qanastek/EMEA-V3 huggingface dataset:
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide BMS is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Prodotti mediċinali affettwati b’ tibdil tal- potassium fis- serum: osservazzjoni perjodika tal - potassium fis- serum hija rrikmandata meta Irbesartan Hydrochlorothiazide BMS jiġi mogħti flimkien ma ’ prodotti mediċinali oħra affettwati b’ disturbi tal- potassium fis- serum (p. e. digitalis glycosides, antiarritmiċi).
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
5 Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by
Ma kienu osservati ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi sinifikanti meta irbesartan ingħata ma ’ warfarin, prodott mediċinali metabolizzat b’ CYP2C9.
Alcohol: potentiation of orthostatic hypotension may occur;
Alkoħol: jista ’ jkun hemm żieda fil- pressjoni baxxa ortostatika;
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
6 Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
When
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
6 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
Since Irbesartan Hydrochlorothiazide BMS contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Billi Irbesartan Hydrochlorothiazide BMS fih hydrochlorothiazide, mhux irrikkmandat waqt l- ewwel trimestru tat- tqala.
Irbesartan Hydrochlorothiazide BMS is contraindicated during breast-feeding.
Irbesartan Hydrochlorothiazide BMS huwa kontra- indikat waqt it- treddigħ.
Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide BMS is unlikely to affect this ability.
Skond il- kwalitajiet farmakodinamiċi tiegħu, Irbesartan Hydrochlorothiazide BMS mhux suppost li jkollu effett fuq din il - ħila.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Il- frekwenza tar- reazzjonijiet avversi hija definita permezz tal- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100, < 1/ 10), mhux komuni (≥ 1/ 1, 000, < 1/ 100), rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Irbesartan/ hydrochlorothiazide combination:
Irbesartan/ hydrochlorothiazide flimkien:
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan/ hydrochlorothiazide and the placebo groups.
Fi studji kliniċi kkontrollati bi plaċebo f’ pazjenti bi pressjoni għolja, l- inċidenza totali ta ’ effetti avversi ma kinetx differenti bejn dawk li ħadu irbesartan/ hydrochlorothiazide u l- grupp li ħa l- plaċebo.
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan/ hydrochlorothiazide-treated patients than for placebo-treated patients.
Twaqqif minħabba xi effeti avversi kliniċi jew tal- laboratorju kienu inqas frekwenti għal dawk il - pazjenti ikkurati b’ irbesartan/ hydrochlorothiazide milli ikkurati bil- plaċebo.
The incidence of adverse events was not related to gender, age, race, or dose within the recommended dose range.
L- inċidenza ta ’ effetti avversi ma kinetx relatata ma ’ sess, età, razza jew doża li ngħatat fil- firxa rrikmandata.
37.5 mg/ 6.25 mg to 300 mg/ 25 mg irbesartan/ hydrochlorothiazide), the following adverse reactions were reported:
Waqt provi ikkontrollati bil- plaċebo fejn 898 pazjenti bi pressjoni għolja rċevew dożi varjati (firxa ta ’ 37. 5 mg/ 6. 25 mg sa 300 mg/ 25 mg irbesartan/ hydrochlorothiazide), l- effetti avversi li ġew irrapportati huma dawn li ġejjin:
dizziness orthostatic dizziness
sturdament
Uncommon:
Mhux komuni: sturdament ortostatiku
syncope, hypotension, tachycardia, oedema
Mhux komuni: sinkope, pressjoni baxxa, takikardija, edema
Vascular disorders:
7 Disturbi vaskulari:
nausea/ vomiting diarrhoea
dardir/ rimettar
Uncommon:
Mhux komuni: dijarea
swelling extremity
Mhux komuni: nefħa fl- estremitajiet
abnormal urination
tneħħi l- awrina b’ mod anormali
Reproductive system and breast disorders:
Disturbi fis- sistema
Uncommon:
riproduttiva u fis- sider:
sexual dysfunction, libido changes
Mhux komuni: disfunzjoni sesswali, tibdil fil- libidu
Investigations: patients treated with irbesartan/ hydrochlorothiazide had changes in laboratory test parameters which were rarely clinically significant Common:
Investigazzjonijiet: pazjenti li ħadu l- kura b’ irbesartan/ hydrochlorothiazide kellhom tibdil fil- parametri tat- testijiet tal- laboratorju li rarament kienu klinikament sinifikanti Komuni:
Uncommon:
żidiet fil- BUN, krejatinina u krejatina kinażi
increases in BUN, creatinine and creatine kinase decreases in serum potassium and sodium
Mhux komuni: tnaqqis fil- livelli ta ’ potassium u sodium fis- serum
In addition, since introduction of irbesartan/ hydrochlorothiazide in the market the following adverse reactions have also been reported:
Minbarra hekk, minn meta irbesartan/ hydrochlorothiazide tqiegħed fuq is- suq, ġew irrapportati wkoll dawn ir- reazzjonijiet avversi oħra:
Rare: rare cases of hypersensitivity reactions such as angioedema, rash, urticaria
Rari: każijiet rari ta ’ reazzjonijiet ta ’ sensittività eċċessiva bħal anġjoedema, raxx, urtikarja.
