qanastek/EMEA-V3 huggingface dataset:
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Jekk ir- rajnajtis allerġiku hija intermittenti (preżenza ta ’ sintomi għal anqas minn 4 ijiem fil- ġimgħa jew għal anqas minn 4 ġimgħat), it- tabib tiegħek ser jirrikkomandalek skeda ta ’ kura li tiddependi mill- passat tal- marda tiegħek.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.
Jekk ir- rajnajtis allerġika huwa persistenti (preżenza ta ’ sintomi għal 4t ijiem fil- ġimgħa jew aktar u għal aktar minn 4 ġimgħat), it- tabib tiegħek jista ’ jirrikkmandalek kura għal aktar fit- tul.
If you take more Aerius orodispersible tablet than you should Take Aerius orodispersible tablet only as prescribed for you.
Jekk tieħu Aerius pillola li tinħall fil- ħalq aktar milli suppost Ħu l- pillola Aerius li tinħall fil- ħalq biss kif ordnawlek.
However, if you take more Aerius orodispersible tablet than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar pillola Aerius li tinħall fil- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Aerius orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Aerius pillola li tinħall fil- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża individwali li nsejt tieħu.
Like all medicines, Aerius can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Aerius jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
However, fatigue, dry mouth and headache were
Madankollu, għejja, ħalq xott u uġigħ ta ’ ras kienu rappurtati b’ mod aktar frekwenti minn dawk li jkun hemm b’ pillola finta.
During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
85 Meta Aerius tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
HOW TO STORE AERIUS ORODISPERSIBLE TABLET
KIF TAĦŻEN AERIUS PILLOLA LI TINĦALL FIL- ĦALQ
Do not use Aerius orodispersible tablet after the expiry date which is stated on the carton and blister.
Tużax Aerius pillola li tinħall fil- ħalq wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja.
Tell your pharmacist if you notice any change in the appearance of Aerius orodispersible tablet.
Għid lill- ispiżjar tiegħek jekk tara xi tibdil fid- dehra ta ’ Aerius pillola li tinħall fil- ħalq.
What Aerius orodispersible tablet contains
X’ fih Aerius pillola li tinħall fil- ħalq:
- The active substance is desloratadine 2.5 mg
- Is- sustanza attiva hi desloratadine 2. 5 mg
- The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch
- Is- sustanzi l- oħra huma microcrystalline cellulose, pregelatinized starch, sodium starch
glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) and flavour Tutti-Frutti.
glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) u togħma ta ’ Tutti- Frutti.
What Aerius orodispersible tablet looks like and contents of the pack
Id- Dehra ta ’ Aerius pillola li tinħall fil- ħalq u l- kontenuti tal- pakkett
Aerius 2.5 mg orodispersible tablet is light red, speckled, and round with “ K” branded on one side.
Aerius 2. 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ K ” fuq naħa.
Aerius orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Aerius pillola li tinħall fil- ħalq qegħda ppakkjata f’ dożi b’ waħdiet f’ pakketti ta ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 u 100 doża ta ’ pilloli li jinħallu fil- ħalq.
85 België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B-1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32-(0)2 370 92 11
86 België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11
86 Ísland Hörgatún 2 IS-210 Garðabær Sími: + 354 535 70 00
87 Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
87 PACKAGE LEAFLET:
88 FULJETT TA ’ TAGĦRIF:
Aerius 5 mg orodispersible tablets desloratadine
Aerius 5 mg pilloli li jinħallu fil- ħalq desloratadine
How to store Aerius orodispersible tablet 6.
Kif taħżen Aerius pillola li tinħall fil- ħalq 6.
These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is- sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk ħmura jew dmugħ fl- għajnejn.
Do not take Aerius orodispersible tablet
Tieħux Aerius pillola li tinħall fil- ħalq
Aerius 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Aerius 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 12 snin ‘ l fuq).
88 Taking Aerius orodispersible tablet with food and drink Aerius orodispersible tablet does not need to be taken with water or liquid.
89 Meta tieħu Aerius pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Aerius pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Water or other liquid is not needed to swallow the dose.
Aerius pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Adults and adolescents (12 years of age and older): take one 5 mg Aerius orodispersible tablet once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Aerius pillola li tinħall fil- ħalq darba kuljum.
89 During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
90 Meta Aerius tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
Aerius 5 mg orodispersible tablet is light red, speckled, and round with “ A” branded on one side.
Aerius 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ A ” fuq naħa.
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B-1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32-(0)2 370 92 11
91 België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11
92 PACKAGE LEAFLET:
93 FULJETT TA ’ TAGĦRIF:
please tell your doctor or pharmacist.
imsemmijjin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Aerius is and what it is used for 2.
X’ inhi Aerius u għalxiex jintuża 2.
Aerius oral solution is an antiallergy medicine that does not make you drowsy.
Aerius soluzzjoni orali hija mediċina kontra l- allerġiji li ma traqdekx.
Aerius oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is - sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Aerius oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Aerius soluzzjoni orali tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Is- serħan minn dawn is- sintomi jibqa ’ ġurnata sħiħa u jgħinek terġa ’ tibda l- attivitajiet ta ’ kuljum u fl - irqad.
