qanastek/EMEA-V3 huggingface dataset:
20 In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
20 Fil- provi kliniċi, il- piż ma nbidilx mill- linja bażi meta vildagliptin 100 mg kuljum ingħata bħala monoterapija (- 0. 3 kg u - 1. 3 kg għal vildagliptin u plaċebo, rispettivament).
Metformin may exert its glucose-lowering effect via three mechanisms:
Metformin jista ’ jeżerċita l- effett tiegħu li jnaqqas il- glucose permezz ta ’ tlett mekkaniżmi:
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
- billi jnaqqas il- produzzjoni tal- glucose mill- fwied billi jimpedixxi l- glukoneoġenesi u
utilisation;
glyjkoġenoliżi;
- by delaying intestinal glucose absorption.
tal- glucose periferali u l- użu tiegħu;
The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long - term benefit of intensive blood glucose control in type 2 di abetes.
L- istudju prospettiv randomised UKPDS (Studju Prospettiv tad- Dijabete UK) stabilixxa l- benefiċċju fuq żmien twil tal- kontroll tal- glucose fid- demm fid- dijabete tat- tip 2.
group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034;
grupp fuq metformin (29. 8 każijiet/ 1, 000 sena tal- pazjent) kontra d- dieta waħidha (43. 3 każijiet/ 1, 000 sena tal- pazjent), p=0. 0023, u kontra l- gruppi b’ sulphonylurea kombinata u monoterapija bl- insulina (40. 1 każijiet/ 1, 000 sena tal- pazjent), p=0. 0034;
7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;
7. 5 każijiet/ 1, 000 sena tal- pazjent, dieta waħidha 12. 7 każijiet/ 1, 000 sena tal- pazjent, p=0. 017;
13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.0 11), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient- years (p=0.021);
kontra dieta waħidha 20. 6 każijiet/ 1, 000 sena tal- pazjent (p=0. 011), u kontra l- gruppi b’ sulphonylurea kombinata u monoterapija bl- insulina 18. 9 każijiet/ 1, 000 sena tal- pazjent (p=0. 021);
Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Distribuzzjoni Vildagliptin jorbot b’ mod dgħajjef mal- proteini tal- plażma (9. 3%) u vildagliptin jinfirex b’ mod ugwali bejn il- plażma u ċ- ċelluli ħomor tad- demm.
23 Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
23 Biotrasformazzjoni Fil- bniedem il- metaboliżmu huwa l- mezz ewlieni li bih jitnehha vildagliptin, li jgħodd 69% tad- doża.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Tmax) is achieved after about 2.5 h..
Metformin Assorbiment Wara doża metformin li tittieħed mill- ħalq, il- konċentrazzjoni massima fil- plażma (Cmax) tintlaħaq wara madwar 2. 5 h.
After oral administration, metformin absorption is saturable and incomplete.
Wara li jingħata mill- ħalq, l- assorbiment ta ’ metformin jiġi saturat u mhux komplet.
24 Food slightly delays and decreases the extent of the absorption of metformin.
24 L- ikel jittardja bi ftit u jnaqqas il- grad ta ’ assorbiment ta ’ metformin.
A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Studju dwar il- kanċeroġeniċità li dam sentejn sar fil- firien b’ dożi mill- ħalq sa ’ 900 mg/ kg (madwar 200 darba l- esponiment fil- bniedem bl- ogħla doża rakkomandata).
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
25 vildagliptin u l- metabolu ewlieni tiegħu, id- dehra tat- tumuri fi speċi waħda biss, u il- proporzonijiet sistemiċi għoljin li bihom dehru dawn it- tumuri.
25 In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Fi studju tossikoloġiku ta ’ 13- il ġimgħa f’ xadini cynomolgus, feriti fil- ġilda kienu reġistrati b’ dożi ta ’ ≥ 5 mg/ kg/ jum.
Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Aluminium/ Aluminium (PA/ Al/ PVC // Al) folja Jiġi f’ pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b’ rita u f’ pakketti b’ ħafna li fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pilloli miksija b’ rita.
Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Il- Ġermanja
Pharmacovigilance system
Sistema ta ’ Farmakoviilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 (17 June 2008) 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.
L- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, hekk kif deskritta f’ verżjoni 3. 0 (17 Ġunju 2008) ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun imwaqqfa u taħdem qabel u waqt li l- prodott ikun fuq is- suq.
Risk Management plan
Pjan ta ’ Immaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 (06 December 2007) 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.
L- MAH jintrabat li jwettaq l- istudji u l- attivitajiet l- oħra ta ’ farmakoviġilanza hekk kif huma dettajlati fil- Pjan ta ’ Farmakoviġilanza, kif miftihem fil- verżjoni 3 (06 Dicembru 2007) fil- Pjan ta ’ l - Immaniġġjar tar- Riskju (RMP) preżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti li jsiru wara mill- RMP mifthema mis- 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- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perijodiku Aġġornat dwar is- Sigurtà (PSUR) li jkun imiss.
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
Minbarra hekk, RMP aġġornat għandu jiġi sottomess • Meta jinkiseb tagħrif ġdid li jista ’ jkollu xi impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, Pjan ta ’ Farmakoviġilianza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 jum minn meta tintlaħaq xi ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis tar - riskju) • Fuq talba ta ’ l- EMEA
29 ANNEX III
29 ANNESS III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Eucreas 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Eucreas 50 mg/ 850 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Kull pillola fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (jikkorrispondi għal 660 mg metformin).
