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siringa mimlija 0. 5 ml għal-lest (ħġieġ) | pre-filled syringe 0.5 ml (glass) |
It-tarbija għandha tkun bilqiegħda mitfugħa lura. | The child should be seated in a reclining position. |
Wara li kkunsidrat ir-Regolament tal-Kummissjoni (KE) Nru 950/2006 tat-28 ta' Ġunju 2006 li jistabbilixxi, għas-snin tas-suq 2006/2007, 2007/2008 u 2008/2009, regoli dettaljati għall-applikazzjoni għall-importazzjoni u l-irfinar ta' prodotti tas-settur taz-zokkor fil-kuntest ta' ċerti kwoti tariffarji u ċerti ftehimiet preferenzjali [2], u partikolarment l-Artikolu 5(3) tiegħu, | Having regard to Commission Regulation (EC) No 950/2006 of 28 June 2006 laying down detailed rules of application for the 2006/07, 2007/08 and 2008/09 marketing years for the import and refining of sugar products under certain tariff quotas and preferential agreements [2], and in particular Article 5(3) thereof, |
Jekk tinnota xi effetti serji jew effetti oħrajn li mhumiex imsemmija f'dan il-fuljett, jekk jogħġbok informa lill-kirurgu veterinarju tiegħek. | If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. |
• Sensittività eċċessiva għas-sustanza attiva jew għal xi wieħed mis-sustanzi mhux attivi. | • Hypersensitivity to the active substance or to any of the excipients. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. |
Artikolu 13 | Article 13 |
L-IMMARKAR ALFABETIKU TAL-KAPAĊITÀ TAL-INTEROPERABBILTÀ | ALPHABETICAL MARKING OF THE INTEROPERABILITY CAPABILITY |
104 Wara kull injezzjoni, il-kappa tal-pinna għandha terġa' titqiegħed fuq il-pinna sabiex tilqa' mid-dawl. | The pen cap must be put back on the pen after each injection in order to protect from light. |
Dr. Chan Nyein Edukazzjoni. | Dr. Chan Nyein |
Raġuni għall-inklużjoni fil-lista: Gvernatur tal-Provinċji ta' Zabol u Uruzgan taħt ir-reġim tat-Taliban. | Grounds for listing: Governor of Zabol and Uruzgan Provinces under the Taliban regime. |
16 ta' Lulju 1997 Data ta' l-aħħar tiġdid: | 16 July 1997 Date of the last renewal: |
Imballaġġ kompost, reċipjent tal-plastik fi drum tal-fibra | Composite packaging, plastic receptacle in fibre drum |
4. | 4. |
Meta wieħed jeqleb minn siringa għal pinna, xi aġġustamenti żgħar għandhom mnejn ikollhom isiru sabiex jiġi evitat li tingħata doża għolja wisq. | Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given. |
Każijiet fatali kkonċernaw l-aktar pazjenti ta' eta`' l fuq minn 65. | Fatal cases mostly concerned patients with an age above 65. |
NovoMix 30 ġie studjat f'pazjenti b'dijabete tip 1 jew tip 2 (294 pazjent) fejn ġie mqabbel ma' insulina tal-bniedem fuq 12- il ġimgħa. | NovoMix 30 has been studied in patients with type 1 or type 2 diabetes (294 patients) where it was compared with human insulin over 12 weeks. |
Xi pazjenti jistgħu jibbenefikaw minn doża ogħla. | Some patients may benefit from a higher dose. |
Disturbi fis-sistema endokrinarja | Endocrine disorders |
Kamran DANESHJOO (magħruf bħala DANESHJOU) | Kamran DANESHJOO (a.k.a. DANESHJOU) |
Il-prodotti li jkunu konformi mad-dispożizzjonijiet tar-Regolament ta' Implimentazzjoni (UE) Nru 29/2012 li jkunu ġew immanifatturati u ttikkettati fl-Unjoni, jew li jkunu ġew impurtati fl-Unjoni u rrilaxxati għaċ-ċirkolazzjoni libera qabel it-13 ta' Diċembru 2014 jistgħu jitqiegħdu fis-suq sakemm il-ħażniet jintużaw kollha. | Products which comply with Implementing Regulation (EU) No 29/2012 and which have been manufactured and labelled in the Union or imported into the Union and put into free circulation before 13 December 2014 may be marketed until all stocks are used up. |
(Kodiċi NM) | (CN code) |
L-assi ta' prijorità 2 | Priority axis 2 |
