FrancophonIA/ELRC3.0 huggingface dataset:
English: Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 1.33 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 1.33 ml
English: ProMeris Duo Spot-on for Medium Sized Dogs(5.1 - 10.0 kg)*
Maltese: għall-klieb ta' daqs medju (5.1 - 10.
English: If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/kg bodyweight by intramuscular injection to reverse these side-effects.
Maltese: Jekk is-sintomi huma severi jew jippersistu jista' jintuża l-antagonist tar-riċettur alpha-2-adreno, atipamezole hydrochloride f'doża ta' 0.2 mg/kg piż tal-ġisem permeżż ta' injezzjoni ġol-muskoli biex ireġġa' lura dawn l-effetti mhux mixtieqa.
English: Do not administer to puppies under 8 weeks of age.
Maltese: Tużax fi ġriewi taħt l-età ta' 8 ġimgħat.
English: Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
Maltese: Kaxxa b'pakkett f'folja ta' 3 x pipetti ta' 3.33 ml Kaxxa b'2 pakketti f'folja ta' 3 x pipetti ta' 3.33 ml
English: ProMeris Duo Spot-on for Large Dogs (25.1 - 40.0 kg)*
Maltese: għall-klieb kbar (25.1 - 40.0 kg) * għall-klieb kbar ħafna (40.1 - 50.0 kg) *
English: Dogs over 8 weeks of age
Maltese: Tagħtix lill-ġriewi taħt l-età ta' 8 ġimgħat.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.67 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 0.67 ml tagħti:
English: The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes over packed in an aluminium foil package.
Maltese: Il-prodott mediċinali veterinarju jiġi ppakkjat f'dożi individwali f'pipetti tal-plastik trasparenti li huma ippakkjati mill-ġdid f'pakkett tal-fojl ta' l-aluminju.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.33 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 1.33 ml tagħti:
English: 10 DATE OF REVISION OF THE TEXT
Maltese: 6.1 Lista ta' ingredjenti
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo XL
Maltese: Il-prodott mediċinali veterinarju jibqa' effettiv jekk l-annimal jixxarrab.
English: In rare cases, transient irritation may occur at the site of product application.
Maltese: F'każijiet rari, tista' sseħħ irritazzjoni temporanja fis-sit ta' l-applikazzjoni tal-prodott.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 5.33 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 5.33 ml tagħti:
English: Maximum concentrations in the hair were generally reached between 2 to 7 days post treatment and gradually declined through 56 days post treatment.
Maltese: Konċentrazzjonijiet massimi fil-pil intlaħqu ġeneralment f'jumejn sa sebat ijiem wara l-kura u naqsu b'mod gradwali tul 56 ġurnata wara l-kura.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 3.33 ml pipette delivers:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta ta' 3.33 ml tagħti:
English: 5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo for Large Dogs 40.1 - 50.0 ProMeris Duo for Extra Large Dogs
Maltese: ProMeris Duo għall-Klieb Kbar 40.1 - 50.0
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/003 - 1 blister card of 3 pipettes of 1.33ml EU/2/06/065/004 - 2 blister cards of 3 pipettes of 1.33ml
Maltese: EU/2/06/065/004 - Żewġ pakketti f'folja ta' 3 pipetti ta' 1.33 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card - Carton box for 2 blister cards
Maltese: Kaxxa tal-kartun b'pakket f'folja - Kaxxa tal-kartun b'2 pakketti f'folja
English: For optimal control of flea and/or tick infestation the product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.
Maltese: Għall-kontroll ottimali ta' infestazzjoni tal-briegħed u/jew qurdien il-prodott għandu jingħata f'intervalli ta' xahar matul l-istaġun tal-briegħed u/jew qurdien, jew il-programm ta' kura jista' jiġi bbażat fuq is-sitwazzjoni epidemjoloġika lokali.
