FrancophonIA/ELRC3.0 huggingface dataset:
English: Careful consideration should also be given to placing permanent skin covers (e.g. autografts) on deep partial thickness wounds soon after NexoBrid debridement.
Maltese: Għandha wkoll tingħata konsiderazzjoni b'attenzjoni li jitpoġġew għata permanenti fuq il-ġilda (eż. awtotrapjanti) fuq feriti bi ħxuna parzjali profonda dritt wara t-tneħħija ta' tessut mejjet permezz ta' NexoBrid.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with NexoBrid in one or more subsets of the paediatric population in the treatment of burns of external body surface (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Direct contact with the eyes should be avoided.
Maltese: Kuntatt dirett mal-għajnejn għandu jiġi evitat.
English: Blood pressure should be monitored in patients receiving ACE inhibitors
Maltese: Il-pressjoni tad-demm għandha tiġi monitorata f'pazjenti li jirċievu impedituri ACE.
English: The use of NexoBrid to remove burnt tissue may lead to fever, to wound inflammation or wound infection, and possibly to general infection.
Maltese: L-użu ta' NexoBrid biex ineħħi tessut maħruq jista' jwassal għal deni, infjammazzjoni tal-feriti jew infezzjoni tal-feriti, u possibbilment għal infezzjoni ġenerali.
English: Aseptic technique must be used when mixing NexoBrid powder with the gel.
Maltese: Dan irid isir flimkien mal-materjal edukattiv li l-utenti potenzjali kollha għandhom jirċievu.
English: • The wound must be cleaned thoroughly and the superficial keratin layer or blisters removed from the wound area, as the keratin will isolate the eschar from direct contact with NexoBrid and prevent eschar removal by NexoBrid.
Maltese: • Iż-żona li minnha jkun tneħħa t-tessut mejjet trid tinkesa immedjatament minn sostituti temporanji jew permanenti tal-ġilda jew faxex biex jiġi evitat tnixxif u/jew il-formazzjoni ta' psewdo tessut mejjet u/jew infezzjoni.
English: Based on:
Maltese: MAH,
English: GROUNDS FOR NEGATIVE OPINION
Maltese: RAĠUNIJIET GĦALL-OPINJONI NEGATTIVA
English: • the rapporteur's and co-rapporteur's assessment reports
Maltese: • tar-rapporti ta' valutazzjoni tar-rapporteur u tal-korapporteur
English: Isotretinoin Ranbaxy 10 mg & 20 mg, capsules (soft) was authorised in the reference member state (UK) under Article 10 of Directive 2001/83/EC and the application was submitted in the concerned member states (France and Spain) under the mutual recognition procedure.
Maltese: Isotretinoin Ranbaxy 10 mg u 20 mg, kapsuli (rotob) ġie awtorizzat fl-Istat Membru ta' referenza (irRenju Unit) skont l-Artikolu 10 tad-Direttiva 2001/83/KE u l-applikazzjoni ġiet ippreżentata fl-Istati Membri kkonċernati (Franza u Spanja) skont il-proċedura ta' rikonoxximent reċiproku.
English: Isotretinoin is a vitamin A derivative indicated for the treatment of severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
Maltese: Isotretinion huwa derivattiv tal-vitamina A indikat għall-kura ta' forom severi ta' akne (bħall-akne nodulari jew konglobat jew akne b'riskju ta' tbajja permanenti) resistenti għal korsijiet adegwati ta' terapija standard b'antibatterji sistematiċi u terapija topika.
English: However, the results failed to show that the Isotretinoin Ranbaxy generic is bioequivalent to the originator product in real conditions of use (fed conditions), as the 90% confidence intervals (CI) fell outside the predefined interval of 80-125%, which constitutes a risk to public health.
Maltese: Madankollu r-riżultati naqsu milli juru li l-mediċina ġenerika Isotretinoin Ranbaxy hija bijoekwivalenti għall-prodott oriġinarju f'kondizzjonijiet reali ta' użu (kondizzjonijiet ta' tmigħ), peress li l-intervalli ta' fiduċja ta' 90% (CI) waqgħu barra l-intervall predefinit ta' 80-125%, li jikkostittwixxi riskju għas-saħħa pubblika.
