FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that VarroMed's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' VarroMed huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It can be used either as a single-dose treatment during the broodless period (winter treatment), or in the presence of brood (spring or autumn treatment) which will usually require repeated treatments.
Maltese: Dan jista' jintuża jew bħala kura b'doża waħda waqt il-perjodu mingħajr duqqajs (kura fix-xitwa), jew fil-preżenza tad-doqqajs (kura fir-rebbiegħa jew fil-ħarifa) li normalment tkun teħtieġ kuri ripetuti.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
Maltese: kunjett (ħġieġ) 10 ml (3.5 mg/ml) 2 kunjetti kunjett (ħġieġ) 10 ml (3.5 mg/ml) 5 (5 x 1) kunjetti (pakkett multiplu)
English: 10 ml (3.5 mg/ml) 1 vial
Maltese: Daqs talpakkett kunjett (ħġieġ) 10 ml (3.5 mg/ml) kunjett 1
English: Benefit-Risk
Maltese: Benefiċċju-Riskju
English: Norditropin was approved in accordance with Article 8(3) of Directive 2001/83/EC.
Maltese: Norditropin kien approvat skont l-Artikolu 8(3) tadDirettiva 2001/83/KE.
English: Safety was assessed by adverse events, HbA1c, IGF-I, haematology, TSH, total T3 and T4, free T3 and T4.
Maltese: Is-sigurtà ġiet evalwata permezz tal-effetti avversi, HbA1c, IGF-I, ematoloġija, TSH, T3 u T4 totali, T3 u T4 ħielsa.
English: The majority of events were of mild/moderate severity.
Maltese: Ilmaġġoranza tal-avvenimenti kienu ta' severità ħafifa/moderata.
English: The mean age at inclusion was 3.8 years (min 0.4 years; max 12.2 years).
Maltese: L-età medja waqt l-inklużjoni kienet ta' 3.8 snin (min 0.4 snin; mass 12.2 snin).
English: IGF-1 SDS at baseline was only available for 28 patients.
Maltese: L-IGF-1 SDS fil-linja bażi kien disponibbli biss għal 28 pazjent.
English: Thirty-three (33.26%) adverse events in 17 (41.5%) children were assessed as probably/possibly related to Norditropin treatment.
Maltese: Tlieta u tletin (33.26%) avveniment avvers fuq 17 (41.5%)-il tifel u tifla ġew evalwati bħala probabbilment/possibbilment relatati mal-kura bi Norditropin.
English: The number of children with an HSDS above -2 was 19 (46%) children at baseline, 27 (66%) children after 1 year of treatment and 35 (85%) children at last observation.
Maltese: In-numru ta' tfal b'HSDS 'il fuq minn -2 kien ta' 19 (46%)-il tifel u tifla fil-linja bażi, 27 (66%) tifel u tifla wara sena kura u 35 (85%) tifel u tifla waqt l-aħħar osservazzjoni.
English: The incidence of PWS is 1 in about 10,000 to 29,000 live births.
Maltese: L-inċidenza ta' PWS hija ta' 1 minn kull 10,000 sa 29,000 twelid ħaj.
English: On 14 May 2010, the MAH submitted a type II variation via the MRP for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (DK/H/0001/005-007 and 011016/II/078), to request an extension of the indications.
Maltese: Fl-14 ta' Mejju 2010, il-MAH issottometta varjazzjoni tat-tip II permezz tal-MRP għal Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro u ismijiet assoċjati (DK/H/0001/005-007 u 011-016/II/078), biex jitlob estensjoni tal-indikazzjonijiet.
English: The most frequent probably/possibly related adverse events were scoliosis (in 8 children, 19.5%) and sleep apnoea (in 3 children, 7.3%).
Maltese: L-aktar avvenimenti avversi frekwenti probabbilment/possibbilment relatati kienu liskoljożi (fi 8 it-tfal, 19.5%) u l-apnea waqt l-irqad (fi 3 tfal, 7.3%).
English: Data on final adult heights are not available.
Maltese: Dejta dwar it-tul finali bħala adulti finali mhijiex disponibbli.
English: Most females with PWS suffer from amenorrhea.
Maltese: Ħafna min-nisa b'PWS isofru minn amenorreja.
English: The safety profile of somatropin-containing products is well known.
Maltese: Il-profil tas-sigurtà ta' prodotti li fihom somatropin huwa magħruf sew.
