FrancophonIA/ELRC3.0 huggingface dataset:
English: Sponge:
Maltese: Sponża:
English: Figure 2: Preparation of TruScient sponges
Maltese: Stampa 2: Preparazzjoni tal-isponoż Truscient
English: 1348 Louvain-la-Neuve Belgium
Maltese: 1348 Louvain-la-Neuve
English: Zoetis Belgium SA Tél/Tel.
Maltese: Tél/Tel.:
English: Two sterile sponges 2.5 x 5 cm in a polyvinyl chloride (PVC) blister package sealed with a Tyvek lid.
Maltese: Żewġ sponoż sterili 2.5 x 5 cm f'pakkett tal-folja polyvinyl chloride (PVC) issiġilat b'għatu Tyvek.
English: *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Maltese: *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) hija proteina umana dderivata minn recombinant cell line tal-ovarja taċ-Chinese Hamster (CHO).
English: Date of first authorisation: 14/12/2011 Date of last renewal:
Maltese: Data tal-ewwel awtorizazzjoni: 14/12/2011 Data tal-aħħar tiġdid:
English: 1 vial (solvent)
Maltese: Vjala 1 (sovent)
English: Type I bovine collagen
Maltese: Collagen Bovine Tip I
English: 2 absorbable collagen sponges 2 sterile 3 ml disposable syringes with needles 1 sterile 6 ml disposable syringe with needle
Maltese: 2 sponoż collagen assorbibbli 2 siringi sterili għal użu ta' darba 3 ml b'labar Siringa 1 sterili għal użu ta' darba 6 ml b'labar
English: Do not use more than 3.2 ml.
Maltese: Tużax aktar minn 3.2 ml.
English: Sodium hydroxide (pH adjustment agent) Hydrochloric acid (pH adjustment agent)
Maltese: Sodium hydroxide (aġent biex jaġġusta l-pH) Aċidu idrokloriku (aġent biex jaġġusta l-pH)
English: 1 vial (lyophilisate)
Maltese: Vjala 1 (lijofiliżżat)
English: Spain
Maltese: España
English: Glutamic acid
Maltese: Aċidu glutamiku
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Rue Laid Burniat 1
English: Kit for implant
Maltese: Kit għall-impjant
English: TruScient should be used by an appropriately qualified veterinarian.
Maltese: TruScient għandu jintuża minn veterinarju kkwalifikat.
English: TruScient is intended for single use only.
Maltese: TruScient huwa intenzjonat għal użu ta' darba.
English: Development of BMP-2 antibodies occurred in 6.9% of dogs receiving TruScient vs. 4.3% of dogs in the control group.
Maltese: L-iżvilupp ta' antikorpi BMP-2 seħħ f'6.9% tal-klieb li ħadu TruScient vs. 4.3% tal-klieb fil-grupp ta' kontroll.
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats.
Maltese: Il-half-life terminali ta' dibotermin alfa meta injettata fil-vina kienet 16-il minuta fil-ġrieden.
English: B. Prepare TruScient sponges in the sterile field:
Maltese: Ipprepara l-isponoż TruScient f'ambjent sterili:
English: The efficacy and safety of the veterinary medicinal product for the treatment of diaphyseal fractures was evaluated in a randomised, controlled, multicenter clinical field study involving dogs randomised to treatment with the veterinary medicinal product plus Standard Of Care (SOC) [n=84] or SOC [n=42] alone.
Maltese: L-effikaċja u s-sigurtà tal-prodott mediċinali veterinarju għat-trattament ta' ksur tal-għadam it-twil ġew evalwati fi studju kliniku randomised, ikkontrollat u f'ħafna ċentri li involvew klieb randomised għat-trattament bil- prodott mediċinali veterinarju flimkien ma' Standard of Care (SOC) [n=84] jew SOC [n=42] waħdu.
English: The safety, including potential immune responses and effectiveness of repeat TruScient administration have not been evaluated in dogs.
Maltese: Is-sigurtà, li tinkludi il-potenzjal ta' effetti immunoloġiċi, u l-effiċenza ta' amministrazzjonijiet ripetuti, ma ġewx evalwati fil-klieb.
English: TruScient 0.66 mg kit for implant for dogs
Maltese: TruScient 0.66 mg kit għall-impjantazzjoni ghall-klieb.