English: Results of a study in healthy adult human male subjects under fed conditions (study No 122_ISOTR_10) were subsequently provided by the marketing authorisation holder.
Maltese: Id-detentur tal-awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda riżultati ta' studju f'soġġetti adulti umani maskili f'saħħithom taħt kondizzjonijiet ta' tmigħ (studju Nru 122_ISOTR_10).
English: • and scientific discussion within the Committee the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Maltese: • u tad-diskussjoni xjentifika li saret fil-Kumitat is-CHMP kien tal-fehma li d-dettalji mressqa b'appoġġ għall-applikazzjoni ma humiex konformi malArtikolu 10 tad-Direttiva 2001/83/KE kif emendata.
English: The totality of data submitted does not support the conclusion that the product is bioequivalent.
Maltese: It-totalità tad-data sottomessa ma ssostnix il-konklużjoni li l-prodott huwa bijoekwivalenti.
English: Isotretinoin is effective against severe acne via a direct effect on the size and activity of sebaceous glands, plus a probable dermal anti-inflammatory effect.
Maltese: Isotretinoin huwa effettiv kontra l-akne sever permezz ta'effett dirett fuq id-daqs u l-attività tal-glandoli sebaċei, flimkien ma' effett antinfjammatorju dermali probabbli.
English: Having regard to the fact that the absorption of Isotretinoin in fed state is larger than that observed in fasted state (which motivates the SPC recommendation of intake with food (as clearly mentioned in the Posology section of the SPC), the CHMP agreed that a study in the fed state was essential.
Maltese: Wara li kkunsidra l-fatt li l-assorbiment ta' Isotretinoin fl-istat mitmugħ huwa akbar minn dak osservat fl-istat ta' sawm, u dan jimmotiva r-rakkomandazzjoni tal-SPC li jittieħed mal-ikel (kif jissemma b'mod ċar fit-taqsima talPosoliġija tal-SPC), is-CHMP qabel li studju fl-istat mitmugħ kien essenzjali.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Maltese: Għalhekk qiegħed jitqies li d-dettalji mressqa b'appoġġ għall-applikazzjoni ma humiex konformi mal-Artikolu 10 tad-Direttiva 2001/83/KE kif emendata.
English: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND
Maltese: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SVIZZERA
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Maltese: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANZA
English: ATCvet code: QI02AT01.
Maltese: QI02AT01
English: Date of last renewal: 05/12/2008.
Maltese: Data tal-aħħar tiġdid: 05/12/2008
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl parahydroxybenzoate
Maltese: 6.1 Lista ta' ingredjenti Methyl parahydroxybenzoate
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
English: IMMUNOLOGICAL PROPERTIES
Maltese: KWALITAJIET IMMUNOLOGICI
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/011/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/99/011/001
English: CONTRAINDICATIONS
Maltese: KONTRADIZZJONIJIET
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/1999.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni:29/03/1999
English: Fürstentum
Maltese: Vaduz
English: The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità passiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
Maltese: Il-prodott jissuplimenta l-proprjetajiet protettivi ta' kolostrum kontra E.coli F5 (K99) adhesin.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, il pussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Maltese: Teħid mill-ħalq ta' 60 ml kemm jista' jkun malajr, preferibbilment mogħtija fl-ewwel 4 siegħat, imma mhux aktar minn 12-il siegħa wara t-twelid.
English: LIECHTENSTEIN
Maltese: FŰRSTENTUM, LIECHTENSTEIN
English: BATCH NUMBER Batch {number}
Maltese: NUMRU TAL-LOTT Lott {numru}
English: This product may contain antibodies against BVD virus.
Maltese: Dan il-prodott jista' jkun fih anti-korpi diretti kontra l-virus tal- BVD.
English: MANUFACTURER'S BATCH NUMBER Batch{number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emergenza, antidoti) jekk ikun hemm bżonn
English: Pack size: 60 ml bottle.
