FrancophonIA/ELRC3.0 huggingface dataset:
English: Mepivacaine maximum concentrations were reported to be between 0.4 - 1.2 µg/ml at around 30 minutes post-intraoral injection with one cartridge and between 0.95-1.70 µg/ml with two cartridges.
Slovenian: 1,2 µg/ml približno 30 minut po intraoralnem injiciranju z enim vložkom in med 0,95 - 1,70 µg/ml z dvema vložkoma.
English: − changes in the color of your skin with confusion, cough, fast heart rate, rapid breathing, sweating: this might be symptoms of a deficiency of oxygen in your tissues (hypoxia);
Slovenian: širjenje krvnih žil (vazodilatacija), spremenjena barva kože z zmedenostjo, kašljem, hitrim bitjem srca, hitrim dihanjem, znojenjem: to so lahko simptomi pomanjkanja kisika v vaših tkivih (hipoksija),
English: 4.1 Therapeutic indications {Scandonest and associated names (see Annex I) strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Slovenian: Zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} je lokalni anestetik, indiciran za lokalno ali lokoregionalno anestezijo pri zobozdravstvenih operacijah pri odraslih, mladostnikih in otrocih, starejših od 4 let (telesna masa približno 20 kg).
English: Hypotension (with possible circulatory collapse)
Slovenian: Žilne bolezni redki hipotenzija (lahko s kolapsom obtoka)
English: − failure of the heart to contract effectively (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
Slovenian: občutek vrtenja (vrtoglavica), nezmožnost srca za učinkovito krčenje (srčni zastoj), hitro in spremenljivo bitje srca (ventrikularna fibrilacija), huda in onesposabljajoča bolečina v prsnem košu (angina pektoris),
English: − low blood pressure;
Slovenian: povišan krvni tlak.
English: As for any cartridge, the diaphragm should be disinfected prior to use.
Slovenian: Kot pri vseh vložkih je treba membrano pred uporabo dezinficirati.
English: Dysesthesia (oral and perioral), including dysgeusia (e.g., taste metallic, taste distorted), ageusia Dizziness (light headedness) Tremor3
Slovenian: dizestezije (oralno in perioralno), vključno z dizgevzijo (npr. kovinski okus, popačen okus), agevzijo, omotica (rahla vrtoglavica), tremor3
English: CNS symptoms (convulsions, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.
Slovenian: Simptome osrednjega živčnega sistema (konvulzije, depresija osrednjega živčnega sistema) je treba ustrezno zdraviti s primerno podporo dihanja in dihalnih poti ter z uporabo antikonvulzivnih zdravil.
English: The medicinal product should only be used by or under the supervision of dentists, stomatologists or other clinicians sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
Slovenian: Zdravilo lahko uporabljajo samo zobozdravniki, stomatologi ali drugo klinično osebje, ki je ustrezno usposobljeno in seznanjeno z diagnostiko in zdravljenjem sistemske toksičnosti, ali pa se uporablja pod njihovim nadzorom.
English: − loss of consciousness, fit (convulsion), coma;
Slovenian: izguba zavesti, epileptični krči (konvulzije), koma,
English: If a rapid intravascular injection is administered, a high blood concentration of mepivacaine in the coronary arteries may lead to myocardial failure, possibly followed by cardiac arrest, before the CNS is affected.
Slovenian: Pri hitrem intravaskularnem injiciranju lahko velika koncentracija mepivkaina v krvi koronarnih arterij vodi do odpovedi miokarda, ki ji lahko sledi zastoj srca, še preden je prizadet osrednji živčni sistem.
English: If you have any further questions on the use of this medicine, ask your doctor or dentist.
Slovenian: Če imate dodatna vprašanja o tem zdravilu, se posvetujte z zdravnikom ali zobozdravnikom.
English: 5 mostly in patients with underlying cardiac disease or those receiving certain drugs; 6 in predisposed patients or those with risk factors of ischemic heart disease; 7 hypoxia and hypercapnia are secondary to respiratory depression and / or to seizures and sustained muscular exertion; 8 by accidental biting or chewing of the lips or tongue while the anaesthesia persists.
