qanastek/EMEA-V3 huggingface dataset:
Pharmacotherapeutic Group:
Kategorija farmakoterapewtika:
There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Hemm tendenza apparenti għal relazzjoni bejn doża u l- ħin ta ’ l- irkupru tal- linja bażi tal- pressjoni sistolika tad- demm (SBP).
18 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika u dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
Absorption of telmisartan is rapid although the amount absorbed varies.
20 L- assorbiment ta ’ telmisartan hu mgħaġġel, għalkemm l- ammont assorbit ivarja.
When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6% (40 mg dose) to approximately 19% (160 mg dose).
Meta telmisartan jittieħed ma ’ l- ikel, it - tnaqqis taż- żona taħt il- kurva tal- konċentrazzjoni tal- plażma- żmien (AUC0- ∞) tvarja minn madwar 6% (doża ta ’ 40 mg) sa madwar 19% (doża ta ’ 160 mg).
By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Sa 3 sigħat wara l- għoti ta ’ telmisartan, il - konċentrazzjonijiet fil- plażma huma simili, kemm jekk telmisartan jittieħed ma ’ ikel kif ukoll mingħajru.
Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Differenzi fil- konċentrazzjonijiet fil- plażma kienu osservati, bis- Cmax u l- AUC li kienu madwar 3 darbiet u darbtejn ogħla, rispettivament, fin- nisa meta mqabbla mal- irġiel.
19 The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Il- farmakokinetiċi ta ’ telmisartan ma jvarjawx bejn l- anzjani u dawk li għandhom inqas minn 65 sena.
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
21 għal dak fil- medda terapewtika klinika, ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit), bidliet fl- emodinamiċi renali (żieda fin- nitrogen ta ’ l- urea u l - krejatinina fid- demm), kif ukoll żieda fil- potassium fis- serum f’ annimali normotensivi.
20 This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
Aluminium/ aluminium blisters (PA/ PA/ Al/ PVC/ Al). One blister contains 7 tablets.
Folja waħda fiha 7 pilloli.
Blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 56, jew 98 pillola jew folji perforati b’ doża waħda bi 28 x 1 pilloli.
EU/ 1/ 98/ 091/ 001 (14 tablets) EU/ 1/ 98/ 091/ 002 (28 tablets) EU/ 1/ 98/ 091/ 003 (56 tablets) EU/ 1/ 98/ 091/ 004 (98 tablets) EU/ 1/ 98/ 091/ 013 (28 x 1 tablets)
EU/ 1/ 98/ 091/ 001 (14- il pillola) EU/ 1/ 98/ 091/ 002 (28 pillola) EU/ 1/ 98/ 091/ 003 (56 pillola) EU/ 1/ 98/ 091/ 004 (98 pillola) EU/ 1/ 98/ 091/ 013 (28 x 1 pillola)
Kinzalmono 80 mg tablets
Kinzalmono 80 mg pilloli
Each tablet contains 80 mg telmisartan.
Kull pillola fiha 80 mg telmisartan.
Each tablet contains 338 mg sorbitol (E420).
Kull pillola fiha 338 mg ta ’ sorbitol (E420).
White oblong tablets engraved with the code number '52H 'on one side.
Pilloli bojod b’ forma oblunga li fuqhom hemm imnaqqax in- numru tal- kodiċi ‘ 52H ’ fuq naħa waħda.
Elderly No dose adjustment is necessary for elderly patients.
L- ebda aġġustament fid- doża mhu meħtieġ għal pazjenti anzjani.
Kinzalmono is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Kinzalmono mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
4.3 Contraindications
24 4. 3 Kontra- indikazzjonijiet
23 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
As with others drugs acting on the renin-angiotensin-aldosterone-system, telmisartan may provoke hyperkalaemia (see section 4.4).
Bħal mediċini oħrajn li jaġixxu fuq is- sistema renin- angiotensin- aldosterone, telmisartan jista ’ jikkawża l- iperkalemija (ara sezzjoni 4. 4).
24 Concomitant use not recommended
L- użu fl- istess ħin mhuwiex rakkomandat
To be taken into account with concomitant use
27 Biex jiġi kkunsidrat mal- użu fl- istess ħin
25 Pregnancy (see section 4.3 and 4.4):
Tqala (ara sezzjoni 4. 3 u 4. 4):
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Filwaqt li m’ hemm l- ebda dejta epidemjoloġika kkontrollata fuq ir- riskju b’ antagonisti tar- riċetturi ta ’ angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il- klassi ta ’ mediċini.
