FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Hirobriz Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Hirobriz Breezhaler f'kull sett tal-popolazzjoni pedjatrika bil-marda pulmonari ostruttiva kronika (COPD) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The following pack sizes are available:
Maltese: Dawn huma l-qisien tal-paketti disponibbli:
English: Only use the capsules with the inhaler provided in this pack (Hirobriz Breezhaler inhaler).
Maltese: Uża dawn il-kapsuli mal-inhaler li hawn f'dan il-pakkett biss (l-inhaler Hirobriz Breezhaler).
English: Other medicines and Hirobriz Breezhaler
Maltese: Għalxiex jintuża Hirobriz Breezhaler
English: Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Maltese: Hirobriz Breezhaler 300 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Children and adolescents Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years.
Maltese: Tfal u adolexxenti Hirobriz Breezhaler m'għandux jingħata lil tfal jew lil adoloxxenti ta' taħt it-18-il sena.
English: Intravitreal implant in applicator Intravitreal use pouch (foil) 1 pouch with applicator system
Maltese: 700 mikrogramma Impjant intravitreali f'applikatur
English: E. Coli and C. perfringens vaccine
Maltese: Coli u C. perfringens
English: It contains parts of the Escherichia coli (E. coli) bacterium called fimbrial adhesins F4ab, F4ac, F5 and F6 and LT toxoid (weakened toxin), as well as toxoid of the Clostridium perfringens (C. perfringens) bacterium type C.
Maltese: Dan fih partijiet tal-batterju Escherichia coli (E. coli) msejjaħ adeżini fimbrijali F4ab, F4ac, F5 u F6 u tossojde LT (tossina mdebbla), kif ukoll tossojde tal-batterju tat-tip C tal-Clostridium perfringens (C. perfringens).
English: An increase in body temperature of up to 2°C may be observed on the day of vaccination.
Maltese: F'nhar it-tilqima jaf tiġi osservata żieda fit-temperatura tal-ġisem sa 2°C .
English: Porcilis ColiClos has been shown to reduce death and the clinical signs of E. coli or C. perfringens infections such as neonatal piglet diarrhoea and necrotic enterotoxaemia (a severe infection of the intestines).
Maltese: Intwera li Porcilis ColiClos inaqqas l-imwiet u s-sinjali kliniċi tal-infezzjonijiet E. coli jew C. perfringens fil-ħnieżer bħad-dijarrea neonatali u l-enterotossjemija nekrotika (infezzjoni gravi fl-imsaren).
English: This summary was last updated on 14 June 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 14/06/2012.
English: Porcilis ColiClos is a vaccine.
Maltese: Porcilis ColiClos huwa vaċċin.
English: To demonstrate protection against E.coli infection, studies were also presented with Porcilis Porcoli Diluvac Forte, a vaccine authorised within the EU with the same E. coli components as Porcilis ColiClos.
Maltese: Biex tintwera l-protezzjoni kontra l-infezzjoni E.coli, ġew ippreżentati wkoll studji dwar Porcilis Porcoli Diluvac Forte, li huwa vaċċin awtorizzat fl-UE blistess komponenti tal-E. coli li għandu Porcilis ColiClos.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Porcilis ColiClos on 14 June 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha lil Porcilis ColiClos fil-14/06/2012.
English: Porcilis ColiClos is given to sows (female pigs that have already given birth to piglets) or gilts (female pigs that have not yet given birth to piglets) to provide their offspring with protection against infections caused by E. coli strains that express the components F4ab, F4ac, F5 or F6, and by C. perfringens type C. The vaccine is used to reduce death and clinical signs of infections caused by these bacteria during the first days of life.
Maltese: Porcilis ColiClos jingħata lill-iskorfi (ħnieżer nisa li jkunu diġà welldu) jew lill-iskrofetti (ħnieżer nisa li ma jkunux għadhom welldu) ħalli l-frieħ tagħhom ikunu protetti kontra infezzjonijiet ikkawżati minn razez tal-E. Coli li jesprimu l-komponenti F4ab, F4ac, F5 jew F6, u mis-C. perfringens tat-tip C.
English: What is Porcilis ColiClos?
Maltese: Kif jaħdem Porcilis ColiClos?
English: What is the risk associated with Porcilis ColiClos?
Maltese: X'inhu r-riskju assoċjat ma' Porcilis ColiClos?
English: A sometimes painful and hard swelling up to 10 cm in diameter may be observed at the injection site for up to 25 days.
