FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of patients with hardware failure (locking screws bent or broken) was significantly lower in the InductOs 1.5 mg/ml group as compared to standard-care group (11% versus 22%; P= 0.0174).
Maltese: Il-proporzjon ta' pazjenti li kellhom ħsara fit-tagħmir tal-metall (viti locking mgħawġin jew miksurin) kien aktar baxx b'mod sinifikanti fil-grupp ta' InductOs 1.5 mg/ml meta mqabbel mal-grupp li ngħata kura standard (11% kontra 22%; P=0.0174).
English: 7 MARKETING AUTHORISATION HOLDER
Maltese: 7 DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Concentration of wetted matrix
Maltese: Konċentrazzjoni tal-matriċi mxarrba
English: The matrix is pre-cut in 2 pieces each of 2.5 x 5 cm.
Maltese: Il-matriċi tinqata' minn qabel f'2 biċċiet, kull waħda ta' 2.5 x 5 ċm.
English: 5 PHARMACOLOGICAL PROPERTIES
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Lumbar interbody fusion surgery
Maltese: • meta jintuża f'tekniċi kirurġiċi oħrajn minbarra fużjoni interkorporali lumbari
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg dibotermin alfa
Maltese: INDIVIDWALI 12 mg dibotermin alfa
English: In acute tibia fracture clinical trials, more InductOs patients receiving concomitant NSAIDs for 14 consecutive days experienced mild or moderate adverse events related to wound healing (e.g., wound drainage) than InductOs patients not taking NSAIDs.
Maltese: Fi studji kliniċi li saru fuq il-ksur akut fil-qasba tas-sieq, aktar pazjenti li ngħataw InductOs u li kienu qed jirċievu NSAIDs fl-istess ħin għal 14-il jum konsekuttiv, kellhom każijiet avversi minn ħfief sa moderati, li kienu assoċjati mal-fejqan tal-ferita (eż. it-tneħħija ta' likwidu mill-ferita) milli minn pazjenti li ngħataw InductOs li ma kinux qed jieħdu NSAIDs.
English: • Healthcare professionals training material The healthcare professionals training material shall contain the following key elements: o Detailed description from the SmPC of the administration procedures of InductOs and of the measures that need to be taken to prevent medication errors, incorrect use, and minimise the risk of heterotopic ossification.
Maltese: • Materjal ta' taħriġ għall-professjonisti tal-kura tas-saħħa Il-materjal ta' taħriġ għall-professjonisti tal-kura tas-saħħa għandu jinkludi l-elementi ewlenin li ġejjin: o Deskrizzjoni dettaljata mis-SKP tal-proċeduri ta' għoti ta' InductOs u tal-miżuri li jridu jittieħdu biex jiġu evitati żbalji fil-medikazzjoni, użu inkorrett, u biex jitnaqqas ir-riskju ta' ossifikazzjoni eterotopika.
English: 1 NAME OF THE MEDICINAL PRODUCT InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix
Maltese: InductOs 1.5 mg/ml trab, solvent u matriċi għall-matriċi ta' impjant
English: 2 needles
Maltese: 2 labar
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 8.4 ml of solvent.
Maltese: Billi tuża s-siringa u l-labra li jibqa' fil-pakkett, irrikostitwixxi l-kunjett b'dibotermin alfa bi 8.4 ml tas-solvent.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MATRIX LABEL FOR 12 MG PACK
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-MATRIĊI GĦALL-PAKKETT TA' 12 MG
English: In clinical studies, the presence of antibodies to collagen was not associated with side effects, such as allergies, nor was it shown to decrease the effectiveness of InductOs.
Maltese: Fi studji kliniċi, il-preżenza ta' antikorpi għal kollaġen ma kinitx assoċjata ma' effetti sekondarji, bħal allerġiji, u lanqas ma ntwera li dan inaqqas l-effettività ta' InductOs.
English: If you get any side effects, talk to your doctor.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Localised infection specific to the fractured limb was very common (≥1/10) in patients in a clinical study in which the intramedullary canal was reamed to cortical chatter.
Maltese: Infezzjoni lokalizzata speċifika għar-riġel miksur kienet komuni ħafna (≥1/10) f'pazjenti fi studju kliniku fejn il-passaġġ intramedullari kien imwessa' maċ-chatter kortikali.
English: In clinical trials when degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with dibotermin alfa, posterior bone formation was observed in CT scans.
Maltese: Fi studji kliniċi fejn mard deġenerattiv tad-diska kien ikkurat bi proċedura ta' fużjoni lumbari interkorporali posterjuri b'dibotermin alfa, f'CT scans ġew osservati formazzjonijiet posterjuri ta' għadam.
