FrancophonIA/ELRC3.0 huggingface dataset:
English: • Vanilla flavour (contains propylene glycol)
Maltese: • Togħma tal-vanilla (fih propylene glycol)
English: • Low blood pressure below the following limits:
Maltese: • Pressjoni tad-demm baxxa taħt il-limiti li ġejjin:
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.
Maltese: Fil-firien irġiel adulti, l-amministrazzjoni ripetuta tal-propranolol f'livelli ta' dożi għoljin (≥ 7.5 mg/kg) ikkaġuna leżjonijiet istopatoloġiċi tal-testikoli, l-epididymis, u nfafet seminali, tnaqqis fil-motilità, ilkonċentrazzjoni taċ-ċelluli fl-isperma, livelli ta' testosterone fil-plażma u żieda sinifikanti f'
English: Treatment was administered to 456 subjects (401 Propranolol at a dose of 1 or 3 mg/kg/day for 3 or 6 months; 55 Placebo), including a titration phase over 3 weeks.
Maltese: Il-kura ingħatat lil 456 individwu (401 bi propranolol b'doża ta' 1 jew 3 mg/kg/kuljum għal 3 jew 6 xhur ; 55 bi Plaċebo ), inkluż fażi ta' titrazzjoni fuq 3 ġimgħat.
English: The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day.
Maltese: L-okkorrenza ta' dijarea tidher li tiddependi mid-doża bejn 1 u 3 mg/kg/kuljum.
English: • Step 2.
Maltese: • Stadju 2.
English: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANCE
Maltese: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance
English: Less than 1% of a dose is excreted as unchanged drug in the urine.
Maltese: Inqas minn 1% tad-doża hi eliminata bħala mediċina mhux mibdula fl-awrina.
English: • Step 8.
Maltese: Stadju 8.
English: Breast-feeding:
Maltese: Dewmien tat-trattament:
English: • Strawberry flavour (contains propylene glycol)
Maltese: • Togħma tal-frawli (fih propylene glycol)
English: Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha1 acid glycoprotein).
Maltese: Madwar 90% ta' propranolol li jiċċirkola huwa marbut mal-proteini tal-plażma (albumina u aċidu glikoproteina alpha 1).
English: Isoproterenol and aminophylline may be used for bronchospasm.
Maltese: Isoproterenol u aminophylline jistgħu jintużaw għal bronkospażmu.
English: Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Maltese: Kura konkomitanti b' kortikosterojdi sistemiċi jistgħu jżidu r-riskju ta' ipogliċemija (ara sezzjoni 4.5).
English: This is called
Maltese: 1 ISEM
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Maltese: 10, rue Bouché Thomas ZAC d'Orgemont
English: • a local haemodynamic effect (vasoconstriction which is a classical consequence of beta adrenergic blockade and a decrease of infantile haemangioma lesion perfusion);
Maltese: • effett emodinamika lokali (vażokostrizzjoni li hija konsegwenza klassika tal-imblokk beta adrenerġiku u tnaqqis ta' perfużjoni b' leżjoni ta' emanġjoma infantili);
English: • Medicines to treat tuberculosis,
Maltese: • Mediċini għall-kura tat-tuberkulożi,
English: • Step 4.
Maltese: • Stadju 4.
English: Bradycardia is defined below the following limits:
Maltese: Bradikardija hija definita taħt il-limiti li ġejjin:
English: Concomitant use can increase the risk of bradycardia.
Maltese: L-użu konkomitanti jista' jżid ir-riskju ta' bradikardija.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: 2 GĦAMLA KWALITATTIVA
English: Do not put the syringe through a sterilizer or dishwasher.
Maltese: Tpoġġix is-siringa ġo sterilizzatur jew dishwasher.
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.
Maltese: Globalment ir-reazzjonijiet avversi irrapportati fil-programm tal-użu b' kumpassjoni u fil-letteratura ikkonċernat mal-ipogliċemija (u avveniment relatat bħal aċċessjoni ta' ipogliċemija) u infezzjonijiet fl apparat respiratorju aggravati bi problemi respiratorji.
English: The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol.
Maltese: Lerba' metaboliti finali kbar huma propranolol glukoronide, aċidu naftiloksilaktiku u aċidu glukuroniku, u l-konjugati ta' sulfat ta' 4-idroksi propranolol.
