qanastek/EMEA-V3 huggingface dataset:
11 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
12 għall- effetti ta ’ l- iżvilupp kien osservat b’ 3 - (valsartan) u 4 - (amlodipine) darbiet l- esponiment kliniku (bażat fuq l- AUC).
Imprida 5 mg/ 160 mg film-coated tablets
Imprida 5 mg/ 160 mg pilloli miksija b’ rita
Imprida 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Imprida 5 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 160 mg waħidhom.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
15 Pazjenti anzjani (età 65 sena jew aktar) F’ pazjenti anzjani, hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
14 Children and adolescents Imprida is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Imprida mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
16 F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
17 Li għandha titqies waqt l- użu fl- istess ħin Oħrajn Mogħti waħdu, amlodipine intuża b’ mod sigur ma ’ dijuretiċi thiazide, beta blockers, inibituri ACE, nitrati li jaħdmu fit- tul, nitrogliċerina ta ’ taħt l- ilsien, digoxin, warfarin, atorvastatin, sildenafil, mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Cardiac disorders
19 Disturbi tal- qalb
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
20 Il- medja ta ’ l- edima periferali li seħħet, meqjusa b’ mod ugwali fil- medda tad- dożi kollha kienet 5. 1% bil- kombinazzjoni amlodipine/ valsartan.
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Imprida as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- mediċina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Imprida ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqeghid fis- suq..
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
22 Valsartan ma jaħdimx bħala impeditur ta ’ ACE, magħruf ukoll bħala kininase II, li jaqleb angiotensin I f’ angiotensin II u jkisser bradykinin.
In patients not adequately controlled on amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg may achieve blood pressure control similar to amlodipine 10 mg with less oedema.
23 F’ pazjenti li mhumiex kontrollati sew fuq amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg jista ’ jwassal għal kontroll tal- pressjoni tad- demm simili għal amlodipine 10 mg b’ anqas edima.
Excretion:
24 Eskrezzjoni:
23 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
25 għall- effetti ta ’ l- iżvilupp kien osservat b’ 3 - (valsartan) u 4 - (amlodipine) darbiet l- esponiment kliniku (bażat fuq l- AUC).
For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.
26 Għas- sustanzi waħidhom ma kienx jidher li hemm effett mutaġenetiku, klastoġenetiku jew karċinoġenetiku.
24 7.
27 7.
Imprida 10 mg/ 160 mg film-coated tablets
Imprida 10 mg/ 160 mg pilloli miksija b’ rita
Imprida 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Imprida 5 mg/ 160 mg.
Imprida 10 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 10 mg jew valsartan 160 mg waħidhom jew b’ Imprida 5 mg/ 160 mg.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
29 Pazjenti anzjani (età 65 sena jew aktar) F’ pazjenti anzjani, hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
26 Children and adolescents Imprida is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Imprida mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
30 F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
31 Li għandha titqies waqt l- użu fl- istess ħin Oħrajn Mogħti waħdu, amlodipine intuża b’ mod sigur ma ’ dijuretiċi thiazide, beta blockers, inibituri ACE, nitrati li jaħdmu fit- tul, nitrogliċerina ta ’ taħt l- ilsien, digoxin, warfarin, atorvastatin, sildenafil, mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Data on a limited number of exposed pregnancies
Studji bl- annimali wrew li hemm tossiċità għas - sistema riproduttiva b’ valsartan/ amlodipine simili ma ’ dik li ġiet deskritta għal valsartan u antagonisti oħra ta ’ angiotensin II (ara sezzjoni 5. 3)..
29 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal- fetu.
Cardiac disorders
33 Disturbi tal- qalb
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
34 Il- medja ta ’ l- edima periferali li seħħet, meqjusa b’ mod ugwali fil- medda tad- dożi kollha kienet 5. 1% bil- kombinazzjoni amlodipine/ valsartan.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
36 Valsartan ma jaħdimx bħala impeditur ta ’ ACE, magħruf ukoll bħala kininase II, li jaqleb angiotensin I f’ angiotensin II u jkisser bradykinin.
In patients not adequately controlled on amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg may achieve blood pressure control similar to amlodipine 10 mg with less oedema.
37 F’ pazjenti li mhumiex kontrollati sew fuq amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg jista ’ jwassal għal kontroll tal- pressjoni tad- demm simili għal amlodipine 10 mg b’ anqas edima.
Excretion:
38 Eskrezzjoni:
35 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
39 għall- effetti ta ’ l- iżvilupp kien osservat b’ 3 - (valsartan) u 4 - (amlodipine) darbiet l- esponiment kliniku (bażat fuq l- AUC).
For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.
40 Għas- sustanzi waħidhom ma kienx jidher li hemm effett mutaġenetiku, klastoġenetiku jew karċinoġenetiku.
36 7.
41 7.
37 ANNEX II
42 ANNESS II
39 ANNEX III
44 ANNESS III
40 A.
45 A.
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Imprida 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
Imprida 5 mg/ 80 mg pilloli miksija b’ rita amlodipine/ valsartan
42 9.
47 9.
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Imprida 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Imprida 5 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
49 9.
54 9.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
51 10.
56 10.
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
53 10.
