FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Maltese: Għandha tingħata attenzjoni meta l-vaċċin jingħata lil persuni b'sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza attiva, għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, għal thiomersal u għar-residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde,
English: Prepandrix consists of two containers:
Maltese: Prepandrix jikkonsisti f'żewġ kontenituri:
English: From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported:
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati minn esperjenza ta' wara t-tqegħid fis-suq b'vaċċini li fihom AS03 li fihom 3.75 µg HA derivati minn A/California/7/2009 (H1N1):
English: The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain.
Maltese: Informazzjoni oħra Instab li r-responsi ta' anti-HA u antikorpi newtraliżżanti għal A/Indonesia/05/2005 misluta minn vaċċin stimulat b'AS03 li fih 3.75μg HA derivati mill-istess razza kienu komparabbli mar-responsi immuni għal A/Vietnam/1194/2004 misluta minn vaċċin stimulat b'AS03 li fih 3.75μg HA derivati mill-istess razza.
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw sa persuna waħda minn kull 10,000
English: Rare: Neuralgia, transient thrombocytopenia.
Maltese: Newralġja, tromboċitopenja li tgħaddi.
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Maltese: Zirkusstraße 40, D-01069 Dresden
English: However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandrix that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Adjupanrix instead of two doses that are required in previously unvaccinated individuals.
Maltese: Madankollu, jekk tkun idikkjarat a uffiċjalment pandemija ta' l-influwenza, persuni mlaqqma qabel b'doża waħda jew tnejn ta' Prepandrix li kien fih l-antiġen HA derivat minn clade differenti ta' l-istess subtip ta' influwenza bħarrazza ta' l-influwenza pandemika jistgħu jirċievu doża waħda ta' Adjupanrix minflok iż-żewġ dożi meħtieġa f'individwi li ma jkunux tlaqqmu qabel.
English: Seroprotection rate1 Booster seroconversion rate2 Booster factor3
Maltese: Rata ta' serokonverżjoni2 Fattur ta‘ serokonverżjoni3
English: • if you have problems with your immune system, since your response to the vaccine may then be poor.
Maltese: • jekk għandek problema bis-sistema immuni, peress li minħabba f'hekk ir-respons tiegħek għalvaċċin jista' jkun batut.
English: Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, inattivat, stimulat)
English: It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Maltese: L-intenzjoni hija li jingħata qabel jew waqt il-pandemija ta' l-influwenza li jmiss biex jilqa' kontra l-influwenza kkawżata mit-tip H5N1 tal-virus.
English: In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
Maltese: F'kull esperiment erba' gruppi ta' 6 inmsa kienu mlaqqma fil-muskolu b'vaċċin stimulat b'AS03 li kien fih HA li tnisslet minn H5N1/A/Vietnam/1194/04
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Maltese: • jekk xi darba kellek reazzjoni allerġika f'daqqa waħda li tkun ta' periklu għal-ħajja għal kwalunkwe ingredjent ta' din it-tilqima (elenkati fis-sezzjoni 6), jew għal xi sustanza oħra li tista' tkun preżenti f'ammonti żgħar ħafna bħal: proteini tal-bajd jew tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
English: However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Maltese: Madankollu, wara li ttieħdet darbtejn doża doppja tal vaċċin, ir-rata ta' seroprotezzjoni f'ġurnata 42 kienet ta' 75%.
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Maltese: 3fattur tal-booster: il-proporzjon tal-medja tat-titru ġeometriku (GMT) wara l-booster u l-GMT qabel il-booster.
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
Maltese: Prepandrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: Your doctor or nurse will give you Prepandrix.
Maltese: It-tabib jew l-infermier tiegħek se jagħtuk Prepandrix.
English: Split influenza virus, inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Maltese: Suspensjoni tal-antiġen għal Prepandrix Razza tixbaħ lil A/Indonesia/05/2005 (H5N1) użata (PR8-IBCDC-RG2) I.M.
English: Talk to your doctor or nurse before you are given Prepandrix:
Maltese: Kellem lit-tabib jew lill-infermier tiegħek qabel tingħata Prepandrix:
English: 21 days after 2nd dose
Maltese: 21 jum wara t-tieni doża
English: Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Maltese: derivati minn A/Vietnam/1194/2004 hija ikkunsidrata rilevanti għall-użu ta' vaċċin stimulat b'AS03 li fih 3.75μg derivati minn A/Indonesia/05/2005.
