FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee concluded that the benefit-risk balance of 0.005 % w/w estradiol, 0.4 % w/w prednisolone containing medicinal products for topical use for the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area in postmenopausal patients, for which weak-acting corticosteroids and low-dose estradiol are indicated remains positive subject to the restrictions, warnings, changes to the product information agreed.
Maltese: Il-Kumitat ikkonkluda li l-bilanċ tal-benefiċċju/riskju ta' prodotti mediċinali li fihom 0.005% w/w estradiol, 0.4% w/w prednisolone għal użu topiku għall-kura esterna inizjali ta' perjodu qasir ta' mard tal-ġilda akut, ħafif, infjammat, ħruq u ħakk fiż-żona esterna ġenitali tan-nisa f'pazjenti wara lmenopawża, li għalihom kortikosterojdi li jaġixxu b'mod dgħajjef u estradiol f'doża baxxa huma indikati jibqa' pożittiv soġġett għar-restrizzjonijiet, it-twissijiet, it-tibdil fl-informazzjoni miftiehma dwar ilprodott.
English: Following the adoption of the CHMP opinion and recommendations during the December 2013 CHMP meeting, a re-examination request on Linoladiol N medicinal product only was received from one MAH.
Maltese: Wara l-adozzjoni tal-opinjoni u r-rakkomandazzjonijiet tas-CHMP waqt il-laqgħa tas-CHMP f'Diċembru 2013, waslet biss talba ta' eżaminazzjoni mill-ġdid dwar il-prodott mediċinali Linoladiol N mingħand MAH wieħed.
English: The primary objective of the study was to estimate the extent of estradiol exposure after application of the test formulation Linoladiol N.
Maltese: L-objettiv primarju tal-istudju kien li tiġi stmata l-firxa talesponiment ta' estradiol wara l-applikazzjoni tal-formulazzjoni tat-test Linoladiol N.
English: Clear information should be reflected in the posology section.
Maltese: Għandha tiġi riflessa informazzjoni ċara fissezzjoni tal-pożoloġija.
English: As vaginal atrophy due to oestrogen deficiency in post-menopausal women is a chronic condition, recurrence of signs and symptoms is expected when topical oestrogen therapy is withdrawn.
Maltese: Peress li l-atrofija vaġinali minħabba nuqqas ta' estroġenu f'nisa wara lmenopawżahija kundizzjoni kronika, hija mistennija ripetizzjoni ta' sinjali u sintomi meta titwaqqaf itterapija topika b'estroġenu.
English: Prolonged use is not recommended and skin irritation, hypersensitivity and spotting were reflected in the undesirable effects.
Maltese: Mhuwiex irrakkomandat użu fit-tul u irritazzjoni tal-ġilda, ipersensittività u tbajja' fl-effetti mhux mixtieqa ġew riflessi.
English: No clinical studies investigating PK/absorption of estradiol and prednisolone, dosefinding and the efficacy of Linoladiol HN in the therapeutic indications approved have been submitted.
Maltese: Ma ġie sottomess ebda studju kliniku li jinvestiga PK/assorbiment ta' estradiol u prednisolone, is-sejba tad-doża u l-effikaċja ta' Linoladiol HN fl-indikazzjonijiet terapewtiċi approvati.
English: Primary variables were AUCδ0-36 and Cδmax of estradiol, i.e. the extent of exposure was estimated as area under the baseline adjusted estradiol concentration curve and the baseline-adjusted maximal plasma concentration of estradiol.
Maltese: Il-fatturi varjabbli primarji kienu AUCδ0-36 u Cδmax ta' estradiol, jiġifieri l-estent tal-esponiment ġie stmat bħala l-erja taħt il-kurva tal-linja bażi ta' konċentrazzjoni ta' estradiol u l-konċentrazzjoni massima tal-plażma aġġustata skont il-linja bażi ta' estradiol.
English: • The Committee is of the opinion that the benefit does not outweigh the risk in the indication of lichen sclerosus genitalis for the 0.005 % w/w estradiol with 0.4 % w/w prednisolone containing medicinal products, in line with current clinical knowledge and therefore this indication should be deleted.
