natgillin/translations-raw huggingface dataset:
Exfoliative dermatitis, urticaria, onycholysis,
epidermalna
Photosensitivit y reaction
zlasti makulo -
Toxic epidermal necrolysis, Stevens- Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
zelo izjemoma
Musculoskeletal and connective tissue disorders
urtikarija,
Muscle spasms, myalgia
nekroliza,
Arthralgia
papulozen
Metabolism and nutrition disorders
oniholiza,
Blood potassium increased
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Anorexia, decreased appetite,
mišični spazmi, mialgija
Blood sodium decreased
artralgija
Vascular
Presnovne in
Hypotension,
zvišanje kalija
Flushing Vascular
anoreksija,
Vascular Hypotension, Flushing Vascular
znižanje natrija
Raynaud’ s
prehranske motnje
disorders
v krvi
orthostatic blood pressure decreased, syncope
zmanjšanje teka,
stenosis, hypoperfusion, vasculitis
v krvi
phenomenon
Žilne bolezni
General disorders and
hipotenzija,
Chest pain, fatigue
zardevanje
Pyrexia
žilna stenoza,
Asthenia
Raynaudov
administration site conditions
ortostatska hipotenzija, sinkopa
29
pojav
Immune system disorders
Splošne težave in spremembe na mestu aplikacije
Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
bolečina v prsih, utrujenost
Hepatobiliary disorders
pireksija
Hepatic enzymes and/ or bilirubin conjugated increased,
Bolezni
Jaundice cholestatic, hepatocellular damage
anafilaktične ali
Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
28 anafilaktoidne imunskega reakcije, sistema zvišanje protijedrnih protiteles akutna odpoved holestatska zvišanje Bolezni jeter, jeter, holestatski zlatenica, jetrnih žolčnika in ali citolitični okvara jetrnih encimov in/ ali žolčevodov hepatitis (zelo celic konjugiranega izjemoma so bilirubina, bili opisani smrtni izidi) ginekomastija prehodna Motnje erektilna reprodukcije in impotenca, dojk zmanjšanje libida
Reproductive system and breast disorders
Psihiatrične
Transient erectile impotence, libido decreased
depresivno
Gynaecomastia
motena
Psychiatric disorders
motnje
Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
razpoloženje, anksioznost, živčnost, nemir, motnje spanja, vključno z zaspanostjo
Confusional state
zmedenosti
Disturbance in attention
pozornost
OVERDOSE
4. 9 Preveliko odmerjanje
PHARMACODYNAMIC PROPERTIES
5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group:
Oznaka ATC:
ACE Inhibitors, plain, ATC code C09AA05.
C09AA05.
In plasma and
Aktivni presnovek ramiprila, ramiprilat, zavira encim dipeptidilkarboksipeptidazo I (sinonima: angiotenzinska konvertaza, kininaza II).
30 tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin.
Ta encim v plazmi in tkivih katalizira pretvorbo angiotenzina I v aktivno vazokonstrikcijsko snov angiotenzin II ter razgradnjo vazodilatatorja bradikinina.
The average response to ACE inhibitor monotherapy was lower in black (Afro- Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Povprečni odziv na monoterapijo z zaviralci ACE je manjši pri črnih (osebah afro- karibskega porekla) hipertenzivnih bolnikih (ki so po navadi nizkoreninska hipertenzivna populacija) kot pri bolnikih nečrncih.
Pharmacodynamic effects
29 Farmakodinamični učinki
Cardiovascular prevention/ Nephroprotection;
Kardiovaskularna preventiva/ zaščita ledvic:
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients.
Izvedena je bila preventivna, s placebom kontrolirana študija (študija HOPE), v kateri so ramipril dodali standardnemu zdravljenju več kot 9. 200 bolnikov.
The HOPE study:
Študija HOPE:
Main results
Glavni rezultati
Ramipril
Ramipril%
Placebo relative risk (95% interval)
Placebo Relativno tveganje (95% interval zaupanja)%
confidence
Vrednost p
p-value
Vsi bolniki
%
n = 4. 645
All patients
n= 4. 652
n=4,645
Primarni kombinirani dogodki Miokardni infarkt Smrt zaradi kardiovaskularnih vzrokov
N=4,652
14, 0 9, 9 6, 1
Primary combined events Myocardial infarction Death from cardiovascular causes Stroke
17, 8 0, 78 (0, 70– 0, 86) 12, 3 0, 80 (0, 70– 0, 90) 8, 1 0, 74 (0, 64– 0, 87)
14.0 9.9 6.1 3.4
< 0, 001 < 0, 001 < 0, 001
17.8 12.3 8.1 4.9
Možganska kap
0.78 (0.70-0.86) 0.80 (0.70-0.90) 0.74 (0.64-0.87) 0.68 (0.56-0.84)
3, 4
< 0.001 < 0.001 < 0.001 < 0.001
4, 9 0, 68 (0, 56– 0, 84)
Secondary endpoints
< 0. 001
31
Sekundarne končne točke
Death from any cause Need for Revascularisation Hospitalisation for unstable angina
Smrt zaradi kateregakoli vzroka Potreba po revaskularizaciji Hospitalizacija zaradi nestabilne angine pektoris
0.84 (0.75-0.95) 0.85 (0.77-0.94) 0.98 (0.87-1.10)
0, 84 (0, 75– 0, 95) 0, 85 (0, 77– 0, 94) 0, 98 (0, 87– 1, 10)
0.005 0.002 NS
0, 005 0, 002 NZ
Hospitalisation for heart failure Complications related to diabetes
Hospitalizacija zaradi srčnega 3, 2 popuščanja
0.88 (0.70-1.10) 0.84 (0.72-0.98)
Zapleti, povezani s sladkorno 6, 4 boleznijo
The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least ≥ 55 years old (with no upper limit of age), with a majority of type 2 diabetes (and at least another CV risk factor), normotensive or hypertensive.
Študija MICRO- HOPE, vnaprej opredeljena podštudija študije HOPE, je raziskala učinek dodatka 10 mg ramiprila trenutni shemi farmakoterapije v primerjavi s placebom pri 3. 577 bolnikih, starih vsaj ≥ 55 let (brez zgornje starostne meje), z večinoma sladkorno boleznijo tipa 2 (in vsaj še enim kardiovaskularnim dejavnikom tveganja), ki so bili normotenzivni ali hipertenzivni.
The primary analysis showed that 117 (6.5%) participants on ramipril and 149 (8.4%) on placebo developed overt nephropathy, which corresponds to a RRR 24%; 95% CI [3-40], p = 0.027.
Primarna analiza je pokazala, da se je razvita nefropatija pojavila pri 117 (6, 5%) sodelujočih, ki so dobivali ramipril, in pri 149 (8, 4%) tistih, ki so dobivali placebo, kar ustreza zmanjšanju relativnega tveganja za 24%; 95% IZ [3– 40], p = 0, 027.
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i. e. mean urinary protein excretion > 1 and < 3 g/ 24 h) or severe proteinuria (≥ 3 g/ 24 h) due to chronic non-diabetic nephropathy.
Namenjena je bila oceni učinka zdravljenja z ramiprilom na zmanjševanje hitrosti glomerularne filtracije (GFR) pri 352 normotenzivnih ali hipertenzivnih bolnikih (starih od 18 do 70 let) z blago (tj. povprečno izločanje beljakovin v urinu > 1 in < 3 g/ 24 ur) ali hudo proteinurijo (≥ 3 g/ 24 ur) zaradi kronične nediabetične nefropatije.
The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/ min/ month, p = 0.038.
Glavna analiza bolnikov z najhujšo proteinurijo (stratum, predčasno odpravljen zaradi koristi v skupini z ramiprilom) je pokazala, da je bila povprečna hitrost zmanjševanja GFR na mesec manjša z ramiprilom kot s placebom: – 0, 54 (0, 66) v primerjavi z – 0, 88 (1, 03) ml/ min/ mesec, p = 0, 038.
The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/ min/ year; 23.1% of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/ or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs.
Razlika med skupinama je bila tako 0, 34 [0, 03 do 0, 65] na mesec in okrog 4 ml/ min/ leto.
45.5% in the placebo group (p = 0.02).
V skupini z ramiprilom je kombinirano sekundarno končno točko podvojitve izhodiščne koncentracije kreatinina v serumu in/ ali končne odpovedi ledvic (potreba po dializi ali presaditvi ledvice) doseglo 23, 1% bolnikov, v skupini s placebom pa 45, 5% (p = 0, 02).
The AIRE study included more than 2,000 patients with transient/ persistent clinical signs of heart failure after documented myocardial infarction.
Študija AIRE je vključila več kot 2. 000 bolnikov s prehodnimi ali trajnimi kliničnimi znaki srčnega popuščanja po dokumentiranem miokardnem infarktu.
The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9% and in the placebo treated patients was 22.6%.
Študija je pokazala, da je bila umrljivost po povprečno 15 mesecih spremljanja med bolniki, zdravljenimi z ramiprilom 16, 9%, in med bolniki, ki so dobivali placebo 22, 6%.
This means an absolute mortality reduction of 5.7% and a relative risk reduction of 27% (95% CI [11-40%]).
To pomeni absolutno zmanjšanje umrljivosti za 5, 7% in zmanjšanje relativnega tveganja za 27% (95% IZ [od 11 do 40%]).
PHARMACOKINETIC PROPERTIES
5. 2 Farmakokinetične lastnosti
Based on urinary recovery, the extent of absorption is at least 56% and is not significantly influenced by the presence of food in the gastrointestinal tract.
Prisotnost hrane v prebavilih nanj ne vpliva bistveno.
The bioavailability of the active metabolite ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is 45%.
Biološka uporabnost aktivnega presnovka ramiprilata je po peroralni uporabi 2, 5 mg in 5 mg ramiprila 45%.
Distribution The serum protein binding of ramipril is about 73% and that of ramiprilat about 56%.
Porazdelitev Vezava ramiprila na beljakovine v serumu je približno 73% in ramiprilata približno 56%.
32 Metabolism Ramipril is almost completely metabolised to ramiprilat, and to the diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat.
Presnova Ramipril se skoraj povsem presnovi v ramiprilat ter v diketopiperazinski ester, diketopiperazinsko kislino in glukuronida ramiprila in ramiprilata.
Elimination Excretion of the metabolites is primarily renal.
31 Izločanje presnovkov je predvsem skozi ledvice.
After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 13- 17 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Efektivni razpolovni čas koncentracije ramiprilata po večkratni uporabi ramiprila enkrat na dan je pri odmerkih od 5 do 10 mg ramiprila od 13 do 17 ur, pri manjših odmerkih (od 1, 25 do 2, 5 mg) pa je daljši.
Patients with renal impairment (see section 4.2) Renal excretion of ramiprilat is reduced in patients with impaired renal function, and renal ramiprilat clearance is proportionally related to creatinine clearance.
Bolniki z okvaro ledvic (glejte poglavje 4. 2) Ledvično izločanje ramiprilata je zmanjšano pri bolnikih z okvarjenim delovanjem ledvic in ledvični očistek ramiprilata je sorazmeren očistku kreatinina.
Patients with hepatic impairment (see section 4.2) In patients with impaired liver function, the metabolism of ramipril to ramiprilat was delayed, due to diminished activity of hepatic esterases, and plasma ramipril levels in these patients were increased.
Bolniki z okvaro jeter (glejte poglavje 4. 2) Pri bolnikih z okvarjenim delovanjem jeter je presnova ramiprila v ramiprilat upočasnjena zaradi manjše aktivnosti jetrnih esteraz in koncentracija ramiprila v plazmi teh bolnikov je povečana.
PRECLINICAL SAFETY DATA
5. 3 Predklinični podatki o varnosti
As an expression of the pharmacodynamic activity of ramipril, pronounced enlargement of the juxtaglomerular apparatus has been noted in the dog and monkey from daily doses of 250 mg/ kg/ d.
Kot izraz farmakodinamskega delovanja ramiprila so pri psih in opicah ugotovili izrazito povečanje jukstaglomerularnega aparata pri dnevnih odmerkih od 250 mg/ kg/ dan.
Rats, dogs and monkeys tolerated daily doses of 2, 2.5 and 8 mg/ kg/ d respectively without harmful effects.
Podgane, psi in opice so prenesli dnevne odmerke 2, 2, 5 in 8 mg/ kg/ dan brez škodljivih učinkov.
The administration of ramipril to female rats during the fetal period and lactation produced irreversible renal damage (dilatation of the renal pelvis) in the offspring at daily doses of 50 mg/ kg body weight or higher.
Uporaba ramiprila pri samicah podgan med fetalnim obdobjem in dojenjem je pri mladičih povzročila ireverzibilno okvaro ledvic (razširitev ledvičnih mehov) v dnevnih odmerkih 50 mg/ telesne mase ali več.
LIST OF EXCIPIENTS
6. 1 Seznam pomožnih snovi
INCOMPATIBILITIES
6. 2 Inkompatibilnosti
33 SHELF LIFE
6. 3 Rok uporabnosti
SPECIAL PRECAUTIONS FOR STORAGE
6. 4 Posebna navodila za shranjevanje
NATURE AND CONTENTS OF CONTAINER
32 6. 5 Vrsta ovojnine in vsebina
SPECIAL PRECAUTIONS FOR DISPOSAL
6. 6 Posebni varnostni ukrepi za odstranjevanje
[See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Glejte Dodatek I – Izpolni država članica] {Ime in naslov} {tel.} {faks} {e- pošta}
MARKETING AUTHORISATION NUMBER(S)
8 ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
9 DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
34 LABELLING
34 PODATKI NA ZUNANJI OVOJNINI
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRTACE and associated names (see Annex I) 10 mg tablets
TRITACE in povezana imena (glejte Dodatek I) 1. 25 mg tablete TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
[See Annex I - to be completed nationally]
[Glejte Dodatek I – Izpolni država članica]
Tablet Hard Capsule
tableta trda kapsula
{Name and address} {Tel} {fax} {e-mail}
{Ime in naslov} {tel.} {faks} {e- pošta}
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRITACE and associated names (see Annex I) 10 mg tablets
TRITACE in povezana imena (glejte Dodatek I) 1. 25 mg tablets TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg tablets TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
TRITACE and associated names (see Annex I) 1.25 mg capsules TRITACE and associated names (see Annex I) 2.5 mg capsules TRITACE and associated names (see Annex I) 5 mg capsules TRITACE and associated names (see Annex I) 10 mg capsules
TRITACE in povezana imena (glejte Dodatek I) 1. 25 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg kapsule
[See Annex I - To be completed nationally] {Name}
[Glejte Dodatek I – Izpolni država članica] {Ime}
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRITACE and associated names (see Annex I) 10 mg tablets
TRITACE in povezana imena (glejte Dodatek I) 1. 25 mg tablets TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules [See Annex I – To be completed nationally]
TRITACE in povezana imena (glejte Dodatek I) 1. 25 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg trde kapsule [Glejte Dodatek I – Izpolni država članica]
Ramipril
ramipril
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Navodilo shranite.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom. • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Do not pass it on to others.
Njim bi lahko celo • škodovalo, čeprav imajo znake bolezni, podobne vašim.
It may harm them even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni • omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What TRITACE is and what it is used for 2.
Kaj je zdravilo TRITACE in za kaj ga uporabljamo 2.
Before you take TRITACE 3.
Kaj morate vedeti, preden boste vzeli zdravilo TRITACE 3.
How to take TRITACE 4.
Kako jemati zdravilo TRITACE 4.
How to store TRITACE 6.
Shranjevanje zdravila TRITACE 6.
WHAT TRITACE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TRITACE IN ZA KAJ GA UPORABLJAMO
TRITACE contains a medicine called ramipril.
Zdravilo TRITACE vsebuje zdravilno učinkovino ramipril.
TRITACE works by: • Decreasing your body’ s production of substances that could raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body.
Zdravilo TRITACE deluje tako, da: • v telesu zmanjša nastajanje snovi, ki lahko zvišajo krvni tlak • sprosti in razširi žile • srcu olajša črpanje krvi po telesu.
TRITACE can be used: • To treat high blood pressure (hypertension) • To reduce the risk of you having a heart attack or stroke • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure.
