlīdzekļu vadīšana un mehānismu apkalpošana Jūs varat justies noguris lietojot nevirapīnu.
English: If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as - fever, - blistering, - mouth sores, - inflammation of the eye, - swelling of the face, - general swelling, - shortness of breath, - muscle or joint pain, - general feelings of illness, - or abdominal pain
Latvian: - sejas tūska, - vispārēja tūska, - elpas trūkums, - muskuļu vai locītavu sāpes, - vispārēja slimības sajūta - vai sāpes vēderā
English: Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Latvian: Maraviroka Cmin NN Maraviroka Cmax ↔ 1,54
English: Clarithromycin Cmin ↓ 0.44 (0.30Clarithromycin Cmax ↓ 0.77 (0.69
Latvian: Lopinavīra AUC ↓ 0,73 Lopinavīra Cmin ↓ 0,54
English: ANTITHROMBOTICS
Latvian: Ketokonazols
English: Lopinavir Cmin ↓ 0.54 (0.28-0.74) Lopinavir Cmax ↓ 0.81 (0.62-0.95)
Latvian: Atazanavīrs/r 400/100 mg: Atazanavīra/r AUC ↓ 0,81 Atazanavīra/r Cmin ↓ 0,41 Atazanavīra/r Cmax ↔1,02 (salīdzinot ar 300/100 mg bez nevirapīna)
English: Adefovir and Nevirapine Teva may be co-administered without dose adjustments.
Latvian: Adefovīru un Nevirapine Teva drīkst lietot vienlaikus bez devas pielāgošanas.
English: Efavirenz AUC ↓ 0.72 (0.66-0.86)
Latvian: Efavirenza AUC ↓ 0,72
English: If you experience symptoms suggesting a damage of the liver, such as - loss of appetite, - feeling sick (nausea), - vomiting, - yellow skin (jaundice), - abdominal pain you should discontinue taking Nevirapine Teva and must contact your doctor immediately.
Latvian: Ja Jums parādās aknu bojājuma pazīmes, tādas kā - apetītes trūkums, - slikta dūša,
English: Atazanavir/r AUC ↓ 0.81 (0.65-1.02)
Latvian: Atazanavīrs/r 300/100 mg: Atazanavīra/r AUC ↓ 0,58
English: Nevirapine: plasma levels: ↑ 1.15
Latvian: Nevirapīns: līmenis plazmā: ↑1,15-1,28, salīdzinot ar iepriekš veikto pārbaužu rezultātiem.
English: Telaprevir is metabolised in the liver by CYP3A and is a P-glycoprotein substrate.
Latvian: CYP3A un tas ir P
English: Cimetidine and Nevirapine Teva can be co-administered without dose adjustments.
Latvian: Cimetidīnu un Nevirapine Teva var lietot vienlaikus bez devas pielāgošanas.
English: Blood and lymphatic system disorders Common granulocytopenia Uncommon anaemia
Latvian: Bieži granulocitopēnija Retāk anēmija
English: Ritonavir and Nevirapine Teva can be co-administered without dose adjustments.
Latvian: Ribavirīnu un Nevirapine Teva drīkst lietot vienlaikus bez devas pielāgošanas.
English: Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
Latvian: Nātrija cietes glikolāts (A tipa)
English: Clarithromycin 500 mg BID
Latvian: Klaritromicīns 500 mg 2 reizes dienā
English: Zidovudine AUC ↓ 0.72 (0.60-0.96)
Latvian: Zidovudīna AUC ↓ 0,72
English: Package leaflet: Information for the patient Nevirapine Teva 200 mg tablets nevirapine
Latvian: Literatūras dati par 20 HIV inficētiem pacientiem liecina, ka pacientiem lietojot 200 mg nevirapīna divreiz dienā, stabila stāvokļa
English: It is important that you continue taking Nevirapine Teva correctly, as described above, unless your doctor instructs you to stop.
Latvian: Ja vien Jūsu ārsts nav ieteicis lietošanu pārtraukt, ir svarīgi turpināt Nevirapine Teva lietot pareizi, kā aprakstīts iepriekš.
English: It may be harmful to the teeth.
Latvian: Tas var kaitēt zobiem.
English: Can't be sold separately.
Latvian: Nav nopērkams atsevišķi.
English: Blood levels of radiolabelled iron were very low and confined to the erythrocytes.
Latvian: Radioaktīvi iezīmētās dzelzs līmenis asinīs bija ļoti zems un aprobežojās tikai ar eritrocītiem.
