FrancophonIA/ELRC3.0 huggingface dataset:
English: Use in paediatric patients aged 6 to 18 years with renal impairment Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Latvian: Pediatrijas pacienti vecum no 6 l dz 18 gadiem ar nieru darb bas trauc jumiem Z u lietošana pediatrijas pacientiem ar kreatin na kl rensu <30 ml/min un pediatrijas pacientiem, kuriem tiek veikta dial ze, nav p t ta, t d šiem pacientiem nav ieteicams lietot valsart nu.
English: EU/EEA Marketing Authorisation Holder
Latvian: Dalbvalsts ES/EEZ Reistrcijas apliecbas pašnieks Pieširtais nosaukums
English: This metabolite is pharmacologically inactive.
Latvian: Šis metabol ts ir farmakolo iski neakt vs.
English: • angioedema (see section “Some symptoms need immediate medical attention”)
Latvian: • angioneirotisk t ska (skat t noda u “Par doties dažiem simptomiem, nepieciešama t l t ja medic niska pal dz ba”)
English: Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.
Latvian: Turiet pudeli vertik li ar augšda u uz augšu un stingri iespiediet š irci peror lai ievad šanai plastmasas adapter .
English: What you will be using
Latvian: Kas Jums b s j izmanto
English: Excipients:
Latvian: Izvad šana:
English: This is a disease in which your adrenal glands make too much of the hormone aldosterone.
Latvian: T ir slim ba, kad virsnieru dziedzeris izdala p r k daudz hormonu aldosteronu.
English: Netherlands
Latvian: Nderlande
English: • The solution is supplied in a pack containing one 180 ml amber glass bottle with a childresistant screw cap and a yellow tamper evident ring.
Latvian: • Š dums iekš gai lietošanai pieejams iepakojumos, kas satur 180 ml dzintara kr sas stikla pudeli ar baltu b rnam neatveramu polipropil na v ci u un dzeltenu droš bas gredzenu.
English: The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age.
Latvian: Valsartna antihipertensv iedarbba p tta divos nejaušintos, dubultmask tos p tjumos, kuros piedaljs 561 pediatrijas pacienti vecum no 6 ldz 18 gadiem.
English: In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Latvian: Hipertensijas pieaugušiem pacientiem veiktos kontrol tos kl niskos p t jumos kop jais nev lamo blakuspar d bu (ADR) biežums bija sal dzin ms ar placebo un atbilstošs valsart na farmakolo ijai.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Latvian: T pat k visiem vazodilatatoriem, paša piesardz ba j iev ro pacientiem ar aortas vai mitr l v rstu a stenozi vai hipertrofisku obstrukt vu kardiomiop tiju (HOCM).
English: • Keep out of the reach and sight of children.
Latvian: • Uzglab t b rniem nepieejam un neredzam viet .
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Latvian: AIIRA lietošana gr tniec bas 2. un 3. trimestra laik ir kontrindic ta (skat t apakšpunktus 4.3 un 4.4).
English: It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Latvian: Tas darbojas selekt vi uz AT1 receptoru apakštipu, kas ir atbild gs par zin mo angiotenz na II darb bu.
English: • The active substance is valsartan.
Latvian: • Akt v viela ir valsart ns.
English: • Always screw the cap back on after use.
Latvian: • Atk rtojiet to katru reizi p c š irces peror lai lietošanas izmantošanas.
English: Diovan oral solution contains poloxamer (188) which may cause softened stools.
Latvian: Diovan š dums iekš gai lietošanai satur poloksam ru (188), kas var izrais t m kstu v dera izeju.
English: As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Latvian: T pat k pieaugušiem pacientiem, Diovan kontrindic ts pediatrijas pacientiem ar smagiem aknu darb bas trauc jumiem, bili ro cirozi un pacientiem, kuriem nov ro holest zi (skat t apakšpunktus 4.3 un 5.2).
English: Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Latvian: Diovan nav ieteicams lietot z d šanas laik un, ja v laties z d t b rnu, rsts var izv l ties citu rst šanu, paši ja b rns ir tikko piedzimis vai dzimis priekšlaic gi.
