FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hypersensitivity to articaine (or any local anaesthetic agent of the amide type), to adrenaline or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na artikain (ili bilo koji lokalni anestetik amidnog tipa), adrenalin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Not known Erythema Hyperhidrosis
Croatian: Nepoznato Eritem Hiperhidroza
English: Use this medicinal product under strict medical supervision due to additive or synergistic increases in blood pressure and/or ischemic response.
Croatian: Ovaj lijek koristite uz strogi medicinski nadzor zbog aditivnog ili sinergističkog učinka na povećanje krvnog tlaka i/ili ishemijske reakcije.
English: Avoid eating, included chewing-gum, until normal sensation is restored because there is a risk that you may bite your lips, cheeks or tongue, especially in children.
Croatian: Izbjegavajte jesti ili žvakati žvakaću gumu dok Vam se ne vrati normalan osjet jer inače postoji rizik od zagrizanja usana, obraza ili jezika, osobito u djece.
English: A plasma cholinesterase deficiency can be suspected when clinical signs of overdose occurs with usual dosage of anesthesia and when a vascular injection has been excluded.
Croatian: Na nedostatak plazmatske kolinesteraze može se posumnjati kada se pojave klinički znakovi predoziranja uz uobičajenu dozu anestetika, a isključeno je vaskularno injiciranje.
English: • rash, itching, swelling of the throat and difficulty breathing: this might be symptoms of an allergic
Croatian: • osip, svrbež, oticanje grla i otežano disanje: to mogu biti simptomi alergijske reakcije
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Croatian: Količinu za ubrizgavanje treba odrediti prema dobi i tjelesnoj težini djeteta te veličini operacije.
English: Articaine, a local amide anaesthetic, reversibly blocks nerve conduction through a well-known mechanism commonly observed with other local amide anaesthetics.
Croatian: Artikain, lokalni amidni anestetik, reverzibilno blokira provođenje živčanih impulsa dobro poznatim mehanizmom općenito uočenim kod drugih lokalnih amidnih anestetika.
English: • a disease called Myasthenia Gravis causing weakness in the muscles;
Croatian: • bolest koja se zove miastenija gravis, a uzrokuje slabost mišića;
English: In the event of inadvertent intravascular administration in the mother, adrenaline can reduce uterine perfusion.
Croatian: U slučaju nehotične intravaskularne primjene kod majke, adrenalin može smanjiti perfuziju maternice.
English: This may be associated with severe adverse reactions, such as convulsions, followed by central nervous and cardiorespiratory depression and coma, progressing to respiratory and circulatory arrest.
Croatian: To može biti povezano s teškim nuspojavama, kao što su konvulzije, nakon kojih slijede depresija središnjeg živčanog sustava i kardiorespiratorna depresija te koma, a progredira u respiratorni i cirkulatorni arest.
English: (7.0 cartridges)
Croatian: (7,0 uložaka)
English: The seriousness of overdose symptoms should have physicians/dentists to implement protocols that foresee the necessity of timely securing the airway and providing assisted ventilation.
Croatian: Zbog ozbiljnosti simptoma predoziranja liječnici/stomatolozi moraju imati razrađene protokole kojima je predviđena nužnost pravovremenog osiguravanja prohodnosti dišnih puteva i primjene potpomognute ventilacije.
English: Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Croatian: Postoji rizik od ugrizne ozljede (usana, obraza, sluznice i jezika), posebno u djece; bolesniku treba reći da izbjegava žvakanje žvakaće gume ili konzumiranje hrane dok mu se ne vrati normalan osjet.
English: • sedatives (such as benzodiazepine, opioids), for example to reduce your apprehension before the dental procedure;
Croatian: • sedative (kao što su benzodiazepin, opioidi), npr. za ublažavanje straha prije stomatološkog zahvata;
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Croatian: Ako nastupi kardiovaskularna depresija (hipotenzija, bradikardija), mora se razmotriti odgovarajuće liječenje intravenskim tekućinama, vazopresorima i/ili inotropnim lijekovima.
English: Keep the cartridges in the tightly closed outer carton in order to protect from light.
Croatian: Uloške čuvati u čvrsto zatvorenom vanjskom pakiranju radi zaštite od svjetlosti.
English: X / Y contains sodium and sodium metabisulfite.
Croatian: X/Y sadrži natrij i natrijev metabisulfit.
