natgillin/translations-raw huggingface dataset:
38 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
The volume of distribution is 53 - 93 litres.
Volumen porazdelitve je 53- 93 litrov.
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Največje plazemske koncentracije so dosežene 1, 5- 2 uri po peroralni uporabi.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/ min, respectively.
Celokupni telesni in ledvični očistek je 157- 176 oziroma 3- 3, 5 ml/ min.
The terminal elimination half-life of irbesartan is 11 - 15 hours.
Končni razpolovni eliminacijski čas irbesartana je 11- 15 ur.
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40 years).
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18- 40 let).
39 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
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).
V nekliničnih raziskavah o varnosti, so visoki odmerki irbesartana (≥250 mg/ kg/ dan pri podganah in ≥100 mg/ kg/ dan pri makako opicah) povzročili zmanjšanje parametrov rdečih krvnih celic (eritrociti, hemoglobin, hematokrit).
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Carnauba wax.
Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3000 karnauba vosek
6.2 Incompatibilities
40 6. 2 Inkompatibilnosti
40 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Cartons of 14 film-coated tablets:
Škatle s 14 filmsko obloženimi tabletami:
1 blister card of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
1 pretisni omot iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 28 film-coated tablets:
Škatle z 28 filmsko obloženimi tabletami:
2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
2 pretisna omota iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 30 film-coated tablets:
Škatle s 30 filmsko obloženimi tabletami:
2 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
2 pretisna omota iz PVC/ PVDC/ aluminija s 15 filmsko obloženimi tabletami.
Cartons of 56 film-coated tablets:
Škatle s 56 filmsko obloženimi tabletami:
4 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
4 pretisni omoti iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 84 film-coated tablets:
Škatle s 84 filmsko obloženimi tabletami:
6 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
6 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 90 film-coated tablets:
Škatle z 90 filmsko obloženimi tabletami:
6 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
6 pretisnih omotov iz PVC/ PVDC/ aluminija s 15 filmsko obloženimi tabletami.
Cartons of 98 film-coated tablets:
Škatle z 98 filmsko obloženimi tabletami:
7 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
7 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
7 perforiranih pretisnih omotov iz PVC/ PVDC/ aluminija za enkratni odmerek z 8 x 1 filmsko obloženo tableto.
51.00 mg of lactose monohydrate per film-coated tablet.
51, 00 mg laktoze monohidrata na filmsko obloženo tableto.
Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba irbesartana pri otrocih in mladostnikih ni priporočljiva (glejte poglavja 4. 8, 5. 1 in 5. 2).
42 4.3 Contraindications
4. 3 Kontraindikacije
43 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
44 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.
45 Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
46 hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan in pri 26, 3% bolnikov v placebo skupini
45 Common:
Pogosti:
Musculoskeletal and connective tissue disorders:
47 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
46 Metabolism and nutrition disorders:
Presnovne in prehranske motnje:
47 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
49 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
48 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
49 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
6.2 Incompatibilities
51 6. 2 Inkompatibilnosti
50 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
102.00 mg of lactose monohydrate per film-coated tablet.
102, 00 mg laktoze monohidrata na filmsko obloženo tableto.
52 4.3 Contraindications
4. 3 Kontraindikacije
53 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
54 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.
56 Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
57 hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan in pri 26, 3% bolnikov v placebo skupini
55 Common:
Pogosti:
Musculoskeletal and connective tissue disorders:
58 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
56 Metabolism and nutrition disorders:
Presnovne in prehranske motnje:
57 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
60 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
58 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
59 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
6.2 Incompatibilities
62 6. 2 Inkompatibilnosti
60 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
3 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
3 pretisni omoti iz PVC/ PVDC/ aluminija z 10 filmsko obloženimi tabletami.
9 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
9 pretisnih omotov iz PVC/ PVDC/ aluminija z 10 filmsko obloženimi tabletami.
