FrancophonIA/ELRC3.0 huggingface dataset:
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Slovenian: Obstajajo dokazi, da sočasna uporaba zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena poveča tveganje za hipotenzijo, hiperkaliemijo in zmanjšano delovanje ledvic (vključno z akutno odpovedjo ledvic).
English: Consequently, uptitration of Ipreziv and concomitant therapy may be needed more frequently for blood pressure control in black patients.
Slovenian: Zato je pri temnopoltih bolnikih za nadzor krvnega tlaka pogosteje potrebno povečanje odmerka zdravila Ipreziv in sočasno zdravljenje.
English: EU/1/11/735/001 14 tablets EU/1/11/735/002 28 tablets EU/1/11/735/012 30 tablets EU/1/11/735/003 56 tablets EU/1/11/735/013 90 tablets EU/1/11/735/004 98 tablets
Slovenian: EU/1/11/735/001 14 tablet EU/1/11/735/002 28 tablet EU/1/11/735/012 30 tablet EU/1/11/735/003 56 tablet EU/1/11/735/013 90 tablet EU/1/11/735/004 98 tablet
English: EU/1/11/735/016 14 tablets EU/1/11/735/009 28 tablets EU/1/11/735/017 30 tablets EU/1/11/735/010 56 tablets EU/1/11/735/018 90 tablets EU/1/11/735/011 98 tablets
Slovenian: EU/1/11/735/016 14 tablet EU/1/11/735/009 28 tablet EU/1/11/735/017 30 tablet EU/1/11/735/010 56 tablet EU/1/11/735/018 90 tablet EU/1/11/735/011 98 tablet
English: There was no evidence of QT/QTc prolongation at a dose of 320 mg of Ipreziv.
Slovenian: Pri odmerku 320 mg zdravila Ipreziv podaljšanje QT/QTc intervala ni bilo ugotovljeno.
English: When Ipreziv is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Slovenian: Če se jemlje zdravilo Ipreziv sočasno s klortalidonom (zdravilo za odvajanje vode), so bile pogosto (pri manj kot 1 od 10 bolnikov) opažene višje vrednosti nekaterih kemičnih snovi v krvi
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Slovenian: Klinični SKT: Povprečna sprememba NK od izhodišča do 6. tedna (mm Hg) (ZOPN)
English: EU/1/11/735/005 14 tablets EU/1/11/735/006 28 tablets EU/1/11/735/014 30 tablets EU/1/11/735/007 56 tablets EU/1/11/735/015 90 tablets EU/1/11/735/008 98 tablets
Slovenian: EU/1/11/735/005 14 tablet EU/1/11/735/006 28 tablet EU/1/11/735/014 30 tablet EU/1/11/735/007 56 tablet EU/1/11/735/015 90 tablet EU/1/11/735/008 98 tablet
English: Exposure to angiotensin II receptor antagonist 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) (see section 5.3).
Slovenian: 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,
English: Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart failure or renal artery stenosis, as there is no experience of use of Ipreziv in these patients (see sections 4.2 and 5.2).
Slovenian: Pri hipertenzivnih bolnikih s hudo ledvično okvaro, kongestivnim srčnim popuščanjem ali stenozo ledvične arterije je potrebna previdnost, ker ni izkušenj z uporabo zdravila Ipreziv pri teh bolnikih (glejte poglavji 4.2 in 5.2).
English: 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).
Slovenian: blokatorjev receptorjev angiotenzina II ali aliskirena zato ni priporočljiva (glejte poglavji 4.5 in 5.1).
English: INFORMATION IN BRAILLE Ipreziv 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ipreziv 40 mg
English: Following discontinuation of treatment, the majority of the elevations that had not resolved during treatment were reversible, with the creatinine levels of most subjects returning to Baseline or nearBaseline values.
Slovenian: Po prenehanju terapije je bila večina dvigov, ki se niso uredili že med terapijo, reverzibilna.
