FrancophonIA/ELRC3.0 huggingface dataset:
English: • After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (Fig. 11).
Maltese: • Wara minimu ta' 5 sekondi, iġbed il-labra 'l barra mill-ġilda waqt li żżomm il-pum li jissettja ddoża magħfus 'l isfel (Fig. 11).
English: • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Maltese: • L-OHSS jista' jsir sever bi tkabbir evidenti tal-ovarji, tnaqqis fil-produzzjoni tal-awrina, żieda fil-piż, diffikultà biex tieħu n-nifs u/jew possibbilment akkumulazzjoni ta' fluwidu fiż-żaqq jew fis-sider.
English: Pergoveris may be mixed with follitropin alfa and co-administered as a single injection.
Maltese: Pergoveris jista' jiġi rrikostitwit ukoll ma' follitropin alfa u jingħataw flimkien bħala injezzjoni waħda.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Maltese: Kull pinna mimlija għal-lest b'ħafna dożi fiha 300 IU (ekwivalenti għal 22 mikrogramma) ta' follitropin alfa* (r-hFSH), u 150 IU (ekwivalenti għal 6 mikrogrammi) ta' lutropin alfa* (r-hLH) f'0.48 mL ta' soluzzjoni.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, thrombophilia or severe obesity (body mass index > 30 kg/m2), treatment with gonadotrophins may further increase the risk.
Maltese: F'nisa b'mard tromboemboliku riċenti jew attwali, jew nisa li għandhom fatturi ta' riskju għal avvenimenti tromboemboliċi bħal storja medika personali jew fil-familja, trombofilja jew obesità severa (indiċi tal-massa tal-ġisem >30 kg/m2), jista' jkun hemm riskju akbar bil-kura b'gonadotropini.
English: Units) of follitropin alfa and 150 IU of lutropin alfa in 0.48 mL and can deliver two doses of Pergoveris 150 IU/75 IU.
Maltese: 48 mL fiha 300 IU (Unità Internazzjonali) ta' follitropin alfa u 150 IU ta' lutropin alfa f'0.48 mL u tista' tagħti żewġ dożi ta' Pergoveris 150
English: How much to use
Maltese: Doża Preskrit ta
English: This is when you have developed a suitable follicle, as assessed using ultrasound scans and blood tests.
Maltese: Dan iseħħ meta tkun żviluppajt follikulu xieraq, kif evalwat permezz ta' skans bl-ultrasound u testijiet tad-demm.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) Each pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa (r-hLH) in 0.48 mL.
Maltese: Kull pinna mimlija għal-lest fiha 300 IU (ekwivalenti għal 22 mikrogramma) ta' follitropin alfa (r-hFSH) u 150 IU (ekwivalenti għal 6 mikrogrammi) ta' lutropin alfa (r-hLH) f'0.48 mL.
English: • Firmly pinch the skin together and insert the needle at a 45° to 90 angle using a dart-like motion.
Maltese: • Oqros il-ġilda u daħħal il-labra f'angolu ta' 45° sa 90° qisek qed twaddab dart.
English: • The powder is a white to off-white lyophilised pellet in a glass vial with a bromobutyl rubber stopper containing 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU
Maltese: • It-trab huwa magħmul minn pellit bajda sa offwajt lajofilizzata f'kunjett tal-ħġieġ b'tapp tal lastku tal-bromobutyl li jkun fih IU 150 (ekwivalenti għal 11-il mikrogramma) ta' follitropin alfa u 75 IU (ekwivalenti għal 3 mikrogrammi) ta' lutropin alfa.
English: Nevertheless there is a possibility that OHSS may occur, which is further described in section 4.4.
Maltese: Madanakollu, hemm il-possibbiltà li jista' jseħħ OHSS, li hu deskritt f'aktar dettall f'sezzjoni 4.4.
English: • abdominal or pelvic pain
Maltese: • uġigħ ta' żaqq jew fil-pelvis
English: • Each pre-filled pen of Pergoveris (300 IU + 150 IU)/0.48 mL contains 300 IU (International
Maltese: • Pergoveris (300 IU + 150 IU)/0.
English: Pergoveris treatment seldom causes severe OHSS.
Maltese: Dan l-effett sekondarju huwa rari ħafna.
