qanastek/EMEA-V3 huggingface dataset:
The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom.
L- Istat Membru ta ’ Referenza kien il- Ġermanja u l- Istati Membri Konċernati kienu l- Awstrija, id- Danimarka, Spanja, il- Finlandja, Franza, l- Italja, il- Lussemburgu, in- Norveġja, il- Polonja, il- Portugall, l- Iżvezja u r - Renju Unit.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma kienux kapaċi jilħqu ftehim rigward ir- Rikonoxximent Reċiproku ta ’ l - Awtorizzazzjoni tat- Tqegħid fis- Suq mogħtoija mill- Istat Membru ta ’ referenza.
Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Il- Ġermanja irreferiet għar - raġunijiet ta ’ nuqqas ta ’ qbil lill- EMEA fid- 29 ta ’ Marzu 2007.
On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies.
Abbażi tal- kwistjonijiet imqajjma mill- Istati Membri, il- punti li għandhom jiġu kkunsidrati mis- CHMP jikkonċernaw il- pożoloġija, l- amministrazzjoni ripetuta u l- profil ta ’ sigurtà f ’ żewġ studji Fażi III.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Il- proċedura ta ’ l- arbitraġġ bdiet fis- 26 ta ’ Lulju 2007 permezz ta ’ l- adozzjoni ta ’ lista ta ’ domandi.
The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Ir - Rapporteur kien Dr Karl Broich u l- Ko- Rapporteur( s) kien Dr Pierre Demolis.
The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Il- Pussessur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq ta ’ spjegazzjonijiet bil- miktub fil- 25 ta ’ Mejju 2007.
During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Waqt il- laqgħa tiegħu tas- 16- 19 ta ’ Lulju ta 'l- 2007, il- CHMP, fid- dawl tat- tagħrif sottomess kollu u fid- dawl tad- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċji u r- riskji kien favorevoli għal Xeomin, li l- objezzjonijiet imqajma ma għandhomx jimpedixxu l- għoti ta' l- Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta 'tagħrif ta' l- Istat Membru ta 'Referenza għandhom jiġu emendati.
A positive opinion was adopted by majority on 19 July 2007.
Ġiet adottata opinjoni pożittiva permezz ta ’ kunsens fid- 19 ta ’ Lulju 2007.
The final opinion was converted into a Decision by the European Commission on 24 October 2007.
L- opinjoni finali hija konvertita f’ Deċiżjoni mill- Kummissjoni Ewropea fl- 24 ta ’ Ottubru 2007.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Dan huwa dwar l- Artikolu 29( 4) tad- Direttiva 2001/ 83/ KE, kif emendat.
2 Germany
Ġermanja
Greece
2 Greċja
3 Luxembourg
Lussemburgu
143, Avenue Louise 1050 Brussel Belgium
143, Avenue Louise 1050 Brussel il- Belġju
0.02 mg / 3 mg
3
Yasminelle Rua da Quinta do Pinheiro, No.
Rua da Quinta do Pinheiro, No.
5 2794-003 Carnaxide Portugal
5 2794- 003 Carnaxide Il- Portugall
Bayer Schering Pharma AG Yasminelle D-13342 Berlin Germany
Bayer Schering Pharma AG D- 13342 Berlin Il- Ġermanja
4 Spain
Spanja
Sweden
Sveżja
United Kingdom
4 Renju Unit
Schering Health Care Ltd The Brow Burgess Hill West Sussex RH15 9NE United Kingdom
Schering Health Care Ltd The Brow Burgess Hill West Sussex RH15 9NE Ir- Renju Unit
The Yasminelle blister is glued in a carton which is subsequently folded to a wallet configuration.
Il- blister ta ’ Yasminelle huwa mwaħħal bil- kolla ma ’ kartuna li mbagħad tintlewa f’ forma ta ’ portafoll.
The wallet with the inserted blister is assembled with a package leaflet (PL) and all components are wrapped together with clear, transparent cellophane wrapping to form the unit pack which prevents the loss of individual components.
Il- portafoll bil- blister infilzat jiġi mmuntat b’ fuljett ta ’ tagħrif (PL) u l- komponenti kollha jitgeżwru flimkien b’ kisja ta ’ cellophane irqiq u trasparenti biex jifforma l- pakkett li jipprevjeni t- telf ta ’ komponenti individwali.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF YASMINELLE AND ASSOCIATED NAMES (see Annex I)
SOMMARJU GLOBALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ YASMINELLE U ISMIJIET ASSOĊJATI (ara l- Anness I)
Once the cellophane wrapping is removed the safe use of the product is still ensured as the cardboard wallets contain the required information.
Ladarba l - kisi tas- cellophane jitneħħa, l- użu sigur tal- prodott ikun għadu żgurat għax il- portafolli tal- kartun ikun fihom it- tagħrif meħtieġ.
In addition it is not possible to separate blisters from cardboard wallets and therefore the users always have access to the required information.
Barra minn hekk ma jkunx possibbli li tifred il- folji mill- portafolli tal - kartun u għalhekk min jużahom dejjem ikollu aċċess għat- tagħrif meħtieġ.
Moreover cardboard wallets protect blisters against damage.
Barra minn hekk il - portafolli tal- kartun jipproteġu l- folji mill- ħsara.
Although different observations in respect to readability of the Braille text through the cellophane wrapping have been made by blind users, it is assumed that before use of the product the cellophane wrapping will be removed and therefore blind person will be in a position to identify the product.
Għalkemm saru osservazzjonijiet differenti dwar il- possibilità ta ’ qari tal- kitba bil- Braille mill- kisi tas - cellophane minn persuni għomja, wieħed jassumi li qabel ma xi ħadd juża l- prodott, dan ineħħi l - kisi tas- cellophane u għalhekk il- persuna għamja tkun tista ’ tidentifika l- prodott.
It has also been confirmed by blind persons that the Braille text on the cardboard is palpable and readable.