English: Short stature, mental retardation, behavioural problems, hormonal dysfunctions, poor muscle tone and hyperphagia as well as hypoactivity are among its features.
Maltese: Fost il-karatteristiċi tiegħu hemm statura qasira, ritardazzjoni mentali, problemi fl-imġiba, disfunzjonijiet ormonali, saħħa muskolari batuta u iperfaġja kif ukoll ipoattività.
English: The actual lean body mass percentage was 61.8% at baseline, 71.9% at Year 1 and 72.9% at last observation.
Maltese: Il-perċentwal attwali tal-massa bla xaħam tal-ġisem kien ta' 61.8% fil-linja bażi, 71.9% fl-Ewwel Sena u ta' 72.9% waqt l-aħħar osservazzjoni.
English: Hence, 35 of 41 (85%) children with PWS had a height within the reference range for normal children after Norditropin treatment.
Maltese: Għalhekk, 35 minn 41 (85%) tifel u tifla b'PWS kellhom tul fil-medda ta' referenza għat-tfal normali wara l-kura bi Norditropin.
English: The most frequent adverse events were respiratory tract infections which are common in young children (14.6% of children) and scoliosis which is common in PWS (19.5% of children).
Maltese: L-aktar avvenimenti avversi frekwenti kienu infezzjonijiet fl-apparat respiratorju li huma komuni fi tfal żgħar (14.6% tat-tfal) u l-iskoljożi li hija komuni f'PWS (19.5% tat-tfal).
English: Furthermore, a wide range of doses has been used in the retrospective study (mean dose 0.03 mg/kg/day - up to 0.06 mg/kg/day).
Maltese: Barra minn hekk, fl-istudju retrospettiv intużaw firxa wiesgħa ta' dożi (doża medja ta' 0.03 mg/kg/kuljum - sa 0.06 mg/kg/kuljum).
English: In the GHLiquid-1961 study forty-one (41) children in Europe with genetically documented PWS were enrolled (19 girls and 22 boys).
Maltese: Fl-istudju GHLiquid-1961 ħadu sehem wieħed u erbgħin (41) tifel u tifla fl-Ewropa b'PWS ġenetikament iddokumentat (19-il tifla u 22 tifel).
English: Efficacy
Maltese: Billi
English: HSDS improved from a baseline mean of -1.8 to -1.2 after 1 year and to0.7 at last observation (approximately 6 years).
Maltese: L-HSDS tjieb minn medja ta' -1.8 fil-linja bażi sa -1.2 wara sena u sa -0.7 waqt l-aħħar osservazzjoni).
English: “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
Maltese: “Titjib fit-tkabbir u fil-kompożizzjoni tal-ġisem fi tfal bis-sindromu ta' Prader-Willi (PWS) ikkonfermat b'testijiet ġenetiċi adegwati”.
English: Children with PWS often have concomitant growth hormone deficiency (GHD) (40 to 100%, depending on the provocation test used).
Maltese: Ħafna drabi tfal b'PWS ikollhom defiċjenza konkomittanti tal-ormon tat-tkabbir (GHD) (40 sa 100%, skont it-test ta' provokazzjoni użat).
English: Body composition was improved, with an estimated mean increase in body mass of 9.9% and a corresponding reduction in fat mass of 9.9% after 1 year of Norditropin treatment.
Maltese: Il-kompożizzjoni tal-ġisem kienet tjiebet, b'żieda medja stmata fl-massa tal-ġisem ta' 9.9% u tnaqqis korrispondenti fil-massa ta' xaħam ta' 9.9% wara sena kura bi Norditropin.
English: Overall summary of the scientific evaluation of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (see annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro u ismijiet assoċjat (ara anness I)
English: In the variation application dossier, the recommended dose from Novo Nordisk for the treatment of short stature and altered body composition in children with PWS was 0.025 to 0.035 mg/kg/day.
Maltese: Fid-dossier tal-applikazzjoni għall-varjazzjoni, id-doża rakkomandata minn Novo Nordisk għall-kura ta' statura qasira u ta' kompożizzjoni mibdula tal-ġisem fi tfal b'PWS kienet ta' 0.025 sa 0.035 mg/kg/jum.
English: In order to demonstrate efficacy and safety in the applied indication, the application dossier was based on the study GHLiquid-1961.