English: Each unit dose (pipette) of ProMeris Duo delivers:
Maltese: U INGREDJENT(I) OĦRA Sustanzi Attivi :
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/007 - 1 blister card of 3 pipettes of 5.33 ml EU/2/06/065/008 - 2 blister cards of 3 pipettes of 5.33 ml
Maltese: EU/2/06/065/008 - Żewġ pakketti f'folja ta' 3 pipetti ta' 5.33 ml
English: For optimal control of flea and/or tick infestation the veterinary medicinal product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.
Maltese: Il-prodott mediċinali veterinarju jipprevjeni l-infestazzjoni mill-briegħed sa 6 ġimgħat u linfestazzjoni tal-qurdien għal 4 ġimgħat wara amministrazzjoni waħda.
English: ADVERSE REACTION*
Maltese: MANIFATTUR RESPONSABBLI
English: Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the skin and hair.
Maltese: attività kontra kemm il-briegħed kif ukoll il-qurdien, rispettivament, minħabba espożizzjoni mhux sistemika tal-parassiti fuq il-ġilda u l-pil.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 5.33ml
Maltese: FOLJA 5.33 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001 - 1 blister card of 3 pipettes of 0.67ml EU/2/06/065/002 - 2 blister cards of 3 pipettes of 0.67ml
Maltese: EU/2/06/065/002 - Żewġ pakketti f'folja ta' 3 pipetti ta' 0.67 ml
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 3.33ml
Maltese: FOLJA 3.33 ml
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
Maltese: L-applikazzjoni tal-prodott mediċinali veterinarju tista' tipproduċi dehra temporanjament żejtnija u tagħqid jew ippuntar tax-xahar fil-post ta' applikazzjoni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.33ml
Maltese: FOLJA 1.33 ml
English: This overview was last updated in 10-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi 10-2019.
English: Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Maltese: ema.europa.eu/medicines/human/EPAR/ozurdex.
English: Other information about Ozurdex
Maltese: Informazzjoni oħra dwar Ozurdex
English: Each implant is in an applicator and contains 700 micrograms of the active substance, dexamethasone.
Maltese: Kull impjant jinsab f'applikatur u fih 700 mikrogramma tas-sustanza attiva, id-deżametason.
English: In one main study involving 229 adults with uveitis, 8 weeks after injection, around 47% of patients treated with 700 micrograms of Ozurdex achieved a vitreous haze score of zero, compared with 36% of patients treated with 350 micrograms of Ozurdex and 12% of patients who received the sham treatment.
Maltese: Fi studju ewlieni wieħed li fih ħadu sehem 229 adult b'uveite, 8 ġimgħat wara l-injezzjoni, madwar 47 % tal-pazjenti li kienu ngħataw kura b'700 mikrogramma ta' Ozurdex kisbu punteġġ ta' ċpar vitruż ta' żero, meta mqabbel ma' 36 % talpazjenti li kienu ngħataw kura bi 350 mikrogramma ta' Ozurdex u 12 % tal-pazjenti li ngħataw il-kura finta.
English: Two main studies involving 1,048 patients compared the effects of a 700 microgram or a 350 microgram implant of Ozurdex.
Maltese: Żewġ studji ewlenin li fihom ħadu sehem 1,048 pazjent qabblu l-effetti ta' impjant ta' Ozurdex ta' 700 mikrogramma jew ta' 350 mikrogramma.
English: The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Maltese: L-effetti sekondarji l-aktar komuni b'Ozurdex (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma żieda fil-pressjoni intraokulari (il-pressjoni ġewwa l-għajn), emorraġija konġuntivali (fsada millmembrana fuq l-abjad tal-għajn) u katarretti (tiċpir tal-lenti - f'pazjenti b'uveite u bid-dijabete).
English: Eyesight was measured using the ‘best corrected visual acuity' (BCVA) indicating how well a person can see (after they have been given corrective lenses).
Maltese: Il-vista tkejlet bl-użu tal-"aktar akutezza viżiva kkoreġuta" (BCVA, best corrected visual acuity) li tindika kemm persuna tkun tista' tara sew (wara li tkun ingħatat lentijiet korrettivi).
