qanastek/EMEA-V3 huggingface dataset:
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, section 4.2)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The marketing Authorisation holder will continue to submit periodic safety update reports on a 2-year cycle.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq se jkompli jissottometti rapporti perjodiċi ta ’ aġġornament dwar is- sigurtà fuq ċiklu ta ’ sentejn.
31 ANNEX III
33 ANNESS III
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin (as acetate)
CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin (bħala aċetat)
Each vial contains:
Kull kunjett fih:
50 mg caspofungin (as acetate).
50 mg caspofungin (bħala aċetat).
Sucrose, mannitol, glacial acetic acid and sodium hydroxide.
Sucrose, mannitol, glacial acetic acid u sodium hydroxide.
1 vial
kunjett
Intravenous use after reconstitution and dilution.
Użu għal ġol- vini wara rikostituzzjoni u dilwizzjoni.
Store in a refrigerator.
Aħżen fi friġġ.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL LABEL
TIKKETTA TAL- KUNJETT
CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin (as acetate) Intravenous use
CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin (bħala aċetat) Użu għal ġol- vini
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKONT IL- PIŻ, VOLUM JEW PARTI INDIVIDWALI
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin (as acetate)
CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin (bħala aċetat)
70 mg caspofungin (as acetate).
70 mg caspofungin (bħala aċetat).
Sucrose, mannitol, glacial acetic acid, and sodium hydroxide.
Sucrose, mannitol, glacial acetic acid, u sodium hydroxide.
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin (as acetate) Intravenous use
CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin (bħala aċetat) Użu għal ġol- vini
40 PACKAGE LEAFLET:
42 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you or your child start taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel ma inti jew it- tifel/ tifla tiegħek tibdew tieħdu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you or your child.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek jew lit- tifel/ tifla tiegħek.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 jew lill- ispiżjar tiegħek.
What CANCIDAS is and what it is used for 2.
X’ inhu CANCIDAS u għalxiex jintuża 2.
Before you take CANCIDAS 3.
Qabel ma tieħu CANCIDAS 3.
How to take CANCIDAS 4.
Kif għandek tieħu CANCIDAS 4.
How to store CANCIDAS 6.
Kif taħżen CANCIDAS 6.
WHAT CANCIDAS IS AND WHAT IT IS USED FOR
X’ INHU CANCIDAS U GĦALXIEX JINTUŻA
CANCIDAS is an antifungal medicine that interferes with the production of a component (glucan polysaccharide) of the fungal cell wall that is necessary if the fungus is to continue living and growing.
CANCIDAS huwa mediċina antifungali li tinterferixxi mal- produzzjoni ta ’ komponent (glucan polysaccharide) tal- ħajt taċ- ċellola fungali li huwa neċessarju jekk il- fungu jrid ikompli jgħix u jikber.
Fungal cells exposed to CANCIDAS have incomplete or defective cell walls, making them fragile and unable to grow.
Iċ- ċelloli fungali esposti għal CANCIDAS għandhom ħitan inkompleti jew difettużi, li jagħmluhom fraġli u inkapaċi li jikbru.
CANCIDAS may have been prescribed to treat a serious fungal infection called invasive candidiasis.
CANCIDAS jista ’ jkun li ngħata biex jikkura infezzjoni fungali msejħa kandidjasi invażiva.
The infection is caused by fungal (yeast) cells called Candida.
Din l - infezzjoni hija kkawżata minn ċelloli fungali (ħmira) msejħa Candida.
These yeast cells are normally found in the digestive tract, and do not cause an infection unless they enter the bloodstream (in which case the infection is referred to as candidaemia) or other tissues or organs, such as the lining of the abdomen (peritonitis), the heart, the kidneys, the liver, bones, muscles, joints, spleen, or eyes.
Dawn iċ- ċelloli tal- ħmira normalment jinstabu fl- apparat diġestiv, u ma jikkawżawx infezzjoni sakemm ma jidħlux fin - nixxiegħa tad- demm (f’ liema każ l- infezzjoni ssir referenza għaliha bħala candidaemia) jew tessuti jew organi oħra, bħar- rita tal- addome (perotinite), il- qalb, il- kliewi, il- fwied, l- għadam, il- muskoli, il - ġogi, il- milsa, jew l- għajnejn.
Persons at high risk for invasive candidiasis include surgical patients and those whose immune systems are deficient.
Il- persuni f’ riskju għoli ta ’ kandidjasi invażiva jinkludu pazjenti kirurġiċi u dawk li s- sistemi immuni tagħhom huma defiċjenti.
Fever and chills that do not respond to antibacterial therapy are the most common symptoms of this type of infection.
Deni u tertir li ma jweġbux għal terapija antibatterika huma l- iżjed sintomi komuni ta ’ din it- tip ta ’ infezzjoni.
Alternatively, your doctor may have prescribed CANCIDAS to treat a fungal infection in your nose, nasal sinuses, or lungs because other antifungal treatments have not been working as well as expected or because the other antifungal treatments are causing side effects.
Inkella, it- tabib tiegħek jista ’ jkun li ordnalek CANCIDAS biex tikkura infezzjoni fungali f’ imnieħrek, fil- kavitajiet tal- imnieħer, jew fil- pulmuni minħabba li trattamenti antifungali oħra ma ħadmux tajjeb daqs kemm kien mistenni jew għax it- trattamenti antifungali l- oħra qed jikkawżaw effetti sekondarji.
This infection is caused by organisms called Aspergillus.
Din l- infezzjoni hija kkawżata minn organiżmi msejħa Aspergillus.
Aspergillus fungal infections begin in the respiratory system (in the nose, sinuses, or lungs) because the spores of the fungus are found in the air we breathe every day.