English: If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
Latvian: Ja J s izj tat smagu reiboni un/vai boni, inform jiet savu rstu un apgulieties, cik tri vien iesp jams.
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Latvian: Pacientiem, kuri sa ma zemas valsart na devas, sistoliskais asinsspiediens, k jau bija paredzams, bija l dz gs k pacientiem, kuri sa ma rst šanu ar placebo.
English: Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
Latvian: Kl nisk pieredze b rniem vecum no 6 gadiem un vec kiem Kl niskaj p t jum , kur piedal j s 261 pediatrijas pacienti vecum no 6 l dz 18 gadiem ar hipertensiju, pacienti ar erme a masu <35 kg sa ma 10, 40 vai 80 mg valsart na tabletes dien (zemas, vid jas un augstas devas), un pacienti ar erme a masu 35 kg sa ma 20, 80, un 160 mg valsart na tabletes dien (zemas, vid jas un augstas devas).
English: Citric acid, anhydrous Sodium citrate
Latvian: Bez dens citronsk be N trija citr ts
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
Latvian: • asins hemoglob na l me a un sarkano asins ermen šu daudzuma samazin šan s (kas smagos gad jumos var izrais t an miju)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Latvian: 11. RE ISTR CIJAS APLIEC BAS PAŠNIEKA NOSAUKUMS UN ADRESE [Skat t Pielikumu I - aizpilda nacion li]
English: Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects.
Latvian: Vienm r lietojiet Diovan tieši t , k rsts Jums st st jis, lai pan ktu lab kus rezult tus un samazin tu blakuspar d bu risku.
English: Methyl parahydroxybenzoate (E218) Potassium sorbate
Latvian: Metilparahidroksibenzo ts (E218) K lija sorb ts
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Latvian: Pediatrijas pacientiem ar kreatin na kl rensu >30 ml/min devas korekcija nav nepieciešama (skat t apakšpunktu 4.2 un 5.2).
English: For example, if the prescribed dose is 13 ml, it will be necessary to measure out the solution in three separate stages: 5 ml + 5 ml + 3 ml.
Latvian: Piem ram, ja parakst t deva ir 13 ml, š dumu n ksies nom r t tr s atseviš os posmos: 5 ml + 5 ml + 3 ml.
English: For children who are unable to swallow tablets, the use of the Diovan oral solution up to 80 mg valsartan (corresponding to 27 ml) is recommended.
Latvian: B rniem, kuriem nav iesp jams lietot tabletes, ieteicams ordin t Diovan š duma iekš gai lietošanai dev s l dz 80 mg (atbilst 27 ml).
English: Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Latvian: T k nav pieejama inform cija par valsart na lietošanu z d šanas laik , nav ieteicama Diovan lietošana un ieteicams izmatot alternat vu rst šanu ar z l m, kuru droš ba ir pier d ta z d šanas laik , paši barojot jaundzimušo vai priekšlaic gi dzimušo b rnu.
English: • fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
Latvian: • drudzis, iekaisis kakls vai las mutes dobum infekciju d (balto asins ermen šu daudzuma samazin šan s simptomi, t.s. neitrop nija)
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Latvian: Ne-kl niskajos droš bas p t jumos lielas valsart na devas (200 l dz 600 mg/kg erme a masas) žurk m izrais ja sarkano asins ermen šu r d t ju (eritroc tu, hemoglob na, hematokr ta) samazin šanos un nieru hemodinamikas izmai as (nedaudz palielin tu plazmas ur nvielas koncentr ciju un nieru ur nvadu hiperpl ziju un bazof liju t vi iem).
English: Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Latvian: R p gi j kontrol nieru funkcijas un k lija l menis serum (skat t apakšpunktu 4.4 un 5.2).
English: Diovan and associated names 3 mg/ml oral solution Valsartan
Latvian: Diovan un citi nosaukumi 3 mg/ml š dums iekš gai lietošanai Valsartanum
English: Impaired renal function
Latvian: Pav jin ta nieru funkcija
English: • 1 ml oral solution contains 3 mg of valsartan.
