natgillin/translations-raw huggingface dataset:
In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis. 
V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila LIFMIOR v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila LIFMIOR v odmerku 25 mg dvakrat na teden.
The 10 mg presentation is for paediatric patients prescribed a dose of 10 mg or less. 
10 mg viala je namenjena za uporabo pri otrocih, ki potrebujejo odmerek 10 mg ali manj.
CARTON TEXT - (50 mg Pre-filled Pen) - EU/1/16/1165/011-013 
BESEDILO NA ŠKATLI - (50 mg napolnjeni injekcijski peresnik) - EU/1/16/1165/011-013
These include the alcohol swab from the LIFMIOR carton and a cotton ball or gauze. 
Pripravite si še druge stvari, ki jih boste potrebovali pri injiciranju, to sta alkoholna blazinica iz škatle z zdravilom LIFMIOR in košček vate ali gaze.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
Alergijske reakcije: Če se pri vas ali otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
LIFMIOR 25 mg powder and solvent for solution for injection etanercept 
LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje etanercept
CARTON TEXT - (50 mg Pre-filled Syringe) - EU/1/16/1165/008-010 
BESEDILO NA ŠKATLI - (50 mg napolnjena injekcijska brizga) - EU/1/16/1165/008-010
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. 
Domnevajo, da je mehanizem delovanja etanercepta kompetitivna inhibicija vezave TNF na receptorje za TNF na površini celice.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject LIFMIOR." 
Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR".
New onset cardiac failure congestive (see section 4.4) 
nastanek kongestivnega srčnega popuščanja (glejte poglavje 4.4)
Remissionc 
Odziv
The presence of hepatic impairment should not require a change in dosage. 
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
25 mg LIFMIOR administered twice weekly is the recommended dose. 
Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden.
• Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
Alergijske reakcije: Če se pri otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
Tell your doctor if the child develops any change in the appearance of the skin or growths on the skin. 
Pri nekaterih bolnikih, ki so prejemali zdravilo LIFMIOR, se je pojavil kožni rak. Povejte zdravniku, če se pri otroku razvije kakšna sprememba videza kože ali rašče na koži.
These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin 
Znaki lahko vključujejo zmanjšanje telesne mase, vročino, pojav otekline (z bolečino ali brez nje), trdovratnega kašlja, zatrdlin ali izrastkov na koži;
Do not inject into tender, bruised or hard skin. 
Ne injicirajte v predelih, kjer je koža občutljiva, poškodovana ali trda.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
Cardiac disorders 
Kongestivno srčno popuščanje
LIFMIOR 25 mg powder and solvent for solution for injection. 
LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje
Each pre-filled syringe of LIFMIOR contains 25 mg etanercept. 
Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 25 mg etanercepta.
A 25 mg strength of LIFMIOR is available for doses of 25 mg. 
Predpisali so vam zdravilo LIFMIOR v jakosti 50 mg. Za 25 mg odmerek je na voljo zdravilo LIFMIOR jakosti 25 mg.
If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
Če se pri otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
• This medicine has been prescribed for you or a child in your care. 
Zdravilo je bilo predpisano vam ali otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
Pairwise comparison p-values: † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR. 
Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z zdravilom LIFMIOR.
The recommended dose is 25 mg LIFMIOR administered twice weekly, or 50 mg administered once weekly. 
Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden ali 50 mg enkrat na teden.
LIFMIOR 25 mg solution for injection in pre-filled syringe etanercept 
LIFMIOR 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept
The solution should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein. 
Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledo rumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
Each MYCLIC pre-filled pen contains 50 mg of etanercept. 
En napolnjeni injekcijski peresnik MYCLIC vsebuje 50 mg etanercepta.
The needle cover should not be removed while allowing the prefilled syringe to reach room temperature. 
Med čakanjem, da se napolnjeni injekcijski peresnik segreje na sobno temperaturo, pokrovčka igle ne smete odstraniti.
Detailed instructions on how to inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”. 
Podrobna navodila o injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
Always use this medicine exactly as the doctor has told you. 
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
Detailed instructions on how to prepare and inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”. 
Podrobna navodila o pripravi in injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
In this study most psoriatic arthritis patients receiving LIFMIOR were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower and few patients had two-fold rises in titres compared to patients not receiving LIFMIOR. 
Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo LIFMIOR, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8). 
Čvrste in hematopoetične maligne bolezni (razen kožnega raka) V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 4.8).
Each vial of LIFMIOR contains 25 mg etanercept. 
Ena viala zdravila LIFMIOR vsebuje 25 mg etanercepta.
