qanastek/EMEA-V3 huggingface dataset:
Following intravenous administration in rats, sapropterin dihydrochloride is mainly excreted in the urine.
Wara l- injezzjoni fil- vini tal- ġrieden, sapropterin dihydrochloride hu prinċipalment imneħħi fl- urina.
Following oral administration it is mainly eliminated through faeces while a small proportion is excreted in urine.
Wara l- għoti mill- ħalq hu prinċipalment imneħħi fil- purgar filwaqt li proporzjon zgħir huwa mneħħi fl- awrina.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology (CNS, respiratory, cardiovascular, genitourinary), and toxicity to reproduction.
Taghrif ta ’ qabel l- użu kliniku bbażat fuq studji konvenzjonali ta ’ sigurta ’ farmakoloġika (Sistemi nervus, respiratorja, kardjovaskolari, ġenitourinarja) juru li ma kien hemm l- ebda periklu għal - bniedem u tossiċita ’ waqt riproduzzjoni.
An increased incidence of altered renal microscopic morphology (collecting tubule basophilia) was observed in rats following chronic oral administration of sapropterin dihydrochloride at exposures at or slightly above the maximal recommended human dose.
Inċidenza ogħla ta ’ difetti fil- morfoloġija mikroskopika tal- kliewi (basophilia fit- tubi fejn tinġabar l - awrina) ġiet osservata fi ġrieden wara l- għoti għal xi żmien mill- ħalq ta ’ sapropterin dihydrochloride f’ livelli tal- massimu tad- doża irrakkomandata fil- bniedem, jew ftit ogħla.
Sapropterin was found to be weakly mutagenic in bacterial cells and an increase in chromosome aberrations was detected in Chinese hamster lung and ovary cells.
Sapropterin instab li kien mutaġenikament fjakk fiċ- ċelluli batterjoloġiċi u żieda f’ aberazzjonijiet kromosomiċi ġiet innutata fiċ- ċelluli pulmonari u ovari tal- ġurdien Ċiniż.
However, sapropterin has not been shown to be genotoxic in the in vitro test with human lymphocytes as well as in in vivo micronucleus mouse tests.
Pero ’, s- sapropterin ma ’ intwerix li hu ġenotossiku u dan kemm fi provi in vitro bl- limfoċiti umani u lanqas fi provi fuq mikronuklei in vivo fi ġrieden.
No tumorigenic activity was observed in an oral carcinogenicity study in mice at doses of up to 250 mg/ kg/ day (12.5 to 50 times the human therapeutic dose range).
Ma ġietx innutata l- ebda attivita ’ tumoriġenika fi studju karċinoġenitiku fil- ġrieden b’ dozi mill- ħalq sa 250 mg/ kg/ kuljum (12. 5 sa 50 darba aktar mill- medda ta ’ doża terapewtika għal bniedem).
Emesis has been observed in both the safety pharmacology and the repeated-dose toxicity studies.
Rimettar ġie osservat kemm fil- farmakoloġija tas- sigurta ’ u kemm fi studji fuq tossiċita ’ wara dożi ripetuti.
Emesis is considered to be related to the pH of the solution containing sapropterin.
Ir- rimettar huwa kkunsidrat li huwa relatat ma ’ pH tas- soluzzjoni li jkun fiha sapropterin.
No clear evidence of teratogenic activity was found in rats and in rabbits at doses of approximately 3 and 10 times the maximum recommended human dose, based on body surface area.
Ma instabet l- ebda prova ċara ta ’ attivita ’ teratoġenika fi ġrieden u fi fniek b’ dożi bejn wieħed u ieħor 3 sa 10 darbiet id- doża massima rrakkomandata għal bniedem, ibbażata fuq l- erja tas- superfiċje tal - ġisem.
Mannitol (E421) Calcium hydrogen phosphate, anhydrous Crospovidone type A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Mannitol (E421) Calcium hydrogen phosphate, anhydrous Crospovidone tip A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Store below 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°C.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sewwa sabiex tilqa ’ mill- umdita ’.
High-density polyethylene (HDPE) bottle with child-resistant closure.
Flixkun tal- politilena ta ’ densita għolja (HDPE) protett biex ma jiftħuhx it- tfal.
The bottles are sealed with an aluminium seal.
Il- fliexken huma ssiġilati b’ siġill ta ’ l- aluminju.
Each bottle of Kuvan contains a small plastic tube of desiccant (silica gel).
Kull flixkun ta ’ Kuvan fih tubu tal- plastiku żgħir mimli dessikant (ġel siliċiku).
Each bottle contains 30, 120 or 240 tablets.
9 Kull flixkun fih 30, 120 jew 240 pillola.
1 bottle per carton.
Flixkun wieħed f’ kull kartuna.
Handling
Immaniġġar ieħor
250 64293 Darmstadt Germany
250 64293 Darmstadt Ġermanja
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF REVISION OF THE TEXT
DATA TA ’ L- EWWEL AWTORIŻŻAZZJONI/ TIĠDID TA ’ L- AWTORIŻŻAZZJONI
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija dwar il- Mediċini Ewropeja (EMEA) http: // www. emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIŻŻAZZJONI TA 'MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIŻŻAZZJONI GĦAT - TQEGĦID FIS- SUQ
Name and address of the manufacturer(s) responsible for batch release
Isem u Indirizz tal- Manifattur responsabbli għal ħruġ tal- lott
250 64293 Darmstadt Germany
Merck KGaA Frankfurter Str. 250 64293 Darmstadt Ġermanja
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIŻŻAZZJONI 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 TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS - SUQ
Medicinal product subject to restricted medical prescription.