English: 24-Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Slovenian: 24-urni srednji SKT: Povprečna sprememba NK od izhodišča do 6. tedna (mm Hg)
English: Placebo at 0.05 level within the framework of the step-wise analysis † Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise analysis # Maximum dose achieved in study 2.
Slovenian: OLM-M = medoksomilolmesartanat, NK = najmanjši kvadrati, ZOPN = zadnje opazovanje preneseno naprej * Pomembna razlika v primerjavi s placebom na nivoju 0,05 v okviru postopne analize † Pomembna razlika v primerjavi s primerjalno učinkovino(nami) na nivoju 0,05 v okviru postopne analize
English: Rebound hypertension was not observed following abrupt cessation of Ipreziv therapy after 6 months of treatment.
Slovenian: Po nenadni prekinitvi 6 mesečnega zdravljenja z zdravilom Ipreziv ni bil opažen povratni hipertenzivni učinek.
English: In particular, tell your doctor if you are taking any of the following medicines: - Lithium (a medicine for mental health problems) - Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib
Slovenian: - litij (zdravilo za težave z mentalnim zdravjem), - nesteroidna protivnetna zdravila, kot so ibuprofen, diklofenak ali celekoksib (zdravila za
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE inhibitor with an angiotensin II receptor blocker.
Slovenian: Uporabo zaviralca ACE v kombinaciji z blokatorjem receptorjev angiotenzina II so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
English: When Ipreziv was coadministered with chlortalidone, the frequencies of blood creatinine increased and hypotension were increased from uncommon to common.
Slovenian: Pri sočasni uporabi zdravila Ipreziv in klortalidona se je pogostnost zvišane koncentracije kreatinina v krvi in hipotenzije z občasne povečala na pogosto.
English: Based on experience with the use of other medicinal products that affect the renin-angiotensinaldosterone system, concomitant use of Ipreziv with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium in hypertensive patients (see section 4.5).
Slovenian: lahko pri bolnikih s povišanim krvnim tlakom sočasno dajanje zdravila Ipreziv z diuretiki, ki zadržujejo kalij, z dodatki kalija, z nadomestki soli, ki vsebujejo kalij, ali z drugimi učinkovinami, ki lahko povečujejo koncentracijo kalija (npr. heparin), vodi k povečani serumski koncentraciji kalija (glejte poglavje 4.5).
English: INFORMATION IN BRAILLE Ipreziv 80 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ipreziv 80 mg
English: Mechanism of action and pharmacodynamic effect Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues (see section 5.2).
Slovenian: Medoksomilazilsartanat je peroralno aktivno predzdravilo, ki se hitro spremeni v aktivni del azilsartan, ki selektivno nasprotuje učinkom angiotenzina II tako, da preprečuje, da bi se le-ta vezal na
English: HOW TO STORE IPREZIV
Slovenian: Shranjevanje zdravila Ipreziv
English: Adverse reactions were reported at a similar frequency for the Ipreziv 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Slovenian: V eni s placebom kontrolirani študiji z 20 mg odmerkom zdravila Ipreziv so bili ugotovljeni neželeni učinki s podobno pogostnostjo, kot pri 40 in 80 mg odmerkih.
English: What Ipreziv looks like and contents of the pack Ipreziv are white round tablets debossed “ASL” on one side and either “20”, “40” or “80” on the other.
Slovenian: Zdravilo Ipreziv so bele, okrogle tablete z vtisnjeno oznako “ASL” na eni in številko “20”, “40” ali “80” na drugi strani.
English: Caution should be exercised in hypertensive patients with congestive heart failure as there is no experience of use of Ipreziv in these patients (see section 4.4).
Slovenian: Pri hipertenzivnih bolnikih s kongestivnim srčnim popuščanjem je potrebna previdnost, ker ni izkušenj z uporabo zdravila Ipreziv pri teh bolnikih (glejte poglavje 4.4)
English: In these clinical studies, adverse reactions associated with treatment with Ipreziv were mostly mild or moderate, with an overall incidence similar to placebo.
