natgillin/translations-raw huggingface dataset:
A review of clinical findings did not reveal an association between A antigenic site sequence changes and RSV disease severity among children receiving palivizumab immunoprophylaxis who develop RSV lower respiratory tract disease. 
Pregled kliničnih odkritij ni odkril povezave med sekvenčnimi spremembami v A antigenskem mestu in stopnjo RSV bolezni med otroki, ki so prejemali profilakso s palivizumabom in pri katerih se je razvila RSV bolezen spodnjih dihal.
*Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells. 
* Palivizumab je rekombinantno humanizirano monoklonsko protitelo, pridobljeno z DNA tehnologijo v mielomskih celicah miši.
50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium). 
50 mg praška v 4 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
- for the solvent: water for injections. 
- v vehiklu: voda za injekcije.
Reconstitute slowly with 0.6 ml water for injections. 
Počasi pripravite z 0,6 ml vode za injekcije.
Slowly add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming. 
Počasi dodajte 1,0 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections. 
Palivizumaba se ne sme mešati z nobenim drugim zdravilom in nobenim drugim vehiklom kot z vodo za injekcije.
Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg, respectively. 
Obe viali, 0,5 ml in 1 ml, vsebujeta presežek za zagotovitev odvzema 50 mg ali 100 mg.
Slowly add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming. 
Počasi dodajte 0,6 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
Two clinical studies were conducted to directly compare liquid and lyophilised formulations of palivizumab. 
Študije, v katerih so uporabljali palivizumab v tekoči obliki Dve klinični študiji sta bili izvedeni za neposredno primerjavo palivizumaba v tekoči in liofilizirani obliki.
In studies in adult volunteers, palivizumab had a pharmacokinetic profile similar to a human IgG1 antibody with regard to volume of distribution (mean 57 ml/kg) and half-life (mean 18 days). 
V raziskavah odraslih prostovoljcev so bile farmakokinetične lastnosti palivizumaba glede volumna distribucije (povprečno 57 ml/kg) in razpolovnega časa (povprečno 18 dni) podobne kot pri človeških protitelesih IgG1.
If he/she is allergic to palivizumab or any of the other ingredients of this medicine(listed in section 6). 
Če je alergičen na palivizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Palivizumab should not be mixed with any medicinal products or diluents. 
Palivizumaba se ne sme mešati z drugimi zdravili ali topili.
What do you need to know before Synagis is given to your child 
Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Synagis
The RSV hospitalisation rate was 10.6% in the placebo group. 
V placebni skupini je bil delež hospitalizacij zaradi RSV 10,6%.
- The other ingredients are, - for the powder: histidine, glycine and mannitol. 
- Druge sestavine so - v prašku: histidin, glicin in manitol.
What Synagis contains 
Kaj vsebuje zdravilo Synagis
How will my child receive Synagis? 
Kako bo otrok dobival zdravilo Synagis?
Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany 
KG D-88397 Biberach an der Riss Nemčija
Concentration of 100 mg/ml solution for injection. 
Koncentracija 100 mg/ml raztopine za injiciranje.
At least one of the palivizumab resistance-associated substitutions, N262D, K272E/Q, or S275F/L was identified in these 8 clinical RSV isolates resulting in a combined resistance-associated mutation frequency of 6.3% in these patients. 
V teh 8 kliničnih izolatih RSV so identificirali vsaj eno od substitucij, ki so povezane z odpornostjo na palivizumab, N262D, K272E/Q ali S275F/L, skupna pogostnost z odpornostjo povezanih mutacij pri teh bolnikih je bila 6,3%.
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents. 
V raziskavi III. faze IMpactRSV pri nedonošenčkih in otrocih z bronhopulmonalno displazijo so bili deleži prejemnikov rednih otroških cepiv, cepiva proti gripi, bronhodilatatorjev ali kortikosteroidov podobni med otroki, ki so dobili placebo, in tistimi, ki so dobili palivizumab.
Synagis may cause serious side effects including: severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms). 
• hudo alergijsko reakcijo; take reakcije lahko ogrozijo življenje ali so smrtne (glejte ''Otrok ne sme dobiti zdravila Synagis'' za seznam znakov in simptomov).
