FrancophonIA/ELRC3.0 huggingface dataset:
English: The dosage of somatropin should be reduced in cases of long lasting swelling (oedema) or severe abnormal sensation (paresthesia), in order to avoid the development of a rare side effect called carpal tunnel syndrome (hand numbness and pain).
Maltese: Id-dożaġġ ta' somatropin għandu jitnaqqas f'każijiet ta' nefħa fit-tul (edima) jew sensazzjoni anormali severa (parasteżija), sabiex jiġi evitat l-iżvilupp ta' effett sekondarju rari msejjaħ is-sindrome tal-carpal tunnel (tirżiħ u wġigħ fl-idejn).
English: Fat tissue decrease (lipodystrophy), thinning of the skin (skin atrophy), inflammation and peeling of skin (exfoliative dermatitis), swelling similar to after insect stings (urticaria), increased growth of male type hair on a woman's body (hirsutism), thickening of skin tissue (skin hypertrophy)
Maltese: Tnaqqis fit-tessut tax-xaħam (lipodistrofija), traqqiq talġilda (atrofija tal-ġilda), infjammazzjoni u tqaxxir tal-ġilda (dermatite bil-qxur), nefħa simili għal dik li tidher wara tingiż tal-insetti (urtikarja), żieda fit-tkabbir ta' xagħar qisu tal-irġiel fuq il-ġisem ta' mara (hirsutism), ħxuna tattessut tal-ġilda (ipertrofija tal-ġilda) Tnaqqis fil-piż tal-muskoli (atrofija tal-muskoli), uġigħ fl
English: The efficacy and safety of Valtropin has been assessed in a randomised, double-blind, parallel, controlled Phase III study in children with growth hormone deficiency.
Maltese: L-effikaċja u sigurtà ta' Valtropin ġew evalwati fi studju parallel, ikkontrollat, b'għażla każwali, double-blind tal-Fażi III fi tfal b'defiċjenza ta' l-ormon tat-tkabbir.
English: Very common: Headache in adults Very common: Paresthesia in adults Common: Hypertonia
Maltese: Komuni ħafna: Uġigħ ta' ras f'persuni adulti Komuni ħafna: Parestesija f'persuni adulti Komuni: Ipertonija
English: Data from an interaction study performed in growth hormone deficient adults, suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Maltese: Tagħrif minn studju ta' l-interazzjoni mwettaq f'persuni adulti b'defiċjenza ta' l-ormon tat-tkabbir, jissuġġerixxi li l-għoti ta' somatropin jista' jżid it-tneħħija ta' komposti magħrufa li jiġu metabolizzati minn isoenzimi taċ-ċitokromu P450.
English: Animal data showed no effect on fertility parameters.
Maltese: Dejta dwar l-annimali ma wriet l-ebda effett fuq ilparametri tal-fertilità.
English: Long-term therapy in growth hormone-deficient patients increases bone mineral density.
Maltese: Terapija fuq perijodu fit-tul f'pazjenti b'defiċjenza ta' l-ormon tat-tkabbir iżżid id-densità tal-minerali fl-għadam.
English: In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test.
Maltese: F'pazjenti b'defiċjenza iżolata ta' l-ormon tat-tkabbir li bdiet fit-tfulija (ebda evidenza ta' mard ipotalamiku-pitwitarju jew ta' radjazzjoni fil-kranju), għandhom jiġu rakkomandati żewġ testijiet dinamiċi, ħlief għal dawk li jkollhom konċentrazzjonijiet baxxi tal-fattur-1 tat-tkabbir (IGF-1) li jixbah lill-insulina (< 2 punteġġ ta' devjazzjoni standard (SDS)), li jistgħu jiġu kkunsidrati għal test wieħed.
English: The MAH should submit an updated Risk Management Plan reflecting: New neoplasm, Second neoplasm in childhood cancer survivors and Intracranial aneurysm and Intracranial haemorrhage as potential risk.
Maltese: Neoplażmu ġdid, it-Tieni neoplażmu f'sopravissuti ta' kanċer fi żmien it-tfulija u anewriżmu intrakranjali u emorraġija intrakranjali bħala riskju potenzjali.