Slovenian: Te klinične študije so pokazale pretežno blage do srednje močne neželene učinke, povezane z dajanjem zdravila Ipreziv, katerih skupna pogostnost je bila podobna pogostnosti pri placebu.
English: OLM-M = olmesartan medoxomil, LS = least squares, LOCF = last observation carried forward * Significant difference vs.
Slovenian: OLM-M = medoksomilolmesartanat, NK = najmanjši kvadrati, ZOPN = zadnje opazovanje preneseno naprej * Pomembna razlika v primerjavi s placebom na nivoju 0,05 v okviru postopne analize
English: INFORMATION IN BRAILLE Ipreziv 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ipreziv 20 mg
English: - Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets') or salt substitutes
Slovenian: - aspirin (acetilsalicilna kislina), če jemljete več kot 3 grame na dan (zdravilo za lajšanje - zdravila, ki povečujejo količino kalija v krvi, vključno z dodatki kalija, zdravili, ki zadržujejo kalij (nekatera “zdravila za odvajanje vode”) ali nadomestki soli, ki vsebujejo kalij,
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Ipreziv in these patients (see sections 4.4 and 5.2).
Slovenian: Pri hipertenzivnih bolnikih s hudo ledvično okvaro in končno stopnjo ledvične bolezni je potrebna previdnost, ker ni izkušenj z uporabo zdravila Ipreziv pri teh bolnikih (glejte poglavji 4.4 in 5.2).
English: Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Ipreziv is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Ipreziv is taken alone (less than 1 in 100 users).
Slovenian: Ipreziv jemali sočasno z amlodipinom (zaviralec kalcijevih kanalčkov za zdravljenje hipertenzije), kot pa, če so jemali samo zdravilo Ipreziv (manj kot 1 od 100 bolnikov).
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 40 mg tablets
Slovenian: IME ZDRAVILA Ipreziv 40 mg tablete
English: Ipreziv is unlikely to have an effect on driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ipreziv verjetno ne bo imelo vpliva na vožnjo ali upravljanje strojev.
English: Ipreziv has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.2 and 5.2).
Slovenian: Uporabe zdravila Ipreziv pri bolnikih s hudo jetrno okvaro niso preučevali, zato njegove uporabe pri tej skupini bolnikov ne priporočamo (glejte poglavji 4.2. in 5.2).
English: Ipreziv has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
Slovenian: Uporabe zdravila Ipreziv pri bolnikih s hudo jetrno okvaro niso preučevali, zato njegove uporabe pri tej skupini bolnikov ne priporočamo (glejte poglavji 4.4. in 5.2).
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Blister pack
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI
English: In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity.
Slovenian: 5.3 Predklinični podatki o varnosti V okviru predkliničnih študij varnosti so raziskovali toksičnost pri ponovljenih odmerkih, vpliv na sposobnost razmnoževanja, mutagenost in kancerogenost medoksomilazilsartanata in glavnega presnovka pri človeku M-II.
English: Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Ipreziv” and “Warnings and precautions”).
Slovenian: Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 7 December 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
English: Rash, pruritus Angioedema
Slovenian: Bolezni kože in podkožja izpuščaj, srbenje angioedem
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Slovenian: Nesteroidna protivnetna zdravila (NSAID), vključno s selektivnimi zaviralci COX-2, acetilsalicilno kislino (> 3 g/dan) in neselektivnimi NSAID
English: No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Slovenian: Študije zdravljenja z medoksomilazilsartanatom ali azilsartanom niso odkrile klinično pomembnih interakcij ob sočasnem dajanju z naslednjimi učinkovinami: amlodipin, antacidi, klortalidon,
English: What Ipreziv contains - The active substance is azilsartan medoxomil (as potassium) either 20 mg, 40 mg or 80 mg - The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose,
Slovenian: Kaj vsebuje zdravilo Ipreziv - Zdravilna učinkovina je medoksomilazilsartanat (v obliki kalijeve soli), 20 mg, 40 mg ali
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 20 mg tablets
Slovenian: IME ZDRAVILA Ipreziv 20 mg tablete
English: DATE OF REVISION OF THE TEXT
Slovenian: Študija 1 Sprememba od izhodišča
English: Musculoskeletal and connective tissue disorders General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost periferni edem
English: For patients with possible depletion of intravascular volume or salt depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics), Ipreziv should be initiated under close medical supervision and consideration can be given to 20 mg as a starting dose (see section 4.4).