Sabiex tinkiseb r-rata ta' referenza applikabbli jridu jiżdiedu marġini mar-rata ta' bażi. | To get the applicable reference rate appropriate margins have to be added to a base rate. |
Impjiegi u żvilupp soċjali | Employment and social development |
ADOTTAT DAN IR-REGOLAMENT: | HAS ADOPTED THIS REGULATION: |
Huwa rakkomandat li d-dilwit fl-ebda ħin ma jwassal għal konċentrazzjoni finali inqas minn 0. 2 MIU (2 μg) / ml. | Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time. |
Huwa disponibbli f'pilloli ovali bojod (75, 150 u 300 mg). | It is available as white, oval tablets (75, 150 and 300 mg). |
ANNESS | ANNEX |
Il-Kunsill Governattiv jibqa » kommess b'mod sod fuq l-istabbiltà tal-prezzijiet matul żmien medju u itwal, u kemm il-pożizzjoni tal-politika monetarja u l-pożizzjoni inġenerali tal-likwidità ser tiġi aġġustata kif jixraq. | The Governing Council remains firmly committed to price stability over the medium to longer term, and both the monetary policy stance and the overall provision of liquidity will be adjusted as appropriate. |
15. | 15. |
L-awtorità kompetenti għandha tiddetermina il-lok tal-punti tat-teħid ta' kampjuni jew kejl li għandhom jintużaw għall-monitoraġġ tal-emissjonijiet. | The competent authority shall determine the location of the sampling or measurement points to be used for the monitoring of emissions. |
16. | 16. |
L-użu ta' interferon alfa- 2b fi tfal u | The use of interferon alfa-2b in children and |
Galantamine u donepezil ma jurux effett kilinikament relevanti fuq il-farmakokinetika ta' risperidone u fuq il-porzjon antipsikotiku attiv. | Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction. |
jissodisfa r-rekwiżiti tar-Regolament (KE) Nru 1688/2005 li jimplementa r-Regolament (KE) Nru 853/2004 tal-Parlament Ewropew u fir-rigward ta' garanziji speċjali li jikkonċernaw is-salmonella għall-konsenji lejn il-Finlandja u l-Iżvezja ta' ċertu laħam u bajd;] | it fulfils the requirements of Regulation (EC) No 1688/2005 implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning Salmonella for consignments to Finland and Sweden of certain meat and eggs;] |
ANNESS | ANNEX |
Il-partijiet kollha interessati ġew mgħarrfa bil-fatti u l-kunsiderazzjonijiet essenzjali li wasslu għall-konklużjonijiet imsemmija u ġew mistiedna biex jikkummentaw. | All interested parties were informed of the essential facts and considerations leading to the above conclusions and were invited to comment. |
Jekk ma tistax issib lit-tabib, mur l-isptar l-iżjed qrib tiegħek u ħu l-pakkett tal-pilloli miegħek. | If you cannot reach your doctor, go to the nearest hospital and take the pack with you. |
IRRISPOSTI TALKUMMISSJONI | REPLY OF THE COMMISSION |
14 | “Hr.Botev” 14 |
Bidu ta' immunità: | Onset of immunity: |
Forom ta' ħadid li jintgħaġen għal lokomottivi/magni tat-trambil/partijiet, użu minbarra fl-inġenji tal-art, komponenti tal-bering, berings ta' xaft lixx, magni bil-pistin, strument għal moviment, taljoli, klaċċijiet, makkinarju | Ductile iron castings for locomotives/rolling stock/parts, use other than in land vehicles, bearing housings, plain shaft bearings, piston engines, gearing, pulleys, clutches, machinery |
Fl-1 ta » Diċembru 2008, fuq talba tal-Ministeru tal-Finanzi Ungeriż, il-Kunsill Governattiv adotta Opinjoni dwar miżuri għat-tisħiħ tas-sistema finanzjarja intermedjarja biex tinżamm l-istabbiltà finanzjarja ( CON / 2008/81 ). | On 1 December 2008, at the request of the Hungarian Ministry of Finance, the Governing Council adopted an Opinion on measures to strengthen the financial intermediary system in order to maintain financial stability ( CON / 2008/81 ). |