Ġie konfermat ukoll minn persuni għomja li l- kitba bil- Braille fuq il- kartun tinħass u tista ’ tinqara.
Therefore blind users will be able to double check the information written on the cardboard wallets (Braille text) with the information obtained from a physician (during the visit).
Għalhekk persuni għomja li jużaw dan il - prodott ikunu jistgħu jiċċekkjaw doppjament it- tagħrif miktub (bil- Braille) fuq il- portafolli tal- kartun bit- tagħrif miksub mit- tabib (waqt iż- żjara).
London, 17 June 2008 EMEA/ 337156/ 2008
Londra, 17 ta 'Ġunju 2008 EMEA/ 337148/ 2008
OPINION FOLLOWING AN ARTICLE 5(11) 1 REFERRAL FOR Yasminelle and associated names (see Annex I)
OPINJONI DWAR RIFERIMENT SKOND L- ARTIKOLU 5( 11) 1 GĦAL Yasminelle u ismijiet oħra assoċjati (ara anness I) Denominazzjoni Komuni Internazzjonali (DKI):
Yasminelle and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Yasminelle u l- ismijiet assoċjati, hija kontraċċettiv orali kombinat li fih 0. 02 mg ethinylestradiol u 3 mg drospirenone.
The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/ 2003.
Id- dententur ta 'l- awtorizzazzjoni għat- tqegħid fuq is- suq (MAH) ippreżenta applikazzjoni għal varjazzjoni suġġetta għall- Proċedura ta' Rikonoxximent Reċiproku ta 'l- Awtorizzazzjoni għat- Tqegħid fis- suq tal - mediċinal fl- ambitu ta' l- Artikolu 5 tar- Regolament tal- Kummissjoni (KE) Nru 1984/ 2003.
The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
L- Istat Membru ta 'referenza kienet l- Olanda u l- Istati Membri kkonċernati kienu l- Awstrija, il- Belġju, Ċipru, ir- Repubblika Ċeka, id- Danimarka, l- Estonja, il - Finlandja, Franza, il- Ġermanja, il- Greċja, l- Irlanda, l- Italja, l- Iżlanda il- Latvja, il- Litwanja, il- Lussemburgu, Malta, in- Norveġja, il- Polonja, il- Portugall, is- Slovakkja, is- Slovenja, Spanja, ir- Renju Unit, l- Ungerija u l - Iżvezja.
These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/ 2003.
Dawn l- Istati Membri ma setgħux jilħqu qbil fir- rigward tal- varjazzjoni ta 'l- Awtorizzazzjoni għat - Tqegħid fis- Suq saż- żmien previst mill- Artikolu 5( 6) tar- Regolament tal- Kummissjoni (KE) Nru 1084/ 2003.
During their December 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Waqt il- laqgħa tiegħu f' Diċembru 2007, is- CHMP, fid- dawl tat- tagħrif kollu mressaq u fid- dawl tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċji u r- riskji huwa favorevoli għal Yasminelle u l- ismijiet assoċjati, li l- oġġezzjonijiet imqajma mill- Ungerija ma għandhomx jimpedixxu l- approvazzjoni tal- varjazzjoni li għalihom tressqet applikazzjoni u li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta 'tagħrif ta' l- Istat Membru ta 'Referenza għandhom ikunu l - verżjonijiet finali milħuqa waqt il- proċedura tal- grupp ta' koordinament.
A positive opinion was adopted by majority on 13 December 2007.
Fit- 13 ta 'Diċembru 2007, ġiet adottata opinjoni pożittiva b' maġġoranza.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
LISTA TA` L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
film-coated tablet
Pillola miksija b’ rita
oral use
Użu mill- ħalq
oral drops, solution
Taqtir tal- ħalq, taħlita likwida
oral solution
Taħlita likwida li tittieħed mill- ħalq
McNeil Roderveld 1 B – 2600 Berchem Belgium
McNeil Roderveld 1 B – 2600 Berchem Il- Belġju
Box 22679 1523 Nicosia Cyprus
Box 22679 1523 Nicosia Ċipru
UCB Pharma SA (BRAINE) Chemin du Foriest Braine-l'Alleud B-1420 Belgium
UCB Pharma SA (BRAINE) Chemin du Foriest Braine- l' Alleud B- 1420 Il- Belġju
Denmark
3 Id- Danimarka
France
4 Franza
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 Franza
France
5 Franza
10 D-40789 Monheim Germany
10 D- 40789 Monheim Il- Ġermanja
1 D-76139 Karlsruhe GERMANY
1 D- 76139 Karlsruhe IL- ĠERMANJA
Greece
6 Il- Greċja
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
UCB Magyarország Kft Árpád fejedelem útja 26- 28 1023 Budapest L- Ungerija
UCB Pharma Ireland Limited, United Drug House, Magna Drive City West Road Dublin 24 Ireland
UCB Pharma Ireland Limited, United Drug House, Magna Drive City West Road Dublin 24 L- Irlanda
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) Italy
Istituto Lusofarmaco Via Walter Tobagi 8 20068 Peschiera Borromeo (MI) L- Italja
SS 156km 50 04010 Borgo San Michele (LT) Italy
SS 156km 50 04010 Borgo San Michele (LT) L- Italja
Lithuania
8 Il- Litwanja
Oral use
Użu mill- ħalq
Luxemburg
9 Il- Lussemburgu
McNeil Sweden AB, Sollentuna Sweden
McNeil Sweden AB, Sollentuna L- Isvezja
Poland
10 Il- Polonja
Mogilska 80 31-546 Krakow Poland
Mogilska 80 31- 546 Krakow Il- Polonja
Kruczkowskiego, 8 00 - 380 Warszawa Poland
Kruczkowskiego, 8 00 - 380 Warszawa Il- Polonja
Portugal
11 Il- Portugall
Maria I Piso 1 A Quinta da Fonte 2770-229 Paco de Arcos Portugal
Maria I Piso 1 A Quinta da Fonte 2770- 229 Paco de Arcos Il- Portugall
UCB GmbH Huttenstraße 205 D-50170 Kerpen Germany
UCB GmbH Huttenstraße 205 D- 50170 Kerpen Il- Ġermanja
UCB SA Pharma Secteur Chemin du Foriest, B-1420 Braine l´Alleud Belgium
UCB SA Pharma Secteur Chemin du Foriest, B- 1420 Braine l´Alleud Il- Belġju
Slovakia
12 Is- Slovakkja
(Slovenia) Brnciceva 1 SLO - 1001 Ljubljiana Slovenia
(Slovenia) Brnciceva 1 SLO - 1001 Ljubljiana Slovenja
Alfonso XII, 587 08918 Badalona (Barcelona) Spain
Alfonso XII, 587 08918 Badalona (Barcelona) Spanja
Spain
13 Spanja
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Spain
Lacer SA Sardenya 346 - 350 E - 08025 Barcelona Spanja
Spain
14 Spanja
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain
Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spanja
UCB Nordic A/ S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
UCB Nordic A/ S Arne Jacobsens Allé 15 DK- 2300 Kobenhavn S Id- Danimarka
United kingdom
15 Ir- Renju Unit
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦAS- SOMMARJI TAL - KARATTERISTIĊI TAL- PRODOTT, TIKKETTAR U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
19 SCIENTIFIC CONCLUSIONS
17 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZYRTEC AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ ZYRTEC U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Zyrtec (cetirizine dihydrochloride) is an antiallergic drug indicated for the relief of nasal symptoms of seasonal and perennial allergic rhinitis.