Angiotensin II receptor antagonist therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Espożizzjoni għall- kura b’ antagonisti tar- riċetturi ta ’ angiotensin II matul it- tieni u t- tielet trimestri hu magħruf li jinduċi fetotossiċità (tnaqqis fil- funzjoni tal- kliewi, oligoidramnios, ittardjar fl - ossifikazzjoni tal- kranju) u tossiċità fit- trabi tat- twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk.
Treddigħ (ara sezzjoni 4. 3) Telmisartan hu kontra- indikat matul it- treddigħ għax mhux magħruf jekk jitneħħiex fil- ħalib tal - bniedem.
4.8 Undesirable effects
28 4. 8 Effetti mhux mixtieqa
Gastrointestinal disorders
29 Disturbi gastro- intestinali
27 Investigations
Investigazzjonijiet
28 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika u dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.
Absorption of telmisartan is rapid although the amount absorbed varies.
31 L- assorbiment ta ’ telmisartan hu mgħaġġel, għalkemm l- ammont assorbit ivarja.
29 Elderly patients:
Pazjenti anzjani:
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
32 għal dak fil- medda terapewtika klinika, ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit), bidliet fl- emodinamiċi renali (żieda fin- nitrogen ta ’ l- urea u l - krejatinina fid- demm), kif ukoll żieda fil- potassium fis- serum f’ annimali normotensivi.
There is no evidence of a teratogenic effect but animal studies indicated some hazardous potential of telmisartan to the postnatal development of the offspring such as lower body weight, delayed eye opening, and higher mortality.
M’ hemm l- ebda evidenza ta ’ effett teratoġeniku, iżda studji fuq l- annimali indikaw li xi potenzjal ta ’ periklu ta ’ telmisartan għall- iżvilupp ta ’ wara t- twelid tal- frieħ bħal piż tal- ġisem iktar baxx, dewmien fil- ftuħ ta ’ l- għajnejn u mortalità ogħla.
30 This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
Blister with 14, 28, 56 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Folja b’ 14, 28, 56, jew 98 pillola jew folji perforati b’ doża waħda bi 28 x 1 pilloli.
EU/ 1/ 98/ 091/ 005 (14 tablets) EU/ 1/ 98/ 091/ 006 (28 tablets) EU/ 1/ 98/ 091/ 007 (56 tablets) EU/ 1/ 98/ 091/ 008 (98 tablets) EU/ 1/ 98/ 091/ 014 (28 x 1 tablets)
EU/ 1/ 98/ 091/ 005 (14- il pillola) EU/ 1/ 98/ 091/ 006 (28 pillola) EU/ 1/ 98/ 091/ 007 (56 pillola) EU/ 1/ 98/ 091/ 008 (98 pillola) EU/ 1/ 98/ 091/ 014 (28 x 1 pillola)
31 ANNEX II
34 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
32 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
35 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
PSURs L- MAH ser jibqa ’ jissottometti l- PSURs kull sena, ħlief jekk ikun speċifikat mod ieħor mis- CHMP.
33 ANNEX III
36 ANNESS III
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Kinzalmono 20 mg tablets telmisartan
Kinzalmono 20 mg pilloli telmisartan
Each tablet contains 20 mg telmisartan.
Kull pillola fiha 20 mg ta ’ telmisartan.
Contains sorbitol (E420).
Fih sorbitol (E420).
Read the package leaflet for further information.
Ara l- fuljett fil- pakkett għal aktar tagħrif.
14 tablets 28 tablets 56 tablets 98 tablets
14- il pillola 28 pillola 56 pillola 98 pillola
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġ l- ebda kundizzjonijiet speċjali tal- ħażna.
{number}
Lott {numru}
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Kinzalmono 40 mg tablets telmisartan
Kinzalmono 40 mg pilloli telmisartan
Each tablet contains 40 mg telmisartan.
Kull pillola fiha 40 mg ta ’ telmisartan.
Contains sorbitol.
Fih sorbitol.
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
14- il pillola 28 pillola 56 pillola 98 pillola 28 x 1 pilloli
This medicinal product does not require any special storage conditions.