Zdravilo TRITACE se lahko uporablja: • za zdravljenje visokega krvnega tlaka (hipertenzije) • za zmanjšanje tveganja za srčni infarkt ali možgansko kap • za zmanjšanje tveganja ali upočasnitev poslabšanja težav z ledvicami (ne glede na to, ali imate sladkorno bolezen ali ne) • za zdravljenje stanja, pri katerem srce ne more prečrpati dovolj krvi po telesu (to stanje imenujemo srčno popuščanje) • kot zdravljenje po srčnem infarktu (miokardnem infarktu), pri katerem se kot zaplet pojavi srčno popuščanje.
BEFORE YOU TAKE TRITACE
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TRITACE
40 Do not take TRITACE: • If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of TRITACE listed in section 6.
39 Ne jemljite zdravila TRITACE: • če ste alergični (preobčutljivi) na ramipril, katerikoli drug zaviralec ACE ali katerokoli sestavino zdravila TRITACE, navedeno v poglavju 6.
Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If you have ever had a serious allergic reaction called “ angioedema”.
Med znaki alergijske reakcije so lahko izpuščaj, težave s požiranjem ali dihanjem, oteklost ustnic, obraza, žrela ali jezika. • če ste kdaj imeli resno alergijsko reakcijo, imenovano "angioedem ”.
The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing • If you are having dialysis or any other type of blood filtration.
Med njenimi znaki so srbenje, koprivnica (urtikarija), rdeče spremembe na rokah, stopalih in žrelu, oteklost žrela in jezika, oteklost okrog oči in ustnic, težko dihanje in težko požiranje. • če se zdravite z dializo ali kakšno drugo vrsto filtracije krvi.
Your doctor will need to make this assessment.
Odvisno od naprave, ki se za to uporablja, je mogoče, da zdravilo TRITACE ni primerno za vas. • če imate težave z ledvicami, pri katerih je prekrvitev ledvic zmanjšana (zožitev ledvične arterije). • v zadnjih 6 mesecih nosečnosti (glejte spodaj poglavje "Nosečnost in dojenje". • če imate nenormalno nizek ali nestabilen krvni tlak To mora oceniti zdravnik.
Take special care with TRITACE Check with your doctor or pharmacist before taking your medicine: • If you have heart, liver or kidney problems • If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis) • If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization) • If you are going to receive an anaesthetic.
Preden vzamete to zdravilo, se posvetujte z zdravnikom ali farmacevtom: • če imate težave s srcem, jetri ali ledvicami. • če ste izgubili veliko telesnih soli ali tekočin (zaradi bruhanja, driske, močnejšega znojenja kot po navadi, uživanja diete z malo soli, dolgotrajnega jemanja diuretikov (tablet za odvajanje vode) ali dialize). • če imate predvideno zdravljenje za odpravljanje alergije na pike čebel ali os (desenzibilizacijo). • če boste dobili anestetik.
You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice • If you have high amounts of potassium in your blood (shown in blood test results) • If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus • You must tell your doctor if you think that you are (or might become) pregnant.
Morda boste morali en dan pred tem nehati jemati zdravilo TRITACE; posvetujte se o tem s svojim zdravnikom. • če imate v krvi veliko kalija (to pokaže preiskava krvi). • če imate kolagensko žilno bolezen, npr. sklerodermo ali sistemski eritematozni lupus. • Zdravniku morate povedati, če se vam zdi, da ste noseči (ali bi lahko zanosili).
TRITACE is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section “ Pregnancy and breast-feeding”.
Zdravila TRITACE ni priporočljivo uporabljati v prvih 3 mesecih nosečnosti, uporaba po 3. mesecu nosečnosti pa lahko otroku resno škoduje (glejte poglavje Nosečnost in dojenje).
Children TRITACE is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.
Otroci Zdravila TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker za to populacijo ni informacij.
If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITACE.
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom, preden vzamete zdravilo TRITACE.
Taking TRITACE with 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 (including herbal medicines).
Jemanje z drugimi zdravili Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, vključno z zeliščnimi pripravki.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.
Naslednja zdravila lahko poslabšajo delovanje zdravila TRITACE: • zdravila za lajšanje bolečin in vnetja (npr. nesteroidna protivnetna zdravila, kakršna so ibuprofen, indometacin ali acetilsalicilna kislina). • zdravila za zdravljenje nizkega krvnega tlaka, šoka, srčnega popuščanja, astme ali alergij, npr. efedrin, noradrenalin ali adrenalin.