English: • Purified water
Maltese: • Ilma purifikat
English: • Breastfed infants, if the mother is treated with medicinal products contraindicated with propranolol
Maltese: • Trabi li jitreddgħu, jekk l-omm tkun ikkurata bi prodotti mediċinali kontraindikati malpropranolol
English: Bronchitis
Maltese: Bronkjolite
English: Propranolol is a beta-blocker that is characterised by three pharmacological properties:
Maltese: Il-propranolol huwa beta-imblokkatur li huwa kkaratterizzat minn tliet proprjetajiet farmakoloġiċi:
English: Box of 1 bottle.
Maltese: Kaxxa bi flixkun.
English: Other medicines and HEMANGIOL
Maltese: Mediċini oħra u HEMANGIOL
English: Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol.
Maltese: Fejn jikkonċerna l-infezzjonijiet tal-apparat respiratorju t'isfel bħal bronkite jew bronkjolite, kien osservat aggravament fis-sintomi (inkluż bronkospażmu) f'pazjenti kkurati b' HEMANGIOL
English: The active ingredient is propranolol.
Maltese: Is-sustanza attiva hija propranolol.
English: • Disease of the sinus node (including sinoatrial block)
Maltese: • Blokok atrijoventrikulari tat-tieni jew tielet grad • Mard tal-glandoli fis-sinus (inklużi blokk sinoatrijali)
English: Reporting of suspected adverse reactions
Maltese: Ir-rapportar ta' reazzjonijiet avversi suspettati
English: Heart rate (beats/min)
Maltese: Taħbit tal-qalb (taħbit/min) 100
English: Lidocaine toxicity (neurological and cardiac adverse events) has been reported following co-administration with propranolol.
Maltese: It-tossiċità tallidocaine (avvenimenti avversi newroloġiċi u kardijaċi) kienet irrappurtata wara t-teħid flimkien ma' propranolol.
English: When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure.
Maltese: Meta pazjent huwa skedat għall-kirurġija, terapija bil-beta-imblokkaturi għandha titwaqqaf mill-inqas 48 siegħa qabel il-proċedura.
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.
Maltese: Mortalità b'relazzjoni mhux magħrufa għalkemm improbabbli kienet osservata fi 40 mg/kg/jum, li jwassal għal NOAEL ta' 20 mg/kg/ġurnata għal tossiċità minorenni.
English: • Hemangiol is for oral use.
Maltese: • Hemangiol huwa għall-użu orali.
English: Agitation Nightmares Irritability
Maltese: Inkubi Irritabilità
English: Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease.
Maltese: Dijarrea kienet irrapportata frekwentement u mhux dejjem kienet assoċjata ma' mard gastro-intestinali infettiv.
English: - For hypoglycaemia: minor symptoms like pallor, tiredness, sweating, shakiness, palpitations, anxiety, hunger, difficulty waking up; major symptoms like excessive sleeping, difficulty to get a response, poor feeding, temperature decrease, convulsions (fits), brief pauses in breathing, loss of consciousness
Maltese: - Għall-ipogliċemija: sintomi minuri bħal sfurija, għeja, għaraq, tregħid ripetut, palpitazzjonijiet, ansjetà, ġuħ, diffikultà biex iqum mill-irqad; sintomi ewlenin bħall-irqad eċċessiv, diffikultà biex tikseb rispons, tmigħ imnaqqas, tnaqqis fit-temperatura, konvulżjonijiet (aċċessjonijiet),
English: The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 mg/kg.
Maltese: Id-doża inizjali rakkomandata hi 1 mg/kg/kuljum li hi maqsuma f'żewġ dożi separati ta' 0.5 mg/kg.
English: 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: 5 PROPRJETAJIET FARMAKOLOĠIĊI 5
English: 6 Contents of the pack and other information What HEMANGIOL contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih HEMANGIOL
English: • The metabolism of intravenous lidocaine is inhibited by co-administration of propranolol, resulting in a 25% increase in lidocaine concentrations.
Maltese: • Il-metaboliżmu ta' lidocaine li jittieħed minn ġol-vina huwa inibit bit-teħid flimkien ma' propranolol, li jirriżulta f'żieda ta' 25 % fil-konċentrazzjonijiet ta' lidocaine.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati fis sezzjoni 6.1
English: Antiarrhythmics
Maltese: Antiarritmiċi
English: 0-3 months
Maltese: 0-3 xhur
English: In the absence of data, administration of the medicinal product is not recommended to infants with hepatic or renal impairment (see section 4.4).
Maltese: Fin-nuqqas ta' dejta, l-amministrazzjoni tal-prodott mediċinali mhuwiex rakkomandat fit-trabi b'indeboliment epatiku jew renali (ara sezzjoni 4.4).
