qanastek/EMEA-V3 huggingface dataset:
Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide solution and hydrochloric acid solution
Fih ukoll mannitol, disodium edetate, sodium citrate, citric acid monohydrate, ilma għall - injezzjonijiet, soluzzjoni ta ’ sodium hydroxide u soluzzjoni ta ’ hydrochloric acid
1 vial - 5 ml
1 fjala - 5 ml
For intravenous use Single use only Any unused solution should be discarded
Użu għal ġol- vini Jintuża darba biss Kwalunkwe soluzzjoni mhux użata għandha tintrema
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ 11.
Lot xxxxxxxx
Lott xxxxxxxx
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING:
INFORMAZZJONI BIL- BRAILLE
Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride) IV use
Aloxi250 mikrogramma soluzzjoni għall- injezzjoni Palonosetron (bħala hydrochloride) Użu għal ġol- vina
• If you have further questions, please ask your doctor or your pharmacist.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
• This medicine has been prescribed for you.
M’ għandekx tgħaddiha lil persuni oħra.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
What Aloxi is and what it is used for.
X’ inhu Aloxi u għalxiex jintuża.
Before you use Aloxi.
Qabel ma tuża Aloxi.
How to use Aloxi.
Kif għandek tuża Aloxi.
Possible side effects.
Effetti sekondarji li jista ’ jkollu.
5 How to store Aloxi.
5 Kif taħżen Aloxi.
Further information.
Aktar tagħrif.
WHAT ALOXI IS AND WHAT IT IS USED FOR
X’ INHU ALOXI U GĦALXIEX JINTUŻA
• Aloxi is a clear colourless solution for injection into a vein. • The active ingredient (palonosetron) belongs to a group of medicines known as serotonin (5HT3) antagonists. • These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting. • Aloxi is used for the prevention of nausea and vomiting associated with cancer chemotherapy.
• Aloxi hu soluzzjoni ċara u bla kulur għall- injezzjoni ġo vina. • Is- sustanza attiva (palonosetron) hija waħda mill- grupp ta ’ mediċini magħrufa bħala antagonisti (5HT3) ta ’ serotonin. • Dawn għandhom il- ħila li jimblukkaw l- azzjoni tal- kimika msejħa serotonin, li jista ’ jikkawża dardir u rimettar. • Aloxi jintuża għall- prevenzjoni ta ’ dardir u rimettar marbuta mal- kemoterapija tal- kanċer.
BEFORE YOU USE ALOXI
QABEL MA TUŻA ALOXI
Do not take Aloxi:
Tieħux Aloxi:
- If you are allergic to the active ingredient, palonosetron or any of the other ingredients of Aloxi.
- Jekk inti allerġiku/ a għas- sustanza attiva, għal palonosetron jew sustanzi oħra ta ’ Aloxi.
Take special care with Aloxi:
Oqgħod attent ħafna b’ Aloxi:
- If you have acute bowel obstruction or a history of repeated constipation.
- Jekk għandek ostruzzjoni akuta fl- imsaren jew storja medika ta ’ stitikezza ripetuta.
- If you are taking Aloxi in addition to other medicines that may induce an abnormal heart
- Jekk qed tieħu Aloxi flimkien ma ’ mediċini oħrajn li jistgħu jikkaġunaw ritmu ta ’ taħbit tal- qalb
rhythm.
mhux floku.
- If you have a personal or family history of QT prolongation.
- Jekk għandek storja medika personali jew fil- familja ta ’ QT itwal milli suppost.
Pregnancy If you are pregnant or think you might be, your doctor will not use Aloxi unless it is clearly necessary.
Tqala Jekk inti tqila jew taħseb li tista ’ tkun tqila, it- tabib tiegħek mhux ser juża Aloxi ħlief jekk dan ikun meħtieġ b’ mod ċar.
19 It is not known whether Aloxi will cause any harmful effects when used during pregnancy.
20 Mhux magħruf jekk Aloxi jikkawżax xi effetti li jagħmlu ħsara meta jintuża matul it- tqala.
You should always ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be.
Għandek dejjem tistaqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel ma tuża kwalunkwe mediċina jekk inti tqila jew taħseb li tista ’ tkun tqila.
Breast-feeding It is not known if Aloxi is found in breast milk.
Treddigħ Mhux magħruf jekk Aloxi joħroġx fil- ħalib tas- sider.
You should ask your doctor or pharmacist for advice before using Aloxi if you are breast-feeding.
Għandek tistaqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel tuża Aloxi jekk qed tredda ’.
Driving and using machines Aloxi may cause dizziness or tiredness.
Sewqan u tħaddim ta ’ magni Aloxi jista ’ jikkawża sturdament jew għeja.
If affected, do not drive or operate machines.
Jekk jiġrilek hekk, issuqx u tħaddimx magni.
HOW TO USE ALOXI
KIF JINTUŻA ALOXI
A doctor or nurse will normally inject Aloxi about 30 minutes before the start of chemotherapy.
Tabib jew ners normalment għandhom jinjettaw Aloxi madwar 30 minuta qabel il- bidu tal - kemoterapija.
The usual dose of Aloxi is 250 micrograms given as a rapid injection into a vein.
Id- doża normali ta ’ Aloxi hi ta ’ 250 mikrogramma mogħtija bħala injezzjoni mgħaġġla fil- vina.
Like all medicines, Aloxi can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aloxi jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
The most common side effects are: headache, dizziness, constipation and diarrhoea.
L- iktar effetti sekondarji komuni huma: uġigħ ta ’ ras, sturdament, stitikezza u dijarea.
Between 1 and 10 out of every 100 patients will experience these side effects.
Bejn 1 u 10 minn kull 100 pazjent ser ikollhom dawn l- effetti sekondarji.
