natgillin/translations-raw huggingface dataset:
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Pritor tablets (see section Further information for a list of other ingredients). • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
• če ste alergični (preobčutljivi na) na telmisartan ali katerokoli sestavino tablet Pritor (glejte poglavje Dodatne informacije, v katerem je seznam pomožnih snovi), • zadnjih šest mesecev nosečnosti (glejte poglavje Nosečnost in dojenje), • če dojite, • če imate hude jetrne težave, na primer holestazo ali zaporo žolčnih poti (težave z iztekanjem žolča iz jeter in žolčnika) ali katerokoli drugo hudo jetrno bolezen.
If any of the above applies to you, tell your doctor or pharmacist before taking Pritor.
Če imate karkoli od naštetega, povejte zdravniku ali farmacevtu, preden boste vzeli Pritor.
Take special care with Pritor
Bodite posebno pozorni pri jemanju zdravila Pritor
• Kidney disease or kidney transplant.
• ledvično bolezen ali ledvični presadek, • stenozo ledvičnih arterij (zožitev krvnih žil, ki vodijo v eno ali obe ledvici),
49 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
49 • jetrno bolezen, • težave s srcem, • povečano raven aldosterona (zadrževanje vode in soli v telesu ter neravnovesje različnih mineralov v krvi), • nizek krvni tlak (hipotenzijo), ki se lahko pojavi, če ste dehidrirani (izgubite preveč vode) ali imate zaradi zdravljenja z diuretikiom (''tabletami za odvajanje vode'') pomanjkanje soli, uživate dieto z majhno vsebnostjo soli, imate drisko ali bruhate, • povečano raven kalija v krvi, • sladkorno bolezen.
Pritor is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breast-feeding).
Uporaba zdravila Pritor ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa lahko povzroči resno škodo vašemu otroku (glejte poglavje Nosečnost in dojenje).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Pritor.
Če boste operirani ali boste prejeli anestezijo, morate vašemu zdravniku povedati, da jemljete Pritor.
As with all other angiotensin II receptor antagonists, Pritor may be less effective in lowering the blood pressure in black patients.
Pritor lahko, tako kot vsi drugi antagonisti angiotenzina, pri temnopoltih bolnikih manj učinkovito zniža krvni tlak.
• Lithium containing medicines to treat some types of depression. • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen), heparin, immunosuppressives (e. g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. • Diuretics ('water tablets'), especially if taken in high doses together with Pritor, may lead to excessive loss of body water and low blood pressure (hypotension).
• zdravila z litijem za zdravljenje nekaterih oblik depresije, • zdravila, ki lahko povečajo raven kalija v krvi, na primer nadomestki soli s kalijem; diuretiki, ki zadržujejo kalij (nekatere tablete za odvajanje vode); zaviralci ACE, angatonisti receptorjev angiotenzina II; nesteroidna protivnetna zdravila (na primer aspirin ali ibuprofen), heparin, imunosupresivi (na primer ciklosporin ali takrolimus); in antibiotik trimetoprim, • diuretiki (tablete za odvajanje vode), zlasti če jemljete velike odmerke sočasno z zdravilom Pritor, ki lahko povzročijo preveliko izgubo vode iz telesa in znižajo krvni tlak (povzročijo hipotenzijo).
As with other blood pressure lowering medicines, the effect of Pritor may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen) or corticosteroids.
Enako kot pri drugih zdravilih za znižanje krvnega tlaka se lahko učinek zdravila Pritor zmanjša, če jemljete nesteroidna protivnetna zdravila (na primer aspirin ali ibuprofen) ali kortikosteroide.
Pritor may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Zdravilo Pritor lahko poveča učinek znižanja krvnega tlaka drugih zdravil za zdravljenje visokega krvnega tlaka.
Taking Pritor with food and drink
Jemanje zdravila Pritor skupaj s hrano in pijačo
You can take Pritor with or without food.
Zdravilo Pritor lahko jemljete s hrano ali brez.
Usually, your doctor will advise you to take another medicine instead of Pritor, as Pritor 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 Pritor, saj jemanje zdravila Pritor v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
Appropriate antihypertensive drug must usually replace Pritor before starting a pregnancy.
V primeru načrtovanja nosečnosti je treba praviloma preiti na drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
Pritor should not be used during the second and third trimester of pregnancy.
Zdravila Pritor ne smete jemati v drugem in tretjem trimesečju nosečnosti.
50 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
50 Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila Pritor takoj, ko izveste, da ste noseči.
