FrancophonIA/ELRC3.0 huggingface dataset:
English: Protocol GTC AT HD 012-04: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis.
Maltese: Studju Multicentre, Multinazzjonali biex Jevalwa s-Sigurtà u l-Effikaċja ta' Antithrombin alfa f'Pazjenti b'Defiċjenza Ereditarja ta' Antithrombin (AT) f'Sitwazzjonijiet ta' Riskju
English: Haemorrhage
Maltese: Emorraġija
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Maltese: L-informazzjoni ta' l-użu mhux kliniku ma wriet l-ebda perikli speċjali għall-bnedmin, ibbażata fuq studji konvenzjonali dwar is-sigurtà farmakoloġika, it-tossiċità tad-doża ripetuta, ġenotossiċità u tossiċità għar-riproduzzjoni.
English: This medicine is used in patients who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Maltese: Din il-mediċina tintuża f'pazjenti li għandhom ‘nuqqas konġenitali ta' antithrombin' (livelli baxxi tal-proteina antithrombin li jkunu ntirtu).
English: Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Maltese: Il-frekwenzi huma definiti bħala: komuni (≥ 1/100 sa < 1/10) u mhux
English: In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Maltese: Fi provi kliniċi oħrajn fuq pazjenti li kellhom operazzjoni fil-qalb u li kellhom ukoll defiċjenza miksuba ta' l-antithrombin (n=118) u fuq voluntiera f'saħħithom (n=102), l-effetti mhux mixtieqa li kienu rrappurtati li kienu marbuta mal-kura b'ATryn li kienu osservati iktar minn darba, huma elenkati skond il-Klassi tas-Sistema tal-Organi fit-tabella hawn taħt.
English: Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Maltese: Mhux komuni Fwawar Eritema fis-sit tal-infużjoni Uġigħ fis-sit tal-infużjoni Raxx fis-sit tal-infużjoni Tbenġil fis-sit tal-venipuntura
English: ATryn 1750 IU powder for solution for infusion.
Maltese: ATryn 1750 IU trab għas-soluzzjoni għall-infużjoni.
English: • dizziness
Maltese: • Pożoloġija
English: The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Maltese: Normalment id-doża tal-manuntenzoni f'pazjenti kirurġiċi b'defiċjenza konġenitali ta' lantithrombin f'sitwazzjonijiet ta' riskju kliniku hija ta' 4-5 IU/kg/h.
English: ATryn 1750 IU powder for solution for infusion
Maltese: ATryn 1750 IU trab għas-soluzzjoni għall-infużjoni
English: Nausea
Maltese: Tqala
English: MedDRA SOC
Maltese: OĦRA, JEKK MEĦTIEĠA
English: Post procedural haemorrhage Wound secretion
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: No information is available on the possible effects of antithrombin alfa on male and female fertility.
Maltese: M'hemm l-ebda informazzjoni disponibbli dwar l-effetti possibbli ta' antithrombin alfa fuq ilfertilità tan-nisa u tal-irġiel.
English: Venipuncture site haemorrhage
Maltese: Therapure Biopharma
English: c)
Maltese: NN:
English: • Information about the currently registered indications and population, including that the product is not indicated in the paediatric population.
Maltese: • Informazzjoni dwar l-indikazzjonijiet u l-popolazzjoni li huma rreġistrati bħalissa, li jinkludu li l-prodott mhuwiex indikat fil-popolazzjoni pedjatrika.
English: No antibodies to antithrombin alfa have been detected up to 90 days following treatment with ATryn.
Maltese: L-ebda anti-korpi għal antithrombin alfa ma kienu osservati sa 90 jum wara l-kura b'ATryn.
English: However, chemical and physical stability has been demonstrated for 3 hours after reconstitution and 8 hours after dilution at a temperature not above 25°C.
Maltese: Madankollu, l-istabbiltà kimika u fiżika ntweriet għal 3 sigħat wara rrikostituzzjoni u għal 8 sigħat wara d-dilwizzjoni f'temperatura ta' mhux iktar minn 25°C.
English: Loading dose (IU) = [(100 - patient's pre-treatment AT activity level in %) /2.28] x Body Weight in kg
Maltese: Doża qawwija tal-bidu (IU) = [(100 - il-livell ta' l-attività AT ta' qabel il-kura talpazjent f'%) /2.28] x il-piż tal-ġisem f'kg
English: ** recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Maltese: ** antithrombin rikombinanti uman hu prodott fil-ħalib ta' mogħoż transġeniċi permezz tat
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Antithrombin (AT) activity in plasma is expressed either as a percentage (relative to human plasma) or in International Units (relative to the International Standard for antithrombin in plasma).
