natgillin/translations-raw huggingface dataset:
- tingling or numbness, pain, loss of reflexes, paralysis on a nerve route, itching and rash.
- ščemenje ali odrevenelost, bolečina, izguba refleksa, paraliza živčnih poti, srbenje in izpuščaj
The following side effects have been reported with other influenza vaccines: • temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin • allergic reactions which can lead in rare cases:
V povezavi z drugimi cepivi proti gripi so poročali o naslednjih neželenih učinkih: • začasno zmanjšanje števila krvnih delcev, imenovanih trombocitov, ki lahko povzročijo modrice ali krvavenje, prehodno oteklost žlez vratu, pazduhe ali dimelj • alergijske reakcije, ki lahko v redkih primerih povzročijo:
A/New Caledonia/20/99 (H1N1) like strain (A/New Caledonia/20/99 (IVR-116)) 15 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (A/ New Caledonia/ 20/ 99 (IVR- 116)) 15 mikrogramov HA **
A/Wisconsin/67/2005 (H3N2) like strain (A/Wisconsin/67/2005 (NYMC X-161)) 15 micrograms HA**
A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 15 mikrogramov HA **
B/ Malaysia/2506/2004 like strain (B/Malaysia/2506/2004) 15 micrograms HA **
B / Malaysia/ 2506/ 2004, podoben sevu (B/ Malaysia/ 2506/ 2004) 15 mikrogramov HA **
39 Per 0.1 ml dose
na 0, 1 ml odmerka
* propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin
39 * razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat ** hemaglutinin
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F -69007 Lyon, France.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F- 69007 Lyon, Francija.
Sanofi Pasteur - Parc Industriel d’Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’Etoile - France
Sanofi Pasteur - Parc Industriel d’ Incarville - 27100 Val- de- Reuil - Francija Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’ Etoile - Francija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ --------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------------
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine. • The vaccine should be allowed to reach room temperature before use. • The vaccine should not be used if foreign particles are present in the suspension. • It is not necessary to shake the vaccine before use. • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
• Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju • Pred uporabo počakajte, da doseže cepivo sobno temperaturo. • Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti. • Cepiva pred uporabo ni potrebno pretresati. • Sistem za mikro- injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro- iglo (1, 5 mm) in s sistemom za zaščito igle.
41 Micro-Injection System
41 Sistem za mikroinjiciranje
42 INSTRUCTIONS FOR USE
42 NAVODILA ZA UPORABO
You hear a click and a shield comes out to cover the needle.
Z isto roko čvrsto pritisnite palec na bat, da aktivirajte zaščito igle.
Imprida is a medicine containing two active substances, amlodipine and valsartan.
Imprida je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
Imprida 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.
Imprida is not recommended for use in patients below 18 years of age.
Uporaba zdravila Imprida ni priporočljiva pri bolnikih, mlajših od 18 let.
Imprida is taken by mouth as one tablet once a day with some water, with or without food.
Zdravilo Imprida se zaužije peroralno kot ena tableta na dan z malo vode, skupaj s hrano ali brez nje.
The dose of Imprida to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Velikost odmerka zdravila Imprida, ki ga je treba vzeti, je odvisna od odmerkov amlodipina ali valsartana, ki ju je bolnik prejemal prej.
Imprida 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 Imprida jemati previdno.
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Imprida 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 Imprida, in ljudeh, ki so jemali obe zdravilni učinkovini ločeno.
The most common side effects with Imprida (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 Imprida (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 Imprida, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Imprida, glejte navodilo za uporabo.
Imprida 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 Imprida 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.
Imprida should not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Zdravila Imprida 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 Imprida’ 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 Imprida 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 Imprida be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Imprida odobri dovoljenje za promet.
Other information about Imprida:
Druge informacije o zdravilu Imprida:
The European Commission granted a marketing authorisation valid throughout the EU for Imprida to Novartis Europharm Limited on 17 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Imprida, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 17. januarja 2007.
