qanastek/EMEA-V3 huggingface dataset:
Do not use ADVATE if the solution is not fully clear or not completely dissolved.
135 Istruzzjonijiet għall- injezzjoni Sabiex jingħata l- użu ta ’ siringa luer- lock hi meħtieġa Nota importanti: • Tipprovax tagħti l- injezzjoni jekk ma ngħatajtx taħriġ speċjalizzat mit- tabib jew l- infermier/ a tiegħek. • Ifli s- soluzzjoni mħejjija biex tara jekk hemmx xi frak u telf ta ’ kulur qabel tingħata (is - soluzzjoni għandha tkun ċara, mingħajr kulur u ħielsa minn partikuli barranin). • Tużax ADVATE jekk is- soluzzjoni ma tkunx kompletament ċara jew mhux maħlula kompletament.
The following table can be used to guide dosing in bleeding episodes and surgery.
136 Fil- każ li jinqalgħu l- każijiet emorraġiċi li ġejjin, l- attività ta ’ fattur VIII m’ għandix tinżel inqas mil - livell tal- attività tal- plażma mogħti (f ’% ta ’ normal jew IU/ dl) fil- perijodu korrispondenti, It- tabella li ġejja tista ’ tintuża bħala gwida għal dożi f’ każijiet ta ’ emorraġiji u kirurġija.
131 PACKAGE LEAFLET:
137 FULJETT TA ’ TAGĦRIF:
ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Octocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
ADVATE is prepared without the addition of any human - or animal-derived protein in the cell culture process, pur ification or final formulation.
ADVATE jiġi preparat mingħajr iż- żieda ta ’ ebda proteina derivata mill- bniedem jew mill- annimal fil - proċess ta ’ tkabbir ta ’ razez ċellulari, purifikazzjoni jew formulazzjoni finali.
132 symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Dawn is- sintomi jistgħu jikkostitwixxu sintomu bikri ta ’ xokk anafilattiku, li l- manifestazzjonijiet tiegħu jistgħu jinkludu wkoll sturdament qawwi, telf mis- sensi, u tbatija kbira biex tieħu n- nifs.
133 Patients developing Factor VIII inhibitors If your plasma Factor VIII fails to reach expected levels with ADVATE, or if bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors.
Pazjenti li jiżviluppaw impedituri tal- Fattur VIII Jekk il- Fattur VIII fil- plażma tiegħek jonqos milli jilħaq il- livelli mistennija b’ ADVATE, jew jekk l - emorraġija ma tkunx ikkontrollata b’ mod xieraq, dan jista ’ jkun dovut għall- impedituri tal- Fattur VIII.
How ADVATE is given ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
139 Kif jingħata ADVATE ADVATE ġeneralment jingħata ġo vina (fil- vini) minn tabib jew infermiera.
134 whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, increase in enzymes that track liver function, reduced percentage of red blood cells and pain in the upper abdomen or lower chest.
140 Relatati ma intervent kirurġiku infezzjoni relatata mal- kateter, tnaqqis fl- għadd ta ’ ċelloli ħomor fid- demm, nefħa fir- riġlejn u d- dirgħajn u fil- ġogi, fsada mtawla wara li jitneħħa l- pajp li minnu jgħaddi l- likwidu li joħroġ mill - ferita, tnaqqis fil- livell ta ’ Fattur VIII u tbenġil wara l- operazzjoni.
Each powder vial contains 2000 IU octocog alfa.
Kull kunjett tat- trab fih 2000 IU octocog alfa.
135 Marketing Authorisation Holder Baxter AG Industriestrasse 67 A-1221 Vienna
141 Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq Baxter AG Industriestrasse 67 A- 1221 Vienna
136 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
142 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
138 INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
144 ISTRUZZJONIJIET GĦALL- PREPARAZZJONI U L- AMMINISTRAZZJONI
Do not use ADVATE if the solution is not fully clear or not completely dissolved.
145 Istruzzjonijiet għall- injezzjoni Sabiex jingħata l- użu ta ’ siringa luer- lock hi meħtieġa Nota importanti: • Tipprovax tagħti l- injezzjoni jekk ma ngħatajtx taħriġ speċjalizzat mit- tabib jew l- infermier/ a tiegħek. • Ifli s- soluzzjoni mħejjija biex tara jekk hemmx xi frak u telf ta ’ kulur qabel tingħata (is - soluzzjoni għandha tkun ċara, mingħajr kulur u ħielsa minn partikuli barranin). • Tużax ADVATE jekk is- soluzzjoni ma tkunx kompletament ċara jew mhux maħlula kompletament.
The following table can be used to guide dosing in bleeding episodes and surgery.
146 Fil- każ li jinqalgħu l- każijiet emorraġiċi li ġejjin, l- attività ta ’ fattur VIII m’ għandix tinżel inqas mil - livell tal- attività tal- plażma mogħti (f ’% ta ’ normal jew IU/ dl) fil- perijodu korrispondenti, It- tabella li ġejja tista ’ tintuża bħala gwida għal dożi f’ każijiet ta ’ emorraġiji u kirurġija.
141 PACKAGE LEAFLET:
147 FULJETT TA ’ TAGĦRIF:
ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 3000 IU trab u solvent għal soluzzjoni għall- injezzjoni Octocog alfa (fattur VIII tal- koagulazzjoni rikombinanti uman)
ADVATE is used in patients with haemophilia A for prevention or treatment of spontaneous or surgery -related bleeding.
ADVATE jintuża f’ pazjenti b’ emofilja A għal prevenzjoni jew kura ta ’ emorraġiji relatati ma ’ interventi kirurġiċi.