Other uncommon side effects are: high or low blood pressure abnormal heart rate or lack of blood flow to the heart discolouration or widening of the veins abnormally high or low levels of potassium in the blood high levels of sugar in the blood or sugar in the urine low levels of calcium in the blood high levels of the pigment bilirubin in the blood high levels of certain liver enzymes elevated moods or feelings of anxiousness sleepiness or trouble sleeping decrease or loss of appetite weakness, tiredness, fever or flu like symptoms numbness, burning, prickling or tingling sensations on the skin itchy skin rash impaired vision or eye irritation motion sickness ringing in the ear hiccups, flatulence, dry mouth or indigestion, abdominal (stomach) pain difficulty urinating joint pain electrocardiogram abnormalities (QT prolongation)
Effetti sekondarji mhux komuni huma: pressjoni tad- demm għolja jew baxxa rata anormali ta ’ taħbit tal- qalb jew nuqqas ta ’ influss ta ’ demm fil- qalb tibdil fil- kulur jew twessigħ tal- vini ikun hemm livelli għolja jew baxxi b’ mod anormali ta ’ potassium fid- demm livelli għolja ta ’ zokkor fid- demm jew zokkor fl- awrina livelli baxxi ta ’ calcium fid- demm livelli għolja tal- bilirubina fid- demm, li għandha kulur safrani livelli għolja ta ’ ċerti enzimi tal- fwied burdati ta ’ ferħ jew tħossok anzjuż/ a irqad żejjed jew problemi biex torqod tnaqqis jew telf tal- aptit dgħjufija, għeja, deni jew sintomi bħal tal- influwenza. tmewwit, ħruq, tingiż jew sensazzjonijiet ta ’ tnemnim tal- ġilda raxx bil- ħakk fil- ġilda indeboliment tal- vista jew irritazzjoni tal- għajnejn dardir waqt il- moviment/ ivvjaġġar tisfir fil- widnejn sulluzzu, gass, ħalq xott jew indiġestjoni, uġigħ ta ’ żaqq (tal- istonku) diffikultà meta tagħmel l- awrina uġigħ fil- gogi anormalitajiet tal- elettrokardjogramm (titwil tal- QT)
Between 1 and 10 out of every 1,000 patients will experience these side effects.
Bejn 1 u 10 minn kull 1, 000 pazjent ser ikollhom dawn l- effetti sekondarji.
In some very rare cases, patients have experienced allergic reactions to Aloxi, or burning or pain at the site of injection.
F’ xi każi rari ħafna, il- pazjenti kellhom reazzjonijiet allerġiċi għal Aloxi, jew ħruq jew uġigħ fis- sit tal- injezzjoni.
20 If you notice any side effects not mentioned in this leaflet, please tell your doctor..
21 Jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ALOXI
KIF TAĦŻEN ALOXI
This medicinal product does not require any special storage conditions Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Single use only, any unused solution should be disposed of..
Jintuża darba biss; kwalunkwe soluzzjoni mhux użata għandha tintrema.
6 FURTHER INFORMATION
6 GĦAL AKTAR TAGĦRIF
What Aloxi contains:
X’ fih Aloxi:
- The active substance is palonosetron (as hydrochloride).
- Is- sustanza attiva hi palonosetron (bħala hydrochloride).
One ml of solution contains 50 micrograms palonosetron.
1 ml ta ’ soluzzjoni fih 50 mikrogramma ta ’ palonosetron.
Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Kull kunjett ta ’ 5 ml ta ’ soluzzjoni fih 250 mikrogramma ta ’ palonosetron.
- The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate,
- Is- sustanzi l- oħra huma mannitol, disodium edetate, sodium citrate, citric acid monohydrate, u
and water for injections, sodium hydroxide solution and hydrochloric acid solution.
ilma għall- injezzjonijiet, soluzzjoni ta ’ sodium hydroxide u soluzzjoni ta ’ hydrochloric acid.
What Aloxi looks like and the contents of the pack Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one glass vial, which contains 5 ml of the solution.
Id- dehra ta ’ Aloxi u l- kontenuti tal- pakkett Is- soluzzjoni għall- injezzjoni ta ’ Aloxi hi ċara u bla kulur u hi fornuta f’ pakkett ta ’ kunjett wieħed tal - ħġieġ, li jkun fih 5 ml tas- soluzzjoni.
Each vial contains one dose.
Kull kunjett fih doża waħda.
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland.
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, l- Irlanda.
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 agħmel kuntatt mar - rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Danmark Biovitrum AB (publ) Næsseslottet
Danmark Biovitrum AB (publ) Næsseslottet
Damastown, Mulhuddart
Damastown, Mulhuddart
21 Dronninggårds Allé 136 DK-2840 Holte Tlf: + 46 8 697 2000
22
IRL-Dublin 15 Tel: + 353 1 822 5404
Dronninggårds Allé 136 Tel: + 353 1 822 5404 DK- 2840 Holte Tlf: + 46 8 697 2000
Österreich CSC Pharmaceuticals Handels GmbH Gewerbegebiet Klein-Engersdorf Gewerbestr.18-20 A-2102 Bisamberg Tel: + 43 (0)2262 606
Polska Ελλάδα Medagro International Sp. z o. o.
Ελλάδα Galenica A. E.
Łazy, ul.
Αχιλλέως 2 GR-104 37 Αθήνα Τηλ: + 30 210 52 81 700
Podleśna 83 Αχιλλέως 2 PL- 05- 552 Wólka Kosowska GR- 104 37 Αθήνα Tel: + 48 (22) 702 8200 Τηλ: + 30 210 52 81 700
Polska Medagro International Sp. z o. o.
Portugal España Angelini Farmacêutica, Lda.
Ł azy, ul.
Italfarmaco S. A.
Tel: + 39 02 64432500
Κύπρος Galenica A. E.
Puh/ Tel: + 46 8 697 2000
Sverige Biovitrum AB (publ)
Sverige Biovitrum AB (publ) Berzelius väg 8 S-112 76 Stockholm Tel: + 46 8 697 2000
23 Berzelius väg 8 S- 112 76 Stockholm Tel: + 46 8 697 2000
This leaflet was last approved on:
Dan il- fuljett kien approvat l- aħħar f ’
London, 28 June 2006 Doc.