If this is the case, start again with another vial. 
V tem primeru si pripravite nov podstavek za odmerjanje.
• Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. 
Bolezni krvi: Če se pri vas ali otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs. 
Eno pakiranje vsebuje 2, 4 ali 12 injekcijskih peresnikov in 2, 4 ali 12 alkoholnih blazinic.
The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. 
Pri otrocih z juvenilnim idiopatskim artritisom, ki imajo telesno maso manjšo od 25 kg, bo morda primernejša uporaba 10 mg viale.
and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). 
Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor.
Each pre-filled syringe of LIFMIOR contains 50 mg etanercept. 
Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 50 mg etanercepta.
• Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. 
Bolezni krvi: Če se pri otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR”. 
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR." 
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF LIFMIOR”. 
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "Navodila za pripravo in dajanje injekcije zdravila LIFMIOR".
LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use Etanercept 
LIFMIOR 10 mg prašek za raztopino za injiciranje etanercept subkutana uporaba
No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. 
V kliničnih preskušanjih pri bolnikih z revmatoidnim artritisom niso opazili take vrste toksičnosti, ki bi omejevala odmerjanje.
LIFMIOR did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg. 
Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, zdravilo LIFMIOR ni povzročilo toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
(If not, don't use the dose tray and consult your pharmacist). 
Podstavek z zdravilom mora vsebovati vse spodaj navedene pripomočke (če jih ne, ne uporabite zdravila in se posvetujte s farmacevtom).
How to store LIFMIOR 
Shranjevanje zdravila LIFMIOR
It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein. 
Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledorumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein. 
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
LIFMIOR 50 mg solution for injection in pre-filled syringe. 
LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Cartons contain 2, 4 or 12 pre-filled syringes of LIFMIOR with 2, 4 or 12 alcohol swabs. 
Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila LIFMIOR in 2, 4 ali 12 alkoholnih blazinic.
LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept 
LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
Each pre-filled pen contains 50 mg of etanercept. 
En napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
2 pre-filled syringes2 alcohol swabs 
2 napolnjeni injekcijski brizgi 2 alkoholni blazinici
Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in napolnjeni injekcijski brizgi poleg oznake ''EXP''.
The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles. 
Raztopina mora biti bistra in brezbarvna do bledo rumena ali bledo rjava in ne sme vsebovati kepic, kosmičev ali delcev.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with LIFMIOR. 
Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19). 
Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 19).
With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force. 
Z izkušnjami boste našli kot, ki je za vas ali otroka najustreznejši.
Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger. 
50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.
LIFMIOR is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown, solution for injection (solution for injection). 
25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo LIFMIOR je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
• This medicine has been prescribed for a child in your care. 
Zdravilo je bilo predpisano otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use. 
LIFMIOR 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih
The solution should be clear, colourless to pale yellow or pale brown, with no lumps or flakes or particles. 
Raztopina mora biti bistra, brezbarvna do bledo rumena oziroma bledo rjava in ne sme vsebovati kepic, kosmičev ali delcev.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - (For paediatric use) - EU/1/16/1165/001 1. 
BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - (za uporabo pri otrocih)EU/1/16/1165/001
b. Setting up for an injection 
Priprava na injiciranje
With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 4). 
Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 4).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/16/1165/002-004 
BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - EU/1/16/1165/002-004
No treatment was given for the majority of injection site reactions in the LIFMIOR treatment groups, and the majority of patients who were given treatment received topical preparations such as corticosteroids, or oral antihistamines. 
V skupinah, ki so prejemale zdravilo LIFMIOR, večine reakcij na mestu injiciranja ni bilo potrebno zdraviti.
Live vaccines should not be given concurrently with LIFMIOR. 
Med zdravljenjem z zdravilom LIFMIOR bolnik ne sme prejeti živih cepiv.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - (25 mg Pre-filled Syringe) - EU/1/16/1165/005 
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - (25 mg napolnjena injekcijska brizga) - EU/1/16/1165/005-007
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL - (For paediatric use) - EU/1/16/1165/001 1. 
BESEDILO NA NALEPKI VIALE - (za uporabo pri otrocih) - EU/1/16/1165/001
Paediatric plaque psoriasis 
Otroška psoriaza v plakih
1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack) 
12 (3 x 4) napolnjen injekcijski peresniks (skupno pakiranje)
Immediate Packaging 
1 napolnjen injekcijski peresnik
Pack size bottle (HDPE) 
Stična ovojnina Velikost pakiranja plastenka (HDPE)
Other medicines and X 
Druga zdravila in zdravilo X
This combination apparently increases the risk for adverse events and is therefore not recommended. 
