FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP was of the opinion that in light of the present clinical and PK/PD data, a standard dose of 500 mg every 6 hours or 1g every 8 hours can be accepted, provided that a recommendation is inserted in the SPC stating that for infections suspected or proven to be due to less susceptible organisms (e.g. P. aeruginosa) and for very severe infections (e.g. in neutropenic patients with a fever), the 1000 mg q.i.d should be used.
Maltese: Is-CHMP kien tal-opinjoni li fid-dawl tad-dejta klinika u PK/PD attwali, doża standard ta' 500 mg kull 6 sigħat jew 1g kull 8 sigħat tista' tiġi aċċettata, diment li tiddaħħal rakkomandazzjoni fl-SPC li tiddikjara li għal infezzjonijiet suspettati jew ipprovati li huma dovuti għal organiżmi inqas suxxettibbli (eż. P. aeruginosa) u għal infezzjonijiet severi ħafna (eż. f'pazjenti newtropeniċi b'deni), għandha tintuża 1000 mg q.i.d.
English: The CHMP did not consider this to be an indication and removed this information from section 4.1.
Maltese: Is-CHMP ma qiesx li din hija indikazzjoni u neħħa din l-informazzjoni mis-sezzjoni 4.1.
English: A referral under Article 30 of Directive 2001/83, as amended, was started in May 2009 for Tienam and associated names.
Maltese: F'Mejju 2009, inbeda riferiment skont l-Artikolu 30 tad-Direttiva 2001/83, kif emendata għal Tienam u l-ismijiet assoċjati.
English: With regards to safety, the CHMP considered that the available documentation supports a similar safety profile of imipenem/cilastatin in children compared to adults.
Maltese: Fir-rigward tas-sigurtà, is-CHMP qies li d-dokumentazzjoni disponibbli tappoġġa profil ta' sigurtà simili ta' imipenem/cilastatin fit-tfal meta mqabbel mal-adulti.
English: The CHMP noted the proposed indication “prevention of certain post-operative infections in patients undergoing contaminated or potentially contaminated surgical procedures or where the occurrence of post-operative infection could be especially serious” and the data provided to support the indication, including several published studies evaluating imipenem or imipenem/cilastatin as prophylaxis antibiotic therapy to prevent post-surgical infections as a result of colorectal surgery, appendectomy, and endoscopic sclerotherapy.
Maltese: Is-CHMP innota l-indikazzjoni proposta “prevenzjoni ta' ċerti infezzjonijiet ta' wara operazzjoni f'pazjenti li jkunu għaddejjin minn proċeduri kirurġiċi kkontaminati jew potenzjalment ikkontaminati jew fejn l-okkorrenza ta' infezzjoni wara operazzjoni tista' tkun speċjalment serja” u d-dejta pprovduta biex tappoġġa l-indikazzjoni, inkluż bosta studji ppubblikati li jevalwaw imipenem jew imipenem/cilastatin bħala kura antibijotika profilassi biex timpedixxi infezzjonijiet wara kirurġija bħala riżultat ta' kirurġija kolorettali, appendettomija u skleroterapija endoskopika.
English: “severe pneumonia including hospital and ventilator-associated pneumonia”
Maltese: “pnewmonja severa inkluż pnewmonja assoċjata ma' sptar jew ventilatur”
English: The CHMP considered that the data provided by the MAH included sufficient evidence that imipenem/cilastatin is efficacious in most studies in treating complicated intra-abdominal infections including e.g., intra-abdominal abscesses, peritonitis, complicated appendicitis, gall bladder empyema.
Maltese: Is-CHMP qies li d-dejta pprovduta mill-MAH inkludiet evidenza biżżejjed li imipenem/cilastatin huwa effikaċi fil-biċċa l-kbira tal-istudji dwar il-kura ta' infezzjonijiet intra-addominali kkumplikati inkluż eż. axxeżi intra-addominali, perintonite, appendiċite kkumplikata, empyema tal-bużżieqa tal-marrara.
English: The CHMP observed that no new safety issues or increased ADRs were observed with the use of imipenem/cilastatin doses of ≥ 4 gm/day as compared to doses of <4 gm/day, based on the review of clinical trial data in the original WMA, PMS data and the literature.
