FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Tredaptive declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Maltese: Fil-pazjenti li komplew fl-ewwel studju (24 ġimgħa), il-frekwenza ta' fawra moderata jew akbar f'pazjenti trattati bi Tredaptive naqset jew avviċinat dik tal-pazjenti li rċevew plaċebo (ara Figura 1), filwaqt li fil-pazjenti trattati bl-aċidu nikotiniku (formulazzjoni li terħi lmediċina bil-mod) il-frekwenza tal-fwawar baqgħet kostanti (wara Ġimgħa 6).
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Maltese: Dieti u trattamenti oħra mhux farmakoloġiċi (eż. eżerċizzju, tnaqqis fil-piż) għandhom jitkomplew matul it-terapija bi Tredaptive.
English: Adverse reaction
Maltese: Tqala Tredaptive
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Tredaptive experienced significantly more flushing than patients who continued taking Tredaptive in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Maltese: Studju ta' 32 ġimgħa, b'ħafna ċentri, randomised, double-blind, ikkontrollat bil-plaċebo, biex jevalwa l-effetti ta' twaqqif ta' laropiprant wera li pazjenti dislipidemiċi fejn laropitant twaqqaf wara li kienu ilhom 20 ġimgħa fuq Tredaptive kellhom b'mod sinifikanti aktar fwawar minn pazjenti li komplew jieħdu Tredaptive bħala numru ta' ġranet fil-ġimgħa bi fwawar moderati jew aktar, p< 0.001, Figura 2.
English: Tredaptive contains lactose
Maltese: Karatteristiċi fil-pazjenti
English: It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Tredaptive co-administered with simvastatin or ezetimibe/simvastatin.
Maltese: F'każ ta' doża eċċessiva, huwa raġonevoli li jintużaw il-miżuri sintomatiċi u supportivi tas-soltu.
English: Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Maltese: Laropiprant ġie muri li huwa effettiv biex inaqqas is-sintomi ta' fawra indotti mill-aċidu nikotiniku.
English: For patients switching from immediate-release nicotinic acid to Tredaptive, therapy should be initiated at the 1,000 mg/20 mg dose and advanced to the 2,000 mg/40 mg maintenance dose after four weeks.
Maltese: Fil każ tal-pazjenti li jaqilbu minn aċidu nikotiniku ta' rilaxx immedjat għal Tredaptive, it-terapija għandha tinbeda bid-doża ta' 1,000 mg/20 mg u tgħaddi għad-doża ta' manteniment ta' 2,000 mg/40 mg wara erba' ġimgħat.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
Maltese: • Evita li tixrob alkoħol jew xarbiet sħan jew li tiekol ikel pikkanti qrib il-ħin meta għandek tieħu Tredaptive.
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Tredaptive experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2,000 mg titration) (p< 0.001).
Maltese: Fit-tieni studju (16-il ġimgħa) fejn kien permess l-acetylsalicylic acid, il-pazjenti li ħadu Tredaptive esperjenzaw ġranet konsiderevolment inqas fil-ġimgħa b'fawra moderata jew akbar meta mqabbel ma' l-aċidu nikotiniku (formulazzjoni li terħi l-mediċina bil-mod meħuda bħala titrazzjoni multi-step ta' 500 mg għal 2,000 mg fuq tnax-il ġimgħa)
English: Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Maltese: Laropiprant jitneħħa prinċipalment permezz ta' acyl glucuronidation, segwita mill-eskrezzjoni tal glucuronide fl-ippurgar (permezz tal-bile) u l-awrina.
English: Effects of other medicinal products on nicotinic acid Bile acid sequestrants: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Maltese: Effetti ta' prodotti mediċinali oħra fuq l-aċidu nikotiniku Sekwestranti ta' l-aċidu biljari: Minħabba li l-għoti fl-istess ħin ta' sekwestranti ta' l-aċidu biljari jista' jnaqqas il-bijodisponibilità ta' prodotti mediċinali aċidużi bħall-aċidu nikotiniku, huwa rakkomandat li Tredaptive jingħata > siegħa qabel jew > 4 sigħat wara l-għoti ta' sekwestrant ta' laċidu biljari.
English: Some people get dizzy after taking Tredaptive.
Maltese: Xi nies jistordu wara li jieħdu Tredaptive.