Londra, 28 ta ’ Ġunju 2006 Dok.
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING APPLICATION for ALPHEON
MISTOQSIJIET U TWEĠIBIET DWAR IR- RAKKOMANDAZZJONI GĦAL RIFJUT TA ’ APPLIKAZZJONI GĦAT- TQEGĦID FIS- SUQ għal ALPHEON
International Non-proprietary Name (INN): interferon alfa-2a
Denominazzjoni Komuni Internazzjonali (INN - Internatinal Non- proproetary Name): interferon alfa- 2a
On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alpheon 6 million IU/ ml solution for injection intended for the treatment of hepatitis C.
Fit- 28 ta ’ Ġunju 2006, il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) adotta opinjoni negattiva, u rrikmanda r- rifjut ta ’ l- awtorizzazzjoni tat- tqegħid fis- suq għall- prodott mediċinali Alpheon 6 miljun IU/ ml soluzzjoni għal injezzjoni maħsuba għat- trattament ta ’ l- epatite Ċ.
The company that applied for authorisation is BioPartners GmbH.
Il- kumpanija li applikat għall- awtorizzazzjoni hija BioPartners GmbH.
They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Jistgħu jitolbu ri - eżaminazzjoni ta ’ l- opinjoni fi żmien 15- il jum minn meta jirċievu n- notifika ta ’ din l- opinjoni negattiva.
What is Alpheon?
X’ inhu Alpheon?
Alpheon is a solution for injection that contains the active substance interferon alfa-2a.
Alpheon huwa soluzzjoni għal injezzjoni li fiha s- sustanza attiva interferon alfa- 2a.
Alpheon was developed as a ‘ biosimilar’ medicine.
Alpheon ġie żviluppat bħala mediċina ‘ bijosimili ’.
This means that Alpheon was intended to be similar to a biological medicine already authorised in the EU which contains the same active substance (also known as the ‘ reference medicine’), Roferon-A.
Dan ifisser li Alpheon kien maħsub sabiex ikun simili għal mediċina bijoloġika diġà awtorizzata fl- UE li fiha l- istess sustanza attiva (magħrufa wkoll bħala l - ‘ mediċina ta ’ referenza ’), Roferon- A.
What was Alpheon expected to be used for?
Għal x’ hiex kien mistenni li jintuża Alpheon?
Alpheon was expected to be used to treat adult patients who have chronic (long-term) hepatitis C (a disease of the liver due to an infection by a virus).
Alpheon kien mistenni li jintuża sabiex jikkura pazjenti adulti li għandhom epatite Ċ kronika (fuq perjodu ta ’ żmien) (marda tal- fwied dovuta għal infezzjoni b’ virus).
The patients must have signs of liver damage: their liver tissues show some damage when observed with a microscope, and they have higher than normal levels of a liver enzyme (ALT) in their blood.
Il- pazjenti għandu jkollhom sinjali ta ’ ħsara tal- fwied: it- tessut tal- fwied tagħhom juri xi ħsara meta osservat b’ mikroskopju, u huma għandhom livelli ogħla min- normal ta ’ enzim tal- fwied (ALT) fid- demm.
They must also show signs of being infected by the hepatitis C virus.
Għandhom juru wkoll sinjali li huma infettati bil- virus ta ’ l- epatite Ċ.
Alpheon was to be used with an antiviral medicine, ribavirin, except when patients could not take ribavirin.
Alpheon kellu jintuża b’ mediċina antivirali, ribavirin, għajr meta l- pazjenti ma setgħux jieħdu ribavirin.
How is Alpheon expected to work?
Kif inhu mistenni li jaħdem Alpheon?
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferons huma sustanzi naturali prodotti mill- ġisem sabiex jgħinuh jiġġieled kontra attakki bħal infezzjonijiet ikkawżati minn virusijiet.
The interferon in Alpheon, interferon alfa-2a, is made by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA) that makes it able to produce it.
Interferon f’ Alpheon, interferon alfa- 2a, huwa magħmul b’ metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: huwa magħmul minn ħmira li rċeviet gene (DNA) li jagħmilha possibbli li jipproduċiha.
What documentation has been presented by the company to support the application to the CHMP?
X’ dokumentazzjoni ġiet ippreżentata mill- kumpanija sabiex tiġi appoġġjata l- applikazzjoni għand il- CHMP?
The company that makes Alpheon presented information showing that Alpheon had been compared to Roferon-A (structure of the active substance, composition and purity of the medicine, the way it works, safety and effectiveness in hepatitis C).
Il- kumpanija li tagħmel Alpheon ippreżentat informazzjoni li Alpheon tqabbel ma ’ Roferon- A (struttura tas- sustanza attiva, kompożizzjoni u purità tal- mediċina, il- mod kif taħdem, is- sigurtà u l - effikaċja kontra l- epatite Ċ).
The study in patients with hepatitis C compared the efficacy of Alpheon with that of the reference medicine in 455 patients.
L- istudju f’ pazjenti bl- epatite Ċ qabbel l- effikaċja ta ’ Alpheon ma ’ dik tal- mediċina ta ’ referenza f’ 455 pazjent.
The study measured how many patients responded (no sign of virus in their blood) after 12 out of the 48 weeks of treatment and 6 months after stopping treatment.
L- istudju kejjel kemm pazjenti kellhom rispons (ebda sinjal ta ’ virus fid- demm tagħhom) wara 12- il ġimgħa minn 48 ġimgħa ta ’ trattament u wara 6 xhur minn meta twaqqfet il- kura.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns which led the CHMP to recommend the refusal of the marketing authorisation?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ kien it- tħassib ewlieni li wassal sabiex il- CHMP jirrikmanda r- rifjut ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq?
The CHMP had major concerns regarding the comparability of Alpheon and Roferon-A, because of differences identified between the two medicines (such as impurities).
