FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of respiratory system
Maltese: Valutazzjoni tas-sistema respiratorja
English: The following side effects have also been reported:
Maltese: Mhux magħruf:
English: For methotrexate-containing medicinal products with oncologic indications
Maltese: Għal prodotti mediċinali li fihom methotrexate b'indikazzjonijiet mhux onkoloġiċi
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Maltese: Mistoqsijiet lill-pazjent fir-rigward tad-disfunzjonijiet pulmonari possibbli, jekk ikun hemm bżonn test tal-funzjoni tal-pulmun.
English: Frequency ‘not known'
Maltese: Frekwenza “mhux magħrufa”
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood
Maltese: − infjammazzjoni tal-pulmuni (sintomi jistgħu jkunu mard ġenerali, sogħla xotta, irritanti, qtugħ ta'
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Maltese: Methotrexate - Emorraġija alveolari pulmonari (EPITT nru
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage* *(has been reported for methotrexate used in rheumatologic and related indications)
Maltese: Frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli): fsada fil-pulmuni* *(ġiet irrapportata għal methotrexate użat f'pazjenti b'marda rewmatoloġika bażi).
English: Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Maltese: 3. Pemetrexed - Insipidus ta' dijabete nefroġenika (EPITT nru 18930)
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux magħruf:
English: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Maltese: Tista' sseħħ pulmonite akuta jew kronika interstizjali, ħafna drabi assoċjata ma' eosinofilija tad-demm, u ġew irrappurtati mwiet.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Maltese: Ħafna mill-pazjenti li fihom seħħew dawn lepisodji kellhom fatturi ta' riskju bażi għall-iżvilupp ta' episodji renali inkluż deidratazzjoni jew pressjoni għolja pre-eżistenti jew dijabete.
English: Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Maltese: Episodji renali serji, inkluż indeboliment renali akut, ġew irrapportati b'pemetrexed waħdu jew f'assoċjazzjoni ma' sustanzi kemoterapewtiċi oħrajn.
English: Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Maltese: Każijiet mhux komuni ta' indeboliment renali akut ġew irrapportati b'pemetrexed waħdu jew f'assoċjazzjoni ma' sustanzi kemoterapewtiċi oħrajn (ara sezzjoni 4.4).
English: Symptoms typically include dyspnoea, cough (especially a dry nonproductive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Maltese: Is-sintomi normalment jinkludu dispnea, sogħla (b'mod speċjali sogħla xotta mhux produttiva), uġigħ toraċiku u deni li għalihom, il-pazjenti għandhom jiġu mmonitorjati f'kull viżta ta' segwitu.
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood* *(has been reported for methotrexate used in patients with underlying rheumatologic disease)
Maltese: Mhux magħruf: ma tistax tittieħed stima mid-data disponibbli Żieda fl-ammont ta' produzzjoni ta' awrina Għatx u żieda fil-konsum tal-ilma Ipernatremija - żieda fl-ammont ta' sodju fid-demm
English: EU/2/17/213/001-002
Maltese: FIS-SUQ EU/2/17/213/001-002
English: Bovine serum Veggie medium Dimethyl sulfoxide
Maltese: Serum bovin Veggie medium Dimethyl sulfoxide
English: UNITED STATES OF AMERICA
Maltese: UNITI TAL-AMERIKA
English: 400 ml 800 ml
Maltese: 800 ml
English: Onset of immunity:
Maltese: Bidu ta` immunità:
English: Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections
Maltese: Diġest tal-casein pankrejatiku Phenolsulfonphthalein (phenol red) Potassium dihydrogen phosphate
English: Administration:
Maltese: Amministrazzjoni:
English: Intervet International B.V. Ambachtstraat 2, 4, 5a 3732 CN De Bilt THE NETHERLANDS
Maltese: Intervet International B.V. Ambachtstraat 2, 4, 5a
English: Major incompatibilities:
Maltese: Inkompatibilitajiet:
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer
English: The vaccine induces active immunity against Newcastle disease, infectious bursal disease (Gumboro disease) and Marek's disease in chickens.
Maltese: Il-vaċċin jinduċi immunità attiva kontra l-marda Newcastle, marda infettiva bursal (marda Gumboro) u l-marda Marek fit-tiġieġ.
