natgillin/translations-raw huggingface dataset:
Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone.
Xgeva je zdravilo, ki se uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih z napredovalim rakom, ki se je razširil na kosti.
The Agency considered that the benefits of Xgeva in giant cell tumour of bone were greater than the risks, and recommended that it be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila Xgeva pri gigantocelularnem kostnem tumorju večje od z njim povezanih tveganj, in priporočila, da se lahko odobri za uporabo v EU.
Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Zdravilo Xgeva se uporablja tudi za zdravljenje vrste kostnega raka, ki se imenuje gigantocelularni kostni tumor, pri odraslih in mladostnikih s popolnoma razvitim okostjem.
In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients' first skeletal-related event.
V naslednji študiji, v katero je bilo vključenih 1 718 bolnikov z novoodkritim diseminiranim plazmacitomom, je bilo zdravilo Xgeva pri odložitvi prvega z okostjem povezanega dogodka enako učinkovito kot zoledronska kislina.
The Agency considered that Xgeva was effective in preventing bone-related events and was less toxic to the kidneys and easier to use than existing treatments.
Zato je menila, da se je zdravilo Xgeva izkazalo za učinkovito pri preprečevanju z okostjem povezanih dogodkov in da je bilo v primerjavi z obstoječimi oblikami zdravljenja manj toksično za ledvice ter preprostejše za uporabo.
Xgeva contains the active substance denosumab.
Zdravilo Xgeva vsebuje učinkovino denosumab.
For the full list of side effects and restrictions with Xgeva, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Xgeva glejte navodilo za uporabo.
By attaching to RANKL and blocking it, denosumab reduces the formation and activity of the osteoclasts.
Denosumab z vezavo na beljakovino RANKL in njenim zaviranjem zmanjšuje nastajanje in delovanje osteoklastov.
How is Xgeva used?
Kako se zdravilo Xgeva uporablja?
Xgeva can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Xgeva je le na recept.
In these studies, Xgeva reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid.
V teh študijah je zdravilo Xgeva v primerjavi z zoledronsko kislino zmanjšalo tveganje za pojav prvega z okostjem povezanega dogodka za 18 %.
In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
V tej študiji je zdravilo Xgeva v primerjavi z zoledronsko kislino zmanjšalo tveganje za pojav prvega z okostjem povezanega dogodka za 16 %.
For more information about using Xgeva, see the package leaflet or contact a doctor or pharmacist.
Med zdravljenjem z zdravilom Xgeva morajo bolniki jemati dodatke kalcija in vitamina D. Za več informacij glede uporabe zdravila Xgeva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other common side effects (seen in up to 1 patient in 10) are development of another form of cancer in patients with advanced cancer, hypophosphataemia (low levels of phosphate in the blood), excessive sweating, tooth loss and osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
prekomerno potenje, izguba zob in osteonekroza čeljustnice (odmiranje kostnega tkiva čeljustnice, kar lahko povzroči bolečine, oteklost v ustih ali majanje zob).
The company presented results of one main study involving 463 patients undergoing different types of
Družba je predstavila rezultate ene glavne študije, ki je vključevala 463 bolnikov, pri katerih so bili opravljeni različni operativni posegi.
The Committee also noted that because the sponge and spray worked differently and should have been studied separately, there was not enough to determine the effects of the spray.
Odbor je tudi ugotovil, da zaradi različnega delovanja gobice in pršila in ker bi ju bilo treba proučevati ločeno, ni bilo dovolj dokazov za opredelitev učinkov pršila.
According to EU requirements, Recothrom should have been compared with a standard treatment that did not contain thrombin.
V skladu z zahtevami EU bi zdravilo Recothrom morali primerjati s standardnim zdravilom, ki ne vsebuje trombina.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na vprašanja, so nekatera tehtna vprašanja še vedno ostala nerešena.
The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Dopis, s katerim družba odbor CHMP obvešča o umiku vloge, je na voljo tukaj.
The effects of Recothrom were first tested in experimental models before being studied in humans.
Učinki zdravila Recothrom so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It contains the active substance thrombin alfa.
Vsebuje zdravilno učinkovino trombin alfa.
Thrombin converts another protein called fibrinogen into smaller units called fibrin.
Trombin pretvarja drugo beljakovino, imenovano fibrinogen, v manjše enote, imenovane fibrin.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Recothrom?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Recothrom?
The CHMP was concerned that the company provided evidence from specialised surgeries, whereas Recothrom was intended for more general use.
CHMP je izrazil zaskrbljenost, da je družba predložila dokaze iz specializiranih operativnih posegov, medtem ko je zdravilo Recothrom namenjeno za splošnejšo uporabo.