English: • HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Maltese: • HEMANGIOL u t-tmigħ għandhom jingħataw mill-istess persuna sabiex jiġi evitat ir-riskju ta'
English: In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis.
Maltese: Fi studji fl'amministrazzjoni tad-dieta li fihom ġrieden u firien kienu kkurati b'hydrochloride ta' propranolol sa 18-il xahar f'dożi sa 150 mg/kg/jum, ma kienx hemm evidenza ta' tumoriġenesi relatata mad-droga.
English: There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in infants and children aged above 5 months.
Maltese: Fin-nuqqas ta' effikaċja klinika u dejta tas-sigurtà, HEMANGIOL m'għandux jintuża fi trabi taħt l-età ta' 5 ġimgħat.
English: FRANCE
Maltese: FRANZA
English: Halogenated Anesthetic Agents
Maltese: Aġenti anestetiċi aloġenati
English: • Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
Maltese: • Amiodarone huwa aġent antiarritmiku bi proprjetajiet kronotropiċi negattivi li jistgħu ikunu addittivi għal dawk li dehru bi β-imblokkaturi bħal propranolol.
English: Date of first authorisation: 23 April 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 23 april 2014
English: Propranolol belongs to a group of medicines known as beta-blockers.
Maltese: Propranolol jappartjeni għal grupp ta' mediċini magħrufa bħala beta-imblokkaturi.
English: • Medicines used for anaesthesia.
Maltese: • Mediċini użati għall-anestesija,
English: Erythema Dermatitis diaper
Maltese: Eritema Dermatite tal ħrieqi
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • Bradycardia (abnormally low heart rate),
Maltese: • Bradikardija (rata tat-taħbit tal-qalb baxxa b'mod anormali),
English: 1 ml of solution contains 4.28 mg of propranolol hydrochloride equivent to 3.75 mg of propranolol.
Maltese: Millilitru ta' soluzzjoni fih 4.28 mg ta' propranolol hydrochloride ekwivalenti għal 3.75 mg ta' propranolol.
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.
Maltese: Id-doża terapewtika hi 3 mg/kg/jum, li għandha tingħata f' żewġ dożi separati ta' 1.5 mg/kg, waħda filgħodu u waħda tard wara nofsinhar, b'intervall ta' mill-inqas 9 sigħat bejn żewġ inġestjonijiet.
English: • Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity.
Maltese: • Ipogliċemija tista' tiżviluppa u manifestazzjonijiet ta' ipogliċemija (rogħda, takikardja) jistgħu jkunu mgħottija bl-effetti kliniċi oħra tat-tossiċità tal-beta-imblokkaturi.
English: Psoriasis
Maltese: Psorajiżi
English: • Somnolence,
Maltese: Madankollu,
English: The volume of distribution of propranolol is approximately 4 L/kg.
Maltese: Il-volum ta' distribuzzjoni ta' propranolol huwa madwar 4 L/kg.
English: Clinical efficacy and safety in the paediatric population The efficacy of propranolol in infants (aged 5 weeks to 5 months at treatment initiation) with proliferating infantile haemangioma requiring systemic therapy has been demonstrated in a pivotal randomised, controlled, multicentre, multidose, adaptive phase II/III study aimed to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind).
Maltese: L-effikaċja ta' propranolol fit-trabi (ta' bejn 5 ġimgħat sa 5 xhur fil-bidu tal-kura) ma' emanġjoma infantili proliferanti li jeħtieġu terapija sistemika kienet dimostrata fi studju randomiżżat, ikkontrollat, multiċentrali, b'ħafna dożi, fażi adattiva
English: Hyperkalaemia has been reported in the literature in few patients with large ulcerated haemangioma (see section 4.4).
Maltese: Iperkalemija ġiet irrapportata fil-letteratura fi ftit pazjenti b'emanġjoma b'ulċeri kbar (ara sezzjoni 4.4).
English: • Minor: pallor, tiredness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up.
Maltese: • Minuri: sfurija, għeja, għaraq, tregħid, palpitazzjonijiet, ansjetà, ġuħ, diffikultà biex tistembaħ.
English: Package leaflet: Information for the user HEMANGIOL 3.75 mg/mL oral solution propranolol
Maltese: Informazzjoni għall-utent HEMANGIOL 3.75 mg/mL soluzzjoni orali propranolol
English: • Decreased appetite,
Maltese: • Tnaqqis fl-aptit,
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rapportar ta' reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali huwa importanti.
English: Beta stimulating agents may be used to counteract the beta-blockade.
