natgillin/translations-raw huggingface dataset:
No specific information is available on the treatment of overdose with Irbesartan Hydrochlorothiazide BMS.
O zdravljenju posledic prevelikega odmerjanja zdravila Irbesartan Hydrochlorothiazide BMS ni specifičnih podatkov.
Irbesartan Hydrochlorothiazide BMS is unlikely to affect your ability to drive or use machines.
Možnost, da bi zdravilo Irbesartan Hydrochlorothiazide BMS vplivalo na sposobnost za upravljanje vozil in strojev je majhna.
Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide BMS were:
Med kliničnimi študijami so pri bolnikih, ki so se zdravili z zdravilom Irbesartan Hydrochlorothiazide BMS, poročali o naslednjih neželenih učinkih:
The two active ingredients in Irbesartan Hydrochlorothiazide BMS work together to lower blood pressure further than if either was given alone.
Zdravilni učinkovini v zdravilu Irbesartan Hydrochlorothiazide BMS znižujeta krvni tlak, in to še bolj kot če bi jemali vsako učinkovino posebej.
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).
Zdravila, na katera vpliva serumska koncentracija kalija: med hkratnim zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide BMS in drugimi zdravili, na katerih delovanje vpliva serumska koncentracija kalija (npr. z digitalisovimi glikozidi, antiaritmiki), je priporočeno redno preverjanje kalija v serumu.
In addition to the side effects listed above, chest pain has also been reported.
Neželeni učinki, ki so povezani z jemanjem irbesartana samega Poleg zgoraj naštetih neželenih učinkov so poročali tudi o pojavu bolečine v prsnem košu.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinized starch, carnauba wax.
Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza, silicijev dioksid, magnezijev stearat, titanov dioksid, makrogol 3350, rdeči, rumeni in črni železov oksid, predgelirani škrob, karnauba vosek.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, hipromeloza, silicijev dioksid, magnezijev stearat, titanov dioksid, makrogol 3000, rdeči in rumeni železov oksid, karnauba vosek.
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Preobčutljivost za zdravilni učinkovini ali katerokoli pomožno snov (glejte poglavje 6.1) ali druge derivate sulfonamidov (hidroklorotiazid je derivat sulfonamidov).
Thiazides cross the placental barrier and appear in cord blood.
Tiazidi prehajajo skozi posteljico in v umbilikalni obtok.
What Irbesartan Hydrochlorothiazide BMS contains The active substances are irbesartan and hydrochlorothiazide.
Kaj vsebuje zdravilo Irbesartan Hydrochlorothiazide BMS Zdravilni učinkovini sta irbesartan in hidroklorotiazid.
Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy.
Poročali so o primerih neonatalne trombocitopenije in fetalne ali neonatalne zlatenice pri nosečnicah, ki so jemale tiazide.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Litij: med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze so opazili reverzibilno zvečanje serumske koncentracije litija in toksičnost.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides (E172).
Pomožne snovi so: mikrokristalna celuloza, premreženi natrijev karmelozat, laktoza monohidrat, magnezijev stearat, hidratirani koloidni silicijev dioksid, predgelirani koruzni škrob, rdeči in rumeni železov oksid (E172).
Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide BMS.
Sočasno uživanje hrane na biološko uporabnost zdravila Irbesartan Hydrochlorothiazide BMS ne vpliva.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate
Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat Hipromeloza silicijev dioksid magnezijev stearat
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg
PODATKI V BRAILLOVI PISAVI Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg
MARKETING AUTHORISATION NUMBERS EU/1/06/369/001-005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/001-005
MARKETING AUTHORISATION NUMBERS EU/1/06/369/017-022
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/017-022
MARKETING AUTHORISATION NUMBERS EU/1/06/369/023-028
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/023-028
MARKETING AUTHORISATION NUMBERS EU/1/06/369/006-010
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/006-010
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinized starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
Jedro tablete: laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat Predgelirani škrob silicijev dioksid magnezijev stearat rdeči in rumeni železov oksid
FOR
Sre
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg were 100%.
Med 24-urnim merjenjem krvnega tlaka pri bolnikih, ki so prejemali zdravilo Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg, je bilo razmerje med najmanjšim in največjim učinkom 100%.
Cartons of 56 x 1 film-coated tablets; 7 blister cards of 8 x 1 film-coated tablets each in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 filmsko obloženo tableto; 7 pretisnih omotov z 8 x 1 filmsko obloženo tableto, vsaka v perforiranem enoodmernem pretisnem omotu iz PVC/PVDC/aluminija.
Cartons of 56 x 1 tablets; 7 blister cards of 8 x 1 tablets each in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 tableto; 7 pretisnih omotov z 8 x 1 tableto, vsaka v perforiranem enoodmernem pretisnem omotu iz PVC/PVDC/aluminija.
MARKETING AUTHORISATION NUMBERS EU/1/06/369/011-016
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/011-016
Although not specifically studied with the Irbesartan Hydrochlorothiazide BMS, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Posebnih študij z zdravilom Irbesartan Hydrochlorothiazide BMS ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg
PODATKI V BRAILLOVI PISAVI Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg
Medicinal product subject to medical prescription
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
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.
Pri merjenju z manšeto v ambulanti je bilo pri bolnikih, ki so jemali zdravilo Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg, to razmerje 68%, pri tistih, ki so dobivali zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg, pa 76%.
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg
PODATKI V BRAILLOVI PISAVI Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
Because no information is available regarding the use of Irbesartan Hydrochlorothiazide BMS during breast-feeding, Irbesartan Hydrochlorothiazide BMS is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Irbesartan Hydrochlorothiazide BMS med dojenjem ni na voljo, zato uporaba zdravila Irbesartan Hydrochlorothiazide BMS med dojenjem ni priporočljiva.
