natgillin/translations-raw huggingface dataset:
Very rare (less than 1 in 10,000 patients): irregular heart rate (e. g. fast heart rate), high blood pressure, inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting), gastrointestinal haemorrhage (blood in stools or when vomiting), hallucinations.
Zelo redki (pri manj kot 1 od 10. 000 bolnikov): nepravilno bitje srca (na primer hitro bitje srca), visok krvni tlak, vnetje trebušne slinavke (huda bolečina v zgornjem delu želodca, pogosto z navzeo in bruhanjem), gastrointestinalna krvavitev (kri v blatu ali pri bruhanju), halucinacije.
There have also been reports about severe vomiting that can lead to a rupture of the oesophagus.
Poročali so tudi o hudem bruhanju, ki lahko pripelje do raztrganja požiralnika.
The expiry date
- Zdravila Exelon ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli
refers to the last day of the month.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- Do not store above 25°C.
- Shranjujte pri temperaturi do 25 °C.
- Keep the transdermal patch in the sachet until use.
- Pred uporabo shranjujte transdermalni obliž v vrečki.
- Do not use any patch that is damaged or shows signs of tampering.
- Ne uporabljajte obliža, če je ovojnina poškodovana ali opazite, da je bila že odprta.
- The active substance is rivastigmine.
- Zdravilna učinkovina je rivastigmin.
Each patch releases 4.6 mg of rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.
Exelon 4, 6 mg/ 24 h transdermalni obliži: vsak obliž sprosti 4, 6 mg rivastigmina na 24 ur, je velik 5 cm2 in vsebuje 9 mg rivastigmina.
Each patch releases 9.5 mg of rivastigmine per 24 hours is 10 cm2 and contains 18 mg of rivastigmine.
Exelon 9, 5 mg/ 24 h transdermalni obliži: vsak obliž sprosti 9, 5 mg rivastigmina na 24 ur, je velik 10 cm2 in vsebuje 18 mg rivastigmina.
- The other ingredients are: polyethylene terephthalate film lacquered, alpha-tocopherol,
- Pomožne snovi so: lakiran polietilen tereftalatni film, α- tokoferol, polimer (butilmetakrilat,
poly(butylmethacrylate, methyl-methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.
metilmetakrilat), akrilni kopolimer, silikonsko olje, dimetikon, poliestrski film obložen s fluoro - polimerom.
What Exelon looks like and contents of the pack Each transdermal patch is a thin patch consisting of three layers.
141 Izgled zdravila Exelon in vsebina pakiranja Vsak transdermalni obliž je tanek obliž, sestavljen iz treh plasti.
- “ Exelon”, “ 4.6 mg/ 24 h” and “ AMCX”,
- “ Exelon ”, “ 4, 6 mg/ 24 h ” in “ AMCX ”,
- “ Exelon”, “ 9.5 mg/ 24 h” and “ BHDI”.
- “ Exelon ”, “ 9, 5 mg/ 24 h ” in “ BHDI ”.
134 One transdermal patch is sealed in one sachet.
V eni vrečki je zaprt en transdermalni obliž.
The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 (2x 30) or 90 (3x 30) sachets.
Obliži so na voljo v pakiranju, ki vsebuje 7 ali 30 vrečk in v skupnem pakiranju, ki vsebuje 60 (2x 30) ali 90 (3x 30) vrečk.
Not all pack sizes may be marketed in your country.
V vaši državi na trgu ni vseh navedenih pakiranj.
España Novartis Farmacéutica, S. A.
142 España Novartis Farmacéutica, S. A.
Exforge is a medicine containing two active substances, amlodipine and valsartan.
Exforge je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da visok krvi tlak ni posledica nobenega drugega bolezenskega stanja.
Exforge is not recommended for use in patients below 18 years of age.
Uporaba zdravila Exforge ni priporočljiva pri bolnikih, mlajših od 18 let.
Exforge is taken by mouth as one tablet once a day with some water, with or without food.
Zdravilo Exforge se zaužije peroralno kot ena tableta na dan z malo vode, skupaj s hrano ali brez nje.
The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Velikost odmerka zdravila Exforge, ki ga je treba vzeti, je odvisna od odmerkov amlodipina ali valsartana, ki ju je bolnik prejemal prej.