61 ANNEX II
64 DODATEK II
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex Francija
Sanofi-Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Sanofi- Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT Velika Britanija
Sanofi Winthrop Industrie 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 France
Sanofi Winthrop Industrie 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 Francija
OTHER CONDITIONS
• DRUGI POGOJI
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
63 ANNEX III
66 DODATEK III
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 97/ 046/ 010 14 tablets EU/ 1/ 97/ 046/ 001 28 tablets EU/ 1/ 97/ 046/ 002 56 tablets EU/ 1/ 97/ 046/ 013 56 x 1 tablets EU/ 1/ 97/ 046/ 003 98 tablets
EU/ 1/ 97/ 046/ 010 14 tablet EU/ 1/ 97/ 046/ 001 28 tablet EU/ 1/ 97/ 046/ 002 56 tablet EU/ 1/ 97/ 046/ 013 56 x 1 tablet EU/ 1/ 97/ 046/ 003 98 tablet
67 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Mon Tue Wed Thu Fri Sat Sun
Pon Tor Sre Čet Pet Sob Ned
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 97/ 046/ 011 14 tablets EU/ 1/ 97/ 046/ 004 28 tablets EU/ 1/ 97/ 046/ 005 56 tablets EU/ 1/ 97/ 046/ 014 56 x 1 tablets EU/ 1/ 97/ 046/ 006 98 tablets
EU/ 1/ 97/ 046/ 011 14 tablet EU/ 1/ 97/ 046/ 004 28 tablet EU/ 1/ 97/ 046/ 005 56 tablet EU/ 1/ 97/ 046/ 014 56 x 1 tablet EU/ 1/ 97/ 046/ 006 98 tablet
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 97/ 046/ 012 14 tablets EU/ 1/ 97/ 046/ 007 28 tablets EU/ 1/ 97/ 046/ 008 56 tablets EU/ 1/ 97/ 046/ 015 56 x 1 tablets EU/ 1/ 97/ 046/ 009 98 tablets
EU/ 1/ 97/ 046/ 012 14 tablet EU/ 1/ 97/ 046/ 007 28 tablet EU/ 1/ 97/ 046/ 008 56 tablet EU/ 1/ 97/ 046/ 015 56 x 1 tablet EU/ 1/ 97/ 046/ 009 98 tablet
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 PODATKI NA ZUNANJI OVOJNINI
14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
14 tablet 28 tablet 30 tablet 56 tablet 56 x 1 tablet 84 tablet 90 tablet 98 tablet
EU/ 1/ 97/ 046/ 016 14 tablets EU/ 1/ 97/ 046/ 017 28 tablets EU/ 1/ 97/ 046/ 034 30 tablets EU/ 1/ 97/ 046/ 018 56 tablets EU/ 1/ 97/ 046/ 019 56 x 1 tablets EU/ 1/ 97/ 046/ 031 84 tablets EU/ 1/ 97/ 046/ 037 90 tablets EU/ 1/ 97/ 046/ 020 98 tablets
EU/ 1/ 97/ 046/ 016 14 tablet EU/ 1/ 97/ 046/ 017 28 tablet EU/ 1/ 97/ 046/ 034 30 tablet EU/ 1/ 97/ 046/ 018 56 tablet EU/ 1/ 97/ 046/ 019 56 x 1 tablet EU/ 1/ 97/ 046/ 031 84 tablet EU/ 1/ 97/ 046/ 037 90 tablet EU/ 1/ 97/ 046/ 020 98 tablet
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 97/ 046/ 021 14 tablets EU/ 1/ 97/ 046/ 022 28 tablets EU/ 1/ 97/ 046/ 035 30 tablets EU/ 1/ 97/ 046/ 023 56 tablets EU/ 1/ 97/ 046/ 024 56 x 1 tablets EU/ 1/ 97/ 046/ 032 84 tablets EU/ 1/ 97/ 046/ 038 90 tablets EU/ 1/ 97/ 046/ 025 98 tablets
EU/ 1/ 97/ 046/ 021 14 tablet EU/ 1/ 97/ 046/ 022 28 tablet EU/ 1/ 97/ 046/ 035 30 tablet EU/ 1/ 97/ 046/ 023 56 tablet EU/ 1/ 97/ 046/ 024 56 x 1 tablet EU/ 1/ 97/ 046/ 032 84 tablet EU/ 1/ 97/ 046/ 038 90 tablet EU/ 1/ 97/ 046/ 025 98 tablet
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 97/ 046/ 026 14 tablets EU/ 1/ 97/ 046/ 027 28 tablets EU/ 1/ 97/ 046/ 036 30 tablets EU/ 1/ 97/ 046/ 028 56 tablets EU/ 1/ 97/ 046/ 029 56 x 1 tablets EU/ 1/ 97/ 046/ 033 84 tablets EU/ 1/ 97/ 046/ 039 90 tablets EU/ 1/ 97/ 046/ 030 98 tablets
EU/ 1/ 97/ 046/ 026 14 tablet EU/ 1/ 97/ 046/ 027 28 tablet EU/ 1/ 97/ 046/ 036 30 tablet EU/ 1/ 97/ 046/ 028 56 tablet EU/ 1/ 97/ 046/ 029 56 x 1 tablet EU/ 1/ 97/ 046/ 033 84 tablet EU/ 1/ 97/ 046/ 039 90 tablet EU/ 1/ 97/ 046/ 030 98 tablet
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
85 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
INFORMATION FOR THE USER Aprovel 75 mg tablets irbesartan
87 NAVODILO ZA UPORABO Aprovel 75 mg tablete irbesartan
What Aprovel is and what it is used for 2.
Kaj je zdravilo Aprovel in za kaj ga uporabljamo 2.
Before you take Aprovel 3.
Kaj morate vedeti, preden boste vzeli zdravilo Aprovel 3.