English: Subjects were continued on their study medication from week 12 to week 55.
Latvian: Pacienti turpināja lietot pētījuma zāles no 12. līdz 55. nedēļai.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 August 2014
Latvian: PIRMĀS REĢISTRĀCIJAS/PĀRREĢISTRĀCIJAS DATUMS Pirmās reģistrācijas datums: 2014. gada 26. augusts Pēdējās pārreģistrācijas datums:
English: This is thought to be most likely an adaptive response to the pharmacological effect of the drug, and not clinically relevant.
Latvian: Tiek uzskatīts, ka tā visticamāk ir adaptīva atbildes reakcija uz zāļu farmakoloģisko iedarbību un nav klīniski nozīmīga.
English: From week 12 to 24, dose titrations were allowed for both tolerability and efficacy reasons.
Latvian: No 12. līdz 24. nedēļai tika atļauta devas titrēšana gan panesamības, gan efektivitātes nolūkā.
English: Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Latvian: D vitamīna un 1,25­dihidroksi­D vitamīna līmenis nemainījās.
English: After first opening of the bottle the chewable tablets can be used for 90 days.
Latvian: Pēc pirmās pudeles atvēršanas košļājamās tabletes var lietot 90 dienas.
English: - Take the tablet during a meal and chew it (if necessary, the tablet may be crushed to make this easier for you).
Latvian: - Lietojiet tableti ēdienreizes laikā un sakošļājiet to (ja nepieciešams, tableti var sasmalcināt, lai atvieglotu tās norīšanu).
English: Drug-drug interaction studies have only been performed in healthy volunteers.
Latvian: Zāļu savstarpējās mijiedarbības pētījumi ir veikti tikai veseliem brīvprātīgajiem.
English: It is unlikely that this medicine would pass into the mother's milk.
Latvian: Maz ticams, ka šīs zāles varētu nonākt mātes pienā.
English: These compounds can be absorbed in the blood.
Latvian: Šie savienojumi var uzsūkties asinīs.
English: This study was an open-label, randomised, activecontrolled (sevelamer carbonate), parallel group study for up to 55 weeks.
Latvian: Šis pētījums bija atklāts, randomizēts, aktīvi kontrolēts (ar sevelamēra karbonātu), paralēlu grupu pētījums, kas ilga līdz pat 55 nedēļām.
English: Patients are not required to drink more fluid than they normally would.
Latvian: Pacientiem nav jālieto vairāk šķidruma kā parasti.
English: Tablets must be chewed and not swallowed whole; tablets may be crushed.
Latvian: Tabletes jāsakošļā, tās nedrīkst norīt veselas; tabletes var arī sasmalcināt.
English: See further information in section 4.4.
Latvian: Sīkāku informāciju skatiet 4.4. apakšpunktā.
English: The serum phosphorus reduction was maintained over 55 weeks.
Latvian: Fosfora līmeņa pazemināšanās serumā tika saglabāta 55 nedēļas.
English: The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet been established.
Latvian: Velphoro drošums un efektivitāte, lietojot bērniem un pusaudžiem vecumā līdz 18 gadiem, nav pierādīta.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Latvian: Ziņošanas biežums ir klasificēts kā ļoti bieži (≥1/10), bieži (≥1/100 līdz <1/10), retāk (≥1/1 000 līdz
English: In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose dependent effects were observed in healthy volunteers.
Latvian: Divos 1. fāzes pētījumos secināja, ka pārmērīgas dzelzs uzkrāšanās iespēja ir minimāla, un veseliem brīvprātīgajiem nenovēroja ar devu saistītu ietekmi.
English: Do not stop taking the medicine before talking to your doctor or pharmacist as the phosphorus level in your blood may increase (see section 1).
Latvian: Nepārtrauciet zāļu lietošanu, iepriekš nekonsultējoties ar ārstu vai farmaceitu, jo Jūsu asinīs var palielināties fosfora līmenis (skatīt 1. punktu).
English: If you have accidentally taken too many tablets, do not take any more and talk to your doctor or pharmacist immediately.
Latvian: Ja nejauši esat lietojis pārāk daudz tablešu, nelietojiet tās vēl vairāk un nekavējoties sazinieties ar ārstu vai farmaceitu.
English: What Velphoro is and what it is used for
Latvian: Kas ir Velphoro un kādam nolūkam to lieto
English: There is no information on the effects of this medicine if taken during pregnancy or breastfeeding.
Latvian: Nav informācijas par šo zāļu iedarbību, ja tās lieto grūtniecības un barošanas ar krūti laikā.