43 Dan il- prodott mediċinali ma jeħtieġ l- ebda kundizzjonijiet speċjali tal- ħażna.
39 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Unit dose blister (28 x 1 tablets pack)
Folja b’ doża waħda (pakkett ta '28 x 1 pilloli)
Kinzalmono 80 mg tablets telmisartan
Kinzalmono 80 mg pilloli telmisartan
Each tablet contains 80 mg telmisartan.
Kull pillola fiha 80 mg ta ’ telmisartan.
43 Store in the original package in order to protect from moisture.
48 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Unit dose blister (28 x 1 tablets pack)
Folja b’ doża waħda (Pakkett ta ’ 28 x 1 pilloli)
47 PACKAGE LEAFLET:
52 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Kinzalmono 20 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Kinzalmono 20 mg pilloli Telmisartan
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Kinzalmono is and what it is used for 2.
X’ inhu Kinzalmono u għalxiex jintuża 2.
Before you take Kinzalmono 3.
Qabel ma tuża Kinzalmono 3.
How to take Kinzalmono 4.
Kif għandek tuża Kinzalmono 4.
How to store Kinzalmono 6.
Kif taħżen Kinzalmono 6.
WHAT KINZALMONO IS AND WHAT IT IS USED FOR
X’ INHU KINZALMONO U GĦALXIEX JINTUŻA
Kinzalmono belongs to a class of medicines known as angiotensin II receptor antagonists.
Kinzalmono jagħmel parti minn klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi ta ’ angiotensin II.
Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure.
Angiotensin II hu sustanza magħmula fil- ġisem tiegħek li tikkawża djieq fil- vini/ arterji tad- demm, u b’ hekk tiżdied il- pressjoni tad- demm.
Kinzalmono blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Kinzalmono jimblokka l- effett ta ’ angiotensin II biex b’ hekk il- vini u l- arterji jitwessgħu, u l- pressjoni tad- demm tiegħek tonqos.
Kinzalmono is used to treat essential hypertension (high blood pressure). ‘ Essential’ means that the high blood pressure is not caused by any other condition.
Kinzalmono jintuża biex jikkura pressjoni għolja essenzjali (pressjoni tad- demm għolja). ‘ Essenzjali ’ tfisser li pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Jekk il- pressjoni tad- demm għolja ma tkunx ikkurata, tista ’ tagħmel ħsara lill- vini jew lill- arterji f’ diversi organi, u dan xi kultant jista ’ jwassal għal attakk tal- qalb, insuffiċjenza tal- kliewi jew tal - qalb, puplesija, jew għama.
BEFORE YOU TAKE KINZALMONO
QABEL MA TUŻA KINZALMONO
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalmono tablets (see section Further information for a list of other ingredients). • 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 liver and gall bladder) or any other severe liver disease.
Tiħux Kinzalmono • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew sustanzi oħra inklużi fil- pilloli Kinzalmono (ara s- sezzjoni Aktar tagħrif għal- lista ta ’ ingredjenti oħrajn). • 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- fwied u mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal - fwied.
If any of the above applies to you, tell your doctor or pharmacist before taking Kinzalmono.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu Kinzalmono.
Take special care with Kinzalmono
53 Oqgħod attent ħafna b’ Kinzalmono
48 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
• Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek. • Dijabete
Kinzalmono 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).
Kinzalmono 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 anaesthesia, you should tell your doctor that you are taking Kinzalmono.
F’ każ li jkollok bżonn ta ’ operazzjoni jew loppju, għandek tgħid lit- tabib tiegħek li qed tieħu Kinzalmono.
The use of Kinzalmono in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ Kinzalmono fit- tfal u fl- adolexxenti sal- età ta ’ 18- il sena mhuwiex rakkomandat.
As with all other angiotensin II receptor antagonists, Kinzalmono may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, Kinzalmono jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
This applies especially to the medicines listed below taken at the same time with Kinzalmono:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ Kinzalmono:
• Lithium containing medicines to treat some types of depression. • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen), heparin, immunosuppressives (e. g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. • Diuretics ('water tablets'), especially if taken in high doses together with Kinzalmono, may lead to excessive loss of body water and low blood pressure (hypotension).
