natgillin/translations-raw huggingface dataset:
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use. 
Posamezno škatlo s 4 peresniki in 4 iglami se lahko shranjuje pri sobni temperaturi, ki ne presega 30 °C, vendar ne več kot skupaj 4 tedne pred uporabo.
In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures below clinical exposure). 
so ob odmerkih ≥ 1 mg/kg/dan (izpostavljenosti, manjše od klinične izpostavljenosti) pri mladičih F1 opažali zmanjšano telesno maso pred odstavitvijo.
There were no albiglutide related findings in thyroids of monkeys given up to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC). 
V ščitnicah opic, ki so dobivale odmerek 50 mg/kg/teden (75-kratnik klinične izpostavljenosti na podlagi AUC) do 52 tednov, niso ugotovili z albiglutidom povezanih sprememb.
This dose was associated with an increased frequency of nausea, vomiting, and headache. 
Ta odmerek je bil povezan z večjo pogostnostjo navzee,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box 
ZUNANJA NALEPKA - Skupno pakiranje vsebuje 12 peresnikov z enkratnim odmerkom in 12 igel za peresnike (3 pakiranja s 4 peresniki in 4 iglami) - z modro škatlo
Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects. 
Enkraten odmerek 100 mg albiglutida je pri zdravih prostovoljcih v primerjavi s placebom upočasnil želodčno praznjenje trdnih in tekočih snovi.
Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect. 
Kot občasen neželen učinek je bil opisan pankreatitis.
Questions and answers about the instructions for use of the pre-filled pen 
Vsebina pakiranja in dodatne informacije Navodila za uporabo napolnjenega injekcijskega peresnika (na hrbtni strani) Vprašanja in odgovori o navodilih za uporabo napolnjenega injekcijskega peresnika
Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as addon therapy in patients inadequately controlled on metformin  sulfonylurea 
Rezultati (po 52 tednih) z aktivno učinkovino kontrolirane študije, ki je primerjala 30 mg zdravila Eperzan na teden subkutano (s fakultativnim zvišanjem na 50 mg na teden) z insulinom glarginom (titriranim tedensko v skladu z informacijami za predpisovanje) kot dodatkom zdravljenju bolnikov, neustrezno urejenih z metforminom ± sulfonilsečnino
UNIQUE IDENTIFIER - HUMAN READABLE DATA 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PODATKI NA ZUNANJI OVOJNINI
Placebo + Metformin 1,500 mg daily + Glimepiride 4 mg daily 
Placebo + metformin ≥ 1.500 mg na dan + glimepirid 4 mg na dan
Step 9 Dispose pen 
5. korak Namestite iglo
Placebo Sitagliptin Glimepiride Albiglutide x axis; Weeks (Rescue free), y axis; Probability of event 
Os x: tedni (brez rešilnega ukrepanja), os y: verjetnost dogodka
Across the 8 clinical trials, and including subjects in all treatment groups, a total of 19% of patients (N = 937) were 65 years of age and older, and 2% (N = 112) were 75 years of age and older, 52% 
(N = 937) starih 65 let ali več in 2 % (N = 112) starih 75 let ali več; 52 % je bilo moških in povprečni indeks telesne mase (ITM) je bil 33 kg/m2.
Pioglitazone + Metformin 1,500 mg daily + Glimepiride 4 mg daily 
Pioglitazon + metformin ≥ 1.500 mg na dan + glimepirid 4 mg na dan
Reduced F1 body weight reversed post-weaning with the exception of F1 females from dams treated perinatally (end of gestation to 10 days postpartum) at 5 mg/kg/day with no other effects on development. 
Zmanjšana telesna masa je pri F1 izginila po odstavitvi; izjema so bile samice F1 samic-mater, ki so perinatalno (od konca gestacije do 10 dni po skotitvi) prejemale
Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily 
Eperzan 30 mg/50 mg na teden + metformin ≥ 1.500 mg na dan
Waiting may result in a blocked or clogged needle. 
To lahko povzroči zamašitev igle.
Over 2,300 patients have received Eperzan in 8 placebo- or active-controlled phase III studies. 
V 8 študijah III. faze, kontroliranih s placebom ali aktivno učinkovino, je zdravilo Eperzan prejemalo več kot
Step 1 Check Pen 
1. korak Preverite peresnik
Similar exposure is achieved with SC administration of albiglutide in the abdomen, thigh, or upper arm. 