Maltese: Sabiex juri l-effikaċja u s-sigurtà fl-indikazzjoni applikata, id-dossier tal-applikazzjoni kien ibbażat fuq l-istudju GHLiquid-1961.
English: The mean HSDS for this subgroup was -0.6 at Year 1 and -0.4 at last observation.
Maltese: L-HSDS medju għal dan is-subgrupp kien ta' -0.6 fl-Ewwel Sena u ta' -0.4 waqt laħħar osservazzjoni.
English: PWS is a genetic disorder.
Maltese: PWS hija marda ġenetika.
English: The data from the study that were submitted with the application of Novo Nordisk to support the proposed indication were not considered sufficient (open-label, non-controlled and retrospective study) and of good quality (wide range of doses used, height measurements incomplete) by the objecting Member States.
Maltese: Id-dejta mill-istudju li ġiet sottomessa mal-applikazzjoni ta' Novo Nordisk biex tappoġġa lindikazzjoni proposta ma tqiesitx suffiċjenti (studju b'tikketta miftuħa, mhux ikkontrollat u retrospettiv) u ta' kwalità tajba (firxa wiesgħa ta' dożi użati, kejl tat-tul mhux komplut) mill-Istati Membri li oġġezzjonaw.
English: The actual fat mass percentage was 38.2% at baseline, 28.1% at Year 1 and 27.1% at last observation.
Maltese: Il-perċentwal attwali tal-massa tax-xaħam kien ta' 38.2% fil-linja bażi, 28.1% fl-Ewwel Sena u ta' 27.
English: HSDS improved from a baseline mean of -0.3 to 1.1 at last observation.
Maltese: L-HSDS tjieb minn medja ta' -0.3 fil-linja bażi sa 1.1 waqt l-aħħar osservazzjoni.
English: • The Committee considered the notification of the referral triggered by Denmark under Article 13 of Commission Regulation (EC) No 1234/2008.
Maltese: Regolament tal-Kummissjoni (KE) Nru 1234/2008.
English: The secondary objectives were to evaluate in the same population the change in HSDS from start of treatment to last observation during Norditropin treatment (referenced to a PWS population), change in body composition (lean body mass and fat mass), height velocity (HV) and change in HV.
Maltese: L-għanijiet sekondarji kienu li fl-istess popolazzjoni tiġi evalwata l-bidla fl-HSDS mill-bidu tal-kura sal-aħħar osservazzjoni waqt il-kura bi Norditropin (referenzjat għal popolazzjoni PWS), il-bidla fil-kompożizzjoni tal-ġisem (massa bla xaħam tal-ġisem u l-massa ta' xaħam), ilveloċità tat-tul (HV) u l-bidla fl-HV.
English: Sleep apnoea and sudden death have been reported in clinical practice after initiating therapy in patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Maltese: L-apnea waqt l-irqad u mwiet f'daqqa kienu rrapportati fil-prattika klinika wara l-bidu ta' terapija f'pazjenti bis-sindromu ta' Prader-Willi li kellhom wieħed jew aktar mill-fatturi ta' riskju li ġejjin: obeżità severa, storja ta' ostruzzjoni tal-passaġġ ta' fuq tan-nifs jew apnea waqt l-irqad, jew infezzjoni respiratorja mhux identifikata.
English: A total of 128 adverse events were reported in 31 (75.6%) children with PWS during Norditropin exposure (mean exposure 4.1 years, range 0.3 to 9.5 years).
Maltese: 6%) tifel u tifla b'PWS matul lespożizzjoni bi Norditropin (espożizzjoni medja ta' 4.1 snin, medda ta' bejn 0.3 sa 9.5 snin).
English: When standardised to the PWS population, an estimated mean gain in HSDS of 0.9 was obtained after 1 year of Norditropin treatment in short children with PWS.
Maltese: Meta ġie standardizzat għall-popolazzjoni PWS, inkisbet żieda medja stmata fl-HSDS ta' 0.9 wara sena kura bi Norditropin fuq tfal qosra b'PWS.
English: • The Committee reviewed all available data submitted by the marketing authorisation holder, to support the safety and efficacy of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names in the applied indication “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
Maltese: NordiFlex, Norditropin FlexPro u ismijiet assoċjati fl-indikazzjoni applikata "Titjib fit-tkabbir u fil-kompożizzjoni tal-ġisem fit-tfal bis-sindromu ta' Prader-Willi ( PWS) ikkonfermat b'testijiet ġenetiċi xierqa”.