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta 'Farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta' farmakoviġilanza kif deskritta fil- verżjoni 4. 0 preżentata fil - Mudell 1. 8. 1 tal- Applikazzjoni għall Awtoriżżazzjoni għat- tqegħid fis- suq, hija f' postha u taħdem, kemm qabel u kemm waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan l’ iManniġjar tar- Riskju L- MAH jimpenja ruħu li jagħmel l- istudji u l- attivitajiet addizzjonali ta 'farmakoviġilanza imsemmija fil- Pjan ta' Farmakoviġilanza, kif miftiehem fil- verżjoni 1. 3 tal- Pjan dwar l’ iManiġġjar tar- Riskju (RMP) preżentat fil- Mudell 1. 8. 2 tal- Applikazzjoni għall- Awtoriżżazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti tal- RMP miftehma mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- linji ta 'gwida CHMP fuq is- Sistemi dwar il- Maniġġjar ta' Riskju għal prodotti mediċinali użati mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin mar- Rapport tas- Sigurta ’ Aġġornat Perjodikament (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Rapport RMP għandu jiġi ppreżentat ukoll: • Meta tirriżulta informazzjoni ġdida li jista ’ jkollha effett fuq l- iSpeċifikazzjoni tas- Sigurta ’ kurrenti, fuq il- Pjan ta 'Farmakoviġilanza jew fuq attivitajiet għat- tnaqqis tar- riskji. • Fi żmien 60 ġurnata wara li tkun intlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis tar- riskji) • Fuq talba ta ’ l- EMEA.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Kuvan 100 mg soluble tablets Sapropterin dihydrochloride
Kuvan 100 mg pilloli li jinħallu Sapropterin dihydrochloride
Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Kull pillola li tinħall fiha 100mg ta ’ sapropterin dihydrochloride (ekwivalenti għal 77 mg ta ’ sapropterin dihydrochloride)
30 soluble tablets 120 soluble tablets 240 soluble tablets
30 pilloli li jinħallu 120 pilloli li jinħallu 240 pilloli li jinħallu
Oral use, after dissolution.
Użu orali, wara li tinħall il- pillola.
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal
Each bottle of Kuvan contains a small plastic tube of desiccant (silica gel).
Kull flixkun ta ’ Kuvan fih tubu tal- plastiku żgħir ta ’ desikkant (ġel siliċiku). Tiblax it- tubu jew il - kontenut.
Do not swallow the tube or the contents.
DATA TA ’ META JISKADI
8.
JIS
SPECIAL STORAGE CONDITIONS
15 Żomm il- flixkun magħluq sewwa sabiex tilqa ’ mill- umdita ’
What Kuvan is and what it is used for 2.
X’ inhu Kuvan u għalxiex jintuża 2.
Before you take Kuvan 3.
Qabel ma ’ tieħu Kuvan 3.
How to take Kuvan 4.
Kif għandek tieħu Kuvan 4.
How to store Kuvan 6.
Kif taħżen Kuvan 6.
WHAT KUVAN IS AND WHAT IT IS USED FOR
X’ INHU KUVAN U GĦALXIEX JINTUŻA
Kuvan is a synthetic copy of a body’ s own substance called tetrahydrobiopterin (BH4).
Kuvan hu kopja sintetika ta ’ sustanza prodotta mill- ġisem magħrufa bħala tetrahydrobiopterin (BH4).
BH4 is required by the body to use an amino acid called phenylalanine in order to build another amino acid called tyrosine.
Il- ġisem għandu bżonn il- BH4 sabiex jiġi uzat amino aċidu imsejjaħ phenylalanine sabiex jinbena amino aċidu ieħor jismu tyrosine.
Kuvan is used for the treatment of hyperphenylalaninaemia (HPA) or phenylketonuria (PKU), due to abnormally high levels of phenylalanine in the blood, which can be harmful.
Kuvan huwa użat għall- kura ta ’ hyperphenylalaninaemia (HPA) jew phenylketonuria (PKU), minħabba livelli għolja mhux normali ta ’ phenylalanine fid- demm, li jistgħu jkunu ta ’ ħsara.
Kuvan reduces these levels in some patients who respond to BH4 and can help increase the amount of phenylalanine that can be included in the diet.
Kuvan inaqqas dawn il- livelli f’ xi pazjenti li jirreaġixxu għal BH4 u jista ’ jgħin biex jiżdied l- ammont ta ’ phenylalanine li jista ’ jkun hemm fid- dieta.
Kuvan is also used for the treatment of an inherited disease called BH4 deficiency, in which the body cannot produce enough BH4.
Kuvan huwa użat ukoll għall- kura ta ’ marda ereditarja imsejħa defiċjenza BH4, fejn il- ġisem ma ’ jipproduċix biżżejjed BH4.
Because of very low BH4 levels phenylalanine is not used properly and its levels rise, resulting in harmful effects.
Minħabba livelli baxxi ħafna ta ’ BH4, il- phenylalanine ma ’ jkunx immetaboliżżat sew u l- livelli tiegħu jogħlew, li jġibu effetti ħżiena.
By replacing the BH4 that the body cannot produce, Kuvan reduces the harmful excess of phenylalanine in the blood and increases the dietary tolerance to phenylalanine.
Bir- rimpjazzament tal- BH4 li l - ġisem ma ’ jistax jipproduċi, Kuvan inaqqas il- ħsara li jagħmel il- ħafna phenylalanine fid- demm u jżid it- tolleranza fid- dieta għal phenylalanine.
BEFORE YOU TAKE KUVAN
QABEL MA ’ TIEĦU KUVAN
Do not take Kuvan If you are allergic (hypersensitive) to sapropterin or any of the other ingredients of Kuvan.
Tieħux Kuvan Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sapropterin jew sustanzi oħra ta ’ Kuvan.
Take special care with Kuvan You should consult your doctor:
Oqgħod attent ħafna b’ Kuvan Għandek tikkonsulta lit- tabib tiegħek:
- if your child that was prescribed Kuvan is under 4 years of age
- jekk it- tifel/ tifla ta ’ eta ’ inqas minn 4 snin ingħataw riċetta għal Kuvan
- if you are 65 years of age or older
- jekk għandek 65 jew aktar
- if you have problems with your kidney or liver
- jekk għandek problemi fil- kliewi jew fil- fwied
- if you are ill.
- jekk int marid.
Consultation with a physician is recommended during illness as blood
Wieħed għandu jkellem lit- tabib jekk ikun ma jiflaħx minħabba li l- livelli ta ’
phenylalanine levels may increase
phenylalanine fid- demm jistgħu jogħlew.
