FrancophonIA/ELRC3.0 huggingface dataset:
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Latvian: Ja caureja samazinājusies līdz ≤1. pakāpei, 5-FU devu samazina par 1 devas līmeni.
English: In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
Latvian: RAISE pētījumā, palielinoties ramucirumaba kopējai iedarbībai, palielinājās ≥ 3. pakāpes neitropēnijas rašanās biežums.
English: Pack of 2 vials of 10 ml.
Latvian: - viens 10 ml flakons, - divi 10 ml flakoni, - viens 50 ml flakons.
English: One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
Latvian: Viens ml koncentrāta infūziju šķīduma pagatavošanai satur 10 mg ramucirumaba (ramucirumabum).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 50 ml vial
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMA
English: Do not freeze or shake the infusion solution.
Latvian: Šķīdumu infūzijāmnedrīkst sasaldēt vai sakratīt.
English: Palmar-plantar erthyrodysaesthesia syndromeg
Latvian: Plaukstu un pēdu eritrodizestēzijas sindromsg
English: An improvement in PFS was also associated with increasing ramucirumab exposure for advanced gastric cancer, NSCLC, and mCRC.
Latvian: Pacientiem ar progresējošu kuņģa vēzi, NSŠPV un mCRC arī PFS uzlabošanās bija saistīta ar palielinātu ramucirumaba kopējo iedarbību.
English: was 0 for 32% of patients, 1 for 67% of patients; 73% of patients had non-squamous histology and
Latvian: funkcionālais stāvoklis pēc ECOG 32 % pacientu bija 0 punkti, 67 % pacientu - 1 punkts, 73 %
English: If stomatitis/mucositis has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Latvian: Ja stomatīts/mukozīts samazinājies līdz ≤1. pakāpei, 5-FU devu samazina par 1 devas līmeni.
English: f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
Latvian: f Pamatojoties uz RAINBOW pētījuma (ramucirumabs kopā ar paklitakselu) un RAISE pētījuma
English: Pack of 1 vial of 10 ml.
Latvian: Iepakojumā viens 10 ml flakons.
English: during treatment with Cyramza or anytime thereafter: - Blocking of the arteries by a blood clot (‘arterial thromboembolic events'):
Latvian: - Artēriju nosprostojums ar trombu (‘arteriāls tromembolisks sarežģījums'):
English: 10.5 months in the Cyramza plus docetaxel arm and 9.1 months in the placebo plus docetaxel arm. PFS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.762; 95% CI: 0.677 to 0.859; p<0.001).
Latvian: Pacientiem Cyramza plus docetaksela grupā PFS bija statistiski nozīmīgi lielāka nekā pacientiem placebo plus docetaksela grupā (HR 0,762; 95 % TI: 0,677; 0,859; p<0,001).
English: If diarrhoea has recovered to Grade ≤1, reduce by 2 dose levels for 5-FU and irinotecan.
Latvian: Ja caureja samazinājusies līdz ≤1. pakāpei, 5-FU un irinotekāna devu samazina par 2 devas līmeņiem.
English: A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy (see section 5.1).
Latvian: Pacientiem, kas progresējuša NSŠPV ārstēšanai saņēma ramucirumaba un docetaksela kombināciju un kuru slimība pirms tam bija progresējusi pēc platīna līdzekli saturošas ķīmijterapijas, tika novērota nosliece uz mazāku efektivitāti, palielinoties vecumam (skatīt 5.1. apakšpunktu).
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 1 level for 5-FU and irinotecan.
Latvian: 5-FU un irinotekāna ievadīšanu atliek ne vairāk kā 28 dienas, līdz BP samazinājusies līdz ≤1. pakāpei, tad 5-FU un irinotekāna devu samazina par 1 devas līmeni.
English: Cyramza 10 mg/ml concentrate for solution for infusion
Latvian: ZĀĻU NOSAUKUMS Cyramza 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
English: This is equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Latvian: Šīs zāles satur aptuveni 85 mg nātrija katrā 50 ml flakonā, kas ir līdzvērtīgi aptuveni 4% no PVO ieteiktās maksimālās 2 g nātrija devas pieaugušajiem.