English: The CHMP concluded that the rationale for the proposed dose (i.e. 0.035 mg/kg/day) is unclear.
Maltese: IsCHMP ikkonkluda li r-raġuni għad-doża proposta (jiġifieri 0.035 mg/kg/kuljum) mhijiex ċara.
English: When standardised to the normal population, an estimated mean gain in HSDS of 0.7 was obtained after 1 year of Norditropin treatment in short children with PWS.
Maltese: Meta standardizzat għall-popolazzjoni normali, inkisbet żieda medja stmata fl-HSDS ta' 0.7 wara sena kura bi Norditropin fuq tfal qosra b'PWS.
English: This was a retrospective, observational, open-label, multicentre, multinational study in children with PWS treated with Norditropin off-label for short stature.
Maltese: Dan kien studju retrospettiv, ta' osservazzjoni, b'tikketta miftuħa, multiċentriku, multinazzjonali fuq tfal b'PWS li rċevew kura bi Norditropin bla tikketta għal statura qasira.
English: Taking into consideration the above mentioned data, the CHMP concluded that the provided study GHLiquid-1961 forming the basis for the application to extend the indication for Norditropin in children with PWS was uncontrolled, open-label and retrospective and not in accordance with the methodological standards for pivotal evidence.
Maltese: Filwaqt li kkunsidra l-informazzjoni msemmija hawn fuq, is-CHMP ikkonkluda li l-istudju pprovdut GHLiquid-1961 li jifforma l-bażi għall-applikazzjoni biex tiġi estiża l-indikazzjoni għal Norditropin fi tfal b'PWS ma kienx ikkontrollat, b'tikketta miftuħa u retrospettiv u ma kienx skont l-istandards metodoloġiċi għal evidenza pivotali.
English: It is also considered that the data are unreliable and therefore the benefit risk balance of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names in the applied indication is unfavourable.
Maltese: Ġie kkunsidrat ukoll li d-dejta mhijiex affidabbli u għalhekk il-bilanċ talbenefiċċju-riskju ta' Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro u ismijiet assoċjati fl-indikazzjoni applikata mhijiex favorevoli.
English: Norditropin contains somatropin which is a human growth hormone produced by recombinant DNA technology that has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Maltese: Norditropin fih somatropin li huwa ormon tat-tkabbir uman prodott permezz ta' teknoloġija rikombinanti tad-DNA li rċieva awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea permezz talProċedura ta' Rikonoxximent Reċiproku (MRP).
English: In Europe, two recombinant GH products are approved for the treatment of children with PWS.
Maltese: Fl-Ewropa, hemm żewġ prodotti rikombinanti tal-GH approvati għall-kura ta' tfal b'PWS.
English: The diagnosis is based on a genetic test and on clinical findings.
Maltese: Iddijanjożi hija bbażata fuq test ġenetiku u fuq sejbiet kliniċi.
English: The primary objective of the study was to investigate changes in height standard deviation score (HSDS) in response to 1 year of Norditropin treatment in children with PWS (referenced to a PWS population).
Maltese: L-għan ewlieni tal-istudju kien li jinvestiga tibdil fil-punteġġ tad-devjazzjoni standard għat-tul (HSDS) bħala reazzjoni għal sena ta' kura bi Norditropin fuq tfal b'PWS (referenzjat għal popolazzjoni PWS).
English: Scientific conclusions and grounds for refusal presented by the EMA
Maltese: Konklużjonijiet xjentifiċi u r-raġunijiet għar-rifjut ippreżentati mill-EMA
English: The inclusion criteria were pre-pubertal children with genetically diagnosed PWS, treated with Norditropin for at least 1 year in the centre.
Maltese: Il-kriterji ta' inklużjoni kienu tfal qabel il-pubertà b'PWS dijanjostikat b'mod ġenerali, li kienu rċevew Norditropin għal mill-inqas sena fiċ-ċentru.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 20 April 2011, Denmark triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Maltese: Minħabba li l-Istati Membri ta' referenza u l-Istati Membri kkonċernati ma setgħux jilħqu ftehim firrigward tal-varjazzjoni, fl-20 ta' April 2011, id-Danimarka bdiet riferiment skont l-Artikolu 13 tarRegolament tal-Kummissjoni KE Nru 1234/2008.