Il- CHMP kellu tħassib ewlieni fir- rigward tal- komparabbiltà ta ’ Alpheon u oferon- A, minħabba d - differenzi identifikati bejn iż- żewġ mediċini (bħal impuritajiet).
They also had concerns that there was not enough data on the stability of the active substance and of the medicine that was going to be marketed.
Kellhom tħassib ukoll li ma kienx hemm biżżejjed informazzjoni fuq l- istabbiltà tas- sustanzi attivi u tal- mediċina li kienet se titpoġġa fis- suq.
Also, the process used for making the finished medicine had not been adequately validated.
Barra minn hekk, il- proċess użat għall- għemil tal- mediċina l- ġdida ma kienx ġie vvalidat b’ mod adegwat.
The number of patients with hepatitis C responding to treatment with Alpheon and Roferon-A was similar in the clinical study.
In- numru ta ’ pazjenti b’ epatite Ċ li kellhom rispons għall- kura b’ Alpheon u Roferon- A kien simili fl - istudju kliniku.
However, some differences were seen between the two medicines: more patients experienced a return of the disease after treatment with Alpheon was stopped than with the reference medicine, and there were more side effects with Alpheon.
Madankollu, ġew osservati xi differenzi bejn iż- żewġ mediċini: aktar pazjenti esperjenzaw il- feġġa mill- ġdid tal- marda wara li l- kura b’ Alpheon twaqqfet milli bil- mediċina ta ’ referenza, u kien hemm aktar effetti sekondarji b’ Alpheon.
In addition, the test used in the study to investigate the potential for the medicine to trigger an immunological response (when the body makes special proteins, called antibodies, against the medicine) had not been sufficiently validated.
Barra minn hekk, it- test użat fl- istudju għall- investigazzjoni tal- potenzjal li l- mediċina tista ’ toħloq rispons immunoloġiku (meta l- ġisem jagħmel proteini speċjali, imsejħa antikorpi, kontra l- mediċina) ma ġiex ivvalidat biżżejjed.
At this point in time, the CHMP was of the opinion that Alpheon could not be considered as a biosimilar medicine of Roferon-A, the reference medicinal product.
F’ dan iż- żmien, il- CHMP kien ta ’ l- opinjoni li Alpheon ma setax jiġi kkunsidrat bħala mediċina bijosimili ta ’ Roferon- A, il- prodott mediċinali ta ’ referenza.
Hence, the CHMP recommended that Alpheon be refused marketing authorisation.
Għaldaqstant, il- CHMP irrikmanda li Alpheon ma jingħatax l- awtorizzazzjoni għat- tqegħid fis- suq.
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Alpheon?
X’ inhuma l- konsegwenza tar- rifjut għal pazjenti li jkunu qegħdin jagħmlu provi kliniċi/ programm ta ’ użu ta ’ kompassjoni b’ Alpheon?
There are no ongoing clinical trials or compassionate use programmes with Alpheon in the European Union.
M’ hemm ebda provi kliniċi jew użu ta ’ kompassjoni għaddejjin b’ Alpheon fl- Unjoni Ewropea.
What is Altargo?
X’ inhu Altargo?
Altargo is an ointment that contains the active substance retapamulin.
Altargo hu ingwent li fih is- sustanza attiva retapamulin.
What is Altargo used for?
Għal x’ hiex jintuża Altargo?
Altargo is an antibiotic medicine.
Altargo hu mediċina antibijotika.
It is used for short-term treatment of superficial skin infections.
Jintuża għat- trattament immedjat ta ’ infezzjonijiet superfiċjali tal - ġilda.
It can be used to treat impetigo (a skin infection causing crusting scabs), and small infected lacerations (cuts), abrasions (grazes) and wounds that have been sutured (stitched).
Jista ’ jintuża fit- trattament ta ’ l- impetiġini (infezzjoni fil- ġilda li twassal għall- formazzjoni ta ’ qxur), u ta ’ laċerazzjonijiet (qatgħat), barxiet u feriti meħjuta iffjammati.
Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection.
Altargo m’ għandux jintuża fit- trattament ta ’ infezzjonijiet li jkun magħruf jew maħsub li ġew ikkawżati minn methicillin- resistant Staphylococcus aureus (MRSA), għax jista ’ ma jaħdimx fuq din it- tip ta ’ infezzjoni.
However, it may be used to treat infections caused by other types of Staphylococcus aureus.
Madankollu, Altargo jista ’ jintuża fit- trattament ta ’ infezzjonijiet ikkawżati minn tipi oħra ta ’ Staphylococcus aureus.
Prescribers should consider official guidance on the use of antibacterial agents.
Min jippreskrivi din il- mediċina għandu jikkunsidra l- gwida uffiċjali fuq l- użu ta ’ l- aġenti antibatteriċi.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta medika.
How is Altargo used?
Kif jintuża Altargo?
Altargo should only be used on the skin.
Altargo għandu jintuża biss fuq il- ġilda.
It is applied onto the affected area as a thin layer twice a day for five days.
Għandu jiġi midluk f’ saff irqiq fuq il- parti tal- ġilda affettwata darbtejn kuljum għal ħamest ijiem.
The treated area can be covered with a sterile bandage or gauze dressing.
Il- parti affettwata tista ’ titgħatta b’ medikazzjoni bil- garża jew b’ faxxa sterili.
Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body’ s surface.
Altargo jista ’ jintuża f’ pazjenti li jkollhom iktar minn disa ’ xhur, iżda f’ pazjenti li jkollhom inqas minn 18- il sena, il- parti ttrattata ma tridx tkun ikbar minn 2% tas- superfiċje tal- ġisem.
If there is no response to treatment after two to three days, doctors should re-evaluate the patient and consider alternative treatments.
Jekk ma jkunx hemm rispons wara jumejn jew tliet ijiem, it- tobba għandhom jevalwaw mill- ġdid il - pazjent u jikkunsidraw trattamenti alternattivi.
How does Altargo work?
Kif jaħdem Altargo?
