natgillin/translations-raw huggingface dataset:
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
U bolesnika koji nisu prikladno kontrolirani samo s irbesartanom, dodatak niske doze hidroklorotiazida (12,5 mg) irbesartanu jedanput na dan rezultira dodatnim placebo prilagođenim sniženjem krvnog tlaka za 7-10/3-6 mm Hg (sistolički/dijastolički).
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i izlučivanju albumina.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Dok je sličan krvni tlak postignut u svim ispitivanim skupinama, manje bolesnika u skupini koja je primala 300 mg irbesartana (5,2%) dostiglo je ishod manifestne proteinurije u odnosu na skupinu koja je primala placebo (14,9%) ili na skupinu koja je primala 150 mg irbesartana
Side effects reported in clinical studies for patients treated with Irbesartan were:
U kliničkim ispitivanjima na bolesnicima liječenima irbesartanom prijavljene su sljedeće nuspojave:
Rebound hypertension has not been observed.
(rebound) hipertenzije.
B e lgië/Belgique/Belgien Pharmathen S.A.
B e lgië /B e lgique /B e lgie n Pharmathen S.A.
INFORMATION IN BRAILLE Sabervel 75 mg
16. PODACI NA BRAILLEOVOM PISMU Sabervel 75 mg
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (<
Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antagonisti angiotenzina II, čisti.
• potassium supplements
• nadomjeske kalija
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
• ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
• Patients with high blood pressure and type 2 diabetes with kidney disease
Bolesnici s visokim krvnim tlakom i šećernom bolešću tipa 2 te bolešću bubrega
Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Poznato je da u ljudi terapija antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja izaziva fetotoksičnost (smanjena bubrežna funkcija, oligohidramnion, usporavanje okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio
Reproductive system and breast disorders: Uncommon:
Poremećaji reproduktivnog sustava i dojki: Manje često:
Each tablet of Sabervel 150 mg contains 150 mg irbesartan.
• Jedna Sabervel 150 mg tableta sadrži 150 mg irbesartana.
Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Oštećena funkcija jetre: u bolesnika s blagom do umjerenom cirozom farmakokinetički parametri irbesartana nisu bitno promijenjeni.
Titanium dioxide (E171)
Film-ovojnica: titanijev dioksid (E171) hipromeloza makrogol 400
Following oral or intravenous administration of
Nakon oralne ili intravenske primjene 14
Each tablet of Sabervel 300 mg contains 300 mg irbesartan.
• Jedna Sabervel 300 mg tableta sadrži 300 mg irbesartana.
INFORMATION IN BRAILLE Sabervel 300 mg
16. PODACI NA BRAILLEOVOM PISMU Sabervel 300 mg
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Litij: tijekom istodobne primjene litija i inhibitora angiotenzin konvertirajućeg enzima zabilježen je reverzibilan porast koncentracije serumskog litija i njegove toksičnosti.
The demonstration of renal benefit of Sabervel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Dokaz koristi Sabervela na bubrežnu funkciju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 zasniva se na ispitivanjima u kojima se irbesartan prema potrebi uzimao kao dopuna ostalim antihipertenzivnim lijekovima za postizanje ciljnog krvnog tlaka (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
U bolesnika na hemodijalizi treba razmotriti započinjanje liječenja nižom početnom dozom (75 mg)
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Klinička studija «Učinak irbesartana na mikroalbuminuriju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 (IRMA 2)» pokazuje da 300 mg irbesartana odgađa progresiju izražene proteinurije u bolesnika s mikroalbuminurijom.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
<primjenjivati> Sabervel” i “Upozorenja i mjere opreza”).
mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovoga lijeka, obratite se svom liječniku ili ljekarniku.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5
mikroalbuminurijom i normalnom bubrežnom funkcijom, hiperkalijemija (≥ 5,5 mEq/L)
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Nakon tri tjedna srednja vrijednost smanjenja krvnog tlaka u odnosu na početne vrijednosti za primarnu varijablu djelotvornosti, sistolički krvni tlak u sjedećem položaju (sjSKT) kod najniže koncentracije u krvi, iznosila je 11,7 mmHg (niska doza), 9,3 mmHg (srednja doza) i 13,2 mmHg
Sabervel is for oral use.
Način primjene Sabervel je namijenjen za primjenu kroz usta.
INFORMATION IN BRAILLE Sabervel 150 mg
16. PODACI NA BRAILLEOVOM PISMU Sabervel 150 mg
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Oštećenje funkcije jetre: nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Kako Sabervel izgleda i sadržaj pakovanja Sabervel 300 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 11 mm .