English: Lean body mass increased by 9.1% from baseline to last observation.
Maltese: Il-massa bla xaħam tal-ġisem żdiedet b'9.1% mil-linja bażi sal-aħħar osservazzjoni.
English: • The Committee is also of the opinion that the particulars submitted in support of the application to extend the indications of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names do not comply with the requirements of a product authorised on the basis of Article 8(3) of Directive 2001/83/EC.
Maltese: • Il-Kumitat huwa wkoll tal-fehma li d-dettalji sottomessi b'appoġġ għall-applikazzjoni biex testendi l-indikazzjonijiet ta' Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro u ismijiet assoċjati m'humiex konformi mar-rekwiżiti ta' prodott awtorizzat abbażi talArtikolu 8 (3 ) tad-Direttiva 2001/83/KE.
English: The CHMP concluded that given the retrospective design of the study, selection bias cannot be excluded.
Maltese: Is-CHMP ikkonkluda li minħabba d-disinn retrospettiv tal-istudju, ma jistax jiġi eskluż il-preġudizzju tal-għażla.
English: the CHMP has recommended the refusal of the variation of the Marketing Authorisations for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (see Annex I).
Maltese: is-CHMP irrakkomanda r-rifjut tal-varjazzjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro u ismijiet assoċjati (ara Anness I).
English: Height at baseline was only available for 37 patients.
Maltese: It-tul fil-linja bażi kien disponibbli biss għal 37 pazjent.
English: The estimated gain in HSDS was 1.3 to last observation (approximately 6 years).
Maltese: Iż-żieda stmata fl-HSDS kienet ta' 1.3 sal-aħħar osservazzjoni (madwar 6 snin).
English: The referral procedure was initiated on 19 May 2011.
Maltese: Il-proċedura ta' riferiment inbdiet fid-19 ta' Mejju 2011.
English: Regarding efficacy on the basis of the available data the CHMP concluded that the demonstration of efficacy for Norditropin in PWS is based on limited and unreliable data of apparent poor quality.
Maltese: B'mod ġenerali, id-dejta retrospettiva miġbura ma kinitx biżżejjed u kienet ta' kwalità dgħajfa.
English: In addition, accepting the same recommended dose as for other GH products was not considered appropriate as Norditropin has not shown comparable efficacy and those two products have different dose recommendations for other indications, i.e. Turner syndrome and chronic renal disease.
Maltese: Barra minn hekk, l-aċċettazzjoni tal-istess doża rakkomandata bħal tal-prodotti l-oħra tal-GH ma kienitx meqjusa adegwata minħabba li Norditropin ma weriex effikaċja komparabbli u dawk iż-żewġ prodotti għandhom rakkomandazzjonijiet differenti tad-doża għal indikazzjonijiet oħra, jiġifieri s-sindromu ta' Turner u mard renali kroniku.
English: Demographics
Maltese: Demografija
English: • fusidic acid (an antibiotic).
Maltese: • fusidic acid (antibijotiku).
English: Adverse reactions (Preferred terms)
Maltese: Reazzjonijiet avversi (Termini ppreferuti)
English: 5 minutes
Maltese: 5 minuti
English: Manufacturer • N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Maltese: Manifattur • N.V. Organon, Kloosterstraat 6, 5349 AB Oss, In-Netherlands
English: NL-5340 BH Oss The Netherlands
Maltese: NL-5340 BH Oss In-Netherlands
English: N.V. Organon Kloosterstraat 6 P.O.
Maltese: N.V. Organon Kloosterstraat 6
English: Elimination half-life (hr)
Maltese: Half-life (hr) ta' eliminazzjoni
English: Box 20
Maltese: P.O. Box 20
English: Mean Predicted PK parameters (CV%)
Maltese: Parametri Medji Mbassra tal-PK (CV%)
English: Clearance (mL/min)
Maltese: Eliminazzjoni (mL/min)
English: The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.
Maltese: Il-pH hu bejn 7 u 8 u l-osmolalità hi bejn 300 u 500 mOsm/kg.