10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
10 pilloli miksijin b’ rita 30 pillola miksija b’ rita 60 pillola miksija b’ rita 120 pilloli miksijin b’ rita 180 pillola miksija b’ rita 360 pillola miksija b’ rita
Store in the original package (blister) in order to protect from moisture.
Aħżen fil- pakkett oriġinali (folja) sabiex tilqa mill- umdità.
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
KARTUNA TAN- NOFS TAL- PAKKETTI B’ ĦAFNA (MINGĦAJR IL- KAXXA ĊELESTI)
60 film-coated tablets Component of a multipack comprising 2 packs, each containing 60 tablets.
60 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 2 pakketti, kull wieħed fih 60 pillola.
60 film-coated tablets Component of a multipack comprising 3 packs, each containing 60 tablets.
60 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed fih 60 pillola.
60 film-coated tablets Component of a multipack comprising 6 packs, each containing 60 tablets.
60 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 6 pakketti, kull wieħed fih 60 pillola.
120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
120 pilloli miksijin b’ rita 180 pillola miksija b’ rita 360 pillola miksija b’ rita
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETTI B’ ĦAFNA (INKLUŻA L- KAXXA ĊELESTI)
180 film-coated tablets Multipack comprising 3 packs, each containing 60 tablets.
120 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 2 pakketti, kull wieħed fih 60 pillola 180 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed fih 60 pillola.
360 film-coated tablets Multipack comprising 6 packs, each containing 60 tablets.
360 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 6 pakketti, kull wieħed fih 60 pillola.
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Eucreas 50 mg/ 1000 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Kull pillola fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (jikkorrispondi għal 780 mg metformin).
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
46 PACKAGE LEAFLET:
46 FULJETT TA ’ TAGĦRIF:
Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets
Eucreas 50 mg/ 850 mg pilloli miksijin b’ rita Eucreas 50 mg/ 1000 mg pilloli miksijin b’ rita
vildagliptin/metformin hydrochloride
vildagliptin/ metformin hydrochloride
What Eucreas is and what it is used for 2.
X’ inhu Eucreas u għalxiex jintuża 2.
Before you take Eucreas 3.
Qabel ma tieħu Eucreas 3.
How to take Eucreas 4.
Kif għandek tieħu Eucreas 4.
How to store Eucreas 6.
Kif taħżen Eucreas 6.
WHAT EUCREAS IS AND WHAT IT IS USED FOR
X’ INHU EUCREAS U GĦALXIEX JINTUŻA
The active substances of Eucreas belong to a group of medicines called “oral antidiabetics”.
Is- sustanzi attivi ta ’ Eucreas jagħmlu parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Eucreas is used to treat patients with type 2 diabetes.
Eucreas jintuża għall- kura ta ’ pazjenti bid- dijabete tat- tip 2.
This type of diabetes is also known as non- insulin-dependent diabetes mellitus.
Din it- tip ta ’ dijabete hija magħrufa wkoll bħala dijabete mellitus li ma tiddependix fuq l- insulina.
Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Id- dijabete tat- tip 2 tiżviluppa jekk il- ġisem ma jagħmilx biżżejjed insulina jew jekk l- insulina li jagħmel il- ġisem ma jaħdimx tajjeb kif suppost.
It can also develop if the body produces too much glucagon.
Tista ’ tiżviluppa wkoll jekk il- ġisem jagħmel wisq glucagon.
Both insulin and glucagon are made in the pancreas.
Kemm l- insulina kif ukoll il- glucagon jiġu magħmula fil- frixa.
Insulin helps to lower the level of sugar in the blood, especially after meals.
L- insulina tgħin biex tbaxxi l- livell taz - zokkor fid- demm, l- aktar wara l- ikliet.
Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.
Il- glucagon jistimola lill- fwied sabiex jibda jagħmel iz- zokkor, u b’ hekk jikkawża żieda fil- livell taz- zokkor fid- demm.
Eucreas contains two active substances called vildagliptin and metformin.
Eucreas fih żewġ sustanzi attivi li jissejħu vildagliptin u metformin.
Both of these substances help to control the level of sugar in the blood.
Dawn iż- żewġ sustanzi t- tnejn li huma jgħinu sabiex jikkontrolla l- livell taz- zokkor fid- demm.
The substance vildagliptin works by making the pancreas produce more insulin and less glucagon.
Is- sustanza vildagliptin taħdem billi iġġiegħel lill- frixa sabiex tagħmel aktar insulina u anqas glucagon.
The substance metformin works by helping the body to make better use of insulin.
Is- sustanza metformin taħdem billi tgħin lill- ġisem jgħamel użu aħjar mill- insulina.
BEFORE YOU TAKE EUCREAS
QABEL MA TIEĦU EUCREAS
Do not take Eucreas
Tieħux Eucreas
- if you are allergic (hypersensitive) to vildagliptin, metformin or any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vildagliptin, metformin jew sustanzi
Eucreas (listed in section 6).
oħra ta ’ Eucreas (elenkati f’ sezzjoni 6).
If you think you may be allergic to any of these, talk to your doctor before taking Eucreas.
Jekk taħseb li tista ’ tkun allerġiku/ a għal kwalunkwe wieħed minn dawn, tkellem mat- tabib tiegħek qabel tieħu Eucreas.
- if you have or have had serious complications of your diabetes, such as diabetic ketoacidosis (a
- jekk għandek kumplikazzjonijiet serji bid- dijabete tiegħek, bħal ketoaċidożi tad- dijabete
complication of diabetes with rapid weight loss, nausea and/or vomiting) or diabetic coma.
(kumplikazzjoni tad- dijabete b’ telf tal- piż f’ daqqa, dardir u/ jew rimettar) jew koma tad- dijabete.