English: Other medicines and Velphoro
Latvian: Citas zāles un Velphoro
English: Non-inferiority to sevelamer carbonate was determined at week 12.
Latvian: Sevelamēra karbonāta līdzvērtība tika konstatēta 12. nedēļā.
English: Other reproduction toxicity studies showed no adverse effects.
Latvian: Citos reproduktīvās toksicitātes pētījumos netika konstatēta nevēlama iedarbība.
English: Patients receiving Velphoro should adhere to their prescribed diets.
Latvian: Pacientiem, kuri saņem Velphoro, jāievēro viņiem nozīmētā diēta.
English: Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 and over, while 8.7% were aged 75 and over.
Latvian: Velphoro klīniskajos pētījumos no kopējā pacientu skaita 29,7% pacientu bija 65 gadus veci un vecāki, bet 8,7% pacientu bija 75 gadus veci un vecāki.
English: Since absorption of iron from Velphoro is minimal (see section 5.2), excretion of iron from Velphoro in breast milk is unlikely.
Latvian: Tā kā Velphoro sastāvā esošās dzelzs uzsūkšanās ir ierobežota (skatīt 5.2. apakšpunktu), maz ticams, ka dzelzs no Velphoro nokļūst mātes pienā.
English: Velphoro may be harmful to the teeth.
Latvian: Velphoro var kaitēt zobiem.
English: The absolute absorption studies in humans were not performed.
Latvian: Absolūtie absorbcijas pētījumi ar cilvēkiem nav veikti.
English: MARKETING AUTHORISATION NUMBER(S)
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(­I)
English: The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Velphoro treatment of up to 55 weeks.
Latvian: Velphoro pašreizējais drošuma profils pamatojas uz pavisam 778 hemodialīzes pacientu un 57 peritoneālās dialīzes pacientu datiem, kuri tika ārstēti ar Velphoro līdz 55 nedēļām.
English: Clinical studies have demonstrated that the systemic absorption of iron from Velphoro is low.
Latvian: Klīniskie pētījumi liecina, ka dzelzs sistēmiskā uzsūkšanās no Velphoro ir zema.
English: What Velphoro is and what it is used for What you need to know before you take Velphoro How to take Velphoro
Latvian: Kas ir Velphoro un kādam nolūkam to lieto Kas Jums jāzina pirms Velphoro lietošanas Kā lietot Velphoro
English: • Haemochromatosis and any other iron accumulation disorders.
Latvian: • Hemohromatoze un citi dzelzs uzkrāšanās traucējumi.
English: Diarrhoea occurred in 11.6% of patients in clinical trials.
Latvian: Klīniskajos pētījumos caureja radās 11,6% pacientu.
English: In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.
Latvian: Pētījumos, kas ilga 55 nedēļas, vairums blakusparādību caurejas formā bija pārejošas, tās radās terapijas sākumposmā un prasīja terapijas pārtraukšanu 3,1% pacientu.
English: Maximum tolerated daily dose
Latvian: Maksimālā pieļaujamā dienas deva
English: If you also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 2 “Warnings”).
Latvian: Ja Jums ir arī tādi simptomi kā pastiprināts nogurums un elpas trūkums, nekavējoties sazinieties ar ārstu (skatīt 2. punktu Brīdinājumi).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia (see section 4.2 for information on paediatric use).
Latvian: Eiropas Zāļu aģentūra atliek pienākumu iesniegt pētījumu rezultātus Velphoro vienā vai vairākās pediatriskās populācijas apakšgrupās hiperfosfatēmijas ārstēšanai (informāciju par lietošanu bērniem skatīt 4.2. apakšpunktā).
English: EU/1/14/943/002 90 chewable tablets
Latvian: EU/1/14/943/002 90 košļājamās tabletes
English: If you have black stools and also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 4).
Latvian: Ja Jums ir melni izkārnījumi un arī tādi simptomi kā pastiprināts nogurums un elpas trūkums, nekavējoties sazinieties ar ārstu (skatīt 4. punktu).
English: Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.
Latvian: Jebkuri Velphoro pārdozēšanas gadījumi (piemēram, hipofosfatēmija) jāārstē saskaņā ar standarta klīnisko praksi.
English: This can result in stiffening of the blood vessels, making it harder for the blood to be pumped around the body.
Latvian: Tas var ietekmēt asinsvadu elastīgumu, apgrūtinot asins plūsmas cirkulāciju visā ķermenī.