The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘ pleuromutilin’ class.
Is- sustanza attiva f’ Altargo, retapamulin, hija antibijotiku fil- klassi tal - ‘ pleuromutilin ’.
It is derived from a compound produced by certain types of fungus.
Hija derivata minn kompost prodott minn ċerti tipi ta ’ fungi.
It works by blocking the bacteria’ s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Taħdem billi timblokka r- ribożomi tal- batterji (il- parti taċ- ċelloli li fihom jiġu manifatturati l- proteini), u b’ hekk trażżan it- tkabbir tal- batterji.
The full list of bacteria against which Altargo is active can be found in the Summary of Product Characteristics.
Il- lista sħiħa ta ’ batterji li fuqhom jaħdem Altargo hi waħda attiva u tinsab fis- Sommarju tal- Karatteristiċi tal - Prodott.
How has Altargo been studied?
Kif ġie studjat Altargo?
The effects of Altargo were first tested in experimental models before being studied in humans.
L- effetti ta ’ Altargo ġew studjati f’ mudelli esperimentali qabel ma ġew studjati fin- nies.
Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards.
Altargo ġie studjat f’ ħames studji ewlenin li fihom ħadu sehem iktar minn 3, 000 pazjent li kellhom 9 xhur jew iktar.
Two studies were carried out in patients with impetigo.
Saru żewġ studji fuq pazjenti b’ impetiġini.
The other three studies 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- ewwel wieħed qabbel l- effett ta ’ ħamest 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 compared the effects of five days’ treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation).
(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 ijiem trattament permezz ta ’ l- Altrago ma ’ dawk ta ’ plaċebo (trattament fint) fuq 213 pazjent, u t- tieni wieħed qabbel Altrago ma ’ fusidic acid (ingwent antibijotiku ieħor) f’ 519- il pazjent.
In all five studies, the main measure of effectiveness was the proportion of patients whose infections had cleared up after the end of treatment.
Fil - ħames studji, il- mezz ewlieni tal- kejl ta ’ l- effettività kien il- proporzjon ta ’ pazjenti li marritilhom l - infezzjoni wara tmiem it- trattament.
What benefit has Altargo shown during the studies?
X’ benefiċċji ta ’ Altargo irriżultaw f’ dawn l- istudji?
In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment.
F’ pazjenti bl- impetiġini, Altargo kien iktar effettiv mill- plaċebo, b’ 119 (85. 6%) mill- 139 pazjent li użaw Altargo u 37 (52. 1%) tal- 71 pazjent li użaw il- plaċebo jirrispondu għat- trattament.
Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment.
Altrago kien effettiv daqs il- fusidic acid ukoll, b’ 314 (99. 1%) mit- 317- il pazjent u 141 (94. 0%) mill- 150 pazjent, rispettivament, jirrispondu għat- trattament.
For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment.
Għat- trattament ta ’ feriti infettati fil- ġilda, Altargo u cefalexin kellhom rati simili ta ’ rispons: meta r- riżultati taż- żewġ studji tal- feriti fil- ġilda ttieħdu flimkien, madwar 90% taż- żewġ gruppi ta ’ pazjenti kellhom rispons għat- trattament.
However, these two studies found that Altargo was not sufficiently effective in the treatment of abscesses (cavities containing pus) or of infections known or likely to be caused by MRSA.
Madankollu, iż - żewġ studji sabu li Altargo ma kienx effettiv biżżejjed fit- trattament ta ’ l- axxessi (ħofor bil- materja) jew ta ’ infezzjonijiet ikkawżati mill- MRSA.
The data presented were insufficient to support the use of Altargo in the treatment of infected dermatitis.
Id- dejta ppreżentata ma kinitx biżżejjed biex turi li l- użu ta ’ Altargo hu effettiv għat- trattament tad - dermatite infettata.
What is the risk associated with Altargo?
X’ inhu r- riskju ta ’ Altargo?
The most common side effect with Altargo (seen in between 1 and 10 patients in 100) is irritation at the site of application.
L- iktar effett sekondarju komuni ta ’ Altargo (li deher f’ bejn wieħed u għaxar pazjenti minn kull 100) hu l- irritazzjoni fil- post ta ’ l- applikazzjoni.
For the full list of all side effects reported with Altargo, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Altargo, ara l- Fuljett ta ’ Tagħrif.
Altargo should not be used in people who may be hypersensitive (allergic) to retapamulin or any of the other ingredients.
Altargo m’ għandux jintuża minn persuni allerġiċi għal retapamulin jew għal xi sustanzi oħra tiegħu.
Why has Altargo been approved?
Għaliex ġie approvat Altargo?
The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo’ s benefits are greater than its risks for the short term treatment of the following superficial skin infections: • impetigo, • infected small lacerations, abrasions or sutured wounds.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Altargo huma ikbar mir- riskji meta wżat għat- trattament immedjat ta ’ dawn l- infezzjonijiet superfiċjali tal- ġilda: • l- impetiġini, • laċerazzjonijiet, barxiet jew feriti meħjuta infettati.
The Committee recommended that Altargo be given marketing authorisation.
Il- Kumitat irrakkomanda li Altargo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Altargo:
Tagħrif ieħor dwar Altargo:
The European Commission granted a marketing authorisation valid throughout the European Union for Altargo to Glaxo Group Ltd on 24 May 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal Altargo lil Glaxo Group Ltd fit- 24 ta ’ Mejju 2007.
The full EPAR for Altargo can be found here.
L- EPAR sħiħ dwar Altargo jista ’ jinstab hawnhekk.
This summary was last updated in 07-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 07- 2007.
