FrancophonIA/ELRC3.0 huggingface dataset:
English: - in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Maltese: - fl-irġiel adulti, b'riskju ogħla ta' ksur, li l-kura għalihom bi prodotti mediċinali oħrajn approvati għall-kura talosteoporożi mhijiex possibbli minħabba, pereżempju, kontraindikazzjonijiet jew intolleranza.
English: The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of adult men and postmenopausal women with osteoporosis.
Maltese: L-effikaċja u s-sigurtà ta' strontium ranelate ġew stabbiliti f'firxa wiesgħa ta' etajiet ta' rġiel adulti u nisa wara l-menopawsa bl-osteoporożi (sa 100 sena meta daħlu fl-istudju).
English: There is no accumulation of ranelic acid and no evidence of metabolism in animals and humans.
Maltese: Ranelic acid ma jakkumulax u m'hemm l-ebda evidenza ta' metaboliżmu flannimali u fil-bnedmin.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (tista' taffettwa sa persuna 1 minn kull 100):
English: - Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Avvenimenti tromboemboliċi fil-vini (VTE) attwali jew preċedenti, inklużi trombożi profonda talvini u emboliżmu pulmonari.
English: Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity)
Maltese: Uġigħ muskoskeletrali (tiġbid fil-muskoli, mijalġja, uġigħ fl-għadam, artralġja u uġigħ fit-trufijiet tal-idejn u s-saqajn)§
English: OSSEOR is a medicine used to treat severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom other alternative treatments are not possible.
Maltese: OSSEOR huwa mediċina li tintuża biex tikkura l-osteoporożi severa: - f'nisa wara l-menopawsa, - f'irġiel adulti, b'riskju ogħla ta' ksur li għalihom, kuri alternattivi mhumiex possibbli.
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS
Maltese: L-ogħla riskju li jitfaċċaw SJS jew TEN huwa fi żmien l-ewwel ġimgħat ta' kura u normalment madwar 3-6 ġimgħat għal DRESS.
English: Itching, hives, skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), bone, limb, muscle and/or joint pain, muscle cramps.
Maltese: Ħakk, ħorriqija, raxx tal-ġilda, anġjoedema (bħal nefħa fil-wiċċ, ilsien jew gerżuma, diffikultà biex tieħu n-nifs jew biex tibla'), uġigħ fl-għadam, riġlejn, muskoli u/jew ġogi, bugħawwiġ.
English: With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Maltese: Meta tħares lejn il-ksur kliniku tas-sinsla (iddefinit bħala ksur assoċjat ma' uġigħ fid-dahar u/jew telf fittul tal-ġisem ta' mill-inqas 1 ċm) ir-riskju relattiv naqas b'38%.
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1).
Maltese: Ma hemm bżonn ta' ebda tibdil fid-doża f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: − Signs of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis): initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Maltese: − Sinjali ta' raxxijiet tal-ġilda li jistgħu jkunu ta' theddida għall-ħajja (Sindromu ta' StevensJohnson, nekroliżi epidermali tossika): jibdew bħala tikek qishom nuffati jagħtu fl-aħmar jew rqajja' tondi spiss b'nuffati fin-nofs fuq it-tronk tal-ġisem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/003
Maltese: EU/1/04/287/006
English: - in postmenopausal women,
Maltese: - f'nisa wara l-menopawsa,
English: - Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest. - Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Maltese: o Immobilizzazzjoni temporanja jew permanenti dovuta għal eż. rkupru wara kirurġija jew serħan fit-tul fuq sodda.
English: What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension.OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Maltese: OSSEOR jinbiegħ f'kaxex ta' 7, 14, 28, 56, 84 jew 100 qartas.
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Maltese: 1 Arikolu 31 tad-Direttiva 2001/83/KE kif emendata, referenza skont interess tal-Komunità.
English: What is valproate?
Maltese: X'inhu valproate?
English: EMA/809287/2010 Rev. EMEA/H/A-31/1163
Maltese: EMA/809287/2009 Rev.
English: The CHMP noted that 25 Member States had authorised the indication in the EU.
Maltese: Is-CHMP innota li 25 Stat Membru awotrizzaw l-indikazzjoni fl-UE.
English: 26 August 2010
Maltese: 26-ta' Awwissu 2010
English: This change also applies to generic medicines, including Valproat Ratiopharm Chrono.
Maltese: Din il-bidla tapplika wkoll għall-mediċini ġeneriċi, inklużi Valproat Ratiopharm Chrono.
English: The review was carried out under an ‘Article 31' referral1.