Latvian: • 1 ml š duma iekš gai lietošanai satur 3 mg valsart na.
English: There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Latvian: Kl nisk pieredze par Diovan lietošanu pediatrijas grupas pacientiem ar viegliem l dz vid ji smagiem aknu darb bas trauc jumiem ir ierobežota.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Latvian: Diagnostic jot gr tniec bu, nepieciešams nekav joties p rtraukt rst šanu ar AIIRA un nepieciešam bas gad jum uzs kt alternat vu rst šanu (skat t apakšpunktus 4.3 un 4.6).
English: If any of these apply to you, tell your doctor before you take Diovan.
Latvian: Jau kaut kas no min tajiem faktiem attiecas uz Jums, past stiet to rstam pirms Diovan lietošanas.
English: CLINICAL PARTICULARS
Latvian: Specifiskas pacientu grupas
English: Myalgia
Latvian: Mialija
English: Valsartan is unlikely to be removed by haemodialysis.
Latvian: Maz ticams, ka valsart nu var tu izvad t ar hemodial zi.
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Latvian: Devas piel gošana nav nepieciešama pacientiem ar kreatin na kl rensu >10 ml/min (skat t apakšpunktus 4.2 un 5.2).
English: Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
Latvian: slaic ga Diovan ordin šana 12 pacientiem ar vienpus ju nieru art rijas stenozi un sekund ru renovaskul ru hipertensiju neizrais ja noz m gas nieru hemodinamikas, seruma kreatin na vai asins ur nvielas sl pek a (BUN) l me a izmai as.
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Latvian: Citi st vok i ar ren na-angiotenz na sist mas stimul ciju Pacientiem, kuriem nieru funkcija var b t atkar ga no RAAS aktivit tes (t.i., pacientiem ar smagu sastr guma sirds mazsp ju), rst šana ar AKE inhibitoriem ir saist ta ar olig riju un/vai progres jošu azot miju un retos gad jumos ar ak tu nieru mazsp ju un/vai n vi.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diovan solution.
Latvian: Ja rsts ir teicis, ka Jums ir kda cukura nepanesba, pirms lietojat Diovan š dumu iekš gai lietošanai, konsult jieties ar rstu.
English: The bottle contains 160 ml of solution.
Latvian: Pudele satur 160 ml š duma iekš gai lietošanai.
English: As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Latvian: T k valsart ns ir angiotenz na II antagonists, nevar izsl gt, ka Diovan lietošana var b t saist ta ar nieru darb bas trauc jumiem.
English: Portugal
Latvian: Portugle
English: The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Latvian: Pieteikuma iesniedz js s ks zin tnisku dialogu ar CHMP zin tnisk s konsultat v s padomes starpniec bu, iesaistot PDCO protokola izstr d ar m r i g t ieskatu hipertensijas kl niskaj p t jum jaun kiem ar valsart nu rst tiem b rniem un lai defin tu m r us un pl nojuma parametrus, p tot efektivit ti šaj pacientu grup .
English: Clinical experience in children less than 6 years of age Two clinical studies were conducted in patients aged 1 to 6 years with 90 and 75 patients, respectively.
Latvian: Veikti divi kl niskie p t jumi ar pacientiem vecum no 1 l dz 6 gadiem, kuros piedal j s attiec gi 90 un 75 pacienti.
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Latvian: Pediatrijas pacientiem ar kreatin na kl rensu >30 ml/min devas korekcija nav nepieciešama.
English: The Risk Management Plan should include the following: o In the safety specification: results of juvenile safety studies regarding the risk of nephrotoxicity and its relevance for the use in the different paediatric groups paediatric exposure in clinical trials and in post marketing use by age group, indication (including off label use), dose, duration of use, gender and ethnicity o As safety concerns: Identified risks: hyperkalemia and hypotension.