Additional side effects Very common (affects at least 1 user in 10): rash fever 
Zelo pogosti (pojavijo se pri vsaj 1 bolniku od 10 bolnikov):
Antibody to palivizumab was evaluated in four additional studies in 4337 patients (children born at 35 weeks of gestation or less and 6 months of age or less, or 24 months of age or less with bronchopulmonary dysplasia, or with haemodynamically significant congenital heart disease were included in these studies) and was observed in 0% - 1.5% of patients at different study timepoints. 
Protitelesa proti palivizumabu so bila ocenjena v štirih dodatnih študijah pri 4337 bolnikih (v to študijo so bili vključeni otroci, rojeni v 35. tednu gestacije ali manj in stari 6 mesecev ali manj ali otroci, stari 24 mesecev ali manj, z bronhopulmonalno displazijo ali s hemodinamično pomembno prirojeno boleznijo srca).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or other humanised monoclonal antibodies. 
Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
Reconstitute slowly with 1.0 ml water for injections. 
Počasi pripravite z 1,0 ml vode za injekcije.
Powder and solvent for solution for injection Contents: 
Prašek in vehikel za raztopino za injiciranje Vsebina:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies. 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
In a placebo-controlled trial in 1,287 patients  24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/kg Synagis reduced the incidence of RSV hospitalisations by 45% (p = 0.003) (congenital heart disease study). 
V preskušanju, ki je bilo kontrolirano s placebom in je zajelo 1.287 bolnikov, starih  24 mesecev in s hemodinamično pomembno prirojeno boleznijo srca (639 jih je dobivalo zdravilo Synagis, 648 placebo), je 5 mesečnih odmerkov zdravila Synagis 15 mg/kg zmanjšalo incidenco hospitalizacij zaradi RSV za 45% (p = 0,003) (raziskava prirojenih bolezni srca).
Swirl gently. 
Obzirno vrtite.
How will my child receive Synagis 
Kako bo otrok dobival zdravilo Synagis
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja Zelo pogosti
The 100 mg vial contains an overfill to allow the withdrawal of 100 mg when reconstituted if following the directions described below. 
100 mg viala vsebuje presežek za zagotovitev odvzema 100 mg pri rekonstituciji, če se sledi spodnjim navodilom.
A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season. 
Dve ločeni raziskavi varnosti palivizumaba, uporabljenega v drugi sezoni RSV, sta zajeli skupno 222 otrok.
Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. 
Palivizumab se aplicira enkrat na mesec intramuskularno, po možnosti v anterolateralni predel stegna.
The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective. 
Učinkovitost palivizumaba pri bolnikih, ki ga dobijo v ponovnem ciklusu naslednjo sezono RSV, ni bila formalno raziskana v kakšni študiji, opravljeni s tem namenom.
The 50 mg vial contains an overfill to allow the withdrawal of 50 mg when reconstituted if following the directions described below. 
50 ml viala vsebuje presežek za zagotovitev odvzema 50 mg pri rekonstituciji, če se sledi spodnjim navodilom.
Also contains histidine, glycine and mannitol. 
Vsebuje tudi histidin, glicin in manitol.
- The active substance is palivizumab. 
- Zdravilna učinkovina je palivizumab.
It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. 
Palivizumab močno nevtralizira seve RSV podtipov A in B in zavira njihovo fuzijsko aktivnost.
Label of 0.5 ml vial 
Nalepka na 0,5 ml viali
Label of 1.0 ml vial 
Nalepka na 1,0 ml viali
However, you should inform your doctor of all medicines your child is currently taking before starting Synagis. 
Ni znano, da bi imelo zdravilo Synagis medsebojne učinke z drugimi zdravili, vendar morate zdravniku pred začetkom uporabe zdravila Synagis povedati za vsa zdravila, ki jih vaš otrok trenutno dobiva.
Synagis 100 mg vial label 
Synagis 100 mg - nalepka na viali
One ml of Synagis solution for injection contains 100 mg of palivizumab. 
1 ml zdravila Synagis raztopina za injiciranje vsebuje 100 mg palivizumaba.
Studies carried out in rodents gave no indication of enhancement of RSV replication, or RSV-induced pathology or generation of virus escape mutants in the presence of palivizumab under the chosen experimental conditions. 
