FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding hepatic impairment, the CHMP considered that a strict contraindication is not appropriate for letrozole, which is a potentially life-saving treatment with a relatively benign safety profile.
Maltese: Rigward l-indeboliment tal-fwied, is-CHMP ħass li mhijiex xierqa kontra-indikazzjoni stretta għal letrozole, li huwa potenzjalment kura li tista' ssalva l-ħajja bi profil tas-sigurtà relattivament beninn.
English: Letrozole inhibits the enzyme involved in the synthesis of oestrogens, which are required for proper embryo and foetal development.
Maltese: Letrozole jinibixxi l-enzima involuta fis-sintesi tal-estroġeni, li huma meħtieġa għall-iżvilupp korrett tal-embriju u tal-fetu.
English: For the remaining sections, the CHMP adopted a harmonised wording in line with the nationally approved SmPCs, although minor revisions were made.
Maltese: Għas-sezzjonijiet l-oħra, is-CHMP adotta kitba armonizzata bi qbil mal-SmPCs approvati b'mod nazzjonali, għalkemm saru reviżjonijiet minuri.
English: The CHMP also added a warning that oestrogens and/or tamoxifen may reduce letrozole plasma levels, thus reducing its pharmacological action, and that co-administration should therefore be avoided.
Maltese: Is-CHMP żied ukoll twissija li l-estroġeni u/jew tamoxifen jistgħu jnaqqsu l-livelli ta' letrozole fil-plażma, u b'hekk inaqqsu l-azzjoni farmakoloġika tiegħu, u li l-għoti tagħhom flimkien għalhekk għandu jiġi evitat.
English: The CHMP noted the absence of adequate clinical trials in pregnant women and that isolated cases of birth defects have been reported in pregnant women exposed to Femara, while nonclinical studies have shown that letrozole is embryotoxic and foetotoxic.
Maltese: Is-CHMP innota n-nuqqas ta' provi kliniċi adegwati fuq nisa tqal u li kienu rrappurtati każijiet iżolati ta' difetti tat-twelid f'nisa tqal esposti għal Femara, filwaqt li studji li mhumiex kliniċi wrew li letrozole huwa embrijutossiku u fetutossiku.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Maltese: • il-kamp ta' applikazzjoni tar-riferiment kienet l-armonizzazzjoni tas-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif
English: The CHMP considered the indication to be well-established and that confirmation of postmenopausal endocrine status of women before initiation of treatment is justified for both efficacy and safety reasons, as studies have shown that women with induced menopausal status may not be of postmenopausal endocrine status.
Maltese: Is-CHMP ikkonkluda li hemm tħassib sinifikanti dwar is-sigurtà li jiġġustifika kontra-indikazzjoni fin-nisa ta' qabel il-menopawsa, b'mod speċifiku f'nisa bi status endokrinali ta' qabel il-menopawsa.
English: 4) Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Maltese: 4) Kanċer tas-sider avanzat wara tfaċċar mill-ġdid jew progressjoni tal-marda, bi status endokrinali naturali jew indott b'mod artifiċjali ta' wara l-menopawsa.
English: The CHMP concluded that no specific warnings or dose adjustments recommendations are needed for patients with CrCl  10 ml/min.
Maltese: Is-CHMP ikkonkluda li mhumiex meħtieġa twissijiet speċifiċi jew rakkomandazzjonijiet għal aġġustamenti fid-doża għal pazjenti b'CrCl  10 ml/min.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Femara and associated names (see Annex I).
Maltese: • is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif proposti middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ġew valutati fuq il-bażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat is-CHMP irrakkomanda l-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq li s-sommarju talkaratteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif għalihom huma ppreżentati f'Anness
English: Regarding renal impairment, the CHMP noted that there is very limited information about patients whose creatinine clearance is below 10 ml/min and therefore agreed on a precaution for these patients.
Maltese: Rigward l-indeboliment tal-kliewi, is-CHMP innota li teżisti informazzjoni limitata ħafna dwar pazjenti li t-tneħħija tal-krejatinina tagħhom hija inqas minn 10 ml/min u għalhekk qabel dwar prekawzjoni għal dawn il-pazjenti.