English: • Feeling dizzy
Maltese: Doża waħda
English: A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Maltese: (i.e. 0.25 ml) tal-adulti (21 jum bogħod minn xulxin) ta' vaċċin pta' preparazzjoni għal pandemikaieħor (H5N1 A/Vietnam/1194/2004 immanifatturat fi Dresden, il-Ġermanja).
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 5,000 subjects 18 years old and above who received Prepandrix containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 µg HA.
Maltese: Studji kliniċi evalwaw l-inċidenza ta' reazzjonijiet avversi f'bejn wieħed u ieħor 5,000 individwu ta' eta' ta' 18-il sena u ‘l fuq li ħadu Prepandrix li fih razza A/Vietnam/1194/2004
English: In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004.
Maltese: Fi studju kliniku, tfal ta' bejn it-3 u d-9 snin irċivew jew żewġ dożi sħaħ tal-adulti (0.5 ml) jew żewġ nofsijiet tad-doża tal-adulti (0.25 ml) ta' tilqima simili li kien fiha A/Vietnam/1194/2004.
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Wara li jitħallat mal-emulsjoni tal-istimulant: 10 dożi ta' 0.5ml
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Maltese: Emulsjoni tal-istimulant għall-injezzjoni 25 kunjett: emulsjoni 2.5 ml
English: Tell the doctor requesting these tests that you have recently received Prepandrix.
Maltese: Għid lit-tabib li qed jordnalek dawn it-testijiet li m'ilekx li ħadt Prepandrix.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Maltese: M'hemm l-ebda data fuq it-teħid ta' tilqim stimulati b'AS03 qabel jew wara tip ta' tilqim ta' l influwenza ieħor intiż għall-użu pre-pandemiku jew pandemiku.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Maltese: It-tilqim għandu jsir b'injezzjoni fil-muskolu preferibbilment fil-muskolu deltojd jew fil-koxxa anterolaterali (skont il-massa ta' muskolu).
English: • Active substance: Split influenza virus, inactivated, containing antigen* equivalent to:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen* ekwivalenti għal
English: The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Maltese: Ir-respons immunoloġiku jista' jonqos jekk il-pazjent ikun qed jingħata xi kura immunosoppressiva.
English: Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Maltese: Anafilassi, reazzjonijiet allerġiċi
English: Blood and lymphatic system disorders Common: lymphadenopathy
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni: limfadenopatija
English: • Diarrhoea, vomiting, stomach pain, feeling sick
Maltese: • Dijarea, rimettar, uġigħ fl-istonku, dardir
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Maltese: Doża waħda ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Indonesia/05/2005 li ingħata wara doża waħda jew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004.
English: In other clinical studies where children 6 months to 17 years received Prepandrix, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Maltese: Fi studji kliniċi oħrajn fejn tfal ta' 6 xhur sa 17-il sena rċevew Prepandrix, dehru żidiet fil-frekwenza ta' xi effetti sekondarji (inkluż uġigħ fis-sit tal-injezzjoni, ħmura u deni) wara t-tieni doża fi tfal li għandhom inqas minn 6 snin.
English: *propagated in eggs **expressed in microgram haemagglutinin
Maltese: *propogat fil-bajd espress bħala mikrogrammi ta' emaglutinina
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Maltese: Indipendentement mill-fatt jekk ingħatatx doża waħda inizjali jew tnejn sitt xhur qabel, ir-rati ta' seroprotezzjoni kontra A/Indonesia kienu ta' >80% wara doża ta' vaċċin stimulat b'AS03 li fih 3.75μg
English: In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21.
Maltese: li fih 3.75μg HA derivat minn A/Indonesia/05/2005 fi ġranet 0 u 21.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Maltese: Dejta minn nisa tqal imlaqqma b'vaċċini differenti tal-istaġun, inattivati, mhux stimulati ma tissuġerix malformazzjonijiet jew tossiċità fil-fetu jew fit-tarbija tat-twelid.
English: In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Maltese: Fi studju kliniku (D-Pan-H5N1-009), tfal ta' bejn it-3 u l-5 snin u s-6 u d-9 snin irċivew żewġ dożi jew ta' doża sħiħa (0.5 ml) jew ta' nofs doża (0.25 ml) ta' tilqima awżiljata b'AS03 li kien fiha 3.75 µg ta'
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Maltese: (2.5ml) jikkorispondi għal 10 dożi ta' vaċċin (5ml).