Maltese: • Il-Kumitat huwa tal-fehma li l-benefiċċji ma jegħlbux ir-riskju fl-indikazzjoni likena sclerosus genitalis għall-prodotti mediċinali li fihom 0.005 % w/w estradiol bi 0.4 % w/w prednisolone, f'konformità mal-għarfien kliniku attwali u għalhekk din l-indikazzjoni għandha titħassar.
English: Vaginal oestrogen therapy has been shown to provide improvement in the signs and symptoms of vaginal atrophy.
Maltese: Intwera li terapija vaġinali blestroġenu tipprovdi titjib fis-sinjali u s-sintomi ta' atrofija vaġinali.
English: Despite any limitations of historical comparisons with other locally applied medicinal products, it can be concluded that exposure to estradiol after administration of Linoladiol N is considerably higher than after administration of other lower dosed estradiol products for topical intravaginal therapy.
Maltese: Minkejja kwalunkwe limitazzjoni ta' paraguni storiċi ma' prodotti mediċinali oħra applikati lokalment, jista' jiġi konkluż li l-esponiment għal estradiol wara l-għoti ta' Linoladiol N huwa ferm ogħla minn dak wara għoti ta' prodotti oħra għal terapija topika intravaġinali b'doża iktar baxxa ta' estradiol.
English: Based on the higher dose and substantial systemic estradiol exposure this product is more comparable to systemic HRT products from a safety point of view.
Maltese: Abbażi tad-doża ogħla u l-esponiment sistemiku sostanzjali għal estradiol, dan il-prodott huwa aktar paragunabbli ma' prodotti HRT sistemiċi millperspettiva tas-sigurtà.
English: Clarification as to the nature of the active substance, estradiol, as the most potent oestrogen and the potential effect on the skin and genetic information were also reflected in the product information, in line with current scientific knowledge.
Maltese: Ġiet riflessa wkoll kjarifika tan-natura tas-sustanza attiva, estradiol, bħala lestroġenu l-iktar qawwi u l-effett potenzjali fuq il-ġilda u informazzjoni ġenetika fl-informazzjoni dwar il-prodott, f'konformità mal-għarfien xjentifiku attwali.
English: Decreases in FSH and LH were also observed, further reflecting the existence of relevant systemic exposure.
Maltese: Ġie osservat ukoll tnaqqis f'FSH u f'LH, li jkompli jirrifletti leżistenza ta' esponiment sistematiku rilevanti.
English: In terms of the PK data, systemic levels of estradiol are of interest due to well-known safety concerns.
Maltese: F'termini tad-dejta tal-PK, livelli sistemiċi ta' estradiol huma ta' interess minħabba tħassib ta' sigurtà magħruf sew.
English: In addition, in study SCO 5174 was observed that estradiol serum concentrations had not returned to baseline levels about 36 h after administration of Linoladiol N.
Maltese: Barra minn hekk, fi studju SCO 5174 kien osservat li l-konċentrazzjonijiet ta' estradiol fis-serum ma reġgħux lura għal-livelli tal-linja bażi madwar 36 siegħa wara l-għoti ta' Linoladiol N.
English: Restriction of the indication to only intravaginal use (and not on the skin of vulva) after a lower oestrogen treatment has failed, as well limiting the duration of the treatment, will better reflect the available scientific and clinical data and the current clinical knowledge on the use of topical administered estradiol containing products and Linoladiol N.
Maltese: Restrizzjoni tal-indikazzjoni għal użu intravaġinali biss (u mhux fuq il-ġilda tal-vulva) wara li ma tkunx irnexxiet kura b'estroġenu iktar baxx, kif ukoll limitazzjoni tal-perjodu ta' kura, sejra tirrifletti aħjar id-dejta xjentifika u klinika disponibbli u l-għarfien kliniku attwali dwar l-użu ta' prodotti li fihom estradiol li jingħataw topikament u Linoladiol N.
English: The Committee, as a consequence, concluded that the benefit-risk balance of the 0.01% w/w estradiol containing medicinal products for topical use as well as the 0.005 % w/w estradiol and 0.4 % w/w prednisolone containing medicinal products for topical use remains favourable subject to variation to the term of the marketing authorisation consisting of restrictions, warnings, and other changes to the product information, as well as the risk minimisation measures agreed, as applicable.