58 10.
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Imprida 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Imprida 10 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
58 10.
63 10.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
66 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
63 PACKAGE LEAFLET:
68 FULJETT TA ’ TAGĦRIF:
What Imprida is and what it is used for 2.
X’ inhu Imprida u għalxiex jintuża 2.
Before you take Imprida 3.
Qabel ma tieħu Imprida 3.
How to take Imprida 4.
Kif għandek tieħu Imprida 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Imprida 5.
WHAT IMPRIDA IS AND WHAT IT IS USED FOR
X’ INHU IMPRIDA U GĦALXIEX JINTUŻA
Imprida tablets contain two substances called amlodipine and valsartan.
Il- pilloli Imprida fihom żewġ sustanzi li jissejjħu amlodipine u valsartan.
Imprida is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Imprida jintuża sabiex jikkura l- pressjoni għolja f’ pazjenti li jkollhom il- pressjoni li ma tkunx qed tiġi kontrollata tajjeb biżżejjed b’ amlodipine jew valsartan waħidhom.
2.
QABEL MA TIEĦU IMPRIDA 2.
BEFORE YOU TAKE IMPRIDA
Tieħux Imprida
Do not take Imprida − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Imprida.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal amlodipine jew mediċini oħra tat- tip
If you think you may be allergic, talk to your doctor before taking Imprida. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal valsartan jew sustanzi oħra ta ’
If any of the above applies to you, do not take Imprida and talk to your doctor.
- Jekk għandek problemi severi tal- fwied, bħal ċirrożi tal- marrara jew kolestażi.
If any of these apply to you, tell your doctor before taking Imprida.
- Jekk għandek problemi severi tal- kliewi jew jekk qed tgħamel dijalisi.
Imprida is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
- Jekk għandek problema tal- glandoli renali li tissejjaħ “ iperaldosteroniżmu primarja ”.
The use of Imprida in children and adolescents is not recommended.
- Jekk it- tabib qallek li l- valvoli ta ’ qalbek djiequ (magħrufa bħala “ stenożi ta ’ l- aorta ” jew
Taking Imprida with food and drink You can take Imprida with or without food.
Meta tieħu Imprida ma ’ l- ikel u max- xorb Tista ’ tieħu Imprida ma ’ l- ikel jew mingħajru.
Imprida and older people Caution is required when increasing the dosage.
Imprida u pazjenti aktar anzjani Kawtela hija meħtieġa meta jkun qed jiżdied id- dożaġġ.
Usually, your doctor will advise you to take another medicine instead of Imprida, as Imprida is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Is- soltu, it - tabib tieghek javżak biex tieħu mediċina oħra minflokk Imprida, għax Imprida mhux irrakkomandat fil- bidu tat- tqala, minħabba li jista ’ jagħmel ħsara lit- tarbija tiegħek jekk jintuża wara 3 xhur tat- tqala.
An appropriate antihypertensive medication must usually replace Imprida before starting a pregnancy.
Mediċina addattata għal kontra il- pressjoni trid tibdel lil Imprida qabel tinbeda tqala.
Your doctor will normally advise you to stop taking Imprida as soon as you know you are pregnant.
It- tabib tiegħek normalment javżak biex tieqaf tieħu Imprida immedjatament kif issir taf li inti tqila.
If you become pregnant during therapy with Imprida, please inform and see your doctor without delay.
Għid u ara lit- tabib tiegħek mingħajr dewmien jekk tinqabad tqila waqt it- terapija b’ Imprida.
Treatment with Imprida is not recommended during breast- feeding.
Kura b’ Imprida mhix rakkomandata waqt it- treddigħ.
Ask your doctor or pharmacist for advice before taking any medicine.
70 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
HOW TO TAKE IMPRIDA
KIF GĦANDEK TIEĦU IMPRIDA
The usual dose of Imprida is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Imprida with or without food.
- Ikun aħjar li tieħu l- mediċina tiegħek fl- istess ħin kuljum, preferibbilment filgħodu
Do not exceed the prescribed dose.
- Tista ’ tieħu Imprida ma ’ l- ikel jew mingħajr ikel.
If you take more Imprida than you should If you have taken too many tablets of Imprida, or if someone else has taken your tablets, consult a doctor immediately.
Jekk tieħu Imprida aktar milli suppost Jekk ħadt iżżejjed mill- pilloli Imprida, jew jekk xi ħadd ieħor ħa l- pilloli tiegħek, ħu parir tat- tabib tiegħek mill- ewwel.
If you forget to take Imprida If you forget to take this medicine, take it as soon as you remember.
Jekk tinsa tieħu Imprida Jekk tinsa ’ tieħu din il- mediċina, ħudha malli tiftakar.
Like all medicines, Imprida can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Imprida jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Other possible side effects:
71 Effetti sekondarji possibli oħra:
HOW TO STORE IMPRIDA
KIF TAĦŻEN IMPRIDA
Do not use Imprida after the expiry date stated on the carton and blister.
Tużax Imprida wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Do not use any Imprida pack that is damaged or shows signs of tampering.
Tuża l- ebda pakkett ta ’ Imprida li jkun danneġġat jew li juri sinjali ta ’ tbagħbis.