Fi studji kliniċi li saru nstab li bejn wieħed u ieħor 5% tal-pazjenti li rċevew abacavir żviluppaw reazzjonijiet ta' sensittività eċċessiva; xi wħud minn dawn il-każijiet kienu ta` periklu għall-ħajja u kienu fatali minkejja li ttieħdu prekawzjonijiet. | In clinical studies approximately 5% of subjects receiving abacavir develop a hypersensitivity reaction; some of these cases were life-threatening and resulted in a fatal outcome despite taking precautions. |
Rebif jintuża għall-kura ta' l-isklerożi multipla. | Rebif is used for the treatment of multiple sclerosis. |
Polimeru ta' N,N'-Bis(1,2,2,6,6-pentametil-4-piperidinil)-1,6-eżandiamina ta' 2,4- dikloro-6-(4-morfolinil)-1,3,5-triażina (CAS RN 193098-40-7) | N,N'-Bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-1,6-hexanediamine, polymer with 2,4-dichloro-6-(4-morpholinyl)-1,3,5-triazine (CAS RN 193098-40-7) |
L-ABE għandha tiżviluppa abbozzi ta' standards tekniċi regolatorji sabiex tispeċifika f'aktar dettall: | EBA shall develop draft regulatory technical standards to specify in greater detail: |
ilma mill-ġisem) jew ikollok defiċjenza ta' melħ minħabba terapija dijuretika (pillola ta' l-awrina), dieta b'livelli baxxi ta' melħ, dijarea, rimettar, jew emodijalisi | water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis. |
Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha. | This Regulation shall be binding in its entirety and directly applicable in all Member States. |
Nota: Id-Dijagramma C turi l-punti tal-kejl għat-traffiku li ġej min-naħa tal-lemin. | Note: Figure C shows the measuring points for right-hand traffic. |
IL KAXXA 2 | BOX 2 |
Dejta storika limitata tindika li kura għal 48 ġimgħa tista' tkum marbuta ma' rata ta' rispons sostnut ogħla (11/ 11) u ma' riskju aktar baxx li jirkadu (0/ 11 imqabbel ma' 7/ 96 fl-24 ġimgħa ta' wara l-kura). | Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment). |
Makkinarji għal użin mhux awtomatiku għal ħwienet, b'kapaċità massima ta' użin ≤ 30 kg | Non-automatic retail weighing machines, maximum weighing capacity ≤ 30 kg |
500 mg darbtejn kuljum sa 750 mg darbtejn kuljum | 500 mg twice daily to 750 mg twice daily |
Ambitu | Scope |
S'issa, m'hemm l-ebda informazzjoni konklużiva dwar l-effett li l-HACA għandhom biex jinnewtralizzaw cetuximab. | No conclusive data on the neutralising effect of HACAs on cetuximab is available to date. |
Wara li kkunsidrat it-Trattat dwar il-funzjonament tal-Unjoni Ewropea, | Having regard to the Treaty on the Functioning of the European Union, |
Magħmul fil-Lussemburgu, it-22 ta' Ottubru 2012. | Done at Luxembourg, 22 October 2012. |
Studji dwar l-effikaċja għall-istudji ACTG 364 u 020 jinstabu f'Tabella 5. | Efficacy results for studies ACTG 364 and 020 are found in Table 5. |
Id-Deċiżjoni tal-Kummissjoni 2008/767/KE tat-2 ta' April 2008, Għajnuna mill-Istat C 41/07 (ex NN 49(07) li r-Rumanija kienet implimentat għal Tractorul, ĠU L 263, 2.10.2008, p. 5, premessa 44. | Commission Decision 2008/767/EC of 2 April 2008 on the State aid C 41/07 (ex NN 49/07) which Romania has implemented for Tractorul, OJ L 263, 2.10.2008, p. 5, recital 44. |
43 Jekk l-emoglobina żdiedet b'minn ta' l-anqas 1 g/ dl (0. 62 mmol/ l) jew l-għadd tar-retikoloċiti żdiedet ≥ 40000 ċelluli/ µl' il-fuq mil-linja bażi wara 4 ġimgħat ta' trattament, id-doża għanda tibqa' ta' 150 IU/ kg 3 darbiet fil-ġimgħa jew 450 IU/ kg darba fil-ġimgħa. | If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly. |
ĠU L 176, 10.7.1999, p. 31. | OJ L 176, 10.7.1999, p. 31. |
http://www.ecb.europa.eu/press/pr/date/2005/html/pr051216.mt.html | http://www.ecb.europa.eu/press/pr/date/2005/html/pr051216.en.html |