Maltese: Ir-reviżjoni saret taħt referenza ‘skont l-Artikolu 31' 1.
English: 3 August and 26 October 2009
Maltese: 3 ta' Awwissu u 26 ta' Ottubru 2009
English: 2 This objection was raised as a referral under Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation.
Maltese: Din l-oġġezzjoni tqajmet bħala referenza skont l-Artikolu 6(12) tar-Regolament (KE) 1084/2003 kif emendat, referenza dwar varjazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq.
English: generic medicine is based.
Maltese: ibbażata l-mediċina ġenerika.
English: On 15 April 2008, the company that markets Valproat Ratiopharm Chrono, a generic medicine containing valproate used as anti-epileptic, applied to the German medicines regulatory agency to extend its use to include the ‘acute treatment of manic episode and prevention of recurrence in patients with bipolar disorder'.
Maltese: Fil-15 ta' April, il-kumpanija li tpoġġi Valproat Ratiopharm Chrono fis-suq, mediċina ġenerika li fiha valproate u użata kontra l-epilessija, applikat mal-aġenzija regolatorja tal-mediċini Ġermaniża sabiex testendi l-użu tagħha biex jinkludi ‘il-kura akuta ta' episodji ta' manija u l-prevenzjoni ta' rikaduta f'pazjenti b'disturb bipolari'.
English: Valproate is a salt (sodium or semisodium) of valproic acid, an anti-epileptic medicine which can also be used in patients with bipolar disorder.
Maltese: Valproate huwa melħ (sodju jew semisodju) tal-aċidu valproiku, mediċina kontra l-epilessija li tista' tintuża wkoll f'pazjenti b'disturb bipolari.
English: However, on 9 March 2009, the Dutch medicines regulatory agency raised an objection to this change2.
Maltese: Madankollu, fid-9 ta' Marzu 2009, l-aġenzija regolatorja tal-mediċini Olandiża qajmet oġġezzjoni għal din il-bidla2.
English: This included published articles reporting the results of 16 clinical studies of valproate in acute mania (either on its own or in combination) and in the prevention of recurrence of mood episodes in bipolar disorder.
Maltese: Dan kien jinkludi artikli ppubblikati li jirrapportaw ir-riżultati ta' 16-il studju kliniku ta' valproate f'manija akuta (jew waħdu jew f'kombinazzjoni) u fil-prevenzjoni ta' rikaduta ta' episodji ta' burdata fid-disturb bipolari.
English: They are marketed in all European Union (EU) Member States under various trade names including Depakine/Deprakine, Depakote and Epilim, and as generic medicines.
Maltese: Huma fis-suq fl-Istati Membri kollha tal-Unjoni Ewropea taħt diversi ismijiet kummerċjali inklużi Depakine/Deprakine, Depakote u Epilim, u bħala mediċini ġeneriċi.
English: The exact way valproic acid works is not fully understood, but it is known to increase the activity of the neurotransmitter gamma-amino butyric acid (GABA), by increasing the amount of GABA available in the gaps between nerve cells.
Maltese: Il-mod eżatt ta' kif jaħdem l-aċidu valproiku mhuwiex mifhum sew, iżda huwa magħruf li jżid l-attività tan-newrotrażmettitur tal-aċidu butiriku gamma-amino (GABA), billi jżid l-ammont ta' GABA disponibbli fl-ispazji bejn iċ-ċelloli tan-nervituri.
English: The European Medicines Agency has completed a review of the safety and effectiveness of valproate in the treatment of manic episodes in bipolar disorder.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' valproate fil-kura ta' episodji ta' manija f'disturb bipolari.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of valproate-containing medicines in the management of manic episodes in bipolar disorder when lithium is contraindicated or not tolerated continue to outweigh its risks, and therefore recommended that all marketing authorisations for these medicines be varied either to include or to amend the indication.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem talAġenzija (CHMP) ikkonkluda li l-benefiċċji ta' valproate f'din il-kundizzjoni huma akbar mir-riskji, u li lawtorizzazzjonijiet għat-tqegħid fis-suq kollha għall-mediċini li fihom valproate madwar l-Ewropa għandhom jiġu emendati sabiex jinkludu l-kura ta' episodji ta' manija f'disturbi bipolari meta l-litju mhuwiex indikat jew mhuwiex ittollerat.
English: The CHMP recommended the use of valproate for the treatment of manic episode in bipolar disorder in patients who cannot take lithium (another medicine used in bipolar disorders).
