qanastek/EMEA-V3 huggingface dataset:
PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
11 PritorPlus hu taħlita ta ’ antagonist tar- riċetturi ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
PritorPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
PritorPlus mogħti darba kuljum jipproduċi tnaqqis effettiv u stabbli fil- pressjoni tad- demm fil- medda kollha tad - doża terapewtika.
Following oral administration of PritorPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing.
Wara l- għoti ta ’ PritorPlus mill- ħalq, il- konċentrazzjonijiet massimi ta ’ hydrochlorothiazide jintlaħqu wara madwar 1. 0 – 3. 0 sigħat wara d- dożaġġ.
Terminal elimination half-life was > 20 hours.
Il- half- life tat - tneħħija terminali kienet > 20 siegħa.
Blister with 14, 28, 30, 56, 90, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 30, 56, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l- unità bi 28 x 1 pillola.
22 April 2002 Date of last renewal:
22 ta ’ April, 2002 Data ta ’ l- aħħar tiġdid:
22 April 2007
22 ta ’ April, 2007
PritorPlus 80 mg/ 12.5 mg tablets
PritorPlus 80 mg/ 12. 5 mg pilloli
PritorPlus fixed dose combination (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
It- taħlita fissa tad- doża ta ’ PritorPlus (80 mg telmisartan/ 12. 5 mg ta ’ hydrochlorothiazide) hi indikata għal pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Monitoraġġ perjodiku tal- livell tal- potassium fis- serum u ECG huma rakkomandati meta PritorPlus jingħata ma ’ ma ’ dawn il- prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum (eż. digitalis glycosides, u anti- arritimiċi) u mal- prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti- arritimici), bl- ipokalemija, li hi fattur li jippredisponi t- torsades de pointes.
- class Ia antiarrythmics (e. g. quinidine, hydroquinidine, disopyramide)
Anti- arritimiċi ta ’ Klassi Ia (eż.: quinidine, hydroquinidine, disopyramide)
21 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa bi PritorPlus, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Gastrointestinal disorders
23 Disturbi gastro- intestinali
Vascular disorders
24 Disturbi vaskulari
Pharmacotherapeutic group:
25 Kategorija farmakoterapewtika:
PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
PritorPlus hu taħlita ta ’ antagonist tar- riċetturi ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
24 The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
L- effetti ta ’ telmisartan fuq il- mortalità u l- morbożità kardjovaskulari għadhom mhumiex magħrufa.
Presumably through blockade of the renin- angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Hu maħsub li permezz ta ’ l- imblukkar tas- sistema renin- angiotensin- aldosterone, l- għoti flimkien ta ’ telmisartan għandu tendenza li jreġġa ’ lura t- telf tal- potassium assoċjat ma ’ dawn id -
Terminal elimination half-life was > 20 hours.
Il- half- life tat - tneħħija terminali kienet ta ’ > 20 siegħa.
25 Special populations
Popolazzjonijiet speċjali
There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
27 hydrochlorothiazide fil- plażma f’ pazjenti nisa milli fl- irġiel.
26 Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
6. 2.
Not applicable.
28 Ma jgħoddx f’ dan il- każ.
PritorPlus 80 mg/ 25 mg tablets
PritorPlus 80 mg/ 25 mg pilloli
PritorPlus fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus 80 mg/ 12.5 mg (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
PritorPlus taħlita fissa tad- doża (80 mg telmisartan/ 25 mg hydrochlorothiazide) hi indikata f’ pazjenti li pressjoni tad- demm tagħhom ma tkunx ikkontrollata b’ mod adegwat bi PritorPlus 80 mg/ 12. 5 mg (80 mg telmisartan/ 12. 5 mg hydrochlorothiazide) jew f’ pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
PritorPlus 80 mg/ 25 mg may be administered in patients whose blood pressure is not adequately controlled by PritorPlus 80 mg/ 12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
PritorPlus 80 mg/ 25 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew bi PritorPlus 80 mg/ 12. 5 mg jew lil pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
PritorPlus is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
PritorPlus hu disponibbli wkoll f’ dożi b’ qawwa ta ’ 40 mg/ 12. 5 mg u 80 mg / 12. 5 mg
28 4.3 Contraindications
30 4. 3 Kontra indikazzjonijiet
29 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
30 Ethnic differences:
Differenzi etniċi:
Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Monitoraġġ perjodiku tal- livell tal- potassium fis- serum u ECG huma rakkomandati meta PritorPlus jingħata ma ’ dawn il - prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum (eż. digitalis glycosides, u anti- arritimiċi) u mal- prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti - arritimici), bl- ipokalemija, li hi fattur li jippredisponi t- torsades de pointes.