- if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine, loratadine jew
of Aerius.
sustanzi oħra ta ’ Aerius.
Aerius oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Aerius soluzzjoni orali tintuża fi tfal minn sena sa 11- il sena, adolexxenti (minn 12- il sena ’ l fuq), u adulti, inklużi l- anzjani.
93 Taking Aerius with food and drink Aerius may be taken with or without a meal.
94 Meta tieħu Aerius ma ’ l- ikel u max- xorb Aerius jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby, taking Aerius oral solution is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Aerius soluzzjoni orali mhux irrakkomandat.
Important information about some of the ingredients of Aerius Aerius oral solution contains sorbitol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Aerius Aerius soluzzjoni orali fiha sorbitol.
Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Tfal minn sena sa 5 snin: ħu 2. 5 ml (1/ 2 kuċċarina ta ’ 5 ml) tas- soluzzjoni orali darba kuljum.
Children 6 through 11 years of age: take 5 ml (one 5 ml spoonful) of oral solution once a day.
Tfal minn 6 snin sa 11- il sena: ħu 5 ml (kuċċarina waħda ta ’ 5 ml) tas- soluzzjoni orali darba kuljum.
Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) of oral solution once a day.
Tfal u adolexxenti (minn 12- il sena ’ l fuq): ħu 10 ml (żewġ kuċċarini ta ’ 5 ml) tas- soluzzjoni orali darba kuljum.
In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.
Jekk mal- flixkun ikun hemm siringa għall- kejl, tista ’ tużaha biex tkejjel id- doża xierqa tas- soluzzjoni orali.
Swallow the dose of oral solution, then drink some water.
Ibla ’ d- doża tas- soluzzjoni orali, imbagħad ixrob ftit ilma.
You can take this medicine with or without food.
Tista ’ tieħu din il- mediċina ma ’ l- ikel jew mingħajr ikel.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius oral solution.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu s- soluzzjoni orali Aerius.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.
Jekk ir- rajnajtis allerġiku huwa persistenti (preżenza ta ’ sintomi għal 4t ijiem fil- ġimgħa jew aktar u għal aktar minn 4 ġimgħat), it- tabib tiegħek jista ’ jirrikkmandalek kura għal aktar fit- tul.
If you take more Aerius than you should Take Aerius oral solution only as it is prescribed for you.
Jekk tieħu Aerius aktar milli suppost Ħu Aerius soluzzjoni orali biss kif ordnawlek.
However, if you take more Aerius oral solution than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Aerius soluzzjoni orali milli suppost, għamel kuntatt mat - tabib jew l- ispiżjar tiegħek.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li nsejt tieħu.
94 4.
95 4.
Like all medicines, Aerius oral solution can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aerius soluzzjoni orali jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Aerius kienu rrapurtati kważi daqs kieku ħadu soluzzjoni jew pillola finta.
During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Aerius tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes u nefħa), u raxx kienu rrappurtati rari ħafna.
Tell your pharmacist if you notice any change in the appearance of the oral solution.
Għid lill- ispiżjar tiegħek jekk tara xi tibdil fid- dehra tas- soluzzjoni orali.
- The active substance is desloratadine 0.5 mg/ ml
- Is- sustanza attiva hi desloratadine 0. 5 mg/ ml
- The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955,
- Is- sustanzi l- oħra humasorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium
hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate and purified water.
citrate dihydrate, essenza naturali u artifiċjali (babbilgamm), citric acid anhydrous, disodium edetate u ilma purifikat.
Aerius oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap.
Aerius soluzzjoni orali, jiġi fi fliexken ta ’ daqsijiet ta ’ 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluqin b’ għatu tal- plastik mhux faċli biex jiftħuh it- tfal.
For all packages except the 150 ml bottle, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml.
Għall- pakketti kollha ħlief għall- flixkun ta ’ 150 ml, hemm kuċċarina tal- kejl immarkata għad- dożi tat- 2. 5 ml u 5 ml.
For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.
Għall- pakkett ta ’ 150 ml, hemm kuċċarina tal- kejl jew siringa mmarkati għad- dożi tat- 2. 5 ml u 5 ml.
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
96 Manifattur: SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju.
95 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW
97 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
London, 26 June 2008 Doc.
Londra, 26 ta ’ Ġunju 2008 Doc.
EMEA/ 306731/ 2008
EMEA/ 545123/ 2008
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name:
MISTOQSIJA U TWEĠIBA DWAR L- IRTIRAR TA 'L- APPLIKAZZJONI GĦAT- TQEGĦID FIS- SUQ għal AFLUNOV Isem komuni:
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/ VietNam/ 1194/ 2004)
Vaċċin prepandemiku ta ’ l- influwenza (H5N1) (antiġen tal- wiċċ, inattivat, imsaħħaħ) (A/ VietNam/ 1194/ 2004)
On 13 June 2008, Novartis Vaccines and Diagnostics S. r. l. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Fit- 13 ta ’ Ġunju 2008, Novartis Vaccines and Diagnostics S. r. l. għarraf uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) bl- intenzjoni li jirtira l- applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis- suq għal Aflunov, għall- prevenzjoni ta ’ l- influwenza avjarja H5N1 fl- adulti u l- anzjani.