English: Frequency not known
Maltese: Rari ħafna
English: If allergy to the accompanying solvent occurs, the vials should be reconstituted with water for injections: please fill a syringe with 1.5 ml of water for injections and follow the same instructions as for the pre-filled syringe (see section 5 ‘How to store Valtropin').
Maltese: Jekk ikun hemm allerġija għas-solvent li jakkumpanjah, il-kunjetti għandhom jiġu rikostitwiti b'ilma għall-injezzjonijiet: jekk jogħġbok imla siringa b'1.5 ml ta' ilma għall-injezzjonijiet u segwi l-istess istruzzjonijiet bħal dawk għas-siringa mimlija għal-lest (ara sezzjoni 5 ‘Kif taħżen Valtropin').
English: Breast-feeding
Maltese: TAL-LOTT
English: • dry gauze or cotton pad
Maltese: • garża xotta jew biċċa tajjar
English: These are: Supplied in the pack
Maltese: MHUX ipprovduti fil-pakkett
English: If not used immediately, in-use storage times and conditions prior to use would normally not be longer than 24 hours at 2°C - 8°C (refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żminijiet u lkondizzjonijiet ta' ħażna qabel l-użu ġeneralment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C - 8°C (friġġ), sakemm ir-rikostituzzjoni ma tkunx saret f'kondizzjonijiet asettiċi kkontrollati u validati.
English: 1.5 ml of solvent in a pre-filled syringe (Type I glass) closed with a tip cap (FluroTec coated butyl rubber)
Maltese: 1.5 ml ta' solvent f'siringa mimlija għal-lest (ħġieġ tat-Tip I) magħluqa b'għatu għall-ponta (gomma tal-butyl miksija bi FluroTec)
English: Non-clinical data reveal no special hazard for humans based on conventional studies with Valtropin of repeated dose toxicity, genotoxicity and reproductive toxicity studies.
Maltese: Informazzjoni li mhijiex klinika ma tikxef ebda periklu speċjali għan-nies fuq il-bażi ta' studji konvenzjonali b'Valtropin dwar it-tossiċità b'doża ripetuta, l-effett tossiku fuq il-ġeni u l-effett tossiku fuq is-sistema riproduttiva.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: HOW TO USE Valtropin
Maltese: X'fih Valtropin
English: Do not use the supplied solvent if you have a known allergy to metacresol preservative.
Maltese: Tużax is-solvent ipprovdut jekk għandek allerġija magħrufa għal preservattiv ta' metacresol.
English: High blood pressure in the skull (benign intracranial hypertension)
Maltese: Pressjoni tad-demm għolja fil-kranju (pressjoni għolja intrakranjali beninna)
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif inkluża f' Modulu 1.8.1 tal-awtorizzazzjoni għat-tqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq.
English: In patients with severe liver dysfunction a reduction of somatropin clearance has been noted.
Maltese: F'pazjenti b'disfunzjoni severa tal-fwied, ġie osservat tnaqqis fit-tneħħija ta' somatropin.
English: Large doses of somatropin may impair glucose tolerance.
Maltese: - Din il-mediċina ġiet mogħtija lilek.
English: - If an allergic reaction to solvent occurs, the vials should be reconstituted with water for injections without preservative (metacresol) and used as a single use vial (see section 5 ‘How to store Valtropin').
Maltese: - Jekk ikun hemm reazzjoni allerġika għas-solvent, il-kunjetti għandhom jiġu rikostitwiti b'ilma għall-injezzjonijiet mingħajr preservattiv (metacresol) u jintużaw bħala kunjett ta' użu ta' darba (ara sezzjoni 5 ‘Kif taħżen Valtropin').
English: Numbness and tingling in fingers and palm of the hand due to squeezed nerve at hand wrist (carpal tunnel syndrome) in adults
Maltese: (apnea tal-irqad) f'persuni adulti Tmewwit u tnemnim fis-swaba' u fil-keff tal-id minħabba nervaturi magħfusin fil-polz (sindrome tal-carpal tunnel) f'persuni adulti
English: Accelerated heart beat (tachycardia) Vomiting
Maltese: (kortikosterojdi), mediċini għall-kura tal-epilessija (eż. carbamazepin) jew cyclosporine
English: Children treated with somatropin have an increased risk of developing pancreatitis compared to adults treated with somatropin.