Maltese: ADRs miżjudin bl-użu ta' dożi ta' imipenem/cilastatin ta' ≥ 4 gm/kuljum meta mqabbel ma' dożi <4 gm/kuljum, fuq il-bażi tar-reviżjoni tad-dejta tal-provi kliniċi fid-dejta u rriċensjoni tal-WMA, PMS oriġinali.
English: The CHMP adopted a harmonised wording for section 4.4 and in particular, the following statement concerning the limited susceptibility of specific pathogens and the concomitant use of an appropriate anti-MRSA agent or of an aminoglycoside was included:
Maltese: Is-CHMP adotta formulazzjoni armonizzata għas-sezzjoni 4.4 u b'mod partikolari ġiet inkluża d-dikjarazzjoni li ġejja dwar is-suxxettibilità limitata ta' patoġeni speċifiċi u l-użu fl-istess ħin ta' sustanza xierqa kontra l-MRSA jew aminoglycoside:
English: SECTION 6 - PHARMACEUTICAL PARTICULARS
Maltese: SEZZJONI 6 - TAGĦRIF
English: In addition, the recommended solutions were specified as being 0.9% sodium chloride solution and water for injection, while the use of 5% glucose was restricted to exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons.
Maltese: Barra minn hekk, is-soluzzjonijiet rakkomandati ġew speċifikati bħala li huma soluzzjoni ta' 0.9% kloridu tas-sodju u ilma għall-injezzjoni, filwaqt li l-użu ta' 5% glukożju ġie ristrett għal ċirkostanzi eċċezzjonali fejn soluzzjoni ta' 0.9% kloridu tas-sodju ma tistax tintuża għal raġunijiet kliniċi.
English: The CHMP assessed the available data regarding use in children, in particular taking into account 2 large efficacy/safety paediatric studies (Paediatric Study 1 and Paediatric Study 2/3) and the available peer-review medical literature.
Maltese: Is-CHMP ivvaluta d-dejta disponibbli rigward l-użu fit-tfal, b'mod partikolari qies 2 studji pedjatriċi kbar tal-effikaċja/sigurtà (Studju Pedjatriku 1 u Studju Pedjatriku 2/3) u r-riċensjoni medika ta' reviżjoni tal-pari disponibbli.
English: The CHMP noted the proposed indication “genitourinary infections” but stated that imipenem/cilastatin should be used only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to imipenem/cilastatin.
Maltese: Is-CHMP innota l-indikazzjoni proposta “infezzjonijiet ġenitourinarji” iżda ddikjara li imipenem/cilastatin għandu jintuża biss f'infezzjonijiet batterjali severi suspettati jew dovuti għal patoġeni reżistenti għal beta-lactams oħrajn u suxxettibbli għal imipenem/cilastatin.
English: 4.1.7 Skin and soft tissue infections
Maltese: 4.1.7 Infezzjonijiet tal-ġilda u tat-tessut artab
English: 4.1.13 Paediatric use
Maltese: 4.1.13 Użu pedjatriku
English: In conclusion, the CHMP adopted a harmonised wording for section 4.2, including the following dose recommendations:
Maltese: Bħala konklużjoni, is-CHMP adotta formulazzjoni armonizzata għas-sezzjoni 4.2, inkluż ir-rakkomandazzjonijiet li ġejjin għad-dożi:
English: 4.1.12 Non-indication in the treatment of meningitis.
Maltese: 4.1.12 Nuqqas ta' indikazzjoni fil-kura tal-meninġite.
English: For paediatric patients ≥1 year of age, the recommended dose is 15 or 25 mg/kg/dose administered every 6 hours.
Maltese: Għal pazjenti pedjatriċi ≥1 sena, id-doża rakkomandata hija 15 jew 25 mg/kg/doża mogħtija kull 6 sigħat.
English: The CHMP noted the proposed indication “gynaecological infections” but commented that the discussion of the available documentation focused primarily on intra- and post-partum infections.
Maltese: Is-CHMP innota l-indikazzjoni proposta “infezzjonijiet ġinekoloġiċi” iżda kkummenta li d-diskussjoni dwar id-dokumentazzjoni disponibbli iffokat primarjament fuq infezzjonijiet waqt u wara t-twelid.
English: Moreover, the use of imipenem in the management of any type of endocarditis has not been mentioned in the EU endocarditis Guideline, 2004.