Maltese: Is-CHMP irrakkomanda l-użu ta' valproate għall-kura ta' episodji ta' manija fid-disturb bipolari f'pazjenti li ma jistgħux jieħdu litju (mediċina oħra użata f'disturbi bipolari).
English: Why was the use of valproate in bipolar disorder reviewed?
Maltese: Għaliex ġie ridevut l-użu ta' valproate fid-disturb bipolari?
English: On 16 April 2009, the Dutch agency also raised general concerns on the effectiveness and safety of valproic acid and valproate in this indication, noting that there were differences among Member States in the marketing authorisations for this indication.
Maltese: Fis-16 ta' April 2009, l-aġenzija Olandiża qajmet ukoll tħassib ġenerali dwar l-effikaċja u s-sigurtà talaċidu valproiku u ta' valproate f'din l-indikazzjoni, u nnotat li hemm differenzi fost l-Istati Membri flawtorizzazzjonijiet għat-tqegħid fis-suq għal din l-indikazzjoni.
English: The Committee reviewed the information supplied by the companies that make valproate-containing medicines to support the use of valproate-containing medicine in bipolar disorders.
Maltese: Il-Kumitat irreveda l-informazzjoni pprovduta mill-kumpaniji li jagħmlu mediċini li fihom valproate biex jappoġġjaw l-użu ta' mediċici li fihom valproate fid-disturb bipolari.
English: DK-7100 Vejle Denmark
Maltese: DK-7100 Vejle
English: Ceva Animal Health A/S Ladegårdsvej 2
Maltese: Id-Danimarka Ceva Animal Health A/S Ladegårdsvej 2
English: A. Nikolakopoulos S.A. 115 Galatsi Avenue 11146, Galatsi Greece
Maltese: Nikolakopoulos S.A. 115 Galatsi Avenue 11146, Galatsi Greece
English: Centurii nr.7 07718, Voluntari Jud.
Maltese: 07718, Voluntari
English: S.C. Pasteur - Filiala Filipesti Str. Principala, nr. 944 Filipestii de Padure Jud.
Maltese: Pasteur - Filiala Filipesti Str.
English: ad us. vet. Bioveta, Czech Republic)6.
Maltese: Bioveta, ir-Repubblika Ċeka)6.
English: Diagonal, 609-615 08028 Barcelona Spain
Maltese: 08028 Barcelona Spain
English: Milk: 108 hours
Maltese: Ħalib: 108 sigħat
English: Whereas,
Maltese: Laħam u ġewwieni:
English: Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen
Maltese: Huvepharma NV Uitbreidingstraat 80 2600
English: Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Ġermanja Huvepharma NV Uitbreidingstraat 80
English: Romvac Company SA Sos.
Maltese: Ir-Rumanija Romvac Company SA Sos. Centurii nr.7
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Maltese: It-tilosina hija antibijotiku makrolidu prodott minn Streptomyces fradiae.
English: However, two publically9,10 available studies were made available to CVMP.
Maltese: Madankollu, żewġ studji disponibbli pubbikament9,10 saru disponibbli għas-CVMP.
English: 4 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf
Maltese: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf
English: Tylosin concentrations in tissues (muscle, fat, liver, kidney, and injection site) were measured at 3, 7, 10 and 21 days post-treatment using a validated high performance liquid chromatography method.
Maltese: Il-konċentrazzjonijiet tat-tilosina fit-tessuti (muskolu, xaħam, fwied, kliewi, u sit tal-injezzjoni) ġew imkejla fil-jiem 3, 7, 10 u 21 wara l-kura permezz ta' metodu vvalidat ta' kromatografija likwida ta' prestazzjoni għolja.
English: Journal of Veterinary Research, 9(2), 138-143 8 http://www.fao.org/tempref/AG/agn/food/tylosin_2006.pdf
Maltese: 8 http://www.fao.org/tempref/AG/agn/food/tylosin_2006.pdf
English: Information was received regarding the composition of the affected products (n=50).
Maltese: Waslet informazzjoni dwar il-kompożizzjoni tal-prodotti affettwati (n=50).
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Tylovectin, containing 200 mg of tylosin per ml, with France as Reference Member State (FR/V/0323/001/DC).
Maltese: Ġiet ippreżentata applikazzjoni skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, jiġifieri, applikazzjoni ġenerika għal awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura deċentralizzata għall-prodott mediċinali veterinarju Tylovectin, li fih 200 mg tat-tilosina għal kull ml, bi Franza bħala l-Istat Membru ta' Referenza (FR/V/0323/001/DC).