EMEA Procedure number
In- numru tal- Proċedura ta ’ l - EMEA
Route of administration Packaging
Mnejn jingħata
Content
Il- Pakkett
Package size
Il- kontenut
Ointment Ointment Ointment Ointment
Ingwent Ingwent Ingwent Ingwent
Cutaneous use Sachet (alu) Cutaneous use Tube (alu) Cutaneous use Tube (alu) Cutaneous use Tube (alu)
Borża żgħira (alu) Tubu (alu) Tubu (alu) Tubu (alu)
12 sachets 1 tube 1 tube 1 tube
12- il borża żgħira tubu 1 tubu 1 tubu 1
Altargo 1% ointment
Ingwent 1% Altargo
For a full list of excipients, see section 6.1.
1 g ta ’ Altargo fiha 10 mg retapamulin (1% w/ w) Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Ointment
Ingwent
Smooth, off-white ointment.
Ingwent lixx, bajdani
Short term treatment of the following superficial skin infections:
Trattament fuq medda qasira ta ’ l- infezzjonijiet superfiċjali fil- ġilda li ġejjin:
Impetigo.
Impetigo
Infected small lacerations, abrasions, or sutured wounds.
Tiċrit żgħir, brix, jew feriti suturati nfettati.
See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Ara s- sezzjonijiet 4. 4 u 5. 1 għal tagħrif importanti dwar l- attivita` klinika ta ’ retapamulin kontra tipi differenti ta ’ Staphylococcus aureus.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata attenzjoni għall- gwida uffiċjali dwar l- użu adattat ta ’ aġenti antibatteriċi.
Retapamulin is for cutaneous use only.
Retapamulin għandu jintuża fuq il- ġilda biss.
Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine months to 11 years)
Adulti (bejn it- 18 u l- 65 sena), adolexxenti (bejn it- 12 u s- 17- il sena), trabi u tfal (minn 9 xhur sa ħdax - il sena)
Safety and efficacy have not been established in the following:
Saff irqiq ta ’ l- ingwent għandu jitqiegħed fuq il- parti affetwata darbtejn kuljum għal ħamest ijiem.
• Impetiginous lesions > 10 in number and exceeding 100 cm2 in total surface area.
Il- parti trattata tista tiġi mgħottija b’ faxxa sterilizzata jew garża.
• Infected lesions that exceed 10 cm in length or a total surface area > 100 cm2.
Ma ġewx stabbiliti sigurta` u effikaċja fil- każi li ġejjin: • Feriti impetiġinużi > 10 f’ dak li hu numru u li jaqbżu il- 100 ċm2 f’ dik li hi superfiċje totali. • Feriti infettati li jaqbżu l- 10 ċm f’ tul jew 100 ċm2 f’ superfiċje totali.
In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
F’ pazjenti ta ’ inqas minn 18- il sena is- superfiċje totali m’ għandux ikun aktar minn 2% tas- superfiċje totali tal- ġisem.
2 Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
Pazjenti li ma juru ebda rispons kliniku fi żmien jumejn jew tlieta għandhom jerġgħu ikunu evalwati u għandha tingħata konsiderazzjoni għal xi terapija oħra (ara sezzjoni 4. 4).
Infants under nine months of age
Trabi ta ’ taħt id- 9 xhur
The safety and efficacy of retapamulin ointment has not been established in paediatric patients less than nine months of age.
Is- sigurta` u l- effikaċja ta ’ l- ingwent retapamulin ma ġewx stabbiliti f’ pazjenti żgħar ta ’ taħt id- 9 xhur.
Elderly (aged 65 and older)
2 Anzjani (ta ’ 65 sena jew akbar)
No dosage adjustment is necessary.
M’ hemmx bżonn ta ’ aġġustament fid- dożaġġ.
See section 5.3.
Ara sezzjoni 5. 3.
Known or suspected hypersensitivity to retapamulin or to the excipient.
Sensittività eċċessiva magħrufa jew suspettata għal retapamulin jew għas- sustanza mhux attiva
In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the infection instituted.
Fil- każ ta ’ sensibilizzazzjoni jew irritazzjoni lokali qawwija mill- użu ta ’ l- ingwent retapamulin, it- trattament għandu jitwaqqaf, l- ingwent għandu jintmesaħ b’ attenzjoni u għandha tinbeda terapija alternattiva xierqa għall- infezzjoni.
Retapamulin ointment must be kept away from the eyes and mucous membranes.
L- ingwent retapamulin għanu jinżamm bogħod mill- għajnejn u minn membrani mukużi.
Care must be taken to avoid ingestion.
Għandha tingħata attenzjoni biex ma jinbelax.
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
Retapamulin m’ għandux jintuża fit- trattament ta ’ infezzjonijiet magħrufa jew li jkunu ġejjin jew aktarx li jkunu ġejjin minn MRSA (ara sezzjoni 5. 1) Fi studji kliniċi dwar feriti infettati sekondarjament u miftuħa, l- effikaċja ta ’ retapamulin ma kenitx adegwata f’ pazjenti b’ infezzjonijiet kawżati minn Staphylococcus aureus (MRSA) li jirreżisti l- metiċillina.
The reason for the reduced clinical efficacy observed in these patients is unknown.
Ir- raġuni għall- effikaċja klinika mnaqqsa osservata f’ dawn il- pazjenti mhijiex magħrufa.
Alternative therapy should be considered if there is no improvement or a worsening in the infected area after 2-3 days of treatment.
Għandha tkun ikkunsidrata terapija alternattiva jekk il- parti nfettata ma jkunx hemm titjib fiha jew jekk tiħżien wara 2- 3 ġranet ta ’ trattament.
Retapamulin should not be used to treat abscesses.
Retapamulin m’ għandux jintuża fit- trattament ta ’ xi axxess.
Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e. g. contact dermatitis), or irritation to the eyes and mucous membranes.
L- ingwent retapamulin fih butylated hydroxytoluene, li jista ’ jikkawża reazzjoni lokali fil- ġilda (e. g. dermatite mill- kuntatt), jew irritazzjoni fl- għajnejn u fil- membrani mukużi.
As with other antibacterial agents, prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.
Bħal fil- każ ta ’ aġenti antibatteriċi oħra, l- użu fit- tul ta ’ retapamulin jista jirriżulta f’ tikbir żejjed ta’ mikro - organiżmi mhux suxxettibbli, inklużi fungi.