English: Pharmacotherapeutic group: Nervous System / Local Anaesthetics / Anaesthetics, local / Amides / Articaine, combinations
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na živčani sustav / Anestetici / Lokalni anestetici / Amidi / Artikain, kombinacije
English: If needle nerve injuries occur, the neurotoxic effect could be aggravated by articaine potential chemical neurotoxicity and the presence of adrenaline as it may impair the perineural blood supply and prevent articaine local wash-out.
Croatian: Ako igla ozlijedi živac, neurotoksični učinci mogu se pogoršati zbog moguće kemijske neurotoksičnosti artikaina i prisutnosti adrenalina koji može ugroziti perineuralnu opskrbu krvlju i spriječiti lokalno ispiranje artikaina.
English: If you experience side effects, including dizziness, blurred vision or fatigue, you should not drive or operate machinery until you recover your abilities (generally within 30 minutes following the dental procedure).
Croatian: U slučaju nuspojava, uključujući omaglicu, zamagljen vid ili umor, ne smijete voziti ni raditi sa strojevima dok se potpuno ne oporavite (obično unutar 30 minuta nakon stomatološkog zahvata).
English: • articaine, a local anaesthetic which prevents pain, and
Croatian: • artikain, lokalni anestetik koji djeluje protiv boli i
English: Bronchospasm / asthma Dyspnoea2
Croatian: Bronhospazam/astma Dispneja2
English: Articainic acid is the major product of cytochrome P450-induced metabolism of articaine, further metabolised to form articainic acid glucuronide.
Croatian: Artikainatna kiselina glavni je produkt metabolizma artikaina induciranog citokromom P450, a dalje se metabolizira u glukuronid artikainatne kiseline.
English: • epilepsy, not adequately controlled by drug treatment.
Croatian: • epilepsije koja nije odgovarajuće kontrolirana lijekovima.
English: Not known Aggravation of the neuromuscular manifestations in Kearns-Sayre syndrome Trismus
Croatian: Nepoznato Pogoršanje neuromuskularnih manifestacija Kearns-Sayreova sindroma Trizam
English: Reduced doses of this medicinal product should be used due to possible increase in blood pressure and an increased risk of bradycardia.
Croatian: Treba koristiti manje doze ovog lijeka zbog mogućeg porasta krvnog tlaka i većeg rizika od bradikardije.
English: Adrenaline and articaine cross the placental barrier, although articaine does so to a lesser extent than other local anaesthetics.
Croatian: Adrenalin i artikain prolaze kroz placetu, iako artikain u manjoj mjeri u odnosu na druge lokalne anestetike.
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Croatian: Stoga bolesnici nakon stomatološkog zahvata ne smiju napustiti ordinaciju sve dok se potpuno ne oporave (obično unutar 30 minuta).
English: At supratherapeutic doses, articaine has cardiodepressant properties and can exert vasodilatory effects.
Croatian: Pri supraterapijskim dozama, artikain ima kardiodepresorna svojstva i može imati vazodilatacijsko djelovanje.
English: For single use.
Croatian: Za jednokratnu uporabu.
English: To avoid risk of infection (e.g. hepatitis transmission), syringe and needles used to draw up the solution must always be fresh and sterile.
Croatian: Kako biste izbjegli rizik od infekcije (npr. prijenos hepatitisa), štrcaljka i igle korištene za uvlačenje otopine uvijek moraju biti svježe izvađene iz pakiranja i sterilne.
English: More than 50% of the dose was eliminated in the urine, 95% as articainic acid, within 8 hours of administration.
Croatian: Više od 50 % doze eliminirano je mokraćom unutar 8 sati od primjene lijeka, 95 % u obliku artikainatne kiseline.
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka.
English: {(Invented) name and associated names (see Annex I)} is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight).
Croatian: {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} je indiciran u odraslih, adolescenata i djece starije od 4 godine (ili od 20 kg tjelesne težine).
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Croatian: <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.>
English: Appropriate precautions should be taken in all patients with porphyria, as this medicinal product can trigger porphyria.
Croatian: U svih bolesnika s porfirijom potrebno je poduzeti odgovarajuće mjere opreza jer ovaj lijek može biti okidač za porfiriju.
English: • inflammation or infection in the area to be injected.
Croatian: • upale ili infekcije u području u kojem treba primijeniti injekciju
English: articaine hydrochloride/adrenaline
Croatian: artikainklorid/adrenalin
English: • coronary artery bypass surgery in the last 3 months;
Croatian: • kirurški zahvat ugradnje premosnice koronarnih arterija u zadnja 3 mjeseca;
English: In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose of articaine is 7 mg/kg only with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight.