English: A second study was conducted with Najdi ewes with 200 mg/ml tylosin (Tylan 200)7.
Maltese: It-tieni studju twettaq b'nagħaġ Najdi b'200 mg/ml tilosina (Tylan 200)7.
English: There are 50 products within the scope of this referral procedure.
Maltese: Hemm 50 prodott fil-kamp ta' applikazzjoni ta' din il-proċedura ta' referenza.
English: 2600 Antwerpen Belgium bovini, ovini, caprini e suini route
Maltese: 2600 Antwerpen Belgium ħnieżer, nagħaġ
English: BOVINS OVINS CAPRINS ET PORCINS
Maltese: PARA BOVINO, OVINO, CAPRINO Y PORCINO
English: Theoretically, a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250%.
Maltese: Teoretikament, perjodu ta' tiżmim ta' 42 jum jakkomoda għal tnaqqis fir-rata ta' rilaxx ta' aktar minn 250 %.
English: • from the data provided the formulation of 49 of the concerned products is very similar.
Maltese: • mid-data pprovduta, il-formulazzjoni ta' 49 mill-prodotti kkonċernati hija simili ħafna.
English: The reference product is Tylan 200 solution for injection, which has been authorised in various Member States.
Maltese: Il-prodott ta' referenza huwa Tylan 200 soluzzjoni għall-injezzjoni, li ġie awtorizzat f'diversi Stati Membri.
English: The chemical forms of the active substance, being tylosin base or tartrate, have been considered to have similar behaviours (FAO, 20062), and tylosin being a weak base with a pKa of 7.73, can be expected to ionize and form salts under physiological conditions (i.e. at pH 7.4).
Maltese: L-għamliet kimiċi tassustanza attiva, li huma bażi jew tartrat tat-tilosina, ġew ikkunsidrati li għandhom imġiba simili (FAO, 20062), u t-tilosina li hija bażi dgħajfa b'pKa ta' 7.73, tista' tkun mistennija li tijonizza u tifforma mluħa taħt kundizzjonijiet fiżjoloġiċi (jiġifieri f'pH ta' 7.4).
English: The proposed sheep meat withdrawal period for the generic product Tylovectin was 42 days, in line with the French reference product, Tylan 200.
Maltese: Il-perjodu ta' tiżmim tal-laħam tan-nagħaġ propost għall-prodott ġeneriku Tylovectin kien ta' 42 jum, f'konformità mal-prodott ta' referenza Franċiż, Tylan 200.
English: A GLP compliant residue depletion study was provided by one of the marketing authorisation holders involved in the procedure, and while a number of shortcoming on the study design were identified, the data allowed the recommendation to have a 42 day withdrawal period for meat and offal for 49 out of the 50 concerned products, i.e., for products containing 50 mg/ml and 200 mg/ml tylosin as a solution for injection for intramuscular use in sheep, containing benzyl alcohol and propylene glycol as excipients.
Maltese: Ġie pprovdut studju dwar it-tnaqqis tar-residwi konformi mal-GLP minn wieħed mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq involuti fil-proċedura, u filwaqt li ġew identifikati numru ta' nuqqasijiet fid-disinn tal-istudju d-data ppermettiet li r-rakkomandazzjoni jkollha perjodu ta' tiżmim ta' 42 jum għal-laħam u l-ġewwieni għad-49 mill-50 prodott ikkonċernati, jiġifieri, għal prodotti li jkun fihom 50 mg/ml u 200 mg/ml tilosina bħala soluzzjoni għal injezzjoni għal użu ġol-muskoli fin-nagħaġ, li jkun fiha l-alkoħol benżiliku u glikol propileniku bħala eċċipjenti.
English: Quality, target animal safety, user safety, and the environmental risk for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Maltese: Il-kwalità, is-sigurtà tal-annimal fil-mira, is-sigurtà tal-utent, u r-riskju ambjentali għall-prodotti mediċinali veterinarji kkonċernati ma ġewx ivvalutati f'din il-proċedura ta' referenza.
English: Applicant / Marketing authorisation holder
Maltese: Applikant / Detentur talawtorizzazzjoni għattqegħid fis-suq
English: Tylosin tartrate
Maltese: Tartrat tattilosina
English: The first study was conducted with 50 mg/ml tylosin (Ivatyl 50 inj.
Maltese: L-ewwel studju sar b'50 mg/ml tilosina (Ivatyl 50 inj. ad us. vet.
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations, which include respiratory infections caused by Gram-positive microorganisms, and mastitis caused by Gram-positive microorganisms.