Kunjetti mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ). | Unopened vials Store in a refrigerator (2°C - 8°C). |
Il-Linji Gwida dwar l-għajnuna mill-Istat għandhom jiġu emendati bl-introduzzjoni ta' kapitolu ġdid dwar l-applikazzjoni, mill-1 ta' Jannar 2012, tar-regoli ta' għajnuna mill-Istat għal miżuri ta' sostenn favur il-banek fil-kuntest tal-kriżi finanzjarja. | The State Aid Guidelines shall be amended by introducing a new chapter on the application, from 1 January 2012, of state aid rules to support measures in favour of banks in the context of the financial crisis. |
Effetti sekondarji oħra f'persuni li jagħtu d-demm tagħhom qabel kirurġija • Kienet osservata żjieda żgħira fl-okkorrenza ta' tgħaqqid tad-demm. | Additional side effects in people donating their own blood before surgery • A slight increase in the occurrence of blood clots has been observed. |
Il-Conseil d'Etat (il-Kunsill tal-Istat), fil-kompetenza ta' kassazzjoni tiegħu, ikkonferma, permezz ta' sentenza tad-29 ta' Marzu 2006, ċerti aspetti mid-deċiżjoni tal-Cour administrative d'appel, b'mod partikolari l-fatt li l-għajnuna inkwistjoni ma kinitx ta' natura sempliċiment li tikkumpensa għall-obbligi ta' servizz pubbliku [14], ma setgħatx tiġi kklassifikata mill-qorti nazzjonali bħala għajnuna eżistenti, u li l-CELF ma setgħatx tinvoka l-aspettattivi leġittimi. | After appealing to the Council of State, by judgment of 29 March 2006 this body confirmed certain aspects of the decision of the Administrative Court of Appeal, particularly the fact that the disputed aid was not of a purely compensatory nature for public service obligations [14], that it could not be described as existing aid by the national judge and that CELF could not claim a legitimate expectation. |
f'termini tar-rekwiżiti ta' rendiment jew ta' funzjoni, inklużi l-karatteristiċi ambjentali, dejjem jekk il-parametri jkunu preċiżi biżżejjed sabiex jippermettu lill-offerenti jiddeterminaw is-suġġett tal-kuntratt u l-awtoritajiet kontraenti jitħallew jagħtu l-kuntratt; | in terms of performance or functional requirements, including environmental characteristics, provided that the parameters are sufficiently precise to allow tenderers to determine the subject-matter of the contract and to allow contracting authorities to award the contract; |
żidiet fil-BUN, krejatinina u krejatina kinażi | Uncommon: |
TAG RIF KLINIKU | CLINICAL PARTICULARS |
Lott xxxxxxxx | Lot xxxxxxxx |
37 4. 5 Prodotti mediċinali oħra li ma jaqblux ma' dan il-prodott u affarjiet oħra li jistgħu jibdlu l-effett farmaċewtiku tal-prodott | 4.5 Interaction with other medicinal products and other forms of interaction |
L-entrati li jikkonċernaw lill-Majott li jinsabu fl-Anness għal dan ir-Regolament għandhom jiddaħħlu fit-tabella fl-Anness II għar-Regolament (UE) Nru 1380/2013 wara l-entrata"Guadeloupe: Speċi pelagiċi. | The entries concerning Mayotte contained in the Annex to this Regulation shall be inserted into the table in Annex II to the Regulation (EU) No 1380/2013 after the entry"Guadeloupe: Pelagic species. |
ĠU L 357, 31.12.2002, p. 72. | OJ L 357, 31.12.2002, p. 72. |
Vanilja | Vanilla |
Il-manifattur jista' jaħtar, permezz ta' mandat bil-miktub, rappreżentant awtorizzat. | A manufacturer may appoint, by written mandate, an authorised representative. |
Yarsanat (magħrufa wkoll bħala Yar Sanat, magħrufa wkoll bħala Yarestan Vacuumi) No. | Yarsanat (a.k.a. Yar Sanat, a.k.a. Yarestan Vacuumi) |
Madankollu, hawn fuq intqal li s-soċjetajiet ċivili u s-sħubijiet jagħmlu parti mill-entitajiet li l-membri tagħhom għandhom responsabbiltajiet illimitati għad-djun. | It has been explained above that both of these forms of partnership are legal persons whose members have unlimited liability for their debts. |