What Imprida contains − The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Imprida − Is- sustanzi attivi ta ’ Imprida huma amlodipine (bħala amlodipine besylate) u valsartan.
What Imprida looks like and contents of the pack Imprida 5 mg/ 80 mg tablets are round and dark yellow with “ NVR” on one side and “ NV” on the other side.
Id- Dehra ta ’ Imprida u l- kontentuti tal- pakkett Imprida 5 mg/ 80 mg pilloli huma tondi u sofor skuri b ’ “ NVR ” fuq naħa u “ NV ” fuq in- naħa l- oħra.
Imprida is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Imprida jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b’ ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola.
Danmark Novartis Healthcare A/ S Tlf: +45 39 16 84 00
73 Danmark Novartis Healthcare A/ S Tlf: +45 39 16 84 00
69 PACKAGE LEAFLET:
74 FULJETT TA ’ TAGĦRIF:
Ask your doctor or pharmacist for advice before taking any medicine.
76 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
72 Rare (affecting less than 1 in 1,000 patients):
77 Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
Each
X’ fih Imprida − Is- sustanzi attivi ta ’ Imprida huma amlodipine (bħala amlodipine besylate) u valsartan.
What Imprida looks like and contents of the pack Imprida 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
Id- Dehra ta ’ Imprida u l- kontentuti tal- pakkett Imprida 5 mg/ 160 mg pilloli huma ovali u sofor skuri b ’ “ NVR ” fuq naħa u “ ECE ” fuq in- naħa l- oħra.
Eesti Novartis Pharma Services Inc.
79 Eesti Österreich Novartis Pharma Services Inc.
75 PACKAGE LEAFLET:
80 FULJETT TA ’ TAGĦRIF:
Ask your doctor or pharmacist for advice before taking any medicine.
82 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
78 Rare (affecting less than 1 in 1,000 patients):
83 Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
What Imprida contains − The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Imprida − Is- sustanzi attivi ta ’ Imprida huma amlodipine( bħala amlodipine besylate) u valsartan.
What Imprida looks like and contents of the pack Imprida 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
Id- Dehra ta ’ Imprida u l- kontentuti tal- pakkett Imprida 10 mg/ 160 mg pilloli huma ovali u sofor ċari b ’ “ NVR ” fuq naħa u “ UIC ” fuq in- naħa l- oħra.
Eesti Novartis Pharma Services Inc.
85 Eesti Österreich Novartis Pharma Services Inc.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
1/ 3 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritt hawn taħt għandhom jiġuu implimentati:
That at launch all physicians who are expected to prescribe INCRELEX are provided with a “ physician information pack” containing the following:
L- MAH għandu jiżgura li, mal- illanċjar, it- tobba kollha li mistennija jippreskrivu INCRELEX jiġu provduti b ’ "pakkett ta ’ informazzjoni għat- tabib" li fih dan li ġej:
Product information Physician information about INCRELEX (information card, dosing guide, and a dose calculator) Patient information pack
Tagħrif dwar il- Prodott Tagħrif għat- tabib dwar INCRELEX (kard ta ’ l- informazzjoni, gwida dwar id- doża, u kalkulatur tad- doża) Pakkett tat- tagħrif għal pazjent
• To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon. • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment. • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms. • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops. • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
It- tagħrif għat- tabib dwar INCRELEX għandu jikkonsisti mill- elementi ewlenin li ġejjin: • Li jeduka lil ġenituri dwar is- sinjali, sintomi u trattament ta ’ l- ipogliċemija, li jinkludi l- injezzjoni ta ’ glucagon. • Li pazjenti għandu jkollhom eżamijiet fuq il- widnejn, l- imnieħer u l- griżmejn kull tant żmien u meta jseħħu xi sintomi kliniċi sabiex jiġu eliminati komplikazzjonijiet potenzjali jew sabiex jibda trattament xieraq. • Sabiex isir eżami funduskopiku ta ’ rutina qabel ma jinbeda t- trattament u kull tant żmien waqt it- trattament jew kif iseħħu xi sintomi kliniċi. • INCRELEX huwa kontra- indikat fil- preżenza ta ’ neoplasja suspettuża u attiva, u t - terapija għandha titwaqqaf jekk ikun hemm evidenza li tiżviluppa n- neoplasja. • Ċaqlieq ta ’ l- epifissi tar- ras tal- femora u progressjoni ta ’ l- iskoljosi jistgħu jseħħu f’ pazjenti li jgħaddu minn tkabbir rapidu.
These conditions should be monitored during INCRELEX treatment. • To inform parents and patients that allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought. • Immunogenicity sampling information.
Dawn il- kundizzjonijiet għandhom jiġu monitorati waqt it- trattament b’ INCRELEX. • Sabiex jinforma lil ġenituri u ‘ l pazjenti li reazzjonijiet allerġiċi huma possibbli u jekk dawn iseħħu t- trattament għandu jiġi interrot u attenzjoni medika fil- pront għandha tiġi mfittxija. • Tagħrif dwar kampjuni immunoġeniċi.