Maltese: Filwaqt li l-effikaċja tal-prodotti kkonċernati fin-nagħaġ ma ġietx speċifikament ivvalutata bħala parti minn din ir-referenza, il-prodotti li qed jiġu vvalutati huma kkunsidrati effettivi fil-kura u l-prevenzjoni ta' infestazzjonijiet, li jinkludu infezzjonijiet respiratorji kkawżati minn mikroorganiżmi Gram pożittivi, u mastite kkawżata minn mikroorganiżmi Gram pożittivi.
English: For three of the products the concentration of tylosin is 50 mg/ml, whereas for the other 47 products it is 200 mg/ml.
Maltese: Għal tlieta mill-prodotti, ilkonċentrazzjoni tat-tilosina hija 50 mg/ml, filwaqt li għas-47 prodott l-oħra hija 200 mg/ml.
English: For only one concerned product (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), the solvent polyethylene glycol 400 is used instead of propylene glycol.
Maltese: Nikolakopoulos S.A), jintuża l-polietilenglikol 400 minflok il-glikol propileniku.
English: An additional risk mitigation measure of restricting the maximum injection volumes to 2.5 ml for sheep of 50 or less kg of bodyweight was considered by the CVMP.
Maltese: Is-CVMP ikkunsidra miżura ta' mitigazzjoni tar-riskji addizzjonali li tillimita l-volumi massimi talinjezzjoni għal 2.5 ml għal nagħaġ ta' 50 kg jew inqas tal-piż tal-ġisem.
English: The CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)1 allows extrapolation of the withdrawal period between animal species, but only from a major species to a minor species.
Maltese: 1 CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf nagħaġ minn 4 ijiem sa 7 ijiem.
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera
Maltese: Il-Ġermanja Biovet JSC 39 Petar Rakov Str.
English: An additional safety factor of 30% was considered necessary in view of the limited number of animals treated (n=3), their weight (12 kg mean bw) and consequently the small injection volume required to treat these three lambs (0.6 ml), together with the lack of analysis of injection site ring samples, resulting in a withdrawal period of 28 days.
Maltese: Fattur ta' sigurtà addizzjonali ta' 30 % kien ikkunsidrat neċessarju minħabba l-għadd limitat ta' annimali kkurati (n=3), il-piż tagħhom (medja ta' 12 kg bw) u, konsegwentement, il-volum żgħir tal-injezzjoni meħtieġ biex jikkura dawn it-tliet iħrief (0.6 ml), flimkien man-nuqqas ta' analiżi tal-kampjuni taċ-ċrieki ta' siti tal-injezzjoni, li jirriżulta f'perjodu ta' tiżmim ta' 28 jum.
English: Regardless of the tylosin strength, the formulation of 49 of the concerned products is very similar.
Maltese: Irrispettivament mill-qawwa tat-tilosina, il-formulazzjoni ta' 49 mill-prodotti kkonċernati hija simili ħafna.
English: 5 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link the influence of increasing the injection volume/site of injection on the absorption rate is difficult to quantify.
Maltese: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link allura jkun meħtieġ li l-perjodu ta' tiżmim jiġi estiż b'madwar 5 ijiem, jiġifieri total ta' 33 jum (li jirriżulta minn 21 jum, flimkien ma' medda ta' sigurtà ta' 30 %, u l-5 ijiem addizzjonali).
English: In this study, seven ewes (Slovak merino) were treated intramuscularly with tylosin base 50 mg per ml at a dosage of 100 mg per 10 kg bw, for five consecutive days.
Maltese: F'dan l-istudju, seba' nagħġiet (merino Slovakk) ġew ikkurati ġol-muskolu b'bażi tat-tilosina ta' 50 mg għal kull ml f'dożaġġ ta' 100 mg għal kull 10 kg bw, għal ħamest ijiem konsekuttivi.
English: The recommended treatment and dose of Tylosin/Anafasis is 10 mg/kg bw for 3-5 days, although most products recommend only 3 days of treatment.
Maltese: Il-kura u d-doża rakkomandati ta' Tylosin/Anafasis hija ta' 10 mg/kg bw għal 3-5 ijiem, għalkemm il-biċċa l-kbira tal-prodotti jirrakkomandaw biss 3 ijiem ta' kura.
English: Cattle,
Maltese: Billi,
English: However, two publically available studies were made available to CVMP.
Maltese: Madankollu, saru disponibbli għas-CVMP żewġ studji disponibbli pubblikament.