- if you have predisposition to convulsions
- jekk għandek predisposizzjoni għall- aċċessjonijiet
- if you are using any of the medicines listed below under “ Taking other medicines”
- jekk qed tuża xi mediċina msemmija hawn taħt (fis- sezzjoni) ‘ Meta tieħu Mediċini oħra ’
18 When you are treated with Kuvan, your doctor will test your blood to verify how much phenylalanine and tyrosine it contains and may decide to adjust the dose of Kuvan or your diet if needed.
Meta tkun ikkurat b’ Kuvan, it- tabib tiegħek jagħmillek eżami tad- demm sabiex jivverifika kemm fih phenylalanine u tyrosine u jista ’ jiddeċidi li jaġġusta d- doża ta’ Kuvan jew id- dieta tiegħek jekk ikun hemm bżonn.
You must continue your diet treatment as recommended by your doctor.
Għandek tkompli l- kura bid- dieta kif irrakkomandalek it- tabib tiegħek.
Do not change your diet without contacting your doctor.
Tbiddilx id- dieta mingħajr ma tgħid lit- tabib.
Taking other medicines You should consult your doctor if you are taking:
Meta tieħu mediċini oħra Għandek tikkonsulta mat- tabib tiegħek jekk qed tieħu:
- levodopa (used to treat Parkinson’ s disease)
- levodopa (użat fil- kura tal- Marda ta ’ Parkinson)
- inhibitors of dihydrofolate reductase (e. g. methotrexate, trimethoprim)
- inibituri ta ’ dihydrofolate reductase (eż. methotrexate, trimethoprim)
- agents that cause vasodilation, including those administered topically, by affecting nitric oxide
- mediċini li jikkawżaw vażodilatazzjoni, li jinkludu dawk li jintużaw topikament, billi jaffetwaw
(NO) metabolism or action, including the classical NO donors (such as glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP) and molsidomin), phosphodiesterase type 5 (PDE-5) inhibitors and minoxidil.
il- metaboliżmu jew l- azzjoni tal- ossidu nitriku (NO), li jinkludu d- donaturi klassiċi NO (bħal glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP) u molsidomin), inibituri ta’ phosphodiesterase tat- tip 5 (PDE- 5) u minoxidil.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok, jekk tkun qed tieħu, jew jekk dan l- aħħar tkun ħadt mediċini oħra, anki dawk mingħajr riċetta, għid lit- tabib jew lill- ispiżjar tiegħek.
Taking Kuvan with food and drink Kuvan should be taken with food at the same time each day preferably in the morning.
Meta tieħu Kuvan ma ’ l- ikel u max- xorb Kuvan għandu jittieħed ma ’ l- ikel kuljum fl- istess ħin preferibbilment filgħodu.
Pregnancy and breast-feeding For Kuvan no information is available for human pregnancies.
Tqala u treddigħ Għal Kuvan ma ’ teżisti l- ebda informazzjoni għat- tqala fil- bniedem.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, birth or postnatal development.
Studji fl- annimali ma ’ wrewx effetti ħżiena, la diretti lanqas indiretti fit- tqala, l- iżvilupp tal- fetu, it- twelid jew l- iżvilupp ta ’ wara l - ħlas.
If maternal phenylalanine levels are not strictly controlled before and during pregnancy, this could be harmful to the mother and the foetus.
Jekk l- livelli ta ’ phenylalanine fl- omm ma ’ jkunux ikkontrollati strettament qabel u waqt it- tqala, dan jista ’ jkun ta ’ dannu kemm għall- omm u kemm għall- fetu. F’ każ ta ’ tqala t- tabib jgħidlek kif tikkontrolla l- livelli ta ’ phenylalanine adegwatament.
In case of pregnancy your doctor will tell you how to control phenylalanine levels adequately.
L- ewwel pass ikun li t- tabib jissorvelja l - ammont ta ’ phenylalanine fid- dieta, qabel u waqt it- tqala.
The use of Kuvan should be considered only if strict dietary management does not adequately reduce blood phenylalanine levels.
L- użu ta ’ Kuvan għandu jiġi kkunsidrat biss jekk l- immaniġjar ta ’ dieta stretta mhix biżżejjed biex tnaqqas il- livelli ta ’ phenylalanine fid- demm.
Be sure to tell your doctor if you are pregnant or breast-feeding, if you think you might be pregnant, or if you are planning to become pregnant or are planning to begin breast-feeding.
Kun ċerta li tinforma lit- tabib tiegħek jekk inti tqila jew qed treddgħa, jew jekk taħseb li inti tqila jew jekk qed tippjana li toħrog tqila jew li tibda treddgħa.
You should not take Kuvan if you are breast-feeding.
M’ għandekx tieħu Kuvan jekk qed treddgħa.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma ’ sarux studji fuq l- effetti fuq is- sewqan u t- tħaddim ta ’ magni.
Kuvan is not expected to affect the ability to drive and use machines. '
Mhux mistenni li Kuvan jaffetwa s - sewqan u t- tħaddim ta ’ magni.
HOW TO TAKE KUVAN
KIF GĦANDEK TIEĦU KUVAN
Always take Kuvan exactly as your doctor has told you.
Dejjem għandek tieħu Kuvan eżatt skond il- parir tat- tabib.
Dosage
Dożagġ
PKU The usual starting dose of Kuvan in adult and paediatric patients with PKU is 10 mg for each kg of body weight.
19 PKU Id- doża normali tal- bidu ta ’ Kuvan f’ pazjenti adulti u pedjatriċi li jsofru bil PKU hi ta ’ 10 mg/ kg.
Take the soluble tablets as a single daily dose with a meal to increase the absorption, and at the same time each day, preferably in the morning.
Ħu l- pilloli li jinħallu bħala doża waħda għal ġurnata ma ’ ikla, sabiex jiżdied l- assorbiment u dan fl- istess ħin kuljum, preferibbilment filgħodu.