English: The CHMP considered that reviews of clinical databases are poorly suited to assess the risk for interactions or to assess reports of lack of interaction and therefore removed references to these reviews.
Maltese: Is-CHMP ħass li l-valutazzjonijiet tad-databases kliniċi ma tantx huma adatti sabiex jiġi valutat ir-riskju ta' interazzjonijiet jew sabiex jiġu valutati rapporti ta' nuqqas ta' interazzjoni u għalhekk neħħa r-referenzi għal dawn il-valutazzjonijiet.
English: The adverse drug reactions table was structured according to the SmPC guideline and several ADRs were relocated under more appropriate system organ class.
Maltese: ADRs ġew rilokati taħt sistema aktar xierqa ta' klassifika tal-organi.
English: In addition, it is essential to avoid pregnancy during letrozole therapy because of the risk of embryotoxicity and foetotoxicity.
Maltese: Barra minn hekk, huwa essenzjali li tiġi evitata t-tqala matul it-terapija b'letrozole minħabba r-riskju ta' embrijutossiċità u fetutossiċità.
English: 1) Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Maltese: 1) Kura adjuvanti ta' nisa li qabżu l-menopawsa li jkollhom kanċer invażiv bikri tas-sider pożittiv għar-riċetturi tal-ormoni.
English: Regarding male breast cancer, the CHMP noted the absence of clinical trials or specific systematic investigation on the use of Femara in male breast cancer.
Maltese: Rigward il-kanċer tas-sider fl-irġiel, is-CHMP innota n-nuqqas ta' provi kliniċi jew ta' investigazzjoni sistematika speċifika dwar l-użu ta' Femara fil-kanċer tas-sider fl-irġiel.
English: EMA/391542/2013 EMEA/H/C/002201
Maltese: 28 ta' Ġunju 2013 EMA/403463/2013 EMEA/H/C/002201
English: The company that applied for authorisation is Laboratoires SMB s.a.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Laboratoires SMB s.a.
English: Refusal of the marketing authorisation for Labazenit (budesonide / salmeterol)
Maltese: Labazenit (budesonide / salmeterol)
English: What is Labazenit?
Maltese: X'inhu Labazenit?
English: Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Maltese: Labazenit huwa mediċina li fiha s-sustanzi attivi budesonide u salmeterol.
English: Salmeterol is a long-acting beta-2 agonist and it works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Maltese: Salmeterol huwa agonist beta-2 li jaġixxi fit-tul u jaħdem billi jaqbad ma' riċetturi magħrufa bħala riċetturi tal-beta-2 li jinsabu fil-muskoli tal-passaġġi tal-arja.
English: On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Labazenit, intended for the treatment of asthma.
Maltese: Fil-21 ta' Marzu 2013, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem(CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Labazenit, maħsub għall-kura tal-ażżma.
English: How is Labazenit expected to work?
Maltese: Għalxiex kien mistenni li jintuża Labazenit?
English: The company presented results of two main studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and one main study comparing Labazenit with budesonide alone in 375 patients.
Maltese: Il-kumpanija ippreżentat riżultati minn żewġ studji ewlenin li qabblu lil Labazenit ma' salmeterol waħdu f'total ta' 83 pazjent bl-ażżma, u studju ewlieni ieħor li qabbel lil Labazenit ma' budesonide waħdu fi 375 pazjent.
English: The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien ibbażat fuq il-volumi espiratorji furzati (FEV1) tal-pazjenti jew l-ogħla fluss espiratorju (PEF) wara l-kura.
English: Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Maltese: Budesonide huwa kortikosterojd li jaħdem bħala sustanza anti-infjammatorja.
English: Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Maltese: Saru wkoll żewġ studji akbar ta' sostenn li kienu jinvolvu 601 pazjent, li qabblu lil Labazenit ma' kuri oħrajn ta' kombinazzjoni ta' kortikosterojdi u agonisti beta-2.
English: Labazenit was expected to be used in the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required.
Maltese: Labazenit kien mistenni li jintuża fil-kura tal-ażżma fl-adulti li għalihom jeħtieġ prodott ta' kombinazzjoni li fih kortikosterojd inalat u agonista beta-2 li jaġixxi fit-tul.