31 Other antihypertensive agents:
Mediċini oħrajn kontra l- pressjoni għolja:
32 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Fixed Dose Combination The overall incidence and pattern of adverse events reported with PritorPlus 80 mg/ 25 mg was comparable with PritorPlus 80 mg/ 12.5 mg.
Taħlita Fissa tad- Doża L- inċidenza totali u l- andament ta ’ l- avvenimenti avversi rrappurtati bi PritorPlus 80 mg/ 25 mg kienu komparabbli ma ’ dawk bi PritorPlus 80 mg/ 12. 5 mg.
A dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients.
Ir- relazzjoni ta ’ l- effetti mhux mixtieqa assoċjati mad- doża ma ’ kinitx stabbilita, u l- effetti ma wrew l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar - razza tal- pazjenti.
33 Infections and infestations
Infezzjonijiet u infestazzjonijiet
34 Investigations
Investigazzjonijiet
Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa bi PritorPlus, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Skin and subcutaneous tissue disorders
37 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
35 Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ hydrochlorothiazide waħdu jinkludu:
36 4.9 Overdose
4. 9 Doża eċċessiva
PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
39 PritorPlus hu taħlita ta ’ antagonist tar- riċetturi ta ’ angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
37 representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
L- effikaċja anti- ipertensiva ta ’ telmisartan hi komparabbli ma ’ dik ta ’ mediċini li jirrappreżentaw kategoriji oħrajn ta ’ prodotti mediċinali kontra l- pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma ’ amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
39 Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/ hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Is- sejbiet tossikoloġiċi magħrufa sew minn studji li kienu saru qabel l- użu kliniku b’ inibituri ta ’ l - enzimi li jibdlu l- angiotensin u b ’ antagonisti tar- riċetturi ta ’ angiotensin II kienu: tnaqqis fil- parametri taċ- ċelluli l- ħomor (eritroċiti, emoglobina, ematokrit), bidliet ta ’ l- emodinamika renali (żieda fin - nitroġenu ta ’ l- urea fid- demm u krejatinina), żieda fl- attività tar- renin fil- plażma, ipertrofija/ iperplasija taċ- ċelluli juxtaglomerulari, u ħsara mukożali gastrika.
Pack sizes: blister with 14, 28, 30, 56, 90 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets
Folja b’ 14, 28, 30, 56, 90, jew 98 pillola jew folji perforati bid- doża ta ’ l- unità bi 28 x 1 pillola.
40 Occasionally, the outer layer of the blister pack has been observed to separate from the inner layer between the blister pockets.
Xi kultant, kien osservat li s- saff ta ’ barra tal- pakkett tal- folji jinqala ’ mis- saff ta ’ ġewwa bejn il - pakketti tal- folji.