Maltese: Il-Kumitat, bħala konsegwenza, ikkonkluda li l-bilanċ tal-benefiċċju/riskju ta' prodotti mediċinali għal użu topiku li fihom 0.01% w/w estradiol kif ukoll prodotti mediċinali għal użu topiku li fihom 0.005 % w/w estradiol b'0.4 % w/w prednisolone jibqa' favorevoli soġġett għall-varjazzjonijiet fit-termini talawtorizzazzjoni għat-tqegħid fis-suq li jikkonsistu minn restrizzjonijiet, twissijiet, u tibdil ieħor flinformazzjoni dwar il-prodott, kif ukoll miżuri ta' tnaqqis ta' riskju miftiehma, kif ikun applikabbli.
English: Clinical monitoring is expected and caution should be used in e.g. patients with a history of malignant oestrogen-dependent tumours or tumours of the womb.
Maltese: Huwa mistenni monitoraġġ kliniku u għandha tingħata attenzjoni eż. f'pazjenti bi storja ta' tumuri malinni li jiddependu mill-estroġenu jew tumuri tal-utru.
English: The MAH favoured the initial indication of “Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women”.
Maltese: L-MAH kien favur l-indikazzjoni inizjali ta' “Kura ta' atrofija vaġinali minħabba nuqqas ta' estroġenu f'nisa wara l-menopawża”.
English: Primarily the MAH disagreed with the recommended restriction of indication for Linoladiol N of “Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women when at least one lower dose topical oestrogen treatment has failed”.
Maltese: Primarjament, l-MAH ma qabilx mar-restrizzjoni rakkomandata tal-indikazzjoni għal Linoladiol N ta' “Kura ta' atrofija vaġinali minħabba nuqqas ta' estroġenu f'nisa wara l-menopawża meta tal-anqas ma tkunx irnexxiet kura topika waħda bl-estroġenu b'doża iktar baxxa”.
English: In addition for further minimisation of any potential safety risk, the MAHs have been requested to provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25 g) to add an applicator in the package and the withdrawal of the 35 g and 50 g pack sizes, in all EU member states where they are currently authorised.
Maltese: iktar tnaqqis ta' kwalunkwe riskju ta' sigurtà potenzjali, l-MAHs intalbu jipprovdu pjan iddettaljat li jinkludi skedi ta' żmien qosra u preċiżi dwar l-adattament tal-pakkett ta' daqs iżgħar (25g) biex jiżdied applikatur fil-pakkett u l-irtirar tal-pakketti ta' daqs ta' 35g u 50g, fl-Istati Membri kollha tal-UE fejn huma awtorizzati attwalment.
English: • For the 0.005 % w/w estradiol with 0.4 % w/w prednisolone containing medicinal products for topical use the Committee considered that in view of the currently available safety data these products should be used for the initial short-term external treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women for which weak acting corticosteroids and estradiol are indicated.
Maltese: • Għall-prodotti mediċinali li fihom 0.005 % w/w estradiol b'0.4 % w/w prednisolone għal użu topiku, il-Kumitat ikkunsidra li fid-dawl tad-dejta ta' sigurtà disponibbli attwalment dawn ilprodotti għandhom jintużaw għall-kura topika esterna inizjali ta' perjodu qasir ta' mard fil-ġilda akut, ħafif, infjammat fiż-żona esterna ġenitali tan-nisa wara l-menopawża li għalihom huma indikati kortikosterojdi li jaġixxu b'mod dgħajjef.
English: However, no conclusions regarding endometrial safety can be drawn based on post-marketing data, due to the low number of total reported cases for Linoladiol N and the confounded cases reporting endometrial events.
Maltese: abbażi tad-dejta ta' wara t-tqegħid fis-suq, minħabba n-numru baxx ta' każijiet totali rrapportati għal Linoladiol u l-każijiet imħawda li jirrapportaw avvenimenti endometrijali.
English: In addition, although Linoladiol HN contains a lower (half) concentration of oestrogen than Linoladiol N, the CHMP considered that the product information should still reflect adequate warnings with regards to risks of hormone replacement therapy.
Maltese: Barra minn hekk, għalkemm Linoladiol HN fih konċentrazzjoni iktar baxxa (nofs) ta' estroġenu minn Linoladiol N, is-CHMP ikkunsidra li l-informazzjoni dwar il-prodott għandha xorta tirrefletti twissijiet xierqa fir-rigward tar-riskji ta' terapija ta' sostituzzjoni tal-ormoni.