L- infezzjonijiet fungali mill - Aspergillus jibdew fis- sistema respiratorja (fl- imnieħer, fil- kavitajiet, jew fil- pulmuni) minħabba li l - ispori tal- fungu jinstabu fl- arja li nieħdu kuljum.
This infection is named invasive aspergillosis.
Din l- infezzjoni tissejjaħ asperġillożi invażiva.
It is possible for the fungus to spread to other tissues and organs.
Huwa possibbli li l- fungu jinfirex għal tessuti u organi oħra.
In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body.
F’ ħafna individwi, il- ħila naturali li jiġġieldu l - mard teqred l- ispori u tneħħihom mill- ġisem.
Some medical conditions lower the body’ s resistance to diseases.
Xi kundizzjonijiet mediċi jnaqqsu r- reżistenza tal- ġisem kontra l- mard.
Also, certain medicines prescribed for patients who are organ or bone marrow recipients lower the body’ s resistance to diseases.
Barra minn hekk, ċerti mediċini mogħtija lil pazjenti li huma riċevituri ta ’ organi jew mudullun inaqqsu r- reżistenza tal- ġisem kontra l- mard.
These are the patients who are most likely to develop an Aspergillus infection.
Dawn huma l- pazjenti li huma l- aktar probabbli li jiżviluppaw infezzjoni tal- Aspergillus.
Persistent fever due to infection may occur following chemotherapy or medical conditions that lower the body’ s resistance to disease by lowering counts of certain white blood cells.
Jista ’ jkun hemm deni persisteni minħabba infezzjoni wara kemjoterapija jew kundizzjonijiet mediċi li jnaqqsu r- reżistenza tal- ġisem kontra l- mard billi jbaxxu l- għadd ta ’ ċelloli bojod tad- demm.
If the fever is not reduced by treatment with an antibiotic, your doctor may suspect that you have a fungal infection and prescribe CANCIDAS to treat it.
Jekk id - deni ma jonqosx bi trattament b’ antibijotiku, it- tabib tiegħek għandu mnejn jissuspetta li għandek infezzjoni fungali u jordnalek CANCIDAS biex tikkuraha.
BEFORE YOU TAKE CANCIDAS
QABEL MA TIEĦU CANCIDAS
Do not take CANCIDAS
Tiħux CANCIDAS
- if you are hypersensitive (allergic) to caspofungin or any of the other ingredients of
- jekk inti sensittiv/ a żżejjed (allerġiku/ a) għal caspofungin jew sustanzi oħra ta ’ CANCIDAS.
Take special care with CANCIDAS
Oqgħod attent ħafna b’ CANCIDAS
- if you have had or now have liver problems.
- jekk kellek jew għandek problemi bil- fwied.
Some patients with liver problems may require a
Xi pazjenti bi problemi fil- fwied jista ’ jkollhom
dosage adjustment.
bżonn aġġustament fid- doża.
- if you are taking cyclosporin, a medicine to help prevent organ transplant rejection or to treat
- jekk qed tieħu cyclosporin, mediċina li tgħin biex tipprevjeni r- rifjut tat- trapjant tal- organi jew
certain problems with your immune system.
biex tikkura ċerti problemi fis- sistema immuni tiegħek.
Your physician may order additional blood tests during your treatment.
It- tabib tiegħek jista ’ jordnalek testijiet tad- demm addizzjonali waqt it- trattament tiegħek.
- if you have any allergies.
- jekk għandek xi allerġiji.
Tell your doctor about any medical conditions you have or have had.
Għid lit- tabib tiegħek dwar xi kundizzjonijiet mediċi li għandek jew kellek.
Children and Adolescents
Tfal u Adoloxxenti
CANCIDAS has been approved for use in children and adolescents for all the infection types described above.
CANCIDAS ġie approvat għall- użu fit- tfal u l- adoloxxenti għat- tipi kollha ta ’ infezzjonijiet deskritti hawn fuq.
The dose used in paediatric patients may differ from the dose used in adult patients.
Id- doża użata f’ pazjenti pedjatriċi tista ’ tkun differenti mid- doża użata f’ pazjenti adulti.
Your physician will determine if any adjustments should be made to other medicines you may be taking.
It- tabib tiegħek jiddeċiedi jekk għandhomx isiru aġġustamenti f’ mediċini oħra li għandu mnejn tkun qiegħed/ qiegħda tiegħu.
If you are receiving cyclosporine, your physician may order additional blood tests during your treatment.
Jekk qed tirċievi cyclosporine, it- tabib tiegħek jista ’ jordnalek testijiet tad - demm addizzjonali waqt it- trattament tiegħek.
It is particularly important for your doctor to know if you are taking certain anti-HIV medicines (including efavirenz or nevirapine), the antiseizure (epilepsy) medicines phenytoin and carbamazepine, the steroid dexamethasone, the antibiotic rifampicin, and the immunosuppressant tacrolimus.
Huwa partikolarment importanti li t- tabib tiegħek ikun jaf jekk intix qiegħed/ qiegħda tieħu ċerti mediċini kontra l- HIV (fosthom efavirenz jew nevirapine), il - mediċini kontra l- aċċessjonijiet (epilessija) phenytoin u carbamazepine, l- isterojdi dexamethasone, l - antibijotiku rifampicin, u l- immunosuppressant tacrolimus.
Pregnancy and breastfeeding
Tqala u treddigħ
CANCIDAS has not been studied in pregnant women, and should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
CANCIDAS ma ġiex studjat f’ nisa tqal, u għandu jintuża fit- tqala biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
Women receiving CANCIDAS should not breast-feed.
In- nisa li jkunu qegħdin jirċievu CANCIDAS m’ għandhomx ireddgħu.
Ask you doctor for advice before taking any medicine.
Itlob il- parir tat- tabib tiegħek qabel tieħu xi mediċina.