EU/ 1/ 02/ 215/ 015-021
EU! 02215015- 021
41 ANNEX II
44 ANNESS II
42 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
45 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
SmithKline Beecham Crawley Manufacturing Site Manor Royal West Sussex RH10 2QJ United Kingdom
SmithKline Beecham Crawley Manufacturing Site Manor Royal West Sussex RH10 2QJ Ir- Renju Unit
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
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju)
43 ANNEX III
47 ANNESS III
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
PritorPlus 40 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
PritorPlus 40 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
14 tablets 28 tablets 28 x 1 unit dose tablets 30 tablets 56 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola tad- doża ta ’ l- unità 30 pillola 56 pillola 90 pillola 98 pillola
PritorPlus 40 mg/ 12.5 mg
PritorPlus 40 mg/ 12. 5 mg
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
PritorPlus 80 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
PritorPlus 80 mg/ 12. 5 mg pilloli telmisartan/ hydrochlorothiazide
PritorPlus 80 mg/ 12.5 mg
PritorPlus 80 mg/ 12. 5 mg pilloli
51 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PritorPlus 80 mg/ 25 mg tablets telmisartan/ hydrochlorothiazide
PritorPlus 80 mg/ 25 mg pilloli telmisartan/ hydrochlorothiazide
PritorPlus 80 mg/ 25 mg
PritorPlus 80 mg/ 25 mg pilloli
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
58 PACKAGE LEAFLET:
62 FULJETT TA ’ TAGĦRIF:
What PritorPlus is and what it is used for 2.
X’ inhu PritorPlus u għalxiex jintuża 2.
Before you take PritorPlus 3.
Qabel ma tieħu PritorPlus 3.
How to take PritorPlus 4.
Kif għandek tieħu PritorPlus 4.
How to store PritorPlus 6.
Kif taħżen PritorPlus 6.
WHAT PRITORPLUS IS AND WHAT IT IS USED FOR
X’ INHU PRITORPLUS U GĦALXIEX JINTUŻA
PritorPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
PritorPlus hu taħlita ta ’ żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f’ pillola waħda.
PritorPlus is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.
PritorPlus jintuża għall- kura ta ’ pressjoni tad- demm għolja (pressjoni għolja essenzjali) f’ pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata biżżejjed meta jew telmisartan jew hydrochlorothiazide jintużaw waħidhom.
BEFORE YOU TAKE PRITORPLUS
QABEL MA ’ TIEĦU PRITORPLUS
Do not take PritorPlus
Tiħux PritorPlus
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in PritorPlus tablets (see "Further information" for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli PritorPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra).
59 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
63 • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide. • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ). • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
If any of the above applies to you, tell your doctor or pharmacist before taking PritorPlus.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu PritorPlus.
Take special care with PritorPlus
Oqgħod attent ħafna bi PritorPlus
PritorPlus is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breast-feeding).
PritorPlus mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek wara 3 xhur ta ’ tqala (ara s- sezzjoni Tqala u treddigħ).
In case of surgery or anaesthetics, you should tell your doctor that you are taking PritorPlus.
F’ każ ta ’ operazzjoni jew anestetiċi, għandek tgħid lit- tabib tiegħek li qed tieħu PritorPlus.
The use of PritorPlus in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ PritorPlus fit- tfal u fl- adolexxenti sa l- età ta ’ 18- il sena mhuwiex rakkomandat.
This applies especially to the medicines listed below taken at the same time with PritorPlus:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ PritorPlus:
60 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
PritorPlus may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking PritorPlus.
PritorPlus jista ’ jżid l- effett li jbaxxi l- pressjoni tad- demm ta ’ mediċini oħrajn, u għandek tkellem lit - tabib tiegħek jekk ikollok bżonn taġġusta d- doża tal- mediċina l- oħra tiegħek meta tkun qed tieħu PritorPlus.
As with other blood pressure lowering medicines, the effect of PritorPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen).
Bħal ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ PritorPlus jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti- inflammatory drugs, eż. aspirina jew ibuprofen).
Taking PritorPlus with food and drink
Meta tieħu PritorPlus ma ’ l- ikel u x- xorb
You can take PritorPlus with or without food.
Tista ’ tieħu PritorPlus ma ’ l- ikel jew mingħajr l- ikel.
Usually, your doctor will advise you to take another medicine instead of PritorPlus, as PritorPlus is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek ser jagħtik parir biex tieħu mediċina oħra minflok PritorPlus, għax PritorPlus mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara 3 xhur ta ’ tqala.
Appropriate antihypertensive drug must usually replace PritorPlus before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi PritorPlus qabel il- bidu ta ’ tqala.
PritorPlus should not be used during the second and third trimester of pregnancy.