English: Suspension: Store and transport frozen in liquid nitrogen (below -140 °C).
Maltese: Aħżen u ttrasporta ffriżat fin-nitroġenu likwidu (taħt -140°C)
English: Store below 25 °C.
Maltese: KIF TAĦŻEN Aħżen taħt 25 °C.
English: Pharmacotherapeutic group: Immunologicals for aves, live viral vaccines for domestic fowls.
Maltese: Grupp farmako-terapewtiku: immunoloġiku għat-tjur, vaċċini virali ħajjin għat-tjur domestiku.
English: SC In ovo
Maltese: Użu taħt il-ġilda jew użu in ovo.
English: Container:
Maltese: Kontenitur:
English: ATCvet code: QI01AD16.
Maltese: QI01AD
English: Duration of immunity: ND: 8 weeks, IBD: 8 weeks,
Maltese: Bidu ta` immunità`: ND: 4 ġimgħat IBD: 3 ġimgħat
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: ND: 4 weeks, IBD: 3 weeks, MD: 9 days.
Maltese: ND: 4 ġimgħat IBD: 3 ġimgħat
English: Read package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Intervet International B.V.
English: Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU1.
Maltese: Ħerpes virus rikombinant tad-dundjan ħaj assoċjat ma' ċelloli (strejn HVP360), li jesprimi l-fusjoni ta' proteini tal-virus tal-marda Newcastle u l-VP2 protein tal-marda virali infettiva tal-bursal: 103.3 - 104.6
English: HVP360
Maltese: TAS-SUSTANZA(I) ATTIVA(I) HVP360
English: EXPIRY DATE
Maltese: DATA TAL-ISKADENZA
English: Innovax-ND-IBD suspension and solvent for suspension for injection for chickens
Maltese: VETERINARJU Innovax-ND-IBD sospensjoni u solvent għal sospensjoni għall-injezzjoni għat-tiġieġ
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 l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: MSD Animal Health Logo
Maltese: Kodici ATC veterinarja:
English: After dilution, administer 1 dose of 0.2 ml vaccine per chicken by subcutaneous injection in the neck or 1 dose of 0.05 ml per egg by in ovo injection.
Maltese: 2ml ta` vaċċin kull tiġieġa taħt il-ġilda fl-għonq u doza 1 ta` 0.05 ml injezzjoni kull bajda
English: In ovo: One single injection of 0.05 ml per chicken egg.
Maltese: Injezzjoni waħda ta` 0.5ml kull fellus.
English: The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing.
Maltese: Is-solvent irid ikun ċar, aħmar fil-kulur, mingħajr sedimenti u f`temperatura tal-kamra (15-25 °C) fil-ħin tat-taħlit.
English: Suspension and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Sospensjoni u solvent għal sospensjoni għall-injezzjoni.
English: Pack sizes:
Maltese: Daqs tal-pakett:
English: Bag of 400 ml solvent or bag of 800 ml solvent.
Maltese: Uża 400ml tas-solvent għal kull 2,000 doża tas-sospensjoni ċellulari jew 800 ml tas-solvent għal kull 4,000 doża tas-sospensjoni ċellulari.
English: The vaccine is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the F protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus.
Maltese: Il-vaċċin huwa ħerpes virus ħaj assoċjat ma' ċelloli rikombinant tad-dundjan (strejn HVP), li jesprimi proteina F tal-virus tal-marda Newcastle u l-VP2 protein tal-marda virali infettiva tal-bursal.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġika maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: - One 800 ml polyethylene or multilayer plastic bag.
Maltese: - Borża tal-plastik polyethylene waħda ta` 400ml jew borża tal-plastik bis-saffi - Borża tal-plastik polyethylene waħda ta` 800ml jew borża tal-plastik bis-saffi
English: Preparation of the vaccine:
Maltese: Preparazzjoni tal-vaċċin:
English: Solvent for cell associated poultry vaccines.
Maltese: Uża s-solvent tas-sospensjoni tal-vaċċin tat-tjur cell associated.
English: Safety and efficacy data are available which demonstrate that Nobilis ND Clone 30 or Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li Nobilis ND clone 30 jew Nobilis ND C2 jista' jiġi amministrat lil flieles ta' ġurnata li huma mlaqqma jew taħt il-ġilda jew in ovo b`InnovaxND-IBD.