English: Figure 1: Reconstitution of dibotermin alfa (rhBMP-2)
Maltese: Stampa 1: Rikostituzzjoni ta' dibotermin alfa (rhBMP-2)
English: Tel: +34 91 4909900
Maltese: Zoetis Spain, S.L. Tel: +34 91 4909900
English: TruScient 0.66 mg kit for implant for dogs dibotermin alfa (rhBMP-2)
Maltese: TruScient 0.66 mg kit għall-impjantazzjoni ghall-klieb. dibotermin alfa (rhBMP-2)
English: Sponge: Bovine Type I collagen
Maltese: Collagen bovine Tip I
English: 10 ml Do not use more than 3.2 ml for reconstitution
Maltese: 10 ml Tużax aktar minn 3.2 ml għar-rikostituzzjoni
English: LYOPHILISATE VIAL LABEL
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: 10 ml Type I glass vial with a chlorobutyl elastomeric closure sealed with an aluminum flipoff seal and plastic cap.
Maltese: Vjala ta' 10 ml ta' ħġieġ Tip I b'għeluq ta' chlorobutyl elastomer b'siġill flip-off tal-aluminju u kappa tal-plastik.
English: In animal studies (rats) using radiolabelled dibotermin alfa on absorbable collagen sponge, the mean residence time at the site of implantation was 4-8 days.
Maltese: Fi studji fuq l-annimali (ġrieden) fejn intuża radiolabelled dibotermin alfa fuq sponża tal-collagen assorbibbli, iż-żmien medju ta' kemm damet filpost tal-impjantazzjoni kien 4-8 ijiem.
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Maltese: L-ogħla livelli ta' dibotermin alfa fiċ-ċirkolazzjoni (0.1% taddoża ippjantata) dehru fi żmien 6 siegħat wara l-impjantazzjoni.
English: Република България Zoetis Luxembourg Holding Sarl Teл: +359 2 970 41 72
Maltese: Slovenská republika Zoetis Luxembourg Holding Sarl, o.z. Tel: +421 2 5939 6190
English: The recommended dose is up to two sponges (2.5 x 5 cm) per dog.
Maltese: Id-doża rrakkomandata hija sa żewġ sponoż (2.5 x 5 cm) għal kull kelb.
English: Gently swirl
Maltese: TWISSIJIET SPEĊJALI
English: 10 ml Type I glass vial with a bromobutyl elastomeric closure sealed with an aluminum flipoff seal and plastic cap.
Maltese: Vjala ta' 10 ml ta' ħġieġ Tip I b'għeluq ta' bromobutyl elastomer b'siġill flip-off tal-aluminju u kappa tal-plastik.
English: As dibotermin alfa (rhBMP-2) is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Maltese: Minħabba l-fatt li dibotermin alfa (rhBMP-2) hija proteina li ma ġietx identifikata fiċ-ċirkolazzjoni ġenerali, x'aktarx li mhix kandidat għal interazzjoni farmakokinetika bejn mediċini.
English: Using aseptic transfer technique and for each 3 ml syringe with needle, withdraw 1.4 ml from the reconstituted vial of dibotermin alfa (rhBMP-2) in the non-sterile field.
Maltese: Bl-użu ta' teknika asettika ta' trasferiment u għal kull siringa ta' 3 ml bil-labra, iġbed 1.4 ml mill-vjali bid-dibotermin alfa (rhBMP-2) irrikostitwit fl-ambjent mhux sterili.
English: Veterinary medicinal product subject to prescription.
Maltese: Armi il-prodott mediċinali veterinarju li ma jiġix użat.
English: : +30 210 6785800 España
Maltese: Zoetis Hellas S.A. Τηλ.: +30 210 6785800
English: After reconstitution TruScient contains 0.2 mg/ml of dibotermin alfa (rhBMP-2)
Maltese: Wara r-rikostituzzjoni TruScient fih 0.2 mg/ml dibotermin alfa (rhBMP-2)
English: Irrigation will wash away the dibotermin alfa (rhBMP-2) solution.
Maltese: Bl-irrigazzjoni is soluzzjoni tad-dibotermin alfa (rhBMP-2) titlaq.