Croatian: U djece u dobi od 4 godine (ili od 20 kg tjelesne težine) ili starije, maksimalna doza artikaina je 7 mg/kg, uz apsolutnu maksimalnu dozu od 385 mg artikaina samo za zdravo dijete tjelesne težine 55 kg.
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.
Croatian: Preporučuje se dentalni zahvat za koji je potrebna primjena artikaina/adrenalina odgoditi za 6 mjeseci nakon moždanog udara zbog povećanog rizika od ponovnih moždanih udara.
English: • Acute decompensated heart failure (acute congestive heart failure)
Croatian: • akutnog dekompenziranog zatajenja srca (akutno kongestivno zatajenje srca)
English: Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis may prevent cardiac arrest.
Croatian: Optimalna oksigenacija i ventilacija te potpora cirkulacije kao i korekcija acidoze mogu spriječiti srčani arest.
English: <[To be completed nationally]>
Croatian: <[Ispunjava država članica]>
English: Very rare cases of prolonged or irreversible nerve injury and gustatory loss have been reported after mandibular block analgesia.
Croatian: Zabilježeni su vrlo rijetki slučajevi dugotrajnog ili nepovratnog oštećenja živca i gubitka okusa nakon anesteziološkog postupka mandibularnog bloka.
English: What you need to know before you are given X / Y 3.
Croatian: Što morate znati prije nego primite X/Y
English: Infiltration and perineural use.
Croatian: Primjena infiltracijom i perineuralno.
English: These medicinal products are authorised in the Member States of the EEA under the following names: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> <[See Annex I - To be completed nationally]>
Croatian: Ovi lijekovi odobreni su u državama članicama Europskog gospodarskog prostora (EGP) pod sljedećim nazivima:
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.
Croatian: Apsorpcija: U trima objavljenim kliničkim ispitivanjima koja opisuju farmakokinetički profil kombinacije artikainklorida 40 mg/ml i adrenalina 10 ili 5 mikrograma/ml, Tmax vrijednosti su bile između 10 i 12 minuta, uz Cmax vrijednosti od 400 do 2100 ng/ml.
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.
Croatian: 2 Nakon davanja artikaina u kombinaciji s adrenalinom opisan je nastup paralize lica s odgodom od 2 tjedna, a stanje se nije promijenilo ni 6 mjeseci kasnije.
English: Maximum dose of articaine hydrochloride (mg)
Croatian: Maksimalna doza artikainklorida (mg)
English: X / Y is used to numb (anaesthetise) your oral cavity during dental procedures.
Croatian: X/Y se koristi za umrtvljivanje (anesteziju) Vaše usne šupljine tijekom stomatoloških zahvata.
English: {(Invented) name and associated names (see Annex I)} contains 0.804 mg sodium per 1 ml of solution i.e. 1.44 mg/1.7 ml.
Croatian: {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} sadrži 0,804 mg natrija u 1 ml otopine, odnosno 1,44 mg/1,7 ml.
English: Neuralgia (neuropathic pain) Hypoesthesia / numbness (oral and perioral) 4
Croatian: Neuralgija (neuropatska bol) Hipoestezija / obamrlost (oralna i perioralna)4
English: • have uncontrolled diabetes;
Croatian: • nekontroliranu šećernu bolesti;
English: Treatment of overdose
Croatian: Liječenje predoziranja
English: • adrenaline, a vasoconstrictor which narrows the blood vessels at the site of injection, and thereby prolongs the effect of articaine.
Croatian: • adrenalin, vazokonstriktor koji sužava krvne žile na mjestu primjene injekcije i tako produljuje djelovanje artikaina.
English: • neuropathic pain - pain due to nerve damage
Croatian: • neuropatska bol - bol uslijed oštećenja živca
English: Clinical efficacy and safety: {(Invented) name and associated names (see Annex I)} has an onset of 1.51.8 min for infiltration and 1.4-3.6 min for nerve block.
Croatian: Klinička djelotvornost i sigurnost: Djelovanje {(Novoizumljeno) ime i pridružena imena (vidjeti Prilog I.)} nastupa za 1,5 - 1,8 minuta pri infiltraciji te za 1,4 - 3,6 minuta pri blokadi živca.
English: If you have any further questions on the use of this medicine, ask your dentist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se stomatologu.