Zyrtec (cetirizine dihydrochloride) huwa mediċina antiallerġenika indikata għas- serħan mis- sintomi nażali tar- rinite allerġika staġjonali u perennali.
The drug is authorised for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and various types of pruritus and dermatological conditions from allergic origin, in particular chronic idiopathic urticaria.
Il- mediċina hija awtorizzata għat- trattament sintomatiku tar- rinite allerġika staġjonali, rinite allerġika perennali, u diversi tipi ta ’ ħakk u kundizzjonijiet dermatoloġiċi minn oriġini allerġika, b’ mod partikolari urtikarja idjopatika kronika.
In adults, all three indications are treated by a 10 mg daily dose of cetirizine.
Fl- adulti, it- tliet indikazzjonijiet huma ttrattati b’ doża ta ’ 10 mg cetirizine kuljum.
The drug is indicated in adults and children aged 2 years and older in all the member states.
Il- mediċina hija indikata fl- adulti u fit- tfal li għandhom sentejn u aktar fl- Istati Membri kollha.
In 16 member states, treatment with cetirizine is also recommended in infants and toddlers aged 1 to 2 years.
Fis- 16- il Stat Membru, it- trattament b’ cetirizine huwa rrakkomandat ukoll fi trabi u tfal żgħar li għandhom bejn sena u sentejn.
The liquid formulations are primarily for children up to 12 years, the solid tablets are for children from 12 years on and for adults.
Il- formulazzjonijiet likwidi huma primarjament għal tfal li għandhom sa 12- il sena, il- pilloli solidi huma għal tfal minn 12- il sena ’ il fuq u għall- adulti.
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/ 83/ EC as amended in order to harmonise the divergent Product Information texts across the EU.
Minħabba d- deċiżjonijiet nazzjonali diverġenti meħudin mill- Istati Membri dwar l- awtorizzazzjoni ta ’ Zyrtec, hemm għadd ta ’ diverġenzi fit- tagħrif dwar il- prodott u għalhekk sar riferiment skond l- Artikolu 30 tad- Direttiva 2001/ 83/ KE tal - Kummissjoni Ewropea kif emendat sabiex jiġu armonizzati t- testi diverġenti tat- Tagħrif dwar il - Prodott madwar l- UE.
A list of Questions was adopted by the CHMP, highlighting the main areas of divergences.
Ġiet adottata lista ta ’ Mistoqsijiet mis- CHMP, li tenfasizza l- partijiet ewlenin tad- diverġenzi.
The CHMP asked the MAH to revise the wording, restrict and define the indication in rhinoconjunctivitis rather than in conjunctivitis alone and discuss seasonal conjunctivitis, itching and allergic pruritis, severe skin reactions induced by mosquito and atopic dermatitis, as they should be considered as separate entities requiring more supportive data.
Is- CHMP talab lill- MAH jirrevedi l- formolazzjoni tal- kliem, jillimita u jiddefinixxi l- indikazzjoni fir - rinokonġuntivite iktar milli fil- konġuntivite waħidha u talbu wkoll jiddiskuti l- konġuntivite staġjonali, il- ħakk u l- ħakk allerġiku, ir- reazzjonijiet severi tal- ġilda kkawżati minn nemus u d- dermatite atopika, għax dawn għandhom jitqiesu bħala entitajiet separati li jeħtieġu iktar dejta ta ’ appoġġ.
The MAH acknowledged that the indication section varies a lot from one Member State to the other but that the wording differences corresponded to three well-identified indications.
Il- MAH irrikonoxxa li s- sezzjoni ta ’ l- indikazzjonijiet tvarja ħafna minn Stat Membru għal ieħor iżda li d- differenzi fil- formolazzjoni tal- kliem ikkorrispondew għal tliet indikazzjonijiet identifikati sew.
The MAH provided extensive testing data from the review of therapeutic trials and the corresponding clinical study reports in support of these indications and proposed the removal of the other indications such as atopic dermatitis, prevention of asthma, mosquito bites as the clinical evidences available to support these indications was considered insufficient.
Il- MAH ipprovda dejta estensiva dwar il- provi mir- reviżjoni tal- provi terapewtiċi u r- rapporti ta ’ l - istudju kliniku korrespondenti b’ appoġġ għal dawn l- indikazzjonijiet u ppropona t- tneħħija ta ’ l - indikazzjonijiet l- oħrajn bħad- dermatite atopika, il- prevenzjoni ta ’ l- ażma u l- gdim tan- nemus billi l - evidenza klinika disponibbli għall- appoġġ tagħhom kienet meqjusa bħala insuffiċjenti.
The corresponding section of the PL was revised accordingly.
Is- sezzjoni korrespondenti tal- PL ġiet riveduta bix- xieraq.
The following indications were agreed upon:
Kien hemm qbil dwar l- indikazzjonijiet li ġejjin:
In adults, children, infants and toddlers 2 year and above: • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis • Cetrizine is indicated for the relief of chronic idiopathic urticaria.
Fl- adulti, tfal, trabi u tfal ta ’ sentejn jew iktar: • Cetirizine huwa indikat għas- serħan mis- sintomi nażali u mis- sintomi okulari tar- rinite allerġika staġjonali u perennali • Cetrizine huwa indikat għas- serħan mill- urtikarja idjopatika kronika.
The current paediatric indications are not disharmonised based on the indication itself but with regards to the definition of the paediatric age groups and with regards to the dosing for these groups.
In- nuqqas ta ’ armonizzazzjoni fl- indikazzjonijiet pedjatriċi attwali m’ huwiex dovut għall- indikazzjoni nnifisha iżda fir- rigward tad- definizzjoni tal- gruppi ta ’ età pedjatrika u fir- rigward tad- dożi għal dawn il- gruppi.
Depending on the member state, the posology is based on the weight or the age, or even a combination of both and a number of age groups and posology groups were identified.
Skond l- Istat Membru, il- pożoloġija hija bbażata fuq il- piż u fuq l- età, jew anke kombinazzjoni tat- tnejn li huma u ġew identifikati għadd ta ’ gruppi ta ’ età u gruppi tal- pożoloġija.
The MAH argued that the paediatric use of cetirizine in the same indications as in adults is justified, as no pathophysiological reason was identified for not using antihistamines in the paediatric population, provided the dose is adequately adapted to different body weight, age and clearance of the drug.
Il - MAH argumenta li l- użu pedjatriku ta ’ cetirizine fl- istess indikazzjonijiet bħal fl- adulti huwa ġġustifikat, billi ma ġiet identifikata l- ebda raġuni patofiżjoloġika li minħabba fiha m’ għandhomx jintużaw antistamini fil- popolazzjoni pedjatrika, sakemm id- doża tkun adattata adegwatament għall - piż tal- ġisem, l- età u r- rati ta ’ tneħħija tal- mediċina mill- ġisem differenti.
A harmonized wording for age groups and relevant posology was agreed upon:
Intlaħaq qbil fuq formolazzjoni armonizzata tal- kliem għall- gruppi ta ’ età u l- pożoloġija relevanti:
• Children aged from 2 to 6 years:
• Tfal ta ’ bejn sentejn u 6 snin:
2.5 mg twice daily (5 drops twice daily). • Children aged from 6 to 12 years:
2. 5 mg darbtejn kuljum (5 qatriet darbtejn kuljum). • Tfal ta ’ bejn 6 u 12- il sena:
5 mg twice daily (10 drops twice daily). • Adults and adolescents over 12 years of age:
5 mg darbtejn kuljum (10 qatriet darbtejn kuljum). • Adulti u adolexxenti ta ’ iktar minn 12- il sena:
10 mg once daily (20 drops).
10 mg darba kuljum (20 qatra).
The posology proposed for children has been tested in clinical trials, but also results from dosing adaptations based on body weight and clearance that varies according to the maturation of the renal system.
Din hija r- raġuni l- għala l- formolazzjoni armonizzata ma
This is why the harmonized wording does not propose a weight – based posology, as weight is clearly not the only factor to define the dose.
18 tipproponix pożoloġija bbażata fuq il- piż, billi jidher ċar li l- piż mhuwiex l- uniku fattur biex tiġi definita d- doża.
20 The MAH was also asked to provide data in support of the recommended dosing in patients with renal impairment and provide justifications for the benefit/ risk ratio of halving the dose.
Il- MAH intalab ukoll jipprovdi dejta b’ appoġġ għad- doża rakkomandata f’ pazjenti bi problemi fil - kliewi u jipprovdi ġustifikazzjonijet għall- bilanċ bejn il- benefiċċju u r- riskju tat- tnaqqis bin- nofs tad - doża.
The systemic exposure with half doses is not documented and insufficient efficacy related to half doses may lead the patients to cumulate other treatments.
L- espożizzjoni sistemika b’ nofs dożi mhijiex dokumentata u l- effikaċja insuffiċjenti relatata man- nofs dożi tista ’ twassal sabiex il- pazjenti jakkumulaw trattamenti oħra.
The MAH was also asked to justify the dosing in paediatric patients suffering from renal impairment and the dosing by weight in the 2-5 year age group and dosing by age groups 2-5, 6-11 and 12-18 as well as dosing for children less than 2 years old.
Il- MAH intalab ukoll jiġġustifika d- doża f’ pazjenti pedjatriċi li jsofru minn insuffiċjenza renali u d- doża skond il- piż fil - gruppi ta ’ età ta ’ bejn sentejn u 5 snin, u d- doża fil- gruppi ta ’ età ta ’ bejn sentejn u 5 snin, 6 u 11- il sena u 12 u 18- il sena kif ukoll id- dożi għal tfal ta ’ inqas minn sentejn.
The MAH stated that the clinical benefit/ risk ratio of cetirizine has not been specifically evaluated in patients with renal impairment and that the dose is therefore based on pharmacokinetic calculations only.
Il- MAH stqarr li l- proporzjon bejn il- benefiċċju u r- riskju kliniku ta ’ cetirizine ma ġiex evalwat speċifikament f’ pazjenti b' insuffiċjenza renali u li għalhekk, id- doża hija bbażata fuq kalkoli farmakokinetiċi biss.
No signal suggesting an unfavourable benefit/ risk ratio for Zyrtec compared to other anti- histamines was ever detected in pharmacovigilance during the 22 years on the market; however the MAH would like to retain the contraindication: “ Patients with severe renal impairment at less than 10 ml/ min creatinine clearance .”