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Za sekundarni studijski ishod fatalnih i nefatalnih kardiovaskularnih događaja, u sveukupnoj ispitivanoj populaciji nije bilo razlika između tri skupine, iako je zabilježena povećana incidencija nefatalnog infarkta miokarda u žena i smanjena incidencija nefatalnog infarkta miokarda u muškaraca u skupini koja je primala irbesartan u odnosu na onu koja je primala placebo.
Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Grčka
PSURs
PSURevi
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Ako se utvrdi trudnoća, mora se odmah prekinuti terapija antagonistima receptora angiotenzina II te treba, ako je to primjereno, uvesti drugu terapiju.
tinnitus
Tinitus
The dose may later be increased to 300 mg once daily
Doza se kasnije može povećati na 300 mg jednom na dan, ovisno o vrijednostima krvnog tlaka.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Tablete treba progutati s dovoljnom količinom tekućine
5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
hiperkalijemija (≥ 5,5 mEq/L) se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
• Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
• Manje često: ubrzani srčani ritam, crvenilo praćeno osjećajem vrućine, kašalj, proljev, probavni poremećaji/žgaravica, problemi sa seksualnom funkcijom, bol u prsištu.
diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr. diuretike, beta blokatore, alfa blokatore) kako bi postigli unaprijed definirani krvni tlak od ≤ 135/85 mmHg ili smanjenje sistoličkog tlaka za 10 mmHg ako je početna vrijednost bila > 160 mmHg.
vertigo, headache Ear and labyrinth disorder: Not known:
Poremećaji uha i labirinta:
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na drugu antihipertenzivnu terapiju s potvrđenom sigurnošću primjene u trudnoći.
Potassium supplements and potassium-sp aring diuretics: based on experience with the use of other medicinal products that affect the reninangiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Nadomjesci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na reninangiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4).
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Smanjenje razine hemoglobina*, koje nije bilo klinički značajno, zabilježeno je u 1,7% hipertenzivnih bolesnika s uznapredovalom dijabetičkom bubrežnom bolesti koji su primali irbesartan.
hypersensitivity reactions such as angioedema, rash, urticaria Metabolism and nutrition disorders:
Reakcije preosjetljivosti kao što su angioedem, osip i urtikarija
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni hipromeloza magnezijev stearat
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Nadomjestci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na renin angiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4.).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
te treba, ako je to primjereno, započeti s drugom terapijom (vidjeti dijelove 4.3 i 4.6).
Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 300 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90 ili 98 filmom obloženih tableta.
White, concave, round, film-coated tablet with 7 mm diameter.
Bijela, konkavna, okrugla, filmom obložena tableta promjera 7 mm
Musculoskeletal and connective tissue disorders: Common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Poremećaji bubrega i mokraćnog sustava: Oštećena funkcija bubrega, uključujući slučajeve zatajenja bubrega u rizičnoj skupini bolesnika (vidjeti dio 4.4).
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
II receptora ili aliskirena stoga se ne preporučuje (vidjeti dijelove 4.5 i 5.1).
Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 75 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90, ili 98 filmom obloženih tableta.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥
U bolesnika sa šećernom bolesti i hipertenzijom, mikroalbuminurijom i normalnom bubrežnom funkcijom,
White, concave, round, film-coated tablet with 11 mm diameter.
Bijela, konkavna, okrugla filmom obložena tableta promjera 11 mm.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo.
do 300 mg jedanput na dan smanjuju krvni tlak u ležećem ili sjedećem položaju u vrijeme najniže koncentracije u krvi (to jest 24 sata nakon uzimanja doze) i to u prosjeku za 8-13/5-8 mm Hg
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Uzimanje antagonista receptora angiotenzina II ne preporučuje se tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4), a kontraindicirana je tijekom drugog i trećeg tromjesečja (vidjeti dijelove 4.3 i 4.4).
The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
(brzina izlučivanja albumina u mokraću (engl. urinary albumin excretion rate, UAER) >300 mg/dan i porast u vrijednostima UAER najmanje 30% od početnih vrijednosti).
Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 150 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90 ili 98 filmom obloženih tableta.
• Patients with high blood pressure The usual dose is 150 mg once a day.
Uobičajena doza iznosi 150 mg jednom na dan.
(It is also better to avoid Sabervel in early pregnancy
Sabervel se ne preporučuje uzimati u ranoj trudnoći.