The effect of concurrent application of retapamulin and other topical products to the same area of skin has not been studied, and is not recommended.
L- effett ta ’ l- applikazzjoni konkorrenti ta ’ retapamulin u prodotti topiċi oħra fuq l- istess parti tal- ġilda ma ġiex studjat, u dan mhuwiex rakkomandat.
3 In human liver microsomes, retapamulin was a strong inhibitor of CYP3A4.
Fil- mikrosomi tal- fwied fil- bniedem, retapamulin kien impeditur qawwi ta ’ CYP3A4.
Based on the low plasma concentration achieved in humans after topical application to abraded skin or infected superficial wounds, a clinically relevant inhibition is not expected in vivo (see section 5.2)
Minħabba l - konċentrazzjoni baxxa fil- plażma miksuba fil- bniedem wara l- applikazzjoni topika fuq ġilda mibruxa jew feriti superfiċjali nfettati, mhux mistenni inibizzjoni kinikament rilevanti in vivo (ara sezzjoni 5. 2).
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 1% ointment on the abraded skin of healthy adult males.
It- teħid fl- istess ħin mill- ħalq ta ’ 200 mg ketoconazole darbtejn kuljum żied il- medja ta ’ AUC( 0- 24) u Cmax ta ’ retapamulin b’ 81% wara l- applikazzjoni topika ta ’ ingwent b’ 1% retapamulin fuq il- ġilda mibruxa ta ’ rġiel f’ saħħithom.
Due to low systemic exposure following topical application in patients, dosage adjustments are considered to be unnecessary when topical retapamulin is applied during systemic treatment with CYP3A4 inhibitors.
Minħabba esponiment sistemiku baxx wara l- applikazjoni topika fuq pazjenti, aġġustamenti fid - dożaġġ ma jinħassx li huma meħtieġa meta jkun applikat retapamulin topiku waqt trattament sistemiku b’ impedituri CYP3A4.
Pregnancy No clinical data on exposed pregnancies are available.
Tqala Ma hawnx tagħrif kliniku dwar tqala esposta.
Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and fetal/ postnatal development (see Section 5.3).
Studji fuq annimali wara li jittieħed mill- ħalq urew tossiċita fis- sistema riproduttiva u m’ humiex biżżejjed rigward l- effetti fuq il- ħlas u l- iżvilupp tal- fetu / ta’ wara t - twelid (ara sezzjoni 5. 3).
Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial agent.
L- ingwent bir- retapamulin għandu jintuża biss waqt tqala meta jkun jidher biċ- ċar il- bżonn ta ’ terapija topika antibatterika u l- użu ta ’ retapamulin hu preferibbli mit- teħid ta ’ aġent antibatteriku sistemiku.
Lactation It is unknown whether retapamulin is excreted in human breast milk.
Treddigħ Mhuwiex magħruf jekk retapamulin joħroġx mal- ħalib tas- sider fil- bniedem.
Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
F’ adulti ġew osservati esponimenti sistemiċi żgħar ħafna, għalhekk l- esponiment fi trabi mreddgħa aktarx ikun negliġibbli.
The excretion of retapamulin in milk has not been studied in animals.
Il- ħruġ ta ’ retapamulin mal- ħalib ma ġiex studjat fuq annimali.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the woman.
Deċiżjoni dwar jekk għandux jitkompla jew jitwaqqaf it- treddigħ jew għandhiex titkompla jew titwaqqaf it- terapija b’ Altargo għandha tittieħed b’ mod li jiġi meqjus il- benefiċċju tat- treddigħ għat- tarbija u l- benefiċċju tat- terapija b’ Altargo għall- mara.
Altargo is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Altargo jintuża topikament u mhux probabbli li jkollu xi effett fuq il- ħila għas- sewqan jew tħaddim ta ’ magni.
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.
Fi studji kliniċi li fihom 2150 pazjent b’ infezzjoni superfiċjali fil- ġilda applikaw Altargo, l- aktar effett mhux mixtieq rappurtat kien irritazzjoni fil- post fejn jindilek, li affettwat madwar 1% tal- pazjenti.
The following convention has been used for the classification of frequency:
Il- metodu li ġej intuża għall- klassifika ta ’ frekwenzi:
Common Uncommon
> 1/ 100 sa < 1/ 10 Komuni
> 1/ 100 to< 1/10 > 1/1000 to< 1/100
> 1/ 1000 sa < 1/ 100
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull aggruppament ta ’ frekwenzi, effetti mhux mixtieqa jidhru skond is- serjeta` dejjem tonqos ta ’ kull każ.
4 Organ systems
Sistemi ta ’ organi
General disorders and administration site conditions
Reazzjonijiet fil -
Application site reactions
Reazzjonijiet fil -
Application site reactions
partijiet li jindilku
Irritation
Irritazzjoni
Pain Pruritus Erythema
Uġigħ Prurite Eritema
Contact dermatitis
Dermatite minn kuntatt
No specific antidote is known.
Kull sinjal jew sintomu ta ’ doża eċċessiva, kemm topikament u kemm jekk jinbela ’ aċċidentalment, għandu jiġi trattat sintomatikament
ATC code:
Prodotti għall- ġilda Kodiċi ATC:
D06AX13
DO6AX13
Mode of action
Mod ta ’ azzjoni
Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).
Retapamulin hu derivattiv semi- sintetiku tal- kompost plewromutilin, li jiġi iżolat permezz ta ’ fermentazzjoni mill - Clitopilus passeckerianus (li qabel kien Pleurotus passeckerianus).
Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non- pleuromutilin antibacterial agents that interact with the ribosome.
Retapamulin selettivament jimpedixxi is- sinteżi tal- proteini batteriċi billi jaħdem f’ sit uniku fis- subunita` 50S tar- ribosoma batterika li hija distinta mis- siti li jwaħħlu ta ’ aġenti oħra antibatteriċi mhux plewromutilini li ma jaqblux mar- ribosoma.