What is Aflunov?
X’ inhu Aflunov?
Aflunov is a vaccine.
Aflunov huwa vaċċin.
It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/ VietNam/ 1194/ 2004.
Jikkonsisti minn sospensjoni għall- injezzjoni li fiha xi partijiet (membrani ta ’ barra) tar- razza tal- vajrus ta ’ l- influwenza magħrufa bħala A/ VietNam/ 1194/ 2004.
What was Aflunov expected to be used for?
Għalxiex kien mistenni li jintuża Aflunov?
Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Aflunov kien mistenni li jintuża għall- adulti u l- anzjani biex jipproteġihom kontra influwenza kkawżata mir- razza( tip) H5N1 tal- vajrus ta ’ l- influwenza A.
Aflunov is a ‘ prepandemic’ vaccine.
Aflunov huwa vaċċin ‘ prepandemiku ’.
This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Dan huwa tip speċjali ta ’ vaċċin li huwa maħsub biex jipproteġi kontra tip ta ’ influwenza li tista ’ tikkawża pandemija fil- ġejjieni.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Pandemija ta ’ l- influwenza sseħħ meta jitfaċċa tip ġdid ta ’ vajrus ta ’ l- influwenza li jkun jista ’ jinfirex malajr minn persuna għal oħra għax in- nies ma jkollhom l- ebda immunità kontrih.
A pandemic can affect most countries and regions around the world.
Pandemija tista ’ taffettwa l- parti l- kbira tal - pajjiżi u reġjuni madwar id- dinja.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
L- esperti tas- saħħa huma mħassba billi l- pandemija ta ’ l- influwenza li jmiss tista ’ tkun ikkawżata mit- tip H5N1 tal- vajrus.
Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Aflunov kien mistenni li jagħti protezzjoni kontra dan it- tip, u għalhekk jista ’ jintuża qabel jew waqt pandemija ta ’ l- influwenza.
How is Aflunov expected to work?
Kif huwa mistenni li jaħdem Aflunov?
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi ruħha kontra marda.
When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf il- partijiet tal - vajrus ta ’ l- influwenza fil- vaċċin bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
The immune system will be able to produce antibodies more quickly when it is exposed to flu virus of the same strain.
Is- sistema immunitarja tkun tista ’ tipproduċi antikorpi iktar malajr meta tkun esposta għal vajrus ta ’ l- influwenza ta ’ l- istess tip.
This helps to protect against the disease.
Dan jgħin fil- protezzjoni kontra l- marda.
Aflunov contains small parts of the H5N1 strain of the flu virus.
Aflunov fih partijiet żgħar tat- tip H5N1 tal- vajrus ta ’ l- influwenza.
The virus used in the vaccine was first inactivated (killed) so that it does not cause any disease.
Il- vajrus użat fil- vaċċin l- ewwel ġie inattivat (maqtul) biex ma jkunx jista ’ jikkawża mard.
Then, the outer membranes that contain the ‘ surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Imbagħad, il- membrani ta ’ barra li fihom l - ‘ antiġeni tal- wiċċ ’ (proteini fuq il- membrana ta ’ barra tal- varjus li l- ġisem jagħraf bħala barranin) ġew estratti u ppurifikati qabel ma ġew inklużi fil- vaċċin.
Aflunov also contains an ‘ adjuvant’ (a compound containing oil), which is expected to stimulate a better response.
Aflunov fih ukoll ‘ adjuvant ’ (kompost li jkun fih żejt), li hu mistenni jistimula rispons aħjar.
What documentation did the company present to support its application to the CHMP?
X' dokumentazzjoni ppreżentat il- kumpanija għas- sostenn ta ’ l- applikazzjoni tagħha lis- CHMP?
The effects of Aflunov were first tested in experimental models before being studied in humans.
L- effetti ta ’ Aflunov għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The main clinical study of Aflunov involved over 4,000 adults.
Fl- istudju kliniku ewlieni dwar Aflunov ħadu sehem iktar minn 4, 000 adult.
It compared Aflunov’ s safety and its ability to stimulate the production of antibodies (‘ immunogenicity’) with those of a similar vaccine against seasonal flu.
Dan qabbel is- sigurtà ta ’ Aflunov u l- abilità tiegħu li jistimula l- produzzjoni ta ’ l- antikorpi (‘ immunoġeneċità ’) ma ’ dawk ta ’
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. vaċċin simili kontra l- influwenza staġjonali.
The application was at day 190 when the company withdrew.
L- applikazzjoni kienet fil- 190 jum meta l- kumpanija rtirat.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Wara li s- CHMP ivvaluta t- tweġibiet mill - kumpanija għal- lista ta ’ mistoqsijiet, kien għad hemm xi kwistjonijiet pendenti.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Abbażi ta ’ l- analiżi tad - dokumentazzjoni inizjali, is- CHMP iħejji lista ta ’ mistoqsijiet fil- 120 jum, u din tintbagħat lill - kumpanija.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ladarba l- kumpanija tkun tat tweġibiet għall- mistoqsijiet, is- CHMP janalizzahom u jista ’, qabel ma ’ jagħti opinjoni, jistaqsi xi mistoqsijiet oħra li jista ’ jkollu fil- 180 jum.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Wara l- opinjoni tas - CHMP, ġeneralment ikunu jridu jgħaddu madwar xahrejn biex il- Kummissjoni Ewropea toħroġ liċenzja.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Abbażi ta ’ l- analiżi tad- dejta u t- tweġiba tal- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP, fi żmien l- irtirar, is- CHMP kellu xi tħassib u kien tal- fehma proviżorja li Aflunov ma setax jiġi approvat għall - prevenzjoni ta ’ l- influwenza avjarja H5N1.