hyperkalaemia
iperkalemja
tinnitus
żarżir tal- widnejn
cough
sogħla
dyspepsia, dysgeusia
dispepsja, togħma ħażina
hepatitis, abnormal liver function
epatite, funzjoni anormali tal- fwied
Musculoskeletal, connective tissue and bone disorders:
Disturbi muskolu- skeltrali u tal- connective tissue:
arthralgia, myalgia
artralġja, majalġja
impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
indeboliment tal- funzjoni renali li tinkludi każijiet iżolati ta ’ insuffiċjenza renali f’ pazjenti b’ riskju (ara sezzjoni 4. 4)
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide BMS.
8 Aktar tagħrif fuq komponenti individwali: minbarra l- effetti avversi msemmijin hawn fuq għal dan il - prodott kombinat, effetti oħra mhux mixtieqa li ġew irrapportati ma ’ wieħed minn dawn il- komponenti individwali jista ’ ikollhom effetti avversi ma ’ Irbesartan Hydrochlorothiazide BMS.
Adverse reactions reported with the use of irbesartan alone include:
Reazzjonijiet avversi rrapportati bl- użu ta ’ irbesartan waħdu jinkludu:
Uncommon:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata:
chest pain
Mhux komuni: uġigħ fis- sider
Adverse events (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone include:
Effetti avversi (irrispettiv mir- relazzjoni mal- prodott mediċinali) li ġew irrapportati waqt l- użu ta ’ hydrochlorothiazide waħdu jinkludu:
Blood and lymphatic system: aplastic anaemia, bone marrow depression, neutropenia/ agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Disturbi tad- demm u tas- sistema limfatika: anemija aplastika, dipressjoni tal- mudullun ta ’ l- għadam, newtropenja/ agranuloċitożi, anemija emolitika, lewkopenja, tromboċitopenja
Psychiatric disorders: depression, sleep disturbances
Disturbi psikjatriċi: dipressjoni, disturbi fl- irqad
Nervous system disorders: vertigo, paraesthesia, light-headedness, restlessness
Vertigo, parasteżija, sturdament, irrekwitezza
Eye disorders: transient blurred vision, xanthopsia
Disturbi fl- għajnejn: vista mċajpra li tgħaddi, xanthopsia
Cardiac disorders: cardiac arrhythmias
Disturbi fil- qalb: arritmji kardijaċi
Vascular disorders: postural hypotension
Disturbi vaskulari: pressjoni baxxa tal- qagħda
Respiratory, thoracic and mediastinal disorders: respiratory distress (including pneumonitis and pulmonary oedema)
Disturbi respiratorji, toraċiċi u medjastinali: diffikultà respiratorja (inkluż pulmonite u edema pulmonari)
Gastrointestinal disorders: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Disturbi gastro- intestinali: pankreatite, anoressja, dijarea, stitikezza, irritazzjoni fl- istonku, sijaladenite, nuqqas ta ’ aptit
Hepatobiliary disorders: jaundice (intrahepatic cholestatic jaundice)
Disturbi fil- fwied u fil- marrara: suffejra (suffejra intraepatika kolestatika)
Skin and subcutaneous tissue disorders: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: reazzjonijiet anafilattiċi, nekroliżi epidermali tossika, anġite nekrotizzanti (vaskulite, vaskulite kutanja), reazzjonijiet tal- ġilda bħal lupus eritematożi, riattivazzjoni tal- lupus eritematożi kutanja, reazzjonijiet fotosensittivi, raxx, urtikarja
Musculoskeletal, connective tissue and bone disorders: weakness, muscle spasm
Disturbi muskolu- skeltrali u tal- connective tissue: għeja, spażmu tal- muskoli
Renal and urinary disorders: interstitial nephritis, renal dysfunction
Disturbi fil- kliewi u fis- sistema urinarja: nefrite interstizjali, disfunzjoni renali
General disorders and administration site conditions: fever
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
9 Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
9 4.9 Overdose
4. 9 Doża eċċessiva
No specific information is available on the treatment of overdose with Irbesartan Hydrochlorothiazide BMS.