There is no information to suggest that CANCIDAS affects your ability to drive or operate machinery.
M’ hemmx informazzjoni li tissuġġerixxi li CANCIDAS jaffettwa l- ħila tiegħek biex issuq jew tħaddem magni.
Important information about some of the ingredients of CANCIDAS
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ CANCIDAS
CANCIDAS contains sucrose.
CANCIDAS fih is- sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE CANCIDAS
KIF GĦANDEK TIEĦU CANCIDAS
CANCIDAS will always be prepared and given to you by a doctor or another healthcare professional.
CANCIDAS dejjem se jiġi ppreparat u mogħti lilek minn tabib jew professjonist ieħor tal- kura tas - saħħa.
42 CANCIDAS should be administered once daily by slow intravenous infusion over approximately 1 hour.
CANCIDAS għandu jingħata darba kuljum b’ infużjoni bil- mod ġol- vina fuq perjodu ta ’ madwar siegħa.
Your physician will determine the duration of your treatment and how much CANCIDAS you will receive each day.
It- tabib tiegħek jiddeċiedi t- tul tat- trattament tiegħek u kemm għandek tieħu CANCIDAS kuljum.
He will monitor your response and condition.
Huwa se jimmonitorja r- rispons u l- kundizzjoni tiegħek.
The dose will not need to be adjusted according to your age or if you are suffering from renal impairment.
Id- doża mhux se jkollha bżonn li tiġi aġġustata skont l- età jew jekk tbati minn indeboliment fil- kliewi.
If you weigh more than 80 kg, a dose adjustment may be required.
Jekk tiżen aktar minn 80 kg, jista ’ jkun meħtieġ aġġustament fid- doża.
If you take more CANCIDAS than you should
Jekk tieħu CANCIDAS aktar milli suppost
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed.
It- tabib tiegħek se jimmonitorja r- rispons u l- kundizzjoni tiegħek sabiex jistabbilixxi xi trattament b’ CANCIDAS huwa meħtieġ.
However, if you are concerned that you may have been given too much CANCIDAS, contact your doctor or another healthcare professional immediately.
Madankollu, jekk inti mħasseb/ imħassba li forsi ngħatajt iżżejjed CANCIDAS, ikkuntattja lit- tabib tiegħek jew lil professjonist ieħor tal- kura tas- saħħa immedjatament.
If you miss/ forget to take a dose of CANCIDAS
Jekk tfalli/ tinsa tieħu doża ta ’ CANCIDAS
However, if you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
Madankollu, jekk inti mħasseb/ imħassba li forsi qbiżt doża, ikkuntattja lit- tabib tiegħek jew lil professjonist ieħor tal- kura tas- saħħa immedjatament.
If you stop taking CANCIDAS
Jekk tieqaf tieħu CANCIDAS
There are no known withdrawal symptoms.
M’ hemmx sintomi magħrufa tat- twaqqif.
Like all medicines, CANCIDAS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CANCIDAS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following terms are used to describe how often side effects have been reported.
It- termini li ġejjin jintużaw biex jiddeskrivu kemm ġew irrappurtati ta ’ spiss l- effetti sekondarji.
Very Common (occurring in at least 1 in 10 patients treated) Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1of 1000 and less than 1 of 100 patients treated) Rare (occurring in at least 1 of 10,000 and less than 1 of 1000 patients treated) Not known (cannot be estimated from the available data)
Komuni ħafna (iseħħu f’ mill- anqas 1 minn kull 10 pazjenti ttrattati) Komuni (iseħħu mill- anqas f’ 1 minn kull 100 u f’ inqas minn 1 minn kull 10 pazjenti ttrattati) Mhux komuni (iseħħu mill- anqas f’ 1 minn kull 1000 u f’ inqas minn 1 minn kull 100 pazjent ittrattati) Rari (iseħħu mill- anqas f’ 1 minn kull 10, 000 u f’ inqas minn 1 minn kull 1000 pazjent ittrattati) Mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Adults 18 years of age or older:
Adulti ta ’ 18- il sena jew aktar:
Common: rapid heart beat Not known: swelling of the hands, ankles or feet
Komuni: taħbita tal- qalb mgħaġġla Mhux magħruf: nefħa fl- idejn, l- għekiesi jew is- saqajn
Common: flushing
Komuni: fwawar
Common: shortness of breath
Komuni: qtugħ ta ’ nifs
Gastrointestinal disorders:
45 Disturbi gastro- intestinali:
Common: stomach pain, nausea, vomiting, diarrhoea
Komuni: uġigħ fl- istonku, dardir, rimettar, dijarea
Common: rash, itching, sweating
Komuni: raxx, ħakk, għaraq
43 General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Very common: fever Common: pain, chills, vein irritations at the infusion site (including itching, redness, discharge, swelling, burning sensation, or clotting)
Komuni ħafna: deni Komuni: uġigħ, tertir, irritazzjonijiet tal- vina fis- sit tal- infużjoni (li jinkludu ħakk, ħmura, tnixxija, nefħa, sensazzjoni ta ’ ħruq, jew tagħqid tad- demm)
Rare: impaired liver function
Rari: indeboliment fil- funzjoni tal- fwied
Common: alterations in some laboratory blood tests (including decreased red blood cell count and increased values of some liver and kidney tests Uncommon: high calcium
Komuni: bidliet f’ xi testijiet tad- demm fil- laboratorju (fosthom tnaqqis fl- għadd ta ’ ċelloli ħomor tad - demm u żidiet fil- valuri ta ’ xi testijiet tal- fwied u tal- kliewi) Mhux komuni: livell għoli ta ’ kalċju
Children and adolescents (12 months to 17 years of age):
Tfal u adoloxxenti (12- il xahar sa 17- il sena):
Common: rapid heart beat
Komuni: taħbita tal- qalb mgħaġġa
Common: flushing, low blood pressure
Komuni: fwawar, pressjoni tad- demm baxxa
Common: rash, itching
Komuni: raxx, ħakk
Very common: fever Common: chills, pain at the catheter site
Komuni ħafna: deni Komuni: tertir, uġigħ fil- post tal- kateter
Common: alterations in some laboratory blood tests (including increased values of some liver tests)
Komuni: bidliet f’ xi testijiet tad- demm fil- laboratorju (li jinkludu żidiet fil- valuri ta ’ xi testijiet tal - fwied)
Possible histamine-mediated symptoms have been reported including reports of rash, swelling of the face and/ or lips, itching, sensation of warmth, or trouble breathing.