English: Ovarian cysts
Maltese: Siġill li
English: How to store Pergoveris
Maltese: Kull Pergoveris (900
English: 1 multidose pre-filled pen of 0.48 mL solution 5 injection needles
Maltese: Pinna waħda mimlija għal-lest b'ħafna dożi ta' 0.48 mL ta' soluzzjoni 5 labriet tal-injezzjoni
English: • Contains 450 IU follitropin alfa and 225 IU lutropin alfa.
Maltese: 72 mL ta' soluzzjoni ta' Pergoveris • Fiha 450 IU ta' follitropin alfa u 225
English: Pergoveris pre-filled pen treatment diary
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution.
Maltese: IU (ekwivalenti għal 66 mikrogramma) ta' follitropin alfa* (r-hFSH), u 450 IU (ekwivalenti għal 18-il mikrogramma) ta' lutropin alfa* (r-hLH) f'1.44 mL ta' soluzzjoni.
English: and show the dose of follitropin alfa.
Maltese: jew IUs, u juru d-doża ta' follitropin alfa.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Nervous system disorders Very common:
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: • Remove the peel-off seal (Fig. 4).
Maltese: • Neħħi s-siġill li jitqaxxar (Fig. 4).
English: Paediatric population There is no relevant use of this medicinal product in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' dan il-prodott mediċinali fil-popolazzjoni pedjatrika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Pergoveris
Maltese: IL-PRODOTT MEDIĊINALI Pergoveris (900
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation.
Maltese: Jekk ikun jeħtieġ żieda fid-doża ta' FSH, dan għandu jsir preferibbilment wara intervalli ta' bejn ġimgħa u ġimagħtejn u preferibbilment b'żidiet ta' 37.5-75
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Maltese: Din tinkludi tkabbir evidenti ta' l-ovarji, sterojdi sesswali għoljin fisserum, u żieda fil-permeabbilità vaskulari li tista' twassal għal akkumulazzjoni ta' likwidu fl-ispazju tal-peritonew, tal-plewra, u rari fl-ispazju tal-perikardju.
English: • If you administer Pergoveris to yourself, please carefully read and follow section “Instructions for Use”.
Maltese: • Jekk tagħti Pergoveris lilek innifsek, jekk jogħġbok aqra u segwi b'attenzjoni s-sezzjoni “Istruzzjonijiet dwar l-użu”.
English: if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen
Maltese: jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida
English: • One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU (equivalent to 3 micrograms) of lutropin alfa.
Maltese: • Kunjett wieħed fih 150 IU (ekwivalenti għal 11 mikrogrammi) ta' follitropin alfa u 75
English: There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple regimens for infertility treatment.
Maltese: Kien hemm rapporti ta' tumuri fl-ovarji u f'organi sesswali oħra, la beninni u anqas malinni, f'nisa li kienu ħadu korsijiet multipli ta' kura għall-infertilità.
English: • Contains 0.72 mL of Pergoveris solution
Maltese: 72 mL ta' soluzzjoni.
English: When you get the desired response, you will be given a single injection of human chorionic gonadotropin (hCG) 24 to 48 hours after your last Pergoveris injection.
Maltese: Meta tikseb ir-rispons mixtieq, tingħata injezzjoni waħda ta' 250 mikrogramma ta' gonadotropin korjoniku uman (hCG), 24 sa 48 siegħa wara l-aħħar injezzjonijiet tiegħek ta' Pergoveris.
English: For instructions on the use of this medicinal product, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-użu ta' dan il-prodott mediċinali, ara sezzjoni 6.6.
English: Powder: 3 mL vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap. 1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Maltese: Kunjett wieħed fih 11 mikrogrammi r-hFSH u 3 mikrogrammi r-hLH.
English: Each pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa (r-hLH) in 0.72 mL.
Maltese: Kull pinna mimlija għal-lest fiha 450 IU (ekwivalenti għal 33 mikrogramma) ta' follitropin alfa (r-hFSH) u 225
English: • Each pre-filled pen of Pergoveris (900 IU + 450 IU)/1.44 mL contains 900 IU (International
Maltese: IU + 450 IU)/1.44 mL fiha 900
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
Maltese: Pazjenti li jbatu minn porphyria jew għandhom storja fil-familja ta' porphyria jridu jkunu monitorjati sew waqt it-trattament bi Pergoveris.
English: • The Dose Feedback Window will indicate the missing amount you need to inject using a new pen.
Maltese: • Il-Feedback Window tad-Doża se tindika l ammont nieqes li jkollok bżonn tinjetta billi tuża pinna ġdida.