142 symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Dawn is- sintomi jistgħu jikkostitwixxu sintomu bikri ta ’ xokk anafilattiku, li l- manifestazzjonijiet tiegħu jistgħu jinkludu wkoll sturdament qawwi, telf mis- sensi, u tbatija kbira biex tieħu n- nifs.
Patients developing Factor VIII inhibitors If your plasma Factor VIII fails to reach expected levels with ADVATE, or if bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors.
Pazjenti li jiżviluppaw impedituri tal- Fattur VIII Jekk il- Fattur VIII fil- plażma tiegħek jonqos milli jilħaq il- livelli mistennija b’ ADVATE, jew jekk l - emorraġija ma tkunx ikkontrollata b’ mod xieraq, dan jista ’ jkun dovut għall- impedituri tal- Fattur VIII.
How ADVATE is given ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
149 Kif jingħata ADVATE ADVATE ġeneralment jingħata ġo vina (fil- vini) minn tabib jew infermiera.
143 If you use more ADVATE than you should Always take ADVATE exactly as your doctor has told you.
Jekk tuża aktar ADVATE milli suppost Dejjem għandek tieħu ADVATE skond il- parir eżatt tat- tabib.
Uncommon side effects itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, increase in enzymes that track liver function, reduced percentage of red blood cells and pain in the upper abdomen or lower chest.
Effetti sekondarji mhux komuni ħakk, żieda fl- għaraq, togħma mhux tas- soltu fil- ħalq, fwawar tal- menopawsa, emigranji, indeboliment tal- memorja, tertir, dijarea, dardir, rimettar, qtugħ ta 'nifs, griżmejn muġugħa, infezzjoni tal- kanali limfatiċi, tibjid tal- ġilda, infjammazzjoni fl- għajnejn, raxxijiet, tagħriq eċċessiv, nefħa fis- saqajn u r - riġlejn, żieda fl- enzimi li jsegwu l- funzjoni tal- fwied, perċentwali mnaqqsa tal- għadd ta ’ ċelluli ħomor tad- demm, u wġigħ fil- parti ta' fuq tal- addome jew fil- parti ta 'isfel tas- sider.
Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise.
150 Relatati ma intervent kirurġiku infezzjoni relatata mal- kateter, tnaqqis fl- għadd ta ’ ċelloli ħomor fid- demm, nefħa fir- riġlejn u d- dirgħajn u fil- ġogi, fsada mtawla wara li jitneħħa l- pajp li minnu jgħaddi l- likwidu li joħroġ mill - ferita, tnaqqis fil- livell ta ’ Fattur VIII u tbenġil wara l- operazzjoni.
144 Rare side effects Since the medicine has been on the market, there have been rare reports of severe and potentially life-threatening reactions (anaphylaxis) and other allergic reactions (see above).
Effetti sekondarji rari Kemm ilha fis- suq il- mediċina, kien hemm rapporti rari ta 'reazzjonijiet severi u possibbilment ta' theddida għall- ħajja (anafilassi) u ta 'reazzjonijiet allerġiċi oħra (ara fuq).
Each powder vial contains 3000 IU octocog alfa.
Kull kunjett tat- trab fih 3000 IU octocog alfa.
Marketing Authorisation Holder Baxter AG Industriestrasse 67 A-1221 Vienna
151 Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq Baxter AG Industriestrasse 67 A- 1221 Vienna
1 45 Manufacturer Baxter SA Boulevard René Branquart 80 B-7860 Lessines Belgium
Manifattur Baxter SA Boulevard René Branquart 80 B- 7860 Lessines Il- Belġju
146 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
152 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
148 INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
154 ISTRUZZJONIJIET GĦALL- PREPARAZZJONI U L- AMMINISTRAZZJONI
Do not use ADVATE if the solution is not fully clear or not completely dissolved.
155 Istruzzjonijiet għall- injezzjoni Sabiex jingħata l- użu ta ’ siringa luer- lock hi meħtieġa Nota importanti: • Tipprovax tagħti l- injezzjoni jekk ma ngħatajtx taħriġ speċjalizzat mit- tabib jew l- infermier/ a tiegħek. • Ifli s- soluzzjoni mħejjija biex tara jekk hemmx xi frak u telf ta ’ kulur qabel tingħata (is - soluzzjoni għandha tkun ċara, mingħajr kulur u ħielsa minn partikuli barranin). • Tużax ADVATE jekk is- soluzzjoni ma tkunx kompletament ċara jew mhux maħlula kompletament.
The following table can be used to guide dosing in bleeding episodes and surgery.
156 Fil- każ li jinqalgħu l- każijiet emorraġiċi li ġejjin, l- attività ta ’ fattur VIII m’ għandix tinżel inqas mil - livell tal- attività tal- plażma mogħti (f ’% ta ’ normal jew IU/ dl) fil- perijodu korrispondenti, It- tabella li ġejja tista ’ tintuża bħala gwida għal dożi f’ każijiet ta ’ emorraġiji u kirurġija.