English: • The Committee, in order to ensure that the 0.01% w/w estradiol containing medicinal products for topical use are not used for periods longer than 4 weeks, imposed the withdrawal of pack size of 100 g in all EU Members States where the products are authorised.
Maltese: • Il-Kumitat sabiex jiżgura li l-prodotti mediċinali li fihom 0.01% w/w estradiol għal użu topiku ma jintużawx għal aktar minn 4 ġimgħat, impona l-irtirar tal-pakketti ta' daqs ta' 100g fl-Istati Membri kollha tal-UE kollha fejn huma awtorizzati l-prodotti.
English: ATCvet code: QP53AX27.
Maltese: QP53AX27
English: Date of latest renewal: 07/01/2016.
Maltese: Data tal-aħħar tiġdid: 07/01/2016.
English: Minimum of 25
Maltese: Minimu ta' 25
English: 5831 AN Boxmeer The Netherlands
Maltese: 5831 AN Boxmeer In-Netherlands
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer In-Netherlands
English: Cats > 4 kg
Maltese: Qtates > 4 kg
English: Date of first authorisation: 18/02/2011.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18/02/2011.
English: The pipette consists of a blister film (polypropylene/cyclic-olefin-copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium sachets.
Maltese: Il-pipetta tikkonsisti f'qoxra (polypropylene/cyclic-olefin-copolymer/polypropylene) u tapp tal-folja (aluminium/polypropylene co-extruded) issiġillati fi qratas tal-aluminju.
English: Ethyl acetoacetate Isopropyl alcohol.
Maltese: Ethyl acetoacetate alkoħol Isopropyl
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Triacetin
English: One unit-dose pipette holds 0.51 ml, 0.77 ml, 1.54 ml, 3.08 ml or 4.62 ml spot-on solution.
Maltese: Pipetta b'doża waħda fiha 0.51 ml, 0.77 ml, 1.54 ml, 3.08 ml jew 4.62 ml ta' soluzzjoni spot-on.
English: One ml contains 195 mg indoxacarb.
Maltese: 1 ml fiha 195 mg indoxacarb.
English: Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family.
Maltese: Indoxacarb huwa ektoparassitiċida tal-familja kimika tal-oxadiazine.
English: Spot-on solution.
Maltese: Soluzzjoni spot-on.
English: Minimum of 15
Maltese: 0.51 Minimu ta' 15
English: Spot-on use
Maltese: Soluzzjoni spot-on
English: Isopropyl alcohol 354 mg/ml.
Maltese: Fih ukoll alkoħol isopropyl 354 mg/ml
English: 1 pipette 4 pipettes 6 pipettes
Maltese: Pipetta waħda 4 pipetti
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) matul il-perjodu ta' trattament wieħed) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Treatment and prevention of flea infestation (Ctenocephalides felis).
Maltese: Trattament u prevenzjoni ta' infestazzjonijiet bil-briegħed (Ctenocephalides felis).
English: Triacetin
Maltese: KWANTITÀ
English: To avoid adverse reactions:
Maltese: Biex jiġu evitati reazzjonijiet mhux mixtieqa:
English: 6.6 - 10 Small dogs
Maltese: 6.6 - 10 Klieb żgħar 10.
English: Volume (ml) Indoxacarb (mg)
Maltese: Volum (ml) Indoxacarb (mg)
English: One unit-dose pipette holds 0.51 ml or 1.03 ml spot-on solution.
Maltese: Pipetta b'doża waħda fiha 0.51 ml jew 1.03 ml ta' soluzzjoni spot-on.
English: Activyl 100 mg spot-on for cats ≤ 4 kg Activyl 200 mg spot-on for cats > 4 kg indoxacarb
Maltese: Activyl 100 mg spot-on għal qtates ≤ 4 kg Activyl 200 mg spot-on għal qtates > 4 kg indoxacarb
English: In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
Maltese: Fi studju kliniċi, Activyl ġie amministrat flimkien ma' kullari tad-deltamethrin b'saħħa sa 4% deltamethrin mingħajr evidenza ta' effetti mhux mixtieqa assoċjati.
English: Unit dose (ml) Indoxacarb (mg)
Maltese: Doża waħda (ml) Indoxacarb (mg)
English: After being converted into a metabolite, indoxacarb is active against adult, larval and egg stages of insects.