Qatt ma nstab li kien hemm xi sinjal li jissuġġerixxi proporzjon mhux favorevoli bejn ir- riskju u l- benefiċċju għal Zyrtec meta mqabbel ma ’ anti- istamini oħrajn fil- farmakoviġilanza matul it- 22 sena li ilu fis- suq; madankollu, il- MAH jixtieq iżomm il- kontraindikazzjoni: “ Pazjenti b' insuffiċjenza renali gravi b’ rata ta ’ eliminazzjoni tal- kreatinina inqas minn 10 ml/ min. ”
For children with renal impairment, the clinical effects or the pharmacokinetics of cetirizine have never been tested but the MAH agreed that the current wording is not entirely correct since the age of the patient is important as it determines its clearance.
Għal tfal b' insuffiċjenza renali, la l- effetti kliniċi u lanqas il- farmakokinetiċi ta ’ cetirizine qatt ma ġew ittestjati iżda l- MAH qabel li l- formolazzjoni tal- kliem attwali mhijiex korretta għal kollox billi l- età tal- pazjent hija importanti għax tiddetermina r- rata ta ’ eliminazzjoni tiegħu.
The sentence will therefore be adapted to: “ In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age, and his body weight”
Għalhekk, is- sentenza sejra tiġi adattata għal: “ Fil- pazjenti pedjatriċi li jbatu minn insuffiċjenza renali, id- doża jkollha tiġi aġġustata fuq bażi individwali filwaqt li titqies ir- rata ta ’ eliminazzjoni mill- kliewi tal- pazjent, l- età tiegħu, u kemm jiżen ”
Regarding the dosing by weight, the MAH responded that systemic exposure to cetirizine is not only a function of body weight but also of renal clearance of the drug, with studies demonstrating that clearance is more important when age is low.
Dwar id- doża skond il- piż, il- MAH wieġeb li l- espożizzjoni sistemika għal cetirizine mhijiex biss funzjoni tal- piż tal- ġisem iżda hija wkoll funzjoni tar- rata ta ’ eliminazzjoni tal- mediċina mill- ġisem, bi studji li juru li r- rata ta ’ eliminazzjoni hija iktar importanti meta l- età tkun żgħira.
The doses proposed for registration have been demonstrated as being safe and effective in many trials performed in children 2 to 12 years old, as reviewed in the clinical expert report provided in the MAH dossier.
Id- dożi proposti għar- reġistrazzjoni ntwerew li huma siguri u effettivi f’ ħafna provi li saru fi tfal ta ’ bejn sentejn u 12 - il sena, kif riveduti fir- rapport kliniku ta ’ l- esperti pprovdut fid- dossier tal- MAH.
Regarding the dosing by age group, the MAH defended the same dosing for age group 12 to 18 as in adults because the increase in body weight is compensated by a decrease in clearance, allowing for an equivalent systemic exposure.
Dwar id- dożi skond il- grupp ta ’ età, il- MAH iddefenda l- istess doża għall- grupp ta ’ età ta ’ bejn 12 u 18- il sena kif ukoll fl - adulti, għax iż- żieda fil- piż tal- ġisem hija kkumpensata minn tnaqqis fir- rata ta ’ eliminazzjoni, u dan jippermetti espożizzjoni sistemika ekwivalenti.
Regarding dosage under the age of 2, the MAH justified the dosing based on PK data.
Dwar id- doża għal min għandu inqas minn sentejn, il - MAH iġġustifika d- doża bbażata fuq id- dejta PK.
The CHMP agreed that no safety or toxicity issues with the use of cetirizine in renal failure have been identified over the many years of clinical experience; however the CHMP adopted a lower age limit of 2 years for the use of cetirizine.
Is- CHMP qabel li l- ebda kwistjoni ta ’ sigurtà jew tossiċità bl- użu ta ’ cetirizine f’ pazjenti b’ insuffiċjenza renali ma ġiet identifikata tul il- ħafna snin ta 'esperjenza klinika; madankollu, is- CHMP adotta limitu ta' età inferjuri ta 'sentejn għall- użu ta' cetirizine.
The MAH also proposed harmonised Product Information texts for section 4.3 Contraindications reflecting the hypersensitivity to formulation constituents and addressing patients with severe renal impairment.
Il- MAH ippropona wkoll testi armonizzati ta ’ Informazzjoni dwar il- Prodott għas- sezzjoni 4. 3 Kontraindikazzjonijiet li jirriflettu s- sensittività eċċessiva għall- kostitwenti tal- formolazzjoni u li jindirizzaw pazjenti b' insuffiċjenza renali gravi.
The Product Information of the tablet and the oral formulations also reflected the additional contraindication related to the excipients.
L- Informazzjoni dwar il- Prodott tal- pilloli u tal - formolazzjonijiet orali jirriflettu wkoll il- kontraindikazzjonijiet addizzjonali relatati mas- sustanzi mhux attivi.
The MAH also reviewed the remaining divergent contra-indications.
Il- MAH irreveda wkoll il- kontra- indikazzjonijiet diverġenti li kien għad fadal.
The MAH proposed a harmonised text for section 4.4 Special Warnings, as the section was extensively disharmonised and added some warnings regarding the suitability of the formulations for certain age ranges and reflecting the lack of appropriate data on the benefit- risk for children below one year old, restricting the use of film-coated tablets in children aged less than 6 years, the use of the oral solution children aged less than 2 years and the use of the drop formulation in infants and toddlers aged less than 1 year old.
Il- MAH ippropona test armonizzat għas- sezzjoni 4. 4 Twissijiet Speċjali, minħabba li s- sezzjoni kellha nuqqas ta ’ armonizzazzjoni estensiv u żied xi twissijiet dwar l- adegwatezza tal- formolazzjonijiet għal ċerti medda ta ’ età u rrifletta n- nuqqas ta ’ dejta xierqa fuq il- bilanċ bejn il- benefiċċju u r- riskju għal tfal ta ’ inqas minn sentejn, u llimita l- użu ta ’ pilloli miksija b’ rita fi tfal ta ’ inqas minn 6 snin, l- użu tas- soluzzjoni orali fi tfal ta ’ inqas minn sentejn u l- użu tal- formolazzjoni tal- qtar fit- trabi u t- tfal ta ’ inqas minn sena.