The fibrin particles then stick together, forming clots which help to stop the bleeding.
Delci fibrina se nato zlepijo in tvorijo strdke, ki pomagajo zaustaviti krvavitev.
The active substance in Recothrom, thrombin alfa, is a copy of thrombin, a protein that is found naturally in the blood.
Zdravilna učinkovina zdravila Recothrom, trombin alfa, je kopija beljakovine trombin, ki je naravno prisotna v krvi.
The company informed the CHMP that at this time there are no ongoing clinical trials or compassionate use programmes with Recothrom in Europe.
Družba je obvestila CHMP, da trenutno ni nobenih kliničnih preskušanj ali programov sočutne uporabe zdravila Recothrom v Evropi.
In addition, not enough evidence was presented to show that Recothrom used with a gelatin sponge was more effective than a sponge alone.
Poleg tega ni bilo predstavljenih dovolj dokazov, ki bi pokazali, da je zdravilo Recothrom skupaj z želatinasto gobico učinkovitejše od samostojne uporabe gobice.
On 11 December 2009, Bayer Schering Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Recothrom, for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Družba Bayer Schering Pharma AG je dne 11. decembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Recothrom, namenjenim zaustavitvi krvavitve med operativnim posegom, kjer standardne operativne tehnike ne zadoščajo.
The study compared Recothrom with another medicine containing thrombin and the main measure of effectiveness was the number of patients whose bleeding stopped within 10 minutes.
ki vsebuje trombin, glavno merilo učinkovitosti pa je bilo število bolnikov, pri katerih se je krvavitev zaustavila v 10 minutah.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Recothrom could not have been approved for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Recothrom ni mogoče odobriti za uporabo pri zaustavitvi krvavitve med operativnim posegom, kjer standardne operativne tehnike ne zadoščajo.
Thrombin also helps to make specialised cells in the blood called platelets to stick together, forming clots which also reduce the bleeding.
Trombin pomaga tudi pri zlepljanju specializiranih celic v krvi, imenovanih trombociti, ki tvorijo strdke, ki prav tako zmanjšajo krvavitev.
Recothrom was expected to be used to stop bleeding during an operation when standard surgical techniques are insufficient.
Zdravilo Recothrom naj bi se uporabljalo za zaustavitev krvavitve med operativnim posegom, kadar standardne operativne tehnike ne zadoščajo.
Finally, there were concerns about the medicine that Recothrom was compared with (the comparator) in the main study.
Nenazadnje pa so obstajali tudi zadržki glede zdravila (primerjalnega zdravila), s katerim so primerjali zdravilo Recothrom v glavni študiji.
What is Recothrom?
Kaj je zdravilo Recothrom?
What was Recothrom expected to be used for?
Za kaj naj bi se zdravilo Recothrom uporabljalo?
Recothrom was expected to be applied to the surgical wounds either using a gelatin sponge soaked with the solution, or by spraying the solution directly into the surgical wound.
Zdravilo Recothrom naj bi se apliciralo na operativne rane z želatinasto gobico, prepojeno z raztopino, ali s pršenjem raztopine neposredno na operativno rano.
How was Recothrom expected to work?
Kako naj bi zdravilo Recothrom delovalo?
Recothrom is a powder and solvent for solution to be applied to a surgical wound.
Zdravilo Recothrom sestavljata prašek in topilo, iz katerih pripravimo raztopino za apliciranje na operativni rani.
After reconstitution: 4 weeks.
Po pripravi: 4 tedne.
Cut at line -------------------------------------------------------------------------------------------------------
Prerežite po črti -----------------------------------------------------------------------------------------------
frequency can not be estimated from the available data
pogostnosti se iz razpoložljivih podatkov ne da oceniti
Stabilisation of the cardiovascular system should be given priority.
Prednost je treba dati stabilizaciji kardiovaskularnega sistema.
{Name and address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov} <{tel}> <{fax}> <{e-naslov}>
The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State for evaluation:
Predlagatelj se zavezuje, da bo pristojnemu nacionalnemu organu referenčne države članice v ocenitev predložil naslednje informacije:
See 4.2 for information on paediatric use.
Glejte 4.2 za informacije glede pediatrične uporabe.
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:
• The follow-up measures as set out in the CHMP Assessment Report
• nadaljnje ukrepe, kot so določeni v poročilu CHMP o oceni zdravila.
Therefore, the use of losartan is not recommended.
Zato uporabe losartana ne priporočamo.
Sector 1, Bucureşti, România
Sector 1, Bukarešta, Romunija
• PSUR should be submitted every 6 months for a year.