The patient information about INCRELEX should contain the following information:
It- tagħrif għal pazjent dwar INCRELEX għandu jikkonsisti mit- tagħrif li ġej:
• That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects. • The signs and symptoms of hypoglycaemia.
• Li INCRELEX għandu jiġi mogħti ftit qabel jew wara xi ikla jew snekk peress li għandu effetti ipogliċmiċi bħal ta ’ l- insulina. • Is- sinjali u s- sintomi ta ’ ipogliċemija.
Instructions on the treatment of hypoglycaemia.
Struzzjonijiet dwar it- trattament ta ’ l - ipogliċemija.
That parents and caregivers should always ensure that the child has a source of sugar.
Li l- ġenituri u l- kuraturi għandhom dejjem jiżguraw li t- tfal dejjem għandhom sors ta ’ zokkor.
Instructions on the administration of glucagon should severe hypoglycaemia occur. • INCRELEX should not be administered if the patient is unable to eat for any reason.
Struzzjonijiet dwar l- għoti ta ’ glukagon jekk ikun hemm ipogliċemija severa. • INCRELEX m’ għandux jingħata jekk il- pazjent mhux kapaċi jiekol għal kwalunkwe raġuni.
The dose of INCRELEX should not be doubled to make up for one or more omitted doses. • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established. • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy. • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/ or adenoids following the beginning of treatment with INCRELEX. • To report the onset of severe headache blurred vision and associated nausea and vomiting to their physician. • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Id- doża ta ’ INCRELEX m’ għandiex tiġi rdoppjata sabiex tpatti għal doża waħda jew aktar mitlufin. • Sabiex jiġi evitat li wieħed jagħmel attivitajiet ta ’ riskju għoli (bħal attività fiżika vigoruża) f’ 2- 3 sigħat wara li jingħata d- doża, b’ mod partikolari wara l- bidu tat- trattament b’ INCRELEX, sakemm tkun ġiet stabbilita doża ta ’ INCRELEX li tkun ittollerata tajjeb. • Struzzjonijiet biex tbiddel u tnewweb is- sit ta ’ l- injezzjoni għal kull injezzjoni sabiex tevita l- iżvilupp ta ’ lipoipertrofija. • Struzzjonijiet biex tirraporta l- bidu jew it- tiħżin ta ’ nħir li jista ’ jindika żieda fit- tkabbir ta ’ tunsilli u/ jew adenojdi wara l- bidu tat- tratatment b’ INCRELEX. • Sabiex jiġi rraportat l- bidu ta ’ vista mċajpra b’ uġigħ ta ’ ras severa u nawsja assoċjata u rimettar lit- tabib tagħhom.
2/ 3 In addition there will be a dosing guide, and a dose calculator, for use by physician and patients to include information on the individualised dose escalation to minimise the risk of medication errors and hypoglycaemia.
2/ 3 • Sabiex jiġi rapportat il- bidu ta ’ zzappip jew ilment tal- ġenb jew uġigħ fl- irkoppa lit - tabib tagħhom sabiex jiġi evalwat.
What is INCRELEX?
X’ inhu INCRELEX?
INCRELEX is a solution for injection containing the active substance mecasermin (10 mg/ ml).
INCRELEX huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva mecasermin (10 mg/ ml).
What is INCRELEX used for?
Għal x’ hiex jintuża INCRELEX?
INCRELEX is used for the long-term treatment of growth failure in children and adolescents who have severe primary deficiency (low blood levels) of a hormone, insulin-like growth factor-1 (IGF-1), which is required for growth.
INCRELEX jintuża għat- trattament, fuq tul ta ’ żmien, ta ’ nuqqas ta ’ żvilupp fi tfal u adolexxenti li għandhom defiċjenza primarja serja (livelli baxxi fid- demm) ta ’ ormon, fattur- 1 ta ’ l- iżvilupp bħall - insulina (IGF- 1), li huwa meħtieġ għall- iżvilupp.
Patients with this disease produce growth hormone (GH) but their body does not respond to it, and they are short for their age.
Pazjenti b’ din il- marda jipproduċu ormon ta ’ l - iżvilupp (GH) iżda ġisimhom ma jirreaġixxix għalih, u huma jkunu qosra għall- età tagħhom.
It is a ‘ primary’ deficiency, meaning that there is no other identified cause for the low levels of IGF-1, such as malnutrition, low levels of thyroid hormone or the use of medicines called steroids to reduce or prevent inflammation.
Hija defiċjenza ‘ primarja ’, dan ifisser li ma hemm l- ebda kaġun ieħor identifikat għal- livelli baxxi ta ’ IGF - 1, bħal nutrizzjoni ħażina, livelli baxxi ta ’ l- ormon tat- tirojde jew l- użu ta ’ mediċini msejjħa sterojdi biex inaqqsu u jipprevjenu l- infjammazzjoni.
Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘ rare’, and INCRELEX was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 22 May 2006.
Minħabba li n- numru ta ’ pazjenti b’ defiċjenza primarja ta ’ IGF- 1 huwa wieħed baxx, il- marda hija meqjusa bħala ‘ rari ’ u fit- 22 ta ’ Mejju 2006, INCRELEX ġie kkategorizzat bħala ‘ mediċina iltiema ’ (mediċina wżata f’ mard rari).