English: What are the risks associated with Ozurdex?
Maltese: X'inhuma r-riskji assoċjati ma' Ozurdex?
English: Macular oedema related to diabetes
Maltese: Edema makulari relatata mad-dijabete
English: In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
Maltese: F'żewġ studji ewlenin li fihom ħadu sehem total ta' 1,267 adult, Ozurdex kien aktar effettiv mill-kura finta fit-titjib tal-vista tal-pazjenti.
English: In the overall group of patients with macular oedema related to diabetes the Agency noted that the benefit was modest and was outweighed by the risks, including the development of cataracts.
Maltese: Fil-grupp globali ta' pazjenti b'edema makulari relatata mad-dijabete, l-Aġenzija nnotat li l-benefiċċju kien modest u kien inqas mir-riskji, inkluż l-iżvilupp ta' katarretti.
English: In patients whose lens had already been surgically replaced, there was an average improvement in BCVA over both studies of 6.5 letters after Ozurdex 700 micrograms, compared with 1.7 letters after sham treatment.
Maltese: F'pazjenti li diġà kellhom il-lenti sostitwita kirurġikament, fiż-żewġ studji kien hemm titjib medju fil-BCVA ta' 6.5 ittri wara Ozurdex 700 mikrogramma, meta mqabbel ma' 1.7 ittri wara kura finta.
English: As for all medicines, data on the use of Ozurdex are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ozurdex hija ssorveljata kontinwament.
English: In the second study, the figures were around 22% for Ozurdex after 90 days and 12% for the sham treatment.
Maltese: Fit-tieni studju, iċ-ċifri kienu ta' madwar 22 % għal Ozurdex wara 90 jum u ta' 12 % għall-kura finta.
English: The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Maltese: Is-sustanza attiva f'Ozurdex, id-deżametason, tagħmel parti minn grupp ta' mediċini magħrufa bħala kortikosterojdi.
English: In patients in whom other types of treatment had not worked or were unsuitable, there was an average improvement in BCVA over both studies of 3.2 letters after Ozurdex 700 micrograms, compared with 1.5 letters after sham treatment.
Maltese: F'pazjenti li fihom tipi oħra ta' kura ma ħadmux jew ma kinux adegwati, fiżżewġ studji kien hemm titjib medju fil-BCVA ta' 3.2 ittri wara Ozurdex 700 mikrogramma, meta mqabbel ma' 1.5 ittri wara kura finta.
English: In the first study, around 23% of the patients receiving Ozurdex had increased BCVA of at least 15 letters after 180 days compared with 17% of the patients receiving the sham treatment.
Maltese: Fl-ewwel studju, madwar 23 % tal-pazjenti li kienu qed jirċievu Ozurdex kellhom żieda filBCVA ta' mill-inqas 15-il ittra wara 180 jum meta mqabbla ma' 17 % tal-pazjenti li kienu qed jingħataw il-kura finta.
English: It is used to treat adults with impaired vision due to macular oedema associated with:
Maltese: Jintuża għall-kura ta' adulti b'vista indebolita minħabba edema makulari assoċjata ma':
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation.
Maltese: Din taħdem billi tidħol fiċ-ċelloli u timblokka l-produzzjoni tal-fattur tat-tkabbir endoteljali vaskulari (VEGF) u tal-prostaglandini, sustanzi li huma involuti fl-infjammazzjoni.
English: Ozurdex can only be obtained with a prescription and must be given by an ophthalmologist (eye specialist) who has experience in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Maltese: Ozurdex jista' jinkiseb biss b'riċetta ta' tabib u għandu jingħata minn oftalmologu (speċjalista talgħajnejn) b'esperjenza fl-għoti ta' injezzjonijiet intravitreali (injezzjonijiet fil-fluwidu vitruż, il-fluwidu li jixbaħ il-ġeli fl-għajn).
English: For the full list of restrictions with Ozurdex, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Ozurdex, ara l-fuljett ta' tagħrif.