PritorPlus m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
Your doctor will normally advise you to stop taking PritorPlus as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu PritorPlus hekk kif issir taf li inti tqila.
If you become pregnant during therapy with PritorPlus, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ PritorPlus, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take PritorPlus if you are breast-feeding.
M’ għandekx tieħu PritorPlus jekk qed tredda ’.
No information is available on the effect of PritorPlus on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ PritorPlus fuq il- ħila li ssuq jew tħaddem makkinarju.
Important information about some of the ingredients of PritorPlus
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ PritorPlus
PritorPlus contains milk sugar (lactose) and sorbitol.
PritorPlus fih zokkor tal- ħalib (lactose) u sorbitol.
If you are intolerant to some sugars, consult your doctor before taking PritorPlus.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu PritorPlus.
HOW TO TAKE PRITORPLUS
KIF GĦANDEK TIEĦU PRITORPLUS
Always take PritorPlus exactly as your doctor has told you.
65 Dejjem għandek tieħu PritorPlus skond il- parir eżatt tat- tabib.
The usual dose of PritorPlus is one tablet a day.
Id- doża normali ta ’ PritorPlus hi ta ’ pillola waħda darba kuljum.
It is important that you take PritorPlus every day until your doctor tells you otherwise.
Hu importanti li tieħu PritorPlus kuljum sakemm it- tabib tiegħek jagħtik parir ieħor.
61 If you take more PritorPlus than you should If you accidentally take too many tablets contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu PritorPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
If you forget to take PritorPlus If you forget to take a dose, do not worry.
Jekk tinsa tieħu PritorPlus Jekk tinsa tieħu doża, tinkwetax.
Like all medicines, PritorPlus can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, PritorPlus jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth, flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain, and increased blood uric acid levels.
Tnaqqis fil- livelli tal- potassium fid- demm; ansjetà; ħass ħażin (sinkope); sensazzjoni ta ’ tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija); tħoss kollox idur bik (vertigo); taħbit tal- qalb mgħaġġel (takikardija), disturbi fir- ritmu tat- taħbit tal- qalb, pressjoni tad- demm baxxa, il - pressjoni tad- demm taqa ’ f’ daqqa meta tkun bilwieqfa; qtugħ ta ’ nifs (dispneja); sintomi ta ’ stonku mqalleb bħal dijarea; ħalq xott, gass; uġigħ fid- dahar, spażmi fil- muskoli, uġigħ fil- muskoli; disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni); uġigħ fis- sider, żieda fil- livelli tal- uric acid fid- demm.
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
66 Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
Side effects of unknown frequency may include: upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e. g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure; weakness; decreased haemoglobin (a blood protein), ineffectiveness of telmisartan.
Infezzjoni fil- parti ta ’ fuq tal- apparat respiratorju (eż. uġigħ fil- griżmejn, sinuses infjammati, riħ komuni), infezzjoni fl- apparat urinarju; żieda f’ ċerti ċelluli bojod tad- demm (eosinofilja), tnaqqis fiċ - ċelluli ħomor tad- demm (anemija), għadd baxx tal- plejtlets (tromboċitopenija); reazzjoni allerġika serja (eż. sensittività eċċessiva, reazzjoni anafilattika, raxx minħabba l- mediċina); livelli għolja ta ’ potassium; rata ta ’ taħbit tal- qalb bil- mod (bradikardija); stonku mqalleb; ekżema (disturb fil- ġilda); infjammazzjoni tat- tendini; indeboliment fil- kliewi li jinkludi insuffiċjenza akuta tal- kliewi; dgħjufija; tnaqqis fl- emoglobina (proteina fid- demm), telmisartan ma jkunx effettiv.
62 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
HOW TO STORE PRITORPLUS
KIF TAĦŻEN PRITORPLUS
Do not use PritorPlus after the expiry date which is stated on the carton after “ EXP”.
Tużax PritorPlus wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
What PritorPlus contains
X’ fih PritorPlus
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
67 Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
What PritorPlus looks like and contents of the pack
Id- dehra ta ’ PritorPlus u l- kontenuti tal- pakkett
PritorPlus 40 mg/ 12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number'H4 '.