M’ hemmx biżżejjed informazzjoni speċifika fuq il- kura ta ’ doża eċċessiva ta ’ Irbesartan Hydrochlorothiazide BMS.
Activated charcoal may be useful in the treatment of overdose.
Il - faħam attivat jista ’ jkun utli fit- trattament ta ’ doża eċċessiva.
Irbesartan Hydrochlorothiazide BMS is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin- II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
10 irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
The addition of 12.5 mg hydrochlorothiazide to
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
10 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
In these patients, an incremental blood pressure lowering effect was observed for both SBP and DBP (13.3 and 8.3 mm Hg, respectively).
F’ dawn il- pazjenti, kien osservat tnaqqis inkrementali fil- pressjoni tad- demm kemm għal SBP kif ukoll għal DBP (13. 3 u 8. 3 mm Hg, rispettivament).
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg were 100%.
Meta mkejla permezz ta ’ osservazzjoni tal- pressjoni ambulatorja l- effetti mill- inqas għal aktar ta ’ Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg kienu 100%.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg and Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg, respectively.
L- effetti mill- inqas għal aktar mkejla mid- dirgħajn waqt il- viżti għand it- tabib kienu 68% u 76% għal Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg u Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg, rispettivament.
These 24-hour effects were observed without excessive blood pressure lowering at peak and are consistent with safe and effective blood-pressure lowering over the once-daily dosing interval.
Dawn l- effetti tul 24 siegħa kienu osservati mingħajr ma sar tnaqqis eċċessiv tal- pressjoni fl- ogħla effett u huma konsistenti mat- tnaqqis sigur u effettiv tal - pressjoni tul l- intervall ta ’ doża waħda kuljum.
Although not specifically studied with the Irbesartan Hydrochlorothiazide BMS, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Għalkemm ma ġiex speċifikament studjat b’ Irbesartan Hydrochlorothiazide BMS, il- pressjoni ma reġgħetx għoliet kemm b’ irbesartan jew b’ hydrochlorothiazide.
There is no difference in response to Irbesartan Hydrochlorothiazide BMS, regardless of age or gender.
Ir- rispons għal Irbesartan Hydrochlorothiazide BMS ma jiddependix mill- età u lanqas mis- sess.
As is the case with other drugs that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Bħal fil- każ ta ’ mediċini oħra li jaffetwaw is- sistema renin- angiotensin, pazjenti suwed bi pressjoni għolja għandhom rispons notevolment anqas għal terapija bi ibersartan waħdu.
Efficacy and safety of Irbesartan Hydrochlorothiazide BMS as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active- controlled, 8-week, parallel-arm study.
L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide BMS bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
11 rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan
Sebgħa u erbgħin fil- mija (47. 2%) tal - pazjenti fuq il- kombinazzjoni laħqu livell minimu ta ’ SeDBP < 90 mmHg meta mqabbel ma ’ 33. 2% tal- pazjenti fuq irbesartan (p = 0. 0005).
Following oral administration of Irbesartan Hydrochlorothiazide BMS, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Wara li jingħata mill- ħalq Irbesartan Hydrochlorothiazide BMS il- biodisponibilità assoluta orali hija 60 - 80% u 50 - 80% għal irbesartan u hydrochlorothiazide, rispettivament.
Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide BMS.
L- ikel ma jaffettwax il- biodisponibilità ta ’ Irbesartan Hydrochlorothiazide BMS.
Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Il- konċentrazzjoni fil - plażma tilħaq l- ogħla livell 1. 5 - 2 sigħat wara li tingħata mill- ħalq għal irbesartan u 1 - 2. 5 sigħat għal hydrochlorothiazide.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
12 bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibbli.
After either oral or IV administration of 14 C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Wara li 14C irbesartan jingħata jew mill- ħalq jew ġol- vini, madwar 20% tar- radjuattività tiġi rkuprata fl- awrina, u l- kumplament fl- ippurgar.
12 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi, minn ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbiddlux b’ mod sinifikanti.
Irbesartan: there was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Fi studji mhux kliniċi ta ’ sigurta`, dożi għoljin ta ’ irbesartan
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
13 (≥ 250 mg/ kg/ jum f’ firien u ≥ 100 mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
13 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall- effett ġenotossiku u karċinoġeniku f’ xi mudelli esperimentali, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l- użu tagħha u żieda fin- neoplażmi.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Ferric oxide aħmar u isfar
19 January 2007 Date of last renewal:
19 ta ’ Jannar 2007 Data ta ’ l- aħħar tiġdid:
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg pilloli.
65.8 mg of lactose monohydrate per tablet.
65. 8 mg ta ’ lactose (bħala monohydrate) kull pillola.
16 Hepatic impairment:
16 Indeboliment epatiku:
17 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
17 Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
18 Pregnancy:
18 Tqala:
19 CYP2C9.
19 Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
20 Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
20 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
Vascular disorders:
21 Disturbi vaskulari:
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide BMS.
22 Aktar tagħrif fuq komponenti individwali: minbarra l- effetti avversi msemmijin hawn fuq għal dan il - prodott kombinat, effetti oħra mhux mixtieqa li ġew irrapportati ma ’ wieħed minn dawn il- komponenti individwali jista ’ ikollhom effetti avversi ma ’ Irbesartan Hydrochlorothiazide BMS.
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
23 Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
23 4.9 Overdose
4. 9 Doża eċċessiva
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
24 irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
24 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
25 rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
26 bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibbli.
26 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi, minn ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbiddlux b’ mod sinifikanti.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
27 (≥ 250 mg/ kg/ jum f’ firien u ≥ 100 mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
27 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall- effett ġenotossiku u karċinoġeniku f’ xi mudelli esperimentali, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l- użu tagħha u żieda fin- neoplażmi.
6.6 Special precautions for disposal
28 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg pilloli miksijin b' rita.
38.5 mg of lactose monohydrate per film-coated tablet.
38. 5 mg ta ’ lactose (bħala monohydrate) kull pillola miksija b' rita.
30 Hepatic impairment:
30 Indeboliment epatiku:
Severe hepatic impairment, biliary cirrhosis and cholestasis.
Indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min), Ipokalimja rifrattorja, iperkalċimja, Indeboliment epatiku sever, ċirrożi biljari u kolestażi.
31 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
31 Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
32 Pregnancy:
32 Tqala:
33 CYP2C9.
33 Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
34 Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
34 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
Vascular disorders:
35 Disturbi vaskulari:
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide BMS.
36 Aktar tagħrif fuq komponenti individwali: minbarra l- effetti avversi msemmijin hawn fuq għal dan il - prodott kombinat, effetti oħra mhux mixtieqa li ġew irrapportati ma ’ wieħed minn dawn il- komponenti individwali jista ’ ikollhom effetti avversi ma ’ Irbesartan Hydrochlorothiazide BMS.
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
37 Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
37 4.9 Overdose
4. 9 Doża eċċessiva
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
38 irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
38 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
39 rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
40 bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibbli.
40 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi, minn ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbiddlux b’ mod sinifikanti.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
41 (≥ 250 mg/ kg/ jum f’ firien u ≥ 100 mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
41 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall- effett ġenotossiku u karċinoġeniku f’ xi mudelli esperimentali, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l- użu tagħha u żieda fin- neoplażmi.
6.3 Shelf life 3 years.
3 snin.
Cartons of 14 film-coated tablets; 1 blister card of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Pakketti ta ’ 14- il pillola miksija b' rita; strixxa ta ’ 14- il pillola miksija b' rita f’ folji tal - PVC/ PVDC/ Aluminju
Cartons of 28 film-coated tablets; 2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
42 Pakketti ta ’ 28 pillola miksija b' rita; 2 strixxi ta ’ 14- il pillola miksija b' rita f’ folji tal - PCV/ PVDC/ Aluminju.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg pilloli miksijin b' rita.