Izpostavljenost je po subkutanem injiciranju albiglutida v trebuh, stegno ali nadlaket podobna.
Difference from glimepiride + metforminb, (95% CI) 
Razlika od kombinacije glimepirid + metforminb, (95 % IZ)
-0.6 (-1.1, -0.1)c a Intent to treat population - Last Observation Carried Forward (ITT-LOCF) b Adjusted mean c P<0.05 for treatment difference 
-0,6 (-1,1, -0,1)c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja (ITT-LOCF - intent to treat popuation - last observation carried forward)
Results at 52 weeks in a placebo-controlled study with two doses of Eperzan (30 vs. 50 mg SC weekly) as monotherapy 
Rezultati s placebom kontrolirane študije dveh odmerkov zdravila Eperzan (30 mg v primerjavi s 50 mg subkutano na teden) kot monoterapije po 52 tednih
Difference from placebo + metforminb, (95% CI) 
Razlika od kombinacije placebo + metforminb, (95 % IZ)
PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles) - without blue box 
ŠKATLA - Skupno pakiranje vsebuje 12 peresnikov z enkratnim odmerkom in 12 igel za peresnike (3 pakiranja s 4 peresniki in 4 iglami) - brez modre škatle
Eperzan 30 mg Weekly + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily) 
Eperzan 30 mg na teden + pioglitazon ≥ 30 mg na dan (+/- metformin ≥ 1.500 mg na dan)
Waiting the full 15 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner. 
S tem, da počakate polnih 15 minut, boste zagotovili, da sta prašek z zdravilom in voda pravilno premešana,
• indigestion 
• bruhanje,
MIXING YOUR MEDICINE AND WAITING 30 MINUTES (STEPS 2-3) What if I do not wait 30 minutes after turning the pen to the Number 2? 
KORAK) Kaj, če po obratu peresnika na številko 2 ne počakam 30 minut?
Proportion Achieving HbA1c <7% Body Weight (kg) 
Delež bolnikov, ki so dosegli HbA1c < 7 % Telesna masa (kg)
Waiting the full 30 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner. 
S tem, da počakate polnih 30 minut, boste zagotovili, da sta prašek z zdravilom in voda pravilno premešana,
The primary endpoint was change in HbA1c from baseline at 32 weeks. 
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 32 tednih.
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 299). 
Učinkovitost zdravila Eperzan so ocenili v 3-letni randomizirani, dvojno slepi multicentrični študiji (n =
-1.5 (-2.1, -1.0) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference 
-1,5 (-2,1, -1,0) c a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji
Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to you. 
Če menite, da kaj od tega velja za vas, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, preden uporabite zdravilo Eperzan.
Difference from placebo + pioglitazoneb (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference 
Razlika od kombinacije placebo + pioglitazonb (95 % IZ) a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji Dodatek kombinaciji metformin + sulfonilsečnina
Each 50 mg pen delivers 50 mg albiglutide in a volume of 0.5 ml. 
Po pripravi peresnik odda 50 mg albiglutida na 0,5-ml odmerek.
Eperzan Insulin glargine ( 20 units per day) 
Insulin glargin (≥ 20 enot na dan)
Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use. 
Peresniki so lahko shranjeni na sobni temperaturi, ki ne presega 30 °C, vendar ne več kot skupaj 4 tedne pred uporabo.
Each 30 mg pen delivers 30 mg albiglutide in a volume of 0.5 ml. 
Po pripravi peresnik odda 30 mg albiglutida na 0,5-ml odmerek.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Remove Outer Needle Cap 
1. korak Odstranite zunanji pokrovček igle
Talk to your doctor, nurse or pharmacist before using Eperzan: 
Pred začetkom uporabe zdravila Eperzan se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom:
Results at 26 weeks in a study of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) versus sitagliptin (dosed according to renal function) in patients with different degrees of renal impairment 
50 mg na teden, če je bilo potrebno) v primerjavi s sitagliptinom (odmerjanim glede na delovanje ledvic) pri bolnikih z različnimi stopnjami okvare ledvic
Increased mortality and morbidity were seen at all doses (1 mg/kg/day) in lactating females in mouse preand postnatal development studies. 
V študijah pre- in postnatalnega razvoja so pri doječih samicah opažali večjo umrljivost in obolevnost pri vseh odmerkih (≥ 1 mg/kg/dan).
MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2-3) What if I do not wait 15 minutes after turning the pen to the Number 2? 