151 ANNEX IV
157 ANNESS IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
BAŻI GĦAL TIĠDID ADDIZZJONALI WIEĦED
152 GROUNDS FOR ONE ADDITIONAL RENEWAL
158 BAŻI GĦAL TIĠDID ADDIZZJONALI WIEĦED
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit/risk balance of Advate remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Skont it- tagħrif disponibbli minn meta ngħatat l- Awtorizzazzjoni għat- Tqegħod fis- Suq inizjali, is- CHMP jikkonsidra li l- bilanċ dwar il- benefiċċju / riskju ta ’ Advate għadu pożittiv, imma jikkonsidra li l- profil tas- sigurtà għandu jibqa ’ jiġi monitorat mill- qrib minħabba r- raġunijiet li ġejjin:
- to follow the implementation of the registry/surveillance system further to the findings of the
- sabiex tiġi segwita l- implimentazzjoni tar- reġistru/ sistema ta ’ sorvelljanza lil hinn mir- riżultati
pharmacovigilance Inspection
tal- Ispezzjoni ta ’ farmakoviġilanza
- to ensure appropriate implementation of the pharmacovigilance system / risk management plan
- sabiex tiġi żgurata l- implimentazzjoni xierqa tas- sistema ta ’ farmakoviġilanza / pjan ta ’ ġestjoni
Therefore, based upon the safety profile of Advate, which requires the submission of 6-monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Għalhekk, skont il- profil tas- sigurtà ta ’ Advate, li jeħtieġ is- sottomissjoni kull sitt xhur ta ’ PSUR, is - CHMP ikkonkluda li l- MAH għandu jissottometti applikazzjoni ta ’ tiġdid addizzjonali fi żmien 5 snin.
Ref.
Londra, 22 ta ’ Jannar 2009 Dok. ta ’ Ref.
EMEA/ 690893/ 2008
EMEA/ 86061/ 2009
Questions and answers on the withdrawal of the marketing application for Advexin
Mistoqsija u Tweġiba dwar l- irtirar tal- applikazzjoni għat- tqegħid fis- suq għal Advexin
International non-proprietary name (INN): contusugene ladenovec
Denominazzjoni Komuni Internazzjonali (DKI): contusugene ladenovec
On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer.
Fis- 17 ta ’ Diċembru 2008 Gendux Molecular Limited uffiċjalment għarrfet lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis- suq għal Advexin, għat- trattament ta ’ kanċer Li- Fraumeni.
Advexin was designated as an orphan medicinal product on 23 October 2006.
Advexin ġie kklassifikat bħala prodott mediċinali orfni fit- 23 ta 'Ottubru 2006.
What is Advexin?
X’ inhu Advexin?
Advexin is a suspension for injection that contains contusugene ladenovec, a genetically modified virus which carries the p53 gene.
Advexin huwa sospensjoni għal injezzjoni li fiha l- contusugene ladenovec, vajrus li huwa ġenetikament modifikat li jġorr il- ġene p53.
What was Advexin expected to be used for?
Għal xiex kien mistenni li jintuża Advexin?
Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Advexin kien mistenni li jintuża għat- trattament ta ’ kanċer Li- Fraumeni f’ pazjenti mill- età ta ’ 18- il sena.
Li-Fraumeni cancer is a type of cancer that occurs in patients with Li-Fraumeni syndrome, a condition where a gene called p53 is defective because of a mutation.
Il- kanċer Li- Fraumeni huwa tip ta ’ kanċer li jseħħ f’ pazjenti bis- sindromu Li- Fraumeni, kondizzjoni fejn il- ġene msejjaħ p53 huwa difettuż minħabba mutazzjoni.
People who have this mutation are more likely to develop cancer.
Nies li għandhom din il - mutazzjoni għandhom ċans akbar li jiżviluppa kanċer fihom.
Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Il- kanċer Li- Fraumeni jista ’ jseħħ f’ bosta partijiet tal- ġisem iżda normalment jaffettwa s- sider, il- moħħ, l- għadam jew it- tessuti rotob (tessuti li jikkolegaw, idawru jew li jżommu stutturi oħrajn fil- ġisem).
How is Advexin expected to work?
Kif kien mistenni li jaħdem Advexin?
The active substance in Advexin, contusugene ladenovec, is a ‘ viral vector’.
Is- sustanza attiva f’ Advexin, contusugene ladenovec, huwa ‘ vettur virali ’.
This is a type of virus that has been altered genetically so that it can carry a gene into the cells of the body.
Dan huwa tip ta ’ vajrus li ġie ġenetikament modifikat sabiex ikun jista ’ jġorr il- ġene fiċ- ċelloli tal- ġisem.
The virus in Advexin is an ‘ adenovirus ’ that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Il- virus f' Advexin hu ‘ adenovirus ’ li jkun ġie manipulat biex ma jkunx jista 'jagħmel kopji tiegħu nnifsu u għalhekk ma jikkawżax infezzjonijiet fil- bniedem.
The gene carried by the virus in Advexin is the normal (non-defective) p53 gene.
Il- ġene li jġorr il- vajrus f’ Advexin huwa l- ġene p53 normali (mhux difettuż).
Advexin was expected to be injected directly into the tumours, thus allowing the cancer cells to produce normal p53 protein again.
Advexin kien mistenni li jiġi injettat direttament fit- tumuri, b’ hekk jippermetti li ċelloli tal- kanċer jipproduċu mill- ġdid il- proteina normali p53.
The p53 protein, which is produced from the non-defective p53 gene present in the human body, normally contributes to the repair of damaged DNA and causes cell death when the DNA cannot be repaired.
Il- proteina p53, prodotta mill- ġene p53 li mhuwiex difettuż preżenti fil- ġisem uman, normalment tikkontribwixxi għat- tiswija ta ’ DNA li saritilha l- ħsara u jikkawża l- mewt taċ- ċelloli meta d- DNA ma tistax tiġi msewwija.
Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Minħabba li ċelloli tal- kanċer fihom DNA li saritilha l- ħsara, l- proteina p53 jew tgħin sabiex tirranġa d- DNA jew tikkawża li ċ - ċelloli jmutu.