The CHMP was concerned over the way the main clinical study was carried out.
Is- CHMP kien imħasseb fuq il- mod kif sar l- istudju kliniku ewlieni.
An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘ good clinical practice’ (GCP).
Ispezzjoni ta ’ wħud mis- siti ta ’ l - istudju wrew li l- istudju ma kienx tmexxa b’ konformità ma ’ ‘ prattika klinika tajba ’ (GCP).
Consequently, the study results could not be considered reliable and could not be used for the evaluation of the vaccine.
Konsegwentament, ir- riżultati ta ’ l- istudju ma setgħux jitqiesu bħala affidabbli u ma setgħux jintużaw għall- evalwazzjoni tal- vaċċin.
As a result, the size of the clinical database for the assessment of the vaccine’ s safety was not sufficient to fulfil the requirements of the EMEA’ s guidelines on prepandemic vaccines.
Minħabba f’ hekk, id- daqs tad- database klinika għall- valutazzjoni tas - sigurtà tal- vaċċin ma kienx biżżejjed biex jissodisfa r- rekwiżiti tal- linji gwida ta ’ l- EMEA fuq il - vaċċini prepandemiċi.
Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Għalhekk, fi żmien l- irtirar, is- CHMP ma setax jasal għal konklużjoni dwar il- bilanċ bejn il- benefiċċju u r- riskju ta ’ Aflunov.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA bl- irtirar tal- applikazzjoni tinsab hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
X’ inhuma l- konsegwenzi ta ’ l- irtirar għal dawk il- pazjenti li jkunu involuti fi provi kliniċi jew programmi ta ’ użu b’ kumpassjoni bl- użu ta ’ Aflunov?
The company informed the CHMP that there are no consequences for individuals currently included in clinical trials with Aflunov.
Il- kumpanija għarrfet lis- CHMP li ma hemmx konsegwenzi għal individwi li attwalment qed jieħdu sehem fi provi kliniċi b’ Aflunov.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Jekk qed tieħu sehem fi prova klinika u teħtieġ iktar tagħrif dwar it - trattament tiegħek, ikkuntattja lit- tabib li qed jagħtihulek.
What is Agenerase?
X’ inhu Agerenase?
Agenerase is a medicine that contains the active substance amprenavir.
Agenerase huwa mediċina li fiha s- sustanza attiva amprenavir.
It is available as cream capsules (50 and 150 mg) and as an oral solution (15 mg/ ml).
Huwa disponibbli f’ kapsuli lewn il - krema (50 u 150 mg) u bħala soluzzjoni orali (15 mg/ ml).
What is Agenerase used for?
Għal xiex jintuża Agenerase?
It is used in combination with other antiviral medicines to treat adults and children over four years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Agenerase huwa mediċina antivirali li tintuża flimkien ma ’ mediċini antivirali oħra fit- trattament ta ’ adulti u tfal ta ’ età ‘ l fuq minn erba ’ snin infettati mill- vajrus tal- immunodefiċjenza umana tat- tip 1 (HIV- 1), vajrus li jikkawża s- sindromu minn immunodefiċjenza akkwiżita (AIDS).
Agenerase should only be used in patients who have previously been treated with the same type of medicine as Agenerase (protease inhibitors).
Agenerase għandu jintuża biss minn pazjenti li jkunu diġà ġew ittrattati bl- istess tip ta ’ mediċina bħal Agenerase (inibituri tal- proteażi).
In adults, Agenerase capsules are usually given with low-dose ritonavir (another antiviral medicine).
Fl- adulti, il- kapsuli ta ’ Agenerase ġeneralment jingħataw ma ’ doża baxxa ta ’ ritonavir (mediċina antivirali oħra).
Although Agenerase oral solution is available for patients who cannot swallow the capsules, it cannot be given with ritonavir because the safety of this combination has not been assessed.
Għalkemm Agenerase huwa disponibbli bħala soluzzjoni orali għal pazjenti li ma jistgħux jibilgħu l- kapsuli, ma jistax jingħata ma ’ ritonavir minħabba li s- sigurtà ta ’ din il - kombinazzjoni ma ġietx valutata.
Doctors should prescribe Agenerase after they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
It- tobba għandhom jippreskrivu Agenerase wara li jkunu eżaminaw il- mediċini antivirali jkun ħa qabel il- pazjent u l- possibbiltà li l- vajrus jirrispondi għall- mediċina.
How is Agenerase used?
Kif jintuża Agenerase?
Treatment with Agenerase should be started by a doctor who has experience in the management of HIV infection.
It- terapija b’ Agenerase għandha tinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni mill- HIV.