89.5 mg of lactose monohydrate per film-coated tablet.
89. 5 mg ta ’ lactose (bħala monohydrate) kull pillola miksija b' rita.
44 Hepatic impairment:
44 Indeboliment epatiku:
45 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
45 Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
46 Pregnancy:
46 Tqala:
47 CYP2C9.
47 Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
48 Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
48 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
Vascular disorders:
49 Disturbi vaskulari:
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide BMS.
50 Aktar tagħrif fuq komponenti individwali: minbarra l- effetti avversi msemmijin hawn fuq għal dan il - prodott kombinat, effetti oħra mhux mixtieqa li ġew irrapportati ma ’ wieħed minn dawn il- komponenti individwali jista ’ ikollhom effetti avversi ma ’ Irbesartan Hydrochlorothiazide BMS.
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
51 Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
51 4.9 Overdose
4. 9 Doża eċċessiva
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
52 irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
52 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
53 rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
54 bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibbli.
54 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi, minn ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbiddlux b’ mod sinifikanti.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
55 (≥ 250 mg/ kg/ jum f’ firien u ≥ 100 mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
55 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall- effett ġenotossiku u karċinoġeniku f’ xi mudelli esperimentali, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l- użu tagħha u żieda fin- neoplażmi.
Cartons of 28 film-coated tablets; 2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
56 Pakketti ta ’ 28 pillola miksija b' rita; 2 strixxi ta ’ 14- il pillola miksija b' rita f’ folji tal - PCV/ PVDC/ Aluminju.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg pilloli miksijin b' rita.
53.3 mg of lactose monohydrate per film-coated tablet.
53. 3 mg ta ’ lactose (bħala monohydrate) kull pillola miksija b' rita.
58 Hepatic impairment:
58 Indeboliment epatiku:
59 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
59 Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
60 Pregnancy:
60 Tqala:
61 CYP2C9.
61 Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
62 Evidenza epidemjoloġika dwar ir- riskju tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
62 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
Vascular disorders:
63 Disturbi vaskulari:
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide BMS.
64 Aktar tagħrif fuq komponenti individwali: minbarra l- effetti avversi msemmijin hawn fuq għal dan il - prodott kombinat, effetti oħra mhux mixtieqa li ġew irrapportati ma ’ wieħed minn dawn il- komponenti individwali jista ’ ikollhom effetti avversi ma ’ Irbesartan Hydrochlorothiazide BMS.
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
65 Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
65 4.9 Overdose
4. 9 Doża eċċessiva
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
66 irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
66 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
67 rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
68 bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibbli.
68 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Indeboliment epatiku: f’ pazjenti b’ ċirrożi, minn ħafifa għal moderata, il- parametri farmakokinetiċi ta ’ irbesartan ma jitbiddlux b’ mod sinifikanti.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
69 (≥ 250 mg/ kg/ jum f’ firien u ≥ 100 mg/ kg/ jum f’ makakki) ikkawżaw tnaqqis fil- parametri taċ- ċelluli ħomor tad- demm (eritroċiti, emoglobina, ematokrit).
69 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall- effett ġenotossiku u karċinoġeniku f’ xi mudelli esperimentali, l- esperjenza estensiva fil- bniedem b’ hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l- użu tagħha u żieda fin- neoplażmi.
6.5 Nature and contents of container
70 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
70 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
71 ANNEX II
71 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR IMPORT AND BATCH RELEASE
DETENTURI TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- IMPORTAZZJONI U L- ĦRUĠ TAL- LOTT
Name and addresses of the manufacturers responsible for import and batch release
Isem u indirizzi tal- manifatturi responsabbli għall- importazzjoni u l- ħruġ tal- lott
The PSUR cycle of Irbesartan Hydrochlorothiazide BMS is aligned with the cross-referred product, KARVEZIDE, until otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Irbesartan Hydrochlorothiazide BMS huwa allinjat mal- prodott cross- referred, KARVEZIDE, sakemm mhux speċifikat mod ieħor.
