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L-Aġenzija għandha tirrimborża lill-Istati Membri għax-xogħol ta' ċertifikazzjoni li jipprovdu f'isimha. | The Agency shall reimburse the Member States for the certification tasks they provide on its behalf. |
Jekk l-armi tan-nar, il-partijiet u l-komponenti essenzjali tagħhom u l-ammunizzjoni ikunu jinsabu fi Stat Membru wieħed jew aktar għajr dak fejn saret l-applikazzjoni għal awtorizzazzjoni tal-esportazzjoni, dan il-fatt għandu jiġi indikat fuq dik l-applikazzjoni. | If the firearms, their parts and essential components and ammunition are located in one or more Member States other than the one where the application for export authorisation has been made, that fact shall be indicated on that application. |
Wara li kkunsidrat ir-Regolament tal-Kunsill (KE) Nru 881/2002 tas-27 ta' Mejju 2002 li jimponi ċerti miżuri speċifiċi restrittivi diretti kontra ċerti persuni u entitajiet assoċjati man-netwerk ta' Al-Qaida [1], u b'mod partikolari l-Artikolu 7(1)(a) u 7a(5) tiegħu, | Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, [1] and in particular Article 7(1)(a) and 7a(5) thereof, |
F'pazjenti b'marda kronika tal-kliewi, l-konċentrazzjoni ta' l-emoglobina miżmuma m'għandhiex taqbeż il-limitu ta' fuq tal-konċentrazzjoni mmirata ta' l-emoglobina rrakkomandata f'sezzjoni 4. 2. | In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2. |
3 pipetti 6 pipetti | 3 pipettes 6 pipettes 4 pipettes 21 pipettes |
Mhux komuni: | Uncommon: |
4. 9 Doża eċċessiva | 4.9 Overdose |
Il-ġogi tal-irkoppa (ara l-Figura 4) | Knee joint (see Figure 4) |
Wara li kkunsidrat t-Trattat dwar il-Funzjonament tal-Unjoni Ewropea, | Having regard to the Treaty on the Functioning of the European Union, |
TITOLU I | TITLE I |
5 | • |
Filkaż ta' kriżi jew fuq it-talba talPresident talParlament Ewropew jew taċ-Chairman talKumitat għallAffarijiet Barranin, idDrittijiet tal-Bniedem, il-Politika Komuni ta' Sigurtà u ta' Difiża, din linformazzjoni għandha tiġi pprovduta kemm jista' jkun malajr. | In the event of a crisis or at the request of the President of the European Parliament or of the Chairman of the Committee on Foreign Affairs, Human Rights, Common Security and Defence Policy, such information shall be provided at the earliest opportunity. |
Il-Pajjiżi l-Baxxi (NL) | Netherlands (NL) |
L-istandards armonizzati għandhom jipprovdu l-metodi u l-kriterji għall-valutazzjoni tal-prestazzjoni tal-prodotti għall-bini fir-rigward tal-karatteristiċi essenzjali tagħhom. | Harmonised standards shall provide the methods and the criteria for assessing the performance of the construction products in relation to their essential characteristics. |
Wara li kkunsidra l-proposta sottomessa mill-Kummissjoni Ewropea (“il-Kummissjoni”) wara li ġie kkonsultat il-Kumitat ta' Konsulenza, | Having regard to the proposal submitted by the European Commission (the Commission) after consulting the Advisory Committee, |
Jekk m'intix żgur, staqsi lit-tabib tiegħek. | If you are not sure, talk to your doctor. |
Stabbiliment istituzzjonali | Institutional set-up |
WERREJ | TABLE OF CONTENTS (LIST OF COMPULSORY ELEMENTS) |
2. | 2. |
Kull pillola miksija b'rita fiha 1, 000 mg levetiracetam. | Each film-coated tablet contains 1,000 mg levetiracetam. |
Magyarország JANSSEN- CILAG Kft. | Magyarország JANSSEN-CILAG Kft. |
Il-klawżola ta' l-arbitraġġ | Arbitration clause |
NETWERKS TRANS-EWROPEJ | TRANS-EUROPEAN NETWORKS |
CPA 16.29.24: Sufra agglomerata; oġġetti magħmula minn sufra agglomerata m.k.b. | CPA 16.29.24: Agglomerated cork; articles of agglomerated cork n.e.c. |
Destinatarji | Addressees |