Data indicate that the binding site involves ribosomal protein L3 and is in the region of the ribosomal P site and peptidyl transferase centre.
Informazzjoni miġbura tindika li s- sit li jwaħħal jinvolvi proteini L3 tar- ribosoma u li qiegħed fir- reġjun tas - sit P tar- ribosoma u ċ- ċentru tal - peptidyl transferase.
By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, partially block P-site interactions, and prevent normal formation of active 50S ribosomal subunits.
Billi jeħlu ma ’ dan is- sit, plewromutilini jimpedixxi t - trasferiment ta ’ peptidyl, u hekk jimblukkaw parzjalment interazzjonijiet fis- sit P, u ma jħallux il - formazzjoni normali ta ’ sub- unitajiet attivi tar- ribosoma 50S.
Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple mechanisms.
Għalhekk il- plewromutilini jidher li jfixklu s - sinteżi ta ’ proteini batteriċi b’ mekkaniżmi multipli.
Retapamulin is predominantly bacteriostatic against S. aureus and S. pyogenes.
Retapalumin hu fil- biċċa l- kbira batterjostatiku kontra S. aureus u S. pyogenes.
Mechanism of Resistance
Mekkaniżmu ta ’ Reżistenza
Due to its distinct mechanism of action, retapamulin does not demonstrate target specific cross-resistance with other classes of antibacterial agents.
Minħabba l- mekkaniżmu distint ta ’ azzjoni tiegħu, retapamulin ma juri ebda target specific cross- resistance ma ’ klassijiet oħra ta ’ aġenti antibatteriċi.
In vitro, two mechanisms have been identified which reduce susceptibility to retapamulin.
In vitro, żewġ mekkaniżmi ġew identifikati li jnaqqsu s- suxxettibilta` għal retapamulin.
One involves mutations in ribosomal protein L3, the other is a non- specific efflux mechanism (ABC transporter vgaAv).
Wieħed jinvolvi tibdil fil- proteina L3 tar- ribosoma, u l- ieħor huwa mekkaniżmu effluss mhux speċifiku (ABC transporter vgaAv).
This non-target specific efflux mechanism has also been demonstrated to reduce the in vitro activity of streptogramin A.
Dan il- mekkaniżmu effluss mhux speċifiku wera wkoll li jnaqqas l- attivita` in vitro ta ’ streptogramin A.
5 No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of < 2µg/ ml.
L- ebda żvilupp ta ’ reżistenza ma ġie osservat waqt trattament b’ retapamulin fil- programm ta ’ studju kliniku u l- iżolati kliniċi kollha kienu mfixkla minn konċentrazzjonijiet ta ’ < 2μg/ ml ta ’ retapamulin.
Antibacterial spectrum
Spettru antibatteriku
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Il- prevalenza ta ’ reżistenza akkwistata tista ’ tvarja ġeografikament u biż- żmien fi speċi magħżula, u informazzjoni lokali dwar reżistenza hi mixtieqa, partikolarment fit- trattament ta ’ infezzjonijiet serji.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Skond il- bżonn, ikun meħtieġ il- parir ta ’ espert meta l- prevalenza lokali ta ’ reżistenza hi hekk li l- utilita` ta ’ l- aġent għallinqas f’ ċerti tipi ta ’ infezzjoni ma tkunx hekk li wieħed jista ’ joqgħod fuqha.
Commonly susceptible species
Speċi komunement suxxettibbli
Inherently resistant organisms
5 Organiżmi reżistenti minnhom infushom
$In vitro, retapamulin was equally active against methicillin-susceptible and methicillin- resistant strains of S. aureus.
Enterococcus faecalis $In vitro, retapamulin kien attiv l- istess kontra razez ta ’ S. aureus suxxettibbli u reżistenti għal metiċillina.
However, see section 4.4 and below regarding clinical efficacy against MRSA.
Madankollu, ara sezzjoni 4. 4 u hawn taħt dwar effikaċja klinika kontra MRSA.
Retapamulin should not be used to treat infections known or thought likely to be due to MRSA.
Retapamulin m’ għandux jintuża fit- trattament ta ’ infezzjonijiet magħrufa li ġew ikkawżati jew aktarx li kienu kkawżati minn MRSA.
* Activity has been satisfactorily demonstrated in clinical studies
* ġiet osservata attivita` sodisfaċenti fi studji kliniċi.
Information from clinical trials
Informazzjoni minn provi kliniċi
Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%:
Ftit MRSA ġew iżolati fi studji dwar impetigo u kollha kienu suċċessi kliniċi (100%:
In studies in impetigo and in two studies of secondarily infected open wounds (SIOW), clinical success rates were high for retapamulin in patients with mupirocin-resistant S. aureus (100%:
Fi studji dwar impetigo u f’ żewġ studji dwar feriti miftuħa infettati sekondarjament (SIOW), rati ta ’ suċċessi kliniċi kienu għolja għal retapalumin f’ pazjenti b ’ S. aureus reżistenti għal mupiroċina (100%:
11/ 11) or fusidic acid-resistant S. aureus (96.7%:
11/ 11) jew S. aureus reżistenti għal aċidu fusidiku (96. 7%:
However, in the two studies that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%).
Madankollu, fiż- żewġ studji li rreġistraw pazjenti bl - SIOW l- effikaċja ta ’ retapamulin f’ infezzjoni kawżati minn MRSA ma kenitx adegwata (75. 7%).
No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Ma ġietx osservata l- ebda differenza fl- attivita` in vitro ta ’ retapamulin kontra S. aureus kemm jekk l- iżolati kienu suxxettibbli jew jekk dawn kienu reżistenti għal retapamulin.
The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may have been influenced by the presence of a particular MRSA clone.
L- ispjega għall- inqas effikaċja klinika kontra MRSA f’ SIOW mhijiex ċara u setgħet ġiet influwenzata mill - preżenza ta ’ klonu partikolari ta ’ MRSA.