English: The HR of OS was 0.82 (95% CI: 0.67 to 1.0) in patients with a KRAS wild type tumour, and 0.89 (95% CI: 0.73 to 1.09) in patients with a KRAS mutant tumour.
Latvian: Pacientiem ar KRAS savvaļas tipa audzēju OS HR bija 0,82 (95 % TI: 0,67; 1,0), bet pacientiem ar KRAS
English: Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management.
Latvian: Smagas hipertensijas gadījumā ramucirumaba lietošana uz laiku jāpātrauc, līdz asinsspiediens tiek kontrolēts ar farmakoterapiju.
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for 5-FU and irinotecan.
Latvian: 5-FU un irinotekāna ievadīšanu atliek ne vairāk kā 28* dienas, līdz BP samazinājusies līdz ≤1. pakāpei, tad 5-FU un irinotekāna devu samazina par 2 devas līmeņiem.
English: FOLFIRI treatment over placebo plus FOLFIRI.
Latvian: grupā un placebo plus FOLFIRI grupā RAISE pētījumā
English: Epistaxis
Latvian: Izsitumia
English: Ramucirumab should be permanently discontinued in patients who experience a severe ATE (see section 4.2).
Latvian: Pacientiem, kam radušies smagi ATS, ramucirumaba lietošana jāpārtrauc pavisam (skatīt 4.2. apakšpunktu).
English: Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Latvian: Pacientiem, kam radusies 3. vai 4. pakāpes asiņošana, ramucirumaba lietošana jāpārtrauc pavisam (skatīt 4.2. apakšpunktu).
English: Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Latvian: Kuņģa-zarnu trakta asiņošanaa,f Kuņģa-zarnu trakta perforācijaa
English: Rate- percent (95% CI)
Latvian: ORR% (95% TI)
English: Cyramza):
Latvian: Ramucirumaba sākumdeva:
English: Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Latvian: Kopējās dzīvildzes Kaplan-Meier līknes Cyramza un paklitaksela kombinācijai, salīdzinot ar placebo un paklitaksela kombināciju RAINBOW pētījumā
English: Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Latvian: Dzīvildzes bez slimības progresēšanas Kaplan-Meier līknes Cyramza un paklitaksela kombinācijai, salīdzinot ar placebo un paklitaksela kombināciju RAINBOW pētījumā
English: b Based on study RAINBOW (ramucirumab plus paclitaxel).
Latvian: b Pamatojoties uz RAINBOW pētījuma datiem (ramucirumabs kopā ar paklitakselu).
English: Permanent discontinuation
Latvian: Pilnīga terapijas pārtraukšana
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan.
Latvian: Ja caureja samazinājusies līdz ≤1. pakāpei, 5-FU un irinotekāna devu samazina par 1 devas līmeni.
English: Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Latvian: Kopējās dzīvildzes Kaplan un Meier līknes Cyramza plus FOLFIRI grupā un placebo plus FOLFIRI grupā RAISE pētījumā
English: c Based on study RAINBOW (ramucirumab plus paclitaxel).
Latvian: c Pamatojoties uz RAINBOW pētījuma datiem (ramucirumabs kopā ar paklitakselu).
English: Common side effects (may affect up to 1 in 10 people): - fever accompanied by low white blood cell counts - low blood levels of a protein called albumin - infusion-related reactions - rash - redness, swelling, numbness/tingling, or pain and/or skin peeling in hands and/or feet (called hand-foot syndrome) - low blood levels of sodium (hyponatraemia) which can cause tiredness and confusion or muscle twitching - confusion and/or disorientation in patients with chronic liver problems - intestinal blockage; symptoms may include constipation and abdominal pain - abnormal growth of blood vessels - serious infection (sepsis) - low blood levels of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm
Latvian: Simptomi ir stipras sāpes vēderā, slikta dūša (vemšana), drudzis vai drebuļi; - smaga asiņošana kuņģa un zarnu traktā: simptomi var būt ārkārtīgs nogurums, vājums, reibonis vai Jūsu fēču krāsas izmaiņas; - trombi artērijās: arteriāli trombi var izraisīt miokarda infarktu vai insultu.