How to take Aprovel 4.
Kako jemati zdravilo Aprovel 4.
How to store Aprovel 6.
Shranjevanje zdravila Aprovel 6.
WHAT APROVEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO APROVEL IN ZA KAJ GA UPORABLJAMO
Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Zdravilo Aprovel spada v skupino zdravil, ki so znana kot antagonisti angiotenzina- II.
This results in an increase in blood pressure.
Angiotenzin- II je snov, ki nastaja v telesu in z vezavo na receptorje v krvnih žilah povzroči oženje žil ter posledično zvišanje krvnega tlaka.
Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Zdravilo Aprovel preprečuje vezavo angiotenzina- II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Aprovel is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Zdravilo Aprovel uporabljamo: za zdravljenje povečanega krvnega tlaka (primarne hipertenzije). za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
BEFORE YOU TAKE APROVEL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO APROVEL
Do not take Aprovel if you are allergic (hypersensitive) to irbesartan or any other ingredients of Aprovel during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding
Ne jemljite zdravila Aprovel če ste alergični na (preobčutljivi za) irbesartan ali katerokoli sestavino zdravila Aprovel če ste noseči že več kot tri mesece (glejte poglavje Nosečnost in dojenje) če dojite
Aprovel should not be given to children and adolescents (under 18 years).
Zdravila Aprovel ne smejo jemati otroci in mladostniki (mlajši od 18 let).
Take special care with Aprovel Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
Bodite posebno pozorni pri jemanju zdravila Aprovel Obvestite svojega zdravnika, če se karkoli od naslednjega nanaša na vas: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Aprovel jemljete zaradi diabetične bolezni ledvic.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics You must tell your doctor if you think that you are (or might become) pregnant.
V tem primeru bo zdravnik morda moral redno opravljati krvne preiskave, še posebej tiste, s katerimi bo v primeru slabega delovanja ledvic spremljal vrednosti kalija v krvi. če imate predvideno operacijo (kirurški poseg) ali boste dobili anestetik Zdravniku morate povedati, če mislite, da ste noseči, ali če načrtujete nosečnost.
Aprovel is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Uporaba zdravila Aprovel ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa lahko povzroči resno škodo vašemu otroku (glejte poglavje Nosečnost in dojenje).
85 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
88 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Aprovel does not usually interact with other medicines.
Zdravilo Aprovel običajno ne vpliva na delovanje drugih zdravil in obratno.
Taking Aprovel with food and drink Aprovel can be taken with or without food.
Jemanje zdravila Aprovel skupaj s hrano in pijačo Zdravilo Aprovel lahko jemljete s hrano ali brez nje.
Pregnancy and breast-feeding You must tell your doctor if you think that you are (or might become) pregnant.
Nosečnost in dojenje Zdravniku morate povedati, če mislite, da ste noseči, ali če načrtujete nosečnost.
Usually, your doctor will advise you to take another medicine instead of Aprovel, as Aprovel is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila Aprovel, saj jemanje zdravila Aprovel v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
Appropriate antihypertensive drug must usually replace Aprovel before starting a pregnancy.
V primeru načrtovanja nosečnosti je treba praviloma preiti na drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding.
Zdravila Aprovel ne smete jemati v drugem in tretjem trimesečju nosečnosti ali če dojite.
Your doctor will normally advise you to stop taking Aprovel as soon as you know you are pregnant.
Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila Aprovel takoj, ko izveste, da ste noseči.
If you become pregnant during therapy with Aprovel, please inform and see your doctor without delay.
Če zanosite med zdravljenjem z zdravilom Aprovel, takoj obvestite svojega zdravnika.
Important information about some of the ingredients of Aprovel Aprovel contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Aprovel Zdravilo Aprovel vsebuje laktozo.
If you have been told by your doctor that you have an intolerance to some sugars (e. g. lactose), contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
HOW TO TAKE APROVEL
KAKO JEMATI ZDRAVILO APROVEL
Always take Aprovel exactly as your doctor has told you.
Pri jemanju zdravila Aprovel natančno upoštevajte zdravnikova navodila.
Method of administration Aprovel is for oral use.
Način uporabe Zdravilo Aprovel je potrebno zaužiti.
Swallow the tablets with a sufficient amount of fluid (e. g. one glass of water).
Tablete morate pogoltniti z zadostno količino tekočine (npr. z enim kozarcem vode).
Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day).
Bolniki z visokim krvnim tlakom Običajen odmerek je 150 mg enkrat na dan (dve tableti).
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
89 Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat na dan.
86 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
Nekaterim bolnikom, kot so bolniki, ki se zdravijo s hemodializo, in bolniki, starejši od 75 let, lahko zdravnik predpiše manjši odmerek, še posebej na začetku zdravljenja.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Največji učinek na znižanje krvnega tlaka se običajno pojavi v 4- 6 tednih po začetku zdravljenja.