FrancophonIA/ELRC3.0 huggingface dataset:
English: The toxicity of beta-blockers is an extension of their therapeutic effects:
Slovenian: Toksičnost antagonistov adrenergičnih receptorjev beta je razširitev njihovih zdravilnih učinkov:
English: Very limited safety data of propranolol in PHACE syndrome patients are available.
Slovenian: Sindrom PHACE Na voljo so zelo omejeni podatki o varnosti propranolola pri bolnikih s sindromom PHACE.
English: 1 NAME OF THE MEDICINAL PRODUCT
Slovenian: 1 IME ZDRAVILA
English: The MAH shall provide an educational pack for the proposed indication, targeting all caregivers who are expected to prepare and administer HEMANGIOL to children.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti izobraževalni paket za predlagano indikacijo, ciljna skupina pa so vsi negovalci, od katerih se pričakuje priprava in dajanje zdravila HEMANGIOL otrokom.
English: Do not shake the bottle before use.
Slovenian: Ne tresite steklenice pred uporabo.
English: One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation.
Slovenian: V enem primeru je atrioventrikularni blok druge stopnje pri bolniku z motnjo prevajanja privedel do dokončne prekinitve zdravljenja.
English: The administration of beta2 agonists and inhaled corticosteroids is possible.
Slovenian: Mogoče je dajanje beta2 agonistov in inhalacijskih kortikosteroidov.
English: In case the child spits up a dose or does not take all of the medicinal product no other dose should be given before the next scheduled dose.
Slovenian: V primeru, da otrok izpljune odmerek ali ne vzame celotnega odmerka zdravila, mu ne dajajte drugega odmerka pred naslednjim načrtovanim odmerkom.
English: • If your child spits up a dose or if you are uncertain whether he/she got all of the medicine, do not give another dose, just wait until the next scheduled dose.
Slovenian: • Če otrok izpljune odmerek oz. niste prepričani, ali je prejel celotno zdravilo, mu ne dajte drugega odmerka, ampak počakajte na naslednji načrtovani odmerek.
English: Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp).
Slovenian: Propranolol je substrat intestinalnega efluksnega transporterja P-glikoproteina (P-gp).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
English: Age (35-90 days / 91150 days), gender and haemangioma location (head / body) subgroups did not identify differences in response to propranolol.
Slovenian: Pri podskupinah po starosti (od 35 do 90 dni/od 91 do 150 dni), spolu in lokaciji hemangioma (glava/telo) ni bilo odkritih razlik v odzivu na propranolol.
English: In case of large ulcerated haemangioma,, your child's blood potassium level should be measured.
Slovenian: V primeru velikega ulceriranega hemangioma, je treba otroku meriti raven kalija v krvi.
English: Please refer to section 2 of this leaflet.
Slovenian: Glejte poglavje 2 tega navodila za uporabo.
English: Use of propranolol alongside hypoglycaemic therapy in diabetic patients should be with caution since it may prolong the hypoglycaemic response to insulin.
Slovenian: Pri uporabi propranolola skupaj s hipoglikemičnim zdravljenjem pri sladkornih bolnikih je potrebna previdnost, saj lahko podaljša hipoglikemični odziv na inzulin.
English: The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol.
Slovenian: Štirje glavni končni presnovki so propranolol glukuronid, naftiloksilaktična kislina in glukuronska kislina ter sulfatni konjugati 4-hidroksi propranolola.
English: • Asthma or history of bronchospasm
Slovenian: • Astma ali anamneza bronhospazma
English: Dermatitis psoriasiform
Slovenian: Psoriaziformni dermatitis
English: Mean apparent oral clearance was 2.71 L/h/kg in infants aged 65- 120 days and 3.27 L/h/kg in infant aged 181- 240 days.
Slovenian: Povprečen opažni peroralni očistek je bil 2,71 l/h/kg pri dojenčkih, starih od 65 do 120 dni, in 3,27 l/h/kg pri dojenčkih, starih od 181 do 240 dni.
English: In adult male rats, repeated administration of propranolol at high dose levels (≥7.5 mg/kg) induced histopathological lesions of the testes, epididymis, and seminal vesicles, decrease in sperm motility, sperm cell concentration, plasma testosterone levels and significant increase in sperm head and tail abnormalities.
Slovenian: Pri odraslih samcih podgan je ponavljajoče dajanje propranolola z visokimi stopnjami odmerkov (≥ 7,5 mg/kg) povzročilo histopatološke lezije testisov, epididimisa in seminalnih veziklov, zmanjšanje gibljivosti sperme, koncentracije spermijev, nivojev testosterona v plazmi in znatno povečanje nepravilnosti glav in repov spermijev.