English: - develop a blood clot in your arteries - develop a hole in the wall of your gut - experience severe bleeding - experience a severe infusion-related reaction - develop high blood pressure that cannot be controlled with medicine - are passing more than a certain amount of protein with your urine or if you develop a severe kidney disease (nephrotic syndrome) - develop abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (fistula) - develop confusion and/or disorientation associated with chronic liver problems - decline in kidney function (in the setting of liver failure)
Latvian: - radīsies smaga asiņošana, - radīsies smaga ar infūziju saistīta reakcija, - radīsies paaugstināts asinsspiediens, kuru nebūs iespējams kontrolēt ar zāļu palīdzību, - olbaltumvielu daudzums urīnā pārsniegs noteiktu koncentrāciju vai radīsies smaga nieru slimība
English: Dose adjustments
Latvian: Paklitaksela devas pielāgošana
English: Table 5: Dose modification of FOLFIRI components due to specific ADRs
Latvian: FOLFIRI shēmas zāļu devas pielāgošana specifisku NBP gadījumā
English: Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Latvian: Ja medicīniski nozīmīgu hipertensiju nav iespējams kontrolēt ar antihipertensīvo līdzekļu terapiju, ramucirumaba lietošana jāpātrauc pavisam (skatīt 4.2. apakšpunktu).
English: Includes: anal haemorrhage, diarrhoea haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haematemesis, haematochezia, haemorrhoidal haemorrhage, Mallory-Weiss syndrome, melaena, oesophageal haemorrhage, rectal haemorrhage, and upper gastrointestinal haemorrhage.
Latvian: Ietver terminus "anāla asiņošana", "asiņaina caureja", "kuņģa asiņošana", "kuņģa-zarnu trakta asiņošana", "hematemēze", "hematohēzija", "hemoroīdu asiņošana",
English: NSCLC
Latvian: NBP
English: For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
Latvian: Atkārtotas 2. pakāpes caurejas gadījumā 5-FU un irinotekāna devu samazina par 1 devas līmeni.
English: Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
Latvian: Kopējās dzīvildzes Kaplan-Meier līknes Cyramza grupā , salīdzinot ar placebo REGARD pētījumā
English: A second dose reduction is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Latvian: Ja proteīnu līmenis urīnā atkārtoti sasniedz ≥ 2 g/24 stundās, ieteicama otrā devas samazināšana.
English: The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab.
Latvian: Lietojot vienlaikus ar ramucirumabu, docetaksela farmakokinētika nemainījās.
English: Efficacy, as measured by improvements in OS, was associated with increasing ramucirumab exposure range produced by 8 mg/kg ramucirumab given every 2 weeks and by 10 mg/kg ramucirumab given every 3 weeks.
Latvian: ramucirumabu ievadot pa 8 mg/kg ik pēc 2 nedēļām un pa 10 mg/kg ik pēc 3 nedēļām.
English: Severe gastrointestinal haemorrhage (see section 4.4) Arterial thromboembolic events (see section 4.4)
Latvian: Smagi arteriāli trombemboliski sarežģījumi (skatīt 4.4. apakšpunktu).
English: Name and address of the manufacturers responsible for batch release
Latvian: Īrija Ražotāja, kas atbild par sērijas izlaidi, nosaukums un adrese
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 ml vial
Latvian: FLAKONA ETIĶETE - 50 ml flakons
English: What Cyramza looks like and contents of the pack
Latvian: Cyramza ārējais izskats un iepakojums
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm. ORR was significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (22.9% vs. 13.6%, p<0.001).
Latvian: Pacientiem Cyramza plus docetaksela grupā ORR, bija nozīmīgi lielāka nekā pacientiem placebo plus docetaksela grupā (attiecīgi 22,9 % un 13,6 %, p<0,001).
English: EXPIRY DATE
Latvian: Ietver terminus
English: Intestinal obstructiona
Latvian: Stomatīts/mukozīts
English: Tel: + 43-(0) 1 711 780
Latvian: Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
English: The recommended dose of paclitaxel is 80 mg/m2 administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle.