Il- pilloli PritorPlus 40 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bil - kodiċi 'H4'.
PritorPlus is available in blisters packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
PritorPlus hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 30, 56, 90 jew 98 pillola, jew pakketti tal - folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
Manufacturer or SmithKline Beecham Crawley Manufacturing Site Manor Royal West Sussex RH10 2QJ United Kingdom
je Crawley Manufacturing Site
64 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
België / Belgique / Belgien Bayer S. A. / N. V.
68 België / Belgique / Belgien Bayer S. A. / N. V.
65 PACKAGE LEAFLET:
69 FULJETT TA ’ TAGĦRIF:
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in PritorPlus tablets (see "Further Information" for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli PritorPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra).
66 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
70 • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide. • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ). • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
67 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
You can take PritorPlus tablets with or without food.
Tista ’ tieħu PritorPlus ma ’ l- ikel jew mingħajr l- ikel.
Always take PritorPlus exactly as your doctor has told you.
72 Dejjem għandek tieħu PritorPlus skond il- parir eżatt tat- tabib.
68 If you take more PritorPlus than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu PritorPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Side effects of unknown frequency may include:
73 Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu:
69 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
The active substances are telmisartan and hydrochlorothiazide.
74 Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
PritorPlus 80 mg/ 12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number'H8 '.
Il- pilloli PritorPlus 80 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bin - numru tal- kodiċi 'H8'.
70 Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Manufacturer
Bayer HealthCare AG
Bayer HealthCare AG D-51368 Leverkusen Germany
D- 51368 Leverkusen
Bayer HealthCare AG or SmithKline Beecham D-51368 Leverkusen Crawley Manufacturing Site Germany Manor Royal West Sussex RH10 2QJ United Kingdom
D- 51368 Leverkusen,
71 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
België / Belgique / Belgien Bayer S. A. / N. V.
75 België / Belgique / Belgien Bayer S. A. / N. V.
72 PACKAGE LEAFLET:
76 FULJETT TA ’ TAGĦRIF:
- Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
Do not take PritorPlus • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in PritorPlus tablets (see “ Further Information” for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder), or any other severe liver disease. • if you have severe kidney disease.
Tiħux PritorPlus • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli PritorPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra). • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide.
73 • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
77 • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ). • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
Always take PritorPlus exactly as your doctor has told you.
79 Dejjem għandek tieħu PritorPlus skond il- parir eżatt tat- tabib.
75 If you take more PritorPlus than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu PritorPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
80 Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
76 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
The active substances are telmisartan and hydrochlorothiazide.
81 Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
PritorPlus 80 mg/ 25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code'H9 '.
Il- pilloli PritorPlus 80 mg/ 25 mg huma sofor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bil - kodiċi 'H9'.
PritorPlus is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
PritorPlus hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 30, 56, 90 jew 98 pillola, jew pakketti tal - folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
77 Marketing Authorisation Holder Bayer HealthCare AG Bayer HealthCare AG D-51368 Leverkusen D-51368 Leverkusen Germany Germany
jew SmithKline Beecham Bayer HealthCare AG
Manufacturer or SmithKline Beecham Crawley Manufacturing Site Manor Royal West Sussex RH10 2QJ United Kingdom
Manor Royal West Sussex RH10 2QJ Ir- Renju Unit
78 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
What is Privigen?
X’ inhu Privigen?
Privigen is a solution for infusion (drip into a vein).
Privigen huwa soluzzjoni għall- infużjoni (dripp fil- vina).
What is Privigen used for?
Għal xiex jintuża Privigen?
Privigen is used in three main groups of patients: • Patients who are at risk of infection because they do not have sufficient antibodies (proteins naturally found in the blood that help the body to fight infections and other diseases).
Privigen jintuża għal tliet gruppi ta ’ pazjenti: • Pazjenti li jkollhom riskju ta ’ infezzjoni għax ma jkollhomx biżżejjed antikorpi (proteini li jinsabu naturalment fid- demm li jgħinu lill- ġisem jikkumbatti infezzjonijiet u mard ieħor).