Kienu rrappurtati sintomi possibbli medjati mill- istamina fosthom rapporti ta ’ raxx, nefħa fil- wiċċ u/ jew fix- xufftejn, ħakk, sensazzjoni ta ’ sħana, jew problemi bin- nifs.
Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have also been reported rarely during administration of CANCIDAS.
Reazzjonijiet allerġiċi ta ’ theddida għall- ħajja li jistgħu jinkludu diffikultà fit- teħid tan- nifs bi tħarħir jew taħżin ta ’ raxx eżistenti ġew irrappurtati wkoll b’ mod rari waqt l- għoti ta ’ CANCIDAS.
Other side effects may also occur rarely, and as with any prescription medicine, some side effects may be serious.
Effetti sekondarji oħra jistgħu wkoll iseħħu b’ mod rari, u bħal kwalunkwe mediċina oħra bir- riċetta, xi effetti sekondarji jistgħu jkunu serji.
Ask your doctor for more information.
Staqsi lit- tabib tiegħek għal iżjed informazzjoni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jekk jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CANCIDAS
KIF TAĦŻEN CANCIDAS
Do not use CANCIDAS after the expiry date which is stated on the carton and the vial.
Tużax CANCIDAS wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kunjett.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
L- ewwel żewġ numri jindikaw ix- xahar; l- erba ’ numri ta ’ wara jindikaw is- sena.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
Store in a refrigerator (2°C to 8°C).
Aħżen fi friġġ (2°C sa 8°C).
44 Reconstituted CANCIDAS should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
CANCIDAS rikostitwit għandu jintuża immedjatament minħabba li ma fihx preservattivi biex jimpedixxu l- kontaminazzjoni batterika.
Only a trained health care professional who has read the complete directions (please see below “ Instructions of how to reconstitute and dilute CANCIDAS”) can properly prepare this medicine for use.
Professjonist fil- kura tas- saħħa biss li jkun qara l - istruzzjonijiet sħaħ (jekk jogħġbok ara hawn isfel (“ Struzzjonijiet dwar kif tirrikostitwixxi u tħallat CANCIDAS ”) jista ’ jipprepara sewwa din il- mediċina għall- użu.
What CANCIDAS contains The active substance of CANCIDAS is caspofungin (as acetate).
X’ fih CANCIDAS Is- sustanza attiva ta ’ CANCIDAS hija caspofungin (bħala aċetat).
The other ingredients are: sucrose, mannitol, glacial acetic acid, and sodium hydroxide.
Is- sustanzi l- oħra huma: sucrose, mannitol, glacial acetic acid, u sodium hydroxide.
What CANCIDAS looks like and contents of the pack CANCIDAS is a sterile, white to off-white, freeze-dried compact powder.
Id- dehra ta ’ CANCIDAS u l- kontenuti tal- pakkett CANCIDAS huwa trab kompatt abjad għal offwajt, sterili, lajofiliżżat.
Each pack contains one vial containing 50 mg Caspofungin (as acetate).
Kull pakkett fih kunjett wieħed li fih 50 mg Caspofungin (bħala aċetat).
Marketing Authorisation Holder and Manufacturer
Id- Detentur tal- Awtorizzazzjoni għat - Tqegħid fis- Suq
Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir- Renju Unit
Product Manufacturer Merck Sharp & Dohme B.
Merck Sharp & Dohme B.
Waarderweg 39, Postbus 581 2003 PC Haarlem The Netherlands
Waarderweg 39, Postbus 581 2003 PC Haarlem L- Olanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
46 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions of how to reconstitute and dilute CANCIDAS:
Struzzjonijiet dwar kif għandek tirrikostitwixxi u tħallat CANCIDAS:
Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose.
Ir- rikostituzzjoni ta ’ CANCIDAS TUŻAX DILWENTI LI FIHOM IL- GLUCOSE għax CANCIDAS mhuwiex stabbli f’ dilwenti li fihom il- glucose.
The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle.
Is- soluzzjoni għal infużjoni tiġi ppreparata billi b’ mod asettiku jiżdied l- ammont xieraq ta ’ konċentrat rikostitwit (kif muri fit- tabella ta ’ hawn isfel) ma ’ borża jew flixkun tal- infużjoni ta ’ 250 ml.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
49 PREPARAZZJONI TAS- SOLUZZJONI GĦAL INFUŻJONI FL- ADULTI
* 10.5 ml should be used for reconstitution of all vials
* 10. 5 ml għandhom jintużaw għar- rikostituzzjoni tal- kunjetti kollha
47 INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
STRUZZJONIJIET GĦALL- UŻU F’ PAZJENTI PEDJATRIĊI
(Mosteller 3 Formula)
(Formula Mosteller 3)
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 50-mg vial) 1.
50 Preparazzjoni tal- infużjoni ta ’ 50 mg/ m2 għal pazjenti pedjatriċi minn 3 xhur ’ il fuq (billi jintuża kunjett ta ’ 50 mg) 1.