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Maltese: 2 Żieda ta' 4 darbiet aktar fit-titre tal-antikorp li jinnewtralizza fis-serum 3 % ta' individwi li jilħqu t-titre ta' mill-anqas 1:80 tal-antikorp li jinnewtralizza fis-serum
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: Do not have Prepandrix if any of the above apply to you.
Maltese: Wieħed għandu jkun jaf li reazzjonijiet avversi jistgħu jkunu aktar qawwija.
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titre and 98-100% had a titre of at least 1:80.
Maltese: Wara żewġ dożi li ingħataw 21 ġurnata jew 6 xhur minn xulxin, 96.0% tal-individwi kellhom żjieda ta' 4 darbiet aktar fit-titru ta' antikorp newtraliżżanti fis-serum u 98-100% kellhom titru ta' almenu
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre;
Maltese: 2rata ta' serokonverżjoni tal-booster: il-proporzjon ta' individwi li kienu jew seronegattivi qabel il booster u għandhom titru protettiv wara l-vaċċinazzjoni ta' ≥1:40, jew li kienu seropożittivi qabel il booster u li għandhom żjieda ta' 4 darbiet aktar fit-titru;
English: EXPIRY DATE EXP: MM/YYYY
Maltese: Antikorp li jinnewtralizza fis-serum
English: The reproductive toxicity studies have been conducted using Prepandrix containing A/Vietnam/1194/2004.
Maltese: Saru studji fuq l-effetti tat-tossiċita' fuq ir-riproduzzjoni bi Prepandrix li kien fiha A/Vietnam/1194/2004.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
Maltese: 2 % ta' individwi b'titres ≥1:28 3 % ta' individwi li laħqu titre ta' mill-anqas 1:80 ta' antikorp li jinnewtralizza fis-serum
English: At day 42, the anti-HA antibody responses were as follows:
Maltese: F'ġurnata 42, ir-respons ta' antikorpi anti-HA kienu kif ġej:
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 92.0% and 100%, respectively.
Maltese: seroprotezzjoni u r-rata ta' rispons tal-vaċċin f'individwi li rċevew il-vaċċin 12-il xahar il-bogħod minn xulxin kienu 92.0% u 100%, rispettivament.
English: Immune response to A/Vietnam/1194/2004 6-9 years
Maltese: derivati minn A/Vietnam/1194/2004
English: The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).
Maltese: Barra minn hekk, aktar pazjenti li ngħataw Ganfort kellhom tnaqqis fil-pressjoni ta' aktar minn 20% (67.9% kontra 48.9%).
English: The values were lowered by about 8-10 mmHg.
Maltese: Il-valuri tnaqqsu bi kważi 8-10 mmHg.
English: Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
Maltese: Ganfort huwa soluzzjoni tat-taqtir tal-għajnejn li fiha żewġ sustanzi attivi: bimatoprost (0.3 mg/ml) u timolol (5 mg/ml).
English: Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only.
Maltese: Ganfort naqqas ilpressjoni għal inqas minn 18 mmHg fi 18.7% ta' dawn il-pazjenti meta mqabbel ma' 10.
English: Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma.
Maltese: Saru erba' studji ewlenin li fihom ħadu sehem 1,964 adult b'ipertensjoni okulari jew bi glawkoma.
English: This is a summary of the European public assessment report (EPAR) for Ganfort.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ganfort.
English: Ganfort was more effective than timolol on its own and was as effective as bimatoprost.
Maltese: Ganfort kien aktar effettiv minn timolol waħdu u effettiv daqs bimatoprost.
English: See the package leaflet for the full list of restrictions.
Maltese: Ara l-fuljett ta' tagħrif għal-lista sħiħa ta' restrizzjonijiet.
English: What is Ganfort?
Maltese: X'inhu Ganfort?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ganfort valida fl-Unjoni Ewropea kollha fid-19 ta' Mejju 2006.
English: It is used in adults with ‘open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Maltese: Jintuża f'adulti bi ‘glawkoma b'angolu miftuħ' jew ipertensjoni okulari li ma jirrispondux b'mod suffiċjenti għal taqtir tal-għajnejn li fihom imblokkaturi beta jew analogi prostaglandini (mediċini oħra użati f'dawn il-kundizzjonijiet).
English: How has Ganfort been studied?
Maltese: Kif ġie studjat Ganfort?