Maltese: Barra minn hekk, l-użu ta' imipenem fil-ġestjoni ta' kwalunkwe tip ta' endokardite ma ssemmiex filLinja Gwida tal-endokardite tal-UE, 2004.
English: The CHMP adopted a harmonised wording for these sections.
Maltese: Is-CHMP adotta formulazzjoni armonizzata għal dawn is-sezzjonijiet.
English: In conclusion, the CHMP therefore deleted the indication.
Maltese: Finalment, għaldaqstant, is-CHMP neħħa l-indikazzjoni.
English: In conclusion, the CHMP was of the opinion that this indication was inadequately substantiated, and therefore deleted the indication.
Maltese: Finalment, is-CHMP kien tal-opinjoni li din l-indikazzjoni ma ġietx sostanzjata biżżejjed, u għaldaqstant neħħa l-indikazzjoni.
English: In addition, the term “genitourinary tract infections” was considered outdated.
Maltese: Barra minn hekk, it-terminu “infezzjonijiet tal-passaġġ ġenitourinarju” tqies antikwat.
English: 4.1.2 Lower respiratory tract infections
Maltese: 4.1.2 Infezzjonijiet fin-naħa t'isfel tal-apparat respiratorju
English: The MAH provided a categorised summary of the enrolled patients, according to age groups to provide a basis for a discussion on the need for limiting the use of imipenem/cilastatin to children above 1 year of age for safety reasons.
Maltese: Il-MAH ipprovda sommarju kategorizzat talpazjenti rreġistrati, skont il-gruppi ta' età sabiex jipprovdi bażi għal diskussjoni dwar il-ħtieġa li jiġi limitat l-użu ta' imipenem/cilastatin għal tfal li għandhom iktar minn sena għal raġunijiet ta' sigurtà.
English: The CHMP also noted the additional information in the form of abstracts or brief publications and considered that an indication for complicated intra-abdominal infections was supported.
Maltese: IsCHMP innota wkoll l-informazzjoni addizzjonali fil-forma ta' astratti jew pubblikazzjonijiet qosra u kkunsidra li kienet appoġġata indikazzjoni għal infezzjonijiet intra-addominali kkumplikati.
English: The CHMP considered that the frequency of seizures in the paediatric population < 1 year was unacceptably high and that this risk was confirmed by spontaneous adverse event reports.
Maltese: Is-CHMP qies li l-frekwenza tal-aċċessjonijiet fil-popolazzjoni pedjatrika < 1 sena kienet għolja b'mod mhux aċċettabbli u li dan ir-riskju ġie kkonfermat b'rapporti ta' episodji avversi spontanji.
English: “complicated skin and soft-tissue infections”
Maltese: “infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab”
English: Advice to physicians was provided regarding infections suspected or proven to be due to less susceptible bacterial species (e.g. Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever), recommending treatment with 25 mg/kg every 6 hours.
Maltese: Huwa rrakkomandat li infezzjonijiet suspettati jew ipprovati li huma dovuti għal speċi batterjali inqas suxxettibbli (bħal Pseudomonas aeruginosa) u infezzjonijiet severi ħafna (eż. f'pazjenti newtropeniċi bid-deni) għandhom jiġu kkurati b'25 mg/kg mogħtija kull 6 sigħat.
English: The CHMP noted and assessed the available clinical trial and publication data showing that imipenem/cilastatin is effective and well tolerated in the treatment of “Complicated Skin and soft-tissue infections”.
Maltese: Is-CHMP innota u vvaluta t-tagħrif minn provi kliniċi u minn pubblikazzjoni disponibbli li juri li imipenem/cilastatin huwa effikaċi u ttollerat sew fil-kura ta' “Infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab”.
English: The CHMP noted the MAH proposal for this section and made a number of revisions.
Maltese: Is-CHMP innota l-proposta tal-MAH għal din is-sezzjoni u agħmel għadd ta' reviżjonijiet.
English: There were no useful comparator-controlled clinical trials conducted and published in the peer-review literature from 2000 through 2010 in this indication and the epidemiological studies were of questionable quality and not sufficiently informative, in particular with regards to the used imipenem/cilastatin dosage.
Maltese: Ma kien hemm ebda prova klinika kkontrollata minn komparatur utli li tmexxiet u li ġiet ippubblikata fir-riċensjoni ta' reviżjoni fost il-pari mill-2000 sal-2010 f'din l-indikazzjoni u l-istudji epidemjoloġiċi kienu ta' kwalità kwestjonabbli u mhux informattivi biżżejjed, b'mod partikolari firrigward tad-dożaġġ imipenem/cilastatin użat.