English: Cases of overdose have been reported; the maximum dose of Tredaptive taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Maltese: Ġew irrappurtati każi ta' doża eċċessiva; l-akbar doża ta' Tredaptive li ttieħdet kienet 5,000 mg/100 mg.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Maltese: farmakoviġilanza ppreżentata f' Modulu 1.8.1 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott mediċinali jkun fis-suq.
English: In an interim analysis of an ongoing clinical outcome study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking Tredaptive and simvastatin 40 mg.
Maltese: F'analiżi interim tar-riżultati kliniċi ta' studju li għadu għaddej, kumitat indipendenti ta' monitoraġġ tas-sigurtà identifika inċidenza ogħla milli mistennija ta' mijopatija f'pazjenti Ċiniżi li kienu qegħdin jieħdu Tredaptive u simvastatin 40 mg.
English: Opaque PVC/Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
Maltese: Folja opaka tal-PVC/Aclar mgħottija b'aluminju push-through f'pakketti ta' 14, 28, 56, 84, 98, 168
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Maltese: Rari: acanthosis nigricans; iperpigmentazzjoni; għaraq (bil-lejl
English: Nicotinic acid is predominantly excreted in the urine as metabolites.
Maltese: L-aċidu nikotiniku jitneħħa prinċipalment fl-awrina bħala metaboliti.
English: The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day.
Maltese: Id-doża tal-bidu hija pillola waħda li terħi l-mediċina b'mod modifikat (1,000 mg aċidu nikotiniku/20 mg laropiprant) darba kuljum.
English: See also point 4.4.
Maltese: Ara wkoll il-punt 4.4.
English: Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
Maltese: 13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
English: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21.
Maltese: VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21.
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emergenza, antidoti):
English: It may be possible to palpate the implant in situ.
Maltese: Jista' jkun possibbli li tħoss l-impjant in situ.
English: 2 implants preloaded in implanters + 1 actuator 5 implants preloaded in implanters + 1 actuator
Maltese: 2 impjanti kkargati fl-impjantaturi + attwatur 1 5 impjanti kkargati fl-impjantaturi + attwatur 1
English: Date of latest renewal: 17/05/2017
Maltese: Data tal-aħħar tiġdid: 17/05/2017
English: Polska VIRBAC Sp. z o.o.
Maltese: VIRBAC Sp. z o.o.
English: In rare cases (>0.01 % to < 0.1%), suspected lack of expected efficacy has been reported (in the majority of cases a lack of reduction of testicle size was reported and/or a bitch was mated).
Maltese: F'każijiet rari (>0.01 % sa < 0.1%), ġie rrapportat suspett ta' nuqqas ta' effikaċja mistennija (filmaġġoranza tal-każijiet ġie rrapportat nuqqas ta' tnaqqis tad-daqs tat-testikoli u/jew kelba ġiet mgħammra.
English: The metabolism of deslorelin is rapid.
Maltese: Il-metaboliżmu ta' deslorelin huwa rapidu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Maltese: Sustanza attiva:
English: Levels of testosterone remain below 0.1 ng/ml for at least 16 months.
Maltese: Il-livelli tat-testosterone jibqgħu taħt 0.1 ng/ml għal mill-inqas 16-il xahar.
English: Remove Luer Lock cap from the implanter.
Maltese: konnessjoni Luer Lock.
English: Implants may be located using ultrasound.
Maltese: L-impjanti jistgħu jiġu lokalizzati permezz ta' mewġ ultrasoniku.
English: Deslorelin (as deslorelin acetate)
Maltese: Deslorelin (bħala deslorelin acetate)
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini: http://www.ema.europa.eu
English: In very rare cases, a testicle may be able to ascend the inguinal ring.
Maltese: F'każijiet ferm rari, jista' jkun li testikola tista' tinżel fir-ring ingwinali.
English: ROUTE(S) OF ADMINISTRATION Subcutaneous route
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: EU/2/07/072/004
Maltese: EU/2/07/072/003 EU/2/07/072/004
English: Infertility is achieved from 8 weeks up to at least 12 months after initial treatment.
Maltese: L-infertilità tinkiseb minn 8 ġimgħat sa tal-anqas 12-il xahar wara t-trattament inizjali.
English: This suppression results in the failure of treated animals to synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the hormones responsible for the maintenance of fertility.
Maltese: Dan it-trażżin jirriżulta fil-falliment tal-annimali trattati li jissintesizzaw u/jew jerħu follicle stimulating hormone (FSH) u luteinising hormone (LH), l-ormoni li huma responsabbli għaż-żamma tal-fertilità.