In Li-Fraumeni cancer, where the p53 gene is defective, the p53 protein does not work properly and the cancer cells can continue to grow and divide.
Il- kanċer Li- Fraumeni, meta l- ġene p53 ikun difettuż, il- proteina p53 ma taħdimx b’ mod kif suppost u ċ- ċelloli tal- kanċer jistgħu ikomplu jikbru u jimmultiplikaw.
Advexin was expected to cure or slow down the disease by restoring the normal protective function of the cells.
Advexin kien mistenni li jikkura jew inaqqas it- tkabbir tal- marda billi jġib lura l- funzjoni protettiva normali taċ- ċelloli.
What documentation did the company present to support its application to the CHMP?
X’ dokumentazzjoni ppreżentat il- kumpanija għas- sostenn tal- applikazzjoni tagħha lis- CHMP?
The effects of Advexin were first tested in experimental models before being studied in humans.
L- effetti ta ’ Advexin għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The company presented information from a study on one patient with Li-Fraumeni cancer in the lower abdomen, the bones and the brain.
Il- kumpanija ppreżentat informazzjoni mill- istudju dwar pazjent b’ kanċer Li- Fraumeni fil- parti t’ isfel taż- żaqq, l- għadam u l- moħħ.
The patient received 12 Advexin injections into some of the tumours over a five-month period.
Il- pazjent irċieva 12- il injezzjoni Advexin f’ xi tumuri fuq perjodu ta ’ ħames xhur.
The effectiveness of the medicine was assessed by using scans to look at how the tumours responded to treatment.
L- effikaċja tal- mediċina ġiet valutata bl- użu ta ’ skens li jeżaminaw kif it- tumuri rrispondew għat- trattament.
The company also presented the results of a number of small studies looking at the effects of a range of doses of Advexin on different types of cancer.
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ numru ta ’ studji żgħar li jeżaminaw l- effetti ta ’ firxa ta ’ dożi ta ’ Advexin fuq tipi differenti ta ’ kanċer.
The application was at day 179 when the company withdrew.
L- applikazzjoni kienet waslet f' jum 179 meta l- kumpanija rtiratha.
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 tar- reviżjoni tad - dokumentazzjoni inizjali, is- CHMP iħejji lista ta 'mistoqsijiet fil- 120 jum, li mbagħad 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 ippreżentat it- tweġibiet tagħha għall- mistoqsijiet imressqa, is - CHMP jirrevedihom u jista ’, qabel ma jagħti opinjoni, iressaq xi mistoqsijiet oħra 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, il- Kummissjoni Ewropea normalment iddum madwar xahrejn sakemm toħroġ l - awtorizzazzjoni.
What was the recommendation of the CHMP at that time?
X’ kienet ir- rakkomandazzjoni tas- CHMP dak iż- żmien?
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 Advexin could not have been approved for the treatment of Li-Fraumeni cancer.
Skont 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 kellu opinjoni proviżorja li Advexin ma setax jiġi approvat għat - trattament tal- kanċer Li- Fraumeni.
The CHMP was concerned that there was not enough evidence to show that the injection of Advexin into Li-Fraumeni tumours led to benefits for patients.
Is- CHMP esprima tħassib li ma kienx hemm evidenza biżżejjed sabiex turi li l- injezzjoni ta ’ Advexin fit- tumuri Li- Fraumeni wasslu għal benefiċċji fil- pazjenti.
The Committee also had concerns over what happens to the medicine in the body, how it should be given and how safe it is.
Il- Kumitat kellu tħassib ukoll dwar x’ jiġri lil mediċina fil- ġisem, kif għandha tingħata u kemm hija sigura.
In addition, the company had not supplied enough evidence to demonstrate that Advexin could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Barra minn dan, il- kumpanija ma pprovdietx evidenza biżżejjed sabiex turi li Advexin jista ’ jsir b’ mod affidabbli, jew li ma tkunx ta ’ ħsara għall- ambjent jew għan- nies li huma b’ kuntatt mill- qrib man- nies.
What were the reasons given by the company to withdraw the application?
X’ kienu r- raġunijiet mogħtija mill- kumpanija għall- irtirar tal- applikazzjoni?
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 dwar l- irtirar tal- applikazzjoni tista 'tiġi kkonsultata hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Advexin?
X' inhuma l- konsegwenzi tal- irtirar għal dawk il- pazjenti li kienu involuti fi provi kliniċi jew programmi ta 'użu b’ kumpassjoni bl- użu ta ’ Advexin?
The company did not inform the CHMP whether there were any consequences of the withdrawal for patients in clinical trials or compassionate use programmes with Advexin.
Il- kumpanija ma infurmatx lis- CHMP dwar jekk kienx hemm konsegwenzi għall- irtirar f’ pazjenti fi provi kliniċi jew programmi ta ’ użu b’ kumpassjoni b’ Advexin.
What is Aerinaze?
X’ inhi Aerinaze?
Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Aerinaze hija mediċina li fiha s- sustanzi attivi desloratadine (2. 5 mg) u pseudoephedrine (120 mg).
It is available as blue and white modified-release tablets. ‘ Modified-release ’ means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.
Hija tiġi bħala pilloli koħol u bojod li jerħu l- mediċina b’ mod modifikat. ‘ Jerħu l- mediċina b’ mod modifikat ’ ifisser li l- pilloli ġew magħmula biex iħallu wieħed mis- sustanzi attivi jintreħa immedjatament u l- ieħor jintreħa wara ftit sigħat.