The recommended dose for patients over 12 years of age is 600 mg twice a day, taken with 100 mg ritonavir twice a day and with other antiviral medicines.
Id- doża rakkomandata għal pazjenti ta ’ età ‘ l fuq minn 12- il sena hija 600 mg darbtejn kuljum, meħuda ma ’ 100 mg ritonavir darbtejn kuljum u ma ’ mediċini antivirali oħra.
If ritonavir is not used, Agenerase is taken at a higher dose (1,200 mg twice a day).
Jekk ma jintużax ritonavir, Agenerase jittieħed f’ doża ogħla (1, 200 mg darbtejn kuljum).
In children aged between four and 12 years and in patients who weigh less than 50 kg, the recommended dose of Agenerase depends on body weight.
Fit- tfal f’ età bejn erbgħa u 12- il sena u fil- pazjenti li jiżnu inqas minn 50 kg, id- doża rakkomandata ta ’ Agenerase tiddependi mill- piż tal- ġisem.
Taking Agenerase with ritonavir should be avoided in children.
Għandu jiġi evitat li, fit- tfal, Agenerase jingħata ma ’ ritonavir.
Agenerase can be taken with or without food.
Agenerase jista ’ jittieħed fuq stonku vojt jew le.
The dose of Agenerase should be reduced in patients who have problems with their liver, and it should be taken without ritonavir by patients who have severe liver problems.
Fil- pazjenti li jbatu minn problemi bil- fwied, id- doża ta ’ Agenerase għandha titnaqqas u fil- pazjenti li jbatu minn problemi gravi fil- fwied il- mediċina għandha tingħata mingħajr ritonavir.
Because amprenavir is less easily absorbed with the oral solution than with the capsules, the two formulations are not interchangeable on a milligram-by-milligram basis.
Billi amprenavir f’ soluzzjoni orali huwa assorbit inqas faċilment meta mqabbel mal- kapsuli; iż- żewġ formulazzjonijiet ma jistgħux jinbiddlu ma ’ xulxin fuq bażi ta ’ milligramm b’ milligramm.
How does Agenerase work?
Kif jaħdem Agenerase?
The active substance in Agenerase, amprenavir, is a protease inhibitor.
Is- sustanza attiva f’ Agenerase, amprenavir, hija inibitur tal- proteażi.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Din timblokka enzima li tissejjaħ proteażi, li għandha sehem fir- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Jekk l- enzima tiġi mblukkata, il- vajrus ma jirriproduċix ruħu bħas- soltu, u dan inaqqas it- tixrid tal- infezzjoni.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir hu inibitur tal- proteażi ieħor li jintuża bħala ‘ booster ’.
It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
Dan inaqqas ir- rata li biha jiġi assorbit amprenavir, u b’ hekk iżid il - livell ta ’ amprenavir fid- demm.
This allows a lower dose of amprenavir to be used for the same effect.
Dan jippermetti li tintuża doża iktar baxxa ta ’ amprenavir għall- istess effett.
Agenerase, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Agenerase, meħud flimkien ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Agenerase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Agenerase ma jfejjaqx infezzjoni mill- HIV jew tal- AIDS, iżda jista ’ jittardja l - ħsara prodotta lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjat mal- AIDS.
How has Agenerase been studied?
Kif ġie studjat Agenerase?
Agenerase, in combination with other antiviral medicines but without ritonavir, has been studied in two main studies including 736 HIV-infected adults who had not previously been treated with protease inhibitors.
Agenerase, f’ kombinazzjoni ma ’ mediċini antivirali oħra iżda mingħajr ritonavir, ġie studjat f’ żewġ studji ewlenin li fihom ħadu sehem 736 adult infettat mill- HIV li ma kinux ġew ittrattati preċedentement b’ inibituri tal- proteażi.
In these studies, Agenerase was compared with placebo (a dummy treatment) and with invirase (another protease inhibitor).
F’ dawn l- istudji, Agenerase tqabbel ma ’ plaċebo (trattament finta) jew ma ’ invirase (tip ieħor ta ’ inibitur tal- proteażi).
Agenerase has also been studied in 268 HIV-infected children aged between six months and 18 years.
Agenerase ġie studjat ukoll f’ 268 tifel u tifla infettati mill- HIV ta ’ età bejn sitt xhur u 18- il sena.
All of the children had previously taken treatment for HIV infection, and 135 of them had been treated with protease inhibitors.
It- tfal kollha kienu sottoposti għal trattament għall- infezzjoni mill- HIV qabel, iżda 135 minnhom kienu ġew ittrattati b’ inibituri tal- proteażi.
Agenerase boosted with low-dose ritonavir has been compared with other protease inhibitors in 206 adults who had taken protease inhibitors in the past.
Agenerase mal- booster ta ’ ritonavir f’ doża baxxa tqabbel ma ’ inibituri tal- proteażi oħra f’ 206 adulti ttrattati fil- passat bl- inibituri tal- proteażi.
Of these, 43 had HIV that was resistant to four other protease inhibitors.
Fost dawn, 43 kellhom HIV reżistenti għal erba ’ inibituri tal - proteażi oħra.
The main measures of effectiveness were the proportion of patients with undetectable levels of HIV in the blood (viral load) or the change in viral load after treatment.