Your doctor may adjust your dose, usually between 5 and 20 mg for each kg of body weight per day, depending on your condition.
It- tabib tiegħek jista ’ jaġġusta d- doża,, normalment bejn 5 u 20 mg/ kg/ kuljum, skond il- kundizzjoni tiegħek.
19 BH4 deficiency The usual starting dose of Kuvan in adult and paediatric patients with BH4 deficiency is 2 to 5 mg for each kg of body weight.
Defiċjenza BH4 Fil- bidu, id- doża normali ta ’ Kuvan f’ pazjenti adulti u pedjatriċi li jsofru bid- defiċjenza BH4 hi minn 2 sa 5 mg/ kg.
Take the soluble tablets as a single daily dose, with a meal to increase the absorption, and at the same time each day, preferably in the morning.
Ħu l- pilloli li jinħallu bħala doża waħda għal ġurnata ma ’ ikla, sabiex jiżdied l - assorbiment u dan fl- istess ħin kuljum, preferibbilment filgħodu.
Your doctor may adjust your dose up to 20 mg for each kg of body weight per day, depending on your condition.
It- tabib tiegħek jista ’ jaġġusta d- doża tiegħek sa 20 mg/ kg/ kuljum, skond il- kundizzjoni tiegħek.
It may be necessary to divide the total daily dose into 2 or 3 doses, distributed over the day, to achieve the best therapeutic effect.
Jista ’ jkun hemm il- bżonn illi d- doża totali tal- ġurnata tiġi maqsuma f’ 2 jew 3 dozi, imqassmin tul il- ġurnata, sabiex wieħed ikollu l- aħjar effett terapewtiku.
The table below is an example of how an appropriate dose is calculated:
It- tabella hawn taħt hija eżempju ta ’ kif wieħed għandu jikkalkula d- doża xierqa:
Body weight (kg)
Piż tal- ġisem (kg)
Number of tablets
Numru ta ’ pilloli
(Kuvan dose 10 mg/ kg)
(Doża ta ’ Kuvan 10 mg/ kg)
(Kuvan dose 20 mg/ kg)
(Doża ta ’ Kuvan 20 mg/ kg)
Method of Administration
Metodu ta ’ kif għandu jingħata
Adults Place the tablets in a glass or cup (120 to 240 ml) of water and stir until dissolved.
Adulti Poġġi l- pilloli f’ tazza jew kikkra (120 sa 240 ml) ilma u ħawwad sakemm jinħallu.
Paediatric patients The prescribed number of tablets should be placed in a glass or cup (up to 120 ml) of water and stir until dissolved.
Pazjenti pedjatriċi In- numru ta ’ pilloli preskritti għandhom jitpoġġew f’ tazza jew kikkra (sa 120 ml) ilma li għandu jiġi imħawwad sakemm jinħallu.
For doses below 100 mg, one tablet should be dissolved in 100 ml of water.
Għal dożi ta ’ anqas minn 100 mg pillola waħda għandha tiġi maħlula f’ 100 ml ilma.
Your doctor will tell you to administer only a certain volume of the solution corresponding to the appropriate dose.
It- tabib tiegħek jgħidlek biex tieħu biss ċertu volum tas- soluzzjoni, li tikkorrispondi għad- doża proprja.
An accurate measuring device with suitable graduations should be used for this purpose.
Għal dan l - iskop għandu jintuża strument tal- kejl preċiż li jkollu l- marki meħtieġa.
It may take a few minutes for the tablets to dissolve.
Jista ’ jkun hemm bżonn ta ’ ftit minuti sakemm il- pilloli jinħallu.
To make the tablets dissolve faster you can crush them.
Jista ’ jagħti l- każ li wieħed jara xi frak fis- soluzzjoni.
Small particles may be visible in the solution, but they will not affect the effectiveness of the medicine.
Dawn pero ’ ma ’ jaffettwawx l - effikaċja tal- mediċina.
Drink the dissolved preparation of Kuvan with a meal, at the same time each day, preferably in the morning within 15 to 20 minutes of its preparation.
Ixrob il- preparazzjoni ta ’ Kuvan maħlul ma ’ ikla fl- istess ħin kuljum, preferibbilment filgħodu mhux aktar tard minn 15 sa 20 minuta wara li tkun tlestiet.
Make sure you do not swallow the desiccant capsule contained in the bottle.
Kun żgur li ma ’ tiblax il- kapsula dessikanti li hemm fil- flixkun.
If you take more Kuvan than you should If you take more Kuvan than prescribed, you may experience side effects that could include headache and dizziness.
Jekk tieħu Kuvan aktar milli suppost Jekk tieħu Kuvan aktar milli suppost, int tista ’ tħoss effetti mhux mixtieqa li jistgħu jinkludu uġigħ ta ’ ras u sturdament.
You should immediately contact your doctor or pharmacist if you take more Kuvan than prescribed.
Għandek tkellem lit- tabib jew spiżjar tiegħek immedjatament jekk tieħu aktar Kuvan milli suppost.
If you forget to take Kuvan Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu Kuvan M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop taking Kuvan Do not stop taking Kuvan without prior discussion with your doctor, as phenylalanine levels in the blood may increase.
20 Jekk tieqaf tieħu Kuvan Peress li l- livelli ta ’ phenylalanine fid- demm jistgħu jiżdiedu, tieqafx tieħu Kuvan qabel ma tiddiskuti mat- tabib tiegħek.
Like all medicines, Kuvan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kuvan jista ’ jkollu effetti sekondarji, għalkemm ma ’ jidhrux fuq kulħadd.
Frequencies of side effects are defined as:
Frekwenzi ta ’ effetti mhux mixtieqa huma definiti bħala:
- very common: affects more than 1 user in 10
- Komuni ħafna: jaffetwa iżjed minn utent f’ 10
- common: affects 1 to 10 users in 100
- Komuni: jaffetwa 1 sa 10 f’ 100 utent
- uncommon: affects 1 to 10 users in 1,000
- Mhux komuni: jaffetwa 1 sa 10 f’ 1, 000 utent
- rare: affects 1 to 10 users in 10,000
- Rari: jaffetwa 1 sa 10 f’ 10, 000 utent
- very rare: affects less than 1 user in 10,000
- Rari ħafna: jaffetwa inqas minn utent 1 f’ 10, 000 utent
- not known: frequency cannot be estimated from the available data.