Latvian: Ieteicamā paklitaksela deva ir 80 mg/m2, ko ar aptuveni 60 minūšu ilgu infūziju ievada
English: Cyramza contains sodium
Latvian: Cyramza satur nātriju
English: (aneurysms and artery dissections).
Latvian: (nefrotiskais sindroms),
English: Each 50 ml vial contains 500 mg of ramucirumab.
Latvian: Katrā 50 ml flakonā ir 500 mg ramucirumaba.
English: Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Latvian: REACH-2 pētījuma efektivitātes datu kopsavilkums - ārstēt paredzēto pacientu
English: It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Latvian: To lieto kopā ar citām zālēm, ko sauc par ‘FOLFIRI ķīmijterapiju'
English: you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Latvian: Tāpēc, Cyramza lietošanas laikā un vismaz 3 mēnešus pēc pēdējās devas ievadīšanas, Jūs nedrīkstat barot bērnu ar krūti.
English: Objective Response Rate (CR + PR)
Latvian: Riska attiecība (95 % TI) Stratificēta log-rangu p vērtība Objektīvas atbildreakcijas biežums (CR + PR)
English: - blood clots in the arteries:arterial blood clots can lead to a heart attack or stroke.
Latvian: - zems kālija līmenis asinīs (hipokaliēmija), kas var izraisīt muskuļu vājumu, raustīšanos vai patoloģisku sirdsdarbības ritmu.
English: Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy.
Latvian: Ramucirumaba lietošanas laikā ir jākontrolē, vai pacientiem nerodas vai nepastiprinās proteinūrija.
English: Odd ratio
Latvian: Perifēra tūska
English: Patients should be monitored during the infusion for signs of hypersensitivity.
Latvian: Infūzijas laikā jānovēro, vai pacientiem nerodas paaugstinātas jutības izpausmes.
English: Tel: + 353-(0) 1 661 4377
Latvian: Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377
English: Vascular disorders
Latvian: Aknu funkciju traucējumi
English: Tel: + 44-(0) 1256 315000
Latvian: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: There was an increase in median survival of 1.6 months in favour of the Cyramza plus FOLFIRI arm: 13.3 months in the Cyramza plus FOLFIRI arm and 11.7 months in the placebo plus FOLFIRI arm. Progression-free survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.793; 95% CI: 0.697 to 0.903; p=0.0005).
Latvian: Pacientiem Cyramza plus FOLFIRI grupā dzīvildze bez slimības progresēšanas bija statistiski nozīmīgi lielāka nekā pacientiem, kas saņēma placebo plus FOLFIRI (HR 0,793; 95 % TI: 0,697; 0,903; p=0,0005).
English: Ramucirumab should be permanently discontinued in the event of hepatic encephalopathy or hepatorenal syndrome (see section 4.2).
Latvian: Ja rodas aknu encefalopātija vai hepatorenālais sindroms, ramucirumaba lietošana pilnībā jāpārtrauc (skatīt 4.2. apakšpunktu).
English: Cyramza will be permanently stopped if you experience severe bleeding.
Latvian: Ja Jums radīsies smaga asiņošana, Cyramza lietošana Jums tiks pārtraukta pavisam.
English: Posology
Latvian: sastāvdaļaa
English: Lilly Deutschland GmbH
Latvian: Cochran-Mantel-Haenszel
English: • Check that you have the correct strength of capsules.
Latvian: • Pārbaudiet, vai Jums ir pareizais kapsulu stiprums.
English: The amount of food you use will depend on how many capsules you need to use every day:
Latvian: Lietojamais ēdiena daudzums ir atkarīgs no tā, cik daudz kapsulu Jums būs nepieciešams lietot katru dienu:
English: Bottle: 5 years.
Latvian: Pudelē: 5 gadi.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Latvian: Vienmēr lietojiet šīs zāles tieši tā, kā kā ārsts vai farmaceits Jums teicis.
English: Blister: 5 years.
Latvian: Blisteros: 5 gadi.