In addition, the MAH agreed to include a warning for the drop formulation, stating that the confirmation of the diagnosis by a practitioner specialized in allergy should be sought before starting a treatment with cetirizine in children under the age of 2, as symptoms of viral infections of the upper respiratory system are misinterpreted as allergic in this age group.
Barra minn hekk, il- MAH qabel li jinkludi twissija għall- formolazzjoni tal- qtar, u stqarr li għandha tinkiseb konferma tad- dijanjosi minn speċjalista fl- allerġiji qabel ma jinbeda trattament b’ cetirizine fi tfal ta ’ taħt is- sentejn, minħabba li s- sintomi ta ’ infezzjoni virali fil- parti ta ’ fuq tas- sistema respiratorja huma miżinterpretati bħala allerġiċi f’ dan il- grupp ta ’ età.
The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years.
Is- CHMP qabel mat- test armonizzat iżda żamm l- limitu ta 'età inferjuri tiegħu ta' sentejn.
The MAH was asked to revise section 4.5 Interaction with other medicinal products, as no pharmacokinetic interactions are awaited with this substance, since it is not metabolised and two third of the ingested dose are eliminated unchanged in urine.
19 Il- MAH intalab ukoll jirrevedi s- sezzjoni 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il - prodott, għax ma hija mistennija l- ebda interazzjoni farmakokinetika ma ’ din is- sustanza, billi ma tiġix metabolizzata u żewġ terzi tad- doża inġestita huma eliminati mhux mibdula fl- awrina.
According to the guideline of the SPC, negative interactions should be mentioned in the SPC only if they are of clinical interest to the prescriber.
Skond il - linja gwida ta ’ l- SPC, għandhom jissemmew interazzjonijiet negattivi fl- SPC biss jekk dawn ikunu ta ’ interess kliniku għal min jippreskrivihom.
The MAH agreed with the CHMP recomendations but considered that the sentence on food interaction should be retained as it is independent from the liver enzymes interactions.
Il- MAH qabel mar- rakkomandazzjonijiet tas- CHMP iżda qies li s- sentenza dwar l- interazzjonijet ma ’ l- ikel għandha tinżamm għaliex hija indipendenti mill - interazzjonijiet ma ’ l- enzimi tal- fwied.
21 The MAH also reworded the entire section 4.8 Undesirable effects in accordance with current guidelines and with the QRD comments received.
Il- MAH bidel ukoll kompletament il- formolazzjoni tas- sezzjoni 4. 8 Effetti mhux mixtieqa b’ mod konformi mal- linji gwida attwali u mal- kummenti fil- QRD rċevuti.
In particular, frequencies were added to the listing of events, as observed from pharmacovigilance surveys.
B’ mod partikolari, żdiedu l - frekwenzi mal- lista ta ’ episodji, kif ġie osservat minn stħarriġ tal- farmakoviġilanza.
The MAH however informed the CHMP that due to the need for translating the old terms into the new ones, the process must start by a recoding of the source documents.
Il- MAH madankollu għarraf lis- CHMP li minħabba l- ħtieġa li t- termini qodma jinqalbu f’ oħrajn ġodda, il - proċess għandu jibda b’ kodifikazzjoni mill- ġdid tad- dokumenti oriġinali.
The CHMP acknowledged the problem of translating from old to new formats and the MAH’ s division of events into frequencies observed in clinical trials and frequencies estimated from post marketing experience could be agreed upon.
Is- CHMP irrikonoxxa l - problema tal- qlib minn formati qodma għal dawk ġodda u seta ’ jintlaħaq ftehim fuq id- diviżjoni ta ’ episodji tal- MAH fi frekwenzi osservati fil- provi kliniċi u l- frekwenzi stmati mill- esperjenza ta ’ wara t- tqegħid fis- suq.
Regarding section 5.1 Pharmacodynamic properties, the MAH was asked to reword section 5.1 and retain only the properties that are relevant with regards to the therapeutic effects.
Dwar is- sezzjoni 5. 1 Karatteristiċi farmakodinamiċi, il- MAH intalab jibdel il- kliem tas- sezzjoni 5. 1 u jżomm biss il- karatteristiċi li huma relevanti għall- effetti terapewtiċi.
The experimental effects observed in animals or at higher than recommended doses and not in line with the indication should be deleted.
L- effetti esperimentali osservati fl- annimali jew f’ dożi ogħla minn dawk irrakkomandati u mhux konformi ma ’ l- indikazzjoni għandhom jitħassru.
The MAH agreed to the text proposed by the CHMP.
Il- MAH qabel mat- test propost mis- CHMP.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTAR U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- rifjut kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, it- tikkettar u l -
labelling and package leaflet,
fuljett ta ’ tagħrif,
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodotti, it- tikkettar u l- fuljett ta ’ tagħrif proposti mid- Detentur ta ’
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
l- Awtorizzazzjoni tat- Tqegħid fis- Suq ġew ivvalutati abbażi tad- dokumentazzjoni sottomessa u d - diskussjoni xjentifika fi ħdan il- Kumitat,
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Zyrtec and associated names (see Annex I).
is- CHMP irrakkomanda l- emenda ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikkettar u l- fuljett ta ’ tagħrif għalihom jinsabu fl- Anness III għal Zyrtec u ismijiet assoċjati (ara l- Anness I).
22 ANNEX III
20 ANNESS III
23 SUMMARY OF PRODUCT CHARACTERISTICS
21 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Zyrtec 10 mg film-coated tablets
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
One film-coated tablets contains 10 mg cetirizine dihydrochloride
Pillola waħda miksija b’ rita fiha 10 mg cetirizine dihydrochloride
Excipients: one film-coated tablet contains 66.40 mg lactose-monohydrate
Sustanzi mhux attivi: pillola miksija b’ rita waħda fiha 66. 40 mg lactose monohydrate.