- if you have recently had a heart attack or if you have heart failure or serious problems with your
- jekk ftit żmien ilu kellek attakk tal- qalb jew jekk kellek insuffiċjenza tal- qalb jew problemi serji
blood circulation or difficulties in breathing which could be a sign of heart problems.
biċ- ċirkolazzjoni tad- demm jew tbatija biex tieħu n- nifs li jista ’ jkun sinjal ta ’ problemi tal- qalb.
- if you have kidney problems.
- jekk għandek problemi bil- kliewi.
- if you have a severe infection or are seriously dehydrated (have lost a lot of water from your
- jekk għandek infezzjoni severa jew deidratat b’ mod serju (tlift ħafna ilma minn ġismek).
- if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).
- jekk ser ikollok kuntrast bir- raġġi- x (tip speċifiku ta ’ x – rays li jinvolvi kimika ta ’ kulur li
Please also see information about this in section “Take special care with Eucreas”.
Jekk jogħġbok ara wkoll l- informazzjoni fuq dan fis- sezzjoni “ Oqgħod attent ħafna b’ Eucreas ”.
- if you have liver problems.
- jekk għandek problemi tal- fwied.
- if you drink alcohol excessively (whether every day or only from time to time).
- jekk tixrob ħafna alkoħol (kemm jekk kuljum kif ukoll darba kultant).
- if you are breast-feeding (see also “Pregnancy and breast-feeding”).
- jekk qed tredda ’ (ara wkoll “ Tqala u treddigħ ”).
Take special care with Eucreas Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called “lactic acidosis”:
Oqgħod attent ħafna b’ Eucreas Tibqax tieħu din il- mediċina u kellem lit- tabib tiegħek jekk tħoss wieħed jew aktar mis- sintomi li ġejjin li jistgħu jkunu relatati ma ’ kundizzjoni imsejjħa “ aċidożi lattika ”:
- feeling cold or uncomfortable
- tħoss il- bard jew tħossok skomdu
- muscle pain
- uġigħ fil- muskoli
- severe nausea or vomiting
- dardir sever jew rimettar
- pain in or around your stomach (abdominal pain)
- uġigħ fl- istonku jew madwaru (uġigħ addominali)
- drowsiness or dizziness
- tħeddil jew sturdament
- rapid breathing
- tieħu n- nifs bl- għaġġla
If you have previously taken Galvus (vildagliptin) or Eucreas but had to stop taking it because of side effects (liver disease), you should not take Eucreas again.
Jekk xi darba hadt Galvus (vildagliptin) jew Eucreas iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Eucreas mill- ġdid.
Diabetic skin lesions are a common complication of diabetes.
Feriti fil- ġilda tad- dijabete huma kumplikazzjoni komuni tad- dijabete.
You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Int konsiljat li ssegwi r - rakkomandazzjonijiet għall- kura tal- ġilda u s- saqajn li jingħatawlek mit- tabib jew infermier tiegħek.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Eucreas.
Int konsiljat ukoll li toqgħod attent b’ mod partikolari għal xi nfatet jew ulċeri li jistgħu joħorġu waqt li tkun qed tieħu Eucreas.
Should these occur, you should promptly consult your doctor.
Jekk dawn iseħħu, għandek tikkonsulta mat- tabib tiegħek minnufih.
If you have stopped using Eucreas due to surgery (you should stop at least 48 hours before planned surgery with general anesthesia and should not start again until at least 48 hours afterwards) or due to an x-ray involving an injectable dye, talk to your doctor before taking Eucreas again.
Jekk waqaft tuża Eucreas minħabba operazzjoni (għandek twaqqfu mill- anqas 48 siegħa qabel ma tkun ippjanata l- operazzjoni b’ loppju ġenerali u m’ għandekx terġa ’ tibdih sa mill- anqas 48 siegħa wara) jew minħabba raġġi- x li jinvolvu l- injezzjoni ta ’ kimika bil- kulur, tkellem mat- tabib tiegħek qabel terġa tibda tieħu Eucreas.
A test to determine your liver function will be performed before the start of Eucreas treatment, at three-month intervals for the first year and periodically thereafter.
Test sabiex tiġi stabbilita l- funzjoni tal- fwied tiegħek se ssir qabel ma tibda l- kura b’ Eucreas, f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
This is so that signs of increased liver enzymes can be detected as early as possible.
Dan isir sabiex sinjali ta ’ żieda fil- livelli ta ’ l- enzimi tal- fwied jintebħu bihom kmieni kemm jista ’ jkun.
Elderly patients (65-74 years) taking Eucreas should have their kidney function monitored regularly.
Pazjenti anjzani (65- 74 sena) li qed jieħdu Eucreas għandu jkollhom il- funzjoni tal- fwied immonitorata b’ mod regolari.
This will happen more often in patients with kidney problems.
Dan iseħħ aktar ta ’ spiss f’ pazjenti li jkollhom problemi tal- kliewi.
Eucreas is not recommended for patients aged 75 years or older.
Eucreas mhux rakkomandat għal pazjenti li għandhom 75 sena jew aktar.