The full EPAR for Imprida can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Imprida je na voljo tukaj.
EU Number EU/ 1/ 06/ 373/ 001 EU/ 1/ 06/ 373/ 002 EU/ 1/ 06/ 373/ 003 EU/ 1/ 06/ 373/ 004 EU/ 1/ 06/ 373/ 005 EU/ 1/ 06/ 373/ 006 EU/ 1/ 06/ 373/ 007 EU/ 1/ 06/ 373/ 008 EU/ 1/ 06/ 373/ 009 EU/ 1/ 06/ 373/ 010 EU/ 1/ 06/ 373/ 011 EU/ 1/ 06/ 373/ 012 EU/ 1/ 06/ 373/ 013 EU/ 1/ 06/ 373/ 014 EU/ 1/ 06/ 373/ 015 EU/ 1/ 06/ 373/ 016 EU/ 1/ 06/ 373/ 017 EU/ 1/ 06/ 373/ 018 EU/ 1/ 06/ 373/ 019 EU/ 1/ 06/ 373/ 020 EU/ 1/ 06/ 373/ 021 EU/ 1/ 06/ 373/ 022 EU/ 1/ 06/ 373/ 023 EU/ 1/ 06/ 373/ 024 EU/ 1/ 06/ 373/ 025 EU/ 1/ 06/ 373/ 026 EU/ 1/ 06/ 373/ 027 EU/ 1/ 06/ 373/ 028 EU/ 1/ 06/ 373/ 029 EU/ 1/ 06/ 373/ 030 EU/ 1/ 06/ 373/ 031 EU/ 1/ 06/ 373/ 032 EU/ 1/ 06/ 373/ 033 EU/ 1/ 06/ 373/ 034 EU/ 1/ 06/ 373/ 035 EU/ 1/ 06/ 373/ 036
Številka EU EU/ 1/ 06/ 373/ 001 EU/ 1/ 06/ 373/ 002 EU/ 1/ 06/ 373/ 003 EU/ 1/ 06/ 373/ 004 EU/ 1/ 06/ 373/ 005 EU/ 1/ 06/ 373/ 006 EU/ 1/ 06/ 373/ 007 EU/ 1/ 06/ 373/ 008 EU/ 1/ 06/ 373/ 009 EU/ 1/ 06/ 373/ 010 EU/ 1/ 06/ 373/ 011 EU/ 1/ 06/ 373/ 012 EU/ 1/ 06/ 373/ 013 EU/ 1/ 06/ 373/ 014 EU/ 1/ 06/ 373/ 015 EU/ 1/ 06/ 373/ 016 EU/ 1/ 06/ 373/ 017 EU/ 1/ 06/ 373/ 018 EU/ 1/ 06/ 373/ 019 EU/ 1/ 06/ 373/ 020 EU/ 1/ 06/ 373/ 021 EU/ 1/ 06/ 373/ 022 EU/ 1/ 06/ 373/ 023 EU/ 1/ 06/ 373/ 024 EU/ 1/ 06/ 373/ 025 EU/ 1/ 06/ 373/ 026 EU/ 1/ 06/ 373/ 027 EU/ 1/ 06/ 373/ 028 EU/ 1/ 06/ 373/ 029 EU/ 1/ 06/ 373/ 030 EU/ 1/ 06/ 373/ 031 EU/ 1/ 06/ 373/ 032 EU/ 1/ 06/ 373/ 033 EU/ 1/ 06/ 373/ 034
Invented name Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida
Izmišljeno ime Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida Imprida
Strength 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
jakost 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg
Pharmaceutical Form 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
farmacevtska oblika 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
Route of administration 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
pot uporabe 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
Packaging 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)
ovojnina 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)
Package size 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 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
velikost pakiranja 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)
Imprida 5 mg/ 80 mg film-coated tablets
Imprida 5 mg/ 80 mg filmsko obložene tablete
Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Zdravilo Imprida je indicirano pri bolnikih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom ali valsartanom.