English: The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Maltese: Il-kumpanija informat lis-CHMP li ma hemm l-ebda prova klinika għaddejja b'Labazenit fl-Ewropa fiżżmien tal-opinjoni tas-CHMP.
English: FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
Maltese: L-FEV1 huwa l-volum massimu ta' arja li persuna tista' tonfoħ ‘il-barra f'sekonda, filwaqt li l-PEF huwa l-veloċità massima li biha persuna tista' toħroġ l-arja mill-pulmuni tagħha.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina l-opinjoni inizjali mill-ġdid, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fis27 ta' Ġunju 2013.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Maltese: X'konsegwenzi għandu dan ir-rifjut għal pazjenti fi programmi kliniċi jew fi programmi ta' użu kompassjonali?
English: The CHMP's main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.
Maltese: L-effetti ta' Labazenit għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Maltese: Għaldaqstant is-CHMP ikkonkluda li l-benefiċċji tal-mediċina ma ntwerewx li huma akbar mir-riskji tagħha u rrakkomanda li ma tingħatax awtorizzazzjoni għat-tqegħid fis-suq.
English: It was to be available as capsules containing powder for inhalation.
Maltese: Kienet disponibbli bħala kapsuli li fihom trab għall-inalazzjoni.
English: North Carolina 27712 U.S.A.
Maltese: North Carolina 27712
English: Medium 199 with Hanks' Salts Minimum Essential Medium, Eagle (MEM) Neomycin
Maltese: Medium 199 b'Hanks' Salts Minimum Essential Medium, Eagle (MEM) Neomycin
English: Interference with laboratory tests: see section 4.5.
Maltese: Interferenza ma' testijiet tal-laboratorju: ara sezzjoni 4.5.
English: Complications associated with varicella
Maltese: Komplikazzjonijiet assoċjati ma' varicella
English: Seroprotection rates [95% CI]
Maltese: [95% CI]
English: Valence (seropro tection level)
Maltese: Valence (livell ta' seropro tezzjoni)
English: • immunocompromised individuals (see section 4.3),
Maltese: Individwi immunokompromessi (ara sezzjoni 4.3)
English: Psychiatric disorders Irritability
Maltese: Disturbi psikjatriċi Irritabilità
English: • If the person to be vaccinated has active untreated tuberculosis.
Maltese: • Jekk il-persuna li se titlaqqam għandha tuberkolożi attiva mhux trattata.
English: 1 dose
Maltese: 2 dożi.
English: ProQuad is available in pack of 1, 10 and 20.
Maltese: ProQuad huwa disponibbli f'pakketti ta' 1, 10 u 20.
English: EU/1/05/323/001 EU/1/05/323/002 EU/1/05/323/003 EU/1/05/323/004 EU/1/05/323/005 EU/1/05/323/006 EU/1/05/323/007 EU/1/05/323/008 EU/1/05/323/009 EU/1/05/323/010 EU/1/05/323/011 EU/1/05/323/012 EU/1/05/323/013
Maltese: EU/1/05/323/005 EU/1/05/323/006 EU/1/05/323/007 EU/1/05/323/008 EU/1/05/323/009 EU/1/05/323/010 EU/1/05/323/011 EU/1/05/323/012 EU/1/05/323/013
English: Cases of herpes zoster in clinical studies
Maltese: Każijiet ta' herpes zoster fi studji kliniċi
English: Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Maltese: Anki f'nisa akbar fl-età (35 sa 45 sena), dawn irreazzjonijiet huma ġeneralment ittollerati sewwa u rarament jinterferixxu ma' attivitajiet normali.
English: Measles (titre ≥255 mIU/mL)
Maltese: Ħosba (titre ≥255 mIU/mL)
English: ProQuad contains sorbitol
Maltese: ProQuad fih sorbitol
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Maltese: Manifattur Responsabbli għall-Ħruġ tal-Lott: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, L-Olanda
English: The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Maltese: Il-persistenza ta' antikorp f'sena waħda wara t-tilqima ġiet evalwata f'subsett ta' 2108 individwi li kienu involuti fi prova klinika.
