natgillin/translations-raw huggingface dataset:
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet, so bili ocenjeni na podlagi posredovane dokumentacije in znanstvene razprave v okviru Odbora,
2700-547 Amadora Portugal
2700-547 Amadora, Portugalska
Taking Cozaar with food and drink
Jemanje zdravila Cozaar skupaj s hrano in pijačo
This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients.
To je resen vendar redek neželeni učinek, ki prizadane več kot 1 od 10.000 bolnikov vendar manj kot 1 od 1.000 bolnikov.
Use of losartan in children and adolescents
Uporaba losartana pri otrocih in mladostnikih
Losartan tablets should be swallowed with a glass of water.
Tablete z losartaom je treba pogoltniti s kozarcem vode.
After careful evaluation, the CHMP considered that this indication is acceptable.
Po skrbnem vrednotenju je CHMP menil, da je ta indikacija sprejemljiva.
Long-term effects of losartan on growth, puberty and general development have not been studied.
Dolgoročni učinki losartana na rast, puberteto in splošen razvoj niso bili preučevani.
Patients with High Blood Pressure
Bolniki z visokim krvnim tlakom
You should not take losartan in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
Losartana naj se v prvih 12 tednih nosečnosti ne bi jemalo, od 13. tedna dalje pa je njegova uporaba celo prepovedana, ker lahko škoduje otroku.
The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnost spodaj naštetih neželenih učinkov je označena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), pogostnost neznana (iz razpoložljivih podatkov se je ne da določiti).
Tatoiou Street, Nea Erythraia 14671 Greece
Tatoiou Street, Nea Erythraia 14671, Grčija
WHAT Cozaar IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO COZAAR IN ZA KAJ GA UPORABLJAMO
If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Če imate občutek, da je učinek losartana premočan ali prešibek, se posvetujte z zdravnikom ali s farmacevtom.
Losartan is indicated for the treatment of hypertension.
Losartan je namenjen zdravljenju hipertenzije.
Dosage should be adjusted according to blood pressure response.
Odmerjanje je treba ustrezno prilagoditi odzivu krvnega tlaka.
Furthermore, the study provided no information on the effect that higher doses of losartan (greater than 50mg) could have on improving efficacy.
Poleg tega študija ni zagotovila nikakršnih informacij o učinku, ki bi ga lahko imeli na izboljšanje učinkovitosti večji odmerki losartana (večji od 50 mg).
The primary endpoint did not show any statistically significant difference between Losartan and captopril in reducing all-cause mortality.
Primarni opazovani dogodek ni pokazal nobene statistično pomembne razlike med losartanom in kaptoprilom v zmanjšanju celokupne smrtnosti.
Data in the pediatric population are limited.
Podatki za pediatrično populacijo so omejeni.
Losartan does not have an agonist effect nor does it block other hormone receptors or ion channels important in cardiovascular regulation.
Losartan nima agonističnega učinka niti ne zavira drugih hormonskih receptorjev ali ionskih kanalov, pomembnih za srčno-žilno regulacijo.
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Če slučajno vzamete preveč tablet, ali če kakšno tableto pogoltne otrok, se takoj posvetujte z zdravnikom.
• flu-like symptoms,
• gripi podobni simptomi
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Če imate ledvično okvaro, lahko sočasna uporaba teh zdravil vodi do dodatnega poslabšanja ledvične funkcije.
Overall, there was a dose-response.
Na splošno so opazili odziv na odmerek.
Sector 1, Bucureşti
Sector 1, Bukarešta, Romunija
Minimal conversion of losartan to its active metabolite was seen in about one percent of individuals studied.
Minimalno pretvorbo losartana v njegov aktivni presnovek so opazili pri približno enem odstotku posameznikov v študijah.
It is important that you continue to take Cozaar until your doctor tells you otherwise.
Pomembno je, da nadaljujete z jemanjem zdravila Cozaar, dokler vam zdravnik ne naroči drugače.
Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Ledvično funkcijo je treba med zdravljenjem z losartanom redno spremljati, saj se utegne poslabšati.
In this study 3152 patients with heart failure (NYHA Class II-IV) were followed for almost two years (median: 1.5 years) in order to determine whether Losartan is superior to captopril in reducing all cause mortality.
V tej študiji so 3.152 bolnikov s srčnim popuščanjem (NYHA razred II-IV) spremljali skoraj dve leti (povprečno 1,5 let) z namenom ugotoviti, ali je losartan v primerjavi s kaptoprilom boljši za zniževanje celokupne smrtnosti.
This was mainly attributable to a reduction of the incidence of stroke.
To so prisodili predvsem zmanjšanju pojavnosti možganske kapi.
Skanstes street 13, LV-1013, Riga
Skanstes street 13, LV-1013, Riga, Latvija
• if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
• če ste alergični na (preobčutljivi za) losartan ali katerokoli sestavino zdravila.