- Mhux magħruf: frekwenza ma ’ tistax tiġi stmata mill- informazzjoni disponibbli.
Very common side effects: headache and runny nose.
Uġigħ ta ’ ras u flissjoni.
Common side effects: sore throat, nasal congestion or stuffy nose, cough, diarrhoea, vomiting, stomach ache and too low levels of phenylalanine in blood tests.
L- effetti mhux mixtieqa Komuni: ħruq fil- griżmejn, konġestjoni jew mnieħer imblukkat, sola, dijarea, rimettar, uġigħ fl- istonku u livelli baxxi hafna ta ’ phenylalanine kif riżultanti mit- testijiet tad - demm.
HOW TO STORE KUVAN
KIF TAĦŻEN KUVAN
Keep out of the reach and sight of children.
Żommu fejn ma ’ jintlaħaqx minn u ma ’ jidhirx għat- tfal.
Do not use Kuvan after the expiry date which is stated on the bottle and the carton after “ EXP”.
Tużax Kuvan wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna wara “ JIS ”.
Store below 25°C.
Aħżen f’ temperatura taħt 25°C.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sewwa sabiex tilqa ’ kontra l- umdita ’.
What Kuvan contains
X’ fih Kuvan
- The active substance is sapropterin dihydrochloride.
- Is- sustanza attiva hija sapropterin dihydrochloride.
Each tablet contains 100 mg of sapropterin
Kull pillola fiha 100 mg ta ’ sapropterin
dihydrochloride (equivalent to 77 mg of sapropterin).
dihydrochloride (ekwivalenti għal 77 mg ta ’ sapropterin).
- The other ingredients are mannitol (E421), calcium hydrogen phosphate anhydrous,
- Is- sustanzi l- oħra huma mannitol (E421), calcium hydrogen phosphate anhydrous, crospovidone
crospovidone type A, ascorbic acid (E300), sodium stearyl fumarate, and riboflavin (E101).
tip A, ascorbic acid (E300), sodium stearyl fumarate, u riboflavin (E101).
What Kuvan looks like and contents of the pack
21 Id- dehra ta ’ Kuvan u l- kontenuti tal- pakkett
Kuvan is supplied as soluble tablets.
Kuvan huwa fornut bħala pilloli li jinħallu.
The soluble tablets are off-white to light yellow and have “ 177 ” imprinted on one face.
Il- pilloli huma ta ’ kulur li jvarja minn abjad b’ xeħta ta ’ griż u isfar sa isfar ċar u għandhom in- numru ‘ 177 ’ immarkat fuq naħa waħda.
It may be available in bottles with child-resistant closure of 30, 120 or 240 soluble tablets.
Jista ’ jkun disponibili fi fliexken ta ’ 30, 120 jew 240 pilloli jinħallu, protetti kontra il- ftuħ mit- tfal,.
Each bottle contains a small plastic tube of desiccant (silica gel).
Kull flixkun fih tubu tal- plastiku żgħir b’ desikkant (ġel siliċiku).
21 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq u l- Manifattur
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtoriżżazzjoni għat- tqegħid fis- suq.
Eesti Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
22 Eesti Österreich Merck Serono Esindaja
Latvija Merck Serono Pā rstā vniecī ba C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kauņ a, Lietuva Tel: +370 37320603
23 Latvija Merck Serono Pārstāvniecība C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kauņa, Lietuva Tel: +370 37320603
23 This leaflet was last approved in
Dan il- fuljett ġie approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) web site: http: // www. emea. europa. eu.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll ‘ links ’ għal siti elettroniċi dwar mard rari u kura għalihom.
London, 23 October 2008 Doc.
Londra, 23 ta ’ Ottubru 2008 Dok.
EMEA/ 522632/ 2008
EMEA/ 605937/ 2008
Questions and answers on the withdrawal of the marketing application for Lacosamide Pain UCB Pharma
Mistoqsija u Tweġiba dwar l- irtirar tal- applikazzjoni għat- tqegħid fis- suq għal Lacosamide Pain UCB Pharma
International non-proprietary name (INN): lacosamide
Denominazzjoni Komuni Internazzjonali (DKI): lacosamide
On 25 September 2008, UCB Pharma S. A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.
Fil- 25 ta ’ Settembru 2008, UCB Pharma S. A. uffiċjalment għarrfet lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis- suq għal Lacosamide Pain UCB Pharma, għat- trattament ta ’ l- uġigħ tan- newropatija diabetika fl- adulti.
What is Lacosamide Pain UCB Pharma?
X’ inhu Lacosamide Pain UCB Pharma?
Lacosamide Pain UCB Pharma contains the active substance lacosamide.
Lacosamide Pain UCB Pharma fih is- sustanza attiva lacosamide.
It was to be available as tablets.
Huwa disponibbli bħala pilloli.
Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.
Lacosamide ġie awtorizzat fl- Unjoni Ewropea (UE) bħala mediċina antiepilettika taħt l- isem kummerċjali Vimpat f’ Awwissu 2008.
What was Lacosamide Pain UCB Pharma expected to be used for?
Għal xiex kien mistenni li jintuza Lacosamide Pain UCB Pharma?
Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Lacosamide Pain UCB Pharma kien mistenni li jintuża f’ adulti biex jittratta l- uġigħ li jirriżulta minn newropatija periferali diabetika (ħsara fin- nervituri fl- estremitajiet li jistgħu jiġru f’ pazjenti li jbatu mid- dijabete).
How is Lacosamide Pain UCB Pharma expected to work?
Kif kien mistenni li jaħdem Lacosamide Pain UCB Pharma?