Maltese: Wara li jinbidel f'metabolit, indoxacarb huwa attiv kontra l-istadji adulti, il-larvi u l-bajd tal-insetti.
English: One pipette of Activyl delivers:
Maltese: Sustanzi mhux attivi:
English: Activyl 100 mg spot-on for dogs 1.5 - 6.5 kg Activyl 150 mg spot-on for dogs 6.6 - 10 kg Activyl 300 mg spot-on for dogs 10.1 - 20 kg Activyl 600 mg spot-on for dogs 20.1 - 40 kg Activyl 900 mg spot-on for dogs 40.1 - 60 kg indoxacarb
Maltese: Activyl 100 mg spot-on għal klieb 1.5 - 6.5 kg Activyl 150 mg spot-on għal klieb 6.6 - 10 kg Activyl 300 mg spot-on għal klieb 10.1 - 20 kg Activyl 600 mg spot-on għal klieb 20.1 - 40 kg Activyl 900 mg spot-on għal klieb 40.1 - 60 kg indoxacarb
English: EU/02/10/118/011 EU/02/10/118/012 EU/02/10/118/013 EU/02/10/118/014 EU/02/10/118/020 EU/02/10/118/021
Maltese: EU/02/10/118/011 EU/02/10/118/012 EU/02/10/118/013 EU/02/10/118/014 EU/02/10/118/020
English: EU/2/10/118/001-010 EU/2/10/118/015-019
Maltese: EU/2/10/118/015-019
English: Indoxacarb 100 mg Indoxacarb 200 mg
Maltese: Indoxacarb 200 mg
English: This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours.
Maltese: Dan iwassal għal waqfien mill-ikel minn 0 sa 4 sigħat wara ttrattament segwit minn twaqqif ta' tqegħid ta' bajd (oviposition), paraliżi u mewt li sseħħ bejn 4 u 48 siegħa wara.
English: Other signs observed include emesis in rare cases or anorexia, lethargy, hyperactivity and vocalisation in very rare cases.
Maltese: Sinjali oħra osservati jinkludu remettar f'każijiet rari jew anoressija, telqa, iperattività u vokalizazzjoni f'każijiet rari ħafna.
English: Batch {number}
Maltese: JISKADI {xahar / sena}
English: In rare cases, neurological signs, such as incoordination, tremor (shakiness), ataxia (unsteady movement), convulsions, mydriasis (pupil dilation) and impaired vision, have been observed.
Maltese: F'każijiet rari, ġew osservati sinjali newroloġiċi bħal sko-ordinazzjoni, rogħda, atassja (movimenti mhux sodi), eċċessjonijiet, midrijasi (ftuħ tal-pupilla) u vista mfixkla.
English: Activyl for small cats (≤ 4 kg) Activyl for large cats (> 4 kg)
Maltese: Activyl għal qtates żgħar (≤ 4 kg) Activyl għal qtates kbar (> 4 kg)
English: EU/2/10/118/011-014 EU/2/10/118/020-021
Maltese: EU/2/10/118/020-021
English: PACKAGE LEAFLET Activyl spot-on solution for cats
Maltese: FIL-PAKKETT Activyl soluzzjoni spot-on għal qtates
English: Store the pipettes in the original package in order to protect from moisture.
Maltese: Aħżen il-pipetti fil-pakkett oriġinali sabiex ikunu protetti mill-umdità.
English: The absorbed indoxacarb is extensively metabolised by the liver to a variety of metabolites.
Maltese: L-indoxacarb li jiġi assorbit jiġi metabolizzat b'mod estensiv fil-fwied f'numru ta' metaboliti.
English: 10.1 - 20 Medium dogs 20.1 - 40 Large dogs
Maltese: Klieb medji 20.1 - 40 Klieb kbar 40.1 - 60
English: Maximum of 50
Maltese: Massimu ta' 50
English: The recommended dose is 25 mg indoxacarb/kg body weight, equivalent to 0.128 ml/kg body weight.
Maltese: Id-doża rakkomandata hija ta' 25 mg indoxacarb/kg piż, ekwivalenti għal 0.128 ml/kg piż.