English: For the full list of side effects of Ozurdex, see the package leaflet.
Maltese: Għallista sħiħa tal-effetti sekondarji rrappurtati b'Ozurdex, ara l-fuljett ta' tagħrif.
English: Ozurdex (dexamethasone)
Maltese: Kif jintuża Ozurdex?
English: Why is Ozurdex authorised in the EU?
Maltese: Għaliex Ozurdex ġie awtorizzat fl-UE?
English: Because dexamethasone is a well-known anti-inflammatory medicine, the company presented studies from the published literature where Ozurdex was compared with a ‘sham' treatment (where an applicator was pressed against their eye but nothing was actually injected).
Maltese: Minħabba li d-deżametason hija mediċina anti-infjammatorja magħrufa sew, il-kumpanija ppreżentat studji minn letteratura ppubblikata fejn Ozurdex tqabbel ma' kura "finta" (fejn applikatur ġie ppressat mal-għajn iżda fil-fatt xejn ma ġie injettat).
English: Ozurdex implants are injected directly into the vitreous humour of the eye.
Maltese: L-impjanti ta' Ozurdex jiġu injettati direttament fil-fluwidu vitruż tal-għajn.
English: Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.
Maltese: Ozurdex jintuża wkoll għall-kura ta' adulti b'uveite mhux infettiva fil-parti ta' wara tal-għajn.
English: Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Maltese: Il-pazjenti ġew segwiti għal 3 snin u setgħu jingħataw kura ripetuta jekk tqies xieraq.
English: The European Medicines Agency decided that Ozurdex's benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and it can be authorised for use in the EU.
Maltese: Ħarsa ġenerali lejn Ozurdex u għalfejn huwa awtorizzat fl-UE
English: Ozurdex was more effective than sham treatment at reducing inflammation in patients with uveitis measured by an improvement in patients' vitreous haze score which gives an indication of inflammation, with zero indicating no inflammation.
Maltese: Ozurdex ma għandux jintuża fuq pazjenti li għandhom jew li huma maħsuba li għandhom infezzjonijiet okulari jew periokulari (infezzjonijiet ġewwa jew madwar l-għajnejn) u fuq pazjenti bi glawkoma avvanzata (ħsara fin-nerv tal-għajn ġeneralment ikkawżata minn pressjoni kbira fl-għajn) li ma tkunx ikkontrollata b'mod adegwat bil-mediċini biss.
English: Clopidogrel BMS 75 mg
Maltese: Mnejn jingħata Il-pakkett
English: p-value <0.001.
Maltese: ¶valur p <0.001.
English: HR=High Risk.
Maltese: HR=Riskju Għoli (High Risk).
English: Papanicolaou test.
Maltese: #Test Papanicolaou.
English: 2031 BN, Haarlem
Maltese: 2031 BN, Haarlem L-Olanda
English: Gardasil 9 N=7099
Maltese: N=7099
English: Evidence of anamnestic (Immune Memory) response
Maltese: Evidenza ta' rispons anamnestiku (Memorja Immuni)
English: Human Papillomavirus = HPV.
Maltese: 1Papillomavirus Uman = HPV.
English: (n)
Maltese: N (n)
English: Polysorbate 80 Borax
Maltese: Polysorbate 80
English: CI=Confidence Interval.
Maltese: CI=Intervall ta' Fiduċja (Confidence Interval).
English: 1 dose (0.5 ml)
Maltese: Doża 1 (0.5 ml)
English: ASC-US=Atypical squamous cells of undetermined significance.
Maltese: ASC-US=Ċelluli skwamużi atipiċi ta' sinifikanza mhux determinata (Atypical squamous cells of undetermined significance).
English: %Efficacy** (95% CI)
Maltese: Effikaċja** (CI ta' 95%)
English: cLIA= Competitive Luminex Immunoassay.
Maltese: Analiżi Immunoloġika Kompettitiva b'Luminex (Competitive Luminex Immunoassay).