English: Solvent for TruScient Water for injections
Maltese: Solvent għal TruScient Ilma għal injezzjonijiet
English: Seroma, excessive licking of incision area, joint stiffness, local swelling, skin ulcer, incisional discharge, incisional dehiscence.
Maltese: Seroma, annimal jilgħaq b'mod eċċessiv iż-żona tal-inċiżjoni, għebusija tal-ġogi, nefħa lokali, ulċera tal-ġilda, tnixxija tal-inċiżjoni, l-inċiżjoni ma tagħlaqx.
English: Using sterile technique, transfer the two 3 ml syringes with needles and the sponges inner package into the sterile field.
Maltese: Bl-użu ta' teknika sterili, ittrasferixxi iż-żewġ siringi ta' 3 ml bil-labar u l-pakkett intern bl isponoż għal ġol-ambjent sterili.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/
English: Use the prepared sponge(s) within 15 minutes to 2 hours of wetting the sponges.
Maltese: Stenna għal MINIMU ta' 15-il minuta qabel tuża l-isponoż ippreparati.
English: One vial of lyophilisate contains 0.66 mg of dibotermin alfa (rhBMP-2) After reconstitution, TruScient solution contains 0.2 mg/ml of dibotermin alfa (rhBMP-2).
Maltese: Vjala waħda ta' lijofiliżżat fiha 0.66 mg dibotermin alfa (rhBMP-2) Wara r-rikostituzzjoni, soluzzjoni TruScient fih 0.2 mg/ml dibotermin alfa (rhBMP-2)
English: Using the 6 ml syringe and needle withdraw 3.2 ml of solvent (more solvent is supplied than is needed).
Maltese: Bis-siringa ta' 6 ml u l-labra iġbed 3.2 ml tas-solvent (hemm aktar solvent milli tiġi bżonn).
English: The influence of anti-BMP-2 antibody formation on foetal development has not been assessed.
Maltese: L-influwenza tal-formazzjoni ta' antikorpi anti-BMP-2 fuq l-iżvilupp tal-fetu ma' ġietx assessjata.
English: Lyophilisate:
Maltese: Lijofiliżzat:
English: Store in the original package.
Maltese: Aħżen fil- pakkett oriġinali
English: The dibotermin alfa (rhBMP-2) is reconstituted to 0.2 mg/ml solution and then distributed uniformly across both sponges.
Maltese: Id-dibotermin alfa (rhBMP-2) tiġi rikostitwita għal soluzzjoni ta' 0.2 mg/ml u imqassma b'mod uniformi fuq iż-żewġ sponoż.
English: Each kit contains:
Maltese: Kull kit fih:
English: These swellings are the result of local proliferation of mesenchymal tissue maturing to new bone and are consistent with the pharmacologic activity of rhBMP-2
Maltese: Dawn in-nefħiet huma riżultat ta' proliferazzjoni tat-tessuti mesenkimali li jkunu qed jimmaturaw f'għadam ġdid u huma konsistenti mal-attività farmakoloġika ta' rhBMP-2.
English: A. Reconstitute dibotermin alfa (rhBMP-2) in a non-sterile field: 1.
Maltese: Irrikostitwixxi id-dibotermin alfa (rhBMP-2) f'ambjent mhux sterili: 1.
English: Uncommon (more than 1 but less than 10 animals in 1000 animals) Mild to moderate Exuberant bony callus associated with persistent (>10 weeks) moderate soft tissue swelling and excessive licking of the incision area.
Maltese: Mhux komuni (aktar minn 1 imma anqas minn 10 f'1000 annimal) Ħafif għal moderat Kallu tal-għadam esuberanti assoċjat ma' nefħa moderata u persistenti (>10 ġimgħat) tattessuti rotob u l-annimal jilgħaq b'mod eċċessiv iż-żona tal-inċiżjoni
English: While there was a treatment-related reduction in time to radiographic fracture union, there was no difference over time between the TruScient treated group and the control group for the individual clinical parameters, lameness and pain, or for an overall score based on clinical signs of fracture healing.
Maltese: Filwaqt li kien hemm tnaqqis fiż-żmien għall-għaqda radjografika tal-frattura relatata mat-trattament, ma kien hemm l-ebda differenza fiż-żmien bejn il-grupp ittrattat b'TruScient u l-grupp ta' kontroll għal parametri individwali, zappip u uġiegħ, jew għall-overall score ibbażat fuq sinjali kliniċi talfejqan tal-ksur.