The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Għadu mhuwiex ċar il- mod eżatt kif jaħdem lacosamide iżda jidher li dan inaqqas l- attività tal- kanali tas- sodju (pori fil- wiċċ taċ- ċelloli tan- nervituri) li jippermettu li ssir it- trażmissjoni ta ’ impulsi elettriċi bejn iċ- ċelloli tan- nervituri.
Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Lacosamide huwa maħsub ukoll li huwa involut fl- iżvilupp ta ’ ċelloli tan - nervituri li tkun saritilhom il- ħsara.
Together, these actions are expected to prevent abnormal electrical activity in nerve cells, reducing pain due to nerve damage.
Flimkien, dawn l- azzjonijiet huma mistennija li jimpedixxu l - attività elettrika mhux normali fiċ- ċelloli tan- nervituri, biex b’ hekk jitnaqqas l- uġigħ minħabba ħsara fin- nervituri.
The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.
L- effetti ta 'Lacosamide Pain UCB Pharma għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil- bniedem.
The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies.
L- effikaċja tat- tliet dożi ta ’ Lacosamide Pain UCB Pharma (200, 400 u 600 mg kuljum) tqabblet ma dik tal- plaċebo (trattament finta) f’ total ta ’ 1, 724 pazjent f’ erba ’ studji ewlenin.
In all four studies, the dose of Lacosamide Pain UCB Pharma was increased gradually over a few weeks before being maintained at a stable dose for 12 weeks.
Fl- erba ’ studji, id- doża ta ’ Lacosamide Pain UCB Pharma ġie miżjud bilmod fuq perjodu ta ’ ftit ġimgħat qabel ma ’ inżamm bħala doża stabbli għal 12- il ġimgħa.
The main measure of effectiveness was the change in pain levels between the start of the study and the last four weeks on the stable dose.
Il- kejl ewlieni tal- effikaċja kien il- bidla fil- livelli ta ’ uġigħ bejn il- bidu tal- istudju u l- aħħar erba ’ ġimgħat bid- doża stabbli.
Pain was measured by the patients on an 11-point scale.
L- uġigħ tkejjel mill- pazjenti fuq skala bi 11- il punt.
The application was at day 181 when the company withdrew.
L- applikazzjoni kienet waslet f' jum 181 meta l- kumpanija rtiratha.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Ladarba l- kumpanija tkun ippreżentat it- tweġibiet tagħha għall- mistoqsijiet imressqa, is -
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.
Skond l- analiżi tad- dejta u t- tweġiba tal- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP, fi żmien l - irtirar, is- CHMP kellu xi tħassib u kellu opinjoni proviżorja li Lacosamide Pain UCB Pharma ma setax jiġi approvat għat- trattament tal- uġigħ li jirriżulta minn newropatija dijabetika fl- adulti.
The CHMP was concerned that the studies had not shown a meaningful benefit of Lacosamide Pain UCB Pharma.
Is- CHMP kien mħasseb dwar il- fatt li l- istudji ma kinux urew benefiċċju sinifikanti ta ’ Lacosamide Pain UCB Pharma.
The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.
Il- mediċina tista ’ tikkawża wkoll effetti sekondarji li jaffettwaw il- qalb u s- sistema nervuża ċentrali (bħal sturdament), li huma ta ’ tħassib f’ pazjenti bid- dijabete.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Lacosamide Pain UCB Pharma had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'Lacosamide Pain UCB Pharma ma kienx intwera biżżejjed u li kwalunkwe benefiċċji li seta' kellu ma kinux jegħlbu r- riskji identifikati.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar ta 'l- applikazzjoni tista ’ tiġi kkonsultata hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?
X' inhuma l- konsegwenzi ta 'l- irtirar għal dawk il- pazjenti li kienu involuti fi provi kliniċi jew programmi ta' użu b’ kumpassjoni bl- użu ta ’ Lacosamide Pain UCB Pharma?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
Il- kumpanija għarrfet lis- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li jkunu għaddejjin minn provi kliniċi jew programmi ta ’ użu b’ kumpassjoni b’ Lacosamide Pain UCB Pharma.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi prova klinika jew fi programm ta 'użu b’ kumpassjoni u tixtieq iżjed tagħrif dwar it - trattament tiegħek, ikkuntattja lit- tabib li jkun qed jagħtik dan it- trattament.
What is happening with Vimpat used for the treatment of epilepsy?
X’ isir b’ Vimpat li jintuża fit- trattament ta ’ l- epilessija?
This withdrawal has no consequences on Vimpat, for which the balance of benefits and risks remains unchanged.
Dan l- irtirar ma jaffettwax Vimpat, li l- bilanċ bejn il- benefiċċji u r- riskji tiegħu jibqa l- istess.
EPAR summary for the public
Sommarju ta 'l- EPAR g all- pubbliku
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat g al Prodotti Medi inali g all- U u mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jaslu g ar- rakkomandazzjonijiet tag hom dwar kif tintu a l- medi ina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti te tie aktar informazzjoni dwar il- kundizzjoni medika tieg ek jew it- trattament tieg ek, aqra l- Fuljett ta 'Tag rif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispi jar tieg ek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abba i tar- rakkomandazzjonijiet ta 'CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Lantus?
X' inhu Lantus?
Lantus is a clear solution for injection containing the active substance insulin glargine.
Lantus huwa soluzzjoni ara g al injezzjoni li fiha s- sustanza attiva insulina glargine.
It is supplied in vials, cartridges, cartridges for OptiClik, or pre-filled disposable pens (OptiSet and SoloStar).
Hija ti i f' kunjetti, skrata, skrata g al OptiClik, jew pinen mimlijin minn qabel li jintremew wara l- u u (OptiSet u SoloStar).
What is Lantus used for?
G alxiex jintu a Lantus?
Lantus is used to treat adults, adolescents and children aged six years or older with diabetes mellitus, when they need insulin.
Lantus jintu a biex g at- trattament ta 'adulti, adolexxenti u tfal minn sitt snin jew akbar li jabtu mid - dijabete mellitu, meta jkollhom b onn l- insulina.
The medicine can only be obtained with a prescription.
Il- medi ina tinkiseb biss permezz ta 'ri etta ta' tabib.
How is Lantus used?