English: • Rare: skin infection; varicella (chickenpox).
Maltese: • Rari: infezzjoni fil-ġilda; variċella (ġidri r-riħ).
English: Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH) Urea
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH) Urea
English: 2) Produced in human diploid lung (WI-38) fibroblasts.
Maltese: (2) Prodott f'fibroblasti diplojdi tal-pulmun uman (WI-38).
English: The antibody persistence rates 1 year postvaccination in recipients of a single dose of ProQuad were 98.9% (1722/1741) for measles, 96.7% (1676/1733) for mumps, 99.6% (1796/1804) for rubella, and 97.5% (1512/1550) for varicella (≥5 gpELISA Units/ml).
Maltese: Ir-rata ta' persistenza ta' l-antikorpi, sena wara t-tilqima f'riċevituri ta' doża waħda ta' ProQuad kienet 98.9 % (1722/1741) għall-ħosba, 96.7 % (1676/1733) għall-gattone, 99.6 % (1796/1804) għar-rubella, u 97.5 % (1512/1550) għall-ġidri r-riħ (≥ 5 gpELISA Units/ml).
English: *50% cell culture infectious dose ** plaque-forming units
Maltese: * 50% doża infettuża tal-kultura taċ-ċelloli ** unitajiet li jiffurmaw plakek
English: 3) Produced in human diploid cells (MRC-5).
Maltese: (3) Prodott f'ċelloli diplojdi umani (MRC-5).
English: Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Maltese: Tagħtix Immunoglobulin (IG) jew Varicella Zoster Immune Globulin (VZIG) fl-istess ħin ta' ProQuad.
English: ProQuad is available in pack of 1 and pack of 10.
Maltese: ProQuad huwa disponibbli f'pakkett ta' 1 u f'pakkett ta' 10.
English: Extravasation
Maltese: Ekstravażazzjoni
English: 3) Produced in human diploid (MRC-5) cells.
Maltese: (3) Prodott f'ċelluli diplojdi umani (MRC-5).
English: Varicella (titre ≥5 gp ELISA units/mL)
Maltese: Ġidri r-riħ (titre ≥5 gp ELISA unitajiet/mL)
English: Measles virus Enders' Edmonston strain .....................................≥ 3.00 log10 CCID50 Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 CCID50 Rubella virus Wistar RA 27/3 strain............................................≥ 3.00 log10 CCID50 Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU
Maltese: Virus tal-ħosba razza Enders' Edmonston .............................................≥ 3.00 log10 CCID50 Virus tal-gattone razza Jeryl Lynn™ (Livell B) ...................................≥ 4.30 log10 CCID50 Virus tar-rubella razza Wistar RA 27/3 ................................................≥ 3.00 log10 CCID50 Virus tal-ġidri r-riħ razza Oka/Merck ....................................................≥ 3.99 log10
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, HCl, NaOH.
Maltese: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 b'Hanks' Salts, MEM, neomycin, phenol red, HCl, NaOH.
English: Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
Maltese: Persuni li qegħdin taħt terapija immunosuppressiva (inkluż dożi għoljin ta' kortikosterojdi) (ara sezzjoni 4.8).
English: Metabolism and nutrition disorders Anorexia, Decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Anoreksja, Tnaqqis fl-aptit
English: Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Maltese: Data tal-aħħar tiġdid: 16 Diċembru 2015
English: The vaccine contains 16 mg of sorbitol.
Maltese: It-tilqima fiha 16-il mg ta' sorbitol.
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.
Maltese: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 b'Hanks' Salts, MEM, neomycin, phenol red, hydrochloric acid u sodium hydroxide.
English: Active untreated tuberculosis.
Maltese: Tuberkulożi attiva li mhux qed tiġi ttrattata.
English: Postdose 1 Postdose 2
Maltese: INDIVIDWALI doża 1
English: These adverse events include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Erythema multiforme, Herpes simplex, Impetigo, Panniculitis, Purpura, Skin induration, StevensJohnson syndrome, Sunburn
Maltese: Eritema multiforme, Erpete simplex, Impetiġini, Pannikulite, Purpura, Ebusija fil-ġilda, Sindrome ta' Stevens-Johnson, Ħruq bix-xemx
English: Mumps (titre ≥10 ELISA Ab units/mL)
Maltese: (titre ≥10 ELISA Ab unitajiet/mL)
English: Persistence of Immune Response
Maltese: Persistenza tar-Rispons ta' Immunità
English: More than 518 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2007).