English: mMU=milli-Merck units.
Maltese: §mMU=milliunitajiet ta' Merck.
English: Gardasil 9 injection IM
Maltese: Gardasil 9 injezzjoni IM
English: A. Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurtà
English: *Adverse reactions included in this table are from 7 clinical trials (PN 001, 002, 003, 005, 006, 007 and 009, N=15,776 individuals) (see section 5.1 for description of the clinical trials).
Maltese: *Ir-reazzjonijiet avversi inklużi f'din it-tabella huma minn 7 provi kliniċi (PN 001, 002, 003, 005, 006, 007 u 009, N=15,776 individwu) (ara sezzjoni 5.1 għal deskrizzjoni tal-provi kliniċi).
English: See sections 4.4 and 5.1 for important information on the data that support these indications.
Maltese: Ara sezzjonijiet 4.4 u 5.1 għal informazzjoni importanti dwar id-dejta li ssostni dawn l indikazzjonijiet.
English: 60 µg HPV Type 31, 33, 45, 52 and 58 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.5 mg Al).
Maltese: 60 µg Proteina L1 ta' HPV tat-Tipi 31, 33, 45, 52 u 58 20 µg adsorbit fuq aluminium hydroxyphosphate sulfate amorfu (0.5 mg Al).
English: Paediatric population (children <9 years of age)
Maltese: Popolazzjoni pedjatrika (tfal b'età <9 snin)
English: Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Maltese: Sodium chloride, histidine, polysorbate 80, borax, ilma għall-injezzjonijiet.
English: GMT=Geometric Mean Titres.
Maltese: GMT= Titres Medji Ġeometriċi (Geometric Mean Titres). cLIA=
English: GMT (95% CI) mMU
Maltese: (CI ta' 95%) mMU§/mL
English: Gardasil 9 contains sodium chloride
Maltese: Gardasil 9 fih sodium chloride
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM03
Maltese: Vaċċini, Vaċċini għal Papillomavirus, Kodiċi ATC: J07BM03 Mekkaniżmu ta' azzjoni
English: qHPV Vaccine N=7105
Maltese: N=7105
English: 2778 South East Side Highway
Maltese: Stonewall Plant 2778 South East Side Highway Elkton, Virginia, 22827,
English: Clinical studies for Gardasil 9
Maltese: Studji kliniċi għal Gardasil 9
English: In the long-term extensions of clinical studies Protocols 001 and 002, effectiveness was observed in the PPE population.
Maltese: Fl-estensjonijiet fit-tul tal-istudji kliniċi tal-Protokolli 001 u 002, l-effikaċja ġiet osservata filpopolazzjoni PPE.
English: Gardasil 9/ qHPV Vaccine
Maltese: Gardasil 9/ Vaċċin qHPV
English: GMT Ratio
Maltese: TAGĦRIF
English: No data are available (see section 5.1).
Maltese: Dejta mhux disponibbli (ara sezzjoni 5.1).
English: Stability data indicate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 25°C or from 0°C to 2°C.
Maltese: Dejta dwar stabbilità tindika li l-komponenti tal-vaċċin huma stabbli għal 72 siegħa meta jinħażen f'temperaturi minn 8°C sa 25°C jew minn 0°C sa 2°C.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, i.e., huwa essenzjalment “ħieles mis-sodium”.
English: Administer the entire dose as per standard protocol.
Maltese: Agħti d doża kollha skont il-protokoll standard.
English: Hormonal contraceptives (for example the pill) did not reduce the protection obtained by Gardasil 9.
Maltese: Kontraċettivi tal-ormoni (per eżempju l-pillola kontraċettiva) ma jnaqqsux il-protezzjoni miksuba b'Gardasil 9.
English: During the clinical development of Gardasil 9; 2,586 women (1,347 in the Gardasil 9 group vs. 1,239 in the qHPV vaccine group) reported at least one pregnancy.