73 ANNEX III
73 ANNESS III
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
75 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FS- SUQ
EU/ 1/ 06/ 369/ 001 14 tablets EU/ 1/ 06/ 369/ 002 28 tablets EU/ 1/ 06/ 369/ 003 56 tablets EU/ 1/ 06/ 369/ 004 56 x 1 tablets EU/ 1/ 06/ 369/ 005 98 tablets
EU/ 1/ 06/ 369/ 001 14- il pillola EU/ 1/ 06/ 369/ 002 28 pillola EU/ 1/ 06/ 369/ 003 56 pillola EU/ 1/ 06/ 369/ 004 56 x 1 pillola EU/ 1/ 06/ 369/ 005 98 pillola
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 369/ 006 14 tablets EU/ 1/ 06/ 369/ 007 28 tablets EU/ 1/ 06/ 369/ 008 56 tablets EU/ 1/ 06/ 369/ 009 56 x 1 tablets EU/ 1/ 06/ 369/ 010 98 tablets
EU/ 1/ 06/ 369/ 006 14- il pillola EU/ 1/ 06/ 369/ 007 28 pillola EU/ 1/ 06/ 369/ 008 56 pillola EU/ 1/ 06/ 369/ 009 56 x 1 pillola EU/ 1/ 06/ 369/ 010 98 pillola
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg
80 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
14 tablets 28 tablets 56 tablets 56 x 1 tablets 84 tablets 98 tablets
14- il pillola 28 pillola 56 pillola 56 x 1 pillola 84 pillola 98 pillola
EU/ 1/ 06/ 369/ 011 14 tablets EU/ 1/ 06/ 369/ 012 28 tablets EU/ 1/ 06/ 369/ 013 56 tablets EU/ 1/ 06/ 369/ 014 56 x 1 tablets EU/ 1/ 06/ 369/ 015 84 tablets EU/ 1/ 06/ 369/ 016 98 tablets
EU/ 1/ 06/ 369/ 011 14- il pillola EU/ 1/ 06/ 369/ 012 28 pillola EU/ 1/ 06/ 369/ 013 56 pillola EU/ 1/ 06/ 369/ 014 56 x 1 pillola EU/ 1/ 06/ 369/ 015 84 pillola EU/ 1/ 06/ 369/ 016 98 pillola
83 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 369/ 017 14 tablets EU/ 1/ 06/ 369/ 018 28 tablets EU/ 1/ 06/ 369/ 019 56 tablets EU/ 1/ 06/ 369/ 020 56 x 1 tablets EU/ 1/ 06/ 369/ 021 84 tablets EU/ 1/ 06/ 369/ 022 98 tablets
EU/ 1/ 06/ 369/ 017 14- il pillola EU/ 1/ 06/ 369/ 018 28 pillola EU/ 1/ 06/ 369/ 019 56 pillola EU/ 1/ 06/ 369/ 020 56 x 1 pillola EU/ 1/ 06/ 369/ 021 84 pillola EU/ 1/ 06/ 369/ 022 98 pillola
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 369/ 023 14 tablets EU/ 1/ 06/ 369/ 024 28 tablets EU/ 1/ 06/ 369/ 025 56 tablets EU/ 1/ 06/ 369/ 026 56 x 1 tablets EU/ 1/ 06/ 369/ 027 84 tablets EU/ 1/ 06/ 369/ 028 98 tablets
EU/ 1/ 06/ 369/ 023 14- il pillola EU/ 1/ 06/ 369/ 024 28 pillola EU/ 1/ 06/ 369/ 025 56 pillola EU/ 1/ 06/ 369/ 026 56 x 1 pillola EU/ 1/ 06/ 369/ 027 84 pillola EU/ 1/ 06/ 369/ 028 98 pillola
89 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS Pilloli 300 mg/ 25 mg irbesartan/ hydrochlorothiazide
91 PACKAGE LEAFLET:
91 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide BMS Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
What Irbesartan Hydrochlorothiazide BMS is and what it is used for 2.
X’ inhu Irbesartan Hydrochlorothiazide BMS u għalxiex jintuża 2.
Before you take Irbesartan Hydrochlorothiazide BMS 3.
Qabel ma tieħu Irbesartan Hydrochlorothiazide BMS 3.
How to take Irbesartan Hydrochlorothiazide BMS 4.
Kif għandek tieħu Irbesartan Hydrochlorothiazide BMS 4.