English: One sterile 6 ml disposable polypropylene syringe with stainless steel needle attached.
Maltese: Siringa wahda sterili għal użu ta' darba 6 ml ta' polypropylene b'labra tal-istainless steel imqabbda magħha.
English: TruScient is active at the site of implantation.
Maltese: TruScient huwa attiv fil-post tal-impjantazzjoni.
English: Achieve definitive fracture reduction, fixation, and hemostasis prior to placement of the prepared sponge.
Maltese: Ilħaq reduzzjoni definitiva tal-ksur, fisazzjoni u emostażi qabel it-tqegħid tal-isponoż ippreparati.
English: Very common (more than 1 in 10 animals) Mild to moderate Lameness Firm swelling within the first 3 weeks postoperatively which recedes gradually over several months Soft swelling which recedes within 3 weeks
Maltese: Komuni ħafna (aktar minn 1 f'10 annimali) Ħafif għal moderat Zappip Nefħa iebsa fi żmien l-ewwel 3 ġimgħat wara l-operzzjoni li tonqos bil-mod fi żmien ħafna xhur.
English: The maximum recommended dosage is the entire contents of a single TruScient kit for each dog (i.e., up to two 2.5 x 5 cm prepared TruScient sponges per dog).
Maltese: Id-doża massima rakkomandata hija il-kontenut sħiħ ta' TruScient kit wieħed għal kull kelb (i.e. sa żewġ sponoż TruScient ippreparati 2.5 x 5 cm għal kull kelb).
English: Dibotermin alfa (rhBMP-2) is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Maltese: Dibotermin alfa (rhBMP-2) hija proteina ostjo-induttiva li twassal għal formazzjoni ta' għadam ġdid fil-post tal-impjantazzjoni.
English: BMP-2 plays a critical role during foetal development.
Maltese: BMP-2 għandu rwol kritiku fl-iżvilupp tal-fetu.
English: Lameness
Maltese: Klieb
English: Sodium chloride
Maltese: Kloru tas-sodju
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Disinfect with alcohol the stoppers of the lyophilisate and the solvent vials.
Maltese: Iddisinfetta bl-alkoħol it-tappijiet tal-vjali tal-lijofiliżżat u tas-solvent.
English: Common (more than 1 but less than 10 animals in 100 animals) Mild to moderate
Maltese: Komuni (aktar minn 1 imma anqas minn 10 f'100 annimal) Ħafif għal moderat
English: One vial of lyophilisate contains:
Maltese: Vjala waħda ta' lijofiliżżat fiha:
English: The kit also includes:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Slowly inject the 3.2 ml of solvent into the lyophilisate vial (see Figure 1) to achieve a 0.2 mg/ml solution of rhBMP-2.
Maltese: Injetta bil-mod it-3.2 ml solvent fil-vjala tal-lijofiliżżat (ara Stampa 1) biex twassal għal soluzzjoni ta' 0.2 mg/ml ta' rhBMP-2.
English: The following adverse reactions have been observed in laboratory studies in dogs: o Heterotopic ossification of the surrounding tissues o Exuberant bone formation at the site of placement and ectopic bone formation o Excessive bone and fluid filled cysts that remodel into normal bone over time o Increased swelling at the site of placement has been observed by 2-3 weeks post surgery.
Maltese: Għalkemm fi studji kliniċi u fi studji ta' sigurtà ma ġewx osservati rabtiet ċari mar-riżultat kliniku u effetti mhux mixtieqa, wieħed ma jistax jeskludi il-possibilità ta' żvilupp ta' antikorpi li jinnewtraliżżaw jew reazzjonijiet ipersensittivi.
English: C. Implantation
Maltese: Impjantazzjoni
English: Pharmacotherapeutic group: Bone Morphogenetic Proteins ATCvet code: QM05BC01
Maltese: Maż-żmien l-għadam eċċessiv u ċ-ċesti mimlija b'likwidu jirrimodellaw f'għadam normali.