Maltese: Matul l-iżvilupp kliniku ta' Gardasil 9; 2,586 mara (1,347 fil-grupp ta' Gardasil 9 vs. 1,239 fil-grupp tal-vaċċin qHPV) irrappurtaw mill-inqas tqala waħda.
English: L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Maltese: 2 Proteina L1 f'għamla ta' partiċelli qishom virus magħmula f'ċelluli tal-ħmira (Saccharomyces cerevisiae CANADE 3C-5 (Razza 1895)) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Gardasil 9 is available in a pack of 1.
Maltese: Gardasil 9 huwa disponibbli f'pakkett ta' 1.
English: In long-term follow-up extension of clinical studies Protocols 001 and 002, persistence of antibody responses was observed:
Maltese: Fl-estensjoni b'segwitu fit-tul tal-istudji kliniċi ta' Protokolli 001 u 002, ġiet osservata persistenza tarrisponsi tal-antikorp:
English: Efficacy against HPV types 6, 11, 16, and 18 was primarily assessed using a bridging strategy that demonstrated comparable immunogenicity (as measured by Geometric Mean Titres [GMT]) of Gardasil 9 compared with qHPV vaccine (Protocol 001, GDS01C/Protocol 009 and GDS07C/Protocol
Maltese: L-effikaċja kontra t-tipi 6, 11, 16, u 18 ta' HPV ġiet stmata primarjament bl-użu tal-istrateġija bridging li uriet immunoġeniċità komparabbli (kif imkejla permezz tat-Titres Medji Ġeometriċi [GMT - Geometric Mean Titres]) ta' Gardasil 9 imqabbla mal-vaċċin qHPV (Protokoll 001, GDS01C/Protokoll 009 u GDS07C/Protokoll 020).
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports 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: Sussegwentement, 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
English: Date of first authorisation: 10 June 2015 Date of latest renewal: {DD month YYYY}
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10 ta' Ġunju 2015
English: Name and address of the manufacturer(s) of the biological active substance(s) Merck Sharp & Dohme Corp.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) Merck Sharp & Dohme Corp.
English: Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Maltese: Tel: 8007 4433 (+356 99917558)
English: In a post hoc analysis for HPV 6 and 11, the GMT ratios were 0.76 and 0.81 respectively.
Maltese: HPV 6 u 11, il-proporzjonijiet ta' GMT kienu 0.76 u 0.81 rispettivament.
English: Slovenská republika Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com
English: In 16- through 26- year-old women (N=20,541) efficacy against HPV 16- and 18-related CIN2/3, AIS or cervical cancer was 98.2% (95% CI: 93.5, 99.8) based on follow-up to 4 years (median 3.6 years); efficacy against HPV 6, 11, 16 or 18-related diseases was 96.0% (95% CI: 92.3, 98.2) for CIN or AIS, 100% (95% CI: 67.2, 100) for VIN2/3, 100% (95% CI: 55.4, 100) for VaIN2/3, and 99.0% (95% CI: 96.2, 99.9) for genital warts.
Maltese: F'nisa b'età minn 16 sa 26 sena (N=20,541) l-effikaċja kontra CIN2/3, AIS jew kanċer tal-għonq tal utru marbuta ma' HPV 16 u 18 kienet ta' 98.2% (CI ta' 95%: 93.5, 99.8) abbażi ta' segwitu sa 4 snin (medjan 3.6 snin); l-effikaċja kontra mard marbut ma' HPV 6, 11, 16 jew 18 kienet ta' 96.0% (CI ta' 95%: 92.3, 98.2) għal CIN jew AIS, 100% (CI ta' 95%: 67.2, 100) għal VIN2/3, 100% (CI ta' 95%: 55.4, 100) għal VaIN2/3, u 99.0% (CI ta' 95%: 96.2, 99.9) għal felul ġenitali.
English: • Genital warts (Condyloma acuminata) caused by specific HPV types.
Maltese: • Felul ġenitali (Condyloma acuminata) ikkawżati minn tipi speċifiċi ta' HPV.
English: HPV types.
Maltese: HPV.