KORAK) Kaj, če po obratu peresnika na številko 2 ne počakam 15 minut?
The primary endpoint was change in HbA1c from baseline at 52 weeks. 
Primarni opazovani dogodek je bila sprememba HbA1c od izhodišča po 52 tednih.
Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with dyspnoea, have been reported with albiglutide. 
V kombinaciji z albiglutidom so poročali o možnih preobčutljivostnih reakcijah vključno z angioedemom
Change at Week 32b Difference from liraglutideb (95% CI) 
Sprememba po 32 tednihb Razlika od liraglutidab (95 % IZ)
Gastrointestinal events with Eperzan occurred more frequently in patients with moderate to severe renal impairment (eGFR 15 to 59 ml/min/1.73 m2) than in those with mild renal impairment or normal renal function. 
(eGFR od 15 do 59 ml/min/1,73 m2) kot pri bolnikih z blago okvaro ali z normalnim delovanjem ledvic.
Remove Inner Needle Cap 
2. korak Odstranite notranji pokrovček igle
Change at Week 26b Difference from sitagliptinb (95% CI) 
Sprememba po 26 tednihb Razlika od sitagliptinab (95 % IZ)
The between-treatment difference in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the prespecified noninferiority margin (0.3%). 
Po 52 tednih je bila razlika HbA1c v primerjavi z izhodiščem med zdravilom Eperzan in insulinom glargin 0,1 % (-0,04, 0,27) in je dosegla vnaprej opredeljeno mejo neinferiornosti (0,3 %).
Add-on combination therapy 
Dodatek v kombiniranem zdravljenju
You will mix them together by twisting the pen. 
Premešate ju s sukanjem peresnika.
Powder for solution for injection: 
Prašek in vehikel za raztopino za injiciranje
8b Press the injection button down slowly and steadily until you hear a “click” (Figure S). 
8b Počasi in enakomerno pritiskajte gumb za injiciranje dol,
Difference from sitagliptin + metforminb, (95% CI) 
Razlika od kombinacije sitagliptin + metforminb, (95 % IZ)
No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg weekly). 
Uporaba enkratnega odmerka racemnega varfarina (25 mg) v stanju dinamičnega ravnovesja albiglutida (50 mg na teden) ni klinično pomembno vplivala na farmakokinetiko R- in S-enantiomera varfarina.
Albiglutide also slows gastric emptying. 
Placebo Sitagliptin Glimepiride Albiglutide
In clinical trials of at least 2 years duration, 8% of subjects in the Eperzan group discontinued active treatment because of an adverse event compared with 6% in the all comparators group. 
8 % preiskovancev v skupini z zdravilom Eperzan in 6 % v skupini z vsemi primerjalnimi zdravili.
Pull off Needle Caps and Discard 
Snemite pokrovčka igle in ju zavrzite
Difference from pioglitazone + met + glimb (95% CI) 
Razlika od kombinacije pioglitazon + met + glimb
• feeling sick (nausea) 
• občutek slabosti v želodcu (siljenje na bruhanje),
Eperzan 50 mg powder and solvent for solution for injection 
Eperzan 50 mg prašek in vehikel za raztopino za injiciranje.
Difference from placebob (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference 
Razlika od placebab (95 % IZ) a Populacija z-namenom-zdravljenja - prenos zadnjega opažanja b Korigirano povprečje c p < 0,05 za razliko med zdravljenji Kombinirano zdravljenje Dodatek metforminu
Effects on embryo-foetal development (embryo-foetal lethality and skeletal variations) were observed at 50 mg/kg/day (at low multiple of clinical exposure). 
Pri 50 mg/kg/dan (to je nizek večkratnik klinične izpostavljenosti) so opažali vplive na embrio-fetalni razvoj (embrio-fetalna umrljivost in spremembe okostja).
Reconstitution time 
Čas priprave.
Eperzan 30 mg powder and solvent for solution for injection 
Eperzan 30 mg prašek in vehikel za raztopino za injiciranje.
STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 30 mg per 0.5 ml following reconstitution. 
En odmerek po pripravi vsebuje 30 mg na 0,5 ml.
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. 
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, medicinske sestre ali farmacevta.
Difference from insulin glargineb (95% CI) 
Sprememba po 52 tednihb Razlika od insulina glarginab (95 % IZ)
Stop taking Eperzan. 
Zanihajte peresnik
Once weekly Eperzan pen 30 mg 
Peresnik zdravila Eperzan 30 mg enkrat na teden
STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 50 mg per 0.5 ml following reconstitution. 