English: If you are breastfeeding your child
Slovenian: Če otroka dojite
English: It can aggravate hypoglycaemia in children, especially in case of fasting, vomiting or overdose.
Slovenian: Pri otrocih lahko poslabša hipoglikemijo, zlasti v primeru posta, bruhanja ali čezmernega odmerka.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: 4 Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnosti ukrepi
English: Propranolol passes through breast milk, mothers being treated with propranolol who breastfeed their infant should inform their health care professional.
Slovenian: Propranolol prehaja v materino mleko, zato morajo matere, ki se zdravijo s propranololom in dojijo, o tem obvestiti svojega zdravnika.
English: Treatment with propranolol resulted in a rapid improvement (within 7-14 days) in all patients and resolution of the target haemangioma was observed in 36.4% of patients by 3 months.
Slovenian: Zdravljenje s propranololom je povzročilo hitro izboljšanje (v 7 do 14 dneh) pri vseh bolnikih, izginotje ciljnega hemangioma pa je bilo opaženo pri
English: Blood sugar decreases observed during clinical studies were asymptomatic.
Slovenian: Zmanjšanja koncentracije sladkorja v krvi, opažene med kliničnimi študijami, so bila asimptomatska.
English: • Citric acid monohydrate
Slovenian: • citronska kislina monohidrat
English: Nervous system disorders
Slovenian: Motnje živčnega sistema
English: • Bradycardia (abnormally low heart rate),
Slovenian: • bradikardija (neobičajno počasen srčni utrip),
English: • a local haemodynamic effect (vasoconstriction which is a classical consequence of beta adrenergic blockade and a decrease of infantile haemangioma lesion perfusion);
Slovenian: • lokalni hemodinamični učinek (vazokonstrikcija, ki je klasična posledica beta adrenergične blokade, in zmanjšanje prekrvitve lezije infantilnega hemangioma);
English: Propranolol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies by dropping blood pressure and attenuating flow through occluded, narrow, or stenotic vessels.
Slovenian: Propranolol lahko poveča tveganje za možgansko kap pri bolnikih s sindromom PHACE s hudimi cerebrovaskularnimi nepravilnostmi zaradi znižanega krvnega tlaka in oslabitve pretoka skozi zamašene, zožene ali stenotične žile.
English: • Bronchiolitis (inflammation of small bronchi with breathing difficulties and wheeze in the chest,
Slovenian: • bronhiolitis (vnetje malih dihalnih poti (bronhiolov) s težavami z dihanjem in piskanjem v prsih,
English: • Bronchospasm (breathing difficulties),
Slovenian: • bronhospazem (težave z dihanjem),
English: Bradycardia should be diagnosed if the heart rate declines by more than 30 bpm from baseline.
Slovenian: Treba je postaviti diagnozo bradikardije, če srčni utrip odstopa za več kot 30 utripov na minuto od izhodiščnega.
English: Paediatric populations
Slovenian: Pediatrične populacije
English: Other medicines and HEMANGIOL
Slovenian: Druga zdravila in zdravilo HEMANGIOL
English: A haemangioma is a collection of extra blood vessels that have formed a lump in or under the skin.
Slovenian: Hemangiom je tvorba dodatnih krvnih žil, ki se oblikujejo v bulo v koži ali pod kožo.
English: • If your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin), as this medicine may worsen the symptoms of this condition.
Slovenian: • če ima otrok psoriazo (luskavico - kožna bolezen, pri kateri nastajajo rdeče, suhe ploščice zadebeljene kože), saj to zdravilo poslabša simptome te bolezni.
English: 1 What HEMANGIOL is and what it is used for What HEMANGIOL is
Slovenian: 1 Kaj je zdravilo HEMANGIOL in za kaj ga uporabljamo Kaj je zdravilo HEMANGIOL
English: Peripheral coldness
Slovenian: Periferna hladnost
English: • The dose should always be measured using the oral syringe supplied with the bottle.
Slovenian: • Odmerek je vedno treba izmeriti s peroralno brizgo, ki je priložena steklenici z zdravilom.
English: 1 bottle of 120 mL and 1 oral syringe.
Slovenian: peroralna raztopina 1 steklenica s 120 ml in 1 peroralna brizga
English: Bradycardia
Slovenian: Bradikardija
English: • an antiangiogenic effect (decrease of vascular endothelial cells proliferation, reduction of the neovascularization and formation of vascular tubules, reduction of the secretion of Matrix
Slovenian: • antiangiogenski učinek (zmanjšanje proliferacije vaskularnih endotelnih celic, zmanjšanje neovaskularizacije in tvorbe vaskularnih tubulov, zmanjšanje izločanja matriksne metaloproteinaze 9);
English: In the event of isolated bronchospasm, treatment must be permanently discontinued.
Slovenian: V primeru izoliranega bronhospazma je treba zdravljenje trajno prekiniti.
English: Stop treatment and contact your doctor immediately if after giving HEMANGIOL to your child you observe the following symptoms suggestive of a bronchospasm (temporary restriction of the bronchial tubes that leads to difficulty breathing): cough, quick or difficult breathing or wheezing, associated or not with a bluish-coloured skin.
Slovenian: Prenehajte z zdravljenjem in takoj obvestite zdravnika, če po uporabi zdravila HEMANGIOL pri otroku opazite naslednje simptome, ki kažejo na bronhospazem (začasna zožitev sapnic, ki povzroča težave z dihanjem): kašelj, hitro ali oteženo dihanje ali piskanje v pljučih, lahko (ne pa nujno) v povezavi z modrikasto kožo.
English: Wipe the outside dry.
Slovenian: Zunanjost obrišite do suhega.
English: • Heart conduction or rhythm disorders (slow or uneven heart beats),
Slovenian: • motnje prevodnosti srca ali srčnega ritma (počasen ali neenakomeren srčni utrip),
English: The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes.
Slovenian: Terapevtski odmerek je 3 mg/kg/dan, ki ga je treba dajati v 2 ločenih odmerkih po 1,5 mg/kg, enega zjutraj in drugega pozno popoldan, med obema vnosoma pa mora miniti vsaj 9 ur.
English: Pack size: carton containing 1 bottle and 1 oral syringe.
Slovenian: Velikost pakiranja: škatla vsebuje 1 steklenico in 1 peroralno brizgo.
English: In particular, in case you are breastfeeding, tell your doctor or pharmacist if you are or if your child is taking:
Slovenian: Zlasti povejte zdravniku ali farmacevtu, če jemljete vi (v primeru dojenja) ali vaš otrok:
English: • Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),
Slovenian: • krči, povezani s hipoglikemijo (neobičajno nizke revni sladkorja v krvi),
English: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANCE
Slovenian: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANCIJA
English: Infants with large facial infantile hemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome, with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Slovenian: Dojenčke z velikim obraznim infantilnim hemangiomom je treba pred zdravljenjem s propranololom temeljito preiskati glede morebitne arteriopatije, povezane s sindromom PHACE, z magnetno resonančno angiografijo glave in vratu ter s slikanjem srca, ki vključuje aortni lok.
English: • has a heart problem (such as disorders of the heart rhythm and heart failure.
Slovenian: • srčne težave (npr. motnje srčnega ritma in srčno popuščanje).
English: • If your child has a PHACE syndrome (a condition combining haemangioma and vascular abnormalities including cerebral blood vessels), as this medicine may increase the risk of cerebral stroke.
Slovenian: • če ima vaš otrok sindrom PHACE (bolezen, ki vključuje hemangiom in žilne nepravilnosti, vključno s cerebralnimi krvnimi žilami), saj lahko to zdravilo poveča tveganje možganske kapi.
English: All beta-blocking agents can mask certain symptoms of hypoglycaemia: palpitations and tachycardia.
Slovenian: Vsi antagonisti adrenergičnih receptorjev beta lahko zakrijejo določene simptome hipoglikemije: palpitacije in tahikardijo.
English: Medicinal products inducing orthostatic hypotension Medicinal products that induce postural hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen…) may add their effects to that of beta-blockers.
Slovenian: Zdravila, ki inducirajo posturalno hipotenzijo (nitratni derivati, zaviralci fosfodiesteraze tipa 5, triciklični antidepresivi, antipsihotiki, dopaminergični agonisti, levodopa, amifostin, baklofen...) lahko dodajo svoj učinek k učinku antagonistov adrenergičnih receptorjev beta.
English: In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Slovenian: V primeru akutne bronhopulmonalne nepravilnosti je treba začetek zdravljenja odložiti.
English: With regard to centrally-acting antihypertensives, betablockers may exacerbate the rebound hypertension after clonidine abrupt withdrawal, and propranolol should be stopped several days before discontinuing clonidine.
Slovenian: Kar zadeva centralno delujoče antihipertenzive, antagonisti adrenergičnih receptorjev beta poslabšajo povratno hipertenzijo po nenadni prekinitvi jemanja klonidina, propranolol je zato treba prenehati jemati nekaj dni pred prenehanjem jemanja klonidina.