Slovenian: Ti podatki izvirajo iz poročil iz obdobja trženja zdravila, večinoma po živčni blokadi v mandibuli in z zajetostjo različnih vej živca trigeminusa; 5 večinoma pri bolnikih z neko osnovno srčno boleznijo ali tistih, ki prejemajo določena zdravila; 6 pri predisponiranih bolnikih ali tistih z dejavniki tveganja za ishemično bolezen srca; 7 hipoksija in hiperkapnija se pojavita posledično zaradi depresije dihanja in/ali konvulzij in dolgotrajnega izčrpanja mišic; 8 zaradi naključnega ugriza ali grizenja ustnic ali jezika, medtem ko anestezija še traja.
English: In vitro and in vivo testing carried out on mepivacaine hydrochloride did not reveal any genotoxic effect of this product.
Slovenian: Preiskave z mepivakainijevim kloridom in vitro in in vivo niso pokazale genotoksičnih učinkov tega zdravila.
English: The availability of appropriate resuscitation equipment and medication and adequately trained staff is recommended before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Slovenian: Pred uvedbo regionalne anestezije z lokalnimi anestetiki je priporočljiva razpoložljivost primerne opreme in zdravil za oživljanje ter ustrezno usposobljeno osebje za zagotovitev ustreznega zdravljenja kakršnih koli respiratornih in srčno-žilnih nujnih stanj.
English: Mepivacaine distribution covers all body tissues.
Slovenian: Mepivakain se porazdeli po vseh telesnih tkivih.
English: Paediatric population {Scandonest and associated names} is contraindicated in children below 4 years of age (ca. 20 kg body weight) (see section 4.3).
Slovenian: Zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} je kontraindicirano pri otrocih do 4. leta starosti (približno 20 kg telesne mase) (glejte poglavje 4.3).
English: The ratio of the average plasma levels following one and two cartridges were approximately 50%, evidencing a dose proportionality at these dose levels.
Slovenian: Razmerje med povprečnimi ravnmi v plazmi po enem in dveh vložkih je bilo približno
English: - If you have any further questions, ask your doctor, dentist or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, zobozdravnikom ali farmacevtom.
English: The patient's state of consciousness should be monitored after each local anaesthetic injection.
Slovenian: Po vsakem injiciranju lokalnega anestetika je treba nadzirati bolnikovo stanje zavesti.
English: Therefore, nursing mothers are advised not to breastfeed within 10 hours following anaesthesia with {Scandonest and associated names}.
Slovenian: Zato je treba doječim materam naročiti, naj ne dojijo 10 ur po anesteziji z zdravilom {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika}.
English: Dizziness (including a feeling of “spinning”, vision disorder and fatigue), loss of consciousness may occur following administration of this medicine (see section 4).
Slovenian: Po uporabi tega zdravila se lahko pojavita omotica (vključno z občutkom vrtoglavice, motnjami vida in utrujenostjo) in izguba zavesti (glejte poglavje 4).
English: You should not leave the dental office until you recover your abilities (generally within 30 minutes) following the dental procedure.
Slovenian: Ne zapustite zobozdravniške ordinacije, dokler si ne opomorete (običajno v
English: Because of their convulsive actions, all local anaesthetics should be used very cautiously.
Slovenian: Vse lokalne anestetike je treba uporabljati zelo previdno, ker delujejo konvulzivno.
English: − heartbeat coordination problems (conduction disorders, atrioventricular block), abnormal slow heartbeat (bradycardia), abnormal rapid heartbeat (tachycardia), palpitations;
Slovenian: težave s koordinacijo bitja srca (motnje prevajanja, atriventrikularni blok), nenormalno počasno bitje srca (bradikardija), nenormalno hitro bitje srca (tahikardija), palpitacije, nizek krvni tlak,
English: The lowest dose leading to efficient anaesthesia should be used.
Slovenian: Treba je uporabiti najmanjši odmerek, ki povzroči učinkovito anestezijo.
English: The following symptoms may be signs of toxicity due to excessive doses of local anaesthetics: agitation, a sensation of numbness in the lips and tongue, prickling and tingling around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears, muscle stiffness and twitching, low blood pressure, low or irregular heart rate.
Slovenian: Če ste prejeli večji odmerek zdravila X, kot bi smeli Naslednji simptomi so lahko znaki toksičnosti zaradi prevelikega odmerka lokalnega anestetika: razdraženost, občutek odrevenelosti v ustnicah in jeziku, zbadanje in ščemenje v okolici ust, omotica, motnje vida in sluha ter šumenje v ušesih, togost in trzanje mišic, nizek krvni tlak, počasno ali neredno bitje srca.
English: Caution is advised when associating the product of interest with these medications as dizziness may last longer (see section 4.7.
Slovenian: Če se izbrano zdravilo kombinira s temi zdravili, se svetuje previdnost, saj lahko omotica traja dlje (glejte poglavje 4.7).
English: 50 x 1.7 ml cartridges
Slovenian: 50 x 1,7 ml vložek
English: Inhibitors of this cytochrome (e.g. ciprofloxacin, enoxacin, fluvoxamine) may decrease its metabolism, increase the risk of adverse effects and contribute to prolonged or toxic blood levels.
Slovenian: enoksacin, fluvoksamin) lahko zmanjšajo njegovo presnovo, povečajo tveganje za neželene učinke in prispevajo k dolgotrajnejšim ali toksičnim ravnem v krvi.
English: 50 x 2.2 ml cartridges
Slovenian: 50 x 2,2 ml vložek
English: Tachycardia
Slovenian: urtikarija
English: One or more of the following side effects may occur following administration of X.
Slovenian: Po uporabi zdravila X se lahko pojavi eden ali več od naslednjih neželenih učinkov.
English: Adverse reactions following administration of {Scandonest and associated names} are similar to those observed with other local amide anaesthetics.
Slovenian: Neželeni učinki po uporabi zdravila {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} so podobni kot pri drugih lokalnih amidnih anestetikih.
English: Mepivacaine hydrochloride
Slovenian: mepivakainijev klorid
English: Not known Hypoxia7 (including cerebral) Hypercapnia7
Slovenian: tahipneja neznana hipoksija7 (vključno z možgansko)
English: This medicinal product contains 24.67 mg sodium per 10 ml (maximum recommended dose), equivalent to 1.23 % of the WHO recommended maximum daily intake of 2g sodium for an adult.
Slovenian: To zdravilo vsebuje 24,67 mg natrija na 10 ml (največji priporočeni odmerek), kar je enako 1,23 %
English: Excipient(s) with known effect
Slovenian: Pomožne snovi z znanim učinkom:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 30 mg of mepivacaine hydrochloride.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml raztopine za injiciranje vsebuje 30 mg mepivakainijevega klorida.
English: Each cartridge of 2.2 ml of solution for injection contains 66 mg of mepivacaine hydrochloride.
Slovenian: En vložek z 2,2 ml raztopine za injiciranje vsebuje 66 mg mepivakainijevega klorida.
English: Balance disorder (disequilibrium) Somnolence
Slovenian: motnje ravnotežja zaspanost neznana nistagmus
English: − metallic taste, taste distortion, taste loss (dysesthesia);
Slovenian: kovinski okus, spremenjen okus, izguba okusa (dizestezija), omotica (vrtoglavica), tremor,
English: Tachyarrhythmia (including ventricular extrasystoles and ventricular fibrillation)5
Slovenian: Srčne bolezni redki zastoj srca bradiaritmija bradikardija tahiaritmija (vključno s ventrikularnimi ekstrasistolami in ventrikularno fibrilacijo)5 angina pektoris 6
English: If any of these situations applies to you, tell your dentist.
Slovenian: Če se kar koli od zgoraj naštetega nanaša na vas, se posvetujte z zobozdravnikom.
English: Not known Myocardial depression
Slovenian: prevodne motnje (atrioventrikularni blok) tahikardija palpitacije neznana depresija miokarda
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9.)
Slovenian: naj hiperventilirajo in uveden naj bo nadzor (glejte poglavje 4.9);
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of mepivacaine (see section 4.8).
Slovenian: Po uporabi mepivakaina se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4.8).
English: Gingival / oral mucosal exfoliation (sloughing) / ulceration Swelling of tongue, lip, gums Not known Stomatitis, glossitis, gingivitis Salivary hypersecretion
Slovenian: Bolezni prebavil redki navzea bruhanje eksfoliacija (lupljenje)/razjede na dlesni ali ustni sluznici oteklost8 jezika, ustnic, dlesni neznana stomatitis, glositis, gingivitis preveliko izločanje sline
English: − ear disturbances, such as ringing in the ears, oversensitivity of hearing;
Slovenian: motnje v ušesu, kot so zvonjenje v ušesih, prevelika občutljivost sluha, nezmožnost srca za učinkovito krčenje (depresija miokarda),
English: - If you get any side effects, talk to your doctor, dentist or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, zobozdravnikom ali farmacevtom.
English: − euphoric mood, anxiety/nervousness;
Slovenian: Psihiatrične motnje neznana evforično razpoloženje anksioznost/živčnost3
English: How to store X
Slovenian: Shranjevanje zdravila X
English: The medicine administration should take place immediately after the opening of the cartridge.
Slovenian: Zdravilo je treba uporabiti takoj po odprtju vložka.
English: What X contains
Slovenian: Kaj vsebuje navodilo
English: Mepivacaine must be used safely and effectively under appropriate conditions: The local anaesthetic effects may be reduced when {Scandonest and associated names} is injected into an inflamed or infected area.
Slovenian: Lokalni anestetični učinki se lahko zmanjšajo, če se zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} injicira v vneto ali okuženo področje.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva redki trzanje mišic mrzlica (drgetanje)
English: Talk to your dentist before using X if: - You suffer from heart disorders; - You have a severe anaemia; - You suffer from high blood pressure (severe or untreated hypertension); - You suffer from a low blood pressure (hypotension); - You suffer from epilepsy; - You suffer from liver disease; - You suffer from kidney disease; - You suffer from a disease which affects the nervous system and results in neurological disorders
Slovenian: imate bolezni srca, imate hudo anemijo, imate visok krvni tlak (hudo ali nezdravljeno hipertnezijo), imate nizek krvni tlak (hipotenzijo), imate epilepsijo, imate bolezen jeter, imate bolezen ledvic,
English: Skin and subcutaneous tissue Rare
Slovenian: Bolezni kože in podkožja redki izpuščaj (izbruh)
English: Sodium hydroxide (for pH-adjustment) Water for injection
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid natrijev hidroksid (za prilagajanje pH) voda za injekcije
English: Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
Slovenian: En vložek z 1,7 ml raztopine za injiciranje vsebuje 51 mg mepivakainijevega klorida.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila X Vsebina pakiranja in dodatne informacije
English: Neuralgia (Neuropathic pain) Paresthesia (i.e., burning, prickling, itching, tingling, local sensation of heat or cold, with no apparent physical cause) of oral and perioral structures Hypoesthesia / numbness (oral and perioral)
Slovenian: pekoč, mravljinčast, srbeč, gomazeč občutek, lokalen občutek toplote ali hladu brez opaznega fizičnega vzroka) v ustih in perioralno,
English: wheezing/asthma, hives (urticaria): these might be symptoms of hypersensitivity reactions (allergic or allergy-like reactions);
Slovenian: izpuščaj, srbenje, oteklost obraza, ustnic, dlesni, jezika in/ali žrela in težave z dihanjem, piskajoče dihanje/astma, koprivnica (urtikarija): to so lahko simptomi preobčutljivostnih reakcij (alergijskih ali alergijam podobnih reakcij),
English: Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in: - elderly people, - patients with renal or hepatic impairment.
Slovenian: Zaradi pomanjkanja kliničnih podatkov je potrebna posebna previdnost, da bi uporabili najmanjši odmerek, ki povzroči učinkovito anestezijo, pri:
English: Ask your dentist, doctor or pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zobozdravnikom, zdravnikom ali farmacevtom.
English: Toxic effects are dose-dependent, comprising progressively more severe neurological manifestations, followed by vascular, respiratory and finally cardiovascular signs such as hypotension, bradycardia, arrhythmia and cardiac arrest
Slovenian: dihalni in končno srčno-žilni znaki, kot so hipotenzija, bradikardija, aritmija in srčni zastoj.
English: Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01 BB 03
Slovenian: mepivakain Oznaka ATC: N01 BB 03
English: Confusional state, disorientation Speech disorder3 (e.g., dysarthria, logorrhea)
Slovenian: presinkopa, sinkopa; stanje zmedenosti, dezorientiranost, motnje govora3 (npr., dizartrija, logoreja), nemir/agitiranost3,
English: Sedatives (central nervous system depressants)
Slovenian: globoka depresija osrednjega živčevja:
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vložki so namenjeni za enkratno uporabo.
English: If you get any side effects, talk to your doctor or dentist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali zobozdravnikom.
English: {Scandonest and associated names} may have a minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Discard unused solution.
Slovenian: Neporabljeno raztopino zavrzite.
English: Anaphylatic / anaphylactoid reactions Angioedema (Face / tongue / lip / throat / larynx1 / periorbital oedema) Bronchospasm / asthma2
Slovenian: Organski sistem po MedDRA Pogostnost Neželeni učinki Bolezni imunskega sistema redki preobčutljivost anafilaktične/anafilaktoidne reakcije angioedem (obraza/jezika/ustnic/žrela/ grla1/periorbitalni edem) bronhospazem/astma2
English: Marketing Authorisation Holder [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet [Glejte Prilogo I - Izpolni država članica]
English: This is equivalent to 1.23 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: − burning sensation, prickling skin sensation, tingling with no apparent physical cause around the mouth
Slovenian: bolečina zaradi poškodbe živca (nevropatska bolečina), pekoč občutek, zbadajoč občutek na koži, mravljinčenje brez očitnega fizičnega razloga v okolici ust (parestezija),
English: Hyperhidrosis (sweating or perspiration)
Slovenian: eritem srbenje otekanje obraza hiperhidroza (potenje ali znojenje)
English: Very rare side effects (may affect up to 1 in 10,000 people): − high blood pressure.
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: Local swelling Injection site swelling Not known Chest pain Fatigue, asthenia (weakness) Feeling hot
Slovenian: Splošne težave in spremembe na mestu aplikacije redki lokalna oteklost oteklost na mestu injiciranja neznana bolečina v prsnem košu utrujenost, astenija (šibkost)
English: Injection site pain
Slovenian: občutek vročine bolečina na mestu injiciranja
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra in brezbarvna raztopina.
English: Common side effects (may affect up to 1 in 10 people): Headache
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: NAME OF THE MEDICINAL PRODUCT {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA {Scandonest in povezana imena (glejte Dodatek I) jakost farmacevtska oblika}
English: − excessive sweating;
Slovenian: - srčno popuščanje,
English: The clearance of mepivacaine may be reduced when associated with propranolol and it may result in higher serum concentrations of the anaesthetic.
Slovenian: To se lahko kaže v večjih koncentracijah anestetika v serumu.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: − pain due to nerve damage (neuropathic pain);
Slovenian: nevralgija (nevropatska bolečina) parestezije (t.j.
English: − swelling at the site of injection.
Slovenian: OVOJNINAH NALEPKA NA VLOŽKU
English: Dysphonia (Hoarseness1)
Slovenian: hiperkapnija7 disfonija (hripavost1)
English: Increased serum levels of amide anaesthetics have been reported after concomitant administration of cimetidine.
Slovenian: Po sočasni uporabi cimetidina so poročali o povišani ravni amidnih anestetikov v serumu.
English: − fatigue, feeling of weakness, feeling hot, pain at the site of injection;
Slovenian: oteklost ust, ustnic, jezika in dlesni, veliko izločanje sline, utrujenost, občutek šibkosti, občutek vročine, bolečina na mestu injiciranja,
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: Package leaflet: Information for the patient {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Slovenian: Navodilo za uporabo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika}
English: Contains sodium, see package leaflet for further information.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X
English: Amaurosis (blindness) Mydriasis
Slovenian: Hornerjev sindrom ptoza veke enoftalmos diplopija (paraliza of okulomotoričnih mišic) amavroza (slepota) midriaza mioza
English: Accommodation disorder Not known Horner's syndrome Eyelid ptosis
Slovenian: Očesne bolezni redki okvara vida zamegljen vid motnja akomodacije neznana
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA IN POT(I) UPORABE [Glejte Prilogo I - jakost farmacevtska oblika] mepivakainijev klorid infiltriranje in perinevralna uporaba
English: Erythema
Slovenian: Antiaritmiki
English: Bioavailability
Slovenian: Biotransformacija
English: Common Headache Rare
Slovenian: glavobol.
English: Precautions to be taken before administering the medicinal product The medicinal product should not be used if cloudy and discoloured.
Slovenian: Zdravila se ne sme uporabiti, če je motno in spremeni barvo.
English: Possible side effects (frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): evforično razpoloženje, zaskrbljenost/živčnost,
English: Miosis
Slovenian: Odmerjanje
English: Ref. EMEA/CHMP/319054/2008
Slovenian: EMEA/CHMP/319054/2008
English: This review was carried out under an ‘Article 31' referral1.
Slovenian: Pregled je bil opravljen v skladu z napotitvenim postopkom po „ lenu 31“