Italia sanofi- aventis S. p. A. | Italia sanofi-aventis S.p.A. |
IDDEĊIDEW KIF ĠEJ: | HAVE DECIDED AS FOLLOWS: |
Jekk Parti taħdem taħt paragrafu 1 ta' dan l-Artikolu, f'kull ħin qabel l-obbligi tal-miżuri ta' kontroll fl-Artikolu 2 A sa 2 E isiru applikabbli għalih, issib lilha nnifisha mhux kapaċi li tikseb forniment adegwat ta' sustanzi kontrollati, trid tinnotifika dan lis-Segretarjat. | If a Party operating under paragraph 1 of this Article, at any time before the control measures obligations in Article 2 A to 2 E become applicable to it, finds itself unable to obtain an adequate supply of controlled substances, it may notify this to the Secretariat. |
Solenojd b'dijaframma, li jopera bi provvista nominali ta' vultaġġ ta' 24 V f'DC nominali ta' 0,08 A, għall-użu fil-fabbrikazzjoni tal-oġġetti tal-intestatura Nru 8517 [1] | Solenoid with a plunger, operating at a nominal supply voltage of 24 V at a nominal DC of 0,08 A, for use in the manufacture of products falling within heading 8517 [1] |
Mhux meħtieġ li jsir aġġustament fid-doża għal pazjenti b'indeboliment tal- | No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD). |
Metodi biex jiddeterminaw u jikkwantifikaw ir-residwi | Methods to determine and quantify residues |
Skart u fdalijiet tal-landa; oġġetti oħra tal-landa | Tin waste and scrap; other articles of tin |
Huwa wkoll neċessarju li jiġi stabbilit ammont ta' referenza finanzjarja intiża biex tkopri l-ispejjeż komuni tal-Atalanta għal perjodu bejn it-13 ta' Diċembru 2012 u t-12 ta' Diċembru 2014. | It is also necessary to lay down the financial reference amount intended to cover the common costs of Atalanta for the period from 13 December 2012 to 12 December 2014. |
Artikolu 1 | Article 1 |
Barra minn hekk, l-implimentazzjoni ta' miżuri addizzjonali minħabba nixfa eċċezzjonali wasslet għal użu iżjed intensiv tas-sistema informatika. | Furthermore, the implementation of additional measures due to exceptional drought led to a more intensive use of the informatics system. |
M'hemmx data fuq l-effetti fit-tul li fulvestrant għandu fuq l-endometriju f'nisa li għaddew mill-menopawża. | There are no data on the long-term effects of fulvestrant on the postmenopausal endometrium. |
Halides u ossidi tal-halide mhux ta' metalli (bl-eskluzjoni ta' kloruri u ossidi tal-kloru tal-fosfru) | Halides and halide-oxides of non-metals (excluding chlorides and chloride oxides of phosphorus) |
Íreland Merck Serono Ltd. | Ireland Merck Serono Ltd. |
ma jkunux instabu ħatja ta' nuqqas serju jew ripetut li jissodisfaw l-obbligi tal-liġi soċjali u tax-xogħol, li jinkludu obbligi skont il-leġiżlazzjoni ta' sikurezza u s-saħħa okkupazzjonali, u l-obbligi tal-liġi doganali fil-każ ta' kumpaniji li jkunu jridu jħaddmu servizzi tat-trasport transkonfinali ta' merkanzija, u li jkunu suġġetti għall-proċeduri doganali. | have not been convicted of serious or repeated failure to fulfil social or labour law obligations, including obligations under occupational safety and health legislation, and customs law obligations in the case of a company seeking to operate cross-border freight transport subject to customs procedures. |
Il-President | The President |
Cucurbits – qoxra li tittiekel | Cucurbits - edible peel |
Kawżi Ġodda | New cases |
- tibdil fix-xaħam tal-ġisem. | - changes in body fat. |
NNHT (2-nitruimminu-5-nitru-eżaidru-1,3,5-trijażin) (CAS 130400-13-4); | NNHT (2-nitroimino-5-nitro-hexahydro-1,3,5-triazine) (CAS 130400-13-4); |