English: b) Tabulated list of adverse reactions
Croatian: b) Tablični popis nuspojava
English: Not known Dysphonia (Hoarseness)1
Croatian: Nepoznato Disfonija (promuklost)1
English: In a clinical trial, plasma concentrations of articaine and articainic acid were shown to decrease rapidly following submucosal injection.
Croatian: kliničkom ispitivanju zapaženo je da koncentracija artikaina i artikainatne kiseline u plazmi nakon submukozne injekcije brzo opada.
English: Adverse reactions following administration of articaine / adrenaline are similar to those observed with other local amide anaesthetics / vasoconstrictors.
Croatian: Nuspojave nakon primjene artikaina/adrenalina slične su onima uočenim kod drugih lokalnih amidnih anestetika/vazokonstriktora.
English: Somnolence (Drowsiness) Nystagmus
Croatian: Somnolencija (omamljenost) Nistagmus
English: Hyperacusis Tinnitus4
Croatian: Hiperakuzija Tinitus4
English: In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg.
Croatian: U odraslih i adolescenata maksimalna doza artikaina je 7 mg/kg uz apsolutnu maksimalnu dozu artikaina od 500 mg.
English: • simultaneously taking some medicines for the treatment of depression and Parkinson's disease
Croatian: • istodobno uzimate određene lijekove za liječenje depresije i Parkinsonove bolesti (triciklički antidepresivi).
English: However, these findings are of little relevance to its clinical use as acute administration.
Croatian: Međutim, ovi su podaci od malog značaja za njihovu kliničku primjenu zbog kratkotrajnosti primjene.
English: Contains sodium and metabisulfite, see package leaflet for further information.
Croatian: Sadrži natrij i metabisulfit, za dodatne informacije vidjeti uputu o lijeku.
English: • Sodium metabisulfite: it may rarely cause severe allergic reactions and breathing difficulties
Croatian: • Natrijev metabisulfit: rijetko može uzrokovati teške alergijske reakcije i otežano disanje (bronhospazam).
English: Non-selective beta-adrenergic blockers (e.g., propranolol, nadolol):
Croatian: Neselektivni beta-adrenergički blokatori (npr. propranolol, nadolol):
English: • Patients with epilepsy not controlled by treatment.
Croatian: • Bolesnici s epilepsijom koja se ne kontrolira liječenjem
English: • Patients with recent (3 months) coronary artery bypass surgery
Croatian: • bolesnika s nedavnim (3 mjeseca) kirurškim zahvatom ugradnje premosnice koronarnih arterija
English: Use immediately after the opening of the cartridge
Croatian: Koristiti odmah nakon otvaranja uloška.
English: The average effective dose of articaine is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively.
Croatian: Prosječna učinkovita doza bila je 2 mg/kg za jednostavne i 4 mg/kg za složene zahvate.
English: • low blood pressure;
Croatian: • nizak krvni tlak;
English: Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
Croatian: Lokalne anestetike treba oprezno ubrizgavati ako su na mjestu ubrizgavanja prisutne upala i/ili infekcija.
English: • swollen face, tongue or pharynx, difficulty to swallow, hives or difficulties to breath (angioedema)
Croatian: • oticanje lica, jezika ili ždrijela, otežano gutanje, koprivnjaču ili otežano disanje (angioedem)
English: In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful.
Croatian: Kako biste izbjegli intraneuralno injiciranje i spriječili ozljede živca vezane uz blokade živca, iglu uvijek treba malo izvući ako se bolesniku tijekom injiciranja javi osjećaj strujnog udara ili ako je injiciranje osobito bolno.
English: Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve.
Croatian: Nehotično intraneuralno injiciranje može uzrokovati retrogradno kretanje lijeka duž živca.
English: • medicines used for migraine attacks (such as methysergide or ergotamine);
Croatian: • lijekove korištene za napadaje migrene (npr. metisergid ili ergotamin);
English: Elimination: Following dental injection, the elimination half-life of articaine was c.a.
Croatian: Eliminacija: Nakon dentalne injekcije, poluvijek eliminacije artikaina je približno 20 - 40 minuta.
English: This medicinal product should be used cautiously due to the presence of hepatic disease although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
Croatian: Ovaj lijek treba oprezno primjenjivati u slučaju bolesti jetre, iako se 90 % artikaina inaktivira nespecifičnim plazmatskim esterazama u tkivu i krvi.
English: Thus, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before the local anaesthetic medicinal product is injected.
Croatian: Zato, kako biste bili sigurni da igla tijekom injiciranja nije ušla u krvnu žilu, prije injiciranja lokalnog anestetika treba aspirirati.