Latvian: Riskvad bas pl n j iek auj š da inform cija: o attiec b uz droš bas specifik cij m: juvenilo droš bas p t jumu rezult ti par nefrotoksicit tes risku un to noz mi, lietojot daž d m b rnu grup m; par lietošanu b rniem kl niskajos p t jumos un par lietošanu p cre istr cijas period atbilstoši vecuma grupai, indik cijai (ar neapstiprin tajai lietošanai), devai, lietošanas ilgumam, dzimumam un etniskai pieder bai.
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Latvian: Hipertensijas pacientiem ar 2. tipa diab tu un mikroalbum n riju valsart nam tika pier d ta album na izdal šan s ur n . MARVAL (mikroalbum n rijas samazin šan s, izmantojot valsart nu) p t jum tika nov rt ta album na izdal šan s ar ur nu (UAE), izmantojot valsart nu (80-160 mg/vienu reizi dien ) sal dzinot ar amlodip nu (5-10 mg/vienu reizi dien ), 332 otr tipa diab ta pacientiem (vid jais vecums: 58 gadi; 265 v rieši) ar mikroalbum n riju (valsart ns: 58 µg/min; amlodip ns: 55,4 µg/min), norm lu vai augstu asinsspiedienu un saglab tu nieru funkciju (asins kreatin ns <120 µmol/l).
English: • lithium, a medicine used to treat some types of psychiatric illness.
Latvian: • Litiju, z l m ko lieto noteiktu psihisku slim bu rst šanai.
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Latvian: P t jum , kur piedal j s 26 pacienti (vecum no 1 l dz 16 gadiem) ar hipertensiju un kuri sa ma vienu valsart na suspensijas devu (vid ji: 0,9 l dz 2 mg/kg, ar maksim lo devu 80 mg), valsart na kl renss (litri/h/kg) bija l dz gs vis s vecuma grup s no 1 l dz 16 gadiem un bija sal dzin ms ar datiem no pieaugušo pacientu grupas, kur pacienti sa ma t du pašu z u formu.
English: Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Latvian: P c pudeles pirmreiz jas atv ršanas to dr kst uzglab t 3 m nešus temperat r l dz 30°C.
English: Novartis Pharma S.A.S.
Latvian: Novartis Pharma S.A.
English: Treatment of hypertension in children and adolescents 6 to 18 years of age.
Latvian: Hipertensijas rst šana b rniem un pusaudžiem vecum no 6 l dz 18 gadiem.
English: The signs may include rash, itching, hives.
Latvian: Simptomi var b t izsitumi, nieze, n trene.
English: Renal function and serum potassium should be closely monitored (see sections 4.2 and 4.4).
Latvian: R p gi j kontrol nieru funkcijas un k lija l menis serum (skat t apakšpunktu 4.2 un 4.4).
English: POSSIBLE SIDE EFFECTS Like all medicines, Diovan can cause side effects, although not everybody gets them.
Latvian: T pat k citas z les, Diovan var izrais t blakuspar d bas, kaut ar ne visiem t s izpaužas.
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
Latvian: Nav pieredzes par drošu lietošanu pacientiem ar kreatin na kl rensu <10 ml/min un pacientiem, kuri p rcietuši dial zi, t d j di valsart nu šiem pacientiem nepieciešams lietot piesardz gi.
English: • You must tell your doctor if you think that you are (or might become) pregnant.
Latvian: • Jums j past sta savam rstam, ja esat (vai var tu b t) gr tniece.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 3 mg of valsartan.
Latvian: KVALITAT VAIS UN KVANTITAT VAIS SAST VS Viens ml š duma iekš gai lietošanai satur 3 mg valsart na (Valsartanum).
English: Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Latvian: Z u lietošana pediatrijas pacientiem ar kreatin na kl rensu <30 ml/min un pediatrijas pacientiem, kuriem tiek veikta dial ze, nav p t ta, t d šiem pacientiem nav ieteicams lietot valsart nu.
English: This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Latvian: Tom r š AUC samazin šan s nav saist ta ar kl niski noz m gu terapeitisk efekta samazin šanos, t p c valsart nu var lietot gan tukš d š , gan ar šanas laik .