Maltese: Aġenti li jistimulaw beta jistgħu jintużaw biex jikkontrobattu l-imblokk tal-beta.
English: Concomitant use may reduce the reflex sympathetic response involved when excessive distal vasodilatation.
Maltese: L-użu konkomitanti jista' jnaqqas ir- rispons simpatetiku rifless involut meta l-vażodilatazzjoni distal hija eċċessiva.
English: 1 ml of solution contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol base.
Maltese: Millilitru ta' soluzzjoni fih 4.28 mg ta' propranolol hydrochloride ekwivalenti għal 3.75 mg ta' bażi propranolol.
English: Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Maltese: Każijiet iżolati ta' bradikardija sintomatika u pressjoni baxxa kienu rrappurtati fil-letteratura.
English: - For bradycardia and hypotension: fatigue, coldness, pallor, bluish-coloured skin, and fainting.
Maltese: - Għall-bradikardija u pressjoni baxxa: għeja, kesħa, sfurija, ġilda blu kulur, u ħass ħażin.
English: A close clinical surveillance of any impaired tolerance of propranolol is requested.
Maltese: Hija mitluba sorveljanza klinika mill-qrib għal kull nuqqas ta' tolleranza ta'propranolol.
English: HEMANGIOL should be administered for a 6-month period.
Maltese: HEMANGIOL għandu jingħata għal perjodu ta' 6 xhur .
English: 1 bottle of 120 mL and 1 oral syringe.
Maltese: Flixkun wieħed ta'120 mL u siringa orali waħda.
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.
Maltese: L- MAH għandu jipprovdi pakkett edukattiv għall- indikazzjoni proposta , li jimmiraw persuni li jieħdu ħsiebhom kollha li huma mistennija tipprepara u tagħti HEMANGIOL lit-tfal .
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u finnutrizzjoni
English: • Premature infants, for whom the corrected age of 5 weeks has not been reached (the corrected age being calculated by subtracting the number of weeks of prematurity from the actual age)
Maltese: • Trabi prematuri, li għalihom l-età korretta ta' 5 ġimgħat għadha ma ntlaħqitx (l-età korretta tiġi kkalkulata billi jitnaqqas in-numru ta' ġimgħat ta' primaturità mill-età attwali)
English: • Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Maltese: • Propafenone għandu proprjetajiet inotropiċi u beta-blokkanti negattivi li jistgħu ikunu addittivi għal dawk ta' propranolol.
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
Maltese: neovaskularizzazzjoni u l-formazzjoni ta' tubi vaskulari, tnaqqis tas-sekrezzjoni ta' Matrix
English: Co-administration of cholestyramine or colestipol with propranolol resulted in up to 50% decrease in propranolol concentrations.
Maltese: L-għoti ta' kolestiramina jew kolestipol flimkien ma' propranolol wassal għal tnaqqis ta' 50 % fil konċentrazzjonijiet tal-propranolol.
English: Discontinuation of treatment does not require a progressive decrease in the dose.
Maltese: Twaqqif tat-trattament ma jeħtieġx tnaqqis progressiv fid-doża.
English: The educational pack must be available for distribution prior to the launch of the new indication (treatment of proliferating infantile haemangioma) in the Member State.
Maltese: Il-pakkett edukattiv għandu jkun disponibbli għad-distribuzzjoni qabel it-tnedija tal-indikazzjoni l-ġdida (trattament ta' emanġjoma infantili proliferanti) fl-Istat Membru.
English: • at least 9 hours interval between two intakes
Maltese: 9 DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI
English: Once corrected by the body weight, primary pharmacokinetic parameters for propranolol (such as plasma clearance) determined in infants were similar to those reported in the literature for adults.
Maltese: Meta korretta skont il-piż tal-ġisem, il-parametri farmakokinetiċi primarji għal jtpropranolol (bħal tneħħija mill-plażma) determinati fi trabi kienu simili għal dawk irrapportati fil-letteratura għall-adulti.
English: 6.3 Shelf life
Maltese: 3-6 xhur
English: Hypotension Vasoconstriction Raynaud's phenomenon
Maltese: Fenomenu ta' Raynaud
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.
Maltese: sigurtà ta' 1.2 fin-nisa u 2.9 fl-irġiel, ibbażati fuq l-espożizzjonijiet medji ta' propranolol fuq PND 21.
English: The effects generally totally reversed after treatment cessation.
Maltese: L-effetti ġeneralment kienu riversati totalment wara l waqfien tal-kura.
English: The posology is expressed in propranolol base.
Maltese: Pożoloġija Il-pożoloġija hi espressa fil-bażi propranolol.