These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID).
Dawn jistgħu jkunu persuni mwielda b’ nuqqas ta ’ antikorpi (sindromu ta ’ l- immunodefiċjenza primarja, PID).
It also includes patients whose lack of antibodies is due to a cancer of the blood (myeloma or chronic lymphoid leukaemia) or children born with acquired immune deficiency syndrome (AIDS), who suffer from frequent infections.
Jinkludu wkoll persuni li n- nuqqas ta ’ antikorpi tagħhom ikun ikkawżat minn kankru fid- demm (mijeloma jew lewċemija linfomatika kronika) jew tfal imwielda bis- sindromu minn immunodefiċjenza akkwiżita (AIDS), li jkunu jsofru minn infezzjonjiet frekwenti.
These types of conditions are called ‘ immunodeficiency syndromes’ and their treatment is called ‘ replacement therapy ’. • Patients with certain immune disorders.
Dawn it- tipi ta ’ kondizzjonijiet jissejħu ‘ sindromi ta ’ l- immunodefiċjenza ’ u t- trattament tagħhom jissejjaħ ‘ terapija sostituttiva ’. • Pazjenti b’ ċerti problemi immunoloġiċi.
These patients have an abnormal immune system (the body’ s defence system) that needs to be adjusted.
Dawn il- pazjenti jkollhom sistema immunitarja (is - sistema difensiva tal- ġisem) anormali li tkun trid tiġi aġġustata.
They include patients with idiopathic thrombocytopenic purpura (ITP) who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding, and patients with certain diseases (Guillain- Barré syndrome or Kawasaki disease).
Dawn jinkludu pazjenti b’ purpura tromboċitopenika idjopatika (ITP) li ma jkollhomx biżżejjed platelets (komponenti tad- demm li jgħinuh jagħqad) u li jkollhom riskju ta ’ ħruġ ta ’ demm, u pazjenti b’ ċertu mard (is- sindromu Guillain Barré jew il- marda ta ’ Kawasaki).
This type of treatment is called ‘ immunomodulation’ (immune adjustment). • Patients who have had a bone marrow transplant.
Dan it- tip ta ’ trattament jissejjaħ ‘ immunomodulazzjoni ’ (aġġustament immunoloġiku). • Pazjenti li jkunu ngħataw trapjant tal- mudullun.
How is Privigen used?
Kif jintuża Priviġen?
Privigen is usually given as an intravenous infusion by a doctor or nurse.
Privigen jingħata b’ infużjoni intravenuża minn tabibn jew infermier.
The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Id- doża u l- frekwenza ta ’ l - infużjoni (kemm jingħataw ta ’ spiss) jiddependu mill- marda li tkun qed tiġi ttrattata.
In replacement therapy, the dose may need to be adjusted for patients depending on their response.
Fit- terapija sostituttiva, id- doża jista ’ jkollha tiġi aġġustata għal pazjenti skond ir- rispons li jkollhom.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Għad - dettalji kollha, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How does Privigen work?
Kif jaħdem Privigen?
It contains immunoglobulin G (IgG), which is a type of antibody.
Is- sustanza attiva fi Privigen, l- immunoglobulina normali tal- bniedem, hi proteina ppurifikata ħafna estratta mill- plażma (parti mid- demm) tal- bniedem.
IgG has been used as a medicine since the 1980s and has a wide range of activity against 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ikun fiha l- immunoglobulina G (IgG), li hi tip ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. organisms that can cause infection.
Reproduction is authorised provided the source is acknowledged. antikorp.
Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Privigen jaħdem billi jreġġa ’ għan- normal livelli baxxi ħafna ta ’ l- IgG fid- demm.
At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.
F’ dożi ogħla jista ’ jgħin fl- aġġustament ta ’ sistema immunoloġika anormali u fil- modulazzjoni tar- rispons immunoloġiku.
How has Privigen been studied?
Kif ġie studjat Privigen?
As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, only two small studies were needed to establish the effectiveness and safety of Privigen in patients.