Ta kombinacija očitno poveča tveganje neželenih učinkov, zato ni priporočljiva.
“Your doctor may need to change your dose and/or to take other precautions: 
“Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe:
• “if you are taking any of the following medicines used to treat high blood pressure: 
• “če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
Section 4.5 - Interaction with other medicinal products and other forms of interaction 
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
I. Summary of Product Characteristics 
I. Povzetek glavnih značilnosti zdravila
“Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
“Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS)
These medicines are for the treatment of heart failure (see “Other medicines and X”).” 
To so zdravila za zdravljenje srčnega popuščanja (glejte "Druga zdravila in zdravilo X")."
Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines. 
Obvestite <zdravnika> <ali> <farmacevta>, če <jemljete> <uporabljate>, ste pred kratkim <jemali> <uporabljali> ali pa boste morda začeli <jemati> <uporabljati> katero koli drugo zdravilo.
Caution should be observed when initiating therapy in patients with heart failure. 
Previdnost je potrebna pri uvajanju zdravljenja bolnikom s srčnim popuščanjem.
Evaluation of patients with heart failure should always include assessment of renal function.” 
Ocena bolnikov s srčnim popuščanjem mora vedno obsegati tudi oceno delovanja ledvic.”
Section 4.3 - Contraindication 
Poglavje 4.3 - Kontraindikacija
Section 5.1 - Pharmacodynamic properties 
Poglavje 5.1 - Farmakodinamične lastnosti
The following wording should be added to this section (for telmisartan-containing products that already have an extensive wording on ONTARGET in section 5.1, the following wording should be added in addition to the existing text, which should be maintained): 
V to poglavje je treba dodati naslednje besedilo (pri zdravilih, ki vsebujejo telmisartan in v poglavju 5.1 že imajo obsežno razlago o študiji ONTARGET, je treba poleg obstoječega besedila (ki ga je treba ohraniti) dodati naslednje besedilo):
“Heart failure 
“Srčno popuščanje
Section 4.1 - Therapeutic indications 
Poglavje 4.1 - Terapevtske indikacije
Section 4.4 - Special warnings and precautions for use 
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
What X is and what it is used for 
1. poglavje Kaj je zdravilo X in za kaj ga uporabljamo
What X is and what it is used for “X can be used to treat symptomatic heart failure in adult patients. 
1. poglavje Kaj je zdravilo X in za kaj ga uporabljamo “Zdravilo X se lahko uporablja za zdravljenje simptomatskega srčnega popuščanja pri odraslih bolnikih.
Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2). 
Ocena bolnikov s srčnim popuščanjem mora vedno obsegati tudi oceno delovanja ledvic (glejte poglavje 4.2).
“Concomitant therapy with an ACE-inhibitor in heart failure 
“Sočasno zdravljenje z zaviralcem ACE pri srčnem popuščanju
Valsartan may be administered with other heart failure therapies. 
Valsartan se lahko uporablja skupaj z drugimi zdravili za zdravljenje srčnega popuščanja.
Annex II Amendments to relevant sections of the summary of product characteristics and package leaflet 
Spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
• “if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren” 
• “če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.”
Use of [Product name] in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2). 
Uporaba zdravila [Ime zdravila] pri bolnikih s srčnim popuščanjem pogosto povzroči določeno znižanje krvnega tlaka, a ob upoštevanju navodil za odmerjanje po navadi ni potrebna prekinitev zdravljenja zaradi dolgotrajne simptomatske hipotenzije (glejte poglavje 4.2).
Do not <take> <use> X <:> 
Ne <jemljite> <uporabljajte> zdravila X<:>
The combination of an ACE-inhibitor, a potassium-sparing diuretic and [Product name] is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).” 
Kombinacija zaviralca ACE, diuretika, ki varčuje s kalijem, in zdravila [Ime zdravila] ni priporočljiva in pride v poštev le po natančni oceni možnih koristi in tveganj (glejte poglavja 4.4, 4.8 in 5.1)."
Use of these combinations should be under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
Uporaba teh kombinacij mora potekati pod nadzorom specialista in s pogostimi natančnimi kontrolami delovanja ledvic, elektrolitov in krvnega tlaka.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosteronesystem (e.g. patients with severe congestive heart failure), treatment with ACE-inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death. 
Pri bolnikih, pri katerih je delovanje ledvic lahko odvisno od delovanja sistema renin-angiotenzinaldosteron (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem), so zdravljenje z zaviralci ACE spremljale oligurija in/ali napredujoča azotemija, ali, redko, akutna odpoved ledvic in/ali smrt.