Raziskave na glodalcih v izbranih eksperimentalnih pogojih in v navzočnosti palivizumaba niso odkrile zvečane replikacije RSV, z RSV izzvane patologije ali nastanka ubežnih virusnih mutantov.
Synagis is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1. 
Zdravilo Synagis sestavljata prašek in vehikel za raztopino za injiciranje (100 mg praška v viali) + 1 ml vehikla v ampuli - pakiranje vsebuje 1 vialo in 1 ampulo.
100 mg Outer Carton 
100 mg - zunanja škatla
50 mg Outer Carton 
50 mg - zunanja škatla
In a placebo-controlled trial of RSV disease prophylaxis in (IMpact-RSV trial) 1502 high-risk children (1002 Synagis; 500 placebo), 5 monthly doses of 15 mg/kg reduced the incidence of RSV related hospitalisation by 55% (p = < 0.001). 
Študije, v katerih so uporabljali palivizumab v liofilizirani oblikiV preskušanju profilakse bolezni RSV, kontroliranem s placebom, (preskušanje IMpact-RSV) pri 1.502 zelo ogroženih bolnikih (1.002 sta dobivala zdravilo Synagis, 500 placebo) je 5 mesečnih odmerkov 15 mg/kg zmanjšalo incidenco hospitalizacij zaradi RSV za 55% (p = < 0,001).
When using Palivizumab 100 mg/1 ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15 
Ko se uporablja palivizumab 100 mg/1 ml, je potrebna količina palivizumaba (izražena v ml), ki se injicira v enomesečnih intervalih = (bolnikova telesna masa v kg) pomnožena z 0,15
Lyophilised formulation of palivizumab 
Palivizumab v tekoči obliki
Palivizumab is administered intramuscularly, preferably in the anterolateral aspect of the thigh. 
Palivizumab se injicira intramuskularno, po možnosti v anterolateralni predel stegna.
Synagis is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1. 
Zdravilo Synagis sestavljata prašek in vehikel za raztopino za injiciranje (50 mg praška v viali) + 1 ml vehikla v ampuli - pakiranje vsebuje 1 vialo in 1 ampulo.
Administrator's Instructions 
Navodila za zdravstveno osebje
Uncommon (affects less than 1 users in 100): fits hives 
Občasni (pojavijo se pri manj kot 1 bolniku od 100 bolnikov):
Do not dilute the product. 
Zdravila ne redčite.
Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection Active substance: palivizumab 
Synagis 50 mg/0,5 ml raztopina za injiciranje Synagis 100 mg/1 ml raztopina za injiciranje učinkovina: palivizumab
Synagis 50 mg vial label 
Synagis 50 mg - nalepka na viali
Common adverse reactions occurring with palivizumab are fever, rash and injection site reaction. 
Pogosti neželeni učinki, ki se pojavijo pri palivizumabu so povišana telesna temperatura, izpuščaj in reakcije na mestu injiciranja.
Also contains: histidine, glycine and mannitol. 
Vsebuje tudi: histidin, glicinin manitol.
Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection 
Synagis 50 mg/0,5 ml raztopina za injiciranje Synagis 100 mg/1 ml raztopina za injiciranje
When using Palivizumab 100 mg/ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15 
Ko se uporablja palivizumab 100 mg/ml, je potrebna količina palivizumaba (izražena v ml), ki se injicira v enomesečnih intervalih = (bolnikova telesna masa v kg) pomnožena z 0,15
The powder is a white to off-white cake. 
Prašek je bel do sivo bel z enakomernimi delci.
1 ml of Synagis solution contains 100 mg of palivizumab*. 
1 ml raztopine zdravila Synagis vsebuje 100 mg palivizumaba*.
Intramuscular use. 
intramuskularna uporaba viala za enkratno uporabo
The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15. 
Količina palivizumaba (izražena v ml), ki jo je potrebno injicirati v enomesečnih intervalih = [telesna masa bolnika v kg] pomnožena z 0,15.
Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration. 
Po aplikaciji palivizumaba so bile opisane alergijske reakcije in anafilaktični šok, vključno z zelo redkimi primeri anafilaksije.
Each 0.5 ml vial contains 50 mg of palivizumab. 