Maltese: Aktar minn 518-il miljun doża tal-vaċċin tal-ħosba, gattone, u rubella mmanifatturati minn Merck & Co., Inc. tqassmu madwar id-dinja (1978 sa l-2007).
English: The vaccine may contain traces of recombinant human albumin (rHA).
Maltese: It-tilqima jista' jkun fiha traċċi ta' albumina umana rikombinanti (rHA - recombinant human albumin).
English: The vaccine response rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for varicella (≥5 gpELISA Units/ml).
Maltese: Ir-rati ta' rispons tal-vaċċin kienu 99.4% għall-ħosba, 99.9% għall-gattone, 98.3% għarrubella, u 99.4% għall-ġidri r-riħ (≥ 5 gpELISA Units/ml).
English: Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem P.O.
Maltese: Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem P.O. BOX 581, 2003 PC Haarlem L-Olanda
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Not known (cannot be estimated from the available data)
Maltese: Rari (≥ 1/10,000, < 1/1,000);
English: After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.
Maltese: Madankollu, l-istabbilità waqt l-użu ntweriet għal 30 minuta meta jinħażen bejn 20°C u 25°C.
English: Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Maltese: Uġigħ u tenerezza fil-post ta' l-injezzjoni kienu rrapportati b'rata statistikament inqas f'individwi li ħadu ProQuad.
English: After reconstitution, 1dose (0.5 ml) contains (live, attenuated):
Maltese: Wara r-rikonstituzzjoni, doża 1 (0.5 ml) fiha (ħaj, attenwat):
English: However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Maltese: Madankollu, it-tilqima tista' tkun inqas effettiva milli fuq persuni mhux infettati (ara Tużax ProQuad).
English: Atypical measles, Encephalitis*, Epididymitis, Herpes zoster*, Infection, Measles, Orchitis, Parotitis
Maltese: Meninġite mhux settika*, Ħosba mhux tipika, Enċefalite*, Epididimite, Erpete zoster*, Infezzjoni, Ħosba, Orkite, Parotite.
English: Oedema of the eyelid, Irritation, Optic neuritis, Retinitis, Retrobulbar neuritis
Maltese: Edima fil-kappell tal-għajn, Irritazzjoni, Nevrite ottika, Retinite, Nevrite retrobulbari
English: In the 30-day timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).
Maltese: Fil-perijodu ta' 30 jum wara t-tilqim, ma kienet osservat l-ebda żieda fir-riskju ta' aċċessjonijiet taddeni (ara sezzjoni 5.1).
English: Solvent for ProQuad
Maltese: Tużax ProQuad
English: ProQuad, when reconstituted, is clear pale yellow to light pink liquid.
Maltese: ProQuad, meta rikonstitwit, huwa likwidu safrani ċar għal roża ċar.
English: Bronchial spasm, Bronchitis, Epistaxis, Pneumonitis (see section 4.3), Pneumonia, Pulmonary congestion, Rhinitis, Sinusitis, Sore throat
Maltese: Spażmu fil-bronki, Bronkite, Epistassi, Pnewmonite (ara sezzjoni 4.3), Pnewmonja, Konġestjoni pulmonari, Rinite, Sinożite, Uġigħ fil-griżmejn
English: dpoc_belux@merck.com
Maltese: malta_info@merck.com
English: In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/Merck), the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p<0.001).
Maltese: Fi studju li jqabbel doża 1 (N=1114) sa 2 dożi (N=1102) ta' Varicella Vaccine live (Oka/Merck), leffikaċja stmata tal-vaċċin kontra s-severitajiet kollha tal-marda tal-ġidri r-riħ għall-perjodu t'osservazzjoni ta' 10 snin kienet ta' 94 % għal doża 1 u 98 % għal 2 dożi (p< 0.001).