Exforge should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Bolniki, ki imajo težave z jetri ali obstruktivno biliarno bolezen (težave z izločanjem žolča), morajo zdravilo Exforge jemati previdno.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Ker
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.
Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Exforge, in ljudeh, ki so jemali obe zdravilni učinkovini ločeno.
The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Najpogostejši neželeni učinki zdravila Exforge (opaženi pri 1 do 10 bolnikov izmed 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
For the full list of all side effects reported with Exforge, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exforge, glejte navodilo za uporabo.
Exforge should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘ dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients.
Zdravila Exforge ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda „ derivatov dihidropiridina “, valsartan ali katero koli drugo sestavino zdravila.
Exforge should also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Zdravila Exforge prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri, ledvicami ali izločanjem žolča, ali bolniki na dializi (postopek prečiščevanja krvi).
The Committee for Medicinal Products for Human Use (CHMP) decided that Exforge’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Exforge pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče ustrezno urejati samo z amlodipinom ali valsartanom, večje od z njim povezanih tveganj.
The Committee recommended that Exforge be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Exforge odobri dovoljenje za promet.
Other information about Exforge:
Druge informacije o zdravilu Exforge:
The European Commission granted a marketing authorisation valid throughout the EU for Exforge to Novartis Europharm Limited on 17 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Exforge, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 17. januarja 2007.
The full EPAR for Exforge can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exforge je na voljo tukaj.
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC)
pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC)
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 280 tablet (4 x 70) 280 tablet (4 x 70) 280 tablet (4 x 70)
Exforge 5 mg/ 80 mg film-coated tablets
Exforge 5 mg/ 80 mg filmsko obložene tablete
Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Zdravilo Exforge je indicirano pri bolnikih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom ali valsartanom.
Exforge 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Exforge 5 mg/ 80 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali z 80 mg valsartana.
Exforge can be used with or without food.
Bolnik lahko Exforge vzame s hrano ali brez nje.
It is recommended to take Exforge with some water.
Exforge je priporočljivo vzeti z nekaj vode.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Exforge containing the same component doses.
Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/ kapsulah, prevesti na Exforge, ki vsebuje enaka odmerka sestavin.
Hepatic impairment Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Okvara jeter Previdnost je potrebna pri uporabi zdravila Exforge pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4. 4).
2 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
2 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Exforge ni priporočljivo uporabljati pri bolnikih, mlajših od 18 let.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
Bolniki s pomanjkanjem natrija in/ ali volumna V študijah, kontroliranih s placebom, so čezmerno hipotenzijo opažali pri 0, 4% bolnikov z nezapleteno hipertenzijo, ki so dobivali Exforge.
Renal artery stenosis No data are available on the use of Exforge in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenoza ledvične arterije Ni podatkov o uporabi zdravila Exforge pri bolnikih z obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice.
Kidney transplantation To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Presaditev ledvice Doslej ni izkušenj glede varnosti uporabe zdravila Exforge pri bolnikih, ki jim je bila nedavno presajena ledvica.
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
3 Okvara ledvic Pri bolnikih z blago do zmerno okvaro ledvic (hitrost glomerulne filtracije > 30 ml/ min/ 1, 73 m2) odmerka zdravila Exforge ni treba prilagajati.
Exforge has not been studied in any patient population other than hypertension.
Exforge ni raziskan pri nobeni drugi populaciji, razen pri hipertenzivnih bolnikih.
Interactions common to the combination No drug interaction studies were performed with Exforge and other medicinal products.
Interakcije, pogoste ob kombinaciji Študij medsebojnega delovanja z zdravilom Exforge in drugimi zdravili ni bilo.
AIIRAs therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5. 3).
There is no experience on the use of Exforge in pregnant women.
5 Z uporabo zdravila Exforge pri nosečnicah ni izkušenj.
The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Varnost zdravila Exforge so ocenili v petih kontroliranih kliničnih študijah s 5. 175 bolniki, od katerih jih je 2. 613 dobivalo valsartan v kombinaciji z amlodipinom.