Ena 0,5 ml viala vsebuje 50 mg palivizumaba.
Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays. 
Palivizumab ne moti testov, ki temeljijo na metodi obratne transkripcije in verižne reakcije s polimerazo (RT-PCR).
Synagis 100 mg/1 ml solution for injection palivizumab 
Synagis 100 mg/1 ml raztopina za injiciranje palivizumab
Take special care with Synagis if your child is unwell. 
Bodite posebno pozorni pri uporabi zdravila Synagis
- Each 1 ml vial contains 100 mg of palivizumab. 
- Vsaka 1 ml viala vsebuje 100 mg palivizumaba.
How to store Synagis 
Shranjevanje zdravila Synagis
To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent. 
Za uporabo odstranite del z zanko na pokrovčku viale in očistite zamašek s 70 % etanolom ali ekvivalentom.
Synagis 50 mg/0.5 ml solution for injection palivizumab 
Synagis 50 mg/0,5 ml raztopina za injiciranje palivizumab
Among 139 children in the congenital heart disease study receiving palivizumab who had cardio-pulmonary bypass and for whom paired serum samples were available, the mean serum palivizumab concentration was approximately 100 g/ml pre-cardiac bypass and declined to approximately 40 g/ml after bypass. 
Pri teh 139 otrocih je bila povprečna koncentracija palivizumaba v serumu pred zunajtelesnim obtokom približno 100 g/ml, po njem pa se je zmanjšala na približno 40 g/ml.
To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent. 
Za rekonstitucijo odstranite del z zanko na pokrovčku viale in očistite kavčukovo zaporko s 70% etanolom ali ekvivalentom.
Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1,000 to < 1/100 ; rare ≥ 1/10,000 to < 1/1,000) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients. 
Klinični in laboratorijski neželeni učinki, so prikazani v naslednjih tabelah po organskih sistemih in pogostnosti (zelo pogosti ≥1/10; pogosti  1/100 do  1/10; občasni  1/1.000 do  1/100; redki ≥ 1/10.000 do < 1/1.000).
Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to <1/1,000 ) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients. 
Klinični in laboratorijski neželeni učinki so prikazani v naslednjih tabelah po organskih sistemih in pogostnosti (zelo pogosti ≥ 1/10; pogosti  1/100 do 1/10; občasni  1/1.000 do  1/100; redki ≥ 1/10.000 do < 1/1.000).
To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent 
Za rekonstitucijo odstranite del z zanko na pokrovčku viale in očistite kavčukovo zaporko z 70% etanolom ali ekvivalentom.
Synagis 100 mg powder and solvent for solution for injection Active substance: palivizumab 
Synagis 100 mg prašek in vehikel za raztopino za injiciranje učinkovina: palivizumab
Each vial contains: 100 mg palivizumab, providing 100 mg/ml of palivizumab when reconstituted as recommended. 
Ena viala vsebuje: 100 mg palivizumaba; koncentracija po navodilu pripravljene raztopine je 100 mg/ml.
When reconstituted as recommended the final concentration is 100 mg/ml. 
Koncentracija po navodilu pripravljene raztopine palivizumaba je 100 mg/ml.
Outer Carton of 0.5 ml vial 
Škatla z 0,5 ml vialo
Solvent for Synagis 
Vehikel za zdravilo Synagis
Synagis 50 mg powder and solvent for solution for injection Active substance: palivizumab 
Synagis 50 mg prašek in vehikel za raztopino za injiciranje učinkovina: palivizumab
Liquid formulation of palivizumab 
Palivizumab v liofilizirani obliki
Each 1 ml vial contains 100 mg of palivizumab. 
Ena 1 ml viala vsebuje 100 mg palivizumaba.
Synagis is a white to off-white cake. 
Zdravilo Synagis je bel do sivo bel prašek z enakomernimi delci.
Synagis 100 mg powder and solvent for solution for injection 
Synagis 100 mg prašek in vehikel za raztopino za injiciranje
Synagis 50 mg powder and solvent for solution for injection 
Synagis 50 mg prašek in vehikel za raztopino za injiciranje
The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point. 