Maltese: Daqs tal-kontenitur: flixkun ta' 60 ml
English: Dispose of waste material in accordance with local requirements.
Maltese: Armi materjal ta' skart skont ir-rekwiżiti lokali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR(I)
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: .2 Inkompatibilitajiet Fin-nuqqas ta' studji dwar kompattibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: Excipient
Maltese: KWANTITÀ
English: Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Maltese: Tnaqqis fil-mortalità kkaġunata minn enterotossikożi assoċjata ma' E. coli F5 (K99) adhesin matul lewwel jiem ta' ħajja bħala suppliment għal kolostrum mill-baqra.
English: 4.3 Contraindications
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Any person intending to manufacture, import, possess, sell, supply and use Locatim must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li għandha l-ħsieb li timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża Locatim għandha tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar il-programmi ta' tilqim fis-seħħ qabel ma timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża.
English: 6.5 Nature and composition of immediate packaging Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
Maltese: Kaxxa tal-kartun li fiha flixkun wieħed ta' 60 ml ta' ħġieġ TipIII magħluq b' għatu ta' polypropylene b'siġill tal-polyethylene u b'annell li jinqalgħa
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ml.
Maltese: Konċentrat tal-lattoserum tal-ifrat li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99) adhesin
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE The manufacture, import, possession, sale, supply and/or use of Locatim may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' Locatim huwa pprojbit jew jista' jkun ipprojbit f'ċertu Stati Membri fit-territorju kollu tagħhom jew f'parti minnu taħt leġizlazzjoni nazzjonali.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥2.8* log10/ml.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Konċentrat tal-lattoserum tal-għoġġiela li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99)
English: PHARMACEUTICAL FORM Oral solution
Maltese: GĦAMLA FARMAĊEWTIKA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim oral solution for neonatal calves less than 12 hours of age
Maltese: VETERINARJU Locatim huwa soluzzjoni orali għal għoġġiela tat-twelid li għandhom anqas minn 12-il siegħa
English: Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment.
Maltese: Sussegwentement, barra anti-korpi għal vaċċinazzjoni għal E.Coli F5 (K99) huwa fih ukoll anti-korpi għal organiżmi oħra, bħala riżultat ta' vaċċinazzjoni u/jew espożizzjoni tal-baqar donaturi għal organiżmi fl-ambjent tagħhom.
English: Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum LIECHTENSTEIN
Maltese: Qabel tuża l-prodottaqra l-fuljett li jinsab fil-pakkett
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Maltese: PREKAWZJONIJIET SPEĊJALI GĦALL-ĦAŻNA
English: figure
Maltese: figura
English: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do South Korea
Maltese: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do Il-Korea t'Isfel
English: D-72764 Reutlingen Germany
Maltese: D-72764
English: Biotransformation / Elimination
Maltese: Bijotrasformazzjoni/Eliminazzjoni
English: The active substance is somatropin.
Maltese: Is-sustanza attiva hi somatropin.
English: This usually takes approximately 60 seconds but can take up to 90 seconds.
Maltese: Dan normalment jieħu madwar 60 sekonda, iżda jista' jieħu sa 90 sekonda.
English: BioPartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
Maltese: BioPartners GmbH Kaiserpassage 11 D-72764
English: It has 191 amino acid residues and a molecular weight of 22,125 Daltons.
Maltese: Għandu 191 residwu ta' amino acids u piż molekulari ta' 22,125 Daltons.
English: Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poland
Maltese: Macierzysz, 12, Poznanska, Str., 05-850
English: -0.5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score.
Maltese: -0.5 mg (il-pazjenti kollha) IGF-I = fattur-I tat-tkabbir qisu insulina, SDS = punteġġ ta' devjazzjoni standard.