Il- kejl ewlieni tal- effikaċja kien il- proporzjon ta ’ pazjenti b’ livelli ta ’ HIV li ma jistgħux jiġu osservati fid- demm (tagħbija virali [viral load]) jew varjazzjoni fit- tagħbija virali wara t- trattament.
What benefit has Agenerase shown during the studies?
X’ benefiċċji wera Agenerase matul dawn l- istudji mwettqa?
In the studies of patients who had not previously taken protease inhibitors, more patients taking Agenerase had viral loads below 400 copies/ ml than those taking placebo after 48 weeks, but Agenerase was less effective than indinavir.
Fl- istudji ta ’ pazjenti li ma kinux ħadu qabel inibituri tal- proteażi, in- numru ta ’ pazjenti ttrattati b’ Agenerase li rreġistraw tagħbija virali inqas minn 400 kopja/ ml kien ogħla minn dak tal- pazjenti ttrattati bil- plaċebo wara 48 ġimgħa, iżda Agenerase irriżulta inqas effikaċi minn indinavir.
Agenerase also reduced viral loads in children, although very few of the children who had taken protease inhibitors in the past responded to treatment.
Barra minn hekk, Agenerase naqqas it- tagħbija virali fit- tfal, minkejja li numru limitat ħafna ta ’ tfal ittrattati fil- passat bl- inibituri tal- proteażi rrispondew għat- trattament.
The studies included very few children aged below four years.
Fl- istudji ħa sehem numru żgħir ħafna ta ’ tfal ta ’ età taħt l- erba ’ snin.
In the study of adults who had taken protease inhibitors in the past, Agenerase boosted with ritonavir was as effective as other protease inhibitors in reducing viral loads after 16 weeks of treatment: around two thirds of the patients in both groups had viral loads below 400 copies/ ml.
Fl- istudju fuq l- adulti li kienu ħadu inibituri tal- proteażi fil- passat, Agenerase bil- booster ritonavir kien effikaċi daqs inibituri tal- proteażi oħrajn fit- tnaqqis tat- tagħbija virali wara 16- il ġimgħa ta ’ trattament: madwar żewġ terzi tal- pazjenti fiż- żewġ gruppi rreġistraw tagħbija virali inqas minn 400 kopja/ ml.
In the patients with HIV that was resistant to four other protease inhibitors, patients taking Agenerase with ritonavir had a greater fall in viral load after four weeks than those continuing to take their previous protease inhibitors: half of those taking Agenerase with ritonavir had viral loads below 400 copies/ ml, compared with none of those continuing to take their previous protease inhibitors.
Fil- pazjenti b’ infezzjoni mill- HIV reżistenti għal erba ’ inibituri tal- proteażi oħrajn, l - individwi ttrattati b’ Agenerase u ritonavir irreġistraw tnaqqis akbar tat- tagħbija virali wara erba ’ ġimgħat meta mqabbla ma ’ dawk li komplew ikunu ttrattati bl- inibituri tal- proteażi preċedenti: f’ nofs il- pazjenti ttrattati b’ Agenerase flimkien ma ’ ritonavir ġiet osservata tagħbija virali inqas minn 400 kopja/ ml, filwaqt li din ma ġiet osservata fl- ebda pazjent li kompla t- trattament preċedenti bl - inibituri tal- proteażi oħrajn.
What is the risk associated with Agenerase?
X’ inhu r- riskju assoċjat ma ’ Agenerase?
The most common side effects with Agenerase (seen in more than 1 patient in 10) are headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
L- effetti sekondarji l- aktar komuni b’ Agenerase (li dehru f’ pazjent 1 minn 10) huma wġigħ ta ’ ras, dijarrea, flatulenza (gass), nawżea (dardir), remettar, raxx u għeja.
For the full list of all side effects reported with Agenerase, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Agenerase, ara l- Fuljett ta ’ Tagħrif.
Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Agenerase ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal amprenavir jew għal xi ingredjent ieħor tiegħu.
Agenerase must not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Agenerase ma għandux jintuża f’ pazjenti li qegħdin jieħdu l- fexfiexa tar- raba ’ (St John’ s wort, preparazzjoni erbali użata għat- trattament tad- depressjoni) jew mediċini li jiġu metabolizzati bl- istess mod bħal Agenerase u huma ta ’ ħsara jekk jilħqu livelli għoljin fid- demm.
See the Package Leaflet for the full list of these medicines.
Ara l- Fuljett ta ’ Tagħrif għal- lista sħiħa ta ’ dawn il- mediċini.
Agenerase boosted with ritonavir must not be taken by patients who have severe problems with their liver, or by patients taking rifampicin (used to treat tuberculosis) or medicines that are broken down in the same way as ritonavir, such as flecainide and propafenone (used to correct irregular heartbeat).
Agenerase bil- booster ritonavir lanqas ma għandu jittieħed minn pazjenti li jbatu minn problemi gravi fil- fwied jew minn pazjenti li qegħdin jagħmlu użu mir- rifampiċina (rifampicin, użata fit- trattament tat- tuberkulożi) jew mediċini li jiġu metabolizzati bl- istess mod bħal ritonavir, bħalma huma flecainide u propafenone (użati biex jikkoreġu l- aritmija kardijaka [taħbit irregolari tal- qalb]).