Slovenian: Pri bolnikih z možnim zmanjšanim intravaskularnim volumnom ali z izgubo soli (npr. pri bolnikih, ki bruhajo, imajo drisko ali jemljejo visoke odmerke diuretikov) je treba zdravljenje z zdravilom Ipreziv uvesti pod skrbnim zdravniškim nadzorom.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči
English: Heart failure
Slovenian: Ledvična okvara
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 80 mg tablets
Slovenian: IME ZDRAVILA Ipreziv 80 mg tablete
English: - have severe liver disease - have heart problems (including heart failure, recent heart attack) - have ever had a stroke - have low blood pressure or feel dizzy or lightheaded - are vomiting, have recently had severe vomiting, or have diarrhoea - have elevated levels of potassium in your blood - have a disease of the adrenal gland called primary hyperaldosteronism - have been told that you have a narrowing of the valves in your heart (called “aortic or mitral valve stenosis”) or that the thickness of your heart muscle is abnormally increased (called
Slovenian: - imate bolezen nadledvičnih žlez, ki se imenuje primarni hiperaldosteronizem, - vam je zdravnik povedal, da imate zožene srčne zaklopke (t.i. aortno ali mitralno stenozo) ali nenormalno zadebeljeno srčno mišico (t. i. obstruktivno hipertrofično kardiomiopatijo),
English: As there is limited experience of use of Ipreziv in patients with mild to moderate hepatic impairment close monitoring is recommended and consideration should be given to 20 mg as a starting dose (see section 5.2).
Slovenian: Izkušnje z uporabo zdravila Ipreziv pri bolnikih z blago do zmerno jetrno okvaro so omejene, zato priporočamo natančno spremljanje.
English: Uncommon side effects affecting less than 1 in 100 people: - Low blood pressure, which may make you feel faint or dizzy - Feeling tired - Swelling of the hands, ankles or feet (peripheral oedema) - Skin rash and itching - Nausea - Muscle spasms - Increased serum creatinine in the blood (an indicator of kidney function) - Increased uric acid in the blood (an indicator of kidney function).
Slovenian: - nizek krvni tlak, zaradi katerega se lahko pojavi omedlevica ali omotica - utrujenost - zatekanje rok, gležnjev ali nog (periferni edem)
English: No initial dose adjustment with Ipreziv is necessary in elderly patients (see section 5.2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension.
Slovenian: Pri zelo starih bolnikih (≥ 75 let), pri katerih obstaja nevarnost hipotenzije, lahko začnete z začetnim odmerkom20 mg.
English: “obstructive hypertrophic cardiomyopathy”).
Slovenian: Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 20 mg tablets azilsartan medoxomil
Slovenian: IME ZDRAVILA Ipreziv 20 mg tablete medoksomilazilsartanat
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 40 mg tablets azilsartan medoxomil
Slovenian: IME ZDRAVILA Ipreziv 40 mg tablete medoksomilazilsartanat
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 80 mg tablets azilsartan medoxomil
Slovenian: IME ZDRAVILA Ipreziv 80 mg tablete medoksomilazilsartanat
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Slovenian: Ena tableta vsebuje 80 mg medoksomilazilsartanata (v obliki kalijeve soli).
English: EXPIRY DATE
Slovenian: Študija VA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Slovenian: Ena tableta vsebuje 40 mg medoksomilazilsartanata (v obliki kalijeve soli).
English: The incidence of adverse reactions with Ipreziv was not affected by gender, age, or race.
Slovenian: Spol, starost ali rasa niso vplivali na pogostnost neželenih učinkov zdravila Ipreziv.