General disorders and administration site conditions
6 Splošne težave in spremembe na mestu aplikacije
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush 6
edemi, testasti edemi, edem obraza, periferni edemi, utrujenost, zardevanje, astenija, navali vročine
2.4
0 2, 5 amlodipin 5 (mg) 10
Amlodipine (mg)
3, 0 8, 0 3, 1 10, 3
2.3 4.8
5, 5 2, 3 4, 8 ni podatka
5.4 2.3
2, 4 5, 4 2, 3 ni podatka
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Dodatne informacije o posameznih zdravilnih učinkovinah Neželeni učinki, opisani za katero od obeh zdravilnih učinkovin (za amlodipin ali valsartan), so lahko tudi neželeni učinki zdravila Exforge, tudi če niso bili ugotovljeni v kliničnih preskušanjih ali v obdobju po prihodu zdravila na trg.
Symptoms There is no experience of overdose with Exforge.
Simptomi Izkušenj s prevelikim odmerjanjem zdravila Exforge ni.
Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Exforge vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
Amlodipine The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipin Amlodipin v zdravilu Exforge zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Exforge once daily in two placebo-controlled trials.
Amlodipin/ valsartan V dveh s placebom kontroliranih preskušanjih je Exforge enkrat na dan dobivalo več kot 1. 400 hipertenzivnih bolnikov.
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg and 62% of patients treated with amlodipine/ valsartan 5 mg/ 160 mg, compared to 53% of patients remaining on valsartan 160 mg.
9 koncu preskušanja) pri 75% bolnikov, ki so dobivali amlodipin/ valsartan 10 mg/ 160 mg, pri 62% bolnikov, ki so dobivali amlodipin/ valsartan 5 mg/ 160 mg in pri 53% bolnikov, ki so ostali na 160 mg valsartana.
Exforge was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Exforge so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 hipertenzivnih bolnikih, ki so imeli diastolični krvni tlak ≥110 mm Hg in < 120 mm Hg.
In this study (baseline blood pressure 171/ 113 mmHg), an Exforge regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
V tej študiji (izhodiščni krvni tlak 171/ 113 mm Hg) je shema z zdravilom Exforge 5 mg/ 160 mg, titrirana do 10 mg/ 160 mg, znižala krvni tlak sede za 36/ 29 mm Hg; v primerjavi s tem je shema lizinopril/ hidroklorotiazid 10 mg/ 12, 5 mg, titrirana do 20 mg/ 12, 5 mg, znižala krvni tlak za 32/ 28 mm Hg.
Age, gender and race did not influence the response to Exforge.
Starost, spol in rasa niso vplivali na odziv na Exforge.
Exforge has not been studied in any patient population other than hypertension.
Exforge ni raziskan pri nobeni drugi populaciji razen pri hipertenzivnih bolnikih.
Valsartan shows multiexponential decay kinetics (t½α < 1 h and t½ß about 9 h).
Valsartan kaže multieksponentno kinetiko 10 upadanja (t½α < 1 uro in t½ß približno 9 ur).
Amlodipine/ Valsartan Following oral administration of Exforge, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipin/ valsartan Po peroralni uporabi zdravila Exforge doseže valsartan največjo koncentracijo v plazmi v 3 urah, amlodipin pa v 6 do 8 urah.
The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Delež in obseg absorpcije zdravila Exforge sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenega v ločenih tabletah.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young, therefore caution is required when increasing the dosage.
Povprečna sistemska AUC valsartana je pri starejših za 70% večja kot pri mladih, zato je pri večanju odmerka potrebna previdnost.
An increased incidence and severity of renal tubular basophilia/ hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8– 13 (valsartan) and 7– 8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
11 Pri izpostavljenosti, ki je bila za valsartan od 8 - do 13- krat večja in za amlodipin od 7 - do 8- krat večja kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina, so ugotovili večjo pojavnostjo in izrazitost bazofilije/ hialinizacije, dilatacije in cilindrov ledvičnih tubulov ter intersticijskega limfocitnega vnetja in hipertrofije arteriolarne medije.
PVC/ PVDC perforated unit dose blisters.
12 PVC/ PVDC perforirani pretisni omoti za enkratni odmerek.
Exforge 5 mg/ 160 mg film-coated tablets
Exforge 5 mg/ 160 mg filmsko obložene tablete
Exforge 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Exforge 5 mg/ 160 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali 160 mg valsartana.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
14 Starejši (starost 65 let in več) Pri starejših bolnikih je treba odmerjanje povečevati previdno.
14 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Exforge ni priporočljivo uporabljati pri bolnikih, mlajših od 18 let.