En odmerek po pripravi vsebuje 50 mg na 0,5 ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/002 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/002
Step 5 Attach needle 5a Peel tab from outer needle cap (Figure L). 
5a Odlepite prelepko z zunanjega pokrovčka igle (Slika L).
or 
Redki
Eperzan 30 mg powder and solvent for solution for injection Each pen delivers 30 mg albiglutide per 0.5 ml dose following reconstitution. 
Vsak peresnik s 30 mg odda 30 mg albiglutida v prostornini 0,5 ml. - Topilo je voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/004 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/004
Talk to your doctor if you are taking acarbose and Eperzan at the same time. 
Če sočasno jemljete akarbozo in zdravilo Eperzan, se posvetujte z zdravnikom.
Discontinuation of treatment 
NAČIN IZDAJANJA ZDRAVILA
Once weekly Eperzan pen 50 mg 
Peresnik zdravila Eperzan 50 mg enkrat na teden
Eperzan 50 mg powder and solvent for solution for injection Each pen delivers 50 mg albiglutide per 0.5 ml dose following reconstitution. 
Vsak peresnik s 50 mg odda 50 mg albiglutida v prostornini 0,5 ml. - Topilo je voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/001
Sitagliptin 100 mg daily + Metformin 1,500 mg daily 
Sitagliptin 100 mg na dan + metformin
Acute pancreatitis 
Igla Prelepka
Twist Pen to Mix Medicine 
Zasučite peresnik, da boste premešali zdravilo
MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/003 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/003
Severe gastrointestinal disease 
Huda bolezen prebavil
DO NOT attach at an angle. 
NE NAMEŠČAJTE igle pod kotom.
Follow the steps below in the exact order they are presented. 
Sledite spodaj opisanim korakom v natančno takšnem zaporedju, v kakršnem so navedeni.
Check with your doctor, nurse or pharmacist if you are not sure. 
Če ste negotovi, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Target species 
Ciljne živalske vrste
• The Committee considered the referral under Article 30 of Directive 2001/83/EC; 
• odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
This may lead to hypotension and circulatory collapse. 
To lahko vodi do hipotenzije in cirkulacijskega kolapsa.
The harmonisation of the quality aspects of this product is considered to be acceptable and adequately justified. 
Šteje se, da je usklajenost vidikov kakovosti tega zdravila sprejemljiva in ustrezno utemeljena.
Mepivacaine was first approved in 1960 by the US Food and Drug Administration. 
Mepivakain je prvič odobril Zvezni urad ZDA za hrano in zdravila leta 1960.
In addition minor editorial changes were introduced to improve readability. 
Poleg tega so bile vključene manjše uredniške spremembe, ki omogočajo boljšo berljivost.
Module 3 - Quality 
Modul 3 - Kakovost
The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. 
Količino za injiciranje je treba določiti glede na otrokovo starost in telesno maso ter velikost operacije.
As a precautionary measure and due to lack of data in this potentially more vulnerable population, the lowest dose leading to efficient anaesthesia should be applied. 
Kot previdnostni ukrep in zaradi pomanjkanja podatkov glede te populacije, ki je lahko ranljivejša, je treba uporabiti najmanjši odmerek, ki zadošča za učinkovito anestezijo.
In section 4.9 regarding overdose, two different types are described; absolute and relative overdose. 
V poglavju 4.9, ki obravnava preveliko odmerjanje, sta opisani dve različni vrsti: absolutno in relativno preveliko odmerjanje.
Pharmacokinetic changes are also observed with aging. 
Farmakokinetične spremembe so ugotovljene tudi pri staranju.
Other ingredients include sodium chloride, sodium hydroxide and water for injection. 
Med drugimi sestavinami so natrijev klorid, natrijev hidroksid in voda za injekcije.
In the EU, Scandonest is authorised in 22 Member States (MS) through national procedures, and in 5 MSs (Sweden, Finland, Portugal, Spain, Malta) through mutual recognition procedure (MRP). 
V EU je bilo zdravilo Scandonest v 22 državah članicah odobreno z nacionalnim postopkom, v petih državah članicah (na Švedskem, Finskem, Portugalskem, v Španiji in na Malti) pa s postopkom z medsebojnim priznavanjem.