Billi l- immunoglobulina normali tal- bniedem ilha tintuża għat- trattament ta ’ dan il- mard, kellhom isiru biss żewġ studji żgħar biex jikkonfermaw l- effikaċja u s- sigurtà ta ’ Privigen fil- pazjenti, skond il - linji gwida attwali.
In the first study, Privigen was used as replacement therapy in 80 patients with PID, with the medicine being infused every three or four weeks.
Fl- ewwel studju, Privigen intuża bħala terapija sostituttiva fi 80 pazjent bil- PID, fejn il- mediċina bdiet tingħata bħala infużjoni kull tlieta jew erba ’ ġimgħat.
The main measure of effectiveness was the number of serious bacterial infections over a year’ s treatment.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien l - għadd ta ’ infezzjonijiet batteriċi serji matul is- sena tat- trattament.
The second study looked at using Privigen for immunomodulation in 57 patients with ITP.
It- tieni studju ħares lejn l- użu ta ’ Privigen għall- immunomodulazzjoni f’ 57 pazjent bl- ITP.
Privigen was given on two consecutive days.
Privigen ingħata fuq żewġ ġranet konsekuttivi.
The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien l- ogħla livell ta ’ platelets fid- demm li ntlaħaq fil- ġimgħa ta ’ wara li kien ingħata Privigen.
Privigen was not compared to any other treatment in either study.
Privigen ma tqabbel ma ’ l- ebda trattament ieħor fl- ebda mill- istudji.
What benefit has Privigen shown during the studies?
Liema benefiċċju wera Privigen waqt l- istudji li ġew mwettqa?
In the first study, the patients had an average of 0.08 serious infections per year.
Fl- ewwel studju, il- pazjenti kellhom medja ta ’ 0. 08 infezzjonijiet serji kull sena.
Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective as replacement therapy.
Billi dan hu inqas mill- kriterju predefinit ta ’ infezzjoni waħda kull sena, dan juri li l- mediċina hi effikaċi bħala terapija sostituttiva.
In the second study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study.
Fit- tieni studju, 46 (81%) mis- 57 pazjent laħqu livell ta ’ platelets ta ’ iktar minn 50 miljun għal kull millilitru ta ’ mill- inqas darba waqt l- istudju.
This confirmed that Privigen is effective in immunomodulation.
Dan ikkonferma li Privigen huwa effikaċi fl - immunomodulazzjoni.
What is the risk associated with Privigen?
X’ inhu r- riskju assoċjat ma ’ Privigen?
The most common side effect with Privigen (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarju komuni mat- teħid ta 'Privigen (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu l- uġigħ ta ’ ras.
Some side effects are more likely to occur when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Privigen before or for a long time.
Uħud mill- effetti sekondarji għandhom ċans ikbar li jseħħu fil- każ li l - infużjoni tingħata b’ rata għolja, fil- każ ta ’ pazjenti b’ livelli baxxi ta ’ immunoglobulina, jew f’ pazjenti li ma jkunux ingħataw Privigen qabel jew għal żmien twil.
For the full list of all side effects reported with Privigen, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati bi Privigen, ara l- Fuljett ta ’ Tagħrif.
Privigen should not be used in people who may be allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Privigen m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għall- immunoglobulina normali tal - bniedem jew għal kwalunkwe mill- ingredjenti l- oħra, jew fil- pazjenti allerġiċi għal tipi oħra ta ’ immunoglobulina, speċjalment meta jkollhom defiċjenza (livelli baxxi ħafna) ta ’ immunoglobulina A (IgA) u jkollhom antikorpi kontra l- IgA.
Privigen must not be used in patients with hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).
Privigen m’ għandux jintuża f’ pazjenti bl- iperprolinemja (problema ġenetika li tikkawża livelli għoljin ta ’ aminoaċidu prolina fid- demm).
Why has Privigen been approved?
Għaliex ġie approvat Privigen?