Maltese: Lattività ta' l-antithrombin (AT) fil-plażma hi espressa jew bħala perċentwali (meta mqabbla mal-plażma umana) jew f'International Units (meta mqabbla ma' l-Istandard Internazzjonali għall-antithrombin fil-plażma).
English: Due date
Maltese: Data mistennija
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tarRegolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li gejjin:
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% of normal (0.8 - 1.2 IU/ml) for the duration of treatment.
Maltese: Il-għan terapewtiku tal-kura b'antithrombin alfa huwa biex tiżdied, u tinżamm l-attività ta' lantithrombin bejn 80 - 120% tan-normal (0.8 - 1.2 IU/ml) għal kemm iddum il-kura.
English: Paediatric antithrombin levels may be different from adult levels, particularly in neonates.
Maltese: Il-livelli ta' antithrombin pedjatriċi jistgħu jkunu differenti mil-livelli tal-adulti, b'mod partikolari fi trabi tat-twelid.
English: After reconstitution, 1 ml of solution contains 175 IU antithrombin alfa.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni jkun fih 175 IU ta' antithrombin alfa.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: EXP
Maltese: PC:
English: Patients treated with this medicine should be monitored for possible clinical immunological reactions.
Maltese: Pazjenti kkurati b'din il-mediċina għandhom ikunu immonitorjati għal reazzjonijiet immunoloġiċi possibbli.
English: The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ATryn fi tfal u adoloxxenti (<18-il sena) ma ġietx stabbilita.
English: In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ml), no dose adjustment is needed.
Maltese: F'każ li l-livell ta' attività ta' l-AT ikun bejn 80% u 120% (0.8 - 1.2 IU/ml), l-ebda bdil fid-doża ma huwa meħtieġ.
English: The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Maltese: Id-doża qawwija tal-bidu għandha tingħata bħala infużjoni ta' 15-il minuta segwita immedjatament mill-bidu ta' l-infużjoni tal-manutenzjoni.
English: The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with a 0.22 micron pore size in-line filter.
Maltese: Il-prodott rikostitwit għandu jingħata permezz ta' infużjoni fil-vini bl-użu ta' siringa sterilizzata li tintrema wara li tintuża jew borża tal-infużjoni b'filtru in-line b'daqs tal-pori ta' 0.22 mikron.
English: Paediatric population
Maltese: • Demografija
English: Gastrointestinal disorders
Maltese: TAL-PRODOTT MEDIĊINALI
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% (0.8 - 1.2 IU/ml) for the duration of treatment.
Maltese: Il-għan terapewtiku tal-kura b'antithrombin alfa hija biex iżżid, u żżomm l-attività ta' lantithrombin bejn 80 - 120% (0.8 - 1.2 IU/ml) għal kemm iddum il-kura.
English: In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Maltese: F'każ li l-livell ta' attività ta' l-AT tkun iktar minn 120%, naqqas ir-rata ta' l-infużjoni tal-manutenzjoni bi 30%.
English: Dizziness headache
Maltese: DATA TA' SKADENZA
English: 5.2 Pharmacokinetic properties
Maltese: Grupp Farmakoterawpewtiku:
English: * recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Maltese: * antithrombin rikombinanti uman hu prodott fil-ħalib ta' mogħoż transġeniċi permezz tat
English: In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Maltese: F'każ li l-livell ta' attività ta' l-AT ikun inqas minn 80%, żid irrata ta' l-infużjoni tal-manutenzjoni b'50%.
English: Treatment should be continued until the risk for venous thromboembolisms is reduced and/or when effective follow-on anticoagulation has been established.
Maltese: Il-kura għandha titkompla sakemm ir-riskju ta' tromboemboliżmi jitnaqqas u/jew meta tkun ġiet stabbilita antikoagulazzjoni ta' follow-on effettiva.
English: The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Maltese: Il-kumplessi ta' l-enzima inibitur-koagulazzjoni jitneħħew mis-sistema retikulo-endoteljali.
English: Therapeutic Monitoring and Dose Adjustment
Maltese: IL-PRODOTT MEDIĊINALI
English: Please discuss possibility of stopping the treatment with your doctor.