What is Aerinaze used for?
Għal x’ hiex tintuża Aerinaze?
Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Aerinaze tintuża biex tittratta s- sintomi ta ’ rinite allerġika staġjonali (hayfever, infjammazzjoni tal - passaġġi nażali ikkaġunata minn allerġija għal polline) f’ pazjenti li għandhom konġestjoni nażali (imnieħer imblokkat).
The medicine can only be obtained with a prescription.
Il- mediċina tinkiseb biss b’ riċetta ta ’ tabib.
How is Aerinaze used?
Kif tintuża Aerinaze?
In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water, with or without food.
F’ adulti u adolexxenti ta ’ aktar minn 12- il sena, id- doża rakomandata ta ’ Aerinaze hija pillola darbtejn kuljum, li tittieħed sħiħa ma ’ tazza mimlija bl- ilma, ma ’ l- ikel jew fuq stonku vojt.
Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared.
It- trattament għandu jitkompla għal żmien qasir kemm jista ’ jkun possibbli meta s- sintomi, prinċipalment il - konġestjoni (imnieħer imblokkat), ikunu sparixxew.
Treatment for more than 10 days is not advisable, as the medicine ’ s effects on nasal congestion may wear off.
Trattament għal aktar minn 10 ijiem m’ huwiex irrakkomandat, minħabba li l- effetti tal- mediċina fuq il- konġestjoni nażali jistgħu jmorru.
Once the nose has cleared, patients can use desloratadine alone.
La darba l - imnieħer jinfetaħ, il- pazjenti jistgħu jużaw desloratadine waħdu.
How does Aerinaze work?
Kif taħdem Aerinaze?
Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant.
Aerinaze fiha żewġ sustanzi attivi: desloratadine, mediċina kontra histamine, u pseudoephedrine, li huwa dekonġestant nażali.
Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Desloratadine jaħdem billi jimblokka r- riċetturi fuq liema normalment teħel histamine, sustanza li tikkaġuna sintomi allerġiċi.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Meta r- riċetturi jkunu imblokkati, histamine ma tistax twettaq l- effett tagħha, u dan iwassal għal tnaqqis fis- sintomi ta ’ l- allerġija.
Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which causes the blood vessels to constrict (narrow).
Pseudoephedrine jaħdem billi jistimola t- trufijiet tan- nervituri biex jerħu l- kimika noradrenaline, li ġġiegħel l- arterji u l - vini jidjiequ (jingħalqu).
This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
Dan inaqqas l- ammont ta ’ fluwidu merħi mill- arterji u l- vini, jirriżulta f’ nefħa iżgħar u fi produzzjoni iżgħar ta ’ mukus fl- imnieħer.
In Aerinaze, the two active substances are used together, since an antihistamine alone may not provide adequate relief for patients with nasal congestion.
F’ Aerinaze, iż- żewġ sustanzi attivi jintużaw flimkien, minħabba li mediċina kontra histamine waħidha tista ’ ma tipprovdiex serħan adegwat mill- konġestjoni nażali għall- pazjenti.
Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Il- pilloli Aerinaze fihom żewġ saffi, wieħed fih desloratadine, u l- ieħor fih pseudoephedrine.
Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours.
Desloratadine jintreħa mis- saff tiegħu immedjatament wara li jittieħed, waqt li pseudoephedrine huwa merħi bil- mod fuq 12- il siegħa.
This means that patients only need to take the tablet twice a day.
Dan ifisser li l- pazjenti jeħtieġu li jieħdu pillola darbtejn kuljum biss.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Desloratadine ilu jinstab fl- Unjoni Ewropea (UE) mill- 2001, u pseudoephedrine huwa użat qatiegħ għal bosta snin f’ mediċini li kienu jiġu mingħajr riċetta ta ’ tabib.
How has Aerinaze been studied?
Kif ġiet studjata Aerinaze?
The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
L- effikaċja ta ’ Aerinaze ġiet stmata f’ żewġ studji ewlenin li jinvolvu total ta ’ 1, 248- il pazjent adult u adolexxenti.
In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone.
Fiż- żewġ studji, Aerinaze kienet imqabbla ma ’ desloratidine waħdu u ma ’ pseudoephedrine waħdu.
The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment.
Il- miżuri ewlenin ta ’ l- effikaċja kienu l- bidla fil- qawwa tas- sintomi tal - hayfever irrapportati mill- pazjenti bejn qabel ma nbeda t- trattament, u matul il- 15- il jum kollha tat - trattament.
The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.
Il- pazjenti iddokumentaw is- sintomi tagħhom fi djarju kull 12- il siegħa waqt l- istudju, u skorjaw fuq skala standard ta ’ sintomi kemm kienu qawwija s- sintomi matul il- perijodu tat- 12- il siegħa ta ’ qabel.
What benefit has Aerinaze shown during the studies?
X’ benefiċċju wriet Aerinaze waqt l- istudji?
Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone.
Aerinaze kienet aktar effettiva fit- tnaqqis tas- sintomi minn jew wieħed jew l- ieħor mis- sustanzi attivi li jittieħdu waħidhom.
When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Meta tħares lejn is- sintomi kollha tal- hayfever ħlief għal konġestjoni nażali, pazjenti li ħadu Aerinaze irrapportaw tnaqqis fis- sintomi ta ’ 46. 0%, meta mqabbla ma ’ 35. 9% ta ’ dawk li ħadu pseudoephedrine waħdu.