il-Liechtenstein hu eżentat mill-ġbir tad-dejta tas-serje tad-9C u 9D skont l-Anness 1. Il-Liechtenstein għandu jforni dejta tal-livell ta' tqassim tal-attività skont il-livell ta' żewġ ċifri biss ta' NACE Rev.2.” | Liechtenstein is exempted from collecting the data of the series of data 9C and 9D according to Annex I. Liechtenstein shall supply data of the level of activity breakdown according to NACE Rev.2, 2-digit level only.'; |
Il-kontijiet tal-Bank Ċentrali Ewropew (BĊE) u tal-banek ċentrali nazzjonali tal-Eurosistema għandhom jiġu verifikati minn awdituri esterni indipendenti rrakkomandati mill-Kunsill Governattiv tal-BĊE u approvati mill-Kunsill tal-Unjoni Ewropea. | The accounts of the European Central Bank (ECB) and of the national central banks of the Eurosystem are to be audited by independent external auditors recommended by the ECB's Governing Council and approved by the Council of the European Union. |
L-awtorità kompetenti nazzjonali tal-Istat Membru kkonċernat għandha tieħu l-miżuri kollha meħtieġa skont l-obbligu msemmi fil-punt (c) tal-paragrafu 2. | The national competent authority of the concerned Member State shall take all the necessary measures in accordance with the obligation referred to in point (c) of paragraph 2. |
33 trid tittieħed f'konsiderazzjoni mit-tabib li qed jippreskrivi u għandu jiġi kkunsidrat l-bżonn ta' mmaniġġjar terapewtiku xieraq. | If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered. |
Għalhekk, jekk l-efavirenz jingħata flimkien ma' amprenavir (600 mg darbtejn kuljum) u ritonavir (100 mg darbtejn kuljum), m'hemmx bżonn ta' ċaqliq fid-doża. | Therefore, if efavirenz is given in combination with amprenavir (600 mg twice daily) and ritonavir (100 mg twice daily), no dose adjustment is necessary. |
Is-sustanza attiva Pseudomonas sp, ir-razza DSMZ 13134, kif speċifikata fl-Anness I, hija approvata skont il-kundizzjonijiet stabbiliti f'dak l-Anness. | The active substance Pseudomonas sp. strain DSMZ 13134, as specified in Annex I, is approved subject to the conditions laid down in that Annex. |
Artikolu 28 | Article 28 |
Il-Kummissjoni għandha tgħarraf lill-Parlament Ewropew u lill-Kunsill b'dak l-att ta' implimentazzjoni. | The Commission shall inform the European Parliament and the Council of that implementing act. |
≥ 55 < 70 | ≥ 55 < 70 |
0,1 %, f'valur assolut, għal kontenuti tal-ammonja ta' 1,0 % jew iktar. | 0,1 %, in absolute value, for ammonia contents of 1,0 % or more. |
- Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar tiegħek. | - If you have any further questions, ask your doctor or pharmacist. |
INFORMAZZJONI BIL-BRAILLE | INFORMATION IN BRAILLE |
Żewġ kampjuni tal-montatura kompluta taċ-ċinturin għandhom jitqiegħdu f'kabinett imkessaħ f'temperatura ta' –10° + 1 °C għal sagħtejn. | Two samples of the complete belt assembly shall be placed in a refrigerated cabinet at – 10° ± 1 °C for 2 hours. |
Manifattura ta' ħwejjeġ oħra ta' fuq | Manufacture of other outerwear |
7. | 7. |
li jemenda l-prezzijiet rappreżentattivi u l-ammonti tad-dazji addizzjonali għall-importazzjoni ta' ċerti prodotti tas-settur taz-zokkor, stabbiliti bir-Regolament (KE) Nru 877/2009 għas-sena tas-suq 2009/10 | amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 877/2009 for the 2009/10 marketing year |
Il-pinna li fiha skartoċċ m'għandiex tinżamm fil-friġġ. | The pen containing a cartridge must not be stored in the refrigerator. |
Artikolu 2 | Article 2 |
Hija saħqet ukoll li dak li ġara sar fi kwantitajiet żgħar u li dawk il-prattiċi ġew imwaqqfa immedjatament. | It also underlined that it concerned only a small quantity and that those practices were immediately ceased. |
Regolament tal-Kunsill (KE) Nru 806/2003 | Council Regulation (EC) No 806/2003 |
Jekk il-kawżi tipiċi ta' nuqqas ta' rispons jiġu esklużi, u l-pazjent għandu retikuloċitopenija, eżami tal-mudullun għandu jiġi kkunsidrat. | If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered. |