This is particularly important if you are already taking any medicine to treat a heart condition or problems with your blood sugar, kidneys or blood pressure such as medicines containing
Dan huwa l- aktar importanti jekk diġà qed tieħu kwalunkwe mediċina biex tikkura kundizzjoni tal- qalb jew problemi biz- zokkor fid- demm tiegħek, kliewi jew pressjoni tad- demm bħal mediċini li jkun fihom
- glucocorticoids generally used to treat inflammation
- glukokortikojdi li b’ mod ġenerali jintużaw għall- kura ta ’ l- infjammazzjoni
- beta-2 agonists generally used to treat respiratory disorders
- agonisti beta- 2 li b’ mod ġenerali jintużaw għall- kura ta ’ disturbi respiratorji
- other medicines used to treat diabetes
- mediċini oħrajn li jintużaw għall- kura tad- dijabete
- diuretics (also called water tablets)
- dijuretiċi (magħrufin ukoll bħala l- pilloli tal- pipì) jew
- ACE inhibitors generally used to treat high blood pressure
- impedituri ACE li b’ mod ġenerali jintużaw għall- kura ta ’ pressjoni għolja tad- demm
- certain medicines affecting the thyroid, or
- ċerti mediċini li jaffettwaw it- tirojde, jew
- certain medicines affecting the nervous system.
- ċerti mediċini li jeffettwaw is- sistema nervuża.
Taking Eucreas with food and drink Take the tablets either with or just after food.
Meta tieħu Eucreas ma ’ l- ikel u max- xorb Ħu l- pilloli ma ’ l- ikel jew eżatt wara l- ikel.
This will lower the risk of an upset stomach.
Dan inaqqas r- riskju li jqalliblek l- istonku.
Avoid alcohol while taking Eucreas since alcohol may increase the risk of lactic acidosis (please see section “Possible side effects”).
Evita l- alkoħol meta tkun qed tieħu Eucreas peress li l- alkoħol jista ’ jżid ir- riskju ta ’ aċidożi lattika (jekk jogħġbok ara “ Effetti Sekondarji li Jista ’ jkollu ”.
48 Pregnancy and breast-feeding
48 Tqala u Treddigħ
- Tell your doctor if you are pregnant, if you think you might be pregnant, or if you are planning
- Għid lit- tabib tiegħek jekk ħriġt tqila, jekk taħseb li jista ’ jkun li ħriġt tqila, jew jekk qed
to become pregnant.
tippjana sabiex toħroġ tqila.
Your doctor will discuss with you the potential risk of taking Eucreas during pregnancy.
It- tabib tiegħek ser jiddiskuti miegħek dwar ir- riskju li jista ’ jkun hemm jekk tieħu Eucreas waqt it- tqala.
- Do not use Eucreas if you are breast-feeding.
- Tużax Eucreas jekk qed tredda ’.
Driving and using machines If you feel dizzy while taking Eucreas, do not drive or use any tools or machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Eucreas, mgħandekx issuq jew tuża l- ebda għodda jew magni.
HOW TO TAKE EUCREAS
KIF GĦANDEK TIEĦU EUCREAS
Always take Eucreas exactly as your doctor has told you.
Dejjem għandek tieħu Eucreas skond il- parir tat- tabib.
How much to take The amount of Eucreas that people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Eucreas li n- nies għandhom jieħdu jvarja skond il- kondizzjoni tagħhom.
Your doctor will tell you exactly the dose of Eucreas to take.
It- tabib tiegħek ser jgħidlek eżattament id- doża ta ’ Eucreas li għandek tieħu.
When and how to take Eucreas
Meta u kif għandek tieħu Eucreas
- Swallow the tablets whole with a glass of water,
- Ibla ’ l- pilloli ma ’ tazza ilma sħiha
- Take one tablet in the morning and the other in the evening with or just after food.
- Ħu pillola waħda filgħodu u l- oħra filgħaxija ma ’ l- ikel jew eżatt wara l- ikel.
Taking the
Meta tieħu l- pillola
tablet just after food will lower the risk of an upset stomach.
eżattament wara l- ikel tnaqqas ir- riskju li jkollok taqlib ta ’ stonku
Continue to follow any advice about diet that your doctor has given you.
Kompli segwi kwalunkwe parir dwar id- dieta li t- tabib tiegħek tak.
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Eucreas.
B’ mod partikolari, jekk qed issegwi dieta ta ’ kontroll tal- piż għad- dijabete, kompli b’ din waqt li qed tieħu Eucreas.
At least once a year, your doctor will check that your kidneys are working normally.
Mill- anqas darba f’ sena, it- tabib tiegħek ser jiċċekkja li l- kliewi tiegħek qed jaħdmu normali.
Your doctor will test your blood and urine for sugar regularly.
It- tabib tiegħek ser jittestja d- demm u l- awrina għaz- zokkor b’ mod regolari.
If you take more Eucreas than you should If you take too many Eucreas tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Jekk tieħu Eucreas aktar milli suppost Jekk tieħu wisq pilloli Eucreas, jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek, kellem lit- tabib jew l - ispiżjar tiegħek mill- ewwel.
Medical attention may be necessary.
Jista ’ jkun hemm bżonn ta ’ attenzjoni medika.
If you have to go to a doctor or hospital, take the pack and this leaflet with you.
Jekk ikollok tmur għand tabib jew l- isptar, ħu l- pakkett u dan il- fuljett miegħek.
If you forget to take Eucreas If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Jekk tinsa tieħu Eucreas Jekk tinsa tieħu pillola, ħudha ma ’ l- ikla li jkun imissek sakemm ma tkunx wasalt sabiex tieħu oħra xorta waħda.
Do not take a double dose (two tablets at once) to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja (żewġ pilloli f’ daqqa) biex tpatti għal kull pillola li tkun insejt tieħu.
If you stop taking Eucreas Do not stop taking Eucreas unless your doctor tells you to.
Jekk tieqaf tieħu Eucreas Tieqafx tieħu Eucreas sakemm it- tabib tiegħek ma jgħidlekx biex tgħamel hekk.