English: Zero days.
Maltese: 2 sigħat
English: For such associated use, an onset of immunity of 3 weeks (when used with Nobilis ND Clone 30) and 2 weeks (when used with Nobilis ND C2), has been demonstrated for ND.
Maltese: Għal l-użu assoċjat, bidu tal-immunità ta` 3 ġimgħat (assoċjat ma' Vobilis ND Clone 30) u 2 ġimgħat (assoċjat ma' Nobilis ND C2), ġew demostrati għall-ND.
English: Thaw the ampoules in clean water at 25-27 °C.
Maltese: Għal din r-raġuni, ħoll il-kunjetti f`ilma nadif bejn 25-27 °C.
English: 1 ampoule, containing 2,000 or 4,000 doses.
Maltese: Kunjett wieħed tal-ħġieġ tip I ta` 2ml li fih 2,000 jew 4,000 dożi.
English: Solvent bag
Maltese: Fil-bajda
English: Bag of 800 ml solvent
Maltese: Borża ta` 400ml jew borża ta` 800ml solvent
English: Veterinary medicinal product subject to prescription.
Maltese: Tużax diżinfettanti kemikali.
English: No information is available on the safety or possible adverse reactions following a 10-fold overdose applied in ovo.
Maltese: M'hemmx informazzjoni fuq doza ta` 10 darbiet akbar applikata in ovo.
English: Gently withdraw the contents of the ampoule into a sterile syringe, fitted with an 18 gauge needle.
Maltese: Iġbed bil-mod il-kontenut tal-kunjet f`siringa sterili, immuntata b`labra 18G.
English: CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes.
Maltese: KAWTELA: huwa magħruf li l-kunjetti jisplodu fuq tibdil f`daqqa fit-temperatura.
English: There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.
Maltese: M`hemmx informazzjoni fuq in-numru ta` dożi fuq il-kunjetti ladarba jitneħħew minn posthom, għalhekk għandha tingħata attenzjoni speċjali sabiex tiżgura u tevita li ma jkunx hemm taħwid tal-kunjetti ma' numru differenti ta` dożi u li s-solvent ittajjeb jiġi użat.
English: MD: entire risk period.
Maltese: MD: il-perjodu kollu ta` riskju
English: Container: Store liquid nitrogen container securely in an upright position in a clean, dry and wellventilated room separated from the hatching/chicken room.
Maltese: Aħżen il-kontenitur tan-nitroġenu likwidu f`pożizzjoni soda u wieqaf f`kamra nadifa, xotta u ventilata tajjeb separata mill-kamra fejn ifaqqsu l-bajd.
English: Innovax-ND-IBD is a virus suspension packed in glass ampoules and stored in liquid nitrogen.
Maltese: Innovax-ND-IBD huwa sospensjoni ta` virus ippakkjat f`kunjetti tal-ħġieġ u maħżun f`nitroġenu likwidu.
English: Gently withdraw the contents of the ampoule into a sterile syringe fitted with an 18 gauge needle.
Maltese: Iġbed bil-mod il-kontenut tal-kunjet f`siringa sterili, immuntata b`labbra 18G.
English: For active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease
Maltese: Għall-immunità attiva tal-flieles ta` ġurnata: - sabiex titnaqqas il-mortalità u s-sinjali kliniċi kkawżati mill-marda virali Newcastle (ND) - sabiex tipprevjeni l-mortalità u tnaqqas s-sinjali kliniċi u leżjonijiet ikkawżati mill-marda virali tal bursal (IBD) - sabiex tnaqqas il-mortalità, sinjali kliniċi u leżjonijiet ikkawżati mill-marda virali tal-Marek (MD).
English: Posology:
Maltese: In ovo:
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Maltese: (numru ta` dożi kull kunjett huwa preżentat fuq il-klippa kodifikata bil-kulur imwaħħla ma' kull cane li fiha l-kunjett)
English: Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for in ovo use) contains:
Maltese: 2ml għal użu taħt il-ġilda jew 0.05 ml għall użu fil-bajd) fih:
English: - One 400 ml polyethylene or multilayer plastic bag.