Učinkovitost palivizumaba pri bolnikih, ki ga dobijo v ponovnem ciklusu naslednjo sezono RSV, ni bila formalno preskušena v kakšni študiji, opravljeni s tem namenom.
Each vial contains 50 mg palivizumab, providing 100 mg/ml of palivizumab when reconstituted as recommended. 
Ena viala vsebuje 50 mg palivizumaba; koncentracija po navodilu pripravljene raztopine je 100 mg/ml.
- Each 0.5 ml vial contains 50 mg of palivizumab. 
- Vsaka 0,5 ml viala vsenbuje 50 mg palivizumaba.
Synagis 50 mg powder and solvent for solution for injection palivizumab 
Synagis 50 mg prašek in vehikel za raztopino za injiciranje palivizumab
Synagis 100 mg powder and solvent for solution for injection palivizumab 
Synagus 100 mg prašek in vehikel za raztopino za injiciranje palivizumab
Synagis 50 mg powder for solution for injection palivizumab 
Synagis 50 mg prašek za raztopino za injiciranje palivizumab i.m.
(3 x 0.15) ml = 0.45 ml palivizumab per month 
Na primer, za dojenčka s telesno maso 3 kg velja naslednji izračun: (3 x 0,15) ml = 0,45 ml palivizumaba na mesec
Synagis 100 mg powder for solution for injection palivizumab 
Synagis 100 mg prašek za raztopino za injiciranje palivizumab i.m.
Common (affects 1 to 10 users in 100): pain, redness or swelling at the injection site a pause in breathing or other breathing difficulties 
Pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov):
Other information about Tekturna: 
Druge informacije o zdravilu Tekturna:
The European Commission granted a marketing authorisation valid throughout the European Union for Tekturna to Novartis Europharm Limited on 22 August 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Tekturna, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 22. avgusta 2007.
Tekturna is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group. 
Zdravilo Tekturna ni priporočeno za uporabo pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej starostni skupini.
The Committee recommended that Tekturna be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Tekturna odobri dovoljenje za promet.
The effects of Tekturna were first tested in experimental models before being studied in humans. 
Učinki zdravila Tekturna so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Tekturna. 
Vzeti ga je treba z lahkim obrokom, najbolje vsak dan ob istem času, vendar pa se zdravilo Tekturna ne sme vzeti skupaj s sokom grenivke.
What benefit has Tekturna shown during the studies? 
Kakšne koristi je zdravilo Tekturna izkazalo med študijami?
Tekturna was studied in 14 main studies involving over 10,000 patients with essential hypertension. 
Zdravilo Tekturna so raziskali v 14 glavnih študijah, v katere je bilo vključeno več kot 10 000 bolnikov z esencialno hipertenzijo.
Tekturna is used to treat essential hypertension (high blood pressure). 
Zdravilo Tekturna se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka).
What is the risk associated with Tekturna? 
Kakšna tveganja so povezana z zdravilom Tekturna?
The recommended dose of Tekturna is 150 mg once a day, either taken alone or in combination with other medicines for hypertension. 
Priporočeni odmerek zdravila Tekturna znaša 150 mg enkrat na dan, bodisi samostojno ali v kombinaciji z drugimi zdravili za zdravljenje hipertenzije.
The studies also showed that Tekturna, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with the decreases produced by these medicines when they are taken without Tekturna. 
Študije so pokazale tudi, da lahko zdravilo Tekturna v kombinaciji z drugimi zdravili (še zlasti hidroklorotiazidom) povzroči še dodatna znižanja krvnega tlaka v primerjavi z znižanji tlaka, ki jih imajo ta zdravila, če se jemljejo brez zdravila Tekturna.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TEKTURNA EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TEKTURNA Povzetek EPAR za javnost
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic). 
Študije so trajale od šest do 52 tednov, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem komor srca (sistolični tlak).
The most common side effect with Tekturna (seen in between 1 and 10 patients in 100) is diarrhoea. 
Najpogostejši neželeni učinek zdravila Tekturna (opažen pri 1 do 10 bolnikih izmed 100) je driska.
Tekturna also reduced blood pressure in patients with diabetes and patients who were overweight. 
Zdravilo Tekturna je krvni tlak znižalo tudi pri bolnikih s sladkorno boleznijo in bolnikih s prekomerno težo.