If you have any questions about how long to take this medicine, talk to your doctor.
Jekk għandek xi mistoqsijiet dwar kemm għandek iddum tieħu din il- mediċina, kellem lit- tabib tiegħek.
Like all medicines, Eucreas can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Eucreas jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 patient in 10 • common: affects 1 to 10 patients in 100 • uncommon: affects 1 to 10 patients in 1,000 • rare: affects 1 to 10 patients in 10,000 49 • very rare: affects less than 1 patient in 10,000 • not known: frequency cannot be estimated from the available data.
49 • mhux komuni: jaffettwaw 1 sa 10 pazjenti f’ 1, 000 • rari: jaffettwaw 1 sa 10 pazjenti f’ 10, 000 • rari ħafna: jaffettwaw anqas minn pazjent 1 f’ 10, 000 • mhux magħruf: il- frekwenza ma tistax tittieħed stima mid- data disponibbli.
Some symptoms need immediate medical attention You should stop taking Eucreas and see your doctor immediately if you experience the following side effects:
Xi sintomi jista ’ jkollhom bżonn attenzjoni medika immedjata Għandek tieqaf tieħu Eucreas u tara t- tabib tiegħek mill- ewwel jekk tħoss kwalunkwe minn dawn l - effetti sekondarji:
- Angioedema (rare):
- Anġjoedema (rari):
Symptoms include swollen face, tongue or throat, difficulty swallowing,
Sintomi jinkludu wiċċ, ilsien jew grieżem minfuħin, tbatija biex tibla ’, tbatija
difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called “angioedema”.
biex tieħu n- nifs, raxx jew ħorriqija li joħorġu f’ daqqa waħda, li tista ’ tindika reazzjoni msejjħa “ anġjoedema ”.
- Liver disease (hepatitis) (rare):
- Mard tal- fwied (epatite) (rari):
Symptoms include yellow skin and eyes, nausea, loss of appetite
Sintomi jinkludu ġilda u għajnejn sofor, tqalligħ, telf ta ’ l- aptit
or dark-coloured urine, which may indicate liver disease (hepatitis).
jew awrina skura, li jista ’ jindika mard tal- fwied (epatite).
Other side effects Some patients have experienced the following side effects while taking Eucreas:
Effetti sekondarji oħrajn Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta kienu qed jieħdu Eucreas:
- vomiting
- rimettar
- pain in and around the stomach (abdominal pain)
- uġiħ fl- istonku u mad- dawra (uġigħ addominali)
- loss of appetite.
- telf ta ’ l- aptit
- trembling that cannot be controlled
- tregħid li ma jkunx jista ’ jiġi kkontrollat
- metallic taste
- togħma ta’ metall
- low blood glucose.
- glucose fid- demm baxx.
- tiredness
- għeja
- constipation
- stitikezza
- swollen hands, ankle or feet (oedema).
- idejn, għaksa jew saqajn minfuħin (edema).
- signs of liver disease (hepatitis)
- sinjali ta ’ mard tal- fwied (epatite)
- sore throat, runny nose, fever
- grieżem misluħin, imnieħer iqattar, deni.
- signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or
- sinjali ta ’ livell għoli ta ’ aċidu lattiku fid- demm (magħruf bħala aċidożi lattika) bħal tħeddil jew
dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing.
sturdament, dardir qawwi jew rimettar, uġigħ addominali, qalb tħabbat irregolari jew profonda, tieħu n- nifs bil- għaġġla.
- redness of the skin, itching
- ħmura tal- ġilda, ħakk.
- decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or
- tnaqqis fil- livelli ta ’ vitamina B12 (pallidità, għeja, sintomi mentali bħal konfużjoni jew disturbi
memory disturbances).
tal- memorja).
HOW TO STORE EUCREAS
KIF TAĦŻEN EUCREAS
- Keep out of the reach and sight of children.
- Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
- Do not use Eucreas after the expiry date which is stated on the blister and carton.
- Tużax Eucreas wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry
Id- data ta ’ skadenza
date refers to the last day of that month.
tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
- Store in the original package (blister) in order to protect from moisture.
- Aħżen fil- pakkett oriġinali (folja) sabiex tilqa ’ mill- umdità.
What Eucreas contains
X’ fih Eucreas
- The active substances are vildagliptin and metformin hydrochloride.
- Is- sustanzi attivi huma vildagliptin u metformin hydrochloride.
- Each Eucreas 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg
- Kull pillola miksija b’ rita ta ’ Eucreas fiha 50 mg vildagliptin u 850 mg metformin hydrochloride
metformin hydrochloride (corresponding to 660 mg of metformin).
(jikkorrispondu għal 660 mg metformin).
- Each Eucreas 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg
- Kull pillola miksija b’ rita ta ’ Eucreas fiha 50 mg vildagliptin u 1000 mg metformin
metformin hydrochloride (corresponding to 780 mg of metformin).
hydrochloride (jikkorrispondu għal 780 mg metformin).
Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium
- Is- sustanzi l- oħra huma Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium
dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.
dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 u talc.
What Eucreas looks like and contents of the pack Eucreas 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Id- Dehra ta ’ Eucreas u l- kontenuti tal- pakkett Eucreas 50 mg/ 850 mg pilloli miksijin b’ rita huma pilloli sofor, ovali b ’ “ NVR ” fuq naħa waħda u “ SEH ” fuq l- oħra.
Eucreas 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Eucreas 50 mg/ 1000 mg pilloli miksijin b’ rita huma pilloli sofor skuri, ovali b ’ “ NVR ” fuq naħa waħda u “ FLO ” fuq l- oħra.
Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi- packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Eucreas jiġi f’ pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b’ rita u f’ pakketti b’ ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b’ rita.
Not all pack sizes and tablet strengths may be available in your country.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu disponibbli f’ pajjiżek.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Manifattur Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Il- Ġermanja
What is Evicel?
X’ inhu Evicel?
Evicel is a medicine that is used as a sealant (glue).
Evicel huwa mediċina li jintuża bħala siġillant (kolla).
It is available as two solutions, one containing the active substance fibrinogen (50 to 90 mg/ ml), and the other containing the active substance thrombin (800 to 1200 International Units per millilitre).
Huwa disponibbli f’ żewġ soluzzjonijiet, waħda li fiha s- sustanza attiva fibrinoġen (50 sa 90 mg/ ml), u l- oħra li fiha s- sustanza attiva trombina (thrombin) (800 sa 1200 Unità Internazzjonali għal kull millilitru).
What is Evicel used for?
Għal xiex jintuża Evicel?
Evicel is used by surgeons to reduce local bleeding during an operation when standard techniques are not sufficient.
Evicel jintuża mill- kirurgi sabiex inaqqsu fsada lokali waqt operazzjoni meta t- tekniki standard ma jkunux biżżejjed.
Evicel can also be used in addition to sutures (stitching) during vascular surgery (surgery on the blood vessels).
Evicel jista ’ jintuża wkoll mas- sutura (punti) waqt interventi tal- kirurġija vaskulari (kirurġija fuq il- vini u l- arterji).
How is Evicel used?
Kif jintuża Evicel?
Evicel should only be used by an experienced surgeon.
Evicel għandu jintuża biss minn kirurgu b’ esperjenza.
Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine.
Qabel l- użu, iż- żewġ soluzzjonijiet ta ’ Evicel jitħalltu flimkien bl- użu ta ’ apparat speċjali li jiġi fornut mal- mediċina.
Evicel is then dripped or sprayed on the surface of the wound until it forms a thin layer.
Imbagħad, Evicel jitqattar jew jitraxxax fuq il- wiċċ tal- ferita sakemm tifforma saff irqiq.
The volume of Evicel to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Il- volum ta ’ Evicel li għandu jintuża jiddependi fuq numru ta ’ fatturi, inkluż it- tip ta ’ intervent kirurġiku, id- daqs tal- ferita u n- numru ta ’ applikazzjonijiet.
Evicel is not recommended for use in children because the information on its safety and effectiveness in this age group is too limited.
Evicel mhux rakkomandat għall- użu fuq it- tfal minħabba li l- informazzjoni dwar is- sigurtà u l - effikaċja tiegħu fuq din il- faxxa ta ’ età hija limitata wisq.
How does Evicel work?
Kif jaħdem Evicel?
The active substances in Evicel, fibrinogen and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Is- sustanzi attivi f’ Evicel, fibrinoġen u trombina, huma sustanzi naturali miksubin mill- plażma umana (il- parti likwida tad- demm).
When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Meta ż- żewġ sustanzi attivi jitħalltu flimkien, it- trombina tqattal - fibrinoġen f’ unitajiet iżgħar imsejħa fibrini.
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Il- fibrini mbagħad jingħaqdu (jeħlu flimkien) u jiffurmaw embolu tal- fibrina li jgħin biex il- ferita tfieq, u jipprevjeni l- fsada.
How has Evicel been studied?
Kif ġie studjat Evicel?
The effects of Evicel were first tested in experimental models before being studied in humans.
L- effetti ta ’ Evicel għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Because the thrombin solution of Evicel is also used in another medicine, Quixil, which is authorised in 14 countries in Europe, the company used some data from Quixil to support the use of Evicel.
Minħabba li s- soluzzjoni tat- trombina ta ’ Evicel tintuża wkoll f’ mediċina oħra, Quixil, li hija awtorizzata f’ 14- il pajjiż fl- Ewropa, il- kumpanija użat xi dejta minn Quixil biex tappoġġja l- użu ta ’ Evicel.
Reproduction is authorised provided the source is acknowledged. pressure) in reducing bleeding during vascular surgery.
L- effikaċja ta ’ Evicel ġiet studjata f’ żewġ studji ewlenin li involvew total ta ’ 282 pazjent.
The main measure of effectiveness was the number of patients with no bleeding (haemostasis) at the site of application, four minutes after having received Evicel or manual compression.
L- ewwel studju qabbel l- effikaċja ta ’ Evicel ma ’ dik tal- kompressjoni manwali (l- applikazzjoni ta ’ pressjoni diretta) fit- tnaqqis ta ’ fsada waqt l- intervent ta ’ kirurġija vaskulari.
The second study compared the effectiveness of Evicel with that of Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy).
It- tieni studju qabbel l- effikaċja ta ’ Evicel ma ’ dik ta ’ Surgicel (materjal użat biex jgħin kontra l- fsada) fit- tnaqqis ta ’ fsada waqt interventi ta ’ kirurġija addominali (operazzjonijiet fuq l- organi taż- żaqq).
The main measure of effectiveness was the number of patients with no bleeding at the site of application, 10 minutes after having received Evicel or Surgicel.
Il - kejl ewlieni tal- effikaċja kien in- numru ta ’ pazjenti mingħajr fsada fis- sit tal- applikazzjoni, 10 minuti wara li kienu rċevew Evicel jew Surgicel.
What benefit has Evicel shown during the studies?
Liema benefiċċju wera Evicel waqt l- istudji mwettqa?
Evicel was more effective than the comparator treatments in reducing the bleeding at the site of application.