Maltese: Tista' tiżviluppa wkoll nefħa, li ġieli tkun tweġġa' u iebsa, b'10 ċm dijametru fis-sit tal-injezzjoni li ddum sa 25 jum.
English: Why has Porcilis ColiClos been approved?
Maltese: Għaliex ġie approvat Porcilis ColiClos?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) tiddefendi ruħha kontra l-mard.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis ColiClos exceed the risks and recommended that Porcilis ColiClos be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji ta' Porcilis ColiClos jisboq ir-riskji tiegħu u għaldaqstant irrakkomanda li Porcilis ColiClos jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The company has presented data from both laboratory and field studies on the effectiveness of the vaccine against the two bacteria.
Maltese: Il-kumpanija ppreżentat data minn studji li saru kemm fil-laboratorji u kemm fuq il-post dwar leffikaċja tal-vaċċin kontra dawn iż-żewġ batterji.
English: 1 PRAC recommendations issued on 11 February 2016
Maltese: 1 Rakkomandazzjonijiet tal-PRAC maħruġa fil-11 ta' Frar 2016
English: The following SGLT2 inhibitors are authorised in the EU: Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin), Vokanamet (canagliflozin / metformin) and Xigduo (dapagliflozin / metformin).
Maltese: Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin), Vokanamet (canagliflozin / metformin) u Xigduo (dapagliflozin / metformin).
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016 (Invokana, Jardiance) and 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet).
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali vinkolanti applikabbli fl-Istati Membri tal-UE kollha fi 25/04/2016 (Invokana, Jardiance) u 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet).
English: More about the procedure
Maltese: Numru ta'
English: • Diabetic ketoacidosis is a serious complication of diabetes.
Maltese: • Il-ketoaċidożi dijabetika hija komplikazzjoni serja tad-dijabete.
English: On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines).
Maltese: Fil-25 ta' Frar 2016, l-Aġenzija Ewropea għall-Mediċini (EMA) ikkonfermat ir-rakkomandazzjonijiet1 sabiex timminimizza r-riskju ta' ketoaċidożi dijabetika f'pazjenti li jkunu qegħdin jieħdu inibituri talSGLT2 (klassi ta' mediċini għad-dijabete tat-tip 2).
English: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are medicines used to treat type 2 diabetes.
Maltese: L-inibituri tal-ko-trasportatur 2 tal-glukożju tas-sodju (SGLT2) huma mediċini użati sabiex jikkuraw iddijabete tat-tip 2.
English: The review of SGLT2 inhibitors was initiated at the request of European Commission in June 2015, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-rieżami tal-inibituri tal-SGLT2 inbeda fuq talba tal-Kummissjoni Ewropea f'Ġunju 2015, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels.
Maltese: Il-ketoaċidożi dijabetika hija kumplikazzjoni serja tad-dijabete kkawżata minn livelli baxxi tal-insulina.
English: • SGLT2 inhibitors in the EU are available under the following trade names: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet and Xigduo.
Maltese: Forxiga, Invokana, Jardiance, Synjardy, Vokanamet u Xigduo.
English: Patients taking these medicines should be aware of the symptoms of diabetic ketoacidosis, including rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Maltese: Il-pazjenti li jieħdu dawn il-mediċini għandhom ikunu konxji tas-sintomi ta' ketoaċidożi dijabetika, inkluż telf fil-piż malajr, dardir jew rimettar, uġigħ fl-istonku, għatx eċċessiv, nifs mgħaġġel u fil-fond, konfużjoni, ngħas u għejja mhux tas-soltu, riħa ħelwa fin-nifs, togħma ħelwa jew metallika fil-ħalq, jew riħa differenti tal-awrina jew tal-għaraq.
English: • Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: • Dejjem ikkunsidra l-possibilità ta' ketoaċidożi dijabetika f'pazjenti li jkunu qegħdin jieħdu l-inibituri tal-SGLT2 li għandhom sintomi mhux speċifiċi bħal dardir, rimettar, rimettar, anoressja, uġigħ addominali, għatx eċċessiv, diffikultà biex tieħu nifs, konfużjoni, għejja mhux tas-soltu jew ħedla.
English: Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes.
Maltese: Finalment, l-EMA fakkret lill-professjonisti tal-kura tas-saħħa li l-inibituri tal-SGLT2 mhumiex awtorizzati għad-dijabete tat-tip 1, fejn innutat li l-każijiet tal-ketoaċidożi seħħew ukoll waqt l-użu barra mit-tikketta u fi provi kliniċi fid-dijabete tat-tip 1.