When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Meta tħares lejn il- konġestjoni nażali, pazjenti li ħadu Aerinaze kellhom tnaqqis tas- sintomi ta ’ 37. 4%, meta imqabbla ma ’ 26. 7% ta ’ dawk li ħadu desloratidine waħdu.
Similar results were seen in the second study.
Fit- tieni studju, intwerew riżultati simili.
What is the risk associated with Aerinaze?
X’ inhu r- riskju assoċjat ma ’ Aerinaze?
The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
L- aktar effetti sekondarji komuni b’ Aerinaze (li dehru f’ madwar pazjent 1 u 10 f’ 100) kienu takikardja (rata mgħaġġla tal- qalb), ħalq xott, sturdament, attività psikomotorili eċċessiva (nuqqas ta ’ sabar), farinġite (uġigħ fil- ġrieżem), anoressja (telf fl- aptit), stitikezza, uġigħ ta ’ ras, għeja kbira, insomnja (diffikultà fl- irqad), somnolenza (ngħas), disturbi fl- irqad u nervożiżmu.
For the full list of all side effects reported with Aerinaze, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b ’ Aerinaze, ara l- Fuljett ta ’ Tagħrif.
Aerinaze should not be used in people who may be hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Aerinaze m’ għandhiex tintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal desloratidine, pseudoephedrine jew għal xi sustanza oħra tiegħu, għal mediċini adrenerġiċi jew għal loratidine (mediċina oħra wżata biex tittratta l- allerġiji).
It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks.
M’ għandhiex tintuża f’ nies li qed jieħdu impeditur ta ’ monoamine oxidase (bħal mediċini użati biex jittrattaw id- dipressjoni) jew li waqfu jieħdu xi waħda minn dawn il- mediċini matul l- aħħar ġimagħtejn.
Aerinaze should also not be taken by people who have narrow- angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Aerinaze m’ għandhiex tintuża minn nies bi glawkoma b’ angolu dejjaq (żieda fil- pressjoni ġol- għajn), żamma awrinarja (diffikultà fil- passaġġ ta ’ l- awrina), mard tal- qalb jew tal- vini u l- arterji inklużi pressjoni għolja, ipertirojdiżmu (glandola tirojde li taħdem ħafna) jew bi storja jew b’ riskju ta ’ puplesija emorraġika (puplesija ikkaġunata minn fsada ġol- moħħ).
Why has Aerinaze been approved?
Għal x’ hiex ġiet approvata Aerinaze?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze’ s benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Aerinaze huma akbar mir- riskji tagħha għat- trattament sintomatiku ta ’ rinite allerġika staġjonali meta akkompanjata minn konġestjoni nażali.
The Committee recommended that Aerinaze be given marketing authorisation.
Il- Kumitat irrikmanda li Aerinaze tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Aerinaze:
Aktar tagħrif dwar Aerinaze:
The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze to SP Europe on 30 July 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Aerinaze lil SP Europe fil- 30 ta ’ Lulju 2007.
The full EPAR for Aerinaze can be found here.
L- EPAR sħiħ għal Aerinaze jista ’ jinstab hawn.
Pharmaceutical Form
Folja (PCTFE/ PVC/ Alu)
Route of Administration
Folja (PCTFE/ PVC/ Alu)
Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet
Pillola li terħi il- mediċina b' mod modifikat
Oral use Oral use Oral use Oral use Oral use Oral use
Pillola li terħi il- mediċina b' mod modifikat
Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu)
Folja (PCTFE/ PVC/ Alu)
2 tablets 4 tablets 7 tablets 10 tablets 14 tablets 20 tablets
Pillola li terħi il- mediċina b' mod modifikat
∗ 2.5 mg desloratadine/ 120 mg pseudoephedrine sulphate
* 2. 5 mg desloratadine/ 120 mg pseudoephedrine sulphate
Aerinaze 2.5mg/ 120 mg modified-release tablets
Aerinaze 2. 5 mg/ 120 mg pilloli li jerħu l- mediċina b’ mod modifikat
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
Kull pillola fiha 2. 5 mg desloratadine u 120 mg pseudoephedrine (bħala sulphate).
Modified-release tablet.
Pillola li terħi l- mediċina b’ mod modifikat.
Blue and white bilayer oval tablet with “ D12” branded to blue layer.
Pillola ovali b’ żewġ saffi ċelesti u abjad b ’’ D 12 ’ immarkata fis- saff ċelesti.
Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Kura tas- sintomi ta ’ rajnajtis allerġiku ta ’ l- istaġun meta jkun hemm ukoll imnieħer imblukkat.
Adults and adolescents 12 years of age and over:
Adulti u adolexxenti minn 12- il sena ‘ l fuq:
The recommended dose of Aerinaze is one tablet twice a day.
Id- doża rakkomandata ta ’ Aerinaze hija pillola waħda darbtejn kuljum.
The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
Il- pillola tista ’ tittieħed ma ’ tazza mimlija bl- ilma u għandha tinbela kollha (mingħajr ma tigdimha, tifqagħha jew tomgħodha).
The tablet may be taken with or without food.
Il - pillola tista ’ tiħodha ma ’ l- ikel jew mingħajr ikel.
Aerinaze should not be used in children below the age of 12 years due to a lack of data on safety and efficacy (see section 5.1).
Aerinaze mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 12- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
It- tul tal- kura għandu jinżamm kemm jista ’ jkun qasir u m’ għandux jitkompla wara li s- sintomi jkunu għebu.
It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish.
Huwa rrakkomandat li l- kura tkun limitata għal 10 ijiem, peress li bl- għotja fit- tul l- attività ta ’ pseudoephedrine tista ’ tonqos.