How is INCRELEX used?
Kif jintuża INCRELEX?
Treatment with INCRELEX should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.
Trattament b’ INCRELEX għandu jiġi sorveljat minn tobba li għandhom esperjenza fid- dijanjożi u t - trattament ta ’ pazjenti b’ disturbi fl- iżvilupp.
The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Id- doża tal- bidu irrakkomandata hija 0. 04 mg kull kilogramm tal- piż tal- ġisem darbtejn kuljum.
The dose should be tailored for each patient according to the speed of growth and certain side effects.
Id- doża għandha tkun imfassla għal kull pazjent skond il- veloċità ta ’ l- iżvilupp u ċerti effetti sekondarji.
The maximum dose is 0.12 mg per kilogram twice a day.
Id- doża massima hija 0. 12 mg għal kull kilogramm tal- piż tal- ġisem darbtejn kuljum.
INCRELEX is given by injection under the skin, and the injection site should be changed with each injection.
INCRELEX jingħata permezz ta ’ injezzjoni taħt il- ġilda, u s- sit ta ’ l- injezzjoni għandu jinbidel ma ’ kull injezzjoni.
It should never be injected into a vein.
M’ għandu qatt jiġi injettat ġol- vina.
The injection should be carried out shortly before or after a meal or snack.
L- injezzjoni għandha ssir ftit qabel jew wara ikla jew kolazzjon.
Treatment should be interrupted if the patient cannot eat for any reason.
It- trattament għandu jiġi interrot jekk il- pazjent għal xi raġuni ma jkunx jista ’ jiekol.
INCRELEX is not recommended for children below two years of age, due to a lack of data on safety and effectiveness in this group.
INCRELEX m’ huwiex irrakkomandat għal tfal li għandhom inqas minn sentejn, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effettività f’ dan il- grupp.
For more information, see the Summary of Product Characteristics.
Għal aktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott.
The active substance in INCRELEX, mecasermin, is a copy of the human hormone IGF-1.
Is- sustanza attiva f’ INCRELEX, mecasermin, hija kopja ta ’ l- ormon uman IGF- 1.
Patients with primary IGF-1 deficiency have low blood levels of IGF-1.
Pazjenti b’ defiċjenza primarja ta ’ IGF- 1 għandhom livelli baxxi ta ’ IGF- 1 fid- demm.
IGF-1 is very important in determining how tall a child grows.
IGF- 1 huwa importanti ħafna biex jiddetermina kemm j/ tikber fit- tul it- tifel jew it- tifla.
It does this by stimulating cells to divide and grow and to absorb nutrients, supporting the growth of body tissues.
Jagħmel dan billi jistimola ċ- ċelloli biex jinqasmu u jikbru u jassorbu nutrijenti, u b’ hekk jappoġġja l- iżvilupp tat- tessuti tal- ġisem.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
INCRELEX jaħdem bl- istess mod bħal IGF- 1 naturali, jisosstitwixxi l- ormon nieqes u jgħin lit- tifel jew tifla biex j/ titwal aktar.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Mecasermin is made using ‘ recombinant DNA technology’: it is made by bacteria that have received a gene that makes them able to produce IGF-1.
Mecasermin isir bl- użu ta ’ ‘ teknoloġija rikombinanti tad- DNA ’: huwa magħmul minn batterji li rċevew ġene li jagħmilhom kapaċi li jipproduċu IGF- 1.
How has INCRELEX been studied?
Kif ġie studjat INCRELEX?
The effects of INCRELEX were first tested in experimental models before being studied in humans.
L- effetti ta ’ INCRELEX ġew l- ewwel ittestjati f’ mudelli esperimentali qabel ġew studjati fil- bnedmin.
INCRELEX has been studied in five studies involving a total of 76 children aged between 1 and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
INCRELEX ġie studjat f’ ħames studji li involvew total ta ’ 76 tifel u tifla ta ’ etajiet bejn 1 u 15- il sena b’ defiċjenza primarja ta ’ IGF- 1 serja, disgħa minnhom irċievew tip ieħor ta ’ IGF- 1 rikombinanti qabel ma ssieħbu f’ dawn l- istudji.
Because the disease is rare, many of the children were included in more than one of the studies.
Minħabba li l- marda hija rari, ħafna mit- tfal kienu inklużi f’ aktar minn studju wieħed.
One study compared INCRELEX to placebo (a dummy treatment) in eight patients, but the others did not compare INCRELEX to any other treatment.
Studju wieħed qabbel INCRELEX ma ’ plaċebo (trattament finta) fi tmien pazjenti, iżda l- oħrajn ma qabblux INCRELEX ma ’ xi trattament ieħor.
The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
L- istudji damu bejn 15- il xahar u tmien snin, u l- miżura ewlenija ta ’ effettività kienet il- veloċità ta ’ l- iżvilupp.
What benefit has INCRELEX shown during the studies?
X’ benefiċċji wera INCRELEX waqt l- istudji?
INCRELEX caused the speed of growth to increase significantly.
INCRELEX għamel żieda sinjifikattiva fil- veloċità ta ’ l- iżvilupp.