English: These actions lead the anaesthetic action.
Croatian: Ovi procesi dovode do anestetskog djelovanja.
English: Sedatives (central nervous system depressants e.g. benzodiazepine, opioids):
Croatian: Sedativi (depresori središnjeg živčanog sustava, npr. benzodiazepin, opioidi):
English: Animal studies with articaine 40 mg/ml + adrenaline 10 micrograms/ml have not shown effects on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama s artikainom 40 mg/ml + adrenalinom 10 mikrograma/ml nisu pokazala učinke na plodnost (vidjeti dio 5.3).
English: The frequencies classification follows the convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000)
Croatian: Učestalost je klasificirana na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: Angioedema (face / tongue / lip / throat / larynx / periorbital oedema) Urticaria
Croatian: Angioedem (edem lica/jezika/usnica/grla/larinksa/periorb italno)
English: • Patients with uncontrolled hypertension
Croatian: • bolesnika s nekontroliranom hipertenzijom
English: • worsening of the neuromuscular symptoms in Kearns-Sayre syndrome
Croatian: • pogoršanje simptoma od strane živčanog i mišičnog sustava kod Kearns-Sayreova sindroma
English: Solution for injection.
Croatian: OBLIK Otopina za injekciju.
English: • problems with your kidneys;
Croatian: • probleme s bubrezima;
English: In case of required reinjection, patient should be strictly monitored, to identity any sign of relative overdose.
Croatian: U slučaju potrebe za ponovnim ubrizgavanjem bolesnike treba strogo nadzirati kako bi se uočio svaki znak relativnog predoziranja.
English: d) Paediatric population
Croatian: Pedijatrijska populacija
English: Adrenaline prolongs the effect duration of the articaine, and reduces the risk of excessive uptake of articaine into the systemic circulation.
Croatian: Adrenalin produljuje učinak artikaina i smanjuje rizik od prekomjernog unosa artikaina u sistemsku cirkulaciju.
English: Dose and rate of administration of this medicinal product should be reduced due to an increased risk of severe hypertension.
Croatian: Dozu i brzinu davanja ovog lijeka treba smanjiti zbog povećanog rizika od teške hipertenzije.
English: MAO inhibitors (both A-selective (e.g. moclobemide) and non-selective (e.g. phenelzine, tranylcypromine, linezolide) :
Croatian: MAO inhibitori (A-selektivni (npr. moklobemid) i neselektivni (npr. fenelzin, tranilcipromin, linezolid):
English: • severe heart rhythm disorders (e.g. second and third-degree AV block);
Croatian: • teške poremećaje srčanog ritma (AV blok drugog i trećeg stupnja);
English: Ageusia
Croatian: Ageuziju
English: If sedatives are employed to reduce patient's apprehension, reduced doses of anaesthetics should be used since local anaesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect (see section 4.2).
Croatian: Ako se za smanjenje straha u bolesnika primjenjuju sedativi, treba primijeniti smanjene doze anestetika jer su lokalni anestetici, kao i sedativi, depresori središnjeg živčanog sustava koji u kombinaciji mogu imati aditivan učinak (vidjeti dio 4.2).
English: • acute heart failure (acute heart weakness, e.g. unexpected chest pain while resting or after myocardial infraction (e.g. heart attack));
Croatian: • akutno zatajenje srca (akutna slabost srca, npr. iznenadna bol u prsima tijekom mirovanja ili nakon infarkta miokarda (srčanog udara);
English: • medicines used to treat irregular heartbeats (for example digitalis, quinidine);
Croatian: • lijekove korištene za liječenje nepravilnih srčanih otkucaja (npr. digitalis, kinidin);
English: Discussion with the anaesthetist before local anaesthetic administration during general anaesthesia is recommended.
Croatian: Preporučuje se razgovarati s anesteziologom prije primjene lokalne anestezije tijekom opće anestezije.
English: • neuroleptic drugs (for example phenothiazines).
Croatian: • neuroleptike (npr. fenotiazini)
English: Animal studies with articaine 40 mg/ml + adrenaline 10 micrograms/ml, as well as with articaine alone, have not shown adverse effects on pregnancy, embryonal/foetal development, birth or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama s artikainom 40 mg/ml + adrenalinom 10 mikrograma/ml, kao i sa samim artikainom, nisu pokazala štetne učinke na trudnoću, embrionalni/fetalni razvoj, rođenje ili postnatalni razvoj (vidjeti dio 5.3).