White, oblong, film-coated tablet, with breakline and Y-Y logo
Pillola miksija b’ rita, bajda, oblunga, b’ sinjal fejn tista ’ tinqasam u logo Y- Y.
In adults and paediatric patients 6 year and above:
F’ adulti u pazjenti tfal ta ’ sitt snin ‘ l fuq:
- Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial
- Cetirizine huwa indikat biex jittaffew sintomi nażali u ta ’ l- għajnejn ta ’ rinite allerġika tal- istaġun
allergic rhinitis.
u perenni.
- Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
- Cetirizine huwa indikat għas- serħan minn sintomi ta’ urtikarja idjopatika kronika.
Children aged from 6 to 12 years:
Tfal ta ’ bejn is- 6 u t- 12- il sena:
5 mg twice daily (a half tablet twice daily).
5 mg darbtejn kuljum (nofs pillola darbtejn kuljum)
Adults and adolescents over 12 years of age:
Adulti u addoloxxenti ‘ l fuq minn 12- il sena:
10 mg once daily (1 tablet).
10 mg darba kuljum (pillola waħda).
The tablets need to be swallowed with a glass of liquid.
Il- pilloli jridu jittieħdu ma ’ tazza b’ xi likwidu.
Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
It- tagħrif ma jindikax li d- doża għandha bżonn titnaqqas f’ pazjenti anzjani, sakemm il- funzjoni tal- kliewi tkun normali.
Patients with moderate to severe renal impairment: there are no data to document the efficacy/ safety ratio in patients with renal impairement.
Pazjenti b’ indeboliment tal- kliewi moderat għal sever: m’ hemmx tagħrif biex juri l- proporzjon ta ’ effikaċja/ sigurta´ f’ pazjenti b’ indeboliment tal- kliewi.
Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function.
Peress li cetirizine jitneħħa prinċipalment mill - kliewi (ara sezzjoni 5. 2), f’ każi fejn m’ hemmx kura alternattiva, l- intervalli ta ’ bejn doża u oħra jridu jiġu individwalizzati skond il- funzjoni tal- kliewi.
Refer to the following table and adjust the dose as indicated.
Irreferi għat- tabella li ġejja u aġġusta d- doża kif indikat.
To use this dosing table, an estimate of the patient’ s creatinine clearance (CLcr) in ml/ min is needed.
Biex tuża din it- tabella ta ’ dożaġġ, hemm bżonn li jitkejjel il- clearance tal- krejatinina tal - pazjent (CLcr) f ’ ml/ min.
The CLcr (ml/ min) may be estimated from serum creatinine (mg/ dl) determination using the following formula:
Il - CLcr (ml/ min) tista ’ tiġi kalkulata mill- valur tal- krejatinina tas- serum (mg/ dl) billi tintuża din il- formula:
[140 − age( years)] x weight (kg) (x 0.85 for women) 72 x serum creatinine (mg / dl)
72 x krejatinina tas − serum( mg / dl)
25 Dosing adjustments for adult patients with impaired renal function
23
Normal Mild Moderate Severe
Dożaġġ u frekwenza
Creatinine
Ħafif Moderat
Dosage and frequency 10 mg once daily 10 mg once daily 5 mg once daily 5 mg once every 2 days
10 mg darba kuljum 5 mg darba kuljum
End-stage renal disease - Patients undergoing dialysis
Sever Mard tal- kliewi fl- aħħar stadju - Pażjenti li jagħmlu d- dijaliżi
Contra-indicated
darba kull jumejn Kontra- indikat
In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.
F’ pazjenti tfal li jbagħtu minn indeboliment tal- kliewi, id- doża trid tiġi aġġustata fuq bażi individwali wara li jitqies il- clearance tal- kliewi, l- eta`u l- piż tal- pazjent..
Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.
Pazjenti b’ indeboliment tal- fwied: m’ hemmx bżonn aġġustament tad- doża f’ pazjenti li għandhom biss indeboliment tal- fwied.
Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).
Pazjenti b’ indeboliment kemm tal- fwied u kemm tal- kliewi: aġġustament tad- doża huwa rrakkomandat (ara Pazjenti b’ indeboliment tal- kliewi moderat għal sever hawn fuq).
Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.
Sensittività eċċessiva għas- sustanza attiva, għal xi sustanzi mhux attivi, għal hydroxyzine jew għal xi derivattiv ta ’ piperazine.
Patients with severe renal impairment at less than 10 ml/ min creatinine clearance.
Pazjenti b’ indeboliment tal- kliewi sever bi clearance tal- krejatinina ta ’ inqas minn 10 ml/ min.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take cetirizine film-coated tablet.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, defiċenza Lapp lactase jew mal - assorbiment ta ’ glucose- galactose m’ għandhomx jieħdu l- pilloli miksijin b’ rita.
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/ L).
Ma kienx hemm effett klinikament sinifikanti f’ dożi terapewtiċi flimkien ma ’ l- alkoħol (livell ta ’ alkoħol fid- demm ta ’ 0. 5 g/ L).
Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Madanakollu, huwa rrakkomandat li jittieħdu prekawzjonijiet jekk jittieħed flimkien ma ’ l- alkoħol.
Caution in epileptic patients and patients at risk of convulsions is recommended.
Hu rrakkomandat li tittieħed attenzjoni f’ pazjenti epilettiċi u pazjenti b’ riskju ta ’ aċċessjonijiet.
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
L- użu tal- formulazzjoni ta ’ pilloli miksija b’ rita mhux irrakkomandat fit- tfal ta ’ taħt is- 6 snin, għaliex b’ din il- formulazzjoni ma tistax tiġi aġġustata d- doża.
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine.