B'konsistenza mal-paragrafu 7.7.1.1., għal magni li huma ttestjati bl-NRSC u anki l-NRTC, il-veloċità tad-denormalizzazzjoni (ndenorm) għandha tintuża minflok il-veloċità kklassifikata meta tiġi stabbilita l-veloċità intermedja. | Consistent with paragraph 7.7.1.1., for engines that are tested with the NRSC and also the NRTC the denormalization speed (ndenorm) shall be used in place of rated speed when determining the intermediate speed. |
Terapija antiretrovirali kombinata ġiet assoċjata ma'tibdil fid-distribuzzjoni mill-ġdid tax-xaħam fil-ġisem (lipodistrofija) f'pazjenti bl-HIV inklużi tnaqqis fix-xaħam periferali u ta' taħt il-ġilda tal-wiċċ, żieda fix-xaħam intra- addominali u tal-vixxri, ipertrofija tas-sider u akkumulazzjoni ta'xaħam dorsoċervikali (buffalo hump). | Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump). |
Meloxicam | Meloxicam |
NUMRU( I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ | MARKETING AUTHORISATION NUMBER(S) |
Il-Litwanja | Lithuania |
Minħabba ż-żmien twil li zonisamide idum fil-ġisem, it-treddigħ m'għandux jitkompla sa xahar wara li t-terapija b'Zonegran tkun tlestiet. | Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed. |
4 mg | 4 mg |
Id-dispożizzjonijiet speċifiċi applikabbli għall-gruppi ta' ikel għal użu ta' nutriment partikolari li jidhru fl-Anness I għandhom jiġu stabbiliti permezz ta' Direttivi speċifiċi. | The specific provisions applicable to the groups of foodstuffs for particular nutritional uses appearing in Annex I shall be laid down by means of specific Directives. |
Dawn jinkludu rapporti spontanji ta' każijiet kif ukoll reazzjonijiet avversi serji minn studji kurrenti, programmi ta' aċċess espansiv, studji kliniċi farmakoloġiċi u studji esplorattivi f'indikazzjonijiet mhux approvati. | This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications. |
Dan inaqqas ir-riskju li ribavirin jitħalla fil-ġisem tal-mara. | ori This will lessen the chance for ribavirin to be left in the woman's body. |
Wara gimgħa jew tnejn ta' terapija, id-doża tal-bidu tkun tista' tiġi rdoppjata jew titniżżel bin-nofs dejjem skond ir-rispons tal-pazjent. | After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response. |
Disturbi fil-kliewi u fis-sistema urinarja | Renal and urinary disorders |
Il-Kaxxa I. 11: L-isem, l-indirizz u n-numru tal-approvazzjoni tal-istabbiliment minn fejn intbagħtu. | Box I.11: Name, address and approval number of establishment of dispatch. |
Dan għandu jippermetti lill-operaturi li jkopru kwalunkwe spiża raġonevoli ta' tqabbid u jipprovdi flessibbiltà għal kompetizzjoni billi joffri perjodi minimi ta' ħlas iqsar. | This will enable operators to cover any reasonable set-up costs and to provide flexibility to compete by offering shorter minimum charging periods. |
4. 4 Twissijiet speċjali u prekawzjonijiet għall-użu | 4.4 Special warnings and precautions for use |
19 (3. 5%) | 19 (3.5%) |
Fi ħdan l-Unjoni, il-prodott simili huwa mmanifatturat minn seba' kumpaniji jew gruppi ta' kumpaniji. | Within the Union, the like product is manufactured by seven companies or groups of companies. |
tat-30 ta' April 2010 | of 30 April 2010 |
ADOTTA DIN ID-DEĊIŻJONI: | HAS ADOPTED THIS DECISION: |
il-protezzjoni mir-radjazzjoni; | radiation protection; |
ĠU L 299, 16.11.2007, p. 1. | OJ L 299, 16.11.2007, p. 1. |
Disturbi tad-demm u tas-sistema limfatika Komuni: tromboċitopenja, lewkopenja, granuloċitopenja Mhux Komuni: lewkoċitosi | Blood and lymphatic system disorders Common: thrombocytopenia, leucopenia, granulocytopenia Uncommon: leucocytosis |