Maltese: Tfal ikkurati b'somatropin għandhom żieda fir-riskju li jiżviluppaw pankreatite meta mqabbla ma' pazjenti adulti kkurati b'somatropin.
English: Total daily dose usually does not exceed 1 mg. IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
Maltese: Il-konċentrazzjonijiet ta' IGF-1 għandhom jinżammu taħt il-limitu ta' fuq tal-medda normali speċifika għall-età.
English: • an adhesive plaster
Maltese: Ipprovduti fil-pakkett
English: Tell especially your doctor if you are taking - adrenal steroid hormone such as cortisone or prednisolone - insulin - oral oestrogen - sex hormones, medicines to treat stress response or inflammation (corticosteroids), medicines to treat epilepsy (e.g. carbamazepin)or cyclosporine (a medicine to suppress the immune system).
Maltese: F'pazjenti b'defiċjenza tal-ormon tat-tkabbir li tibda meta jkunu saru adulti, nefħa, uġigħ fil-muskoli, uġigħ u mard fil-ġogi kienu rrapportati bikri fit-terapija b'somatropin iżda dawn l-effetti kellhom tendenza li jkunu temporanja (ma jdumux).
English: Preparing the injection
Maltese: Preparzzjoni ta' l-injezzjoni
English: NAME OF THE MEDICINAL PRODUCT Valtropin 5 mg/1.5 ml powder and solvent for solution for injection
Maltese: Valtropin 5 mg/1.5 ml trab u solvent għal soluzzjoni għall-injezzjoni
English: Long-term overdose could result in signs and symptoms of acromegaly consistent with the known effects of excess human growth hormone.
Maltese: Doża eċċessiva fuq perijodu fit-tul tista' tirriżulta f'sinjali u sintomi ta' akromegalija konsistenti ma' l-effetti magħrufa ta' eċċess ta' ormoni tat-tkabbir uman.
English: Abnormal sensation, such as pricking, tingling, or itchiness (paresthesia) in adults Joint pain (arthralgia) in adults Tissue swelling caused by accumulation of fluid in tissue (oedema) in adults
Maltese: Uġigħ ta' ras f'persuni adulti Sensazzjoni mhux normali, bħal tingiż, tnemnim, jew ħakk (parestesija) f'persuni adulti Uġigħ fil-ġogi (artralġja) f'persuni adulti
English: Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin.
Maltese: Pazjenti b'defiċjenza severa ta' l-ormon tat-tkabbir f'età adulta huma definiti bħala pazjenti b'patoloġija ipotalamika-pitwitarja magħrufa u mill-anqas b'defiċjenza oħra magħrufa ta' ormon pitwitarju li ma jkunx prolactin.
English: Posology
Maltese: Ipotirojdiżmu
English: It is a human growth hormone, also called somatropin.
Maltese: Hu tip ta' ormon tat-tkabbir uman, imsejjaħ ukoll somatropin.
English: Your medicine is called Valtropin.
Maltese: Il-mediċina tiegħek jisimha Valtropin.
English: You have an increased risk of developing an inflammation of your pancreas (pancreatitis) compared to adults treated with somatropin.
Maltese: Għandek żieda fir-riskju li tiżviluppa infjammazzjoni fil-frixa tiegħek (pankreatite) meta mqabbel ma' persuni adulti kkurati b'somatropin.
English: Enlargement of the male breast gland (gynaecomastia) in
Maltese: Użu għal taħt il-ġilda
English: Graudins A. Overdose with modified-release paracetamol (Panadol Osteo®) presenting to a metropolitan emergency medicine network: a case series.
Maltese: Overdose with modified-release paracetamol (Panadol Osteo®) presenting to a metropolitan emergency medicine network: a case series.
English: They are available in Belgium, Denmark, Finland, Greece, Iceland, Luxembourg, the Netherlands, Portugal, Romania, and Sweden under various names including Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard and Pinex Retard.
Maltese: Dawn huma disponibbli fil-Belġju, idDanimarka, il-Finlandja, il-Greċja, l-Iżlanda, il-Lussemburgu, in-Netherlands, il-Portugall, ir-Rumanija, u l-Iżvezja taħt diversi ismijiet fosthom Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard u Pinex Retard.
English: 15 December 2017 EMA/811872/2017
Maltese: EMA/109109/2018
English: Graudins A, Chiew A, Chan B. Overdose with modified-release paracetamol results in delayed and prolonged absorption of paracetamol.
Maltese: Overdose with modified-release paracetamol results in delayed and prolonged absorption of paracetamol.
English: The review of modified-release paracetamol was initiated on 30 June 2016 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' paracetamol li jiġi rilaxxat b'mod modifikat inbdiet fit-30 ta' Ġunju 2016 fuq talba talIżvezja, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Modified-release medicines containing paracetamol with the opioid painkiller tramadol are available under the names Diliban Retard or Doreta SR in Bulgaria, Czech Republic, Estonia, Hungary, Iceland, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia and Spain, and these medicines are also covered by this review.
Maltese: Il-mediċini li fihom paracetamol li jiġi rilaxxat b'mod modifikat flimkien mal-mediċina li ttaffi l-uġigħ opjojde tramadol huma disponibbli taħt l-ismijiet Diliban Retard jew Doreta SR fil-Bulgarija, irRepubblika Ċeka, l-Estonja, l-Ungerija, l-Iżlanda, il-Latvja, il-Litwanja, il-Polonja, il-Portugall, irRumanija, is-Slovakkja, is-Slovenja u Spanja, u dawn il-mediċini huma wkoll koperti minn din irreviżjoni.
English: These results confirm a similar Australian case series.2,3
Maltese: Dawn irriżultati jikkonfermaw serje ta' każijiet Awstraljani simili.2,3
English: − if NAC treatment has been initiated, it should be prolonged beyond the first 21-hour NAC course if paracetamol level remains above the limit of detection (or greater than 10 mg/L) or if ALT is increasing (greater than 100 U/L), and should be continued until paracetamol is below the limit of detection (or 10 mg/L) or if ALT is falling below 100 U/L;
Maltese: − jekk il-kura NAC tkun bdiet, jenħtieġ li din tiġi mtawla lil hinn mill-kors tal-NAC ta' 21 siegħa jekk il-livell ta' paracetamol jibqa' ogħla mil-limitu ta' detezzjoni (jew aktar minn 10 mg/L) jew jekk l-ALT tiżdied (aktar minn 100 U/L), u jenħtieġ li tkompli sakemm il-paracetamol ikun taħt il-limitu ta' detezzjoni (jew 10 mg/L) jew jekk l-ALT jaqa' taħt il-100 U/L;
English: The Agency's recommendations are based on a review of available data including a retrospective pharmacokinetic and clinical analysis of 53 cases of acute overdose with modified-release paracetamol by the Swedish Poison Information Centre,1 which found that the standard treatment protocol utilising solely the Rumack-Matthew nomogram (or variations thereof) based on conventional paracetamol formulations may not be effective for overdoses with modified-release paracetamol formulations.
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq reviżjoni ta' data disponibbli inkluża analiżi farmakokinetika u klinika retrospettiva ta' 53 każ ta' doża eċċessiva akuta b'paracetamol li jiġi rilaxxat b'mod modifikat miċ-Ċentru ta' Informazzjoni tal-Avvelenament Żvediż,1 li sab li l-protokoll ta' kura standard li juża biss in-nomogramma Rumack-Matthew (jew varjazzjonijiet tagħha) abbażi ta' formulazzjonijiet ta' paracetamol konvenzjonali jista' ma jkunx effettiv għal dożi eċċessivi b'formulazzjonijiet ta' paracetamol li tiġi rilaxxata b'mod modifikat.
English: − where <10 g of paracetamol has been ingested and time since ingestion is known, multiple serum paracetamol samples should be taken at suitable intervals (e.g. 4, 6, and 8 hours after ingestion).
Maltese: − meta <10 g ta' paracetamol ikunu ġew inġestiti u l-ħin mill-inġestjoni jkun magħruf, jenħtieġ li bosta kampjuni ta' serum ta' paracetamol jittieħdu f'intervalli xierqa (eż. 4, 6 u 8 sigħat wara linġestjoni).
English: Paracetamol-containing immediate-release products have been authorised in all EU Member States but are not included in EMA's review.
Maltese: Il-prodotti li fihom paracetamol li jiġi rilaxxat b'mod immedjat ġew awtorizzati fl-Istati Membri kollha tal-UE iżda mhumiex inklużi fir-reviżjoni tal-EMA.
English: − where overdose with ≥10 g of paracetamol (or ≥150 mg/kg body weight in children) is known or suspected, or where dose is unknown, treatment with antidote (N-acetylcysteine, NAC) should be started immediately regardless of the initial serum paracetamol level, since serum paracetamol level after acute overdose with modified-release products may peak up to 24 hours after ingestion;
Maltese: − meta tkun magħrufa jew issuspettata doża eċċessiva b'≥10 g ta' paracetamol (jew ≥150 mg/kg piż tal-ġisem fit-tfal), jew meta d-doża ma tkunx magħrufa, jenħtieġ li tinbeda kura bl-antidotu (N-acetylcysteine, NAC) immedjatament, irrispettivament mil-livell ta' serum ta' paracetamol inizjali, minħabba li l-livell ta' serum ta' paracetamol wara doża eċċessiva akuta bi prodotti li jerħu l-mediċina b'mod modifikat jista' jiżdied sa 24 siegħa wara linġestjoni;
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp li jirrappreżenta l-Istati Membri tal-UE kif ukoll l-Iżlanda, il-Liechtenstein u n-Norveġja.
English: If serum paracetamol levels exceed the treatment nomogram at any time point, treatment with antidote (NAC) is indicated;
Maltese: Jekk il-livelli ta' serum ta' paracetamol jaqbżu n-nomogramma tal-kura fi kwalunkwe ħin, hija ssuġġerita kura bl-antidotu (NAC);
English: The recommendation was made by the Agency's experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-rakkomandazzjoni saret mill-esperti tal-Aġenzija fis-sikurezza talmediċini, il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Maltese: Irrakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati - Bniedem (CMDh), li adotta pożizzjoni.
English: • Some modified-release medicines are available in combination with another painkiller, tramadol.
Maltese: • Xi mediċini li jiġu rilaxxati b'mod modifikat huma disponibbli f'kombinazzjoni ma' mediċina oħra li ttaffi l-uġigħ, it-tramadol.
English: Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue France
Maltese: Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue Franza
English: Singapore 636986
Maltese: Singapor 636986
English: Ltd. BioProduction Operations Singapore 8 Tuas Bay Lane
Maltese: BioProduction Operations Singapore 8 Tuas Bay Lane
English: Baseline IgE (IU/ml)
Maltese: IgE (IU/ml)
English: Chronic spontaneous urticaria (CSU)
Maltese: Urtikarja spontanja kronika (CSU)
English: Allergic granulomatous vasculitis (i.e. Churg-Strauss syndrome)
Maltese: Vaskulite granulomatuża allerġika (i.e.sindrome ta' ChurgStrauss)
English: 1 vial and 1 ampoule.
Maltese: Kunjett 1 u ampulla 1.
English: BOCF=baseline observation carried forward; mITT=modified intention-to-treat population
Maltese: BOCF=osservazzjoni kontinwata tal-linja bażi; mITT=popolazzjoni modifikata maħsuba għat-trattament
English: Placebo N=210
Maltese: Plaċebo N=210
English: Table 4 Adverse reactions
Maltese: Tabella 4 Reazzjonijiet avversi
English: Arterial thromboembolic events (ATE)
Maltese: Episodji tromboemboliċi ta' l-arterji (ATE)
English: Systemic lupus erythematosus
Maltese: Lupus eritematożi sistemika
English: Pyrexia**
Maltese: Valur-p**
English: Total injection volume (ml)
Maltese: Volum totali tal-injezzjoni (ml)
English: - Systemic lupus erythematosus (SLE).
Maltese: - Lupus eritematożi sistemika (SLE).