English: Not all parameters of sexual activity have been tested specifically (seborrhoea, urine marking and aggressiveness).
Maltese: Mhux il-parametri kollha tal-attività sesswali ġew ittestjati speċifikament (seborea, immarkar bl-urina u aggressività).
English: The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
Maltese: L-agonista ta' GnRH, deslorelin, jaħdem billi jrażżan il-funzjoni tal-assi pitwitarju-gonadali meta jkun applikat f'doża baxxa kontinwa.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues.
Maltese: Grupp farmakoterapewtiku: ormoni u analogi pitwarji u ipotalamiċi.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - Komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - Mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1000 annimal) - Rari (aktar minn wieħed iżda inqas minn 10 annimali f'10 000 annimal) - Rari ħafna (inqas minn annimal wieħed f' 10 000 annimal, inklużi rapport iżolati).
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' tiżmin
English: During the treatment period, rare clinical effects have been reported: hair coat disorders (e.g. hair loss, alopecia, hair modification), urinary incontinence, down-regulation associated signs (decrease in testicle size, reduced activity).
Maltese: Matul il-perjodu tat-trattament, ġew irrapportati effetti kliniċi rari: disturbi fil-pil (eż. telf tal-pil, alopeċja, modifika tal-pil), inkontinenza tal-urina, sinjali assoċjati mas-sottoregolazzjoni (eż. tnaqqis fid-daqs tat-testikoli, attività mnaqqsa).
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Maltese: Ormoni u analogi pitwitarji u ipotalamiċi, ormoni li jirrilaxxaw il gonadotrofin (GnRH), Kodiċi ATC veterinarja:
English: In very rare cases, the temporary infertility may last more than 18 months.
Maltese: F'każijiet rari ħafna l-infertilità temporanja tista' ddum aktar minn 18-il xahar.
English: The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs, libido and spermatogenesis and lower the plasma testosterone levels, from 4-6 weeks after implantation.
Maltese: Id-doża baxxa u kontinwa ta' deslorelin tnaqqas il-funzjonalità tal-organi riproduttivi tar-raġel, il-libido u l-ispermatoġenesi u tnaqqas il-livell ta' testosterone fil-plażma, minn 4-6 ġimgħat wara l-impjantazzjoni.
English: Dogs:
Maltese: Teл:
English: Only testosterone levels (i.e. an established surrogate marker of fertility) could definitely confirm a lack of efficacy of the treatment.
Maltese: Il-livelli ta' testosterone biss (jiġifieri markatur sostitut stabbilit ta' fertilità) setgħu jikkonfermaw b'mod definittiv nuqqas ta' effikaċja tat-trattament.
English: Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction of infection.
Maltese: Id-disinfezzjoni tas-sit tal-impjantazzjoni għandha ssir qabel l-impjantazzjoni biex tiġi evitata l introduzzjoni ta' infezzjoni.
English: Hydrogenated palm oil Lecithin
Maltese: Żejt tal-palma idroġenizzat Leċitina
English: Ferrets:
Maltese: Nimsa:
English: With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials more than 80 % of dogs administered one or more implants, returned to normal plasma testosterone levels (≥0.4 ng/ml) within 12 months of implantation.
Maltese: Fir-rigward ta' livelli ta' testosterone (marka stabbilita sostituta għal kejl tal-fertilità), waqt provi kliniċi aktar minn 80 % ta' klieb li tqegħdilhom impjant wieħed jew aktar, irritornaw għal-livelli normali ta' testosterone fil-plażma (≥0.4 ng/ml) fi żmien 12-il xahar mill-impjantazzjoni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/07/2007
Maltese: Data tal-ewwel awtorizazzjoni: 10/07/2007
English: Moderate swelling at the implant site was observed observed for 14 days during safety/efficacy studies.
Maltese: Nefħa moderata fis-sit tal-impjant tista' tiġi osservata għal 14-il jum waqt studji ta' sikurezza/effikaċja.
English: Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml, and suppression of musky odour) is achieved between 5 weeks and 14 weeks after initial treatment under laboratory conditions.