English: It should be noted however, that pregnancy itself as well as OHSS also carries an increased risk of thromboembolic events.
Maltese: Madankollu, wieħed irid iżomm quddiem għajnejh, li t-tqala nfisha kif ukoll OHSS jistgħu jwasslu għal riskju akbar ta' avvenimenti tromboemboliċi.
English: In these trials the ovulation rate per cycle was 70-75%.
Maltese: F'dawn il-provi, ir-rata tal-ovulazzjoni f'kull ċiklu kienet ta' 70-75%.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa* (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa* (r-hLH).
Maltese: U KWANTITATTIVA Kunjett wieħed fih 150 IU (ekwivalenti għal 11 mikrogrammi) follitropin alfa* (r-hFSH), u 75
English: Getting your Pergoveris pre-filled pen ready for injection 5.1.
Maltese: Uża labra ġdida. 5.4.
English: Storing the Pergoveris pre-filled pen.
Maltese: Spiss tintuża doża ta' kunjett wieħed ta' Pergoveris kuljum.
English: • 1 fine bore needle for injection under the skin
Maltese: • 1 labra fina għal injezzjoni taħt il-ġilda
English: Alternatively, intrauterine insemination (IUI) may be performed.
Maltese: Inkella tista' ssir inseminazzjoni ġewwa l-utru (IUI).
English: After reconstitution, each mL of the solution contains 150 IU follitropin alfa and 75 IU lutropin alfa per milliliter.
Maltese: Wara r-rikostituzzjoni, kull mL tas-soluzzjoni jkun fih 150 IU ta' follitropin alfa u 75 IU ta' lutropin alfa f'kull millilitru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/396/005
English: How Pergoveris works
Maltese: Pergoveris (900
English: Solvent: 3 mL vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap. 1 vial of solvent contains 1 mL of water for injections.
Maltese: Solvent: kunjetti ta' 3 mL (ħġieġ Tip I) b'tapp tal-gomma li huwa miksi b'Teflon u siġill ta' laluminju u għatu li jfaqqa f'postu.
English: Each Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen contains 0.48 mL of solution for injection and can deliver two doses of Pergoveris 150 IU/75 IU.
Maltese: 48 mL pinna mimlija għal-lest fih 0.48 mL ta' soluzzjoni għallinjezzjoni u jista' jagħti żewġ dożi ta' Pergoveris 150 IU/75 IU.
English: If you have ever had this type of reaction to a similar medicine, talk to your doctor before using Pergoveris.
Maltese: Jekk qatt kellek din ittip ta' reazzjoni għal mediċina simili, kellem lit-tabib tiegħek qabel tuża Pergoveris.
English: In one clinical study of women with hypogonadotrophic hypogonadism and an endogenous serum LH concentration below 1.2 IU/L the appropriate dose of r-hLH was investigated.
Maltese: Fi studju kliniku ta' nisa b'ipogonadiżmu ipogonadotrofiku u konċentrazzjoni endoġena tas-serum LH taħt 1.2 IU/L, id-doża xierqa ta' r-hLH ġiet studjata.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Maltese: Wara li jingħata fil-vina, follitropin alfa jinfirex fl-ispazju tal-fluwidu extra-ċellulari b'half-life inizjali ta' madwar sagħtejn u jitneħħa mill-ġisem b'half-life terminali ta' madwar ġurnata.
English: Pack of 1 Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen and 5 injection needles.
Maltese: Pakkett ta' Pergoveris (300 IU + 150 IU)/0.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution.
Maltese: Kull pinna mimlija għal-lest b'ħafna dożi fiha 450 IU (ekwivalenti għal 33 mikrogramma) ta' follitropin alfa* (r-hFSH), u 225
English: The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Maltese: Is-sintomi li ġejjin jistgħu jiġu osservati f'każi severi ta' OHSS: uġigħ ta' żaqq, nefħa fiż-żaqq, tkabbir sever tal-ovarji, żieda fil-piż, dispneja, oligurja, u sintomi gastrointestinali li jinkludu dardir, rimettar u dijarea.
English: To minimise skin irritation, select a different injection site each day.
Maltese: Biex titnaqqas l-irritazzjoni tal-ġilda, agħżel sit ta' injezzjoni differenti kuljum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/396/006
English: For further instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet addizzjonali fuq ir-rikostituzzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Pergoveris solution for injection in pre-filled pen may be administered concomitantly with a licensed follitropin alfa preparation as separate injections.
Maltese: Tista' tuża Pergoveris flimkien ma' preparazzjoni liċenzjata ta' follitropin alfa bħala injezzjonijiet separati jekk inhu preskritt mit-tabib tiegħek.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Maltese: Hu maħsub li dan jirriżulta minħabba xi differenzi filkaratteristiċi tal-ġenituri (eż. età materna, karatteristika ta' l-isperma) u tqala multipla.
English: • Sucrose, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, as well as concentrated phosphoric acid and sodium hydroxide for pH-adjustment.
Maltese: • Sukrożju, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/396/004
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (450 IU + 225 IU)/0.72 mL injection Follitropin alfa/Lutropin alfa
Maltese: 72 mL fiha 450 IU (Unità Internazzjonali) ta' follitropin alfa u 225
English: • primary ovarian failure
Maltese: • insuffiċjenza primarja ta' l-ovarji
English: • headache
Maltese: ġewwa.
English: Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation.
Maltese: Dejta dwar numru limitat ta' tqaliet esposti ma tindika l-ebda reazzjoni avversa ta' follitropin alfa u lutropin alfa fuq it-tqala, fuq liżvilupp tal-embriju jew tal-fetu, fuq il-ħlas jew l-iżvilupp ta' wara t-twelid wara stimulazzjoni kkontrollata tal-ovarji.
English: In women whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Maltese: F'nisa fejn is-sekrezzjoni tal-gonadotrofina endoġena hija mrażżna, instab li follitropin alfa xorta waħda jistimula b'mod effettiv l-iżvilupp follikulari u l-isterojdoġenesi, minkejja livelli ta' LH li ma jistgħux jiġu mkejjla.
English: • Hold the outer needle cap firmly.
Maltese: • Erġa' poġġi l-għatu fuq il-pinna.
English: Pergoveris contains potent gonadotrophic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: 17 April 2019 EMA/248364/2019 Rev 1
Maltese: 17 ta' April 2019 EMA/248364/2019 Rev1
English: Active substance (max daily dose)
Maltese: Sustanza attiva kuljum)
English: Temporary limits for NDMA and NDEA impurities
Maltese: Limiti temporanji għall-NDMA u l-NDEA, impuritajiet NDMA
English: EMA and national authorities will continue investigating the presence of nitrosamine impurities in medicines, including other impurities such as N-nitrosoethylisopropylamine (EIPNA), Nnitrosodiisopropylamine (DIPNA) and N-nitroso-N-methylamino butyric acid (NMBA).
Maltese: L-EMA u l-awtoritajiet nazzjonali se jkomplu jinvestigaw il-preżenza ta' impuritajiet tan-nitrożammini fil-mediċini, inklużi impuritajiet oħra bħal N-nitrożoetilisopropilammina (EIPNA), Nnitrożodiisopropilammina (DIPNA) u N-nitrożo-N-metilamino-aċidu butiriku (NMBA).
English: On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.
Maltese: Fl-20 ta' Settembru 2018, ir-rieżami ġie estiż biex jinkludi mediċini li fihom candesartan, irbesartan, losartan u olmesartan.
English: The limits are based on the maximum daily intake for each impurity derived from animal studies: 96.0 nanograms for NDMA and 26.5 nanograms for NDEA.
Maltese: Il-limiti huma bbażati fuq id-doża massima ta' kuljum għal kull impurità derivata mill-istudji fuq lannimali: 96.0 nanogrammi għall-NDMA u 26.5 nanogrammi għall-NDEA.
English: A similar step - involving diethylamine (DEA) - is linked to the presence of NDEA.
Maltese: Pass simili - li jinvolvi dietilammina (DEA) - huwa marbut mal-preżenza tal-NDEA.
English: NDMA
Maltese: kuljum (ng)
English: The CHMP opinion was forwarded to the European Commission, which issued final legally binding decisions for the medicines concerned between 2 April and 17 April 2019 that are applicable in all EU Member States.
Maltese: Lopinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjonijiet legalment vinkolanti finali għall-mediċini kkonċernati bejn it-2 ta' April u s-17 ta' April 2019 li huma applikabbli fl-Istati Membri kollha tal-UE.
English: It concluded that if 100,000 patients took valsartan from Zhejiang Huahai (where the highest levels of impurities were found) every day for 6 years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients.
Maltese: Huwa kkonkluda li jekk 100,000 pazjent ħadu valsartan minn Zhejiang Huahai (fejn instabu l-ogħla livelli ta' impuritajiet) kuljum għal 6 snin fl-ogħla doża, jista' jkun hemm 22 każ addizzjonali ta' kanċer minħabba l-NDMA tul il-ħajja ta' dawk il-100,000 pazjent.
English: The review concerns candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists).
Maltese: Ir-rieżami jikkonċerna candesartan, irbesartan, losartan, olmesartan u valsartan, li jappartjenu għal klassi ta' mediċini msejħin sartans (magħrufin ukoll bħala antagonisti tar-riċetturi tal-anġjotensina
English: Before June 2018, NDMA and NDEA were not among the impurities identified in sartan medicines and were therefore not detected by routine tests.
Maltese: Qabel Ġunju 2018, l-NDMA u l-NDEA ma kinux fost l-impuritajiet identifikati fil-mediċini sartan u għalhekk ma nstabux permezz ta' testijiet ta' rutina.
English: • For NDMA, the key step involves dimethylamine (DMA) which forms the impurity in the presence of nitrites, usually under acidic conditions.
Maltese: • Għall-NDMA, il-pass ewlieni jinvolvi d-dimetilammina (DMA) li jifforma l-impurità fil-preżenza tannitriti, normalment f'kundizzjonijiet aċidużi.
English: Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review.
Maltese: Mediċini oħra tal-klassi li ma għandhomx dan iċ-ċirku, bħal azilsartan, eprosartan u telmisartan, ma kinux inklużi fir-rieżami.
English: These recommendations follow EMA's review of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are classified as probable human carcinogens (substances that could cause cancer) and have been detected in some sartan medicines.
Maltese: Dawn ir-rakkomandazzjonijiet isegwu r-rieżami tal-EMA ta' N-nitrożodimetilammina (NDMA) u Nnitrożodietilammina (NDEA), li huma kklassifikati bħala karċinoġeni umani probabbli (sustanzi li jistgħu jikkawżaw il-kanċer) u ġew skoperti f'xi mediċini sartan.
English: Investigation continuing
Maltese: Investigazzjoni li tkompli
English: • EMA is now taking further action to prevent these impurities from being present in future batches of sartan medicines.
Maltese: • L-EMA issa qed tieħu azzjoni ulterjuri biex tipprevjeni dawn l-impuritajiet milli jkunu preżenti f'lottijiet futuri ta' mediċini sartan.
English: • These impurities can form during the production of sartans that contain a tetrazole ring when certain reaction conditions are met or when contaminated materials are used.
Maltese: • Dawn l-impuritajiet jistgħu jiffurmaw waqt il-produzzjoni tas-sartans li fihom ċirku tat-tetrażol meta jiġu ssodisfati ċerti kundizzjonijiet ta' reazzjoni jew meta jintużaw il-materjali kkontaminati.
English: The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami tal-mediċini valsartan inbeda mill-Kummissjoni Ewropea fil-5 ta' Lulju 2018 skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: Dividing these by the maximum daily dose for each active substance gives the limit in parts per million (see Table 1).
Maltese: Jekk dawn jiġu diviżi biddoża massima ta' kuljum għal kull sustanza attiva, dan jagħti l-limitu f'partijiet għal kull miljun (ara tTabella 1).
English: On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) review their manufacturing processes so that they do not produce nitrosamine impurities.
Maltese: Fit-31 ta' Jannar 2019, l-EMA rrakkomandat li l-kumpaniji li jagħmlu mediċini għal pressjoni tad-demm sartan (magħrufin ukoll bħala imblokkaturi tar-riċetturi tal-anġjotensina
English: • Nitrosamines are potent carcinogens in animals and probable carcinogens in humans.
Maltese: • In-nitrożammini huma karċinoġeni qawwija fl-annimali u l-karċinoġeni probabbli fil-bnedmin.
English: NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.1
Maltese: L-NDEA f'dawn il-mediċini tista' twassal għal 8 każijiet żejda f'100,000 pazjent li kuljum jieħdu l-mediċina fl-ogħla doża għal 4 snin.
English: • There is a very low risk that nitrosamine impurities at the levels previously found in some sartan medicines could cause cancer in humans.
Maltese: • Hemm riskju baxx ħafna li l-impuritajiet tan-nitrożammini fil-livelli li qabel kienu jinstabu f'xi mediċini sartan jistgħu jikkawżaw il-kanċer fil-bnedmin.