After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary.
Wara li l- konġestjoni tal- mukużi tal- passaġġ tan- nifs tan- naħa ta ’ fuq, il- kura tista ’ tibqa għaddejja b’ desloratadine waħdu, jekk ikun hemm bżonn.
Hypersensitivity to the active substance, to any of the excipients, to adrenergic agents or to loratadine.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi, għal aġenti adrinerġiċi jew għal loratadine.
As Aerinaze contains pseudoephedrine, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Peress li Aerinaze fih pseudoephedrine, huwa kontra- indikat ukoll f’ pazjenti li qed jirċievu terapija b’ inibituri tal- monoamine oxidase (MAO) jew waqt l- ewwel ġimgħatejn wara li jwaqqfu dan it- tip ta ’ trattament.
Aerinaze is also contraindicated in patients with: • narrow-angle glaucoma, • urinary retention, • cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension, • hyperthyroidism,
Aerinaze huwa kontraindikat ukoll f’ pazjenti b ’: • glawkoma tat- tip narrow angle, • retenzjoni ta ’ l- awrina, • mard kardjuvaskulari bħal mard iskemiku tal- qalb, taki- arritmija u pressjoni għolja b’ mod sever, • ipertirojdiżmu, • b’ storja medika ta ’ puplesija emorraġika jew b’ fatturi ta ’ riskju li jistgħu jżidu r- riskju ta ’ puplesija emorraġika.
2 • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
2 ħalq kif ukoll mill- imnieħer (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline …).
Do not exceed the recommended dosage and the duration of treatment (see section 4.2).
Taqbiżx id- dużaġġ rakkomandat u t- tul tal- kura (ara sezzjoni 4. 2).
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine.
Pazjenti li għandhom ’ l fuq minn 60 sena għandhom aktar mnejn iħossu reazzjonijiet avversi minn prodotti mediċinali simpatomimetiċi, bħal pseudoephedrine.
The safety and efficacy of the combination have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Is- sigurtà u l- effikaċja tal- kombinazzjoni ma ġewx stabbiliti f’ din il- popolazzjoni, u m’ hemmx biżżejjed tagħrif sabiex ikunu jistgħu jingħataw rakkomandazzjonijiet xierqa fuq id- doża.
Therefore the combination product should be used with caution in patients above 60 years of age.
Għalhekk il- prodott kombinat għandu jintuża b’ kawtela f’ pazjenti li għandhom ’ l fuq minn 60 sena.
Renal or hepatic impairment:
Indeboliment renali jew epatiku:
The safety and efficacy of Aerinaze has not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Is- sigurtà u l- effikaċja ta ’ Aerinaze ma ġietx stabbilita f’ pazjenti li għandhom indeboliment tal- funzjoni renali jew epatika, u m’ hemmx biżżejjed data sabiex ikunu jistgħu jingħataw rakkomandazzjonijiet xierqa fuq id- doża.
The combination product is not recommended for use in patients with impaired renal or hepatic function.
Il- prodott kombinat mhux rakkomandat biex jintuża f’ pazjenti li għandhom indeboliment tal- funzjoni renali jew epatiku.
Aerinaze should not be used in children below the age of 12 years (see section 4.2).
Aerinaze m’ għandux jintuża fi tfal taħt it- 12- il sena (ara sezzjoni 4. 2).
Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache or increased headache).
Pazjenti għandhom ikunu infurmati li l- kura għandha titwaqqaf f’ każ ta ’ pressjoni għolja, takikardija, palpitazzjonijiet jew arritmiji kardijaċi, tqalligħ jew kwalunkwe sinjal newroloġiku ieħor (bħal uġigħ ta ’ ras jew żieda fl- uġigħ ta ’ ras).
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Stimulazzjoni tas- sistema nervuża centrali b’ aċċessjonijiet jew kollass kardjovaskulari flimkien ma ’ pressjoni baxxa tista ’ tiġi kkawżata minn amines simpatomimetiċi.
These effects may be more likely to occur in children, elderly patients, or in cases of overdose (see section 4.9).
Dawn l- effetti jistgħu x’ aktarx iseħħu l- aktar fi tfal, pazjenti anzjani jew f’ każijiet ta ’ dożi eċċessivi (ara sezzjoni 4. 9).
Caution should be exercised in the following patient groups: • Patients receiving digitalis • Patients with cardiac arrhythmias • Patients with hypertension • Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm.
Għandu jkun hemm kawtela f’ dawn il- gruppi ta ’ pazjenti: • Pazjenti li jkunu qed jirċievu diġitalis • Pazjenti b’ arritmiji kardijaċi • Pazjenti bi pressjoni għolja • Pazjenti li fil- passat kellhom infart mijokardijaku, dijabete mellitus, l- għonq tal- bużżieqa ta ’ l - awrina mblukkat, jew anamneżi pożittiva tal- bronkospażmu.
Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of the vesical cervix.
Uża b’ kawtela f’ pazjenti b’ ulċera fl- istonku bi stenożi, imblukkar tal- piloru- duwodenu, u imblukkar taċ- ċerviċi vessikali.
Caution should also be exercised in patients being treated with other sympathomimetics.
Għandu jkun hemm kawtela wkoll f’ pazjenti li jkunu qed jiġu kkurati b’ simpatomimetiċi oħra.
These include: • decongestants • anorexogenics or amphetamine-type psychostimulants • antihypertensive agents • tricyclic antidepressants and other antihistamines.