• Mediċini li fihom il- lithium għall- kura ta ’ xi tipi ta ’ dipressjoni. • Mediċini li jistgħu jżidu il- livelli tal- potassium fid- demm bħal sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium (ċerti ‘ pilloli tal- awrina ’), inibituri ACE, antagonisti tar- riċettur ta ’ angiotensin II, NSAIDs (mediċini mhux sterojdi kontra l - infjammazzjoni, eż. aspirina jew ibuprofen), eparina, immunosoppressivi (eż. cyclosporin jew tacrolimus), u l- antibijotiku trimethoprim. • Id- dijuretiċi (‘ pilloli tal- awrina ’), speċjalment jekk jittieħdu f’ dożi għoljin flimkien ma ’ Kinzalmono, jistgħu jwasslu għal telf eċċessiv ta ’ ilma mill- ġisem u pressjoni tad- demm baxxa (ipotensjoni).
As with other blood pressure lowering medicines, the effect of Kinzalmono may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen) or corticosteroids.
Bħala ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ Kinzalmono jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra l- infjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
Kinzalmono may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Kinzalmono jista ’ jżid l- effett ta ’ tnaqqis tal- pressjoni tad- demm ta ’ mediċini oħra li jintużaw għall - kura ta ’ pressjoni tad- demm għolja.
Taking Kinzalmono with food and drink
Meta tieħu Kinzalmono ma ’ l- ikel u max- xorb
You can take Kinzalmono with or without food.
54 Tista ’ tieħu Kinzalmono mal- ikel jew mingħajr l- ikel.
Usually, your doctor will advise you to take another medicine instead of Kinzalmono, as Kinzalmono 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 Kinzalmono, għax Kinzalmono 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 Kinzalmono before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi Kinzalmono qabel il- bidu ta ’ tqala.
Kinzalmono should not be used during the second and third trimester of pregnancy.
Kinzalmono m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
49 Your doctor will normally advise you to stop taking Kinzalmono as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Kinzalmono hekk kif issir taf li inti tqila.
If you become pregnant during therapy with Kinzalmono, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ Kinzalmono, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take Kinzalmono if you are breast-feeding.
M’ għandekx tieħu Kinzalmono jekk qed tredda ’.
No information is available on the effect of Kinzalmono on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ Kinzalmono fuq il- ħila li ssuq jew tħaddem makkinarju.
Important information about some of the ingredients of Kinzalmono
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Kinzalmono
Kinzalmono contains sorbitol.
Kinzalmono fih is- sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Kinzalmono.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu Kinzalmono.
HOW TO TAKE KINZALMONO
KIF GĦANDEK TUŻA KINZALMONO
Always take Kinzalmono exactly as your doctor has told you.
Dejjem għandek tuża Kinzalmono skond il- parir eżatt tat- tabib tiegħek.
The usual dose of Kinzalmono is one tablet a day.
Id- doża normali ta ’ Kinzalmono hi ta ’ pillola waħda darba kuljum.
You can take Kinzalmono with or without food.
Tista ’ tieħu Kinzalmono mal- ikel jew mingħajr l- ikel.
It is important that you take Kinzalmono every day until your doctor tells you otherwise.
Hu importanti li tieħu Kinzalmono kuljum sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you have the impression that the effect of Kinzalmono is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Kinzalmono hu qawwi jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
The usual dose of Kinzalmono for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Id- doża normali ta ’ Kinzalmono għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
Your doctor has recommended a lower dose of one 20 mg tablet daily.
It- tabib tiegħek irrakkomandalek doża aktar baxxa ta ’ pillola waħda ta ’ 20 mg kuljum.
Kinzalmono may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Kinzalmono.
Kinzalmino jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il- pressjoni tad- demm b’ Kinzalmono.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
Jekk il- fwied tiegħek ma jkunx qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg darba kuljum.
If you take more Kinzalmono than you should
Jekk tieħu Kinzalmono aktar milli suppost
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja immedjatament lit- tabib, lill- ispiżjar tiegħek, jew lid- dipartiment tal- emerġenza ta ’ l- eqreb sptar.
If you forget to take Kinzalmono
55 Jekk tinsa tieħu Kinzalmono
If you forget to take a dose, do not worry.
Jekk tinsa tieħu doża, tinkwetax.
Take it as soon as you remember then carry on as before.