English: Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan.
Maltese: Bimatoprost huwa analogu prostaglandin, (kopja tas-sustanza naturali prostaglandin) li jaħdem billi jżid il-ħruġ tal-fluwidu mill-għajn.
English: Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways.
Maltese: Ganfort fih żewġ sustanzi attivi, bimatoprost u timolol, li jnaqqsu l-pressjoni fl-għajn b'modi differenti.
English: Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone.
Maltese: Ganfort kien, madankollu, aktar effettiv minn bimatoprost fil-pazjenti li l-pressjoni tagħhom ma kinitx ikkontrollata permezz ta' qtar tal-għajnejn weħidhom li kien fihom prostaglandini.
English: What is the risk associated with Ganfort?
Maltese: X'inhu r-riskju assoċjat ma' Ganfort?
English: ‘Ocular hypertension' is when the pressure in the eye is higher than normal.
Maltese: ‘Ipertensjoni okulari' hija meta l-pressjoni fl-għajn tkun ogħla min-normal.
English: The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ganfort huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Ganfort been approved?
Maltese: Għaliex ġie approvat Ganfort?
English: By lowering the pressure, Ganfort reduces the risk of damage.
Maltese: Billi jnaqqas il-pressjoni, Ganfort inaqqas ir-riskju ta' ħsara.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Maltese: Il-kombinazzjoni taż-żewġ sustanzi attivi għandha effett addittiv, li tnaqqas il-pressjoni fl-għajn aktar milli waħda mill-mediċini użata weħidha.
English: The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range).
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis medju fil-pressjoni flgħajn jew in-numru ta' pazjenti li l-pressjoni fl-għajn tagħhom waqgħet taħt il-mira ta' 18 mmHg (li jagħmilha fil-firxa normali).
English: Raised pressure in the eye causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Maltese: Il-pressjoni għolja fl-għajn tikkawża ħsara lir-retina (il-membrana sensittiva għad-dawl fuq wara talgħajn) u lin-nerv ottiku li jibgħat is-sinjali mill-għajn lill-moħħ.
English: Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s.
Maltese: B'mod ġenerali, l-istudji wrew li Ganfort huwa effettiv fit-tnaqqis tal-pressjoni fl-għajn.
English: MA (EU) number (Invented) name
Maltese: Isem (ivvintat)
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the results of study CC-5013TOX-004
Maltese: • Il-ħtieġa li tiġi evitata l-espożizzjoni tal-fetu minħabba t-teratoġeniċità ta' lenalidomide flannimali u l-effett teratoġeniku mistenni ta' lenalidomide fil-bnedmin, li jinkludi sommarju tar-riżultati ta' studju CC-5013-TOX-004
English: Educational Brochures for patients
Maltese: Pamflets edukattivi għall-pazjenti
English: • Pregnancy test dates and results
Maltese: • Dati li fihom sar it-test tat-tqala u riżultati
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Maltese: • Qabel ma jagħtu r-riċetta (fejn xieraq, u bi ftehim ma' l-Awtorità Kompetenti Nazzjonali, jagħtu l-mediċina) il-Professjonisti fil-Qasam tas-Saħħa kollha li jkollhom l-intenzjoni li jagħtu riċetta (u jagħtu) Revlimid jiġu pprovduti b'pakkett ta' tagħrif għat-tobba li jkun fih dan li ġej: o Kitt edukattiv tal-Professjonisti fil-Qasam tas-Saħħa o Pamflets edukattivi għall-Pazjenti o Kards tal-pazjent o Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett ta' Tagħrif u Tikketta
English: • That Revlimid may cause neutropenia and thrombocytopenia and the need for regular blood tests
Maltese: • Li Revlimid jista' jikkawża newtropenja u tromboċitopenja u l-ħtieġa għal testijiet regolari tad-demm
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Maltese: • Deskrizzjoni tal-PPP u l-kategorizzazzjoni ta' pazjenti bbażata fuq is-sess u l-potenzjal li jista' jkollhom it-tfal o Algorithm għall-implimentazzjoni tal-PPP o Definizzjoni ta' nisa li jista' jkollhom tfal (WCBP, Women of ChildBearing Potential) u azzjonijiet li t-tabib għandu jieħu jekk ma jkunx ċert
English: • Adverse event reporting forms
Maltese: • Formoli tar-rappurtaġġ għall-avvenimenti avversi