English: The CHMP noted the proposed indication “mixed infections” but was of the opinion that this wording is not in line with the current antimicrobial guidelines and recent European regulatory decisions, which require a site of infection to be specified.
Maltese: Is-CHMP innota l-indikazzjoni proposta “infezzjonijiet imħallta” iżda kien tal-opinjoni li din il-formulazzjoni ma kinitx konformi mal-linji gwida antimikrobjali attwali u maddeċiżjonijiet regolatorji Ewropej reċenti, li jeħtieġu li jiġi speċifikat sit ta' infezzjoni.
English: “Tienam may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.”
Maltese: “Tienam jista' jintuża fil-ġestjoni ta' pazjenti newtropeniċi b'deni li huwa ssuspettat li huwa dovut għal infezzjoni batterjali.”
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 1000 mg administered every 6 hours.
Maltese: Huwa rrakkomandat li infezzjonijiet suspettati jew ipprovati li huma dovuti għal speċi batterjali inqas suxxettibbli (bħal Pseudomonas aeruginosa) u infezzjonijiet severi ħafna (eż. f'pazjenti newtropeniċi bid-deni) għandhom jiġu kkurati b'1000 mg mogħtija kull 6 sigħat.
English: The CHMP considered that imipenem/cilastatin is a broad spectrum antibiotic which should be used in the treatment of severe/life-threatening infections accompanying with microbial resistance and/or when microbial resistance is demonstrated.
Maltese: Is-CHMP qies li imipenem/cilastatin huwa antibijotiku ta' spettru wiesa' li għandu jintuża fil-kura ta' infezzjonijiet severi/ta' theddida għall-ħajja li jkunu akkompanjati b'reżistenza mikrobijali u/jew meta tkun intweriet reżistenza mikrobijali.
English: The presented data were very scarce and imipenem/cilastatin is not considered one of the most effective agents against staphylococci and methicillin-resistant staphylococci are known to be resistant to imipenem/cilastatin.
Maltese: Id-dejta ppreżentata kienet skarsa ħafna u imipenem/cilastatin mhuwiex meqjus bħala wieħed mill-iktar aġenti effikaċi kontra stafilokokki u stafilokokki reżistenti għall-metiċillina huma magħrufin li huma reżistenti għal imipenem/cilastatin.
English: The CHMP noted the proposed indication “endocarditis” but considered that the claimed indication in the treatment of endocarditis was insufficiently substantiated.
Maltese: Is-CHMP innota l-indikazzjoni proposta “endokardite” iżda qies li l-indikazzjoni kklejmjata fil-kura talendokardite ma kinitx issostanzjata biżżejjed.
English: The CHMP also deleted the low doses of 250 mg every 6 hours as mild infections should not be treated with imipenem/cilastatin.
Maltese: Is-CHMP ħassar ukoll id-dożi l-baxxi ta' 250 mg kull 6 sigħat minħabba li infezzjonijiet ħfief ma għandhomx jiġu kkurati b'imipenem/cilastatin.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Maltese: • l-iskop tar-riferiment kien l-armonizzazzjoni tas-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif
English: These infections are mostly caused by Gram-positive bacteria, S. aureus being the most important.
Maltese: Dawn linfezzjonijiet huma kkawżati l-iktar minn batterji Gram-pożittivi, S. aureus li huma l-iktar importanti.
English: The MAH acknowledged that the spectrum of imipenem/cilatstatin does not cover Chlamydia trachomatis, and that there is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with this agent.
Maltese: IlMAH għaraf li l-ispettru ta' imipenem/cilatstatin ma jkoprix Chlamydia trachomatis, u li ma hemmx evidenza biżżejjed li Neisseria gonorrhoeae huwa mira tajba għal terapija b'din is-sustanza.
English: c Nominal significance.
Maltese: c Sinifikanza nominali.
English: Cumulative Incidence (%)
Maltese: Inċidenza Kumulattiva (%)
English: • Allergic reactions including rash
Maltese: • Reazzjonijiet allerġiċi inkluż raxx
English: Placebo 13780 Repatha 13784
Maltese: Plaċebo 13780 Repatha 13784
English: of solution (120 mg/mL).