English: Common: Hypercortisolism (7.7%), hypothyroidism (2.2%), adrenal cortical insufficiency (3.3%), hypothyreosis secondary to TSH deficiency (2.6%), decreased free thyroxine (4.4%), increased blood TSH (2.2%)
Maltese: Iperkortisoliżmu (7.7%), ipotirojdiżmu (2.2%), insuffiċjenza kortikali adrenali (3.3%), ipotireożi sekondarja għal defiċjenza TSH (2.6%), tnaqqis ta' thyroxine ħieles (4.4%), żieda ta' TSH fid-demm (2.2%)
English: Malignancies/tumours
Maltese: Tumuri malinni/tumuri
English: Common: Epistaxis
Maltese: Komuni: Epistassi
English: 1.5 mL medium chain triglycerides
Maltese: INDIVIDWALI 1.5 mL medium chain triglycerides
English: Common: headache (4.4%), lethargy (1.1%), dizziness (2.6%) Rare: paraesthesia*
Maltese: Komuni: uġigħ ta' ras (4.4%), letarġija (1.1%), sturdament (2.6%) Rari: parestesija*
English: For adults
Maltese: Għall-adulti
English: Investigations Common: decreased blood cortisol (2.2%)
Maltese: Komuni: tnaqqis ta' cortisol fid-blood (2.2%)
English: 7 mg (21 IU)
Maltese: INDIVIDWALI 7 mg (21 IU)
English: 4 vials of 1.5 mL solvent
Maltese: 4 kunjetti b'1.5 mL ta' solvent
English: +1.5 mg (female on oral oestrogen) +1.0 mg (all other patients)
Maltese: +1.5 mg (mara fuq estroġenu orali) +1.0 mg (il-pazjenti l-oħrajn kollha)
English: *produced in Saccharomyces cerevisiae by recombinant DNA technology For the full list of excipients, see section 6.1.
Maltese: *prodott f'Saccharomyces cerevisiae minn teknoloġija ta' DNA rikombinanti Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Common: Paraesthesia, hypoaesthesia, carpal tunnel syndrome, dizziness, somnolence Rare: Benign intracranial hypertension*
Maltese: Komuni: Parastesija, ipoaestesija, sindrome tal-carpal tunnel, sturdament, ngħas Rari: Pressjoni tad-demm għolja intrakranjali beninna*
English: 10 mg (30 IU)
Maltese: INDIVIDWALI 10 mg (30 IU)
English: 1 vial of 1.5 mL solvent
Maltese: 1 kunjett b'1.5 mL ta' solvent
English: Injection volume (mL)
Maltese: Volum ta' injezzjoni (mL)
English: Powder: sodium hyaluronate, egg phospholipids, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous.
Maltese: Trab: sodium hyaluronate, egg phospholipids, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous.
English: Insulin sensitivity
Maltese: Sensittività għall-insulina
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 33% of the paediatric patients.
Maltese: Somatropin Biopartners ikkawża l-formazzjoni ta' antikorpi f'madwar 33% tal-pazjenti pedjatriċi.
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Common: injection site pain (9.9%), injection site discolouration (8.8%), injection site erythema (7.7%), injection site nodule (4.4%), injection site reaction (1.1%), injection site warmth (1.1%), pyrexia (2.6%), oedema (local and generalised)*
Maltese: Komuni: uġigħ fis-sit tal-injezzjoni (9.9%), tibdil fil-kulur fis-sit tal-injezzjoni (8.8%), eritema fis-sit tal-injezzjoni (7.7%), għoqda fis-sit tal-injezzjoni (4.4%), reazzjoni fis-sit tal-injezzjoni (1.1%), sħana fis-sit tal-injezzjoni (1.1%), deni (2.6%), edema (lokali u ġeneralizzata)*
English: Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Maltese: Somatropin jistimula l-metaboliżmu tal-lipidi; iżid il-fatty acids fil-plażma u (HDL)-kolesterols ta' lipoproteina ta' densità għolja, u jnaqqas il-kolesterol totali fil-plażma.
English: Somatropin may induce insulin resistance.
Maltese: Somatropin jista' jinduċi reżistenza għall-insulina.
English: Paediatric patients with endocrine disorders, including GHD, may develop slipped capital femoral epiphyses more frequently.