Maltese: Jekk jogħġbok iddiskuti l-possibbiltà li twaqqaf il-kura mat-tabib tiegħek.
English: The results of completed study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period have been submitted.
Maltese: Protokoll GTC AT HD 012-04:
English: If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Maltese: Jekk tesperjenza ħorriqija, tbenġil jew ġerħiet bil-ħakk mal-ġilda kollha, għafis fuq is-sider, tħarħir (diffikultà biex tieħu nifs), għandek tikkuntattja minnufih lit-tabib tiegħek minħabba li dawn jistgħu jkunu s-sintomi ta' reazzjoni allerġika qawwija.
English: Package leaflet: Information for the user ATryn 1750 IU powder for solution for infusion antithrombin alfa (rDNA) This medicine is subject to additional monitoring.
Maltese: ATryn 1750 IU trab għas-soluzzjoni għall-infużjoni antithrombin alfa (rDNA)
English: A risk to the suckling child cannot be excluded.
Maltese: Riskju għall-wild li jkun qiegħed jerda' ma jistax jiġi eskluż.
English: If diluted, the solution prepared in infusion bags should be administered immediately and no longer than 8 hours after dilution.
Maltese: Jekk tkun dilwita, is-soluzzjoni ppreparata fil-boroż tal-infużjoni għandha tingħata immedjatament u mhux iktar tard minn 8 sigħat wara d-dilwizzjoni.
English: Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Maltese: Is-sostituzzjoni ta' l-antithrombin waqt l-għoti ta' mediċini li jraqqu d-demm li jżidu l-attività ta' antithrombin biex iraqqaq id-demm (eż. eparina, eparina b'piż molekulari baxx), jistgħu iżidu r-riskju ta' ħruġ ta' demm.
English: In studies with ATryn the following side effects were reported: Common side effects (may affect up to 1 in 10 people) are:
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni ) huma:
English: Response may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Maltese: Irrispons jista' jvarja f'pazjenti individwali, u jilħaq livelli differenti ta' rkuprar in vivo u halflives differenti.
English: In the treatment of congenital antithrombin deficiency, the dose and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Maltese: Fil-kura tad-defiċjenza konġenitali ta' l-antithrombin, id-doża u t-tul ta' żmien tal-kura għandhom jitfasslu għal kull pazjent, u l-istorja medika tal-familja tiġi kkunsidrata fir-rigward ta' avvenimenti tromboemboliċi, il-fatturi tar-riskji attwali kliniċi, u levalwazzjoni tal-laboratorju.
English: See the end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 biex tara kif għandek tirrapporta effetti sekondarji.
English: • Information regarding the resulting efficacy issues associated with off-label use of ATryn, especially
Maltese: • Reazzjonijiet avversi tal-mediċina li jinkludu nuqqas ta'
English: Name and address of the manufacturer(s) of the biological active substance(s) Therapure Biopharma Inc.
Maltese: Il-kura inizjali tibda b'doża qawwija tal-bidu biex jintlaħaq livell ta' attività ta' l-antithrombin ta' 100%.
English: It is unknown whether antithrombin alfa or its metabolites are excreted in human milk.
Maltese: Mhuwiex magħruf jekk antithrombin alfa jew il-metaboliti tiegħu jiġux eliminati fil-ħalib talbniedem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1, 10 OR 25 VIALS)
Maltese: Daqsijiet tal-pakketti ta' 1, 10 jew 25 kunjett.
English: EU/1/14/919/001
Maltese: FIS-SUQ EU/1/14/919/001
English: Method of administration
Maltese: Metodu ta' amministrazzjoni
English: Absorption and distribution:
Maltese: Assorbiment u distribuzzjoni:
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: Blood pressure (mmHg) 65/45
Maltese: Pressjoni tad-demm(mmHg) 65/45
English: • Severe peripheral arterial circulatory disturbances (Raynaud's phenomenon)
Maltese: • Disturbi fiċ-ċirkolazzjoni arterjali periferali severa (fenomenu ta' Raynaud)
English: • the absence of cardioselective beta-1 beta-blocking activity,
Maltese: • l-assenza ta' attività tal-beta- 1 beta- imblukkaturi kardjoselettivi,
English: • The active substance is propranolol.
Maltese: • Is-sustanza attiva hi propranolol.