English: Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
Maltese: Għaldaqstant, ilprofessjonisti tal-kura tas-saħħa għandhom jikkunsidraw il-possibbiltà ta' ketoaċidożi f'pazjenti li jkunu qegħdin jieħdu inibituri tal-SGLT2 li għandhom sintomi konsistenti mal-kundizzjoni anke jekk il-livelli taz-zokkor fid-demm mhumiex għoljin.
English: • Rare cases of diabetic ketoacidosis have occurred in people with type 2 diabetes taking diabetes medicines known as SGLT2 inhibitors.
Maltese: • Il-professjonisti tal-kura tas-saħħa huma mfakkra li l-inibituri tal-SGLT2 huma awtorizzati biss sabiex jikkuraw id-dijabete tat-tip 2.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), li kkonfermahom u adotta l-opinjoni finali talAġenzija.
English: • Rare cases of diabetic ketoacidosis, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors, used to treat type 2 diabetes.
Maltese: • Każijiet rari ta' ketoaċidożi dijabetika, inklużi dawk ta' theddida għall-ħajja, seħħew f'pazjenti li kienu qegħdin jieħdu l-inibituri tal-SGLT2, użati sabiex jikkuraw id-dijabete tat-tip 2.
English: Healthcare professionals should be aware of possible atypical cases
Maltese: Il-professjonisti tal-kura tas-saħħa għandhom ikunu konxji ta' każi atipiċi possibbli
English: • Stop treatment with SGLT2 inhibitors temporarily in patients undergoing major surgical procedures or hospitalised due to acute serious medical illnesses.
Maltese: • Waqqaf il-kura bl-inibituri tal-SGLT2 b'mod temporanju f'pazjenti li jkunu għaddejjin minn proċeduri kirurġiċi maġġuri jew li jkunu ddaħħlu l-isptar minħabba mard mediku serju akut.
English: • PecFent nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain
Maltese: • PecFent hu indikat biss għall-immaniġġjar ta' wġigħ temporanju li jseħħ għal għarrieda f'persuni adulti li diġà qed jirċievu terapija ta' manteniment bl-opjojdi għal uġigħ kroniku talkanċer
English: • The prescribers of PecFent nasal spray must critically select the patients and closely follow o Instructions for use of the nasal spray device o Instructions for opening and closing of the child-resistant box o Information on the correct indication
Maltese: L-Istati Membri għandhom jiżguraw li l-kundizzjonijiet jew restrizzjonijiet kollha fir-rigward ta' l-użu mingħajr periklu u effettiv tal-prodott mediċinali deskritti hawn taħt, ikunu implimentati.
English: • The PecFent nasal spray dose strengths can not be compared with other PecFent products
Maltese: • Il-qawwiet tad-doża ta' PecFent sprej nażali ma jistgħux jitqabblu ma' prodotti PecFent oħrajn
English: • The pharmacist must be familiar with the educational material of PecFent nasal spray before using it in his/her organization
Maltese: • L-ispiżjar irid ikun familjari mal-materjal edukattiv ta' PecFent sprej nażali qabel ma jużah florganizzazzjoni tiegħu/tagħha
English: The MAH shall ensure that, at launch, all physicians, pharmacists and patients expected to prescribe/use PecFent are provided with educational material informing about the correct and safe use of the product.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, fit-tnedija tal-prodott, ittobba, l-ispiżjara u l-pazjenti kollha li huma mistennija li jagħtu riċetta/jużaw PecFent, jingħataw materjal edukattiv li jinfurmahom dwar l-użu korrett u bla periklu ta' dan il-prodott.
English: • Only use PecFent nasal spray if you have been experiencing breakthrough cancer pain episodes
Maltese: • Tużax PecFent sprej nażali għal kura ta' iktar minn erba' episodji ta' wġigħ temporanju tal kanċer kuljum
English: • PecFent nasal spray should be prescribed only by physicians experienced in the management of opioid therapy in cancer patients.
Maltese: • PecFent sprej nażali għandu jiġi preskritt biss minn tobba b'esperjenza fl-immaniġġjar ta' terapija b'opjojdi f'pazjenti bil-kanċer.
English: Educational material for pharmacists should highlight the following:
Maltese: Il-materjal edukattiv għall-ispiżjara jrid jenfasizza dan li ġej:
English: 1 pre-filled syringe
Maltese: Għamla farmaċewtika
English: Subjects with immune deficiencies
Maltese: Suġġetti b'defiċjenzi immunitarji
English: Section 4.6 - Fertility, pregnancy and lactation Fertility
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: Pregnancy
Maltese: Fertilità
English: The intramuscular route of administration was initially investigated in a small number of subjects (N=40) with seroconversion rates of 96.7%, 97.5% and 100% against measles, mumps and rubella, respectively.