Mhux mistennija interazzjonijiet b’ din l- antistamina, minħabba l- profil farmakokinetiku, farmakodinamiku u ta ’ tolleranza ta ’ cetirizine.
Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/ day).
Infatti, ma kienux irrappurtati la interazzjonijiet farmakdinamiċi u lanqas interazzjonijiet farmakokinetiċi sinifikanti fi studji li saru dwar l- effetti ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott, speċjalment b’ psewdo- efedrine jew theophylline (400 mg/ ġurnata).
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
Il- livell t’ assorbiment ta ’ cetirizine mhux imnaqqas bl- ikel, għalkemm ir- rata ta ’ assorbiment kienet mnaqqsa.
For cetirizine very rare clinical data on exposed pregnancies are available.
Hemm tagħrif kliniku rari ħafna dwar każi ta ’ tqala esposti għal cetirizine.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ fetal development, parturition or postnatal development.
Studji fuq l- annimali ma jurux effetti ħżiena diretti jew indiretti fejn tidħol it- tqala, żvillup ta ’ embriju/ fetu, ħlas jew żvillup ta ’ 24 wara t- tqala.
Caution should be exercised when prescribing to pregnant or breast feeding women because cetirizine passes into breast milk.
Trid tittieħed attenzjoni meta jinkiteb għal nisa tqal jew li jkunu qed ireddgħu għaliex cetirizine jgħaddi ġol- ħalib ta ’ l- omm.
Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg.
Kejl oġġettiv tal- ħila biex ssuq, il- ħin sakemm torqod, u l- ħila f’ linja ta ’ immuntar ma wrewx effetti klinikament sinifikanti fid- doża rrakkomandata ta ’ 10 mg.
Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.
Pazjenti li għandhom intenzjoni li jsuqu, li jagħmlu xi attivita` li tista ’ tkun perikoluża jew li jħaddmu magni m’ għandhomx jieħdu iżjed mid- doża rrakkomandata u għandhom iqisu r- rispons tagħhom għall- mediċina.
In these sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.
F’ dawn il- pazjenti sensittivi, l- użu flimkien ma ’ l- alkoħol jew depressanti oħra tas - sistema nervuża ċentrali (CNS) jista ’ jikkawża tnaqqis addizzjonali fil- viġilanża jew impediment fil - ħila.
Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache.
Studji kliniċi juru li cetirizine fid- dożaġġ irrakkomandat kellu effetti mhux mixtieqa ħfief fuq is- CNS, li jinkludu ngħas tqil, għeja, sturdament u uġigħ ta ’ ras.
In some cases, paradoxical CNS stimulation has been reported.
F’ xi każi, kienet irrapportata stimulazzjoni paradossali tas- CNS.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Għalkemm cetirizine huwa agonist selettiv ta ’ riċetturi H1 periferali u huwa relattivament ħieles minn attivita` antikolinerġika, kienu rrappurtati każi iżolati ta ’ diffikulta` biex tgħaddi l- awrina, disturb biex tiffoka l- għajn, u ħalq xott.
Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported.
Kienu rrappurtati każi ta ’ funzjoni anormali tal- fwied b’ livelli għolja ta ’ enżimi tal- fwied u bilirubin.
Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
Dawn ġeneralment jitjiebu meta jitwaqqaf it- trattament b’ cetirizine hydrochloride.
Clinical trials
Provi Kliniċi
Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
Provi kliniċi jew farmakokliniċi kkontrollati double- blind li jqabblu cetirizine mal - plaċebo jew mediċini oħra kontra l- istamina fid- doża rrakkomandata (10 mg kuljum għal cetirizine), fejn sar kejl ta ’ tagħrif ta ’ sigurta`, inkludew iżjed minn 3200 persuna li kienu esposti għal cetirizine.
From this pooling, the following adverse events were reported for cetirizine 10 mg in the placebo- controlled trials at rates of 1.0% or greater:
Minn dan il- grupp, l- effetti mhux mixtieqa li ġejjin kienu rrappurtati b’ cetirizine 10 mg fi provi kkontrollati bil- plaċebo f’ rati ta ’ 1. 0% jew aktar:
Adverse event
Effett Mhux Mixtieq
Cetirizine 10 mg
Cetirizine 10 mg
Fatigue
Għeja Mard tas- sistema nervuża ċentrali u periferali
1.63%
1. 63%
0.95%
0. 95%
Dizziness Headache Gastro-intestinal system disorders
Sturdament Uġigħ ta ’ ras Mard tas- sistema gastro- intestinali
1.10% 7.42%
1. 10% 7. 42%
Abdominal pain Dry mouth Nausea Psychiatric disorders
Uġigħ addominali Ħalq xott Dardir Mard psikjatriku
0.98% 2.09% 1.07%
0. 98% 2. 09% 1. 07%
1.08% 0.82% 1.14%
1. 08% 0. 82% 1. 14%
Somnolence Respiratory system disorders
Ngħas tqil Mard tas- sistema respiratorja
9.63%
9. 63%
5.00%
5. 00%
1.29%
1. 29%
1.34%
1. 34%
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases.
Għalkemm statistikament iżjed komuni minn bil- plaċebo, in- ngħas tqil kien ħafif għal moderat fil - biċċa l- kbira tal- każi.
Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Fi studji oħra f’ voluntieri żgħar f’ saħħithom saru testijiet oġġettivi li wrew li fid- doża rrakkomandata tas- soltu, ma kienux affetwati l- attivitajiet tas- soltu ta ’ kuljum.
Adverse drug reactions at rates of 1% or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical or pharmacoclinical trials are:
25 Ir- reazzjonijiet mhux mixtieqa għal mediċina fit- tfal t’ eta` ta ’ bejn 6 xhur u 12- il xahar, f’ rati ta ’ 1% jew aktar, inklużi fi provi kliniċi u farmakokliniċi kkontrollati double- blind huma:
Adverse drug reactions
Effett Mhux Mixtieq
Cetirizine
Cetirizine
Gastro-intestinal system disorders
Mard tas- sistema gastro- intestinali