Maltese: Pazjenti pedjatriċi b'disturbi endokrinarji, li jinkludu GHD, jistgħu jiżviluppaw slipped capital femoral epiphyses aktar ta' spiss.
English: 20 mg (60 IU)
Maltese: INDIVIDWALI 20 mg (60
English: Side effects were generally transient and mild to moderate.
Maltese: L-effetti sekondarji rrappurtati ġeneralment kienu temporanji u ta' severità minn ħafifa sa moderata.
English: Very common: Formation of antibodies against growth hormone (33%), see section “Descriptions of selected adverse reactions”, under “Immunogenicity”.
Maltese: Komuni ħafna: Formazzjoni ta' antikorpi kontra l-ormon tat-tkabbir (33%), ara s-sezzjoni “Deskrizzjonijiet ta' reazzjonijiet avversi magħżula”, taħt “Immunoġeniċità”.
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients.
Maltese: Somatropin Biopartners ikkawża l-formazzjoni ta' antikorpi f'madwar 4% tal-pazjenti adulti.
English: Common: Conjunctivitis, visual acuity reduced
Maltese: Komuni: Konġuntivite, tnaqqis fiċ-ċarezza tal-vista
English: With regard to antibodies against host cell proteins, low anti-S. cerevisiae protein antibody titres similar to levels in the normal untreated population were found in some patients treated with this medicinal product.
Maltese: Fir-rigward ta' antikorpi kontra proteini taċ-ċelluli ospitu, instabu titres baxxi ta' antikorpi ta' proteini anti-S. cerevisiae li kienu simili għal-livelli fil-popolazzjoni normali mhux ikkurata f'xi pazjenti kkurati b'dan il-prodott mediċinali.
English: Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD).
Maltese: Somatropin Biopartners hu indikat għat-terapija ta' sostituzzjoni tal-ormon tat-tkabbir endoġenu f'adulti bil-bidu b'defiċjenza tal-ormon tat-tkabbir (GHD - growth hormone deficiency) li seħħ fit-tfulija jew f'età adulta.
English: Cases of malignant and benign tumour recurrences, de-novo and secondary tumours have been reported in temporal relationship with somatropin therapy.
Maltese: Każijiet ta' rikorrenzi tumuri malinni u beninni, de-novo u tumuri sekondarji, ġew irrappurtati f'relazzjoni temporali ma' terapija b'somatropin.
English: IGF-I SDS lower than -1
Maltese: SDS inqas minn -1
English: Somatropin promotes cellular protein synthesis and nitrogen retention.
Maltese: Somatropin jippromwovi s-sintesi ta' proteini ċellulari u ż-żamma tan-nitrogen.
English: Similar results were achieved for all other parameters assessed including height SDS (standard deviation score), bone maturation, IGF-I and IGF BP-3.
Maltese: Riżultati simili nkisbu għall-parametri l-oħrajn kollha evalwati li jinkludu SDS (standard deviation score - punteġġ ta' devjazzjoni standard) tat-tul, maturazzjoni tal-għadam, IGF-I u IGF BP-3.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 05 t'Awwissu 2013
English: Uncommon: Gynaecomastia*
Maltese: Rari ħafna: ġinekomastija*
English: Growth hormone increases the extrathyroidal conversion of thyroxin (T4) to triiodothyronine (T3) and may unmask central hypothyroidism.
Maltese: L-ormon tat-tkabbir iżid il-konverżjoni extratirojdali ta' thyroxin (T4) għal triiodothyronine (T3) u jista' jikxef ipotirojdiżmu ċentrali.
English: The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be increased resulting in lower plasma levels of these compounds.
Maltese: It-tneħħija ta' komposti metabolizzati minn ċitokrom P450 3A4 (eż. sterojdi tas-sess, kortikosterojdi, mediċini kontra l-konvulżjoni u cyclosporine) tista' tiżdied, u dan jirriżulta f'livelli iktar baxxi ta' dawn il-komposti fil-plażma.
English: 4 mg (12 IU)
Maltese: INDIVIDWALI 4 mg (12 IU)