48 Preparation notes:
Noti dwar il- preparazzjoni:
a The white to off-white cake will dissolve completely.
a Il - “ cake ” abjad għal offwajt għandu jinħall kompletament.
b Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion.
b Eżamina viżwalment is- soluzzjoni rikostitwita għal frak jew tidnis waqt ir- rikostituzzjoni u qabel l - infużjoni.
c CANCIDAS is formulated to provide the full labeled vial dose (50 mg) when 10 ml is withdrawn from the vial.
ċ CANCIDAS huwa fformulat sabiex jipprovdi d- doża ttikkettjata kollha tal- kunjett (50 mg) meta jinġibdu 10 ml mill- kunjett.
49 PACKAGE LEAFLET:
51 FULJETT TA ’ TAGĦRIF:
dosage adjustment.
bżonn aġġustament fid- doża
CANCIDAS has not been studied in pregnant women, and should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus
CANCIDAS ma ġiex studjat f’ nisa tqal, u għandu jintuża fit- tqala biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
51 CANCIDAS should be administered once daily by slow intravenous infusion over approximately 1 hour.
CANCIDAS għandu jingħata darba kuljum b’ infużjoni bil- mod ġol- vina fuq perjodu ta ’ madwar siegħa.
If you stop taking CANCIDAS There are no known withdrawal symptoms.
M’ hemmx sintomi magħrufa tat- twaqqif.
Gastrointestinal disorders:
54 Disturbi gastro- intestinali:
52 General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
53 Reconstituted CANCIDAS should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
CANCIDAS rikostitwit għandu jintuża immedjatament minħabba li ma fihx preservattivi biex jimpedixxu l- kontaminazzjoni batterika.
Only a trained health-care professional who has read the complete directions (please see below “ Instructions of how to reconstitute and dilute CANCIDAS”) can properly prepare this medicine for use.
Professjonist fil- kura tas- saħħa biss li jkun qara l - istruzzjonijiet sħaħ (jekk jogħġbok ara hawn isfel (“ Struzzjonijiet dwar kif tirrikostitwixxi u tħallat CANCIDAS ”) jista ’ jipprepara sewwa din il- mediċina għall- użu.
Each pack contains one vial containing 70 mg Caspofungin (as acetate).
Kull pakkett fih kunjett wieħed li fih 70 mg Caspofungin (bħala aċetat).
55 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
7.2 mg/ ml.
Il- konċentrazzjoni tal- kunjetti rikostitwiti se jkun 7. 2 mg/ ml.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
58 PREPARAZZJONI TAS- SOLUZZJONI GĦAL INFUŻJONI FL- ADULTI
Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle
Volum ta ’ CANCIDAS rikostitwit għal
(from two 50-mg vials)** 35 mg for moderate
(minn żewġ kunjetti ta ’ 50 mg) ** 35 mg għal insuffiċjenza moderata tal- fwied
* 10.5 ml should be used for reconstitution of all vials ** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50-mg vials
* 10. 5 ml għandhom jintużaw għar- rikostituzzjoni tal- kunjetti kollha ** Jekk ikun hemm kunjett ta ’ 70 mg disponibbli, id- doża ta ’ 70 mg tista ’ titħejja minn żewġ kunjetti ta ’ 50 mg.
56 INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
STRUZZJONIJIET GĦALL- UŻU F’ PAZJENTI PEDJATRIĊI
(Mosteller 4 Formula)
(Formula Mosteller 4)
Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.
Neħħi mill- kunjett il- volum ta ’ mediċina ugwali għal- loading dose kkalkulata (Pass 1). Ittrasferixxi b’ mod asettiku dan il- volum (ml) c ta ’ CANCIDAS rikostitwit għal borża (jew flixkun) IV li fiha 250 ml ta ’ 0. 9%, 0. 45%, jew 0. 225% Injezzjoni ta ’ Klorur tas- Sodju, jew Injezzjoni Lactated ta ’ Ringers.
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.
59 Preparazzjoni tal- infużjoni ta ’ 50 mg/ m2 għal pazjenti pedjatriċi minn 3 xhur ’ il fuq (billi jintuża kunjett ta ’ 70 mg) 1.
57 Preparation notes:
Noti dwar il- preparazzjoni:
b Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion.
b Eżamina viżwalment is- soluzzjoni rikostitwita għal frak jew tidnis waqt ir- rikostituzzjoni u qabel l - infużjoni.
c CANCIDAS is formulated to provide the full labeled vial dose (70 mg) when 10 ml is withdrawn from the vial.
ċ CANCIDAS huwa fformulat sabiex jipprovdi d- doża ttikkettjata kollha tal- kunjett (70 mg) meta jinġibdu 10 ml mill- kunjett.
What is Carbaglu?
X’ inhu Carbaglu?
It is available as dispersible tablets. ‘ Dispersible ’ means that the tablets can be dispersed (mixed) in water.
Carbaglu huwa mediċina li fiha s- sustanza attiva aċidu karglumiku (carglumic acid) Huwa jinsab disponibbli bħala pilloli li jistgħu jiġu mdewwba. ‘ Jistgħu jiġu mdewwba ’, ifisser li l- pilloli jdubu (meta mħallta) fl- ilma.
What is Carbaglu used for?
Għal xiex jintuża Carbaglu?
Carbaglu is used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients who lack an enzyme called N-acetylglutamate synthase (NAGS).
Carbaglu jintuża għat- trattament ta ’ iperammonemja (livelli għoljin ta’ ammonja fid- demm) f’ pazjenti li ma jkollhomx enżim imsejjaħ N- aċetilglutamat sintażi (NAGS).
This enzyme normally helps to break down ammonia.
Dan l- enżim normalment jgħin jiddekomponi l- ammonja.
If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Jekk l- enżim ma jkunx preżenti, l- ammonja ma tkunx tista ’ tiġi mkissra u tkompli takkumula fid- demm.