Kif jintu a Lantus?
Lantus is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder).
Lantus jing ata permezz ta 'injezzjoni ta t il - ilda addominali (aqq), il- koxxa, jew fir- re jun deltojde (spalla).
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Il- punt ta 'l- injezzjoni g andu jinbidel ma' kull injezzjoni biex ikun evitat tibdil fil - ilda (b al t axxin) li jista 'j ieg el lill- insulina ma ta dimx tajjeb daqs kemm mistenni.
The patient ’ s blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Il- gluko ju fid- demm tal- pazjent (zokkor) g andu jkun ittestjat regolarment biex tinsab l- aktar do a baxxa effettiva.
Lantus is given once daily at any time during the day provided that it is the same time each day.
Lantus ting ata darba kuljum fi kwalunkwe in matul il- jum bil- kundizzjoni li dan isir dejjem fl- istess in tal - jum.
This should be in the evening when used in children.
Fit- tfal dan g andu jkun filg axija.
Lantus can also be given together with anti-diabetes medicines taken by mouth in patients who have non-insulin-dependent diabetes (type 2 diabetes).
Lantus tista 'ting ata wkoll flimkien ma' medi ini kontra d - dijabete mog tijin mill - alq f' pazjenti li g andhom id- dijabete u li mhumiex dipendenti fuq l- insulina (dijabete tip 2).
How does Lantus work?
Kif ja dem Lantus?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Id- dijabete hija marda li biha l - isem ma jipprodu ix bi ejjed insulina biex jikkontrolla l- livell tal - gluko ju fid- demm jew meta l - isem ma jkunx kapa i ju a l- insulina b' mod effika i.
Lantus is a replacement insulin that is very similar to the insulin made by the pancreas.
Lantus hija insulina ta 'sostituzzjoni li hija simili g all- insulina mag mula mill- frixa (pankreas).
The active substance in Lantus, insulin glargine, is produced by a method known as ‘ recombinant technology’.
Is- sustanza attiva f' Lantus, insulina glargine, hija mag mula permezz ta 'metodu mag ruf b ala' teknolo ija rikombinanti '.
It is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.
Hija mag mula minn batterju li r ieva ene (DNA), li jag mlu kapa i jipprodu i insulina glargine.
Insulin glargine is very slightly different from human insulin.
L- insulina glargine hija ftit biss differenti mill- insulina tal- bniedem.
The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Il- bidla tfisser li hija assorbita aktar bil- mod u regolari mill - isem wara injezzjoni, u li g andha tul ta 'mien ta' azzjoni itwal.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L - insulina ta 'sostituzzjoni ta ixxi bl- istess mod b al insulina mag mula naturalment u tg in il- gluko ju jid ol fi - elluli mid- demm.
By controlling blood glucose levels, the symptoms and complications of diabetes are reduced.
Billi tikkontrolla l- livelli ta 'gluko ju fid- demm, is- sintomi u l - kumplikazzjonijiet tad- dijabete jonqsu.
Reproduction is authorised provided the source is acknowledged How has Lantus been studied?
Reproduction is authorised provided the source is acknowledged Kif iet studjata Lantus?
Lantus was originally studied in 10 studies, in both type 1 and type 2 diabetes.
Lantus kien ori inarjament studjat f' 10 studji, kemm f' dijabete tat- tip 1 kif ukoll tat- tip 2.
A total of 2,106 patients received Lantus in all trials combined.
Total ta '2, 106 pazjenti r evew Lantus fil- provi kollha kkombinati.
The main studies compared Lantus given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day.
L- istudji ewlenin qabblu Lantus mog ti darba kuljum fil - in ta 'qabel l- irqad ma' insulina tal- bniedem NPH (insulina b' azzjoni intermedja) mog ti darba jew darbtejn kuljum.
Injections of fast-acting insulin were also used at mealtimes.
L- injezzjonijiet ta 'l- insulina b' azzjoni immedjata ntu aw ukoll fil - inijiet ta' l- ikel.
In one study, patients with type 2 diabetes also received anti-diabetes medicines by mouth.
Fi studju wie ed, pazjenti b' dijabete tat- tip 2 ir evew oralment ukoll medi ini kontra d- dijabete.
Further studies were carried out to compare Lantus and human insulin NPH in children and adolescents aged between five and 18 years, 200 of whom received Lantus.
Saru aktar studji biex iqabblu Lantus u insulina tal- bniedem NPH fi tfal u adolexxenti ta 'etajiet bejn amsa u 18- il sena, 200 minnhom ir evew Lantus.
Studies were also carried out in nearly 1,400 adult patients with type 1 or type 2 diabetes to measure the effectiveness of Lantus injected at any time during the day, compared with an evening injection.
Saru wkoll studji fi kwa i 1, 400 pazjent b' dijabete tat- tip 1 u tat- tip 2 biex ikejlu l- effika ja ta 'Lantus injettata fi kwalunkwe in tal- jum, imqabbla ma' injezzjoni filg axija.
All of the studies measured the level of ‘ fasting’ blood glucose (measured after not eating for at least eight hours) or of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
L- istudji kollha kejlu l- livell ta 'gluko ju fid- demm' fi stat ta 'sawm' (imkejjel wara li ma jitti idx ikel g al ta 'l- inqas tmien sig at) jew ta' sustanza fid- demm mag rufa b ala emoglobina glikosilata (HbA1c), li tag ti indikazzjoni fuq kemm ikun qieg ed ji i kkontrollat tajjeb il- gluko ju fid- demm.
What benefit has Lantus shown during the studies?
Liema benefi ju wera Lantus waqt l- istudji mwettqa?
Lantus led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin.
Lantus wassal g al tnaqqis fil- livell ta 'HbA1c, u dan jindika li l- livelli tal- gluko ju fid- demm kienu ew ikkontrollati g al livell simili g al dak li jidher b' insulina tal- bniedem.
Lantus was effective for both type 1 and type 2 diabetes.
Lantus kien effika i kemm g ad- dijabete tat- tip 1 kif ukoll g as- dijabete tat- tip 2.