Evicel kien aktar effikaċi mit- trattamenti li tqabblu miegħu fit- tnaqqis ta ’ fsada fuq is- sit tal - applikazzjoni.
In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72).
Fl- interventi ta ’ kirurġija vaskulari, 85% tal- pazjenti ma kellhom l- ebda fsada għal erba ’ minuti wara li ġew ittrattati b’ Evicel (64 minn 75), meta mqabbla ma ’ 39% tal- pazjenti ttrattati bil- kompressjoni manwali (28 minn 72).
During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69).
Waqt l- interventi ta ’ kirurġija addominali, 95% tal- pazjenti ma kellhom l- ebda fsada 10 minuti wara li ġew ittrattati b’ Evicel (63 min 66), meta mqabbla ma ’ 81% tal- pazjenti ttrattati b’ Surgicel (56 minn 69).
What is the risk associated with Evicel?
X’ inhu r- riskju assoċjat ma ’ Evicel?
As for other sealants, Evicel may cause an allergic reaction.
Bħal siġillanti oħra Evicel jista ’ jikkawża reazzjoni allerġika.
In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
F’ każijiet rari, il- pazjenti jistgħu jiżviluppaw ukoll antikorpi għall- proteini f’ Evicel, li jistgħu jinterferixxu mal- għaqid tad- demm.
Thromboembolic complications (blood clots) may occur if Evicel is unintentionally injected into a blood vessel.
Jistgħu jseħħu kumplikazzjonijiet tromboemboliċi (emboli tad- demm) jekk Evicel tkun injettata aċċidentalment f’ xi arterja jew vina.
For the full list of all side effects reported with Evicel, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rappurtati b’ Evicel, ara l - Fuljett ta ’ Tagħrif.
Evicel should not be used in people who may be hypersensitive (allergic) to fibrinogen, thrombin or any of the other ingredients.
Evicel ma għandux jintuża fuq nies li jistgħu jkunu ipersensittivi (allerġiċi) għall- fibrinoġen, it - trombina jew għal xi wieħed mill- ingredjenti l- oħra.
It must not be given as an injection into a blood vessel.
Dan ma għandux jingħata bħala injezzjoni f’ arterja jew vina.
Why has Evicel been approved?
Għaliex ġie approvat Evicel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Evicel’ s benefits are greater than its risks as supportive treatment in surgery for the improvement of haemostasis where standard techniques are insufficient, and as suture support for haemostasis in vascular surgery.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Evicel huma ikbar mir- riskji tiegħu bħala trattament ta ’ sostenn fl- interventi kirurġiċi għat- titjib tal - emostażi fejn it- tekniki standard ma jkunux biżżejjed, u bħala għajnuna għas- sutura għall- emostażi f ’ interventi ta ’ kirurġija vaskulari.
The Committee recommended that Evicel be given marketing authorisation.
Il- Kumitat irrakkomanda li Evicel jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Evicel:
Aktar tagħrif dwar Evicel:
The European Commission granted a marketing authorisation valid throughout the European Union for Evicel to Omrix Biopharmaceuticals S. A. on 6 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha, għal Evicel lil Omrix Biopharmaceuticals S. A. fi 6 ta ’ Ottubru 2008.
The full EPAR for Evicel can be found here.
L- EPAR sħiħ għal Evicel jista ’ jiġi kkonsultat hawn.
Route of Administration
Mnejn u kif jingħata
Packaging
Ippakkjar
Solutions for sealant
Soluzzjonijiet għal siġill
Epilesional use
Użu epileżjonali
vial (glass)
kunjett (tal - ħġieġ)
2 vials
2 kunjetti
EVICEL solutions for sealant
EVICEL soluzzjonijiet ta 'siġillanti
The active ingredients are as follows:
Is- sustanzi attivi huma kif ġejjin:
1 ml vial
kunjett ta '1 ml
2 ml vial
kunjett ta '2 ml
5 ml vial
kunjett ta '5 ml
Human clottable protein containing mainly fibrinogen and fibronectin * Component 2
Proteina umana li tagħqad li fiha prinċipalment fibrinoġen u fibronektina * Komponent 2
800 – 1,200 IU
800 – 1, 200 IU
1,600 – 2,400 IU
1, 600 – 2, 400 IU
4,000 – 6,000 IU
4, 000 – 6, 000 IU
* Total quantity of protein is 80 - 120 mg/ ml
hija 80 - 120 mg/ ml
For a full list of excipients see section 6.1.
Għal- lista kompleta ta 'eċċipjenti, ara sezzjoni 6. 1.
Solutions for sealant.
Soluzzjonijiet ta 'siġillant.
Clear or slightly opalescent solutions.
Soluzzjonijiet ċari jew xi ftit opalexxenti.
EVICEL is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
EVICEL jintuża bħala kura ta 'appoġġ fil- kirurġija, għal titjib ta' l- emostażi, fejn tekniċi kirurġiċi standard mhumiex biżżejjed (ara sezzjoni 5. 1).
EVICEL is also indicated as suture support for haemostasis in vascular surgery.
EVICEL huwa wkoll indikat bħala appoġġ għas- sutura għall- emostażi f' kirurġija vaskulari.
The use of EVICEL is restricted to experienced surgeons.
L- użu ta 'EVICEL huwa ristrett għall- kirurgi espert.
The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Il- volum ta 'EVICEL li jrid jiġi applikat u l- frekwenza ta' l- applikazzjoni għandhom dejjem ikunu orjentati lejn il- ħtiġijiet kliniċi bażiċi tal- pazjent.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Id- doża li trid tiġi applikata hija regolata permezz ta 'varjabblili jinkludu, iżda mhux limitati għal, it- tip ta' intervent kirurġiku, id- daqs ta 'l- erja u l- mod ta' applikazzjoni intenzjonata, u n- numru ta 'applikazzjonijiet.