English: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Latvian: Iz emot atsevišus gadjumus, kad nov roja ku a-zarnu trauc jumus (piem ram, s pes v der , slikta d ša, vemšana) un reiboni, nekonstat ja b tiskas atš ir bas starp droš bas profiliem pediatrijas pacientiem vecum no 6 l dz 18 gadiem un pieaugušiem pacientiem p c nev lamo blakuspar d bu tipa, biežuma un smaguma.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Latvian: 10. TEKSTA PDJ S P RSKAT ŠANAS DATUMS [Aizpilda nacion li]
English: At 24 weeks, UAE was reduced (p<0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Latvian: 24 ned s, UAE (album na izdal šan s ar ur nu) samazin j s (p<0,001) par 42% (-24,2 µg/min; 95% CI: -40,4 l dz -19,1), izmantojot valsart nu un apm ram par 3% (-1,7 µg/min; 95% CI: -5,6 l dz 14,9), izmantojot amlodip nu, lai gan asinsspiediena samazin šan s bija l dz ga ab s grup s. Diovan prote n rijas samazin šanas p t jum (DROP) tika veikti turpm ki valsart na efektivit tes p t jumi UAE samazin šan 391 hipertens viem pacientiem (asinsspiediens=150/88 mmHg) ar otr tipa diab tu, album n riju (vid ji=102 µg/min; 20-700 µg/min) un saglab tu nieru funkciju (vid jais seruma kreatin ns = 80 µmol/l).
English: In some cases your doctor may ask you to take up to 80 mg of valsartan (corresponding to 27 ml of the solution).
Latvian: Atseviš os gad jumos rsts var likt Jums lietot pat l dz 80 mg valsart na (atbilst to 27 ml š duma).
English: • Once you have inserted it, do not remove it.
Latvian: • P c ievietošanas vairs to neiz emiet.
English: All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Latvian: Tika secin ts, ka visas izmai as izrais ja valsart na farmakolo isk iedarb ba, kas, paši p rti iem, rad ja ilgstošu hipotensiju.
English: PHARMACEUTICAL FORM Clear, colourless to pale yellow solution.
Latvian: Z U FORMA Dzidrs, bezkr sains vai gaiši dzeltens š dums.
English: Not known
Latvian: Nav zin mi
English: The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Latvian: Kontrol tajos kl niskajos p t jumos konstat tais droš bas profila miokarda infarktu p rcietušiem un/vai sirds mazsp jas pieaugušiem pacientiem atš iras no hipertensijas pacientiem konstat t visp r j droš bas profila.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Latvian: PIELIKUMS I Z U NOSAUKUMI, Z U FORMAS, STIPRUMI, LIETOŠANAS VEIDI UN RE ISTR CIJAS APLIEC BAS PAŠNIEKI DAL BVALST S
English: Fertility
Latvian: Litijs
English: • medicines that increase the amount of potassium in your blood.
Latvian: • Z l m, kas palielina k lija daudzumu asin s.
English: • increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
Latvian: • k lija l me a palielin šan s asin s (kas smagos gad jumos var izrais t musku u spazmas un sirds ritma izmai as)
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Latvian: Nepieciešama b rnu, kuru m tes ir lietojušas AIIRA, r p ga nov rošana hipotensijas konstat šanai (skat t ar apakšpunktus 4.3 un 4.4).
English: 320 mg/day and a 60-kg patient).
Latvian: 320 mg/dien devu).
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Latvian: Žurk m, lietojot matern lo toksisko devu (600 mg/kg/dien ) gr tniec bas p d j trimestra un lakt cijas period , p cn c jiem tika konstat ta nedaudz samazin ta dz vildze, maz ks svara pieaugums un neliela att st bas aizkav šan s (v l ka ausu gliemežn cu un r j dzirdes kan la atv ršan s) (skat t apakšpunktu 4.6).
English: Methyl parahydroxybenzoate
Latvian: Metilparahidroksibenzo ts
English: • slowly pull the plunger all the way out so that the oral syringe fills with medicine.
Latvian: • l ni pavilkt virzuli l dz galam uz leju, lai š irce peror lai ievad šanai piepild tos ar z l m.