Maltese: soluzzjoni (120 mg/mL).
English: Type BF Applied Part
Maltese: Parti Applikata Tip BF
English: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A.
Maltese: Inc., One Amgen Center Drive, Thousand Oaks, CA, L-Istati Uniti talAmerika
English: (HMD) (combined atorvastatin groups)
Maltese: (HMD) (gruppi kkombinati ta' atorvastatin)
English: N Injection takes about 9 minutes.
Maltese: L-injezzjoni tieħu madwar 9 minuti.
English: 45 minutes.
Maltese: Stenna 45 minuta.
English: Name and address of the manufacturer of the biological active substance Immunex Rhode Island Corporation 40 Technology Way
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Immunex Rhode Island Corporation 40 Technology Way
English: MedDRA system organ class (SOC)
Maltese: Klassi tas-Sistemi u tal-Organi (SOC - system organ class) MedDRA
English: Altitude range is -300 metres to 3,500 metres (-984 feet to 11,483 feet).
Maltese: Il-firxa ta' altitudni hija ta' -300 metru sa 3,500 metru (-984 pied sa 11,483 pied).
English: ATC code: C10AX13
Maltese: C10AX13
English: GRH0465 v1
Maltese: GRH0527MT v1
English: Key: OLE = open-label extension.
Maltese: OLE = estensjoni open label.
English: 15 Seconds
Maltese: 15-il Sekonda
English: (HMD) (combined rosuvastatin, simvastatin, & atorvastatin groups)
Maltese: (HMD) (gruppi kkombinati ta' rosuvastatin, simvastatin, u atorvastatin)
English: Sterilised using ethylene oxide
Maltese: Sterilizzat permezz ta' ethylene oxide
English: Placebo (N = 13,780) n (%)
Maltese: Plaċebo (N = 13,780) n (%)
English: Placebo Repatha
Maltese: Plaċebo Repatha
English: Relative humidity range is 15% to 85%.
Maltese: Il-firxa ta' umdità relattiva hija 15 % sa 85 %.
English: Evolocumab was estimated to have an effective half-life of 11 to 17 days.
Maltese: Evolocumab ġie stmat li għandu half-life effettiva ta' 11 sa 17-il jum.
English: Hazard Ratio, 0.80 (95% CI, 0.73, 0.88) P<0.0001
Maltese: Proporzjon ta' Periklu, 0.80 (Cl ta' 95%, 0.73, 0.88) P<0.0001
English: Automated mini-doser operating temperature range is 15ºC to 40ºC.
Maltese: Il-firxa ta' temperatura għall-operazzjoni tal-mini-doser awtomatizzat hija 15ºC sa 40ºC.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: A total of 194 severe familial hypercholesterolaemia (non-HoFH) patients and 106 homozygous familial hypercholesterolaemia patients enrolled in TAUSSIG.
Maltese: Total ta' 194 pazjent b'iperkolesterolemija familjali severa (non-HoFH) u 106 pazjenti b'iperkolesterolemija familjali omozigota rreġistraw fi TAUSSIG.
English: Solution for injection (injection) (SureClick).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni) (SureClick).
English: Multipack: 3 (3 packs of 1) cartridges and automated mini-dosers.
Maltese: Pakkett multiplu: 3 (3 pakketti ta' wieħed) skrataċ u mini-dosers awtomatizzati.
English: The absolute bioavailability after SC dosing was determined to be 72% from pharmacokinetic models.
Maltese: Il-bijodisponibilità assoluta wara dożaġġ SC kienet determinata bħala 72 % minn mudelli farmakokinetiċi.
English: Hazard ratioa (95% CI)
Maltese: Proporzjon ta' periklua (CI ta' 95%)
English: Stroke (fatal/non-fatal) d
Maltese: Puplesija (fatali/mhux fatali)d
English: • The automated mini-doser contains batteries, electronics, and a needle.
Maltese: • Il-mini-doser awtomatizzat fih batteriji, elettroniċi, u labra.
English: 3.5 ml
Maltese: INDIVIDWALI 3.5 mL
English: Automated mini-doser
Maltese: Mini-doser awtomatizzat
English: Treatment in the absence of a statin
Maltese: Trattament fl-assenza ta' statin
English: Repatha (N = 13,784) n (%)
Maltese: Repatha (N = 13,784)
English: The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni matul il-provi pivitali, bid-dożi rakkomandati, kienu nażofarinġite (7.4%), infezzjoni fl-apparat respiratorju ta' fuq (4.6%), uġigħ fid-dahar (4.4%), artralġja (3.9%), influwenza (3.2%), u reazzjonijiet fis-sit tal-injezzjoni (2.2%).