English: 1.2 mg/kg rocuronium
Maltese: 1.2 mg/kg ta' rocuronium
English: Median (minutes) Range
Maltese: Medjan (minuti) Medda
English: Renal impairment and age:
Maltese: L-indeboliment renali u l-età:
English: Moderate 30 31 (23) Severe 10 9 (22)
Maltese: Moderata 30 31 (23) Severa 10 9 (22)
English: Marked bradycardia:
Maltese: Bradikardija evidenti:
English: Volume of distribution at steady state (L)
Maltese: Volum ta' distribuzzjoni fi stat fiss (L)
English: Impaired Mild 48 44 (23)
Maltese: Indebolita Ħafifa 48 44 (23)
English: Moderate 29 27 (22) Severe 10 8 (21)
Maltese: Moderata 29 27 (22) Severa 10 8 (21)
English: Bridion can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
Maltese: Bridion jista' jkun injettat ġol-linja ta' l-infużjoni kontinwa ġol-vini bis-soluzzjonijiet ta' ġol-vini li ġejjin: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%) sodium chloride 4.5 mg/mL (0.45%) u glucose 25 mg/mL (2.5%), soluzzjoni ta' Ringers lactate, soluzzjoni ta' Ringers, glucose 50 mg/mL (5%) f'sodium chloride 9 mg/mL (0.9%).
English: Hormonal contraceptives:
Maltese: Kontraċettivi ormonali:
English: Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Maltese: Dejta limitata ma tindika l-ebda differenzi fil-parametri farmakokinetiċi f'Amerikani jew Afrikani Suwed.
English: 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium
Maltese: 0.6 mg/kg ta' rocuronium jew 0.1 mg/kg ta' vecuronium
English: • on coumarin derivates and at an INR above 3.5;
Maltese: • fuq derivati ta' coumarin u b'INR ogħla minn 3.5;
English: Interference with laboratory tests:
Maltese: Tfixkil ta' testijiet tal-laboratorju:
English: The incidence of adjudicated hypersensitivity was 1.3%, 6.6% and 9.5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively.
Maltese: L-inċidenza ta' sensittività eċċessiva aġġudikata kienet 1.3%, 6.6% u 9.5% fil-gruppi ta' plaċebo, sugammadex 4 mg/kg u sugammadex 16 mg/kg, rispettivament.
English: Impaired Mild 26 19 (22)
Maltese: Indebolita Ħafifa 26 19 (22)
English: The dose of Bridion for children is 2 mg/kg (children and adolescents between 2-17 years old).
Maltese: Id-doża ta' Bridion għat-tfal hi ta' 2 mg/kg (tfal u adolexxenti bejn l-età ta' 2-17).
English: Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent.
Maltese: Sugammadex hu gamma cyclodextrin modifikata li hi Aġent Selettiv Rilassanti li Jorbot.
English: Pulmonary patients:
Maltese: Pazjenti pulmonari:
English: Adolescent
Maltese: Adolexxenti
English: Merck Sharp and Dohme Ireland (Human Health) Limited
Maltese: Merck Sharp and Dohme Ireland (Human
English: But even if this happens, it is unlikely to cause any problems.
Maltese: Iżda anki jekk jiġri dan, mhux mistenni li jikkawża xi problema.
English: Impaired Mild 50 51 (24)
Maltese: Indebolita Ħafifa 50 51 (24)
English: In the Pooled Phase 1 database, AEs considered common (≥ 1/100 to < 1/10) or very common (≥ 1/10) and more frequent among subjects treated with sugammadex than in the placebo group, include dysgeusia (10.1%), headache (6.7%), nausea (5.6%), urticaria (1.7%), pruritus (1.7%), dizziness (1.6%), vomiting (1.2%) and abdominal pain (1.0%).
Maltese: Fid-database Miġbur ta' Fażi 1, AEs ikkunsidrati komuni (≥ 1/100 sa <1/10) jew komuni ħafna (≥ 1/10) u aktar frekwenti fost individwi kkurati b'sugammadex milli fil-grupp ta' plaċebo, jinkludu disgewsja (10.1%) , uġigħ ta' ras (6.7%), dardir (5.6%), urtikarja (1.7%), prurite (1.7%), sturdament (1.6%), rimettar (1.2%) u uġigħ addominali (1.0%).
English: Renal function Creatinine clearance (mL/min)
Maltese: Eliminazzjoni tal-kreatinina (mL/min)
English: Cis-atracurium and neostigmine (50 mcg/kg)
Maltese: Cis-atracurium u neostigmine (50 mcg/kg)
English: Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: + 30 210 98 97 300 dpoc_greec@merck.com