Ħudha hekk kif tiftakar, imbagħad kompli bħas- soltu.
Do not take a double dose to make up for forgotten individual doses.
Tiħux doża doppja biex tpatti għad- dożi individwali li tkun insejt tieħu.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
These side effects may occur with certain frequencies, which are defined as follows:
Bħal kull mediċina oħra, Kinzalmono jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
50 very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
High potassium levels, fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), low blood pressure (hypotension), shortness of breath, abdominal pain, diarrhoea, dry mouth, discomfort in the abdomen, bloating, increased sweating, itching, muscle pain (myalgia), kidney impairment including acute kidney failure, and pain in the chest.
Livelli għolja ta ’ potassium, ħass ħażin (sinkope), diffikultà biex torqod, sensazzjoni li kollox qed idur bik (sturdament), pressjoni tad- demm baxxa (ipotensjoni), qtugħ ta ’ nifs, uġigħ ta ’ żaqq, dijarea, ħalq xott, skonfort fiż- żaqq, nefħa fiż- żaqq, żieda fl- għaraq, ħakk, uġigħ fil- muskoli (majalġja), indeboliment fil- kliewi li jinkludi insuffiċjenza akuta tal- kliewi, u wġigħ fis- sider.
Upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia), feeling anxious, feeling sad (depression), impaired vision, fast heart beat (tachycardia), dizziness on standing up (orthostatic hypotension), upset stomach, vomiting, abnormal liver function, redness of skin, rapid swelling of the skin and mucosa (angioedema), hives (urticaria), joint pain (arthralgia), back pain, muscle cramps, pain in extremity, symptoms of weakness, flu-like-illness, increased levels of uric acid, creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Effetti sekondarji rari jistgħu jinkludu: infezzjoni fl- apparat respiratorju ta ’ fuq (eż. uġigħ fil- griżmejn, sinuses infjammati, riħ komuni), nuqqas ta ’ ċelluli ħomor tad- demm (anemija), għadd baxx ta ’ plejtlits (tromboċitopenja), tħossok ansjuż/ a, tħossok imdejjaq/ imdejqa (dipressjoni), indeboliment fil- vista, rata mgħaġġla ta ’ taħbit tal - qalb (takikardija), tistordi meta tqum bilwieqfa (ipotensjoni ortostatika), stonku mqalleb, rimettar, funzjoni anormali tal- fwied, ħmura tal- ġilda, nefħa b’ mod mgħaġġel tal- ġilda u tal- mukuża (anġjodema), urtikarja, uġigħ fil- gogi (artralġja), uġigħ fid- dahar, bugħawwieġ fil- muskoli, uġigħ fl - estremitajiet, sintomi ta ’ dgħjufija, mard li jixbah l- influwenza, żieda fil- livelli tal- uric acid, krejatinina, enzimi epatiċi jew ta ’ creatine phosphokinase fid- demm.
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e. g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Kinzalmono and decreased haemoglobin (a blood protein).
Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu: infezzjonijiet fl- apparat urinarju, żieda f’ ċerti ċelluli tad- demm bojod (eosinofilja), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n- nifs, tħarħir, nefħa tal- wiċċ jew pressjoni tad- demm baxxa), rata ta ’ taħbit tal- qalb bil- mod (bradikardija), raxx minħabba l- mediċina, ekżema (disturb tal- ġilda), infjammazzjoni tal- tendini, ineffettività ta ’ Kinzalmono u tnaqqis fl- emoglobina (proteina tad- demm).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KINZALMONO
KIF TAĦŻEN KINZALMONO
Do not use Kinzalmono after the expiry date which is stated on the carton after “ EXP”.
Tużax Kinzalmono wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
This medicine does not require any special storage conditions.
56 Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
You should store your medicine in the original package in order to protect the tablets from moisture.
Għandek taħżen il- mediċina tiegħek fil- pakkett oriġinali sabiex tipproteġi l- pilloli mill- umdità.
What Kinzalmono contains
X’ fih Kinzalmono
The active substance is telmisartan.
Is- sustanza attiva hi telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.
Is- sustanzi l- oħra huma povidone, meglumine, sodium hydroxide, sorbitol (E420) u magnesium stearate.
What Kinzalmono looks like and contents of the pack
Id- dehra ta ’ Kinzalmono u l- kontenuti tal- pakkett
51 Kinzalmono 20 mg tablets are white, round and engraved with the code number '50H 'on one side and the company logo on the other side.