English: (treatment in the absence of a statin)
Maltese: (trattament flassenza ta' statin)
English: Battery strip
Maltese: Strippa tal-batterija
English: A total of 3,681 patients enrolled in OSLER-2.
Maltese: Total ta' 3,681 pazjent irreġistraw f'OSLER-2.
English: LIST OF EXCIPIENTS Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Maltese: TA' EĊĊIPJENTI Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, ilma għall-injezzjonijiet.
English: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Maltese: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, L-Olanda
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 July 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Lulju 2015
English: OLE Week 216
Maltese: Ġimgħa 216 ta' OLE
English: Repatha reduced both percent atheroma volume (PAV; 1.01% [95% CI 0.64, 1.38], p < 0.0001) and total atheroma volume (TAV; 4.89 mm3 [95% CI 2.53, 7.25], p < 0.0001) compared with placebo.
Maltese: Repatha naqqas kemm il-volum perċentwali talateroma (PAV - percent atheroma volume; 1.01% [CI ta' 95% 0.64, 1.38], p < 0.0001) kif ukoll ilvolum totali tal-ateroma (TAV - total atheroma volume; 4.89 mm3 [CI ta' 95% 2.53, 7.25], p < 0.0001) meta mqabbel ma' plaċebo.
English: Repatha contains sodium
Maltese: Repatha fih sodium
English: INFORMATION IN BRAILLE Repatha 420 cartridge
Maltese: INFORMAZZJONI BIL-BRAILLE Repatha 420 skartoċċ
English: In the integrated clinical safety analysis set, the subject incidence of adverse events potentially associated with hypersensitivity was 4.45% in any evolocumab group and 3.95% in subjects in any control group; the relative risk ratio was 1.13 (95% CI: 1.02, 1.25).
Maltese: Fis-sett tal-analiżi tas-sigurtà klinika integrata, l-inċidenza tal-individwi ta' avvenimenti avversi potenzjalment assoċjati ma' sensittività eċċessiva kienet ta' 4.45 % fil-grupp ta' kwalunkwe evolocumab u 3.95 % f'individwi fil-grupp ta' kwalunkwe kontroll; il-proporzjon tar-riskju relattiv kien 1.13 (Cl ta' 95 %: 1.02, 1.25).
English: INFORMATION IN BRAILLE Repatha 140 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Repatha 140 pinna
English: Do not leave the orange cap off for more than 5 minutes.
Maltese: Tħallix il-pinna mingħajr lgħatu oranġjo għal aktar minn 5 minuti.
English: OLE Week 144
Maltese: Ġimgħa 144 ta' OLE
English: Of the 18,546 patients treated with Repatha in double-blind clinical studies 7,656 (41.3%) were ≥ 65 years old, while 1,500 (8.1%) were ≥ 75 years old.
Maltese: Minn 18,546 pazjent ittrattati b'Repatha fi studji kliniċi double-blind 7,656 (41.3%) kellhom ≥ 65 sena, filwaqt li 1,500 (8.1%) kellhom ≥ 75 sena.
English: b p value < 0.001 when compared with placebo.
Maltese: b valur p < 0.001 meta mqabbel mal-plaċebo.
English: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Maltese: Hemm esperjenza limitata b'Repatha f'pazjenti b'indeboliment sever tal-kliewi (definiti bħal eGFR < 30 mL/min/1.73 m2) (ara sezzjoni 5.2).
English: • Plaster.
Maltese: • Stikka.
English: There were 97 cases of systemic hypersensitivity reactions retrieved from the MAH's safety database.
Maltese: Kien hemm 97 każ ta' reazzjonijiet sistemiċi ta' sensittività eċċessiva miksuba mid-database dwar issigurtà tal-MAH.
English: It contains electronics that should not get wet.
Maltese: Fih elettroniċi li ma jistgħux jixxarbu.
English: OLE Week 48
Maltese: Ġimgħa 48 ta' OLE
English: Solution for injection (injection) (automated mini-doser).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni) (mini-doser awtomatizzat).