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets
NAZIV GOTOVOG LIJEKA Sabervel 75 mg filmom obložene tablete
Luxe mbourg/Luxemburg Portfarma ehf.
Luxe mbourg/Luxe mburg Portfarma ehf.
What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Sabervel 75 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 7 mm
Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Greece
Pharmathen S.A. 6, Dervenakion str., 153 51 Pallini Attiki, Grčka
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 75 mg irbesartan
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Jedna tableta sadrži 75 mg irbesartana
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets irbesartan
NAZIV GOTOVOG LIJEKA Sabervel 75 mg filmom obložene tablete irbesartan
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
• Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, hipromeloza , magnezijev stearat.
The study of the “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2
Klinička studija «Ispitivanje irbesartana u bolesnika s dijabetičkom nefropatijom« (Irbesartan Diabetic
Hypromellose
Hiperkalijemija
White, concave, round, film-coated tablet with 9 mm diameter.
Bijela, konkavna, okrugla filmom obložena tableta promjera 9 mm
Respiratory, thoracic and mediastinal disorders: Uncommon:
Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često:
Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Nephropathy Trial, IDNT) pokazuje da irbesartan smanjuje progresiju bubrežne bolesti u bolesnika s kroničnom bubrežnom insuficijencijom i manifestnom proteinurijom.
jaundice
kašalj
What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.
Sabervel 150 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 9 mm
tachycardia Vascular disorders:
Poremećaji probavnog sustava: Dizgeuzija
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory
• liječenje visokog krvnog tlaka (esencijalne hipertenzije) • zaštitu bubrega u bolesnika sa šećernom bolesti tipa 2 koji imaju povišeni krvni tlak i laboratorijski dokazanu oslabljenu bubrežnu funkciju.
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets irbesartan
NAZIV GOTOVOG LIJEKA Sabervel 300 mg filmom obložene tablete irbesartan
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan Excipient with known effect:
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 300 mg irbesartana
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan Excipient with known effect:
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg irbesartana
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets irbesartan
NAZIV GOTOVOG LIJEKA Sabervel 150 mg filmom obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets
NAZIV GOTOVOG LIJEKA Sabervel 150 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets
NAZIV GOTOVOG LIJEKA Sabervel 300 mg filmom obložene tablete
România Pharmathen S.A.
Slovenská republika Pharmathen S.A.
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Ibesartan i tiazidski diuretici imaju aditivan učinak na sniženje krvnog tlaka.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan Excipient with known effect:
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 75 mg irbesartana 20mg laktoze hidrat u jednoj filmom obloženoj tableti
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria,
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze,
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A. ROK VALJANOSTI Rok valjanosti
Adverse reactions additionally reported from post-marketing experience are also listed.
Sljedeće dodatne nuspojave prijavljene su nakon stavljanja lijeka u promet; te nuspojave proizlaze iz spontanog prijavljivanja te stoga njihova učestalost nije poznata.
Skin and subcutaneous tissue disorders: Not known:
Poremećaji kože i potkožnog tkiva: Leukocitoklastični vaskulitis
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Ako dojite ili trebate početi s dojenjem obavijestite svog liječnika.
hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
se razvila u 46,3% bolesnika koji su primali irbesartan te u 26,3% bolesnika u placebo skupini.
40 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
40 mg laktoze hidrat u jednoj filmom obloženoj tableti
80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
80 mg laktoze hidrat u jednoj filmom obloženoj tableti
Sabervel is used in adult patients
Sabervel se primjenjuje za
Gastrointestinal disorders: Common:
Poremećaji probavnog sustava: Disgeuzija
After either oral or IV administration of
Nakon oralne ili i.v. primjene 14C
It contains the active substance filgrastim (30 or 48 million units).
Sadrži djelatnu tvar filgrastim (30 ili 48 milijuna jedinica).
The full EPAR for Filgrastim Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za Filgrastim Hexal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure in these studies was the neutrophil count over the first 10 days of treatment.
Glava mjera u tim ispitivanjima bio je broj neutrofila tijekom prvih 10 dana liječenja.
Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim.
Filgrastim se proizvodi metodom „tehnologije rekombinantne DNK“: proizvodi se od bakterije u koju je ugrađen gen (DNK) koji omogućava stvaranje filgrastima.
The replacement acts in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.
Ta zamjena djeluje na isti način kao i prirodno stvoren G-CSF tako što potiče koštanu srž na stvaranje većeg broja bijelih krvnih stanica.