The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
Največji antihipertenzivni učinek dosežemo 3-6 tednov po začetku zdravljenja.
The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) needed to be amended to include the outcome of the PhVWP report on ACE Inhibitors and angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007).
CHMP je menil, da je treba besedilo v zvezi z nosečnostjo in dojenjem v SPC (poglavja 4.3, 4.4 in 4.6) dopolniti tako, da bo vključevalo izid poročila PhVWP o zaviralcih ACE in antagonistih receptorjev angiotenzina II (AIIRA) ter priporočilo glede uporabe v prvem trimesečju nosečnosti (EMEA/CHMP/PhVWP/474692/2007).
00-867 Warsaw
00-867 Varšava, Poljska
This medicinal product is authorized in the Member States of the EEA under the following names:
To zdravilo je v državah članicah EGP odobreno pod naslednjimi imeni: Država članica Ime zdravila
The following wording has been added to SPC Section 4.8 Undesirable effects:
Naslednje besedilo je bilo dodano v poglavje 4.8 SPC „Neželeni učinki“:
Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Bolnike, ki so kdaj imeli angioedem (otekanje obraza, ustnic, žrela in/ali jezika) je treba pozorno spremljati (glejte poglavje 4.8).
The most likely symptoms, depending on the extent of overdose, are hypotension, tachycardia, possibly bradycardia.
Najverjetnejši simptomi, odvisni od velikosti prevelikega odmerka, so hipotenzija, tahikardija, verjetno bradikardija.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years.
Zdravnik lahko predlaga manjši odmerek predvsem na začetku zdravljenja določenih bolnikov, kot so tisti, ki se zdravijo z velikimi odmerki diuretikov, bolniki z okvaro jeter ali bolniki, starejši od 75 let.
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
V kontroliranih kliničnih preizkušanjih so bile klinično pomembne spremembe standardnih laboratorijskih parametrov redko povezane z jemanjem tablet z losartanom.
Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Za bolnike, starejše od 75 let, je treba razmisliti o začetku zdravljeja s 25 mg odmerkom, vendar pa prilagoditev odmerjanja pri starejših običajno ni potrebna.
For more information, talk to your doctor.
Za več informacij se posvetujte s svojim zdravnikom.
The main areas of disharmony of the existing Summary of Product Characteristics were section 4.1 Therapeutic Indications, section 4.3 Contraindications, and section 4.4 Special Warnings and Precautions for Use.
Glavna področja neskladnosti obstoječih povzetkov glavnih značilnosti zdravila so bila poglavje 4.1 Terapevtske indikacije, poglavje 4.3 Kontraindikacije in poglavje 4.4 Posebna opozorila in previdnostni ukrepi.
1407 Sofia
1407 Sofija, Bolgarija
In vitro and in vivo losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of the source or route of its synthesis.
In vitro in in vivo losartan in njegov farmakološko aktivni karboksikislinski presnovek E-3174 blokirata vse fiziološko pomembne učinke angiotenzina II, ne glede na njegov izvor ali sintezno pot.
However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
Vendar pa je pri vožnji ali upravljanju s stroji treba upoštevati, da se pri antihipertenzivnem zdravljenju občasno lahko pojavi omotica ali dremavost, še posebej na začetku zdravljenja ali pri povečanju odmerka.
In addition to the active metabolite, inactive metabolites are formed.
Poleg aktivnega presnovka nastajajo tudi neaktivni presnovki.
Cozaar (losartan) was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union.
Zdravilo Cozaar (losartan) je bilo vključeno na seznam izdelkov, za katere je potrebno uskladiti informacije o zdravilu, ki ga je pripravila usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v humani medicini (CMD(h)), v skladu s členom 30(2) direktive 2001/83/ES, da bi odpravili razhajanja med nacionalno odobrenimi povzetki glavnih značilnosti zdravila (SPC) in tako uskladili te razlikujoče se SPC-je po celi Evropski uniji.
Angiooedema.
Angioedem.
The systemic bioavailability of losartan tablets is approximately 33%.
Sistemska biološka uporabnost losartana je približno 33 %.
WEEK 1 (day 1-7)
TEDEN (1.-7. dan)
Contra-indications (SPC section 4.3)
Kontraindikacije (poglavje 4.3 SPC)
If this combination proves essential, serum lithium level monitoring is recommended during concomitant use.
Če se ta kombinacija izkaže za nujno, med sočasno uporabo priporočamo spremljanje vrednosti litija v serumu.
Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
Simptomi prevelikega odmerjanja so nizek krvni tlak, povišan srčni utrip, mogoče zmanjšan srčni utrip.
Other antihypertensive agents may increase the hypotensive action of Losartan.
Drugi antihipertenzivi lahko povečajo hipotenzivni učinek losartana.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Čeprav ni na voljo kontroliranih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II (AIIA-jev), lahko podobno tveganje obstaja tudi za to skupino zdravil.
Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
Na podlagi podatkov, predloženih v okviru postopka napotitve po členu 30, ter izida vrednotenja teh pediatričnih podatkov, izvedenega v okviru projekta EU za delitev dela, je CHMP menil, da je treba zaključke Evropskega pediatričnega projekta delitve dela o losartanu vključiti v poglavja 4.2, 4.4, 4.8, 5.1 in 5.2 Povzetka glavnih značilnosti zdravila ter v ustrezna poglavja navodila za uporabo.
Both Losartan and its principal active metabolite have a far greater affinity for the AT1-receptor than for the AT2-receptor.
Oba, losrtan in njegov osnovni aktivni presnovek, imata precej večjo afiniteto za AT1 receptor kot za AT2 receptor.
Each pack contains a total of 35 tablets:
Vsako pakiranje vsebuje 35 tablet:
Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5% of patients in hypertension clinical trials.
Hiperkaliemija (kalij v serumu > 5,5 mol/l) se je v kliničnih preizkušanjih hipertenzije pojavila pri 1,5 % bolnikov.
• if you have problems with your heart valves or heart muscle,
• če imate težave s srčnimi zaklopkami ali srčno mišico.
Pharmacotherapeutic group: Angiotensin II Receptor Antagonists, ATC code: C09CA01
Farmakoterapevtska skupina: antagonisti angiotenzina II, oznaka ATC: C09CA01
Very rare cases have also been reported with antiotensin II receptor antagonists.
O zelo redkih primerih so poročali tudi pri antagonistih angiotenzina II.
• if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects'),
• če ste kdaj imeli angioedem (otekanje obraza, ustnic, grla in/ali jezika) (glejte tudi poglavje 4 "Možni neželeni učinki").
Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
Zvišanje ALT se je redko pojavilo in se je običajno popravilo po prekinitvi zdravljenja.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Huda alergijska reakcija (izpuščaj, srbenje, otekanje obraza, ustnic, v ustih ali žrelu, ki lahko oteži požiranje ali dihanje).
Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin/angiotensin system and an important determinant of the pathophysiology of hypertension.
Angiotenzin II, močan vazokonstriktor, je primarni aktivni hormon sistema renin/angiotenzin in pomemben faktor v patofiziologiji hipertenzije.
Each pack contains a total of 28 tablets:
Vsako pakiranje vsebuje 28 tablet:
• If you have any further questions, ask your doctor or your pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Following an oral dose/intravenous administration of 14C-labeled losartan in man, about 35% / 43% of radioactivity is recovered in the urine and 58%/ 50% in the faeces.
Po peroralnem/intravenskem odmerku s 14C označenega losartana pri človeku najdemo približno 35 % / 43 % radioaktivnosti v urinu, 58 % / 50 % pa v blatu.
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rim, Italija
Therefore, concomitant use is not recommended.
Zato sočasne uporabe ne priporočamo.
Like all medicines, Cozaar can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Cozaar neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Therapeutic Indications (SPC section 4.1)
Terapevtske indikacije (poglavje 4.1 SPC)
Therefore, the use of Losartan tablets is not recommended.
Zato uporabe losartana ne priporočamo.
Despite the marked decrease in blood pressure, Losartan had no clinically significant effects on heart rate.
Kljub znatnemu znižanju krvnega tlaka losartan ni imel nobenega klinično pomembnega vpliva na frekvenco srca.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavlejnei zaviralcem ACE,, vendar pa majhnega povečanja tveganja ni možno izključiti.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
Uporaba losartana pri bolnikih, starih manj kot 6 let, ni priporočljiva, saj so za te skupine bolnikov na voljo le omejeni podatki.
What Cozaar is and what it is used for Before you take Cozaar How to take Cozaar Possible side effects How to store Cozaar Further information
Kaj je zdravilo Cozaar in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cozaar Kako jemati zdravilo Cozaar Možni neželeni učinki
The tablets should be swallowed with a glass of water.
Tablete morate pogoltniti cele s kozarcem vode.
The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment.
Največji učinek zmanjšanja krvnega tlaka naj bi bil dosežen 3-6 tednov po začetku zdravljenja.
After oral intake the administration of a sufficient dose of activated charcoal is indicated.
Po peroralnem zaužitju je indicirana uporaba zadostnega odmerka aktivnega oglja.
Pharmacokinetics in paediatric patients
Farmakokinetika pri pediatričnih bolnikih
Characteristics in Patients
Značilnosti pri bolnikih
Furthermore Losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin.
Nadalje, losartan ne zavira ACE (kininaze II), encima, ki razgrajuje bradikinin.
Angiotensin II also stimulates smooth muscle cell proliferation.
Angiotenzin II pospešuje tudi proliferacijo celic gladkih mišic.