The updated sections of Module 3 sections include: Active substance, Control of active substance, Specification, Finished product, Description and composition of the finished substance, Manufacture, Description of manufacturing process and process controls, Process validation and/or evaluation, Control of Excipients, Control of Finished substance, Specifications, Analytical procedures, Container Closure System and Stability. 
Posodobljena poglavja Modula 3 vključujejo naslednja poglavja: Učinkovina, Kontrola učinkovine, Specifikacija, Končni izdelek, Opis in sestava končne snovi, Proizvodnja, Opis proizvodnega postopka in kontrole postopka, Validacija in/ali vrednotenje postopka, Kontrola pomožnih snovi, Kontrola končne snovi, Specifikacije, Analitični postopki, Sistem zapiranja vsebnika in Stabilnost.
Moreover information on managing dose-related toxicity and other acute emergencies has been included. 
Dodatno so bile vključene informacija o obravnavi toksičnosti, povezane z odmerjanjem, in drugih nujnih akutnih stanj.
Thus, local anaesthetics should not be used in epileptic patients whose seizures are poorly controlled. 
Zato se lokalni anestetiki ne smejo uporabljati pri epileptičnih bolnikih, katerih napadi so slabo nadzirani.
The maximum recommended dose is 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg. 
Največji priporočeni odmerek je 4,4 mg/kg telesne mase, absolutni največji priporočeni odmerek pa ne sme preseči
The CHMP deemed the submitted evidence adequate to support the indication in adults and in children from 4 years of age (ca. 20 kg body weight). 
Po mnenju odbora CHMP so predloženi dokazi zadostni za podporo indikaciji pri odraslih in otrocih, starejših od štirih let (s telesno maso približno 20 kg).
This recommendation is also supported by the inconsistency of recognition and professional rights of chiropodist profession across EU. 
V prid temu priporočilu govori tudi neskladnost priznavanja in poklicnih pravic pedikerjev v državah EU.
The wording for the method of use was harmonised to the standard terms “infiltration and perineural use” taking in consideration the requirements from the EDQM (European Directorate for the Quality of Medicines & HealthCare). 
Besedilo za način uporabe je bilo usklajeno s standardnimi izrazi „infiltracija in perinevralna uporaba“, pri čemer so bile upoštevane zahteve Evropskega direktorata za kakovost zdravil in zdravstvenega varstva (EDQM).
• The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including based on the documentation submitted and the scientific discussion within the Committee; 
• odbor je pregledal podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom, med drugim na podlagi predložene dokumentacije in znanstvene razprave v odboru;
The CHMP considers that the data submitted in support of the chiropody procedures indication are not adequate to establish the efficacy of using mepivacaine for all chiropody applications and recommended the deletion of this indication. 
Odbor CHMP meni, da podatki, predloženi v podporo indikaciji za postopke pedikure, ne zadoščajo za določitev učinkovitosti uporabe mepivakaina pri vseh uporabah za pedikuro in je zato priporočil, da se ta indikacija izbriše.
Local anaesthetics as cardiovascular depressants exert a negative inotropic and chronotropic effect on the myocardium and produce peripheral vasodilation. 
Lokalni anestetiki, kot so kardiovaskularni depresorji, imajo negativen inotropni in kronotropni učinek na miokardij ter povzročajo periferno vazodilatacijo.
The CHMP concluded that the benefit-risk balance of Scandonest and associated names remains favourable, subject to the agreed changes to the product information. 
Odbor je zaključil, da je razmerje med tveganji in koristmi zdravila Scandonest in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
As a result of the review of mepivacaine during a worksharing procedure in accordance to Article 45 of Regulation No 1901/2006, in 2010, the use of mepivacaine is contraindicated in children below 4 years of age (and less than 20kg of body weight). 
Kot rezultat pregleda mepivakaina med postopkom delitve dela iz leta 2010 skladno s členom 45 Uredbe št. 1901/2006 je uporaba mepivakaina kontraindicirana pri otrocih, mlajših od štirih let (s telesno maso manj kot 20 kg).
For the recommended doses the patient's body weight has to be taken into account. 
Za uporabo priporočenih odmerkov je treba upoštevati telesno maso bolnika.
The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines. 
Imetnik dovoljenja za promet z zdravilom je predlagal usklajena priporočila za odmerjanje, ki temeljijo na odmerkih, ki so jih proučevali v kliničnih preskušanjih, in ki jih podpirajo farmakodinamični in farmakokinetični podatki ter so skladni z mednarodnimi, evropskimi in nacionalnimi smernicami.