English: • Agitation, nightmares, irritability,
Maltese: • Aġitazzjoni, inkubi, irritabilità,
English: HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:
Maltese: HEMANGIOL huwa indikat fil-kura ta' emanġjoma infantili proliferanti li jeħtieġ terapija sistemika:
English: For the full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: PHACE syndrome
Maltese: Sindromu PHACE
English: Respiratory disorders
Maltese: Disturbi respiratorji
English: Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp).
Maltese: Propranolol huwa substrat għat-trasportatur effluss intestinali, P -glikoprotein (P -gp).
English: Pharmacotherapeutic group: Beta-Blocking agent, non-selective, ATC code: C07AA05
Maltese: Aġent beta-imblokkatur, mhux selettiv, Kodiċi ATC: C07AA05
English: Biotransformation and elimination:
Maltese: Bijotrasformazzjoni u eliminazzjoni:
English: • an antiarrhythmic effect,
Maltese: • l-effett antiarritmiku,
English: • Prinzmetal's angina
Maltese: • Anġina ta' Prinzmetal
English: • lack of partial agonist activity (or intrinsic sympathomimetic activity).
Maltese: • in-nuqqas ta' attività agonista parzjali (jew attività simpatomimetika intrinsika).
English: PIERRE FABRE MEDICAMENT PRODUCTION Site PROGIPHARM, Rue du Lycée 45500 GIEN
Maltese: Site PROGIPHARM, Rue du Lycée 45500 GIEN
English: Patients (71.3% female; 37% aged 35-90 days old and 63% aged 91-150 days old) presented a target haemangioma on the head in 70% and majority of the infantile haemangiomas were localized (89%).
Maltese: Pazjenti (71.3% nisa; 37% ta' bejn 3590 ġurnata u 63% ta' bejn 91-150 jum) ppreżentaw emanġjoma fuq ir-ras f'70% u l-maġġoranza talemanġjomi infantili kienu lokalizzati (89 %).
English: 6-12 months
Maltese: 6-12 xhur
English: Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5.
Maltese: Treddigħ Ommijiet li qed ireddgħu: ara sezzjoni 4.4 u sezzjoni 4.5.
English: Dermatitis psoriasiform
Maltese: Dermatite psorjasiformi
English: Age (35-90 days / 91150 days), gender and haemangioma location (head / body) subgroups did not identify differences in response to propranolol.
Maltese: L-età ( ġranet 35-90/91-150 ġranet), is-sess u s-sottogruppi tal-post tal-emanġjoma (ras/ġisem) ma identifikax differenzi fir-rispons għal propranolol.
English: In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse reactions in infant treated with HEMANGIOL were sleep disorders (16.7%), aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea (16.5%), and vomiting (11.5%).
Maltese: F'provi kliniċi għal emanġjoma infantili proliferanti, ir-reazzjonijiet avversi tal-mediċina l-aktar irrapportati fi trabi kkurati bil-HEMANGIOL kienu disturbi fl-irqad (16.7%), infezzjonijiet fl-apparat respiratorju aggravati bħal bronkite u bronkjolite assoċjati ma' sogħla u deni, dijarea (16.5%), u rimettar (11.5%).
English: AV block
Maltese: Blokk AV
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.
Maltese: It-tneħħija apparenti b'mod orali medja kienet 2.71 L/h/kg fit-trabi ta' età ta' 65-120 jum u 3.27 L/h/kg f'trabi ta' età bejn 181-240 jiem.
English: Cardiovascular medicinal products
Maltese: Prodotti mediċinali kardjovaskulari
English: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance F- 92100 Boulogne
Maltese: Pierre Fabre Dermatologie 45, place Abel Gance F-92100 Boulogne Franza
English: The percentage contributions of these routes to total metabolism are 42%, 41% and 17%, respectively, but with considerable variability between individuals.
Maltese: Il-kontribuzzjonijiet perċentwali ta' dawn il-passaġġi għall- metaboliżmu totali huma 42%, 41% u 17%, rispettivament, iżda b'varjabilità konsiderevoli bejn l-individwi.
English: • Bronchitis (inflammation of the bronchi),
Maltese: • Bronkite (infjammazzjoni tal-bronki),
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - 2D BARCODE 2D barcode li għandu l-identifikatur uniku inkluż.
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).
Maltese: Il-frekwenza tagħhom hija definita skont dawn il-konvenzjonijiet: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10, 000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism.