However, there were too few children aged below six years to determine the medicine ’ s effectiveness in this group.
Madankollu, kien hemm ftit wisq tfal ta t l- età ta 'sitt snin biex tkun stabbilita l- effika ja tal- medi ina f' dan il- grupp.
The effectiveness of Lantus was seen regardless of the time of the injection.
L- effika ja ta 'Lantus dehret indipendentement mill - in ta' l- injezzjoni.
What is the risk associated with Lantus?
X' inhu r- riskju asso jat ma 'Lantus?
The most common side effect with Lantus (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
L- aktar effett sekondarju komuni b' Lantus (deher f' aktar minn pazjent 1 minn kull 10) huwa ipogli emija (livelli baxxi ta 'gluko ju fid- demm).
Reactions at the site of the injection (redness, pain, itching and swelling) have been seen more often in children than in adults.
Reazzjonijiet fil- punt ta 'l- injezzjoni (mura, u ig, akk u nef a) dehru aktar ta' spiss fit- tfal milli fl- adulti.
For the full list of all side effects reported with Lantus, see the Package Leaflet.
G al- lista s i a ta 'l- effetti sekondarji kollha rrapportati b' Lantus, ara l- Fuljett ta' Tag rif.
Lantus should not be used in people who may be hypersensitive (allergic) to insulin glargine or to any of the other ingredients.
Lantus m' g andux jintu a f' persuni li jistg u jkunu ipersensittivi (aller i i) g al insulina glargine jew g al kwalunkwe mis- sustanzi attivi l- o rajn.
Lantus doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Do i ta 'Lantus jistg u wkoll je tie u li ji u a ustati meta mog tijin ma' xi medi ini o rajn li jista 'jkollhom effett fuq il- livelli ta' gluko ju fid- demm.
The full list is available in the Package Leaflet.
Il - lista s i a tinsab fil- Fuljett ta 'Tag rif.
Why has Lantus been approved?
G aliex iet approvata Lantus?
The Committee for Medicinal Products for Human Use (CHMP) decided that Lantus’ s benefits are greater than its risks for the treatment of adults, adolescents and children of six years or above with diabetes mellitus, where treatment with insulin is required.
Il- Kumitat g all- Prodotti Medi inali g al U u mill- Bniedem (CHMP) idde ieda li l- benefi ji ta 'Lantus huma akbar mir- riskji tieg u g at- trattament ta' adulti, adolexxenti u tfal ta 'sitt snin jew aktar li jbatu mid- dijabete mellitu, fejn hija me tie a kura bl- insulina.
The Committee recommended that Lantus be given marketing authorisation.
Il- Kumitat irrakkomanda li Lantus jing ata awtorizzazzjoni g at- tqeg id fis- suq.
Other information about Lantus:
Tag rif ie or dwar Lantus:
The European Commission granted a marketing authorisation valid throughout the European Union for Lantus to Sanofi-Aventis Deutschland GmbH on 9 June 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni g at- tqeg id fis- suq valida fl- Unjoni Ewropea kollha g al Lantus lil Sanofi- Aventis Deutschland GmbH fid- 9 ta 'unju 2000.
The marketing authorisation was renewed on 9 June 2005.
L- awtorizzazzjoni g at - tqeg id fis- suq iet im edda fid- 9 ta 'unju 2005.
The full EPAR for Lantus is available here.
L- EPAR s i g al Lantus jista 'ji i kkonsultat hawn.
This summary was last updated in 04-2008
Dan is- sommarju ie a
EU/ 1/ 00/ 134/ 001
Numru ta ’ l- EU EU/ 1/ 00/ 134/ 001
Lantus
Isem inventat Lantus
100 Units/ ml
Qawwa 100 Unità / ml
Solution for injection in a vial
Għamla farmaċewtika Soluzzjoni għall- injezzjoni f ’ kunjett Soluzzjoni għall- injezzjoni f ’ kunjett
Subcutaneous use
Mnejn jingħata Użu għal taħt il- ġilda Użu għal taħt il- ġilda
5 ml
Kontenut 5 ml
1 vial
Daqs tal- pakkett 1 kunjett
100 Units/ ml
100 Unità / ml
Solution for injection in a vial
Soluzzjoni għall- injezzjoni f ’ kunjett
10 cartridges
10 kunjetti
EU/ 1/ 00/ 134/ 008
EU/ 1/ 00/ 134/ 005 EU/ 1/ 00/ 134/ 006 EU/ 1/ 00/ 134/ 007 EU/ 1/ 00/ 134/ 008
Lantus
Lantus Lantus Lantus Lantus
100 Units/ ml
100 Unità / ml 100 Unità / ml 100 Unità / ml 100 Unità / ml
Solution for injection
Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni f ’ skartoċċ Soluzzjoni għall- injezzjoni
Subcutaneous use
Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda Użu għal taħt il- ġilda
cartridge (glass) in a pre- filled pen (OptiSet)
skartoċċ (ħġieġ) skartoċċ (ħġieġ) skartoċċ (ħġieġ) skartoċċ (ħġieġ) f’ pinna mimlija għal - lest (Optiset)
3 pre-filled pens
4 skartoċċi 5 skartoċċi 10 skartoċċi 3 pinnen mimlija għal- lest
cartridge (glass) in a pre- filled pen (OptiSet)
skartoċċ (ħġieġ) f’ pinna mimlija għal - lest (Optiset)
4 pre-filled pens
4 pinnen mimlija għal- lest
5 pre-filled pens
5 pinnen mimlija għal- lest
10 ml
10 pinnen mimlija għal- lest
EU/ 1/ 00/ 134/ 014
EU/ 1/ 00/ 134/ 012 EU/ 1/ 00/ 134/ 013 EU/ 1/ 00/ 134/ 014 EU/ 1/ 00/ 134/ 015 EU/ 1/ 00/ 134/ 016
Lantus
Lantus Lantus Lantus Lantus Lantus
100 Units/ ml
100 Unità / ml 100 Unità / ml 100 Unità / ml 100 Unità / ml 100 Unità / ml