The recommended dose of Imprida is one tablet per day.
Priporočeni odmerek zdravila Imprida je ena tableta na dan.
Imprida 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.
Imprido 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.
Imprida can be used with or without food.
Bolnik lahko Imprido vzame s hrano ali brez nje.
It is recommended to take Imprida with some water.
Imprido je priporočljivo vzeti z nekaj vode.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Imprida containing the same component doses.
Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/ kapsulah, prevesti na Imprido, ki vsebuje enaka odmerka sestavin.
Hepatic impairment Caution should be exercised when administering Imprida to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Okvara jeter Previdnost je potrebna pri uporabi zdravila Imprida pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4. 4).
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
2 Starejši (starost 65 let in več) Pri starejših bolnikih je treba odmerjanje povečevati previdno.
2 Children and adolescents Imprida 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 Imprida 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 Imprida 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 Imprido.
Renal artery stenosis No data are available on the use of Imprida in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenoza ledvične arterije Ni podatkov o uporabi zdravila Imprida 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 Imprida in patients who have had a recent kidney transplantation.
Presaditev ledvice Doslej ni izkušenj glede varnosti uporabe zdravila Imprida pri bolnikih, ki jim je bila nedavno presajena ledvica.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
3 Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je največji priporočeni odmerek 80 mg valsartana.
Renal impairment No dosage adjustment of Imprida is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Okvara ledvic Pri bolnikih z blago do zmerno okvaro ledvic (hitrost glomerulne filtracije > 30 ml/ min/ 1, 73 m2) odmerka zdravila Imprida ni treba prilagajati.
Imprida has not been studied in any patient population other than hypertension.
Imprida ni raziskana pri nobeni drugi populaciji, razen pri hipertenzivnih bolnikih.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
4 Interakcije, povezane z valsartanom Sočasna uporaba ni priporočljiva Litij Med sočasno uporabo zaviralcev ACE so poročali o reverzibilnem povečanju koncentracije litija v serumu in povečanju njegovih toksičnih učinkov.
Despite the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Kljub pomanjkanju izkušenj s sočasno uporabo valsartana in litija ta kombinacija ni priporočljiva.
Interactions common to the combination No drug interaction studies were performed with Imprida and other medicinal products.
Interakcije, pogoste ob kombinaciji Študij medsebojnega delovanja z zdravilom Imprida in drugimi zdravili ni bilo.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, an, if appropriate, alternative therapy should be started.
Ob potrjeni nosečnosti je treba zdavljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
5 V primeru izpostavljenosti antagonistom angiotenzina II od drugega trimesečja nosečnosti dalje se priporoča ultrazvočni pregled lobanje in delovanja ledvic.
There is no experience on the use of Imprida in pregnant women.
Z uporabo zdravila Imprida pri nosečnicah ni izkušenj.
The safety of Imprida has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Varnost zdravila Imprida so ocenili v petih kontroliranih kliničnih študijah s 5. 175 bolniki, od katerih jih je 2. 613 dobivalo valsartan v kombinaciji z amlodipinom.
Cardiac disorders
6 Srčne bolezni
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
7 Povprečna incidenca perifernih edemov, enakovredno uravnotežena za vse odmerke kombinacije amlodipin/ valsartan, je bila 5, 1%.
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 Imprida 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 amplodipin ali valsartan) so lahko tudi neželeni učinki zdravila Imprida, tudi če niso bili ugotovljeni v kliničnih preskušanjih tega zdravila ali v obdobju po prihodu tega zdravila na trg.
Symptoms There is no experience of overdose with Imprida.
Simptomi Izkušenj s prevelikim odmerjanjem zdravila Imprida ni.
Imprida 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.
Imprida 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 Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipin Amlodipin v zdravilu Imprida zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
Posledica je znižanje krvnega tlaka leže in stoje.