Maltese: KONTENUT BIL-PIŻ, BIL-VOLUM JEW BIN-NUMRU TA` DOŻi 400 ml
English: Ampoules are stored on a cane and attached to the cane is a coloured clip displaying the dose (2,000 doses: salmon-pink coloured clip, and 4,000 doses: yellow coloured clip).
Maltese: Il-kunjetti huma maħżuna fuq cane u mwaħħla mal-cane hemm klippa kkulurita li turi d-doża (2,000 dożi: klippa kulur roża salamun u l-4,000 doża: klippa safranija).
English: Invented name Strength
Maltese: Isem inventat Qawwa
English: Blister (PA/Al/PVC//Al) 336 (3x112) tablets
Maltese: 336 (3x112) pillola
English: Invented name
Maltese: Isem inventat Qawwa
English: Section 4.1 “Therapeutic indications”
Maltese: Sezzjoni 4.1 “Indikazzjonijiet terapewtiċi”
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri u flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stipulati f'Kapitlu 4 ta' Titolu III ta' Direttiva 2001/83/KE.
English: Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Maltese: Terapija ta' sostituzzjoni b'testosterone għal ipogonadiżmu maskili, meta d-defiċjenza ta' testosterone tiġi kkonfermata minn karatteristiċi kliniċi u testijiet bijokimiċi.
English: Section 4.4 “Special Warnings and Precautions for Use”
Maltese: Sezzjoni 4.4 “Twissijiet speċjali u prekawzjonijiet għall-użu”
English: In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Maltese: F'pazjenti li jkunu qed jirċievu terapija b'androġen fit-tul, il-parametri tal-laboratorju li ġejjin ukoll għandhom jiġu mmonitorjati regolarment: emoglobina u ematokrit, testijiet tal-funzjoni tal-fwied u lprofil tal-lipidi.
English: This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: impotence infertility low sex drive tiredness depressive moods bone loss caused by low hormone levels
Maltese: Dan għandu jiġi kkonfermat minn żewġ miżuri separati ta' testosterone fid-demm u għandhom jinkludu wkoll sintomi kliniċi bħal: impotenza infertilità aptit sesswali baxx għeja burdati depressivi telf ta' għadam ikkawżat minn livelli baxxi ta' ormoni
English: Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Maltese: Ittobba għandhom jaġġustaw id-dożaġġ individwalment biex jiżguraw il-manteniment ta' livelli ta' testosterone ewgonadali.
English: Haematocrit increased, Red blood cell count increased, Haemoglobin increased Frequency common.
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa Żieda fl-ematokrit, Żieda fiċ-ċelluli ħomor tad-demm, Żieda fl-emoglobina Frekwenza komuni.
English: There is limited experience on the safety and efficacy of the use of <name of product>in patients over 65 years of age.
Maltese: Hemm esperjenza limitata dwar is-sigurtà u l-effikaċja tal-użu ta' <isem il-prodott> f'pazjenti li għandhom aktar minn 65 sena.
English: Frequency common: Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
Maltese: Frekwenza komuni: Żieda fl-għadd ta' ċelluli ħomor tad-demm, tal-ematokrit (il-perċentwal ta' ċelluli ħomor tad-demm fid-demm) u tal-emoglobina (il-komponent ta' ċelluli ħomor tad-demm li jġorr lossiġnu), identifikata permezz ta' testijiet tad-demm perjodiċi.
English: Testosterone level should be monitored at baseline and at regular intervals during treatment.
Maltese: Il-livell tat-testosterone għandu jiġi mmonitorjat fil-linja bażi u f'intervalli regolari matul il-kura.
English: What <name of product> is and what it is used for <name of product> is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism).
Maltese: X'inhu <isem il-prodott> u għalxiex jintuża <isem il-prodott> jintuża f'irġiel adulti għas-sostituzzjoni tat-testosterone biex jikkura diversi problemi tas-saħħa kkawżati minn nuqqas ta' testosterone (ipogonadiżmu maskili).