Maltese: L-infertilità (soppressjoni tal-ispermatoġenesi, tnaqqis fid-daqs tat-testikoli, livelli tat-testosterone inqas minn 0.1 ng/ml u tnaqqis ta' riħa miżża) tinkiseb minn 5 ġimgħat sa tal-anqas 14-il ġimgħa wara t-trattament inizjali skont kundizzjonijiet tal-laboratorju.
English: PACKAGE LEAFLET FOR: Suprelorin 4.7 mg implant for dogs
Maltese: Suprelorin 4.7 mg impjant għall-klieb
English: Dogs (male).
Maltese: Klieb (Irġiel).
English: One out of 75 dogs treated with the veterinary medicinal product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Maltese: Wieħed minn 75 kelb ittrattati b'dan il-prodott mediċinali veterinarju waqt il-provi kliniċi tgħammar u ntrabat ma' kelba sħuna fi żmien sitt xhur tal-impjantazzjoni, iżda dan ma rriżultax fi tqala.
English: Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Maltese: Ormoni li jirrilaxxaw ilgonadotrofin (GnRH), Kodiċi ATC-veterinarja:
English: 1ère avenue 2065 m LID FR-06516 Carros Tel: +33-(0)4 92 08 73 00
Maltese: VIRBAC. 1ère avenue 2065 m LID FR-06516 Carros Tel: +33-(0) 4 92 08 73 00
English: Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight should be subject to a risk/benefit assessment performed by the veterinarian.
Maltese: Minħabba data limitata, l-użu tas-Suprelorin fil-klieb li huma anqas minn 10 kg jew iżjed minn 40 kg ta' toqol tal-ġisem għandhom ikunu suġġetti għal valutazzjoni ta' riskju/benefiċju minn veterinarju.
English: Dogs: No clinical adverse reactions other than those described in section 4.6 have been observed following subcutaneous administration of up to 6 times the recommended dose.
Maltese: Klieb: L-ebda reazzjonijiet kliniċi avversi minbarra dawk li ġew deskritti f'sezzjoni 4.6 ma ġew osservati wara t-tqegħid sa 6 darbiet id-doża rakkomandata.
English: 95 % of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Maltese: 95% tal-klieb irritornaw għall-livelli normali ta' testosterone fil-plażma fi żmien sentejn u nofs mill-impjantazzjoni.
English: White to pale yellow cylindrical implant.
Maltese: L-impjanti jistgħu jinstabu bl ultrasound.
English: 4.9 Amounts to be administered and administration route Subcutaneous use.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each implant contains Deslorelin (as deslorelin acetate) 4.7 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Deslorelin (bħala deslorelin acetate) 4.7 mg
English: With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials 68 % of dogs administered one implant, returned to fertility within 2 years of implantation.
Maltese: Fir-rigward ta' livelli ta' testosterone (marka stabbilita sostituta għal kejl tal-fertilità), waqt provi kliniċi 68% tal-klieb li tqegħdilhom impjant wieħed reġgħu saru fertili fi żmien sentejn mill impjantazzjoni.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Deslorelin (as deslorelin acetate)
Maltese: 4.7 mg deslorelin (bħala deslorelin acetate)
English: 95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Maltese: 95% tal-klieb irritornaw għal-livelli normali ta' testosterone fil-plażma fi żmien sentejn u nofs mill-impjantazzjoni.
English: Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration following simultaneous subcutaneous administration of up to 10 times the recommended dose.
Maltese: Istoloġikament, reazzjonijiet lokali ħfief b'infjammazzjoni kronika tat-tessut konnettiv u xi formazzjoni kapsula u deposizzjoni kollaġen ġew osservati fi żmien 3 xhur wara l-amministrazzjoni wara l-għoti taħt il-ġilda sa 10 darbiet id-doża rakkomandata.
English: The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Maltese: Ma ġietx investigata s-sigurtà wara impjantazzjonijiet ripetuti b'Suprelorin f'nimsa.
English: Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration following simultaneous subcutaneous administration of up to 6 times the recommended dose.
Maltese: Istoloġikament, reazzjonijiet lokali ħfief b'infjammazzjoni kronika tat-tessut konnettiv u xi formazzjoni kapsula u depożizzjoni kollaġen ġew osservati fi żmien 3 xhur wara l-amministrazzjoni wara t-tqegħid taħt il-ġilda sa 6 darbiet id-doża rakkomandata.
English: MANUFACTURER'S BATCH NUMBER Batch
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: TARGET SPECIES Dogs (male).
Maltese: “Twissijiet Speċjali”).