Blood pressure reduction at the end of the dosing interval was 70 - 80 % of the effect seen 5-6 hours postdose.
Znižanje krvnega tlaka ob koncu odmernega intervala je znašalo približno 70-80 % učinka, ki so ga opazili 5-6 ur po odmerku.
• to treat patients with high blood pressure (hypertension)
• za zdravljenje bolnikov z visokim krvnim tlakom (hipertenzijo).
Therefore, the CHMP considered that this is an acceptable indication.
Posledično je CHMP menil, da je ta indikacija sprejemljiva.
Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
Krvni tlak vam lahko zniža tudi katero od naslednjih zdravil/skupin zdravil: triciklični antidepresivi, antipsihotiki, baklofen, amifostin.
WEEK 2 (Day 8-14)
TEDEN (8.-14. dan)
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
• od odmerka odvisni ortostatski učinki, kot je padec krvnega tlaka, ko vstanete iz ležečega ali sedečega položaja
The results showed that the active metabolite is formed from losartan in all age groups.
Rezultati so pokazali, da se iz losartana tvori aktivni presnovek v vseh starostnih skupinah.
Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations.
Tako kot druge snovi, ki neposredno vplivajo na sistem renin-angiotenzin, ima tudi losartan neželene učinke na pozni razvoj ploda, kar povzroči smrt ploda in malformacije.
RENAAL-Study
Študija RENAAL
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
• zvečana količina alaninaminotransferaze (ALT) v krvi, ki se po prekinitvi zdravljenja običajno popravi
• if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• če veste, da imate zožanje ali zaprtje krvnih žil, ki vodijo do ledvic, ali če so vam pred kratkim presadili ledvico,
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor.
• Zdravila, ki vsebujejo litij, se v kombinaciji z losartanom brez natančnega nadzora zdravnika ne smejo uporabljati.
The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/ kg, did not appear to offer consistent antihypertensive efficacy.
Pri najmanjših preučevanih odmerkih, 2,5 mg in 5 mg, ustrezajočih povprečnemu dnevnemu odmerku 0,07 mg/ kg, ni kazalo, da bi zagotavljala konsistentno antihipertenzivno učinkovitost.
Cozaar is unlikely to affect your ability to drive or use machines.
Zelo malo verjetno je, da bi zdravilo Cozaar vplivalo na sposobnost vožnje in upravljanja s stroji.
The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Farmakokinetični parametri za presnovek so se med starostnimi skupinami razlikovali v večji meri.
Importantly, an ongoing study (HEAAL) comparing 50mg with 150mg losartan in patients with heart failure, may give relevant information on the dosing issue and address other open issues such as the negative results observed in patients on beta-blockers and losartan.
Pomembno je omeniti, da utegne potekajoča študija (HEAAL), primerjajoča 50 mg s 150 mg losartana pri bolnikih s srčnim popuščanjem, posredovati relevantne informacije v zvezi s problematiko odmerjanja ter odgovoriti na odprta vprašanja, kot so negativni rezultati, ugotovljeni pri bolnikih, prejemajočih zaviralce beta in losartan.
Therefore, the proposed indication was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”.
Posledično je bila predlagana indikacija z večino glasov na plenarnem zasedanju CHMP ocenjena za sprejemljivo ter je podprta z naslednjim besedilom: „zmanjšanje tveganja kapi pri hipertenzivnih bolnikih s hipertrofijo levega prekata, dokazano z EKG-jem“.
The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Razlog za to širšo indikacijo je dejstvo, da študija LIFE ni bila s placebom kontrolirana študija, ki bi preučevala le učinek na kap v primerjavi s placebom, temveč aktivno kontrolirana raziskava, ki je primerjala antihipertenzivno zdravljenje na podlagi losartana z zdravljenjem na podlagi atenolola ob uporabi sestavljene primarne končne točke - srčnožilne smrti, kapi in miokardnega infarkta.
• if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
• če imate koronarno srčno bolezen (zaradi zmanjšanega krvnega obtoka v srčnih žilah) ali možganskožilno bolezen (zaradi zmanjšanega krvnega obtoka v možganih).
Measurements of blood pressure 24 hours post-dose relative to 5 - 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Meritve krvnega tlaka 24 ur po odmerku so v primerjavi z meritvami 5 - 6 ur po odmerku pokazale 24 urno znižanje krvnega tlaka; ohranjen je bil naravni vsakodnevni ritem.
2 tablets = 25 mg once daily
2 tableti = 25 mg enkrat dnevno
Via G. Fabbroni 6, 00191 Rome, Italy
Via G. Fabbroni 6, 00191 Rim, Italija
• very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke),
• zelo hitro in neredno bitje srca (atrijska fibrilacija), možganska kap
See leaflet for further information.
Za nadaljnje informacije glejte Navodilo za uporabo.