Il- pilloli Kinzalmono 20 mg huma bojod, b’ forma tonda u mnaqqxa bin- numru tal- kodiċi ‘ 50H ’ fuq naħa waħda u l- logo tal- kumpanija fuq in- naħa l- oħra.
Kinzalmono is available in blister packs containing 14, 28, 56, or 98 tablets.
Kinzalmono hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 56 u 98 pillola.
Not all pack sizes may be marketed in your country.
Mhux il- pakketti tad- daqsijiet kollha jistgħu jitpoġġew fis- suq fil- pajjiż tiegħek.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
52 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
57 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
53 PACKAGE LEAFLET:
58 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Kinzalmono 40 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Kinzalmono 40 mg pilloli Telmisartan
Take special care with Kinzalmono
Oqgħod attent ħafna b’ Kinzalmono
54 • Kidney disease or kidney transplant. • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
59 • Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek. • Dijabete.
As with all other angiotensin antagonists, Kinzalmono may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha ta ’ angiotensin, Kinzalmono jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
As with other blood pressure lowering medicines, the effect of Kinzalmono may be reduced when you take NSAIDs (non steroidal anti-inflammatory mediciens, e. g. aspirin or ibuprofen) or corticosteroids.
Bħala ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ Kinzalmono jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra l- infjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
You must tell your doctor if you think that you are (or might become) pregnant.
60 Għandek tgħid lit- tabib tiegħek jekk taħseb li inti (jew jekk tista ’ toħroġ) tqila.
55 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 Kinzalmono, għax Kinzalmono mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara 3 xhur ta ’ tqala.
Your doctor will normally advise you to stop taking Kinzalmono as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Kinzalmono hekk kif issir taf li inti tqila.
The usual dose of Kinzalmono for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Id- doża normali ta ’ Kinzalmono għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg.
Madankollu, xi kultant it- tabib tiegħek jista ’ jirrakkomanda doża aktar baxxa ta ’ 20 mg jew doża ogħla ta ’ 80 mg.
Alternatively, Kinzalmono may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Kinzalmono.
Inkella, Kinzalmono jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il- pressjoni tad- demm b’ Kinzalmono.
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja immedjatament lit- tabib, lill- ispiżjar tiegħek, jew lid- dipartiment tal- emerġenza tal- eqreb sptar.
If you forget to take Kinzalmono
Jekk tinsa tieħu Kinzalmono
If you forget to take a dose, do not worry.
61 Jekk tinsa tieħu doża, tinkwetax.
56 Like all medicines, Kinzalmono can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kinzalmono 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 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Medicines should not be disposed of via wastewater or household waste.
62 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
57 What Kinzalmono looks like and contents of the pack
Id- dehra ta ’ Kinzalmono u l- kontenuti tal- pakkett
Kinzalmono 40 mg tablets are white, oblong-shaped and engraved with the code number '51H 'on one side.
Il- pilloli Kinzalmono 40 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi ‘ 51H ’ fuq naħa waħda.
Kinzalmono is available in blister packs containing 14, 28, 56 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Kinzalmono hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 56 u 98 pillola jew pakketti bil- folji bid- doża tal- unità li fihom 28 x 1 pilloli.
Bayer HealthCare AG D-51368 Leverkusen Germany
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
58 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
63 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
59 PACKAGE LEAFLET:
64 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Kinzalmono 80 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Kinzalmono 80 mg pilloli Telmisartan
Take special care with Kinzalmono
65 Oqgħod attent ħafna b’ Kinzalmono
60 • Kidney disease or kidney transplant. • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
• Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek. • Dijabete.
Taking Kinzalmono with food and drink
66 Meta tieħu Kinzalmono ma ’ l- ikel u max- xorb
61 Kinzalmono should not be used during the second and third trimester of pregnancy.
Kinzalmono m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
67 Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja immedjatament lit- tabib, lill- ispiżjar tiegħek, jew lid- dipartiment tal- emerġenza tal- eqreb sptar.
Like all medicines, Kinzalmono can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kinzalmono jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
62 These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Do not use Kinzalmono after the expiry date which is stated on the carton after “ EXP”.