English: In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Maltese: Fil-każ ta' anormalità bronko-pulmonari akuta, il-bidu tat-trattament għandu jiġi pospost.
English: Due to the clinical trial database size rare and very rare categories are not represented.
Maltese: Minħabba d-daqs tal-bażi tad-dejta tal-provi kliniċi ir-rati tall-kategoriji rari u rari ħafna mhumiex rappreżentati.
English: Similar results were obtained following intra-testicular administration of propranolol and using in vitro models.
Maltese: Riżultati simili kienu miksuba wara l-għoti intra-testikolari ta' propranolol u l-użu fil-mudelli in vitro.
English: CARTON BOX / BOTTLES NAME OF THE MEDICINAL PRODUCT
Maltese: KAXXA TAL-KARTUNA / FLIEXKEN
English: Hemangiol is started in infants aged 5 weeks to 5 months, when: - the localisation and/or extend of the lesions are life- or function threatening (might impair vital organs or senses such as vision or hearing); - the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful, and/or does not respond to simple wound care measures; - there is a risk of permanent scars or disfigurement.
Maltese: Hemangiol tibda fi trabi ta' età minn 5 ġimgħat sa 5 xhur, meta: - l-lokalizzazzjoni u/jew il-limitu tal-leżjonijiet huma ta' theddida għall-ħajja jew għall-funzjoni (jista' jfixkel organi jew sensi vitali bħal vista jew smigħ);
English: • Bronchospasm (breathing difficulties),
Maltese: • Bronkospażmu (diffikultà fin-nifs),
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.
Maltese: Trabi b'emanġjoma infantili kbira għandhom jiġu investigati b'mod komplet għall arterjopatija potenzjali assoċjata mas-sindrome ta' PHACE , ma' anġjografija tar-reżonanza manjetika tar-ras u l għonq u immaġini tal-qalb li jinkludu l-arka tal-aorta, qabel ma tiġi kkunsidrata t-terapija talpropranolol.
English: Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning.
Maltese: Blokki atrijoventrikulari, dewmien fil-konduzzjoni intraventrikulari, u insuffiċjenza tal-qalb konġestiva jistgħu jseħħu ma' avvelenament aktar severi.
English: • Bradycardia below the following limits:
Maltese: • Bradikardija taħt il-limiti li ġejjin:
English: The mixing may be done with one teaspoonful (approximately 5 mL) of milk for children weighing up to 5 kg, or with a tablespoonful (approximately 15 mL) of milk or fruit juice for children weighing more than 5 kg, delivered in a baby's bottle.
Maltese: magħrfa (madwar 15 mL) ħalib jew meraq tal-frott għat-tfal li jiżnu aktar minn 5 kg, mogħti filflixkun tat-tarbija.
English: The 4-hydroxy-propranolol metabolite was quantified, its plasma exposure accounting for less than 7% of the parent drug exposure.
Maltese: Il- 4-idroksi-propranolol metabolit kienet kwantifikata, l-esponiment fil-plażma jammonta għal inqas minn 7% tal-espożizzjoni tal-mediċina prinċipali.
English: General anaesthesia
Maltese: Anestesija ġenerali
English: Second week (2 mg/kg/day)
Maltese: (2 mg/kg/jum)
English: Treatment with HEMANGIOL should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available.
Maltese: Il-kura b'HEMANGIOL għandha tinbeda minn tobba li għandhom opinjoni esperta fid-dijanjosi, ilkura u l-ġestjoni ta' emanġjoma infantili, fi sfond kliniku kkontrollat fejn faċilitajiet adegwati għallimmaniġġjar ta' reazzjonijiet avversi, inklużi dawk li jeħtieġu miżuri urġenti, huma disponibbli.
English: • Nappy rash.
Maltese: (psorjasi)/raxx.
English: Agranulocytosis
Maltese: Agranuloċitosi
English: In the context of the 4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration.
Maltese: Fil-kuntest talmonitoraġġ kardjovaskulari tal-4 sigħat matul il-jiem tat-titrazzjoni, kien osservat tnaqqis ta' rata tattahbit tal-qalb (madwar 7 bpm) u tal-pressjoni tad-demm sistolika (inqas minn 3 mmHg) wara l-għoti tal-mediċina.
English: Sleep disorder
Maltese: Disturbi vaskulari
English: • has circulation problems which make the toes and fingers numb and pale.
Maltese: • għandha problemi taċ-ċirkolazzjoni li jagħmlu l-saqajn u swaba mtarrxa.