Maltese: Studju in vitro indikaw li CYP2D6 (idroksilazzjoni aromatiku), CYP1A2 (ossidazzjoni fil-katina) u f'livell inqas CYP2C19 kienu nvoluti fil-metaboliżmu ta' propranolol.
English: It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
Maltese: Għandha tinbeda fi trabi ta'età ta' 5 ġimgħat sa 5 xhur (ara sezzjoni 4.2).
English: Fertility
Maltese: Fertilità:
English: This medicine contains 2.08 mg of propylene glycol/kg/day.
Maltese: Dan il-prodott mediċinali fih 2.08 mg ta' propylene glycol/kg/jum.
English: 10 rue Bouché Thomas ZAC Sud d'Orgemont 49000 ANGERS FRANCE
Maltese: ZAC Sud d'Orgemont 49000 ANGERS
English: HEMANGIOL 3.75 mg/mL oral solution
Maltese: HEMANGIOL 3.75 mg/mL soluzzjoni orali
English: • The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water.
Maltese: • Is-sustanzi l-oħra huma hydroxyethylcellulose, sodium saccharin, togħma ta' frawli (fih propylene glycol), togħma ta' vanilla (fih propylene glycol), citric acid monohydrate, ilma ppurifikat.
English: • Haemangioma with a risk of permanent scars or disfigurement.
Maltese: • Emanġjoma b'riskju ta' ċikatriċi permanenti jew sfigurament.
English: Bradycardia -inducing calcium-channel blockers (diltiazem, verapamil, bepridil) Co-administration with propranolol can cause altered automaticity (excessive bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disorders, and increased risk of ventricular arrhythmias (torsades de pointes) along with heart failure.
Maltese: Imblokkaturi tal-kanali tal-kalċju li jinduċu bradikardija (diltiazem, verapamil, bepridil) L-għoti flimkien ma' propranolol jista' jikkawża awtomatiċità alterata (bradikardija eċċessiva, arrest tas-sinus), disturbi tal-konduzzjoni sinoatrijali u atrijoventrikulari, u riskju akbar ta' arritmiji ventrikulari (torsades de pointes) flimkien ma' insuffiċjenza tal-qalb.
English: The pharmacokinetics of repeated administrations of HEMANGIOL at 3 mg/kg/day given in 2 intakes has been investigated in 19 infants aged 35 to 150 days at the beginning of treatment.
Maltese: Il-farmakokinetika ta' amministrazzjonijiet ripetuti ta' HEMANGIOL fi 3 mg/kg/jum mogħtija f' 2 darbiet ġiet investigata f' 19-il tarbija ta' età bejn 35-150 jum fil-bidu tal-kura.
English: The potential effects of propranolol on the development of juvenile rats were evaluated following daily oral administration from post-natal Day 4 (PND 4) to PND 21 at dose-levels of 0, 10, 20 or 40 mg/kg/day.
Maltese: Jum wara t-twelid (PND 4) sa PND 21 f' livelli ta'doża ta' 0, 10, 20 jew 40 mg/kg/jum.
English: • Step 9.
Maltese: • Stadju 9.
English: Risks of bronchospasm
Maltese: Riskji ta' bronkospażmu
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.
Maltese: Fosfodijsterasi, antidepressanti triċikliċi, antipsikotiċi, agonisti dopaminerġiċi, levodopa, amifostine, baclofen ...) jistgħu jżidu l-effetti tagħhom ma' dik tal-beta-imblokkaturi.
English: 'phaeochromocytoma'.
Maltese: Din tissejjaħ " feokromoċitoma".
English: HEMANGIOL 3.75 mg/mL oral solution propranolol
Maltese: HEMANGIOL 3.75 mg/mL soluzzjoni orali propranolol
English: • Urticaria (allergic reaction of the skin), alopecia (loss of hair),
Maltese: • Urtikarja (reazzjoni allerġika tal-ġilda), alopeċja (telf tax-xagħar),
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Hija tippermetti monitoraġġ kontinwu tal-bilanċ ta' benefiċċju/riskju tal-prodott mediċinali.
English: • Step 7.
Maltese: • Stadju 7.
English: Very limited safety data of propranolol in PHACE syndrome patients are available.
Maltese: Dejta ta' sigurtà limitat ħafna ta' propranolol f'pazjenti b'sindromu PHACE huwa disponibbli.
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).
Maltese: II tal-istudju) ippreżentat 60.4% ta' suċċess kontra 3.6% fil-fergħa tal-plaċebo (valur p < 0.0001).