Maltese: Il-metodu ta' għoti fil-muskolu kien investigat inizjalment f'għadd żgħir ta' suġġetti (N=40) b'rati ta' serokonverżjoni ta' 96.7 %, 97.5 % u 100 % kontra l-ħosba, il-gattone u r-rubella, rispettivament.
English: The theoretical maximum risk for CRS after administration of the vaccine at 1.6%, is much lower than the risk of major non-CRS induced congenital defects during pregnancy (Bozzo et al., 2011).
Maltese: Ir-riskju massimu teoretiku għas-CRS wara l-għoti ta' 1.6 % vaċċin, huwa ħafna aktar baxx mir-riskju ta' difetti konġenitali kbar mhux ikkawżati mis-CRS waqt it-tqala (Bozzo et al., 2011).
English: The final agreed wording is: “PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
Maltese: Il-kliem finali li kien hemm qbil dwaru huwa: “PRIORIX jista' jingħata fl-istess waqt (iżda f'postijiet differenti ta' injezzjoni) ma' kull wieħed minn dawn il-vaċċini monovalenti jew ikkombinati li ġejjin [inklużi vaċċini eksavalenti (DTPa-HBVIPV/Hib)]: il-vaċċin tad-difterite-tetnu-pertussis aċellulari (DTPa), il-vaċċin tal-Haemophilus influenzae tat-tip b (Hib), il-vaċċin tal-poljo mhux attivat (IPV), il-vaċċin tal-epatite B (HBV), ilvaċċin tal-epatite A (HAV), il-vaċċin konjugat meninġokokkali serotip C (MenC), il-vaċċin tal-ġidri rriħ zoster (VZV), il-vaċċin tal-poljo orali (OPV) u l-vaċċin konjugat pnewmokokkali 10-valenti skont ir-rakkomandazzjonijiet lokali.
English: The data available do not suggest any clinically relevant interference in the antibody response to each of the individual antigens (Carmona et al., 2010; Pace et al., 2008).
Maltese: Iddejta disponibbli ma tindika l-ebda interferenza klinikament rilevanti fir-rispons tal-antikorpi għal kull antiġenu individwali (Carmona et al., 2010;
English: The MAH amended the corresponding part accordingly and also added another sentence to reflect the documented transplacental transmission.
Maltese: Il-MAH emenda l-parti korrispondenti skont dan u żied ukoll sentenza oħra li tirrifletti t-trażmissjoni transplaċentali ddokumentata.
English: Some vaccines that can be co-administered with Priorix are listed in the SmPC of Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Luxemburg, Malta, The Netherlands, Poland, Romania and United Kingdom.
Maltese: Xi vaċċini li jistgħu jingħataw flimkien ma' Priorix huma elenkati fl-SmPC tal-Belġju, tal-Bulgarija, ta' Ċipru, tad-Danimarka, tal-Estonja, ta' Franza, tal-Lussemburgu, ta' Malta, tal-Pajjiżi l-Baxxi, talPolonja, tar-Rumanija u tar-Renju Unit.
English: The incidence rates among the cases in both these age categories were above 50 and 45 cases per 100,000 respectively.
Maltese: Ir-rati ta' inċidenza fost il-każijiet f'dawn iż-żewġ kategoriji ta' età kienu ogħla minn 50 u 45 każ għal kull 100,000 rispettivament.
English: MMR-associated thrombocytopenia is rare and generally self-limited.
Maltese: It-tromboċitopenja assoċjata mal-MMR hija rari u ġeneralment limitata għall-individwu.
English: An association between lack of measles-specific antibodies after vaccination and low CD+ T-lymphocyte counts (<600cells/mm3) was reported in published studies (Moss et al. 2003).
Maltese: Ġiet irrappurtata konnessjoni bejn in-nuqqas ta' antikorpi speċifiċi għall-ħosba wara t-tilqim u l-għadd baxx ta' limfoċiti CD+ T (<600 ċellola/mm3) fi studji ppubblikati (Moss et al. 2003).
English: The geometric mean titers (GMTs) for seroconverters were 2431.9 mIU/ml, 1010.0 U/ml and 67.1 IU/ml for the anti-measles, anti-mumps and anti-rubella antibodies, respectively which were slightly lower than the values reported following subcutaneous administration (2958 mIU/ml, 1400 U/ml and 73 IU/ml, respectively).