English: Before you start taking Mimpara, tell your doctor if you have or have ever had:
Latvian: Pirms Jūs sākat lietot Mimpara, informējiet ārstu, ja Jums ir vai jebkad ir bijuši:
English: Insufficient data are available.
Latvian: Nav pieejami pietiekami dati.
English: • if you start or stop smoking, as this may affect the way Mimpara works.
Latvian: • ja Jūs sākat vai pārtraucat smēķēšanu, jo tas var ietekmēt veidu, kā Mimpara darbojas.
English: The dose can be increased to achieve a desired target iPTH range.
Latvian: Devu var palielināt, lai sasniegtu vēlamo mērķa iPTH diapazonu.
English: Other medicines and Mimpara
Latvian: Citas zāles un Mimpara
English: • Over a clean work surface remove from the bottle the number of capsules your doctor or pharmacist told you to use.
Latvian: • Virs tīras darba virsmas izņemiet no pudeles tādu kapsulu skaitu, kādu ārsts vai farmaceits Jums licis lietot.
English: Your doctor will tell you how much Mimpara you must take.
Latvian: Ārsts Jums pateiks, cik daudz Mimpara Jums jālieto.
English: Not known: frequency cannot be estimated from available data
Latvian: Nav zināms: sastopamības biežumu nevar noteikt pēc pieejamiem datiem
English: What Mimpara is and what it is used for
Latvian: Kas ir Mimpara un kādam nolūkam to lieto
English: It is important that you take your dose of Mimpara as advised by your doctor.
Latvian: Ir svarīgi, lai Jūs lietotu Mimpara devu, kā ieteicis ārsts.
English: Seventeen patients received at least one dose of cinacalcet and 11 completed at least 12 weeks of treatment.
Latvian: Septiņpadsmit pacienti saņēma vismaz vienu cinakalceta devu un 11 pabeidza vismaz 12 nedēļu ārstēšanu.
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Latvian: Tās var būt pazīmes tam, ka Jūsu kalcija līmenis ir pārāk zems (hipokalciēmija);
English: Mimpara has not been tested in pregnant women.
Latvian: Mimpara nav pārbaudīta grūtniecēm.
English: Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Latvian: Ļoti bieži: var skart vairāk nekā 1 no 10 cilvēkiem • slikta dūša un vemšana; šīs blakusparādības parasti ir samērā vieglas un nav ilgstošas.
English: The dose should be adjusted based on iPTH as shown below:
Latvian: Deva jāpielāgo, pamatojoties uz iPTH, kā norādīts zemāk:
English: Reduction of hypercalcaemia in adult patients with:
Latvian: Hiperkalciēmijas mazināšana pieaugušiem pacientiem ar:
English: 84 tablets
Latvian: 84 tabletes
English: No change in starting dose is necessary.
Latvian: Izmaiņas sākuma devā nav nepieciešamas.
English: In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.
Latvian: Grūtniecības gadījumā ārsts var izlemt mainīt ārstēšanu, jo Mimpara var kaitēt vēl nedzimušajam bērnam.
English: Increases in plasma cinacalcet concentration are similar, regardless of the fat content of the meal.
Latvian: Cinakalceta koncentrācijas palielināšanās plazmā ir līdzīga, neatkarīgi no tauku satura ēdienā.
English: The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks.
Latvian: Deva jāpalielina secīgi, piemērojot pieejamos devu līmeņus (skatīt 1. tabulu) ne biežāk kā ik pēc 4 nedēļām.
English: Available sequential dose levels (mg)
Latvian: Pieejamie secīgie devu līmeņi (mg)
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Latvian: Saskaņā ar CHMP vadlīnijām attiecībā uz cilvēkiem paredzēto zāļu riska vadības sistēmām, atjaunināts RPP jāiesniedz vienlaicīgi ar nākamo periodiski atjaunojamo drošuma ziņojumu (PADZ).
English: Treatment should be reinitiated using the next lowest dose of Mimpara.
Latvian: Ārstēšana jāatsāk, lietojot nākamo mazāko Mimpara devu.