If you become pregnant during therapy with Pritor, please inform and see your doctor without delay.
Če zanosite med zdravljenjem z zdravilom Pritor takoj obvestite in svojega zdravnika.
You must not take Pritor if you are breast-feeding.
Če dojite, zdravila Pritor ne smete jemati.
No information is available on the effect of Pritor on the ability to drive or operate machinery.
Ni podatkov o učinku zdravila Pritor na sposobnost vožnje ali upravljanja s stroji.
Important information about some of the ingredients of Pritor
Pomembne informacije o nekaterih sestavinah zdravila Pritor
HOW TO TAKE PRITOR
KAKO JEMATI ZDRAVILO PRITOR
The usual dose of Pritor is one tablet a day.
Običajni odmerek zdravila Pritor je ena tableta na dan.
The usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Za večino bolnikov je običajni odmerek zdravila Pritor za 24- urni nadzor krvnega tlaka ena tableta po 40 mg enkrat na dan.
Like all medicines, Pritor can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Pritor neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
51 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Neželeni učinki so razvrščeni po pogostnosti: zelo pogosti: več kot 1 na10 bolnikov; 51 pogosti: več kot 1 na 100 bolnikov, toda manj kot 1 na 10 bolnikov; občasni: več kot 1 na 1000 bolnikov, toda manj kot 1 na 100 bolnikov; redki: več kot 1 na 10. 000 bolnikov, toda manj kot 1 na 1000 bolnikov; zelo redki: manj kot 1 na 10. 000 bolnikov; neznana: ni mogoče oceniti iz razpoložljivih podatkov.
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e. g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Pritor and decreased haemoglobin (a blood protein).
Možni neželeni učinki neznane pogostnosti: okužbe sečil, povečanje določenih belih krvničk (eozinofilija), alergijska reakcija (na primer izpuščaj, srbež, težave z dihanjem, piskanje, otekanje obraza ali nizek krvni tlak), počasen srčni utrip (bradikardija), medikamentni izpuščaj, ekcem (kožna bolezen), vnetje kit, neučinkovitost zdravila Pritor in znižana raven hemoglobina (krvne beljakovine).
HOW TO STORE PRITOR
SHRANJEVANJE ZDRAVILA PRITOR
Do not use Pritor after the expiry date which is stated on the carton after “ EXP”.
Zdravila Pritor ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
Pritor 20 mg tablets are white, round and engraved with the code number '50H 'on one side and the company logo on the other side.
Tablete zdravila Pritor 20 mg so bele, okrogle tablete z vtisnjenim logom podjetja in kodno številko 50H.
52 Pritor is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets.
52 Zdravilo Pritor je na voljo v pretisnih omotih po 14, 28, 30, 56, 90 ali 98 tablet.
Manufacturer Bayer HealthCare AG D-51368 Leverkusen Germany
Izdelovalec Bayer HealthCare AG D- 51368 Leverkusen Nemčija
53 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
53 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
INFORMATION FOR THE USER Pritor 40 mg tablets Telmisartan
54 NAVODILO ZA UPORABO Pritor 40 mg tablete Telmisartam
Pritor belongs to a group of medicines known as angiotensin II receptor antagonists.
Pritor sodi v skupino zdravil, ki jih imenujemo antagonisti angiotenzina II.
• Kidney disease or kidney transplant.
• če imate ledvično bolezen ali ledvični presadek, • stenozo ledvičnih arterij (zožitev krvnih žil, ki vodijo v eno ali obe ledvici),
55 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
55 • jetrno bolezen, • težave s srcem, • povečano raven aldosterona (zadrževanje vode in soli v telesu ter neravnovesje različnih mineralov v krvi), • nizek krvni tlak (hipotenzijo), ki se lahko pojavi, če ste dehidrirani (izgubite preveč vode) ali imate zaradi zdravljenja z diuretikiom (''tabletami za odvajanje vode'') pomanjkanje soli, uživate dieto z majhno vsebnostjo soli, imate drisko ali bruhate, • povečano raven kalija v krvi, • sladkorno bolezen.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta..
Taking Pritor with food and drink
Jemanje zdravila PRITOR skupaj s hrano in pijačo
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.