Maltese: U/ml u 67.1 IU/ml għall-antikorpi ta' kontra l-ħosba, ta' kontra l-gattone u ta' kontra r-rubella, rispettivament li kienu xi ftit aktar baxxi mill-valuri rrappurtati wara l-għoti minn taħt il-ġilda (2958 mIU/ml, 1400 U/ml u 73 IU/ml, rispettivament).
English: Priorix is a combined freeze-dried measles (M), mumps (M), and rubella (R) vaccine (live) preparation.
Maltese: Priorix huwa preparazzjoni kkombinata u mnixxfa bil-kesħa tal-vaċċin (ħaj) tal-ħosba (M), talgattone (M), u tar-rubella (R).
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction Clinical studies demonstrated that Priorix can be administered concomitantly with live attenuated varicella vaccine, DTPa-IPV and combined hepatitis A/B vaccine (Marshall et al., 2006; Stuck et al., 2002; Usonis et al., 2005; Wellington and Goa, 2003).
Maltese: Sezzjoni 4.5 - Prodotti mediċinali oħra li ma jaqblux ma' dan il-prodott u affarijiet oħra li jistgħu jibdlu l-effett farmaċewtiku tal-prodott Studji kliniċi urew li Priorix jista' jingħata fl-istess waqt mal-vaċċin tal-ġidri r-riħ attenwat, il-vaċċin DTPa-IPV u l-vaċċin ikkombinat tal-epatite A/B (Marshall et al., 2006; Stuck et al., 2002;
English: The risk for measles vaccination (enhancement of spontaneous abortion of stillbirth) is indicated to be unknown.
Maltese: Ir-riskju għat-tilqim kontra l-ħosba (iż-żieda ta' abort spontanju ta' fetu mejjet) huwa indikat li m'huwiex magħruf.
English: In the SmPC of Bulgaria, Cyprus, Estonia, Malta and the United Kingdom, it is stated that pregnancy must be avoided for one month after vaccination as compared to the three months in the SmPC of the countries involved in the MRP and other countries.
Maltese: Fl-SmPC tal-Bulgarija, Ċipru, l-Estonja, Malta u r-Renju Unit, huwa ddikjarat li t-tqala għandha tkun evitata għal xahar wara t-tilqim meta mqabbel ma' tliet xhur fl-SmPC tal-pajjiżi involuti fl-MRP u f'pajjiżi oħra.
English: The CHMP agreed that the sentence regarding fructose intolerance should change from “Patients with rare hereditary problems of fructose intolerance should not take this medicine.” to “Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol”.
Maltese: Is-CHMP qabel li s-sentenza rigward in-nuqqas ta' tolleranza għall-fruttożju għandha tinbidel minn “Pazjenti bi problemi ereditarji rari ta' nuqqas ta' tolleranza għall-fruttożju m'għandhomx jieħdu din il-mediċina.” għal “Pazjenti bi problemi ereditarji rari ta' nuqqas ta' tolleranza għall-fruttożju m'għandhomx jitlaqqmu bi PRIORIX minħabba li fih is-sorbitol”.
English: The MAH proposed to use a general sentence and not to list the different vaccines.
Maltese: Il-MAH ippropona li juża sentenza ġenerali u li ma jelenkax il-vaċċini differenti.
English: The immunogenicity of Priorix was evaluated in several clinical trials in children aged from 12 to 24 months, 11 to 23 months and 9 to 12 months.
Maltese: L-immunoġeniċità ta' Priorix kienet evalwata f'bosta provi kliniċi fi tfal minn 12 sa 24 xahar, minn 11 sa 23 xahar u minn disa' sa 12-il xahar.
English: Priorix is indicated for the active immunisation against measles, mumps and rubella.
Maltese: Priorix huwa indikat għat-tilqim attiv kontra l-ħosba, il-gattone u r-rubella.
English: Although there are only limited data, it was noted that intramuscular administration is standard practice in many Member States.
Maltese: Għalkemm hemm biss dejta limitata, kien innutat li l-għoti filmuskolu huwa prattika standard f'bosta Stati Membri.
English: The CHMP therefore suggested adding the information from a recent systematic review that “MMR-associated thrombocytopenia is rare and generally self-limited”.
Maltese: Għaldaqstant isCHMP irrakkomanda li jiżdied it-tagħrif minn analiżi sistematika reċenti li “tromboċitopenja assoċjata mal-MMR hija rari u ġeneralment limitata għall-individwu”.