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 84 film-coated tablets; 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 84 filmsko obloženimi tabletami; 6 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg ni dovolj znižal.
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients.
Starostniki: pri starostnikih odmerka zdravila Irbesartan Hydrochlorothiazide BMS ni treba prilagajati.
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 tabletami; 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 56 tablets; 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle s 56 tabletami; 4 pretisni omoti iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 14 tablets; 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 tabletami; 1 pretisni omot iz PVC/PVDC/aluminija s 14 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets.
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete
Cartons of 28 tablets; 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 tabletami; 2 pretisna omota iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
B.
V
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 tablet EU/1/06/369/018 - 28 tablet EU/1/06/369/019 - 56 tablet EU/1/06/369/020 - 56 x 1 tableta EU/1/06/369/021 - 84 tablet EU/1/06/369/022 - 98 tablet
Each tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Cartons of 28 film-coated tablets; 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 28 filmsko obloženimi tabletami; 2 pretisna omota iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
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 tablet EU/1/06/369/012 - 28 tablet EU/1/06/369/013 - 56 tablet EU/1/06/369/014 - 56 x 1 tableta EU/1/06/369/015 - 84 tablet EU/1/06/369/016 - 98 tablet
Cartons of 56 film-coated tablets; 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 56 filmsko obloženimi tabletami; 4 pretisni omoti iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Each tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
No dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Pri bolnikih z blago do zmerno jetrno okvaro prilagoditev odmerka ni potrebna (glejte poglavje 4.3).
Cartons of 98 film-coated tablets; 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 98 filmsko obloženimi tabletami; 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported.
Pri bolnikih, ki so jemali po 12,5 mg hidroklorotiazida, kolikor ga vsebuje zdravilo Irbesartan Hydrochlorothiazide BMS, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
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 tablet EU/1/06/369/024 - 28 tablet EU/1/06/369/025 - 56 tablet EU/1/06/369/026 - 56 x 1 tableta EU/1/06/369/027 - 84 tablet EU/1/06/369/028 - 98 tablet
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Cartons of 14 film-coated tablets; 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 14 filmsko obloženimi tabletami; 1 pretisni omot iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg.
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg ni dovolj znižal.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets.
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete
Dosage
aritmija
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 tablet EU/1/06/369/002 - 28 tablet EU/1/06/369/003 - 56 tablet EU/1/06/369/004 - 56 x 1 tableta EU/1/06/369/005 - 98 tablet
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 tablet EU/1/06/369/007 - 28 tablet EU/1/06/369/008 - 56 tablet EU/1/06/369/009 - 56 x 1 tableta EU/1/06/369/010 - 98 tablet
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets.
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablete irbesartan/hidroklorotiazid
Irbesartan Hydrochlorothiazide BMS is for oral use.
Zdravilo Irbesartan Hydrochlorothiazide BMS je potrebno zaužiti.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets.
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete
While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Irbesartan Hydrochlorothiazide BMS, čeprav to pri zdravljenju z njim ni bilo dokazano.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets.
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje: Zdravilo Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
Film-coating:
ŠTEVILKA SERIJE Serija:
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Izgled zdravila Irbesartan Hydrochlorothiazide BMS in vsebina pakiranja Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike.
BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO IRBESARTAN HYDROCHLOROTHIAZIDE BMS
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
Evropska komisija je dovoljenje za promet z zdravilom Biograstim, veljavno po vsej Evropski uniji, odobrila družbi CT Arzneimittel GmbH dne 15. septembra 2008.
This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
To pomeni, da je zdravilo Biograstim podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebujejo enako zdravilno učinkovino (t.i. „referenčno zdravilo“).
Other information about Biograstim:
Druge informacije o zdravilu Biograstim:
The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Najpogostejši neželeni učinek zdravila Biograstim (opažen pri več kot 1 bolniku izmed 10) je mišičnoskeletna bolečina (bolečina v mišicah in kosteh).
During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Med prvim 21 dnevnim ciklom kemoterapije so imeli bolniki, zdravljeni bodisi z zdravilom Biograstim ali Neupogen, hudo netropenijo v povprečju 1,1 dan, v primerjavi s 3,8 dnevi pri tistih, ki so prejemali placebo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BIOGRASTIM EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) BIOGRASTIM Povzetek EPAR za javnost
Biograstim is used to stimulate the production of white blood cells in the following situations:
Zdravilo Biograstim se uporablja za spodbujanje tvorbe belih krvničk v naslednjih primerih:
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Učinkovina v zdravilu Biograstim, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (granulocyte colony stimulating factor - G-CSF).
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Za preučitev varnosti zdravila Biograstim sta bili izvedeni še dve študiji z bolniki s pljučnim rakom in z neHodgkinovim limfomom.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for.
Pri več kot 1 bolniku izmed 10 se lahko pojavijo tudi drugi neželeni učinki, v odvisnosti od stanja, zaradi katerega se zdravilo Biograstim uporablja.
The Committee recommended that Biograstim be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Biograstim odobri dovoljenje za promet.
What benefit has Biograstim shown during the studies?
Kakšne koristi je zdravilo Biograstim izkazalo med študijami?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Biograstim podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Neupogen.
Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Zdravilo Biograstim se običajno daje v specializiranem zdravstvenem centru, vendar pa si ga lahko bolniki, ki ga prejemajo s podkožno injekcijo, dajejo tudi sami, pod pogojem, da so bili ustrezno usposobljeni.