56 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
56 Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila Pritor takoj, ko izveste, da ste noseči.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100
Neželeni učinki so razvrščeni po pogostnosti: zelo pogosti: več kot 1 na10 bolnikov; pogosti: več kot 1 na 100 bolnikov, toda manj kot 1 na 10 bolnikov; občasni: več kot 1 na 1000 bolnikov, toda manj kot 1 na 100 bolnikov;
57 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
57 redki: več kot 1 na 10. 000 bolnikov, toda manj kot 1 na 1000 bolnikov; zelo redki: manj kot 1 na 10. 000 bolnikov; neznana: ni mogoče oceniti iz razpoložljivih podatkov.
Pritor 40 mg tablets are white, oblong-shaped and engraved with the code '51H 'on one side.
Tablete zdravila Pritor 40 mg so bele, podolgovate tablete z vtisnjeno kodno številko 51 H.
58 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
Zdravilo Pritor je na voljo v pretisnih omotih po 14, 28, 30, 56, 90, 98 ali 280 tablet ali pretisnih omotih za enkratni odmerek po 28 x 1 tableto.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
59 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
INFORMATION FOR THE USER Pritor 80 mg tablets Telmisartan
60 NAVODILO ZA UPORABO Pritor 80 mg tablete Telmisartan
WHAT PRITOR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PRITOR 80 MG IN ZA KAJ GA UPORABLJAMO
61 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
61 • jetrno bolezen, • težave s srcem, • povečano raven aldosterona (zadrževanje vode in soli v telesu ter neravnovesje različnih mineralov v krvi), • nizek krvni tlak (hipotenzijo), ki se lahko pojavi, če ste dehidrirani (izgubite preveč vode) ali imate zaradi zdravljenja z diuretikiom (''tabletami za odvajanje vode'') pomanjkanje soli, uživate dieto z majhno vsebnostjo soli, imate drisko ali bruhate, • povečano raven kalija v krvi, • sladkorno bolezen.
As with all other angiotensin antagonists, Pritor may be less effective in lowering the blood pressure in black patients.
Pritor lahko, tako kot vsi drugi antagonisti angiotenzina, pri temnopoltih bolnikih manj učinkovito zniža krvni tlak.
62 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
62 Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila Pritor takoj, ko izveste, da ste noseči.
You must not take Pritor if you are breast-feeding.
Če dojite, zdravila Pritor ne smete jemati
If you are intolerant to some sugars, consult your doctor before taking Pritor.
Če ne prenašate nekaterih sladkorjev, se posvetujte s svojim zdravnikom, preden vzamete zdravilo Pritor..
The usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Za večino bolnikov je običajni odmerek zdravila Pritor za 24- urni nadzor krvnega tlaka ena tableta po 40 mg enkrat na dan.
63 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
63 redki: več kot 1 na 10. 000 bolnikov, toda manj kot 1 na 1000 bolnikov; zelo redki: manj kot 1 na 10. 000 bolnikov; neznana: ni mogoče oceniti iz razpoložljivih podatkov.
Pritor 80 mg tablets are white, oblong-shaped and engraved with the code '52H 'on one side.
Tablete zdravila Pritor 80 mg so bele, podolgovate tablete z vtisnjeno kodno številko 52 H.
64 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
Zdravilo Pritor je na voljo v pretisnih omotih po 14, 28, 30, 56, 90, 98 ali 280 tablet ali pretisnih omotih za enkratni odmerek po 28 x 1 tableto.
Not all pack sizes may be marketed in your country.
64 Na trgu ni vseh navedenih pakiranj.
Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Bayer HealthCare AG D- 51368 Leverkusen Nemčija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
65 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white:
40 mg ali 80 mg telimisartana in 12, 5 mg hidroklorotiazida; rumene in bele:
PritorPlus is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da ni posledica nobenega drugega bolezenskega stanja.
The safety and effectiveness of PritorPlus have not been established in patients below 18 years of age.
Varnost in učinkovitost zdravila PritorPlus nista bili ugotovljeni pri bolnikih, mlajših od 18 let.
PritorPlus is taken by mouth once a day with liquid, with or without food.
Zdravilo PritorPlus se jemlje peroralno enkrat na dan s tekočino, s hrano ali brez nje.
The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Odmerek zdravila PritorPlus je odvisen od odmerka telmisartana, ki ga je bolnik jemal do takrat: bolniki, ki so prejemali 40 mg telmisartana, morajo jemati tablete po 40/ 12, 5 mg, tisti, ki pa so prejemali 80 mg telmisartana, pa morajo jemati tablete po 80/ 12, 5 mg.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Tablete po 80/ 25 mg se dajejo bolnikom, pri katerih se krvni tlak ne uravna z jemanjem tablet po 80/ 12, 5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo PritorPlus.
PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Zdravilo PritorPlus so preučevali v petih glavnih študijah, v katerih je sodelovalo skupno 2985 bolnikov z blago do zmerno hipertenzijo.
In four of these studies (2,272 patients), PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone.
V štirih študijah (2272 bolnikov) so zdravilo PritorPlus primerjali s placebom (zdravilom brez zdravilne učinkovine) in telmisartanom kot samostojnim zdravilom.
PritorPlus was more effective than placebo and than telmisartan alone in reducing diastolic blood pressure.
Zdravilo PritorPlus je bilo učinkovitejše od placeba in telmisartana, uporabljenega samostojno, pri zniževanju diastoličnega krvnega tlaka.
The most common side effects with PritorPlus (seen in between 1 and 10 patients in 100) are bronchitis (inflammation of the lungs), pharyngitis (sore throat), sinusitis (inflammation of the sinuses, air-filled passageways in the bones around the nose and eyes), upper respiratory tract infections (colds), urinary tract infections (infections of the structures that carry urine), hypercholesterolaemia (high blood cholesterol levels), hypokalaemia (low blood potassium levels), anxiety, dizziness, vertigo (a spinning sensation), abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), gastritis (inflammation of the stomach lining), eczema (itchy, scaly skin), arthralgia (joint pain), osteoarthritis (swelling and pain in the joints), muscle spasms, pain in the extremities (arms and legs), myalgia (muscle pain), erectile dysfunction (inability to get or keep an erection), flu-like illness and pain.
Najpogostejši neželeni učinki zdravila PritorPlus (opaženi pri 1 do 10 bolnikih od 100) so bronhitis (vnetje pljuč), faringitis (vneto grlo), sinuzitis (vnetje sinusov, z zrakom napolnjenih prehodov v kosteh okoli nosu in oči), okužbe zgornjih dihal (prehladi), okužbe sečil (okužba struktur za odvajanje urina), hiperholesterolemija (visoke ravni holesterola v krvi), hipokaliemija (nizke ravni kalija v krvi), anksioznost, omotica, vrtoglavica (občutek vrtenja), bolečine v trebuhu (želodcu), driska, dispepsija (zgaga), gastritis (vnetje želodčne sluznice), ekcem (srbeča, luskasta koža), artralgija (bolečine v sklepih), osteoartritis (otekanje in bolečine v sklepih), krči v mišicah, bolečina v okončinah (rokah in nogah), mialgija (bolečine v mišicah), erektilna disfunkcija (nezmožnost doseči ali obdržati erekcijo), gripi podobna bolezen in bolečina.
For the full list of all side effects reported with PritorPlus, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila PritorPlus, glejte navodilo za uporabo.
PritorPlus should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol).
Zdravila PritorPlus ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila (vključno s sorbitolom).
PritorPlus should also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Zdravilo PritorPlus se prav tako ne sme uporabljati pri osebah, ki imajo huda obolenja jeter, ledvic ali žolčnika, ter osebe s prenizkimi ravnmi kalija v krvi ali previsokimi ravnmi kalcija v krvi.
The Committee for Medicinal Products for Human Use (CHMP) decided that PritorPlus’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila PritorPlus pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvni tlak ni zadostno nadzorovan s telmisartanom, uporabljenim samostojno, večje od z njim povezanih tveganj.
The Committee recommended that PritorPlus be given marketing authorisation.
Odbor je priporočil, da se za zdravilo PritorPlus odobri dovoljenje za promet.
Other information about PritorPlus:
Druge informacije o zdravilu PritorPlus:
The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Evropska komisija je dovoljenje za promet z zdravilom PritorPlus, veljavno po vsej Evropski uniji, odobrila dne 22. aprila 2002.
The marketing authorisation holder is Bayer Healthcare AG.
Imetnik dovoljenja za promet z zdravilom je družba Bayer Healthcare AG.
The marketing authorisation was renewed on 22 April 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 22. aprila 2007.
The full EPAR for PritorPlus is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PritorPlus je na voljo tukaj.
PritorPlus 40 mg/ 12.5 mg tablets
PritorPlus 40 mg/ 12, 5 mg tablete
PritorPlus fixed dose combination (40 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
PritorPlus, fiksna kombinacija (40 mg telmisartana in 12, 5 mg hidroklorotiazida), je indicirana za bolnike, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
Adults PritorPlus should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
Odrasli Bolniki, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom, jemljejo PritorPlus enkrat na dan s tekočino, s hrano ali brez nje.