English: • The active substance is propranolol.
Slovenian: • Učinkovina je propranolol.
English: Their frequency is defined using the following conventions: 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); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000);
English: • The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water.
Slovenian: • Druge sestavine zdravila so hidroksietilceluloza, natrijev saharin, aroma jagode (vsebuje propilenglikol), aroma vanilje (vsebuje propilenglikol), citronska kislina monohidrat, prečiščena voda.
English: Isoproterenol and aminophylline may be used for bronchospasm.
Slovenian: Za bronhospazem se lahko uporabljata izoproterenol in aminofilin.
English: Beta-blockers will result in an attenuation of reflex tachycardia and an increased risk of hypotension.
Slovenian: Antagonisti adrenergičnih receptorjev beta bodo povzročili atenuacijo refleksne tahikardije in povečano tveganje hipotenzije.
English: The regimen 3 mg/kg/day during 6 months (selected at the end of the phase II part of the study) presented 60.4% of success versus 3.6% in the placebo arm (p value < 0.0001).
Slovenian: faze študije) je bil uspešen v 60,4 % v primerjavi s 3,6-odstotnim uspehom pri placebu (vrednost p < 0,0001).
English: Dose by intake Timing of intakes
Slovenian: Odmerek na vnos Časovni razpored vnosov
English: In adult female rats, propranolol given into the uterus or by intravaginal administration is a powerful anti-implantation agent at dose ≥4 mg per animal, the effects being reversible.
Slovenian: Pri odraslih samicah podgan je propranolol, dan v maternico ali prek intravaginalnega dajanja, močno sredstvo proti implantaciji pri odmerku ≥4 mg na žival, učinki pa so reverzibilni.
English: • Medicines for diabetes,
Slovenian: • zdravila za sladkorno bolezen,
English: Check the HEMANGIOL dose in milligrams (mg) as prescribed by your doctor.
Slovenian: • 2. korak: Preverite odmerek Preverite odmerek zdravila HEMANGIOL v miligramih (mg), kot je predpisal zdravnik.
English: Bradycardia is defined below the following limits:
Slovenian: Bradikardija je definirana pod naslednjimi mejami: Starost
English: However, several reports of hypoglycaemia with related hypoglycaemic seizure were reported during the compassionate use program and in literature, especially in case of fasting period during intercurrent illness (see section
Slovenian: Vseeno pa so poročali o nekaj primerih hipoglikemije s povezanim hipoglikemičnim napadom med programom sočutne uporabe in v literaturi, zlasti v primeru obdobja posta med sočasno boleznijo
English: • The metabolism of propranolol is reduced by co-administration of quinidine, leading to a twothree-fold increased blood concentration and greater degrees of clinical beta-blockade.
Slovenian: • Presnovo propranolola zmanjšuje sočasna uporaba kinidina, ki povzroči od dva- do trikratno povečanje koncentracije v krvi in višje stopnje kliničnih beta blokad.
English: Patients with infantile haemangioma may be at increased risk if they have received or are concomitantly receiving treatment with corticosteroids because adrenal suppression may result in loss of the counterregulatory cortisol response and increase the risk of hypoglycaemia.
Slovenian: Pri bolnikih z infantilnim hemangiomom je morda povečano tveganje, če so bili zdravljeni ali se sočasno zdravijo s kortikosteroidi, saj lahko supresija nadledvične žleze privede do izgube protiregulatornega odziva na kortizol in poveča tveganje hipoglikemije.
English: In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to worsening of the reaction and resistance to its treatment with adrenaline at normal doses.
Slovenian: Pri bolnikih, pri katerih obstaja verjetnost hude anafilaktične reakcije ne glede na izvor, zlasti pri uporabi jodiranih kontrastnih sredstev, lahko zdravljenje z antagonisti adrenergičnih receptorjev beta privede do poslabšanja reakcije in odpornosti na zdravljenje z adrenalinom v običajnih odmerkih.
English: • Sodium saccharin
Slovenian: • natrijev saharinat
English: Globally, the adverse reactions reported in the compassionate use program and in literature concerned hypoglycemia (and related event like hypoglycaemic seizure) and aggravated respiratory tract infections with respiratory distress.
Slovenian: Globalno so bili neželeni učinki, o katerih so poročali v programu sočutne uporabe in v literaturnih podatkih, hipoglikemija (in povezani dogodki, kot so hipoglikemične konvulzije) in poslabšanje okužbe dihal z dihalno stisko.
English: Mortality with unknown although unlikely relationship to treatment was observed at 40 mg/kg/day, leading to a NOAEL of 20 mg/kg/day for juvenile toxicity.