English: Another GnRH analogue has been shown to be foetotoxic in laboratory animals.
Maltese: Analogu ieħor ta' GnRH ieħor ġie muri li huwa fetotossiku f'annimali fil-laboratorju.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 9.4 mg deslorelin (as deslorelin acetate).
Maltese: U INGREDJENT(I) OĦRA Suprelorin huwa impjant ċilindriku abjad fl-isfar ċar, li fih 9.4 mg deslorelin (bħala deslorelin acetate).
English: INDICATION(S) For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.
Maltese: Għall-induzzjoni ta' infertilità temporanja fi klieb irġiel f'saħħithom, mhux kastrati, u sesswalment maturi.
English: In rare cases, suspected lack of expected efficacy has been reported (in the majority of cases a lack of reduction of testicle size was reported and/or a bitch was mated).
Maltese: F'każijiet rari ġie rrapportat suspett ta' nuqqas ta' effikaċja mistennija (fil-maġġoranza tal-każijiet ġie rrapportat nuqqas ta' tnaqqis tad-daqs tat-testikoli u/jew kelba ġiet mgħammra).
English: Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least six months following administration of the veterinary medicinal product.
Maltese: Kejl ta' konċentrazzjonijet ta' testosterone fil-plażma wera leffett farmakoloġiku persistenti tal-preżenza kontinwa ta' deslorelin fiċ-ċirkulazzjoni għal tal-anqas sitt xhur wara t-tqegħid tal-prodott.
English: Dogs: No adverse reactions other than those described in section “Adverse effects” have been observed following subcutaneous administration of up to 6 times the recommended dose.
Maltese: Klieb: L-ebda reazzjoni mhux mixtieqa ħlief għal dawk deskritti fis-sezzjoni “Reazzjonijiet mhux mixtieqa” ma ġiet osservata wara l-amministrazzjoni taħt il-ġilda sa 6 darbiet id-doża rakkomandata.
English: For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
Maltese: Għall-induzzjoni ta' infertilità temporanja fi klieb u nimsa rġiel f'saħħithom, sħaħ, u sesswalment maturi.
English: Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
Maltese: Evita l-injezzjoni tal-impjant ġox-xaħam, peress li lħelsien tas-sustanza attiva jista' jkun imxekkel f'partijiet b'vaskularizzazzjoni baxxa.
English: The use of the veterinary medicinal product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore, should be subject to a risk/benefit assessment performed by the veterinarian.
Maltese: Għaldaqstant, l-użu tal-prodott mediċinali veterinarju fi klieb ta' piż tal-ġisem ta' anqas minn 10 kg jew aktar minn 40 kg, għandu jkun suġġett għal stima ta' riskju/benefiċċju magħmula minn veterinarju.
English: Infertility is achieved from 6 weeks up to at least 6 months after initial treatment.
Maltese: L-infertilità tinkiseb minn 6 ġimgħat sa tal-anqas 6 xhur wara t-trattament inizjali.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin acetate).
Maltese: U INGREDJENT(I) OĦRA Suprelorin huwa impjant ċilindriku abjad fl-isfar ċar, li fih 4.7 mg deslorelin (bħala deslorelin acetate).
English: The actuator is attached to the implanter using the Luer Lock connection.
Maltese: Neħħi t-tapp Luer Lock minn mal-impjantatur.
English: In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals were not capable of successfully siring offspring.
Maltese: Fi 2 minn 30 kelb fil-provi kliniċi l-infertilità ma seħħitx sa bejn wieħed u ieħor 12-il ġimgħa wara ttrattament inizjali, iżda f'ħafna każijiet dawn l-annimali mhumiex kapaċi li jsiru missierijiet ta' ġriewi.
English: 13o χλμ Ε.Ο.
Maltese: 12-il xahar wara t-tqegħid tal-prodott.
English: BATCH NUMBER Batch {number}
Maltese: jekk meħtieġ.
English: If loss of the implant is suspected following re-implantation after 6 months, then a progressive increase will be seen in scrotal circumference and/or plasma testosterone levels.
Maltese: Jekk ikun hemm suspett ta' telf tal-impjant wara li jkun ġie impjantat mill-ġdid wara 6 xhur, f'dak ilkaż tiġi osservata żieda progressiva fiċ-ċirkonferenza tal-iskrotu u/jew fil-livelli ta' testosteron plasma.