Caution is needed when Agenerase is taken at the same time as some other medicines.
Agenerase għandu jintuża b’ kawtela meta jittieħed fl- istess ħin ma ’ mediċini oħra.
See the Package Leaflet for full details.
Ara l- Fuljett ta ’ Tagħrif għad- dettalji kollha.
As with other anti-HIV medicines, patients taking Agenerase may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal għal mediċini oħra ta ’ kontra l- HIV, il- pazjenti ttrattati b’ Agenerase jista ’ jkollhom riskju ta ’ lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt ta ’ tessut tal - 2/ 3 għadam) jew sindromu tar- riattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver may be at an elevated risk of liver damage when taking Agenerase.
Il- pazjenti li jkollhom problemi bil- fwied jistgħu jkunu esposti aktar għar- riskju li jiżviluppaw ħsara fil- fwied jekk ittrattati b’ Agenerase.
2/ 3 Why has Agenerase been approved?
Għaliex ġie approvat Agenerase?
The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase’ s benefits are greater than its risks for use in combination with other antiretroviral agents in the treatment of protease inhibitor experienced HIV-1 infected adults and children above the age of four years.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Agenerase huma ogħla mir- riskji tiegħu meta użat flimkien ma ’ aġenti antiretrovirali oħra fit - trattament ta ’ adulti u tfal ta ’ età ‘ l fuq minn erba ’ snin infettati mill- HIV- 1, diġà ttrattati b’ inibituri tal- proteażi.
It is normally taken with the pharmacokinetic enhancer ritonavir, but the Committee noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
Il- mediċina normalment tittieħed mal- booster farmakokinetiku ritonavir, madankollu l - Kumitat nnota li l- benefiċċji ta ’ Agenerase meħud ma ’ ritonavir ma ntwerewx f’ pazjenti li fil- passat ma kinux ħadu inibituri tal- proteażi.
The Committee recommended that Agenerase be given marketing authorisation.
Il- Kumitat irrakkomanda li Agenerase jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Agenerase was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament, Agenerase kien ġie awtorizzat f ’ “ Ċirkostanzi Eċċezzjonali ”, minħabba li meta ngħatat l- awtorizzazzjoni, kien disponibbli tagħrif limitat, għal raġunijiet xjentifiċi.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 10 March 2004.
Billi l- kumpanija pprovdiet it- tagħrif addizzjonali mitlub, iċ - “ Ċirkostanzi Eċċezzjonali "ntemmu fl- 10 ta ’ Marżu 2004.
Other information about Agenerase:
Aktar tagħrif dwar Agenerase:
The European Commission granted a marketing authorisation valid throughout the European Union for Agenerase to Glaxo Group Limited on 20 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Agenerase lil Glaxo Group Limited fl- 20 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 20 October 2005.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 20 ta ’ Ottubru 2005.
The full EPAR for Agenerase can be found here.
L- EPAR sħiħ għal Agenerase jista ’ jiġi kkonsultat hawn.
Agenerase 50 mg soft capsules.
Agenerase 50 mg, kapsuli rotob
Each capsule contains 50 mg of amprenavir.
Kull kapsula fiha 50 mg ta ’ amprenavir.
Excipients: d-sorbitol (E420)
Sustanzi mhux attivi: d- sorbitol (E420)
Soft capsule.
Kapsula ratba.
Oblong, opaque, off-white to cream coloured, printed with ‘ GX CC1’.
Forma rettangolari, opaki, b’ lewn abjad maħmuġ jkanġi għall- krema, stampati bl- ittri ‘ GX CC1 ’.
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
4. 1 Indikazzjonijiet terapewtiċi
Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5).
Il- kapsuli ta ’ Agenerase huma normalment mogħtija flimkien ma ’ doża baxxa ta ’ ritonavir, li jservi ta ’ pharmacokinetic enhancer għal amprenavir (ara 4. 2 u 4. 5).
The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
L- għażla ta ’ amprenavir tiddependi fuq it - testijiet tar- reżistenza ta ’ l- individwu għall- vajrus u fuq l- istorja tal- kura tal- pazjent (ara 5. 1).
The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI naïve patients (see section 5.1)
Il- kura b ’ Agenerase mogħti flimkien ma ’ ritonavir ma ġietx ippruvata li hija ta ’ vantaġġ f’ pazjenti li qatt ma jkunu ngħataw kura permezz ta ’ inibituri protease (ara 5. 1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tiġi mibdija minn tabib li għandu esperjenza fil- qasam tal- kura ta ’ infezzjonijiet bl - HIV.
The importance of complying with the full recommended dosing regimen should be stressed to all patients.
L- importanza li l- pazjenti kollha jobdu eżatt il- mod ta ’ kif jieħdu l- mediċina hekk kif ordnati mit- tabib trid tiġi enfasizzata.
Agenerase is administered orally and can be taken with or without food.
Agenerase għandu jittieħed mill- ħalq u jistà jittieħed kemm ma ’ l- ikel kif ukoll waħdu.
Agenerase is also available as an oral solution for use in children or adults unable to swallow capsules.
Amprenavir huwa 14% inqas bijodisponibbli meta jittieħed bħala soluzzjoni orali milli bħala kapsuli.
Amprenavir is 14% less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Għalhekk, il- kapsuli rotob ta ’ Agenerase u s- soluzzjoni orali ta ’ Agenerase ma jistgħux jiġu mibdula ma ’ xulxin fuq bażi ta ’ milligramma għal milligramma (ara 5. 2).
Adults and adolescents of 12 years of age and older (greater than 50 kg body weight): the recommended dose of Agenerase capsules is 600 mg twice daily with ritonavir, 100 mg twice daily, in combination with other antiretroviral agents.
Adulti u Adoloxxenti minn 12- il sena ‘ l fuq (piż tal- ġisem aktar minn 50 kg): id- doża rakkomandata ta ’ kapsuli ta ’ Agenerase hija ta ’ 600 mg darbtejn kuljum flimkien ma ’ ritonavir, li jingħata f’ doża ta ’ 100 mg darbtejn kuljum, flimkien ma ’ mediċini antiretrovirali oħra.
If Agenerase capsules are used without the boosting effect of ritonavir higher doses of Agenerase (1200 mg twice daily) should be used.
Jekk il- kapsuli ta ’ Agenerase ma jingħatawx flimkien ma ’ doża ta ’ ritonavir, għandha tingħata doża akbar ta ’ Agenerase (1200 mg darbtejn kuljum).
2 Children (4 to 12 years) and patients less than 50 kg body weight: the recommended dose of Agenerase capsules is 20 mg/ kg body weight twice a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2400 mg (see section 5.1).
2 Tfal (minn 4 sa 12- il sena) u pazjenti li għandhom piż tal- ġisem inqas minn 50 kg: id- doża rakkomandata ta ’ kapsuli ta ’ Agenerase hija ta ’ 20 mg għal kull kilogramm ta ’ piż tal- gisem darbtejn kuljum, flimkien ma ’ mediċini antiretrovirali oħra, mingħajr ma tinqabeż id- doża totali ta ’ 2400 mg kuljum (ara sezzjoni 5. 1).
The pharmacokinetics, efficacy and safety of Agenerase in combination with low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
Il- proprjetajiet farmakokinetiċi, l- effikaċja u r- riskju marbutin ma ’ l- użu ta ’ Agenerase flimkien ma ’ doża baxxa ta ’ ritonavir jew inibituri protease oħra ma ġewx valutati fit- tfal.
Therefore, such combinations should be avoided in children.
Għalhekk, taħlit ta ’ dawn il- mediċini fit- tfal m’ għandux isir.
Agenerase is not recommended in children below 4 years due to lack of data on safety and efficacy (see section 5.2).
Tfal taħt l- 4 snin: l- użu ta ’ Agenerase fi tfal taħt l- 4 snin m’ huwiex irrikmandat minħabba nuqqas ta ’ informazzjoni fuq is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Elderly: the pharmacokinetics, efficacy and safety of amprenavir have not been studied in patients over 65 years of age (see section 5.2).
Anzjani: il- proprjetajiet farmakokinetiċi, l- effikaċja u s- sigurtà marbutin mal- użu ta ’ Agenerase ma ġewx studjati f’ pazjenti li għandhom ‘ il fuq minn 65 sena (ara 5. 2).
Renal impairment: no dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Indeboliment tal- Kliewi: m’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti li għandhom ħsara fil- kliewi (ara 5. 2).
Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
Indeboliment tal- Fwied: ir- rotta prinċipali tal- metaboliżmu ta ’ amprenavir hija permezz tal- fwied.
Agenerase capsules should be used with caution in patients with hepatic impairment.
Il - kapsuli ta ’ Agenerase għandhom jintużaw b’ attenzjoni f’ pazjenti li jbatu minn indeboliment tal- fwied.
Clinical efficacy and safety have not been determined in this patient group.
L- effikaċja klinika u r- riskju marbutin ma ’ din il- mediċina m’ humiex magħrufa f’ dawn in- nies.
For subjects with hepatic impairment, pharmacokinetic data are available for the use of Agenerase capsules without the boosting effect of ritonavir.
Għal dawk li jbatu minn ħsara fil- fwied jeżisti tagħrif farmakokinetiku dwar l- użu tal- kapsuli ta ’ Agenerase mingħajr l- użu fl- istess ħin ta ’ ritonavir.
Based on pharmacokinetic data, the dose of Agenerase capsules should be reduced to 450 mg twice a day for adult patients with moderate hepatic impairment and to 300 mg twice a day for adult patients with severe hepatic impairment.
Id- doża f’ dawk il- pazjenti adulti li jbatu minn indeboliment kbir fil- fwied hija ta ’ 300 mg darbtejn kuljum.
No dose recommendation can be made in children with hepatic impairment (see section 5.2).
M’ hemmx doża rakkomandabbli għal tfal li jbatu minn indeboliment fil- fwied (ara 5. 2).
The use of amprenavir in combination with ritonavir has not been studied in patients with hepatic impairment.
L- użu ta ’ amprenavir flimkien ma ’ ritonavir f’ pazjenti li jbatu minn ħsara fil- fwied ma ’ sarx studju fuqu.