When the results of all four studies were taken together, the average growth rate was 2.8 cm per year before treatment.
Meta r- riżultati ta ’ l- erba ’ studji ittieħdu flimkien, ir- rata ta ’ żvilupp medja kienet 2. 8 ċm kull sena qabel it- trattament.
This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Din żdiedet għal 8. 0 ċm fl- ewwel sena tat- trattament u 5. 8 ċm fit- tieni.
The growth rate stabilised at around 4.7 cm per year from the fourth year of treatment.
Ir- rata ta ’ l- iżvilupp stabbilizzat ruħha għal madwar 4. 7 ċm fis- sena mir- raba ’ sena tat- trattament.
Some of the studies had also included children who had defects in the gene for GH and who had developed antibodies (inhibitors) against GH, as INCRELEX could also be used to treat such patients.
Xi wħud mill- istudji inkludew ukoll tfal li kellhom difetti fil- ġene għal GH li kienu żviluppaw antikorpi (inibituri) kontra GH, minħabba li INCRELEX jista ’ jintuża wkoll biex jittratta pazjenti bħal dawn.
The company did apply for an authorisation to use INCRELEX in these children, but withdrew its application after the end of the medicine’ s assessment, as this disease is not listed in the medicine ’ s ‘ orphan’ designation.
Il- kumpanija applikat għal awtorizzazzjoni biex tuża INCRELEX f’ dawn it- tfal, iżda irtirat l - applikazzjoni tagħha wara t- tmiem ta ’ l- istima tal- mediċina, minħabba li din il- marda m’ hix elenkata fil- lista ta ’ mediċini iltiema.
What is the risk associated with INCRELEX?
X’ inhu r- riskju assoċjat ma ’ INCRELEX?
The most common side effects with INCRELEX (seen in more than 1 patient in 10) are hypoglycaemia (low blood sugar levels), thymus hypertrophy (growth of the thymus gland, a gland below the breastbone that is involved in producing infection-fighting cells), headache, hypoacusis (hearing loss), tonsillar hypertrophy (growth of the tonsils), snoring and injection site hypertrophy (lumps at the site of injection).
L- aktar effetti sekondarji komuni ta’ INCRELEX (dehru f’ aktar minn pazjent 1 minn 10) huma ipogliċemija (livelli baxxi ta ’ zokkor fid- demm), ipertrofija tat- tajmus (żvilupp tal- glandola tajmus, glandola li tinstab taħt l- għadma tas- sider li hija involuta fil- produzzoni ta ’ ċelloli li jiġġieldu l - infezzjoni), uġigħ ta ’ ras, ipoakużi (nuqqas ta ’ smigħ), ipertrofija tonsillari (żvilupp tat- tunsilli), inħir u ipertrofija tas- sit ta ’ l- injezzjoni (għoqod fis- sit ta ’ l- infezzjoni).
For the full list of all side effects reported with INCRELEX, see the Summary of Product Characteristics.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ INCRELEX, ara s- Sommarju tal- Karatteristiċi tal- Prodott.
INCRELEX should not be used in people who may be hypersensitive (allergic) to mecasermin or any of the other ingredients.
INCRELEX m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal mecasermin jew għal xi sustanza oħra.
It should also not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
M’ għandux jintuża f’ pazjenti li jkollhom, jew huwa maħsub li għandhom neoplejżia attiva (żvilupp ta ’ ċelloli annormali)).
Treatment with INCRELEX should be stopped if neoplasia develops.
Trattament b’ INCRELEX għandu jitwaqqaf jekk tiżviluppa neoplejżia.
It should not be used in babies.
M’ għandux jintuża fit- trabi.
Why has INCRELEX been approved?
Għal x’ hiex ġie approvat INCRELEX?
The Committee for Medicinal Products for Human Use (CHMP) decided that INCRELEX’ s benefits are greater than its risks for the long-term treatment of growth failure in children and adolescents with severe primary IGF-1 deficiency.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ INCRELEX huma akbar mir- riskji tiegħu għat- trattament fuq tul ta ’ żmien fi tfal u adolexxenti b’ defiċjenza primarja ta ’ IGF- 1 serja.
The Committee recommended that INCRELEX be given marketing authorisation.
Il- Kumitat irrikkomanda li INCRELEX jingħata awtorizzazzjoni għat- tqegħid fis- suq.
INCRELEX has been authorised under “ Exceptional Circumstances”.
INCRELEX ġie awtorizzat taħt “ Ċirkostanzi Eċċezzjonali ”.
This means that because the disease is rare, it has not been possible to obtain complete information about INCRELEX.
Dan ifisser li minħabba li l- marda hija rari, ma kienx possibbi li jinkiseb tagħrif sħiħ dwar INCRELEX.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea tal - Mediċini (EMEA) se tirrevedi kull tagħrif ġdid li jista ’ jsir disponibbli u dan is- sommarju jiġi aġġornat kif neċessarju.
What information is still awaited for INCRELEX?
X’ tagħrif għadu mistenni għal INCRELEX?
The company that makes INCRELEX will supply information packs for doctors and for patients explaining how the medicine is used and its side effects.