Application of the product must be individualised by the treating physician.
L- applikazzjoni tal- prodott jeħtieġ li tkun individwalizzata mit- tabib li jkun qiegħed jagħti t- trattament.
In clinical trials in vascular surgery, the individual dosage used was up to 4 ml, whereas in retroperitoneal or intra- abdominal surgery the individual dosage used was up to 10 ml.
Fi provi kliniċi f' kirurġija vaskulari, id- dożaġġ individwali użat kien sa 4 ml, filwaqt li f' kirurġija retroperitoneali u intraddominali, id- dożaġġ individwali użat kien sa 10 ml.
However, for some procedures (e. g. liver traumata) larger volumes may be required.
Madankollu, għal xi proċeduri (eż. trawmi epatiċi) jistgħu jkunu meħtieġa volumi ikbar.
The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Il- volum inizjali tal- prodott li jrid jiġi applikat fis- sit anatomiku magħżul jew l- erja tal- wiċċ fil- mira għandu jkun biżżejjed biex jiksi kompletament l- erja ta 'applikazzjoni intenzjonata.
The application can be repeated, if necessary.
L- applikazzjoni tista 'tiġi rrepetuta, jekk meħtieġ.
Method and route of administration 2 For epilesional use.
2 Metodu u mnejn jingħata
Prepare the solution as described in section 6.6.
Ipprepara s- soluzzjoni kif deskritt fis- sezzjoni 6. 6.
Before application, the surface of the wound should be as dry as possible.
Qabel l- applikazzjoni, il- wiċċ tal- ferita għandu jkun kemm jista 'jkun xott.
See section 6.6 for more detailed instructions.
Għal struzzjonijiet iktar iddettaljati ara s- sezzjoni 6. 6.
EVICEL must not be applied intravascularly.
EVICEL m' għandux jiġi applikat intravaskularment.
Hypersensitivity to the active substances or to any of the excipients.
Ipersensittività għas- sustanzi attivi jew għal xi eċċipjenti.
For epilesional use only.
Għal użu epileżjonali biss.
Do not apply intravascularly.
Tapplikax ġol- vini.
Life threatening thromboembolic complications may occur if the product is unintentionally applied intravascularly.
Kumplikazzjonijiet tromboemboliċi ta 'theddid għall- ħajja jistgħu jseħħu jekk il- prodott jiġi applikat intravaskularment b' mod mhux intenzjonat.
Adequate data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
M' hemmx tagħrif adegwat biex jappoġġja l- użu ta 'dan il- prodott fit- twaħħil ta' tessuti, newrokirurġija, applikazzjoni permezz ta 'endoskopju flessibbli għat- trattament ta' emorraġiji jew f' anastomożijiet gastrointestinali.
Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Qabel l- għoti ta 'EVICEL, għandha tingħata attenzjoni li partijiet tal- ġisem barra mill- erja ta' l- applikazzjoni mixtieqa jkunu protetti biżżejjed (mgħottijin) biex jimpedixxu twaħħil tat- tessuti fis- siti mhux mixtieqa.
As with any protein product, allergic type hypersensitivity reactions are possible.
Bħalma jseħħ bi kwalunkwe prodott tal- proteini, reazzjonijiet ta 'ipersensittività tat- tip allerġiċi huma possibbli.
Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Sinjali ta 'ipersensittività jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tas- sider, tħarħir, ipotensjoni u anafilassi.
If these symptoms occur, the administration should be immediately discontinued.
Jekk iseħħu dawn is- sintomi, l- għoti għandu jitwaqqaf minnufih.
In case of shock, standard medical treatment for shock should be implemented.
F' każ ta 'xokk, għandha tkun implimentata kura medika standard għal xokk.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Miżuri standard biex jimpedixxu infezzjonijiet li jirriżultaw minn prodotti mediċinali ppreparati minn demm jew plażma umani jinkludu l- għażla ta 'donaturi, eżamijiet ta' donazzjonijiet individwali u pools tal- plażma għal markaturi speċifiċi ta 'infezzjonijiet u l- inklużjoni ta' passi effikaċi ta 'manifattura għall - inattivazzjoni/ tneħħija ta' virusijiet.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infections agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali ppreparati minn demm jew plażma umani, il- possibilità li jiġu trażmessi aġenti infettivi ma tistax tiġi totalment eskluża.
This also applies to unknown or emerging viruses and other pathogens.
Din tapplika wkoll għal virusijiet mhux magħrufin jew emerġenti u patoġeni oħrajn.
The measures taken are considered effective for enveloped viruses such as HIV, Hepatitis C Virus and Hepatitis B Virus and for the non-enveloped virus Hepatitis A Virus.
Il- miżuri meħudin huma kkunsidrati effikaċi għall- virusijiet enveloppati bħalma huma HIV, Virus ta 'l - Epatite Ċ u Virus ta' l- Epatite B u għall- virus mhux enveloppat tal- Virus ta 'l- Epatite A.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Il- miżuri meħudin jistgħu jkunu ta 'valur illimitat kontra virusijiet mhux envelopati bħal parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoyesis (e. g. haemolytic anaemia).
Infezzjoni b' Parvovirus B19 tista 'tkun serja għal nisa tqal (infezzjoni fetali) u għal individwi b' immunodefiċjenza jew b' żieda fl- eritropojeżi (ngħidu aħna, anemija emolitika).