Slovenian: Smrtnost z neznano, čeprav malo verjetno povezanostjo z zdravljenjem je bila opažena pri odmerkih 40 mg/kg/dan, zaradi česar se za vrednost NOAEL za toksičnost za juvenilne živali smatra
English: • HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Slovenian: • Zdravilo HEMANGIOL in hrano mora dati ista oseba, da se prepreči tveganje hipoglikemije.
English: - For bradycardia and hypotension: fatigue, coldness, pallor, bluish-coloured skin, and fainting.
Slovenian: - Za bradikardijo in hipotenzijo: utrujenost, hladnost, bledica, modrikasta koža in nezavest.
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indications
Slovenian: 4.1 Terapevtske indikacije
English: • Phaeochromocytoma
Slovenian: • Feokromocitom
English: • Decreased blood sugar levels,
Slovenian: • znižana raven sladkorja v krvi,
English: Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities.
Slovenian: Propranolol lahko zaradi svojega farmakološkega učinkovanja povzroči ali poslabša bradikardijo ali nepravilnosti krvnega tlaka.
English: • The metabolism of intravenous lidocaine is inhibited by co-administration of propranolol, resulting in a 25% increase in lidocaine concentrations.
Slovenian: • Presnovo intravenoznega lidokaina zavira sočasna uporaba propranolola, posledica pa je 25odstotno povečanje koncentracije lidokaina.
English: • has a high blood pressure caused by a tumour on the adrenal gland.
Slovenian: • visok krvni tlak, ki ga povzroča tumor nadledvične žleze.
English: Discard the syringe once the bottle is finished.
Slovenian: Odvrzite brizgo, potem ko izpraznite steklenico.
English: Blood levels of propranolol may be decreased by co-administration of enzyme inducers like rifampicin or phenobarbital.
Slovenian: Induktorji encimov Koncentracije propranolola v krvi se lahko znižajo ob sočasni uporabi induktorjev encimov, kot sta rifampicin ali fenobarbital.
English: Duration of treatment:
Slovenian: Trajanje zdravljenja
English: Replace the plastic cap on the bottle by turning it clock-wise (to the right).
Slovenian: Namestite plastični pokrovček na steklenico, tako da ga zavrtite v smeri urnega kazalca (v desno).
English: In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment should be temporarily discontinued.
Slovenian: V primeru okužbe spodnjih dihalnih poti, povezane z dispnejo in piskanjem v pljučih, je treba zdravljenje začasno prekiniti.
English: This medicine contains 2.08 mg of propylene glycol/kg/day.
Slovenian: To zdravilo vsebuje 2,08 mg propilenglikola/kg/dan.
English: In the absence of data in children, propranolol is not recommended in case of renal or hepatic impairment (see section 4.2).
Slovenian: Zaradi pomanjkanja podatkov pri otrocih ne priporočamo propranolola v primeru motenj delovanja ledvic ali jeter (glejte poglavje 4.2).
English: The advice of a cardiologist should be sought.
Slovenian: Posvetujte se s kardiologom.
English: If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment.
Slovenian: Če se pojavijo klinični znaki hipoglikemije, mora otrok piti sladko raztopino in je zdravljenje treba začasno prekiniti.
English: HEMANGIOL contains sodium and propylene glycol
Slovenian: Zdravilo HEMANGIOL vsebuje natrij in propilenglikol
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: 9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Tell the your doctor that he/she is taking HEMANGIOL.
Slovenian: Povejte svojemu zdravniku, da otrok jemlje zdravilo HEMANGIOL.
English: HEMANGIOL should be administered directly into the child's mouth using the graduated oral syringe, calibrated in mg of propranolol base, supplied with the oral solution bottle (see instructions for use in section 3 of the patient information leaflet).
Slovenian: Zdravilo HEMANGIOL se daje neposredno v otrokova usta z uporabo graduirane brizge za peroralno dajanje, umerjene v miligramih propranolola, ki je priložena steklenici s peroralno raztopino (glejte navodila za uporabo v poglavju 3 navodil za uporabo).
English: In terms of reproductive development, growth and neurological development there were no propranolol-related effects or toxicologically significant findings at 40 mg/kg/day, correlating to safety margins of 1.2 in females and 2.9 in males, based on mean propranolol exposures on PND 21.
Slovenian: povezanih z propranololom, ali toksikološko pomembnih ugotovitev pri 40 mg/kg/dan, kar ustreza varnostni meji 1,2 pri samicah in 2,9 pri samcih, na osnovi povprečne izpostavljenosti propranololu na PND 21.