Il- kumpanija li taghmel INCRELEX se tagħmel studju fuq tul ta ’ żmien li jħares lejn is- sigurtà tal - mediċina, meta t- trattament jinbeda fi tfal żgħar u jitkompla sakemm jilħqu l- istat ta ’ adulti.
The record of INCRELEX’ s designation as an orphan medicine is available here.
Ir- reġistrazzjoni tan- nominazzjoni ta ’ INCRELEX bħala mediċina orfni hija disponibbli minn hawn.
The full EPAR for INCRELEX can be found here.
L- EPAR sħiħ għal INCRELEX jinstab hawn.
This summary was last updated in 06-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 06- 2007.
INCRELEX
Increlex
Solution for injection.
Soluzzjoni għall - injezzjoni
Vial (glass)
kunjett (tal- ħġieġ)
1 Vial
kunjett 1
INCRELEX 10 mg/ ml solution for injection.
INCRELEX 10 mg/ ml soluzzjoni għall- injezzjoni.
Each ml contains 10 mg of mecasermin.
Kull ml fih 10 mg ta 'mecasermin.
Each vial contains 40 mg of mecasermin.
Kull kunjett fih 40 mg ta 'mecasermin.
Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Mecasermin huwa fattur ta 'l- iżvilupp- 1 (IGF- 1) li jixbaħ l- insulina umana derivata minn DNA rikombinanti prodott f' Escherichia coli.
One ml contains 9 mg of benzyl alcohol.
Kull ml fih 9 mg ta 'benzyl alcohol.
Aqueous, clear and colourless solution.
Soluzzjoni milwiema, ċara u bla kulur.
For the long-term treatment of growth failure in children and adolescents with severe primary insulin- like growth factor-1 deficiency (Primary IGFD).
Għat- trattament fuq tul ta ’ żmien ta ’ nuqqas ta ’ żvilupp fit- tfal u l- adolexxenti b’ defiċjenza primarja severa tal- fattur ta ’ l- iżvilupp- 1 li jixbaħ l- insulina (IGFD Primarja).
Severe Primary IGFD is defined by: • height standard deviation score ≤ – 3.0 and • basal IGF-1 levels below the 2.5th percentile for age and gender and • GH sufficiency. • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
IGFD Primarja severa hija ddefinita bi: • skor tad- devjazzjoni standard tat- tul ≤ – 3. 0 u • livelli ta ’ GF 1 bażali taħt it- 2. 5 perċentwali għal età u sess u • suffiċjenza ta ’ GH • Esklużjoni ta ’ forom sekondarji ta ’ defiċjenza ta ’ IGF 1, bħal ma ’ huma nuqqas ta ’ ikel sustanzjuż, ipotirojdiżmu, jew trattament kroniku b’ dożi farmakoloġiċi ta ’ sterojdi kontra l- infjammazzjoni.
Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
IGFD Primarja Severa tinkludi pazjenti b’ mutazzjonijiet fir- riċettur ta ’ GH (GHR), fil- mogħdija tas- senjalar ta ’ wara- GHR, u difetti fil- ġene IGF- 1; huma mhumiex defiċjenti mill- GH, u għaldaqstant, mhux mistennija li jirreaġixxu adegwatament għal trattament bi GH eżoġenu.
It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Huwa rakkomandat li d- dijanjosi tiġi kkonfermata billi tagħmel test ta ’ ġenerazzjoni ta ’ IGF- 1.
Treatment with INCRELEX should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Trattament b’ INCRELEX għandu jkun immexxi minn tobba b’ esperjenza fid- dijanjożi u l- ġestjoni ta ’ pazjenti b’ disturbi ta ’ l- iżvilupp.
The dose should be individualised for each patient.
Id- doża għandha tiġi individwalizzata għal kull pazjent.
The recommended starting dose of mecasermin is 0.04 mg/ kg twice daily by subcutaneous injection.
Id- doża tal- bidu ta ’ mecasermin rakkomandata hija ta ’ 0. 04 mg/ kg darbtejn kuljum taħt il- ġilda.
If no significant treatment-related adverse events occur for at least one week, the dose may be raised in increments of 0.04 mg/ kg to the maximum dose of 0.12 mg/ kg given twice daily.
Jekk ma jkunx hemm avvenimenti avversi sinifikanti relatati mat- trattament għal tul ta ’ żmien ta ’ l- anqas ġimgħa, id- doża tista ’ tiġi mgħollija b’ inkrimenti ta ’ 0. 04 mg/ kg sa doża massima ta ’ 0. 12 mg/ kg mogħtija darbtejn kuljum.
Doses greater than 0.12 mg/ kg given twice daily have not been evaluated in children with severe Primary IGFD.
Dożi akbar minn 0. 12 mg/ kg mgħotija darbtejn kuljum ma ġewx evalwati fi tfal b’ IGFD primarja severa.
2 If the recommended dose is not tolerated by the subject, treatment with a lower dose can be considered.
2 Jekk id- doża rakkomandata ma tkunx ittollerata mis- suġġett, trattament b’ doża aktar baxxa jista ’ jiġi kunsidrat.
Treatment success should be evaluated based on height velocities.
Is- suċċess tat- trattament għandu jiġi evalwat fuq bażi ta ’ veloċitajiet tat- tul.