• redno letno poročilo o varnosti zdravila (PSUR) je treba predložiti vsakih šest mesecev za posamezno leto.
Losartan has been evaluated in clinical studies as follows:
Losartan so ocenjevali v naslednjih kliničnih študijah:
The mean length of follow-up was 4.8 years.
Spremljanje je povprečno trajalo 4,8 let.
After that year the safety data will be evaluated and it will be decided whether a longer PSUR period is permitted.
Po tem letu bodo podatki o varnosti ocenjeni, sprejeta pa bo odločitev, ali bo dovoljeno daljše obdobje za predložitev letnega poročila o varnosti zdravila.
Exposure in infants/ toddlers was comparatively high.
Izpostavljenost pri dojenčkih/malčkih je bila sorazmerno visoka.
Shake the suspension prior to each use and return promptly to the refrigerator.
Pred vsako uporabo suspenzijo pretresite in jo potem takoj vrnite v hladilnik.
This also applies to children 6 to 16 years of age.
To velja tudi za otroke, stare 6 do 16 let.
11415 Tallinn, Estonia
11415 Talin, Estonija
28027 MADRID, Spain
28027 MADRID, Španija
The doctor may increase the dose if blood pressure is not controlled.
Zdravnik lahko odmerek poveča, če tlak ni pod nadzorom.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
HOW TO MEASURE AND GIVE A DOSE OF ORAL SUSPENSION
KAKO ODMERITI IN DATI ODMEREK PERORALNE SUSPENZIJE
Losartan is not recommended:- for use in children below 6 years old due to insufficient data on safety and/or efficacy in these patient groups.
Uporabe losartana ne priporočamo: - pri otrocih, mlajših od 6 let, zaradi pomanjkljivih podatkov glede varnosti in/ali učinkovitosti za to starostno skupino.
• if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
• če ste alergični (preobčutljivi) na losartan ali katerokoli sestavino zdravila,
Austria, Belgium/Luxembourg, Bulgaria, Cyprus, Germany, Denmark, Estonia, Greece, Finland, France, Hungary, Ireland, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom, Iceland, Norway
COZAAR 2,5 mg/ml prašek in vehikel za peroralno suspenzijo v Avstriji, v Belgiji/Luksemburgu, v Bolgariji, na Cipru, na Danskem, v Estoniji, na Finskem, v Franciji, v Grčiji, na Irskem, na Islandiji, v Italiji, v Latviji, v Litvi, na Madžarskem, na Malti, v Nemčiji, na Nizozemskem, na Norveškem, na Poljskem, na Portugalskem, v Romuniji, v Sloveniji, v Španiji, na Švedskem, v Veliki Britaniji.
Your doctor will decide on the appropriate dose of COZAAR, depending on your condition and whether you are taking other medicines.
Zdravnik vam bo predpisal ustrezen odmerek zdravila COZAAR glede na vaše stanje in glede na to, ali jemljete še katera druga zdravila.
H-1123 Budapest, Hungary
H-1123 Budimpešta, Madžarska
For patients who can swallow tablets, this dosage form is also available.
Za bolnike, ki lahko pogoltnejo tablete, je na voljo tudi taka farmacevtska oblika.
Losartan may be administered with or without food.
Losartan se lahko zaužije s hrano ali brez nje.
Measures are depending on the time of medicinal product intake and kind and severity of symptoms.
Ukrepi so odvisni od časa zaužitja ter vrste in jakosti simptomov.
Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, vključno s tistimi, ki ste jih dobili brez recepta ali zdravili rastlinskega izvora in naravnimi izdelki.
75114 Paris Cedex 08, France
75114 Paris Cedex 08, Francija
Side effects in children are similar to those seen in adults.
Neželeni učinki pri otrocih so podobni tistim, ki so jih opazili pri odraslih.
1407 Sofia, Bulgaria
1407 Sofija, Bolgarija
• reduced number of thrombocytes,
• zmanjšano število trombocitov
00-867 Warsaw, Poland
00-867 Varšava, Poljska
The patients should have a left ventricular ejection fraction ≤ 40 % and should be stabilised under the treatment of the chronic heart failure.
Bolniki morajo imeti iztisno frakcijo levega prekata ≤ 40 % in morajo biti stabilni ob zdravljenju kroničnega srčnega popuščanja.
• inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
• vnetje krvnih žil (vaskulitis, vključno s Henoch-Schönlein purpuro)
• if you are breast-feeding (see also "Pregnancy and breast-feeding").
• če dojite (glejte tudi "Nosečnost in dojenje").
Very rare cases have also been reported with angiotensin II receptor antagonists.