English: Very common (more than 1 in 10 animals) Mild to moderate
Maltese: Mhux komuni (aktar minn 1 imma anqas minn 10 f'1000 annimal) Ħafif għal moderat
English: Use care to ensure that accurate volumes are used in reconstitution and application of the dibotermin alfa (rhBMP-2) solution to the sponge.
Maltese: Uża l-attenzjoni biex tiżgura li jintużaw volumi eżatti fir-rikostituzzjoni u l-applikazzjoni tas-soluzzjoni tad-dibotermin alfa (rhBMP-2) fuq lisponża.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life in the vial after reconstitution according to directions: 3 hours Discard any unused veterinary medicinal product.
Maltese: Żmien li l-prodott jibqa' tajjeb fil-vjala wara li jiġi rikostitwit: 3 siegħat Armi il-prodott mediċinali veterinarju li ma jiġix użat.
English: Both rhBMP-2 and bovine Type I collagen can elicit an immune response in dogs.
Maltese: Kemm rhBMP-2 kif ukoll collagen bovine Tip I iwettqu rispons immunoloġiku fil-klieb.
English: The ability of TruScient to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by TruScient with that of the surrounding bone.
Maltese: Il-kapaċità ta' TruScient biex jissapportja r-rimodellar tal-għadam tista' tkun responsabbli għallintegrazzjoni bioloġika u biomekkanika tal-għadam il-ġdid iffurmat minn TruScient mal-għadam talmadwar.
English: SOLVENT VIAL LABEL
Maltese: DAQS TAL-PAKKETT
English: - exuberant bone formation at the site of placement and ectopic bone formation
Maltese: Istruzzjonijiet għall-preparazzjoni u l-użu
English: For reconstitution.
Maltese: U KWANTITATTIVA
English: - heterotopic ossification of the surrounding tissues
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: Two sponges made of Bovine Type I collagen.
Maltese: Żewġ sponoż magħmula minn collagen Bovine Tip I.
English: Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy.
Maltese: Tużax fi klieb li għandhom skeletru immature, għandhom infezzjoni fil-post tal-operazzjoni, ksur patoloġiku, jew kanċer malinn.
English: Biomechanical data suggest these voids had little influence on the biomechanical properties of the induced bone or its integration with the abutting cortices.
Maltese: TruScient ma jipprovdix stabilità mekkanika u m'għandux jintuża biex jimtlew spazji fejn hemm forzi kompressivi.
English: Zoetis Lietuva UAB Tel: +370 525 12029
Maltese: Tel: +370 525 12029
English: Ctra.
Maltese: Tasarx.
English: Severe
Maltese: IEĦOR
English: The two important criteria were:
Maltese: Iż-żewġ kriterji importanti kienu:
English: • testosterone levels below castration for both products.
Maltese: • livelli ta' testosteron taħt dak ta' kastrazzjoni għaż-żewġ prodotti.
English: CHMP's position
Maltese: Il-pożizzjoni tas-CHMP
English: During the GCP inspection 19 findings were identified, of which 9 were classified as critical, 7 as major, and 3 as minor.
Maltese: Matul l-ispezzjoni tal-GCP ġew identifikati 19-il konklużjoni, li 9 minnhom kienu kklassifikati bħala kritiċi, 7 bħala maġġuri, u 3 bħala minuri.
English: Overall summary of the scientific evaluation of Goserelin cell pharm 3,6 mg Implantat and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Goserelin cell pharm 3,6 mg Implantat u lismijiet assoċjati (ara Anness I)
English: The contract laboratory performed the analysis of the plasma samples for the clinical studies GOS/001/C and GOS/002/C.
Maltese: Il-laboratorju taħt kuntratt wettaq lanaliżi tal-kampjuni tal-plasma għall-istudju kliniċi GOS/001/C u GOS/002/C.
English: Considering the above, the CHMP is of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Maltese: Meta qies dan kollu, is-CHMP kien tal-opinjoni li d-dettalji sottomessi b'appoġġ għall-applikazzjoni ma jikkonformawx mal-Artikolu 10 tad-Direttiva 2001/83/KE kif emendata.
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormone-depending prostate carcinoma.
Maltese: Huwa antagonist LHRH (analogu tal-ormon naturali li jirrilaxxa l-ormon lewtanizzanti) u jrażżan it-testosteron fis-serum għal-livell ta' kastrazzjoni biex jinibixxi t-tkabbir talkarċinoma tal-prostata li hija dipendenti fuq l-ormon.