Dawn jinkludu • dikonġestjonanti • anoressoġeniċi jew psiko- stimulanti tat- tip amphetamine • aġenti kontra l- pressjoni għolja • anti- dipressanti triċikliċi u anti- histaminiċi oħrajn.
Caution should be exercised in patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors.
Għandu jkun hemm kawtela f’ pazjenti li jbatu minn emikranja li jkunu qed jiġu kkurati b’ vażikostritturi tat- tip ergot alkalojd.
Pseudoephedrine sulphate carries the risk of abuse.
Pseudoephedrine sulphate jista ’ jiġi abbużat.
Increased doses may ultimately produce toxicity.
Dożi aktar għoljin jistgħu jikkawżaw tossiċità.
Continuous use can lead to tolerance resulting in an increased risk of overdosing.
L- użu kontinwu jista ’ jwassal għal tolleranza li tirriżulta f’ riskju akbar ta ’ doża eċċessiva.
Depression may follow rapid withdrawal.
Jista ’ jkun hemm dipressjoni jekk jitwaqqaf f’ daqqa.
3 Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Pressjoni għolja peri- operattiva tista ’ sseħħ jekk anestetiċi aloġenati volatili fl- arja jintużaw waqt il - kura b’ aġenti simpatomimetiċi indiretti.
Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Għalhekk jekk ikun hemm skedat li ssir operazzjoni, ikun aħjar jekk il- kura titwaqqaf 24 siegħa qabel il- loppju.
Athletes should be informed that treatment with pseudoephedrine could lead to positive doping tests.
L- atleti għandhom jiġu avżati li l- kura b’ pseudephedrine tista ’ twassal għal testijiet doping pożittivi.
The administration of Aerinaze should be discontinued at least 48 hours before skin tests since antihistamines maybe prevent or reduce other wise positive reaction to dermal reactivity index.
3 L- għotja ta ’ Aerinaze għandha titwaqqaf mill- anqas 48 siegħa qabel testijiet tal- ġilda peress li anti - histaminiċi jistgħu jwaqqfu jew jnaqqsu r- reazzjoni għall- indiċi ta ’ reattività tal- ġilda f’ każ li jkollu jiġi pożittiv.
No interaction studies have been performed.
Ma sarux studji dwar interazzjonijiet.
However, no clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered.
Madankollu, ma dehrux interazzjonijiet klinikament rilevanti jew bidliet tal- konċentrazzjonijiet ta ’ desloratadine fil- plażma fi provi kliniċi b’ desloratadine mogħti ma ’ erythromycin jew ketoconazole fliemkien.
Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood pressure.
Inibituri MAO riversibbli u irriversibbli jistgħu jikkawżaw: riskju ta ’ vażokostrizzjoni u żieda fil - pressjoni tad- demm.
Concurrent administration with sympathomimetic medicines may result in critical hypertension reactions.
L- użu fl- istess ħin ma ’ mediċini simpatomimetiċi jista ’ jirriżulta f’ każijiet kritiċi ta ’ pressjoni għolja.
The following combinations are not recommended: • bromocriptine • cabergoline • lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Il- kombinazzjonijiet li ġejjin mhumiex rakkomandati: • Bromocriptine • cabergoline • lisuride, pergolide: riskju ta ’ vażokostrizzjoni u żieda fil- pressjoni tad- demm.
Dihydroergotamine, ergotamine, methylergometrine: risk of vasoconstriction and increase in blood pressure.
Dihydroergotamine, ergotamine, methylergometrine: riskju ta ’ vażokostrizzjoni u żieda fil- pressjoni tad- demm.
Other vasoconstrictors used as nasal decongestant, by oral or nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…): risk of vasoconstriction.
Vażokostritturi oħrajn li jintużaw bħala dikonġestjonanti għall- imnieħer, li jittieħdu mill- ħalq jew mill- imnieħer (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline …): riskju ta ’ vażokostrizzjoni.
Sympathomimetic medicines reduce the antihypertensive effect of α -methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine.
Mediċini simpatomimetiċi jnaqqsu l- effett kontra l- pressjoni għolja ta ’ α- methyldopa, mecamylamine, reserpine, veratrum alkaloids, u guanethidine.
Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.
Antaċidi jżidu r- rata ta ’ assorbiment ta ’ pseudoephedrine sulphate, kaolin jnaqqasha.
The interaction with Aerinaze and alcohol has not been studied.
L- interazzjoni bejn Aerinaze u alkoħol ma ġietx studjata.
However, in a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Madankollu, fi prova farmakoloġika meta desloratadine ittieħed ma ’ l- alkoħol ma kienx hemm żieda fl- effetti li jxekklu l- ħila li jkollu l- alkoħol.
No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Ma nstabux differenzi fir- riżultati tat- testijiet psikomotriċi bejn desloratadine u gruppi fuq placebo, kemm mogħtija waħidhom kif ukoll ma ’ l- alkoħol.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded.
L- enzima responsabbli għall- metaboliżmu ta ’ desloratadine għada ma ġietx identifikata, u għalhekk, xi interazzjonijiet ma ’ prodotti mediċinali oħrajn ma tistax tiġi eskluża għal kollox.
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Desloratadine ma jinibixxix CYP3A4 in vivo, u studji in vitro wrew li l- prodott mediċinali ma jinibixxix CYP2D6 u la huwa sottostrat u lanqas jinibixxi l- glikoproteina- P.
Neither desloratadine nor the combination of loratadine and pseudoephedrine were teratogenic in animal studies.
La desloratadine lanqas il- kombinazzjoni ta ’ loratadine u pseudoephedrine ma kienu teratoġeniċi fi studji bl- annimali.