The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/ kg BID.
L- anqas doża li kienet assoċjata ma ’ żidiet sostanzjali fl- iżvilupp fuq bażi individwali kienet ta '0. 04 mg/ kg BID.
INCRELEX should be administered shortly before or after a meal or snack.
INCRELEX għandu jingħata ftit qabel jew wara ikla jew snekk.
If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced.
Jekk bid- dożi rakkomandati ikun hemm ipogliċemija, minkejja li t- teħid ta ’ l- ikel ikun adegwat, id- doża għandha titnaqqas.
If the patient is unable to eat, for any reason, INCRELEX should be withheld.
Jekk il - pazjent ma jkunx jista ’ jiekol, għal kwalunkwe raġuni, INCRELEX għandu jiġi miżmum.
The dose of mecasermin should never be increased to make up for one or more omitted doses.
Id- doża ta ’ mecasermin m’ għandha qatt tiġi miżjuda biex tpatti għal doża waħda jew aktar li ma kienux ittieħdu.
Injection sites should be rotated to a different site with each injection.
Is- siti ta ’ l- injezzjoni għandhom jiġu mdawwra għal sit differenti ma ’ kull injezzjoni differenti.
INCRELEX should be administered using sterile disposable syringes and injection needles.
INCRELEX għandu jiġi mogħti permezz ta ’ siringi u labar ta ’ l- injezzjoni sterili li jintremew wara l - użu.
The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Is- siringi għandhom ikunu ta ’ volum zgħir biżżejjed li d- doża miktuba mit- tabib tista ’ tkun miġbuda mill- kunjett b’ eżattezza raġonevoli.
INCRELEX is not recommended for use in children below age 2 due to a lack of data on safety and efficacy (see section 5.1).
INCRELEX mhuwiex rakkomandat għal użu fi tfal taħt l- età ta ’ sentejn minħabba nuqqas ta ’ dejta fuq is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
Intravenous administration.
Amministrazzjoni għal ġol- vina.
Active or suspected neoplasia.
Neoplejżja attiva jew issuspettata.
Therapy should be discontinued if evidence of neoplasia develops.
It- terapija għandha tiġi mwaqqfa jekk tiżviluppa evidenza ta ’ neoplejżia.
Benzyl alcohol must not be given to premature babies or neonates.
Benzyl alcohol m’ għandux jingħata lil trabi li twieldu qabel iż- żmien jew li għadhom kif twieldu.
Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.
Defiċjenzi tat- tirojde u tan- nutrizzjoni għandhom ikunu irranġati qabel ma ’ jinbeda trattament b’ INCRELEX.
INCRELEX is not a substitute for GH treatment.
INCRELEX mhuwiex sostitut għal trattament bil- GH.
INCRELEX should not be used for growth promotion in patients with closed epiphyses.
INCRELEX m’ għandux jiġi użat għal promozzjoni ta ’ l- iżvilupp f’ pazjenti bl- epifissi magħluqa.
INCRELEX should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects.
INCRELEX għandu jiġi mogħti ftit ħin qabel jew wara ikla jew snekk, għaliex jista ’ jkollu effetti ipogliċemiċi bħal ta ’ l- insulina.
Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake.
Attenzjoni speċjali għandha tingħata lil tfal żgħar, tfal bi storja ta ’ ipogliċemija u tfal li mhumiex konsistenti fit- teħid ta ’ l- ikel.
Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well tolerated dose of INCRELEX has been established.
Il- pazjenti għandhom jevitaw li jagħmlu xi attivitajiet ta ’ riskju għoli fi żmien 2- 3 sigħat wara l- iddożar, partikolarment fil- bidu ta ’ trattament b’ INCRELEX, sakemm doża li tkun ittollerata sew ta ’ INCRELEX tkun ġiet stabbilita.
If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Jekk persuna b’ ipogliċemija severa mhix f’ sensiha jew b’ xi mod ma tistax tibla ’ l- ikel b’ mod normali, jista ’ jkun hemm bżonn ta ’ injezzjoni ta ’ glukagon.
Persons with a history of severe hypoglycemia should have glucagon available.
Persuni li għandhom storja ta ’ ipogliċemija severa għandhom ikollhom glukagon disponibbli.
At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Waqt iż- żmien li tingħata l- ewwel riċetta, it- tobba għandhom jgħallmu lill- ġenituri s- sinjali, sintomi u trattament ta ’ ipogliċemija, inkluża l- injezzjoni ta ’ glukagon.
Doses of insulin and/ or other hypoglycaemic agents may need to be reduced for diabetic subjects using INCRELEX.
Dożi ta ’ insulina u/ jew mediċini oħra ipogliċemiċi għandhom mnejn ikollhom jiġu mnaqqsa f’ pazjenti dijabetiċi li jkunu qegħdin jieħdu INCRELEX.
Echocardiogram is recommended before initiation of INCRELEX treatment in all patients.
Ekokardjogramma hi rakkomandata fuq il- pazjenti kollha qabel ma jinbeda t- trattament ta ’ INCRELEX.
Patients who terminate treatment should also have an echocardiogram.
Pazjenti