English: 1 x 2 ml solvent ampoule
Maltese: Ampulla 1 x 2 ml solvent
English: Table 4 Adverse reactions in allergic asthma
Maltese: Tabella 4 Reazzjonijiet avversi f'pazjenti b'ażma allerġika
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Maltese: Il-Manifattur Novartis Pharma GmbH Roonstrasse 25
English: Date of first authorisation: 25 October 2005 Date of latest renewal: 22 June 2015
Maltese: Data tal-aħħar tiġdid: 22 ta' Ġunju 2015
English: SEE TABLE 2
Maltese: Tabella 5
English: In a multivariate analysis controlling for available baseline cardiovascular risk factors, the hazard ratio was 1.32 (95% confidence interval 0.91-1.91).
Maltese: F'analiżi kontrollanti multivarjata għall-fatturi ta' riskju kardjovaskulari fil-linjabażi disponibbli, il-proporzjon ta' periklu kienet ta' 1.32 (95% intervall ta' kunfidenza 0.91-1.91).
English: Systemic lupus erythematosus (SLE)
Maltese: Lupus eritematożi sistemika (SLE)
English: Photosensitivity, urticaria, rash, pruritus
Maltese: Fotosensittività, urtikarja, raxx, ħakk
English: - Store in a refrigerator (2°C - 8°C).
Maltese: - Aħżen fi friġġ (2°C - 8°C).
English: Whole study 1 population Xolair N=209
Maltese: Popolazzjoni sħiħa ta' studju 1 Xolair N=209
English: Adults and adolescents (12 years of age and older)
Maltese: Adulti u adoloxxenti (età ta' 12-il sena u aktar)
English: Immune system disorders For further information, see section 4.4.
Maltese: Għal aktar informazzjoni, ara sezzjoni 4.4.
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Il-kategoriji tal-frekwenza huma definiti bħala: 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) u rari ħafna (<1/10,000).
English: Oral corticosteroid, theophylline and leukotrienemodifier maintenance therapies were allowed (22%, 27%, and 35% of patients, respectively).
Maltese: Terapiji ta' manteniment b'kortikosterojdi li jittieħdu mill-ħalq, theophylline u modifikaturi ta' leukotriene tħallew (22%, 27% u 35% tal-pazjenti rispettivament).
English: Allergic bronchospasm, coughing
Maltese: Bronkospażmu allerġiku, sogħla
English: EU/1/05/319/008 EU/1/05/319/009 EU/1/05/319/010 EU/1/05/319/011
Maltese: EU/1/05/319/008 EU/1/05/319/009 EU/1/05/319/010
English: • Alcohol swab.
Maltese: • Tajjara bl-alkoħol.
English: The definition of the composite endpoint ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause).
Maltese: Id-definizzjoni tal-punt finali kompost tinkludi puplesija, attakk iskemiku għal żmien qasir, infart mijokardijaku, anġina instabbli, u mewta kardjovaskulari (inkluż mewta mingħajr raġuni magħrufa).
English: Musculoskeletal and connective tissue disorders Arthralgia
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Artralġja
English: The adverse reactions are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi qed jingħataw skont is-sistema tal-klassifika tal-organi MedDRA.
English: Rare (may affect up to 1 in 1,000 people) - parasitic infection
Maltese: Rari (jista' jaffettwa sa persuna waħda f'kull 1,000 ruħ) - infezzjoni ta' parassiti
English: Liver elimination of IgG includes degradation in the reticuloendothelial system and endothelial cells.
Maltese: Eliminazzjoni ta' IgG mill-fwied tinkludi degradazzjoni fis-sistema retikulo-endotiljali u fiċ-ċelloli endotiljali.
English: Parasitic (helminth) infections
Maltese: Infezzjonijiet ta' parassiti (elminti)
English: Multipack comprising 10 packs
Maltese: Pakkett multiplu li fih 10 pakketti
English: In studies 3, 4 and 5 patients treated with Xolair had respective reductions in asthma exacerbation rates of 37.5% (p = 0.027), 40.3% (p<0.001) and 57.6% (p<0.001) compared to placebo.
Maltese: Fi studji 3, 4 u 5 pazjenti ittrattati bi Xolair kellhom tnaqqis rispettiv fir-rati ta' l-aggravar ta' l-attakki ta' l-ażma ta' 37.5% (p=0.027), 40.3% (p<0.001) u 57.6% (p<0.001) imqabbla mal-plaċebo.
English: Store in the refrigerator between 2°C and 8°C.
Maltese: Aħżen filfriġġ bejn 2°C u 8°C.