68 Tużax Kinzalmono wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
63 Kinzalmono 80 mg tablets are white, oblong-shaped and engraved with the code number '52H 'on one side..
Il- pilloli Kinzalmono 80 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi ‘ 52H ’ fuq naħa waħda.
64 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
69 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
What is Kiovig?
X' inhu Kiovog?
Kiovig is a solution for infusion (drip into a vein).
Kiovig huwa soluzzjoni għall- infużjoni (dripp fil- vina).
What is Kiovig used for?
Għal xiex jintuża Kiovig?
Kiovig 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).
Kiovig jintuża għal tliet gruppi ewlenin 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).
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 kanċer fid- demm (mjeloma jew lewċemija linfomatika kronika) jew tfal imwielda bis- sindromu minn immunodefiċjenza akkwiżita (AIDS), li jkunu jsofru minn infezzjonjiet frekwenti.
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) anomala 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 'fsada, u pazjenti b' ċertu mard (is- sindromu ta' Guillain - Barré jew il- marda ta 'Kawasaki).
How is Kiovig used?
Kif jintuża Kiovig?
Kiovig is usually given as an intravenous infusion by a doctor or nurse.
Kiovig jingħata b' infużjoni intravenuża minn tabib 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.
Kiovig can be diluted before administration.
Kiovig jista 'jinħall fl- ilma qabel ma jingħata.
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 Kiovig work?
Kif jaħdem Kiovig?
It contains immunoglobulin G (IgG), which is a type of antibody.
Is- sustanza attiva f' Kiovig, 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.
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
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Reproduction is authorised provided the source is acknowledged. organisms that can cause infection.
L- IgG ilu jintuża bħala mediċina mit- tmeninijiet u jaħdem b' diversi modi kontra organiżmi li jistgħu jikkawżaw infezzjoni.
Kiovig works by restoring abnormally low IgG levels to their normal range in the blood.
Kiovig 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 anomala u fil- modulazzjoni tar- rispons immunoloġiku.
How has Kiovig been studied?
Kif ġie studjat Kiovig?
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 Kiovig 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' Kiovig fil- pazjenti, skond il- linji gwida attwali.
In the first study, Kiovig was used as replacement therapy in 22 patients with PID who had very low or no levels of immunoglobulin.
Fl- ewwel studju, Kiovig intuża bħala terapija sostitutiva fi 22 pazjent li jbatu minn PID li kellhom livelli baxxi ħafna ta 'immunoglobina jew xejn.
The main measure of effectiveness was the number of serious bacterial infections and the amount of antibiotic used.
Il- kejl ewlieni ta 'l- effikaċja kien l- għadd ta' infezzjonijiet gravi minn batterji u l- kwantità ta 'antibijotiku użat.
The second study looked at using Kiovig for immunomodulation in 23 patients with ITP.
It- tieni studju eżamina l- użu ta 'Kiovig għall- immunomodulazzjoni f' 23 pazjent bl- ITP.
The main measure of effectiveness was the increase in platelets.
Il- kejl ewlieni ta 'l- effikaċja kien iż- żieda fil- platelets.
What benefit has Kiovig shown during the studies?
Liema benefiċċji wera Kiovig f' dawn l- istudji?
In the first study, Kiovig was as effective as the standard treatment in preventing infections and reducing antibiotic use.
Fl- ewwel studju, Kiovig kellu effett analogu għat- trattament standard għall- prevenzjoni ta 'infezzjonijiet u t- tnaqqis ta' l- użu antibijotiku.
In the second study, Kiovig was shown to be effective in increasing the platelet count.
Fit- tieni studju, Kiovig wera li kien effikaċi biex iżid l - għadd ta 'platelets.
What is the risk associated with Kiovig?
X' inhu r- riskju assoċjat ma 'Kiovig?
The most common side effects with Kiovig (seen in more than 1 patient in 10) are headache and pyrexia (fever).
L- aktar effetti sekondarji komuni b' Kiovag (li dehru f' aktar minn pazjent 1 minn kull 10) huma wġigħ ta 'ras u piressija (deni).
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 Kiovig before or for a long time.
Uħud mill- effetti sekondarji għandhom aktarx 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 Kiovig qabel jew għal żmien twil.
For the full list of all side effects reported with Kiovig, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Kiovig, ara l- Fuljett ta' Tagħrif.