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Goserelin cell pharm 3,6 mg Implantat and associated names as listed in Annex I.
Maltese: • Il-Kumitat ikkunsidra r-riferiment mibdi taħt l-Artikolu 36 tad-Direttiva 2001/83/KE għal Goserelin cell pharm 3,6 mg Implantat u l-ismijiet assoċjati kif elenkati f'Anness I.
English: • comparable AUC of testosterone after sufficient treatment days for MAH's product and comparator
Maltese: • AUC komparabbli ta' testosteron wara ġranet suffiċjenti ta' kura bil-prodott tal-MAH u lkomparatur
English: Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Maltese: Minħabba li l-livelli ta' testosteron mkejla kienu jew taħt jew viċin il-limitu ta' kwantitazzjoni (0.1 ng/ml) u b'mod ċar taħt il-livell ta' kastrazzjoni ta' 0.5 ng/ml l-effikaċja klinika hija assigurata anki jekk ilmetodu analitiku mhuwiex preċiż biżżejjed.
English: These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Maltese: Dawn kienu jinkludu validazzjoni insuffiċjenti tal-metodi bijoanalitiċi, it-tneħħija ta' dejta mhux ipproċessata permezz ta' injezzjoni mill-ġdid ta' kampjuni, inkonsistenza firreintegrazzjoni manwali ta' kromatogrammi, nuqqas ta' kriterji kruċjali ta' aċċettazzjoni għall-analiżi u immaniġġjar insuffiċjenti tal-kwalità mill-isponsor.
English: MAH's position
Maltese: Il-pożizzjoni tal-MAH
English: The performance of a GCP-valid clinical and bioanalytical study is required to support application under such legal basis.
Maltese: Il-prestazzjoni ta' studju kliniku u bjoanalitiku validu għall-GCP hija meħtieġa biex tappoġġa applikazzjoni taħt tali bażi legali.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1-month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Maltese: Matul l-analiżi bijoanalitika tal-kampjuni tad-demm kemm minn GOS/001 (formulazzjoni depot ta' xahar 1) u GOS/002 (formulazzjoni depot ta' xahar 1 u ta' 3 xhur) inkixfu vjolazzjonijiet kritiċi fl-istandards fundamentali tal-ICH GCP u fl-istandards tal-laboratorju aċċettati fuq livell internazzjonali.
English: It was the aim of the inspection to verify whether the clinical studies GOS/001/C and GOS/002/C were conducted in compliance with GCP and applicable regulations and whether the validity and quality of the submitted data are adequate.
Maltese: L-għan talispezzjoni kien li tivverifika jekk l-istudji kliniċi GOS/001/C u GOS/002/C kinux saru f'konformità malGCP u mar-regolamenti applikabbli u jekk il-validità u l-kwalità tad-dejta sottomessa humiex xierqa.
English: Goserelin is among others, authorised for patients with advanced prostate cancer where an endocrine treatment is indicated.
Maltese: Goserelin huwa fost l-oħrajn, awtorizzat għall-pazjenti bil-kanċer tal-prostata avvanzat fejn hija indikata kura endokrinali.
English: Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Maltese: Aspetti importanti bħad-diffikultà ta' livelli endoġeniċi ta' testosteron fil-plasma blank tan-nisa kienu kkunsidrati biss fir-rapport ta' validazzjoni retrospettiva b'ittestjar addizzjonali fuq jew matriċi ttrattati minn qabel jew magħżula minn qabel.
English: Due to the observed critical and major findings in the studies GOS/001/C and GOS/002/C, a GCP compliant conduct could not be confirmed.
Maltese: Minħabba s-sejbiet kritiċi u maġġuri osservati flistudji GOS/001/C u GOS/002/C, ma setgħetx tiġi kkonfermata kondotta konformi mal-GCP.
English: Scientific conclusions and grounds for suspension of the marketing authorisation(s) presented by the EMA
Maltese: Konklużjonijiet xjentifiċi u r-raġunijiet għas-sospensjoni talawtorizzazzjoni(ijiet) għat-tqegħid fis-suq ippreżentati mill-EMA