English: When reconstituted, contains 1.5 mg/ml dibotermin alfa.
Maltese: Meta rikostitwit, ikun fih 1.5 mg/ml ta' dibotermin alfa.
English: Very common
Maltese: Komuni ħafna
English: Formation of a fluid collection (pseudocyst, localised oedema, implant site effusion), sometimes encapsulated and in some cases resulting in nerve compression and pain, has been reported associated with the use of InductOs.
Maltese: Il-formazzjoni ta' ġbir ta' fluwidu (psewdoċisti, edima lokalizzata, effużjoni fis-sit tal-impjant), xi kultant enkapsulata, li f'xi każijiet irriżultat f'kompressjoni tan-nervaturi u wġigħ, kienet irrappurtata f'assoċjazzjoni mal-użu ta' InductOs.
English: Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Maltese: Dibotermin alfa hu proteina osteoinduttiva li tirriżulta fl-induzzjoni ta' tessut ġdid tal-għadam fis-sit tal-impjant.
English: Using aseptic transfer technique and the syringe and needle from step 1, withdraw 8.0 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal.
Maltese: Billi tuża t-teknika asettika tat-trasferiment, u s-siringa u l-labra minn pass 1, iġbed 8.0 ml tassoluzzjoni rikostitwita ta' dibotermin alfa mill-kunjett fil-kamp mhux sterili, filwaqt li żżomm il-kunjett ta' taħt fuq biex tiffaċilita l-ġbid.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MATRIX LABEL FOR 4 MG PACK
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-MATRIĊI GĦALL-PAKKETT TA' 4 MG
English: Malignancy
Maltese: Pożoloġija
English: InductOs is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: In addition, several non-clinical studies indicate that there is a negative feedback mechanism at the molecular level that limits bone induction by BMPs.
Maltese: Flimkien ma' dan, diversi studji mhux kliniċi jindikaw li hemm mekkaniżmu negattiv tal-feedback fil-livell molekulari, li jillimita l-formazzjoni ta' l-għadam induzzjoni mill-BMPs.
English: InductOs should not be used in patients with history or clinical suspicion of malignancy at the site of application (see section 4.3).
Maltese: InductOs m'għandux jintuża f'pazjenti bi storja medika jew suspett kliniku ta' tumur malinn fis-sit tal-applikazzjoni (ara sezzjoni 4.3).
English: Discard syringe and needle after use.
Maltese: Armi s-siringa u llabra wara l-użu.
English: Unknown
Maltese: ISEM
English: InductOs must not be implanted posterior to the lumbar interbody fusion device where direct access to the spinal canal and/or nerve root(s) is possible.
Maltese: InductOs m'għandux ikun impjantat wara t-tagħmir tal-fużjoni interkorporali lumbari fejn ikun possibbli aċċess dirett għall-kanal tas-sinsla tad-dahar u/jew l-għerq/għeruq tan-nerv.
English: − Keep this leaflet.
Maltese: Iċċaqlaqx bis-saħħa.
English: Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ml.
Maltese: Ġaladarba jkun ippreparat, InductOs ikun fih dibotermin alfa f'konċentrazzjoni ta' 1.5 mg/ml.
English: Do not shake.
Maltese: DATA TA' SKADENZA
English: • if you have an active infection at the surgery site.
Maltese: • jekk għandek infezzjoni attiva fis-sit tal-operazzjoni.
English: There is no information on the excretion of dibotermin alfa/metabolites in human milk.
Maltese: M'hemmx informazzjoni dwar l-eliminazzjoni ta' dibotermin alfa/metaboliti miill-ħalib tas-sider talbniedem.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Il-ġustifikazzjoni biex ma' jkunx inkluż il-Braille hija aċċettata
English: Efficacy information in tibia fracture is available only from controlled clinical trials in which open tibial fractures were treated using intramedullary nail fixation (see section 5.1).
Maltese: Informazzjoni dwar l-effikaċja fil-ksur tal-qasba tas-sieq, hi disponibbli biss mill-provi kliniċi biss li fihom ksur miftuħ tal-qasba tas-sieq kien ikkurat bl-użu ta' twaħħil permezz ta' msiemer intramedullari (ara sezzjoni 5.1).
English: It is concluded, therefore, that at the site of implantation, dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Maltese: Għalhekk, wieħed jista' jikkonkludi li fis-sit ta' l-impjantazzjoni, dibotermin alfa jintreħa bil-mod mill-matriċi u jitneħħa malajr meta jidħol fiċċirkolazzjoni sistemika.
English: How to store InductOs
Maltese: Kif gћandek tieћu InductOs
English: 09 December 2015 EMA/685398/2015
Maltese: EMA/685398/2015
English: Dried bilberry fruit EMA/895398/2015
Maltese: Frott tal-mirtillu EMA/895398/2015
English: Dried bilberry fruit
Maltese: Frott tal-mirtillu
English: Results from laboratory studies, although limited, indicate that the tannins in dried bilberry fruit have antimicrobial and astringent properties which can explain the traditional use of the dried fruit for treating mild diarrhoea and minor inflammation of the lining of the mouth.
Maltese: Ir-riżultati minn studji fil-laboratorju, għalkemm limitati, jindikaw li t-tannins fil-frott tal-mirtillu għandhom karatteristiċi antimikrobjali u astrinġenti li jistgħu jispjegaw l-użu tradizzjonali tal-frott imnixxef għall-kura ta' dijarea ħafifa u infjammazzjoni ħafifa tal-kisja tal-ħalq.
English: Dried bilberry fruit is the common name for the dried fruit of the plant Vaccinium myrtillus L. Dried bilberry fruit preparations are obtained by comminuting (reducing into tiny pieces) the ripe, dry fruit.
Maltese: Fiż-żmien tal-valutazzjoni tal-HMPC, ma kien ġie rrappurtat ebda effett sekondarju bil-mediċini li fihom il-frott tal-mirtillu.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Maltese: Għal informazzjoni dettaljata dwar l-istudji vvalutati mill-HMPC, ara r-rapport ta' valutazzjoni tal-HMPC.
English: Further information on the HMPC assessment of dried bilberry fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What are the risks associated with dried bilberry fruit medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-frott tal-mirtillu?
English: Further information on the risks associated with dried bilberry fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-frott tal-mirtillu, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fis-sit web tal-Aġenzija:
English: Dried bilberry fruit should only be used in adults and children over the age of 12 years.
Maltese: Il-frott tal-mirtillu għandu jintuża biss f'adulti u fi tfal ta' età 'l fuq minn 12-il sena.
English: The HMPC conclusions on the use of dried bilberry fruit medicines for treating mild diarrhoea and minor inflammation of the lining of the mouth are based on their ‘traditional use'.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom il-frott tal-mirtillu, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (All Documents') fis-sit elettroniku tal-Aġenzija:
English: The HMPC concluded that, on the basis of its long-standing use, dried bilberry fruit can be used for the treatment of mild diarrhoea and minor inflammation of the lining of the mouth.
Maltese: Il-konklużjonijiet tal-HMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt l-evalwazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini tal-ħxejjex li fihom il-frott imnixxef tal-mirtillu.
English: 95% Confidence Interval
Maltese: 95% Intervall ta' Kunfidenza
English: multicentre randomised trial.
Maltese: WHO multicentre randomised trial.
English: N total
Maltese: N totali
English: Similar analyses were performed.
Maltese: Twettqu analiżijiet simili.
English: Interval
Maltese: Kunfidenza
English: Scientific conclusions
Maltese: Konklużjoni ġenerali
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Maltese: Rata ta' tqala 0.00% 1.23% 1.29% 2.57%
English: LNG is a synthetic progestagen.
Maltese: LNG huwa proġestoġenu sintetiku.
English: Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
Maltese: Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
English: 1 von Hertzen H et al. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
Maltese: Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
English: 5 Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
Maltese: Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
English: Pregnancy rate 1.56% 0.96% 2.36% 5.19% Confidence
Maltese: Rata ta' tqala 1.56% 0.96% 2.36% 5.19% Intervall ta'
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO
Maltese: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a
English: Pregnancy rate 1.83% 0.99% 0.57% 1.17% Confidence
Maltese: Rata ta' tqala 1.83% 0.99% 0.57% 1.17% Intervall ta'
English: Contraception 2010; 82: 373-378.
Maltese: Contraception 2010; 82: 373-378. 4 Creinin MD et al.
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Maltese: Tabella 2: Meta-analiżi fuq studji ta' Creinin et al., 2006 u Glasier et al., 2010
English: The data used in the analyses of effect of UPA in relation to weight/BMI are partly based on the same studies two abovementioned studies for LNG, and another randomised controlled study (HRA2914-507, HRA2914-508, HRA2914-513) as well as an open label study (HRA2914-509).
Maltese: Id-dejta użata fl-analiżijiet tal-effett tal-UPA fir-rigward tal-piż/BMI hija parzjalment ibbażata fuq listess studji, żewġ studji msemmija hawn fuq għal LNG, u studju kkontrollat randomizzat (HRA2914-507, HRA2914-508, HRA2914-513) kif ukoll studju b'tikketta miftuħa (HRA2914-509).
English: Ulipristal acetate (UPA) (30 mg) (ellaOne) is an orally synthetic progesterone receptor modulator, which acts via high affinity binding to the human progesterone receptor.
Maltese: Ulipristal acetate (UPA) (30 mg) (ellaOne) huwa modulatur orali sintetiku tar-riċettur ta' proġesteron, li jaġixxi permezz ta' affinità għolja li jeħel mar-riċettur tal-proġesteron tal-bniedem.
English: Table 3: Meta-analysis on four clinical studies conducted with UPA
Maltese: Tabella 3: Meta-analiżi fuq erba' studji kliniċi mwettqa bl-UPA
English: For emergency contraception one tablet of 1.5 mg LNG needs to be taken, or two tablets of 0.75 mg LNG at once.
Maltese: Għal kontraċezzjoni ta' emerġenza, trid tittieħed pillola waħda ta' 1.5 mg LNG, jew żewġ pilloli ta' 0.75 mg LNG f'daqqa.
English: This is reflected in the wide range of estimates of prevented fraction across different studies.
Maltese: Dan huwa rifless fil-medda wiesgħa ta' stimi ta' frazzjoni evitata fi studji differenti.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for the emergency contraceptive medicinal products containing LNG or UPA.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għallprodotti mediċinali kontraċettivi ta' emerġenza li fihom LNG jew UPA.
English: Both meta-analyses excluded off-label use of LNG-containing of emergency contraceptives, i.e. intake later than 72 hours after unprotected intercourse and women who had further acts of unprotected intercourse.
Maltese: Iż-żewġ meta-analiżijiet eskludew l-użu ta' kontraċettivi ta' emerġenza li fihom LNG, jiġifieri teħid aktar tard minn 72 siegħa wara kopulazzjoni mhux protetta u nisa li kellhom atti oħra ta' kopulazzjoni mhux protetta.
English: A range of different factors have an impact on a woman´s fertility and the ability of emergency contraceptives to prevent a pregnancy, e.g. timing of intake of emergency contraception in relation to intercourse, conception probability, further acts of unprotected intercourse, age, ethnicity, previous infections of the genital tract, male fertility, etc.
Maltese: Medda ta' fatturi differenti għandhom impatt fuq il-fertilità tan-nisa u l-abbiltà ta' kontraċettivi ta' emerġenza biex jipprevjenu tqala, eż. l-għażla taż-żmien ta' teħid ta' kontraċettiv ta' emerġenza b'rabta mal-kopulazzjoni, il-probabbiltà ta' konċepiment, atti oħra ta' kopulazzjoni mhux protetta, letà, l-etniċità, infezzjonijiet preċedenti tal-passaġġ ġenitali, il-fertilità tal-irġiel, eċċ.
English: In addition the CHMP is of the opinion that conducting a pharmacodynamic/pharmacokinetic (PD/PK) study may provide some information which may help to further characterise the risk of decreased efficacy in women with high body weight/BMI and ovulation inhibition.
Maltese: Minbarra dan, is-CHMP huwa tal-opinjoni li t-twettiq ta' studju farmakodinamika/farmakokinetika (PD/PK) jista' jipprovdi xi informazzjoni li tista' tgħin biex tikkaratterizza r-riskju ta' tnaqqis fleffikaċja fin-nisa b'piż tal-ġisem/BMI għoli u inibizzjoni tal-ovulazzjoni.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) BMI (kg/m2)
Maltese: Tabella 1: Meta-analiżi fuq tliet studji tad-WHO (Von Hertzen et al., 1998 u 2002;
English: The use of emergency contraception is an occasional method that is far less effective compared with most contraceptive products used on a regular basis, e.g. combined hormonal contraceptives, gestagen-only pills and various long-acting methods like intra-uterine devices and implants.
Maltese: L-użu ta' kontraċezzjoni ta' emerġenza huwa metodu okkażjonali li huwa ferm anqas effikaċi meta mqabbel mal-biċċa l-kbira tal-kontraċettivi użati fuq bażi regolari, eż. kontraċettivi ormonali kkombinati, pilloli ta' gestagen biss u diversi metodi b'azzjoni fit-tul bħal tagħmir u impjanti ġewwa l-utru.
English: Eight relevant studies with LNG-containing emergency contraceptives are available in public literature.
Maltese: Tmien studji rilevanti b'kontraċettivi ta' emerġenza li fihom LNG huma disponibbli fiddokumentazzjoni pubblika.
English: In the three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) no trend for a reduced efficacy with increasing body weight/BMI was observed, whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI.
Maltese: Dada et al., 2010), ma kien osservat ebda tnaqqis fl-effikaċja b'piż tal-ġisem/BMI dejjem jiżdied, filwaqt li fiż-żewġ studji l-oħra (Creinin et al., 2006 u Glasier et al., 2010), kien osservat tnaqqis fl-effikaċja kontraċettiva b'piż tal-ġisem jew BMI dejjem jiżdied.
English: N pregnancies 1
Maltese: Anness II
English: The CHMP proposed that a warning in section 4.4 of the summary of product characteristics (SmPC) is an appropriate routine risk minimisation measure to reflect that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI.
Maltese: Is-CHMP ippropona li twissija f'sezzjoni 4.4 tas-sommarju tal-karatteristiċi tal-prodott (SmPC) hija miżura ta' minimizzazzjoni tar-riskju ta' rutina xierqa biex tirrifletti li hija preżenti dejta limitata u inkonklużiva dwar tnaqqis possibbli fl-effikaċja fin-nisa b'piż tal-ġisem/BMI għoli.
English: The products are indicated for emergency contraception within 72 hours (3 days) of unprotected sexual intercourse or contraceptive failure, and have been approved in more than 100 countries worldwide and used for more than 30 years.
Maltese: Il-prodotti huma indikati għal kontraċezzjoni ta' emerġenza fi żmien 72 siegħa (3 ijiem) ta' kopulazzjoni sesswali mhux protetta jew nuqqas ta' kontraċettiv, u ġew approvati f'aktar minn 100 pajjiż madwar id-dinja u użati għal aktar minn 30 sena.
English: In contrast, in the two comparative studies of Creinin and colleagues (2006) and Glasier and colleagues (2010), primarily including Caucasian women, a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2).
Maltese: colleagues (2006) u Glasier and colleagues (2010), li primarjament jinkludu nisa Kawkasi, kien osservat tnaqqis fl-effikaċja kontraċettiva flimkien ma' piż tal-ġisem jew BMI dejjem jiżdied (Tabella 2).
English: • The CHMP concluded that the available data is limited and does not support a definite conclusion that increased bodyweight reduces efficacy of emergency contraceptives medicinal products containing LNG or UPA.
Maltese: • Is-CHMP ikkonkluda li d-dejta disponibbli hija limitata u ma tappoġġjax konklużjoni definittiva li żieda fil-piż tal-ġisem tnaqqas l-effikaċja tal-prodotti mediċinali ta' kontraċettivi ta' emerġenza li fihom LNG jew UPA.
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one LNG-containing emergency contraceptive medicinal product (Norlevo).
Maltese: Flimkien, id-dejta attwali mhijiex ikkunsidrata b'saħħitha biżżejjed biex tappoġġja r-rakkomandazzjoni attwali fit-tnaqqis tal-effikaċja fin-nisa b'piż tal-ġisem ta' aktar minn 75 kg u ineffikaċja fin-nisa b'piż tal-ġisem ta' aktar minn 80 kg kif inhu inkluż attwalment fl-informazzjoni dwar il-prodott ta' prodott mediċinali kontraċettiv ta' emerġenza wieħed li fih LNG (Norlevo).
English: During the data submission an analysis was provided on three WHO studies (Von Hertzen et al., 1998 1 and 2002 2; Dada et al., 2010 3) as well as an analysis on two other studies (Creinin et al., 2006 4; Glasier et al., 2010 5).
Maltese: Dada et al., 2010 3) kif ukoll analiżi dwar żewġ studji oħra (Creinin et al., 2006 4; Glasier et al., 2010 5).
English: However, the analyses are based on a limited number of women, especially in the highest body weight/BMI categories, which subsequently result in very wide and overlapping 95% confidence limits.
Maltese: Madankollu, l-analiżijiet huma bbażati fuq numru limitat ta' nisa, speċjalment fil-kategoriji bl-ogħla piż tal-ġisem/BMI, li sussegwentement jirriżultaw f'medda wiesgħa ħafna u limiti ta' fiduċja ta' 95% li jikkoinċidu.
English: There are limited and inconclusive data from clinical trials that evaluated the effect of high body weight/high BMI on the contraceptive efficacy.
Maltese: Hemm dejta limitata u inkonklużiva minn provi kliniċi li evalwat l-effett ta' piż tal-ġisem għoli/BMI għoli fuq l-effikaċja kontraċettiva.