The disease is extremely rare.
Il- marda hija estremament rari.
Patients with severe complete NAGS deficiency rapidly develop high levels of ammonia in the blood soon after birth.
Il- pazjenti li jkollhom defiċjenza kompluta u severa ta ’ l- NAGS jiżviluppaw malajr livelli għoljin ta ’ ammonja fid- demm ftit wara t - twelid.
Patients with partial NAGS deficiency (a milder form of the disease) can have symptoms at almost any time of life following a stressful event such as an infection or a viral illness.
Il- pazjenti b’ defiċjenza parzjali ta ’ l- NAGS (forma inqas qawwija tal- marda) jista ’ jkollhom s - sintomi fi kważi kull moment ta ’ ħajjithom wara li jkunu għaddew minn xi esperjenza stressanti bħal infezzjoni jew marda virali.
Because the number of patients with NAGS deficiency is low, it is considered ‘ rare’ and Carbaglu was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 October 2000.
Billi n- numru ta 'pazjenti li jbatu mid- defiċjenza NAGS huwa wieħed baxx, il- marda hi meqjusa bħala waħda' rari 'u fit- 18 ta ’ Ottubru tas- sena 2000, Carbaglu ġie ddeżinjat bħala ‘ mediċina orfni' (mediċina użata fil- mard rari).
How is Carbaglu used?
Kif jintuża Carbaglu?
Carbaglu treatment should be started by a doctor who has experience in treating patients with metabolic diseases.
It- trattament b’ Carbaglu għandu jinbeda minn tabib li jkollu esperejenza fit- trattament ta ’ pazjenti b’ mardiet metaboliċi.
Treatment may be started as early as the first day of life.
It- trattament jista ’ jinbeda daqshekk kmieni daqs l- ewwel jum tal- ħajja.
The first daily dose should be 100 mg per kilogram body weight, but up to 250 mg/ kg can be used if necessary.
L - ewwel doża ta ’ kuljum għandha tkun ta ’ 100mg għal kull kilogramm li jiżen il- ġisem, iżda jekk meħtieġ jista ’ jintuża sa 250mg għal kull kilogramm.
The tablets should be dispersed (mixed) in a small amount of water before being given to the patient.
Id- doża għandha mbagħad tiġi aġġustata sabiex iżżomm livelli normali ta ’ ammonnja fid- demm: id- dożi ta ’ kuljum normalment ivarjaw minn 10 sa 100mg/ kg.
The medicine is used for the patient ’ s whole life.
Il- pilloli għandhom jitħalltu f’ ammont żgħir ta ’ ilma qabel ma jingħataw lil pazjent.
People with NAGS deficiency cannot break down and excrete ammonia.
Huma jistgħu faċilment jinqasmu f’ żewġ nofsijiet ta ’ l- istess daqs.
When this happens, ammonia builds up in the blood.
Il- mediċina tintuża matul il- ħajja kollha tal- pazjent.
How has Carbaglu been studied?
Kif jaħdem Carbaglu?
Carbaglu has been studied in 20 patients, 12 of whom had NAGS deficiency and were treated for an average of about three years.
Carbaglu ġie studjat f’ 20 pazjent, fejn 12 minnhom kellhom defiċjenza NAGS u kienu trattati għal medja ta ’ madwar tliet snin.
The other eight patients were treated for hyperammonaemia of another cause.
It- tmien pazjenti l- oħra ġew trattati għal iperammonemija minn kawża oħra.
The company also presented information from the published literature on a further four patients treated with the active substance in Carbaglu.
Il- kumpanija ppreżentat ukoll informazzjoni minn dokumentazzjoni pubblikata dwar erba ’ pazjenti oħra trattati bis- sustanza attiva Carbaglu.
What benefit has Carbaglu shown during the studies?
Liema benefiċċju wera Carbaglu waqt l- istudji li ġew mwettqa?
In most patients, ammonia levels were brought back to normal after Carbaglu treatment.
Fil- biċċa l- kbira tal- pazjenti, il- livelli ta’ ammonja reġgħu għan- normal wara trattament b’ Carbaglu.
Patients on Carbaglu could be kept stable without a need for restrictions to the diet or the use of other medicines.
Il - pazjenti li jkunu qed jieħdu Carbaglu setgħu jinżammu stabbli mingħajr il- bżonn ta ’ restrizzjonijiet ta ’ dieta jew ta ’ l- użu ta ’ mediċini oħrajn.
What is the risk associated with Carbaglu?
X’ inhu r- riskju assoċjat ma ’ Carbaglu?
The most common side effect with Carbaglu (seen in between 1 and 10 patients in 100) is increased sweating.
L- iktar effett sekondarju komuni b' Carbaglu (li deher f' bejn pazjent wieħed u 10 minn kull 100) huwa l- ħruġ ta ’ l- għaraq.
For the full list of side effects reported with Carbaglu, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji b’ Carbaglu ara l- Fuljett ta ’ Tagħrif.
Carbaglu should not be used in people who may be hypersensitive (allergic) to carglumic acid or any of the other ingredients.
Carbaglu m’ għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għall- aċidu karglumiku jew għal xi sustanza oħra tiegħu.
Why has Carbaglu been approved?
Għaliex ġie approvat Carbaglu?
NAGS deficiency is a rare, serious disease, with potentially devastating consequences and for which there are no other similar treatments.
Id- defiċjenza NAGS hija marda serja u rari li jista ’ jkollha konsegwenzi devastanti u għal liema m’ hemm l- ebda trattament ieħor simili.
On the basis of the limited information on effectiveness and safety that was submitted, the Committee for Medicinal Products for Human Use (CHMP) concluded that Carbaglu was effective in reducing blood ammonia to normal levels.