English: In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Maltese: F'pazjenti li jbatu minn insuffiċjenza severa tal-qalb, insuffiċjenza tal-fwied jew tal-kliewi jew mard iskemiku tal-qalb, il-kura b'testosterone tista' tikkawża kumplikazzjonijiet severi kkaratterizzati minn edima bi jew mingħajr insuffiċjenza konġestiva tal-qalb.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tas-sommarju tal-karatteristiċi tal prodott u l-fuljetti ta' tagħrif
English: Testosterone may cause a rise in blood pressure and <name of product> should be used with caution in men with hypertension.
Maltese: Testosterone jista' jikkawża żieda fil-pressjoni tad-demm u <isem il-prodott> għandu jintuża b'attenzjoni f'irġiel li jbatu minn pressjoni għolja.
English: Currently, there is no consensus about age specific testosterone reference values.
Maltese: Bħalissa, m'hemm l-ebda qbil dwar il-valuri ta' referenza ta' testosterone speċifiċi għall-età.
English: The relevant authorities of the concerned marketing authorisations are: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
Maltese: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
English: A potential serious risk to public health was raised by the Netherlands.
Maltese: In-Netherlands qajmu riskju serju potenzjali għas-saħħa pubblika.
English: The worksharing procedure SE/H/xxxx/WS/190 started on 20 January 2018.
Maltese: Il-proċedura ta' kondiviżjoni tax-xogħol SE/H/xxxx/WS/190 bdiet fl-20 ta' Jannar 2018.
English: considered established.
Maltese: stabbiliti.
English: Safety data of the new gelling agent Simulgel 600 PHA has been evaluated in 2008 for Epiduo 0.1%, which contains adapalene 0.1% and benzoyl peroxide 2.5%, in a vehicle containing Simulgel 600 PHA.
Maltese: PHA ġiet evalwata fl-2008 għal Epiduo 0.1 %, li fih adapalene 0.1 % u benzoyl peroxide 2.5%, f'veikolu li fih Simulgel 600
English: This variation relates to a change of formulation for Basiron in order to replace the gelling agent Carbomer 940 with Simulgel 600 PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Maltese: PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate u ilma).
English: On 1 December 2017, a Quality type II variation application was submitted by Galderma Nordic AB in line with Article 10(1) of Commission Regulation (EC) No 1234/2008 under the worksharing procedure in accordance with Article 20 of Commission Regulation (EC) No 1234/2008 (SE/H/xxxx/WS/190) for the marketing authorisations for Basiron AC 5% w/w gel and 10% w/w gel to change the formulation by replacing the gelling agent excipient Carbomer 940 with Simulgel 600 PHA (acrylamide sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Maltese: Fil-1 ta' Diċembru 2017, Galderma Nordic AB ressqet applikazzjoni għal varjazzjoni fil-kwalità ta' Tip II minn f'konformità mal-Artikolu 10(1) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008 skont ilproċedura ta' kondiviżjoni tax-xogħol skont l-Artikolu 20 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008 (SE/H/xxxx/WS/190) għall-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Basiron AC 5% w/w ġell u 10% w/w ġell biex tinbidel il-formulazzjoni billi jiġi sostitwit l-eċċipjent ġelifikanti Carbomer 940 b'Simulgel 600
English: The MAH conducted two in-vitro studies which showed that there were differences in the absorbed dose (35% lower absorbed dose) and less significant differences in the penetrated doses.
Maltese: L-MAH wettaq żewġ studji in-vitro li wrew li kien hemm differenzi fid-doża assorbita (doża assorbita 35 % aktar baxxa) u differenzi inqas sinifikanti fid-dożi minfuda.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008;
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 13 tar-Regolament (KE) Nru 1234/2008;
English: As per the Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents (EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
Maltese: Skont in-Nota għal Gwida dwar ir-rekwiżiti kliniċi għal prodotti applikati lokalment, li jaġixxu lokalment u li jkun fihom kostitwenti magħrufa (EMA CPMP/EWP/239/95), fil-prinċipju hija meħtieġa data klinika biex tiġi stabbilita l-ekwivalenza terapewtika bejn żewġ prodotti.
English: • The Committee considered the totality of the data submitted by the MAH in support of the type II quality variation for Basiron AC gels 5% w/w and 10% w/w;
Maltese: • Il-Kumitat ikkunsidra d-data sottomessa kollha mill-MAH b'appoġġ għall-varjazzjoni fil-kwalità tattip II għal Basiron AC ġellijiet 5% w/w u 10% w/w;