O zelo redkih primerih so poročali tudi pri antagonistih angiotenzina II.
Therefore, concomitant use is not recommended (see section 4.5).
Zato sočasne uporabe ne priporočamo (glejte poglavje 4.5).
The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, to < 1/10); uncommon (≥ 1/1,000, to < 1/100); rare (≥ /10,000, to < 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 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), pogostnost neznana (iz razpoložljivih podatkov se je ne da določiti).
You should not take losartan in the first 12 weeks of pregnancy, and you must not take it at all after the 13th week as its 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.
Use in children and adolescents COZAAR has been studied in children.
Uporaba pri otrocih in mladostnikih Zdravilo COZAAR so preizkušali pri otrocih.
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
V kontroliranih kliničnih preskušanjih so bile klinično pomembne spremembe standardnih laboratorijskih parametrov redko povezane z uporabo tablet z losartanom.
Infants whose mothers have taken losartan should be closely observed for hypotension.
Otroke, katerih matere so prejemale losartan, je treba pozorno spremljati zaradi možnosti pojava hipotenzije.
Do not take a double dose to make up for a forgottendose.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
The observation of the ELITE Study, that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study, which is described in the following.
Opažanje iz študije ELITE, da je losartan v primerjavi s kaptoprilom zmanjšal tveganje za smrt, v naslednji študiji ELITE II, ki je opisana v nadaljevanju, ni bilo potrjeno.
Other warnings and precautions:
Druga opozorila in previdnostni ukrepi
For reconstitution see section 6.6.
Za navodila za pripravo glejte poglavje 6.6.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of medicinal products.
Čeprav ni na voljo kontroliranih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II (AIIRA-jev), lahko podobno tveganje obstaja tudi za to skupino zdravil.
Dosage should be adjusted according to blood pressure response.
Odmerek je treba prilagoditi glede na odziv krvnega tlaka.
MSD Hungary Ltd 50, Alkotas str.
Madžarska MSD Hungary Ltd 50, Alkotas str.
Important information about some of the ingredients of COZAAR COZAAR contains lactose monohydrate and sorbitol.
Pomembne informacije o nekaterih sestavinah zdravila COZAAR Zdravilo COZAAR vsebuje laktozo monohidrat in sorbitol.
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 pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Farmakokinetični parametri presnovka so se med različnimi starostnimi skupinami bolj razlikovali.
However, when driving vehicles or operating machines 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.
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 zdravljenja s 25 mg odmerkom, vendar pa prilagoditev odmerjanja pri starejših običajno ni potrebna.
Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5 % of patients in hypertension clinical trials.
Hiperkaliemija (vrednost serumskega kalija > 5,5 mmol/l) se je pojavila pri 1,5 % bolnikov iz kliničnih preskušanj hipertenzije.
The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school-age children and adolescents.
Rezultati so pokazali, da so farmakokinetični parametri losartana po peroralni aplikaciji pri dojenčkih in malčkih, predšolskih otrocih, šoloobveznih otrocih in mladostnikih približno podobni.
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.
Najmanjša preizkušana odmerka, 2,5 mg in 5 mg, ki ustrezata povprečnima dnevnima odmerkoma 0,07 mg/kg, nista imela dosledne antihipertenzivne učinkovitosti.
Both Losartan and its principal active metabolite have a far greater affinity for the AT1-receptor than for the AT2-receptor.
Oba, losartan in njegov osnovni aktivni presnovek, imata precej večjo afiniteto za AT1 receptor kot za AT2 receptor.
The systemic bioavailability of losartan tablets is approximately 33 %.
Sistemska biološka uporabnost losartana je približno 33 %.
Turn the whole thing to an upright position.
Vse skupaj spet obrnite v pokončen položaj.
Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
Povišanja vrednosti ALT so bila redka in so se običajno popravila po prekinitvi zdravljenja.
SPECIAL STORAGE CONDITIONS Store in the original container.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini.
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome, Italy
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rim, Italija
Other antihypertensive agents may increase the hypotensive action of losartan.
Drugi antihipertenzivi lahko povečajo hipotenzivni učinek losartana.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S), ROUTE(S) OF ADMINISTRATION OF THE MEDICINAL PRODUCT(S), MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Angioedema.
Angioedem.
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.
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.
To be prepared by medical or healthcare professionals only.
Zdravilo lahko pripravi samo zdravstveno osebje.
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.
There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see section 5.1).
Podatkov o učinkovitosti in varnosti losartana za zdravljenje hipertenzije pri otrocih in mladostnikih, starih 6 do 16 let, je malo (glejte poglavje 5.1).