Abbażi ta ’ l- informazzjoni limitata li ngħatat dwar l- effikaċja u s- sigurtà, il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Carbaglu kien effikaċi fit- tnaqqis ta ’ l- ammonja fid- demm sabiex din terġa ’ tiġi għal livelli normali.
The Committee decided that Carbaglu’ s benefits are greater than its risks for the treatment of hyperammonaemia due to NAGS deficiency.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Carbaglu huma akbar mir- riskji tiegħu għat- trattament ta ’ l - iperammonemija minħabba defiċjenża NAGS.
The Committee recommended that Carbaglu be given marketing authorisation.
Il- Kumitat irrakkomanda li Carbaglu għandu jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Carbaglu was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it had not been possible to obtain complete information on the medicine.
Carbaglu ġie awtorizzat taħt “ Ċirkostanzi ta ’ Eċċezzjoni ”, minħabba, li billi l- marda hija rari, ma kienx possibbli li jinkiseb tagħrif komplut fuq il- mediċina.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 26 June 2006.
Billi l- kumpanija pprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkostanzi ta 'Eċċezzjoni" ntemmu fis- 26 ta' Ġunju 2006.
Other information about Carbaglu:
Tagħrif ieħor dwar Carbaglu:
The European Commission granted a marketing authorisation valid throughout the European Union for Carbaglu to Orphan Europe on 24 January 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Carbaglu lil Orphan Europe fl- 24 ta ’ Jannar 2003.
The marketing authorisation was renewed on 24 January 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 24 ta ’ Jannar 2008.
The record of Carbaglu’ s designation as an orphan medicine is available here.
Ir- reġistru tan- nominazzjoni ta ’ Carbaglu bħala mediċina orfni huwa disponibbli minn hawn.
The full EPAR for Carbaglu is available here.
L- EPAR sħiħ għal Carbaglu jista ’ jiġi kkonsultat hawn.
This summary was last updated in 04-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
SUMMARY OF PRODUCT CHARACTERISTICS
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
Carbaglu 200 mg dispersible tablets
Carbaglu 200 mg pilloli li jinfirxu
Each tablet contains 200 mg of carglumic acid.
Kull pillola fiha 200 mg ta ’ carglumic acid.
For a full list of excipients, see section 6.1
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Dispersible tablet The tablets are white and elongated with three score marks.
Il- pilloli huma bojod u mtawwlin bi tlett ixquq.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ żewġ partijiet ugwali
Treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency.
Trattament ta ’ iperammonemija kkawżata minħabba nuqqas ta ’ N- acetylglutamate synthase.
Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
It- trattament b’ Carbaglu għandu jinbeda taħt is- superviżjoni ta ’ tabib b’ esperjenza fit- trattament ta ’ disturbi tal- metaboliżmu.
Based on clinical experience, the treatment may be started as early as the first day of life.
Skond l- esperjenza klinika, it- trattament jista ’ jinbeda minn kmieni sa mill- ewwel jum ta ’ ħajja.
The initial daily dose should be 100 mg/ kg, up to 250 mg/ kg if necessary.
Id- doża inizjali tal- bidu għandha tkun ta ’ 100 mg/ kg, sa 250 mg/ kg jekk meħtieġ.
It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Imbagħad, din għandha tkun mibdula skond il- ħtieġa individwali b’ mod li jinżamm il- livell normali ta ’ ammonja fil- plażma (ara sezzjoni 4. 4).
In the long term, it may not be necessary to increase the dose according to body weight as long as adequate metabolic control is achieved; daily doses range from 10 mg/ kg to 100 mg/ kg.
Fuq medda itwal ta ’ żmien, jista ’ ma jkunx meħtieġ li tiżdied id- doża skond il- piż tal- ġisem kemm- il darba jkun qiegħed jinkiseb kontroll adegwat tal- metaboliżmu; id- dożi ta ’ kuljum ivarjaw minn 10 mg/ kg sa 100 mg/ kg.
Carglumic acid responsiveness test It is recommended to test individual responsiveness to carglumic acid before initiating any long term treatment.
Test għar- rispons għal Carglumic acid Hu rakkomandat li jsir test għar- rispons individwali għal carglumic acid qabel jingħata bidu għal xi trattament fuq medda twila ta ’ żmien.
As examples
Bħala eżempji
- In a comatose child, start with a dose of 100 to 250 mg/ kg/ day and measure ammonia plasma
- F ’ tarbija f’ koma, ibda b’ doża ta ’ 100 sa 250 mg/ kg/ kuljum u kejjel il- konċentrazzjoni ta ’ ammonja
concentration at least before each administration; it should normalise within a few hours after starting Carbaglu.
fil- plażma mill- anqas darba qabel kull għotja; Din għandha tinormalizza fi ftit siegħat wara li jibda jingħata Carbaglu.
- In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/ kg/ day
- Fuq pazjent b’ iperammonemija moderata, agħti doża ta ’ prova ta ’ 100 sa 200 mg/ kg/ kuljum għal
for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
tliet ijiem b’ għoti kostanti ta ’ proteini u kejjel b’ mod ripetut il- konċentrazzjoni ta ’ ammonja fil - plażma (siegħa qabel u siegħa wara ikla); biddel d- doża b’ mod li żżomm il- livelli normali ta ’ ammonja fil- plażma.
Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four doses to be given before meals or feedings.
Abbażi ta ’ l- informazzjoni farmakokinetika u esperjenza klinika, hu rakkomandat li d- doża totali ta ’ kuljum titqassam f’ żewġ sa erba ’ dożi li għandhom jingħataw qabel l- ikel jew it- tmiegħ.
The breaking of the tablets in halves allows most of the required posology adjustments.
Il- qsim tal - pilloli min- nofs jippermetti parti kbira mit- tibdil fil- pożoloġija meħtieġa.
Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician.
Minn daqqiet, l- użu ta ’ kwart ta ’ pillola jista ’ jkun utli biex tinbidel il- pożoloġija skond ir- riċetta tat- tabib.
The tablets must be dispersed in a minimum of 5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube.
Il- pilloli għandhom jinfirxu f’ minimu ta ’ 5- 10 ml ta ’ ilma u jittieħdu immedjatament jew mogħtija b’ għafsa ta ’ malajr permezz ta ’ siringa minn tubu nażogastriku.
2 4.3 Contraindications
2 Is- sospensjoni għandha togħma ftit aċiduża.
Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
4. 3 Kontra- indikazzjonijiet
4.4 Special warnings and precautions for use
It- treddigħ waqt l- użu ta ’ carglumic acid hu kontra- indikat (ara sezzjonijiet 4. 6 u 5. 3).
Therapeutic monitoring Plasma levels of ammonia and amino acids should be maintained within normal limits.
Monitoraġġ terapewtiku Il- livelli ta ’ ammonja u amino acids fil- plażma għandhom jinżammu fil- limiti normali.
As very few data on the safety of carglumic acid are available, systematic surveillance of liver, renal, cardiac functions and haematological parameters is recommended.
Minħabba li teżisti biss ftit informazzjoni dwar is- sigurtà ta ’ carglumic acid, hu rakkomandat li ssir sorveljanza sistematika tal- funzjonijiet tal- fwied, tal- kliewi, tal- funzjoni tal- qalb u tal- parametri ematoloġiċi.
Nutritional management Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Immaniġġjar nutrizzjonali Tista ’ tkun indikata restrizzjoni ta ’ proteini u teħid żejjed ta ’ arginine f’ każ ta ’ tolleranza baxxa ta ’ proteini.
No specific interaction studies have been performed.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
For carglumic acid no clinical data on exposed pregnancies are available.
carglumic acid l- ebda dejta klinika fuq tqalat esposti mhu disponibbli.
Animal studies have revealed minimal developmental toxicity (see section 5.3).
Studji ta ’ l- annimali rrivelaw tossiċità minima ta ’ l- iżvilupp (ara sezzjoni 5. 3).
Caution should be exercised when prescribing to pregnant women.
Għandha tiġi eżerċitata kawtela meta jiġi preskritt lil nisa tqal.
Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be present in the milk of lactating rats (see section 5.3).
Għalkemm mhux magħruf jekk carglumic acid jitnixxiex fil- ħalib uman, intwera li huwa preżenti fil - ħalib ta ’ firien li jreddgħu (ara sezzjoni 5. 3).
(see section 4.3).
Għalhekk, it- treddigħ waqt l- użu ta ’ carglumic acid hu kontra- indikat (ara sezzjoni 4. 3).
Clinical experience has been collected in about 170 patient-years.
L- esperjenza klinika ġiet miġbura minn fuq madwar 170 patient- years,
Reported adverse reactions are listed below, by system organ class and by frequency.
Reazzjonijiet avversi rapportati huma elenkati hawn isfel, skond is- sistema tal- klassifika ta ’ l- organi u skond il- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100).
Il- frekwenzi huma mfissra bħala: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10) u mhux komuni (≥1/ 1, 000 to < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
F’ kull ragruppament ta ’ frekwenzi, effetti mhux mixtieqa huma ppreżentati skond skond is- serjetà tagħhom.
Uncommon: increased transaminases
Mhux komuni: transaminases ogħla
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common: increased sweating
Komuni: aktar tagħriq
4.9 Overdose
3 4. 9 Doża eċċessiva
In one patient treated with carglumic acid, where the dose was increased up to 750 mg/ kg/ day, symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness.
F’ pazjent wieħed trattat b’ carglumic acid, fejn id- doża żdiedet sa 750 mg/ kg/ kuljum, kien hemm sintomi ta ’ intossikazzjoni li jistgħu jiġu kkaraterizzati bħala reazzjoni simpatomimetika: takikardja, żjieda qawwija ta ’ għaraq, żjieda ta ’ tnixxija mill- bronki, żjieda fit- temperatura tal- ġisem u irrekwitezza.
These symptoms resolved once the dose was reduced.
Dawn is- sintomi waqqfu hekk kif id- doża tnaqqset.
Amino acids and derivatives; ATC code:
Aċidi aminiċi u derivati; Kodiċi ATC:
Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Carglumic acid hu strutturalment analogu għal N- acetylglutamate, li hu attivatur, preżenti b’ mod naturali, ta ’ carbamoyl phosphate synthetase, l- ewwel enżima fiċ- ċiklu ta ’ l- urea.
Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase.
In vitro, instab li carglumic acid jattiva carbamoyl phosphate synthetase fil- fwied.
Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Minkejja l- affinità aktar baxxa ta ’ carbamoyl phosphate synthetase għal carglumic acid milli għal N- acetylglutamate, in vivo instab li carglumic acid jistimula carbamoyl phosphate synthetase u li hu ħafna aktar effettiv minn N- acetylglutamate biex iħares kontra l- intossikazzjoni bl- ammonja fil- firien.
This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for N- acetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
Dan jista ’ jkun spjegat permezz ta ’ l- osservazzjonijiet li ġejjin: i) Ir- rita mitokondrijali hi aktar permeabbli għal carglumic acid milli għal N- acetylglutamate. ii) Carglumic acid hu aktar reżistenti minn N- acetylglutamate għall- idroliżi minn aminoacylase preżenti fis- cytosol.
Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Studji oħra li saru fuq il- firien taħt kundizzjonijiet sperimentali differenti wasslu għal żjieda fid - disponibilità ta ’ l- ammonja (nuqqas ta ’ ikel, dieta mingħajr proteini jew b’ ħafna proteini).