English: EU/1/04/292/001 - 30 mg carton with 14 tablets EU/1/04/292/002 - 30 mg carton with 28 tablets EU/1/04/292/003 - 30 mg carton with 84 tablets EU/1/04/292/004 - 30 mg bottle with 30 tablets EU/1/04/292/005 - 60 mg carton with 14 tablets EU/1/04/292/006 - 60 mg carton with 28 tablets EU/1/04/292/007 - 60 mg carton with 84 tablets EU/1/04/292/008 - 60 mg bottle with 30 tablets EU/1/04/292/009 - 90 mg carton with 14 tablets EU/1/04/292/010 - 90 mg carton with 28 tablets EU/1/04/292/011 - 90 mg carton with 84 tablets EU/1/04/292/012 - 90 mg bottle with 30 tablets
Latvian: EU/1/04/292/001 - 30 mg kastīte ar 14 tabletēm EU/1/04/292/002 - 30 mg kastīte ar 28 tabletēm EU/1/04/292/003 - 30 mg kastīte ar 84 tabletēm EU/1/04/292/004 - 30 mg pudele ar 30 tabletēm EU/1/04/292/005 - 60 mg kastīte ar 14 tabletēm EU/1/04/292/006 - 60 mg kastīte ar 28 tabletēm EU/1/04/292/007 - 60 mg kastīte ar 84 tabletēm EU/1/04/292/008 - 60 mg pudele ar 30 tabletēm EU/1/04/292/009 - 90 mg kastīte ar 14 tabletēm EU/1/04/292/010 - 90 mg kastīte ar 28 tabletēm EU/1/04/292/011 - 90 mg kastīte ar 84 tabletēm EU/1/04/292/012 - 90 mg pudele ar 30 tabletēm
English: This analysis showed no significant impact of age, sex, race, body surface area, and body weight on cinacalcet pharmacokinetics.
Latvian: Šī analīze neuzrādīja nozīmīgu vecuma, dzimuma, rases, ķermeņa virsmas laukuma un ķermeņa svara ietekmi uz cinakalceta farmakokinētiku.
English: The clinical relevance is unknown, however, the potential for cinacalcet to act on these secondary targets cannot be fully excluded.
Latvian: Klīniskā nozīme nav zināma, tomēr nevar pilnībā izslēgt cinakalceta potenciālu iedarboties uz šiem sekundārajiem mērķiem.
English: • Hold each capsule upright (with the coloured cap on top).
Latvian: • turiet katru kapsulu vertkāli (ar krāsainu vāciņu uz augšu).
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Latvian: Pēc rūpīgas ieguvuma/riska izvērtēšanas jāpieņem lēmums pārtraukt vai nu bērna barošanu ar krūti, vai ārstēšanu ar Mimpara.
English: Gender: Clearance of cinacalcet may be lower in women than in men.
Latvian: Dzimums: cinakalceta klīrenss sievietēm var būt mazāks nekā vīriešiem.
English: Do not initiate cinacalcet or increase the dose if non-compliance is suspected.
Latvian: Neuzsāciet ārstēšanu ar cinakalcetu un nepalieliniet devu, ja ir aizdomas par neatbilstību.
English: Cinacalcet did not show any genotoxic or carcinogenic potential.
Latvian: Cinakalcetam nekonstatēja genotoksicitātes vai kancerogenitātes potenciālu.
English: (Hypromellose, macrogol)
Latvian: (Hipromeloze, makrogols)
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Latvian: Aklara/PVH/PVAc/Alumīnija blisteris ar 14 tabletēm.
English: Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment.
Latvian: iPTH un Ca x P samazināšanās tika saglabāta līdz 12 mēnešiem ārstēšanas laika.
English: You must open the capsules and administer the entire content of granules.
Latvian: Jums jāattaisa kapsulas un jālieto viss granulu saturs.
English: 4.8 Undesirable effects a) Summary of the safety profile
Latvian: Nevēlamās blakusparādības a) Drošuma profila kopsavilkums
English: Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Latvian: Apmēram 97% cinakalceta piesaistās pie plazmas proteīniem un minimāli izkliedējas sarkanajās asins šūnās.