According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Skond il- linji gwida attwali, il- mediċini li ntwerew li huma effikaċi fil- pazjenti bil- PID u fil- pazjenti bl- ITP jistgħu jiġu approvati wkoll għall- użu fit- trattament ta ’ kull tip ta ’ immunodefiċjenza primarja, kif ukoll għal- livelli baxxi ta ’ antikorpi minħabba kankri tad- demm jew minħabba l- AIDS fit- tfal.
They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing a bone marrow transplant, without the need for specific studies in these diseases.
Jistgħu jiġu approvati wkoll għat- trattament ta ’ pazjenti bis- sindromu Guillain Barré, pazjenti bil - marda ta ’ Kawasaki u pazjenti li jkunu ħadu trapjant tal- mudullun, mingħajr il- ħtieġa għal studji speċifiċi għal dawn il- mardiet.
Therefore, the Committee for Medicinal Products for Human Use (CHMP) concluded that Privigen’ s benefits are greater than its risks for patients who require IgG for replacement therapy, for immunomodulation or because of bone marrow transplantation.
Għalhekk, il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l - benefiċċji ta ’ Privigen huma ikbar mir- riskji għal pazjenti li jkunu jeħtieġu l- IgG għat- terapija sostituttiva, għall- immunomodulazzjoni jew minħabba trapjant tal- mudullun.
The Committee recommended that Privigen be given marketing authorisation.
Il- Kumitat irrakkomanda li Privigen jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Privigen:
Tagħrif ieħor dwar Privigen:
The European Commission granted a marketing authorisation valid throughout the European Union for Privigen to CSL Behring GmbH on 25 April 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Privigen valida fl- Unjoni Ewropea kollha lil CSL Behring GmbH fi Fil- 25 ta ’ April 2008.
The full EPAR for Privigen can be found here.
L- EPAR sħiħ għal Privigen jista ’ jiġi kkonsultat hawn.
Pharmaceutical Form Solution for infusion Solution for infusion Solution for infusion
Soluzzjoni għall- infużjoni Soluzzjoni għall- infużjoni Soluzzjoni għall- infużjoni
Route of Administration Intravenous use Intravenous use Intravenous use
Użu għal ġol- vini Użu għal ġol- vini Użu għal ġol- vini
Packaging Vial (glass) Vial (glass) Vial (glass)
Kunjett (ħġieġ) Kunjett (ħġieġ) Kunjett (ħġieġ)
Package size 1 vial 1 vial 1 vial
1 kunjett 1 kunjett 1 kunjett
Privigen 100 mg/ ml solution for infusion
Privigen 100 mg/ ml soluzzjoni għall- infużjoni
Human normal immunoglobulin (IVIg).
Immunoglobulina normali umana (IVIg).
One ml contains: human plasma protein…………………………………………………………………………... 100 mg (purity of at least 98% IgG)
1 ml fih: proteina tal- plażma umana …………………………………………………………………………... 100 mg (purità ta ’ mill- inqas 98% IgG)
One vial of 50 ml contains:
1 kunjett ta ’ 50 ml fih:
5 g One vial of 100 ml contains:
5 g 1 kunjett ta ’ 100 ml fih:
10 g One vial of 200 ml contains:
10 g 1 kunjett ta ’ 200 ml fih:
Distribution of the IgG subclasses (average values):
Distribuzzjoni tas- sottoklassijiet ta ’ IgG (valuri medji):
2.3% 1.2%
2. 3% 1. 2%
The maximum IgA content is 0.025 mg/ ml (average of 0.0027 mg/ ml).
Il- kontenut massimu ta ’ IgA hu ta ’ 0. 025 mg/ ml (medja ta ’ 0. 0027 mg/ ml).
The solution is clear or slightly opalescent and colourless to pale yellow.
Is- soluzzjoni hi ċara jew ftit opalexxenti u hi bejn bla kulur sa safra ċara.
Privigen is isotonic, with an osmolality of 320 mOsmol/ kg.
Privigen hu isotoniku, b’ osmolalità ta ’ 320 mOsmol/ kg.
Replacement therapy in • Primary immunodeficiency (PID) syndromes such as:
Terapija tas- sostituzzjoni f ’ • Sindromi ta ’ immunodefiċjenza primarja (PID) bħal: