FrancophonIA/ELRC3.0 huggingface dataset:
English: • decreased amounts of oxygen in the body's tissues (hypoxia), high blood potassium (hyperkalaemia)
Slovenian: • zmanjšano količino kisika v telesnih tkivih (hipoksijo), visoko raven kalija v krvi (hiperkaliemijo) in presnovne motnje, ki so posledica preveč kisline v krvi (metabolično acidozo).
English: The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
Slovenian: Pri otrocih in mladostnikih, starih od 4 do 18 let, je varnostni profil podoben kot pri odraslih, vendar pa so pogosteje poročali o nenamernih poškodbah mehkih tkiv, še posebej pri otrocih, starih od 3 do
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9 of SmPC).
Slovenian: V primeru pojava teh znakov je treba bolnika spodbuditi k hiperventilaciji ter ga nadzorovati (glejte poglavje 4.9 v povzetku glavnih značilnosti zdravila).
English: This medicine should not be used if the solution is cloudy or discoloured.
Slovenian: Tega zdravila ne smete uporabljati, če je raztopina motna ali kakor koli obarvana.
English: No genotoxicity effect was observed during in-vitro and in-vivo studies conducted with articaine alone or in an in vivo study conducted with articaine in combination with adrenaline.
Slovenian: V študijah in vitro ter in vivo, kjer so uporabili samo artikain, oziroma v študiji in vivo, kjer so uporabili artikain v kombinaciji z adrenalinom, niso opazili genotoksičnih učinkov.
English: Other side effects not listed above may also occur in some patients.
Slovenian: Pri nekaterih bolnikih pa se lahko pojavijo še drugi neželeni učinki.
English: The patient's state of consciousness should be monitored after each local anaesthetic injection.
Slovenian: Po vsakem injiciranju lokalnega anestetika je treba spremljati bolnikovo stanje zavesti.
English: 1 NAME OF THE MEDICINAL PRODUCT
Slovenian: IME ZDRAVILA
English: • COMT-inhibitors to treat Parkinson's disease (such as entacapone or tolcapone);
Slovenian: • zaviralce katehol-O-metiltransferaze (zaviralci COMT), ki jih uporabljamo za zdravljenje Parkinsonove bolezni (kot sta entakapon ali tolkapon),
English: • Concomitant treatment with tricyclic antidepressants, as these active substances can intensify the cardiovascular effects of adrenaline.
Slovenian: • sočasno zdravljenje s tricikličnimi antidepresivi, ker lahko te učinkovine okrepijo kardiovaskularne učinke adrenalina (glejte poglavje 4.5).
English: • inflammation or infection in the area to be injected.
Slovenian: • vnetje ali okužbo na predelu, kamor se bo injiciralo zdravilo,
English: • recession displacement of the eyeball into the orbit (Enophthalmos)
Slovenian: • pomik očesnega zrkla nazaj v očesno jamico (enoftalmus),
English: Use this medicinal product under strict medical supervision due to additive or synergistic increases in blood pressure and/or ischemic response.
Slovenian: Zaradi aditivnih ali sinergističnih učinkov na zvišanje krvnega tlaka in/ali ishemični odziv je treba to zdravilo uporabljati pod skrbnim zdravniškim nadzorom.
English: • tumour called pheochromocytoma;
Slovenian: • tumor, imenovan feokromocitom,
English: Adrenaline is a vasoconstrictor added to articaine to slow down absorption into the systemic circulation and thus prolong maintenance of active articaine tissue concentration.The volume of distribution in plasma was about 4 l/kg.
Slovenian: Adrenalin je vazokonstriktor, ki je dodan k artikainu, da upočasni absorpcijo artikaina v sistemski krvni obtok ter s tem podaljša ohranitev aktivne tkivne koncentracije artikaina.
English: It is recommended that dental treatment with articaine/adrenaline be deferred for six months following a stroke due to the increased risk of recurrent strokes.
Slovenian: • bolnikih z motnjami v cerebralnem obtoku, možgansko kapjo v anamnezi Priporočljivo je, da se zobozdravstveni poseg z uporabo artikaina/adrenalina odloži za šest mesecev po kapi zaradi povečanega tveganja za ponovitev kapi.
English: • nausea, vomiting, diarrhea
Slovenian: • slabost, bruhanje, driska,
English: • Sodium metabisulfite: it may rarely cause severe allergic reactions and breathing difficulties
Slovenian: To zdravilo vsebuje natrijev metabisulfit, ki lahko redko povzroči resne alergijske reakcije in težave z dihanjem (bronhospazem).
English: <[To be completed nationally]>
Slovenian: [<Izpolni država članica.>]
English: Contradictory findings were raised from in-vitro and in-vivo genotoxicity studies with adrenaline.
Slovenian: Študije genotoksičnosti in vitro ter in vivo, kjer so uporabili adrenalin, so pokazale protislovne ugotovitve.
English: Reduced doses of this medicinal product should be used due to possible increase in blood pressure and an increased risk of bradycardia.
Slovenian: Zaradi možnega povišanja krvnega tlaka in povečanega tveganja za bradikardijo je treba uporabiti manjši odmerek tega zdravila.
English: For more complex procedures, such as requiring pronounced hemostasis, it is preferable to use {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml.
Slovenian: Pri zapletenejših posegih, ki na primer zahtevajo izrazito hemostazo, je bolje uporabiti {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 10 mikrogramov/ml.
English: Elevated product plasma levels may occur in patients with cholinesterase deficiency or under acetylcholinesterase inhibitors treatment since the product is inactivated at 90% by plasmatic esterases.
Slovenian: Pri bolnikih s pomanjkanjem plazemske holinesteraze ali pri zdravljenju z zaviralci acetilholinesteraze lahko pride do povišanih ravni zdravila v plazmi, saj 90 % artikainijev klorid inaktivirajo esteraze v plazmi.
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of {(Invented) name and associated names (see Annex I)} (see Section 4.8 of SmPC).
Slovenian: Po aplikaciji zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4.8 v povzetku glavnih značilnosti zdravila).
English: Discussion with the anaesthetist before local anaesthetic administration during general anaesthesia is recommended.
Slovenian: Pred aplikacijo lokalnega anestetika med splošno anestezijo je priporočljiv posvet z anesteziologom.
English: How to store X / Y
Slovenian: Shranjevanje zdravila X/Y
English: A reduced amount of adrenaline in dental anaesthesia should be given to patients on COMT inhibitors.
Slovenian: Pri bolnikih, ki se zdravijo z zaviralci COMT, je pri dentalni anesteziji treba uporabiti manjši odmerek adrenalina.
English: (bronchospasm).
Slovenian: (angioedem),
English: • muscle twitch, involuntary muscle contraction
Slovenian: • trzanje mišic, nehotno krčenje mišic,
English: • Patients with uncontrolled hypertension
Slovenian: • bolnikih z nenadzorovano sladkorno boleznijo
English: • medicines used to treat irregular heartbeats (for example digitalis, quinidine);
Slovenian: • zdravila za zdravljenje motenj srčnega ritma (npr. digitalis, kinidin),
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Cardboard carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla iz lepenke
English: 1 Allergic reactions should not be mistaken with syncopal episodes (cardiac palpitations due to adrenaline).
Slovenian: občutek vročine, občutek mraza c) Opis izbranih neželenih učinkov Alergijskih reakcij se ne sme pomotoma zamenjati z epizodami sinkope (srčne palpitacije zaradi adrenalina).
English: Due to adrenaline:
Slovenian: Simptomi zaradi prevelikega odmerjanja adrenalina:
English: (TCAs) Tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline):
Slovenian: Triciklični antidepresivi (TCA) (npr. amitriptilin, dezipramin, imipramin, nortriptilin,
English: Pharmacotherapeutic group: Nervous System / Local Anaesthetics / Anaesthetics, local / Amides / Articaine, combinations
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila z delovanjem na živčevje; anestetiki; lokalni anestetiki; amidi;
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml) (4.1 cartridges) (5.2 cartridges) (6.2 cartridges)
Slovenian: Skupna prostornina (ml) in ustrezajoče število vložkov (1,7 ml) (4,1 vložka) (5,2 vložka) (6,2 vložka)
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila X/Y Vsebina pakiranja in dodatne informacije
English: Rare side effects: may affect up to 1 in 1,000 people:
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: For most routine dental procedures, it is preferable to use {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml.
Slovenian: Pri večini rutinskih zobozdravstvenih posegov je bolje uporabiti zdravilo {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml.
English: The lowest dose providing effective dental anaesthesia should be used.
Slovenian: Uporabiti je treba najnižji odmerek, ki zagotovi učinkovito zobozdravstveno anestezijo.
English: Due to articaine:
Slovenian: Simptomi zaradi prevelikega odmerjanja artikaina:
English: - The other ingredients are sodium chloride, disodium edetate, sodium metabisulfite (E223), sodium hydroxide and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev klorid, dinatrijev edetat, natrijev metabisulfit (E223), natrijev hidroksid in voda za injekcije.
English: • drooping of the eyelid, and constriction of the pupil (Horner's syndrome)
Slovenian: • povešenost očesne veke in zoženje zenice (Hornerjev sindrom),
English: For all populations, the lowest dose leading to effective anaesthesia should be used.
Slovenian: Pri vseh populacijah je treba uporabiti najmanjši odmerek, ki zagotovi učinkovito anestezijo.
English: Sympathomimetic vasopressors (e.g., mainly cocaine but also amphetamines, phenylephrine, pseudoephedrine, oxymetazoline):
Slovenian: Simpatikomimetični vazopresorji (npr. predvsem kokain, vendar pa tudi amfetamini, fenilefrin,
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml) (2.1 cartridges) (3.1 cartridges) (4.1 cartridges) (5.6 cartridges)
Slovenian: Skupna prostornina (ml) in ustrezajoče število vložkov (1,7 ml) (2,1 vložka) (3,1 vložka) (4,1 vložka) (5,6 vložka)
English: Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions.
Slovenian: Najpogostejši neželeni učinki so bolezni živčevja, reakcije na mestu injiciranja, preobčutljivost, srčne in žilne bolezni.
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Slovenian: Zaradi tega bolniki po zobozdravstvenem posegu ne smejo zapustiti zobozdravstvene ordinacije, dokler si ne opomorejo
English: 2 A 2 week delay in the onset of facial paralysis has been described following administration of articaine combined with adrenaline, and the condition was unchanged 6 months later.
Slovenian: 2 Po aplikaciji artikaina v kombinaciji z adrenalinom so poročali o pojavu paralize obraznega živca, ki se je pojavila z 2-tedensko zakasnitvijo.
English: Absorption: In three published clinical studies describing the pharmacokinetic profile of the combination articaine hydrochloride 40 mg/ml with adrenaline 10 or 5 micrograms/ml, Tmax values were between 10 and 12 minutes, with Cmax values ranging from 400 to 2100 ng/ml.
Slovenian: Absorpcija: Farmakokinetični profil kombinacije artikainijevega klorida v odmerku 40 mg/ml in adrenalina v odmerku 10 ali 5 mikrogramov/ml je opisan v treh objavljenih kliničnih študijah.
English: Sodium chloride, disodium edetate, sodium metabisulfite (E223), sodium hydroxide, water for injections.
Slovenian: Natrijev klorid, dinatrijev edetat, natrijev metabisulfit (E223), natrijev hidroksid in voda za injekcije.
English: Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to effective anaesthesia in elderly patients and in patients with renal disorders.
Slovenian: Zaradi pomanjkanja kliničnih podatkov je pri starejših bolnikih in bolnikih z okvaro ledvic potrebna posebna previdnost, da se uporabi najmanjši odmerek, ki zagotovi učinkovito anestezijo.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica.]
English: • tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine,
Slovenian: • triciklične antidepresive (vrsta zdravil za zdravljenje depresije kot so amitriptilin, dezipramin,
English: Elimination: Following dental injection, the elimination half-life of articaine was c.a.
Slovenian: Izločanje: Razpolovni čas izločanja artikaina po dentalnem injiciranju znaša približno 20-40 minut.
English: − If you get any side effects, talk to your dentist, doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zobozdravnikom, zdravnikom ali s farmacevtom.
English: Patients receiving treatment with antiplatelets / anticoagulants: {(Invented) name and associated names (see Annex I)} should be administered with caution in patients, who are using antiplatelet/anticoagulant medicines or are suffering from coagulation disorder, because of higher risk of bleeding.
Slovenian: Prilogo I)} previdno uporabljati pri bolnikih, ki uporabljajo protitrombocitna zdravila/antikoagulante ali imajo motnje strjevanja krvi.
English: Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to effective anaesthesia in elderly patients and in patients with renal disorders (section 4.4 and
Slovenian: Zaradi pomanjkanja kliničnih podatkov je pri starejših bolnikih in bolnikih z okvaro ledvic potrebna posebna previdnost, da se uporabi najmanjši odmerek, ki zagotovi učinkovito anestezijo (glejte poglavji 4.4 in 5.2).
English: • swelling of cheeks and local swelling
Slovenian: • otekanje lic in lokalna oteklina,
English: • nervousness, anxiety
Slovenian: • nervoznost, tesnoba,
English: • facial nerve disorder (facial palsy)
Slovenian: • motnje obraznega živca (ohromelost obraza),
English: If you get any side effects, talk to your dentist, doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zobozdravnikom, zdravnikom ali s farmacevtom.
English: X / Y is for children over 4 years of age (ca. 20 kg in body weight), adolescents and adults.
Slovenian: mladostnikih in otrocih, starejših od 4 let (ali s telesno maso, večjo od 20 kg).
English: • MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine,
Slovenian: • zaviralce monoaminooksidaz (zaviralci MAO), ki jih uporabljamo za zdravljenje depresivnih ali anksioznih motenj (kot so moklobemid, fenelzin, tranilcipromin, linezolid);
English: Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks
Slovenian: Hornerjev sindrom (ptoza veke, enoftalmus, mioza), somnolenca (bolezenska zaspanost), nistagmus zelo redki parestezija3 (persistentna hipestezija in izguba okusa) po blokadi mandibularnega ali spodnjega alveolarnega živca
English: In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg.
Slovenian: Odrasli in mladostniki (stari od 12 do 18 let) Največji odmerek artikainijev klorid pri odraslih in mladostnikih je 7 mg/kg, pri čemer absolutni največji odmerek artikainijev klorid znaša 500 mg. Absolutni največji odmerek 500 mg artikainijev klorida velja pri zdravem odraslem s telesno maso več kot 70 kg.
English: Excipients with known effect: sodium metabisulfite (E223), sodium chloride, disodium edetate, sodium hydroxide.
Slovenian: Pomožne snovi z znanim učinkom: natrijev metabisulfit (E223), natrijev klorid, dinatrijev edetat in natrijev hidroksid (za uravnavanje pH).
English: Patients with cardiovascular disorders:
Slovenian: Bolniki s srčno-žilnimi boleznimi
English: Reproductive toxicity studies conducted with articaine 40 mg/ml + adrenaline 10 micrograms/ml administered by the subcutaneous route at doses up to 80 mg/kg/day revealed no adverse effects on fertility, embryonal/foetal development, or pre- and postnatal development.
Slovenian: 10 mikrogramov/ml v odmerkih do 80 mg/kg/dan niso pokazale neželenih učinkov na plodnost, razvoj zarodka/plodu ali prenatalni/postnatalni razvoj.
English: The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (presyncope, syncope, headache, restlessness, agitation, confusional state, disorientation, dizziness (lightheadedness), tremor, stupor, deep CNS depression, loss of consciousness, coma, convulsion (including tonic-clonic seizure), speech disorder (e.g., dysarthria, logorrhea), vertigo, balance disorder (disequilibrium)), eyes manifestations (mydriasis, vision blurred, accommodation disorder) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, yawning, respiratory depression) and finally cardiac (cardiac arrest, myocardial depression) toxicity.
Slovenian: (vključno s tonično-kloničnimi krči), motnje govora (npr. disartrija, logoreja), vrtoglavica, motnje ravnotežja (disekvilibrij)), očesne znake (midriaza, zamegljen vid, motnje akomodacije), ki jim sledijo znaki toksičnosti za ožilje (bledica (lokalna, regionalna, generalna)) in dihala (apneja (respiratorni zastoj), bradipneja, tahipneja, zehanje, respiratorna depresija) ter nazadnje znaki toksičnosti za srce (srčni zastoj, depresija miokarda).
English: Very rare cases of prolonged or irreversible nerve injury and gustatory loss have been reported after mandibular block analgesia.
Slovenian: Pri blokadi mandibularnega živca so poročali o zelo redkih primerih dolgotrajne ali ireverzibilne poškodbe živca in izgube čuta za okušanje.
English: The availability of resuscitation equipment and medication should be ensured before administration of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Slovenian: Pred dajanjem regionalne anestezije z lokalnimi anestetiki je treba zagotoviti, da so na razpolago oprema in zdravila za oživljanje, da se omogoči takojšnje zdravljenje morebitnih respiratornih in srčno-žilnih nujnih stanj.
English: Patients with severe hepatic disease:
Slovenian: Bolniki s hudo boleznijo jeter
English: It is not likely that you will be given too much of this injection but if you should begin to feel unwell, tell your dentist.
Slovenian: A če se začnete slabo počutiti, o tem obvestite zobozdravnika.
English: The availability of appropriate resuscitation equipment and medication should be ensured before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Slovenian: Pred dajanjem regionalne anestezije z lokalnimi anestetiki je treba razpolagati z vso potrebno opremo in zdravili za oživljanje, da se zagotovi takojšnje zdravljenje morebitnih respiratornih in srčno-žilnih nujnih stanj.
English: Sodium metabisulfite (E223) Sodium hydroxide (for pH-adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid dinatrijev edetat natrijev metabisulfit (E223) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Common side effects: may affect up to 1 in 10 people:
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Box containing glass cartridges 50 x 1.7 ml.
Slovenian: Škatla s 50 steklenimi vložki po 1,7 ml.
English: Allodynia
Slovenian: Dojenje
English: Use with caution in patients taking phenothiazines considering the risk of hypotension due to possible inhibition of adrenaline effect.
Slovenian: Upoštevati je treba tveganje za hipotenzijo zaradi možnega zavrtja učinka adrenalina.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Allergic1, anaphylactic / anaphylactoid reactions
Slovenian: anafilaktične/anafilaktoidne reakcije
English: 7 MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Prilogo I - Izpolni država članica.]
English: Interactions requiring precautions for use:
Slovenian: Interakcije, zaradi katerih je potrebna previdnost: Drugi lokalni anestetiki:
English: The maximum articaine dose of 500 mg corresponds to a healthy adult of more than 70 kg body weight.
Slovenian: Absolutni največji odmerek artikainijev klorid pri zdravem otroku s telesno maso 55 kg znaša 385 mg.
English: • Patients with pheochromocytoma: This medicinal product should be used cautiously due to the presence of adrenaline.
Slovenian: • bolnikih s feokromocitomom Zaradi prisotnosti adrenalina je treba to zdravilo previdno uporabljati.
English: • Patients with thyreotoxicosis: This medicinal product should be used cautiously due to the presence of adrenaline.
Slovenian: • bolnikih s tirotoksikozo Zaradi prisotnosti adrenalina je treba to zdravilo previdno uporabljati.
English: {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection
Slovenian: {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 10 mikrogramov/ml raztopina za injiciranje
English: What you need to know before you are given X / Y Do not use X / Y if you suffer from any of the following conditions:
Slovenian: Kaj je zdravilo X/Y in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo X/Y Kako uporabljati zdravilo X/Y
English: Postganglionic adrenergic blocking agents (e.g., guanadrel, guanethidine, and rauwolfia alkaloids): Reduced doses of this medicinal product should be used under strict medical supervision with careful aspiration due to possible increase response to adrenergic vasoconstrictors: risk of hypertension and other cardiovascular effects.
Slovenian: Pod skrbnim zdravniškim nadzorom in ob skrbni aspiraciji je treba uporabiti manjši odmerek tega zdravila, zaradi možnega večjega odziva na adrenergične vazokonstriktorje: tveganje za hipertenzijo in druge srčno-žilne učinke.
English: • abnormal slow heartbeat
Slovenian: • nenormalno počasno bitje srca,
English: • relative overdose such as: - inadvertent injection into a blood vessel, or - abnormal rapid absorption into the systemic circulation, or - delayed metabolism and elimination of drug.
Slovenian: neobičajno hitra absorpcija v sistemski krvni obtok, upočasnjena presnova in izločanje zdravila.
English: On account of its lower adrenaline content, the use of {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection over {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection should be preferred.
Slovenian: Zaradi manjše vsebnosti adrenalina je treba uporabi zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje dati prednost pred uporabo zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg + 10 mikrogramov/ml raztopina za injiciranje.
English: • inflammation of the tongue and mouth
Slovenian: • vnetje jezika in ustne sluznice,
English: [(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection]
Slovenian: [{(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje]
English: • somnolence
Slovenian: • hripavost,
English: Therefore, the lowest dose leading to effective anaesthesia should be used.
Slovenian: Zaradi tega je treba uporabiti najmanjši odmerek, ki zagotovi učinkovito anestezijo.