KLASSIFIKAZZJONI ĠENERALI TA' KIF JINGĦATA | GENERAL CLASSIFICATION FOR SUPPLY |
ma' obbligant/garanti mhux sovran fejn il-primjum mitlub huwa inqas minn dak stabbilit mill-Kategorija tar-Riskju tax-Xerrej CC1, jiġifieri CC0 jew SOV+; | with a non-sovereign obligor/guarantor where the premium charged is below that set by Buyer Risk Category CC1, i.e. CC0 or SOV+; |
15. | 15. |
Spanja 16-il bastiment | Spain 16 vessels |
tal-5 ta' Settembru 2012 | of 5 September 2012 |
Magħmul fi Brussell, id-29 ta' Jannar 2014. | Done at Brussels, 29 January 2014. |
1 ml fih 100 U (ekwivalenti għal 3. 5mg) t'insulina lispro (ta' oriġini rikombinanti tad-DNA magħmul minn E. coli). | One ml contains 100U (equivalent to 3.5mg) insulin lispro (recombinant DNA origin produced in E. coli). |
Tumuri | Tumours |
ĠU C 229, 22.9.2006, p. 38. | OJ C 229, 22.9.2006, p. 38. |
3'-O-mesyl-5'-O-tritylthymidine | 3′-O-mesyl-5′-O-tritylthymidine |
Brunġiel | Aubergine or Egg plant |
Ir-Reġjun tal-Liguria: Il-Provinċji ta' Imperia, Savona, | Region Liguria: Provinces of Imperia, Savona, |
Tagħrif importanti dwar xi wħud mis-sustanzi ta' Insuman Rapid | Important information about some of the ingredients of Insuman Rapid |
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA | 41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING |
PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN | SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE |
Wara li kkunsidrat ir-Regolament tal-Kummissjoni (KE) Nru 951/2006 tat-30 ta' Ġunju 2006 dwar regoli ddettaljati għall-applikazzjoni tar-Regolament tal-Kunsill (KE) Nru 318/2006 f'dak li għandu x'jaqsam mal-iskambji mal-pajjiżi terzi fis-settur taz-zokkor [2], u b'mod partikolari l-Artikolu 36(2), it-tieni subparagrafu, it-tieni sentenza tiegħu, | Having regard to Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector [2], and in particular Article 36(2), second subparagraph, second sentence thereof, |
Trasferiment ta' jiem bejn bastimenti tas-sajd li jtajru l-bandiera ta' Stat Membru | Transfer of days between fishing vessels flying the flag of a Member State |
Il-metodu tal-forza fil-magħżel tat-tajer | Force method at tyre spindle |
Diklorometanu (klorur tal-metilin) | Dichloromethane (methylene chloride) |
ANNESS | ANNEX |
Parti I: Dettalji tal-kunsinja mibgħuta | Part I: Details of dispatched consignment |
Is-sitt klassi: 00-70-X-00, | Sixth class: 00-70-X-00, |
paroxetine, amitriptyline, risperidone jew litju. | treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium. |
Minbarra hekk, tfal kienu kurati f'żewġ studji ta' fażi I u wieħed ta' Fażi II. | In addition, children have been treated in two phase I studies and one phase II study. |
Tagħmlux fil-friġġ. | Do not refrigerate. |
Rata ta' firxa (%) | Spread rate (%) |
PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN | SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE |
Punt (a) ta' l-Artikolu 17 (7) għandu japplika. | Point (a) of the third subparagraph of Article 17(7) shall apply. |
• KUNDIZZJONIJIET OĦRA | • OTHER CONDITIONS |
Għandek tieħu clopidogrel sakemm it-tabib jibqa' jagħmillek ir-riċetta. | You should take clopidogrel for as long as your doctor continues to prescribe it. |
Emenda fir-Regolament (KE) Nru 209/2008 | Amendment to Regulation (EC) No 209/2008 |
4. 3 Kontra- indikazzjonijiet | 4.3 Contraindications |
potassium - 12, 5 mg hydrochlorothiazide | Film-coated tablet |
Fejn jinsab(u) (i)l-benefiċjarju/i: | Sector(s) of the beneficiary(ies): |
ĠU L 256, 7.9.1987, p. 1. | OJ L 256, 7.9.1987, p. 1. |