English: Common side effects affecting less than 1 in 10 people: - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Slovenian: - omotica - driska - zvišanje vrednosti kreatin-fosfokinaze (pokazatelj poškodbe mišic).
English: Before you take, or whilst you are taking Ipreziv, tell your doctor if you: - have kidney problems - are on dialysis or had a recent kidney transplant
Slovenian: - ste na dializi ali vam je bila pred kratkim presajena ledvica, - imate hudo bolezen jeter,
English: Hepatic impairment
Slovenian: - mišični krči
English: - For patients who recently have lost body fluids e.g. through vomiting or diarrhoea, or by taking water tablets, your doctor may recommend a lower starting dose of 20 mg once a day.
Slovenian: Zdravnik lahko ta odmerek glede na reakcijo vašega krvnega tlaka poveča na največ 80 mg enkrat na dan. - Pri starejših starostnikih (75 let in več) lahko zdravnik priporoči nižji začetni odmerek 20 mg - Če imate blago ali zmerno jetrno bolezen, vam bo zdravnik morda priporočil nižji začetni - Če ste pred kratkim izgubili več telesnih tekočin, npr. zaradi bruhanja, driske ali zaradi zdravil za odvajanje vode, vam bo zdravnik morda priporočil nižji začetni odmerek 20 mg enkrat na - Če imate drugo sočasno bolezen kot npr. hudo ledvično bolezen ali srčno popuščanje, se bo zdravnik odločil za najbolj primeren začetni odmerek.
English: The main measure of effectiveness was the increase in height of patients after one year of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo povečanje telesne višine bolnikov po enem letu zdravljenja.
English: However, these antibodies do not seem to have an effect on the way the medicine works.
Slovenian: Vendar se zdi, da ta protitelesa ne vplivajo na način delovanja zdravila.
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Slovenian: Žleza spodbuja rast v otroštvu in mladostništvu ter vpliva na način, kako telo presnavlja beljakovine, maščobe in ogljikove hidrate.
English: In addition, the company that markets Somatropin Biopartners will provide further long-term data on the effectiveness and safety of the medicine.
Slovenian: Poleg tega bo družba, ki trži zdravilo Somatropin Biopartners, zagotovila nadaljnje dolgoročne podatke o učinkovitosti in varnosti zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Somatropin Biopartners' benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) agencije je zaključil, da so koristi zdravila Somatropin Biopartners večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR for Somatropin Biopartners can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Somatropin Biopartners je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Somatropin Biopartners.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Somatropin Biopartners.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Somatropin Biopartners on 05.08.2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Somatropin Biopartners, veljavno po vsej Evropski uniji, odobrila 05.08.2013.
English: It is used to treat children aged 2 to 18 years who are failing to grow normally because they do not have enough growth hormone.
Slovenian: Uporablja se za zdravljenje otrok, starih od 2 do 18 let, ki zaradi pomanjkanja rastnega hormona ne rastejo ustrezno.
English: Somatropin Biopartners is injected under the skin once a week.
Slovenian: Zdravilo Somatropin Biopartners se injicira pod kožo enkrat na teden.
English: In adults, the most common side effects (which may affect more than 1 in 10 people) are swelling, mild hyperglycaemia (high blood sugar levels) and headache.
Slovenian: Pri odraslih so najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 od 10 oseb) otekanje, blaga hiperglikemija (visoke ravni sladkorja v krvi) in glavobol.
English: In adults, the recommended dose is 2 mg injected once a week, except for female patients also taking oral oestrogen who should receive 3 mg once a week.
Slovenian: Pri odraslih je priporočen odmerek 2 mg, ki se injicira enkrat na teden, razen pri ženskih bolnicah, ki sočasno jemljejo peroralni estrogen in morajo prejeti 3 mg enkrat na teden.
English: The dose may need to be adjusted, depending on the patient's response to treatment and the side effects the patient experiences.
Slovenian: Odmerek bo morda treba prilagoditi glede na bolnikov odziv na zdravljenje in pojavljajoče se neželene učinke.