English: Activyl 100 mg spot-on solution for small cats (≤ 4 kg) Activyl 200 mg spot-on solution for large cats (> 4 kg)
Maltese: Activyl 100 mg soluzzjoni spot-on għal qtates żgħar (≤ 4 kg) Activyl 200 mg soluzzjoni spot-on għal qtates kbar (> 4 kg)
English: OÜ ZOOVETVARU,
Maltese: Qtates żgħar
English: The recommended dose is 15 mg indoxacarb/kg body weight, equivalent to 0.077 ml/kg body weight.
Maltese: Id-doża rakkomandata hija ta' 15 mg indoxacarb/kg piż, ekwivalenti għal 0.077 ml/kg piż tal-ġisem.
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 talAġenzija Ewropea għall-Mediċini (EMA) (http://www.ema.europa.eu/).
English: Activyl 100 mg spot-on solution for very small dogs (1.5 - 6.5 kg) Activyl 150 mg spot-on solution for small dogs (6.6 - 10 kg) Activyl 300 mg spot-on solution for medium dogs (10.1 - 20 kg) Activyl 600 mg spot-on solution for large dogs (20.1 - 40 kg) Activyl 900 mg spot-on solution for extra large dogs (40.1 - 60 kg)
Maltese: Activyl 100 mg soluzzjoni spot-on għal klieb żgħar ħafna (1.5 - 6.5 kg) Activyl 150 mg soluzzjoni spot-on għal klieb żgħar (6.6 - 10 kg) Activyl 300 mg soluzzjoni spot-on għal klieb medji (10.1 - 20 kg) Activyl 600 mg soluzzjoni spot-on għal klieb kbar (20.1 - 40 kg) Activyl 900 mg soluzzjoni spot-on għal klieb kbar ħafna (40.1 - 60 kg)
English: The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija tat-trattament għall-kontroll tad-dermatite allerġika mill-briegħed (FAD).
English: • administer the product in a well-ventilated area;
Maltese: • amministra l-prodott f'żona b'ventilazzjoni tajba;
English: Other signs observed include emesis (vomiting) in rare cases or anorexia (loss of appetite), lethargy (drowsiness), hyperactivity and vocalisation in very rare cases.
Maltese: Sinjali oħra osservati jinkludu remettar f'każijiet rari jew anoressija (tnaqqis t'aptit), telqa, iperattività u vokalizazzjoni f'każijiet rari ħafna.
English: Correct application (see section 9) will minimise licking of the application site.
Maltese: Applikazzjoni korretta (ara sezzjoni 9) tnaqqas iċ-ċans li l-annimal jilgħaq iż-żona tal-applikazzjoni.
English: 40.1 - 60 Extra large dogs
Maltese: Klieb 40.1 - 60 kg
English: No adverse effects were observed in cats aged 8 weeks or older when administered 5 times the recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose on 6 occasions at 2 weeks intervals.
Maltese: Ma dehrux effetti mhux mixtieqa ta' età ta' 8 ġimgħat jew aktar meta ġew amministrati doża ħames darbiet ogħla minn dik rakkomandata għal 8 darbiet f'intervalli ta' 4 ġimgħat jew amministrati doża ħames darbiet ogħla minn dik rakkomandata għal 6 darbiet f'intervalli ta' ġimgħatejn.
English: Ensure that the dosage (pipette) corresponds to the weight of the treated cat (see section 4.9).
Maltese: Assigura li d-dożaġġ (pipetta) jikkorrispondi għall-piż tal-qattus ittrattat (ara sezzjoni 4.9).
English: For cats: Veterinary medicinal product subject to prescription.
Maltese: Għall-qtates: Prodott mediċinali veterinarju li għandu bżonn riċetta.
English: No adverse effects were observed in dogs aged 8 weeks or older when administered 5 times the recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose on 6 occasions at 2 weeks intervals.
Maltese: Ma dehrux effetti mhux mixtieqa fi klieb u qtates ta' età ta' 8 ġimgħat jew aktar meta ġew amministrati doża ħames darbiet ogħla minn dik rakkomandata għal 8 darbiet f'intervalli ta' 4 ġimgħat jew amministrati doża ħames darbiet ogħla minn dik rakkomandata għal 6 darbiet f'intervalli ta' ġimagħtejn.
English: EU/02/10/118/001 EU/02/10/118/002
Maltese: EU/02/10/118/021