natgillin/translations-raw huggingface dataset:
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Potrebne su pažljive kontrole glikemije te razmotriti prilagodbu doze unutar preporučenog raspona doza i promjenu liječenja šećerne bolesti kad se istovremeno primjenjuju kationski lijekovi koji se eliminiraju tubularnom sekrecijom u bubrezima.
Metformin is contra-indicated
< 30 Metformin je kontraindiciran
The film-coated tablets (tablets) are white to off white, oblong, convex, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Filmom obložene tablete (tablete) su bijele do gotovo bijele boje, ovalne, konveksne s utisnutim „15 / 850“ na jednoj strani i „4833M“ na drugoj.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Ako bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, što može uključivati mučninu, povraćanje, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2 x 98 TABLETS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA (S PLAVIM OKVIROM) SAMO VIŠESTRUKO PAKIRANJE (2 x 98 TABLETA)
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
U toksikološkim su ispitivanjima dosljedno opažene ekspanzija volumena plazme sa hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca nakon ponovljenog doziranja u miševa, štakora,
- if you have uncontrolled diabetes, with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section“Risk of lactic acidosis”) or ketoacidosis.
- ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti dio
It is recommended, therefore, that patients treated with Competact undergo periodic monitoring of liver enzymes.
Stoga se u bolesnika liječenih lijekom Competact preporučuje povremeno kontrolirati jetrene enzime.
The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Opaženo povećanje rizika od prijeloma kosti u žena koje su u ovom ispitivanju uzimale pioglitazon stoga je iznosilo 0,5 prijeloma na 100 bolesnik-godina primjene.
When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually.
(npr. prethodni infarkt miokarda, simptomatska bolest koronarnih arterija ili starija dob), liječnici trebaju započeti s najnižom dostupnom dozom i postupno je povećavati.
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Stariji bolesnici Farmakokinetika u stanju dinamičke ravnoteže u bolesnika u dobi od 65 ili više godina slična je onoj u mlađih osoba.
- The active substances are pioglitazone and metformin hydrochloride.
- Djelatne tvari su pioglitazon i metforminklorid.
Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Jedna tableta sadrži 15 mg pioglitazona (u obliku pioglitazonklorida) i 850 mg metforminklorida.
Allergic reactions have been reported with frequency not known (cannot be estimated from available data) in patients taking Competact.
U bolesnika koji su uzimali Competact zabilježene su alergijske reakcije s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
- if you have a problem with your liver.
- ako imate tegobe s jetrom.
Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Ispitivanja na životinjama nisu pokazala teratogene učinke, ali opažena je fetotoksičnost povezana s farmakološkim djelovanjem
Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production.
Tiazolidindioni primarno djeluju tako da smanjuju inzulinsku rezistenciju, a bigvanidi tako da smanjuju endogenu proizvodnju glukoze u jetri.
General disorders and administration site conditions oedema7
Opći poremećaji i reakcije na mjestu primjene edemi7
If you experience these symptoms for the first time talk to your doctor as soon as possible.
Ako je to prvi put da ste osjetili ove simptome, čim prije obavijestite svog liječnika.
Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) treated patients in comparative controlled trials with pioglitazone.
3-4% i hematokrita za 3,6-4,1%) u usporednim kontroliranim ispitivanjima s pioglitazonom.
Component of a multipack.
(ISKLJUČUJUĆI VIŠESTRUKA PAKIRANJA)
Competact should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5.
Competact treba prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.5.
Competact must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Primjena Competact se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.4.
Your doctor will ask you to have blood tests periodically during treatment with Competact.
Liječnik će Vam savjetovati da za vrijeme liječenja lijekom Competact povremeno napravite krvne pretrage, da bi se provjerilo je li funkcija jetre normalna.
abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common
bol u trbuhu vrlo često vrlo često proljev vrlo često vrlo često nadutost manje često gubitak apetita vrlo često vrlo često mučnina vrlo često vrlo često povraćanje vrlo često vrlo često
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
1000 bolesničkih godina (p = 0,021) - značajno sniženje rizika od infarkta miokarda: metformin s 11 događaja na 1000 bolesničkih godina, samo dijeta s 18 događaja na 1000 bolesničkih godina, (p = 0,01).
Frequency of adverse reactions Pioglitazone Metformin Competact
Pioglitazon Metformin Competact
Given the accumulation of data since the implementation of the additional risk minimisation measures, the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures.
Uzimajući u obzir akumuljrane podatake od implementacije dodatnih mjera minimizacije rizika,
Maximum daily dose is 1,000 mg.
30-44 Maksimalna dnevna doza je 1000 mg.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (S PLAVIM OKVIROM)
Metformin is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga, vidjeti dio 4.2. Metformin je kontraindiciran u bolesnika s GFR < 30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, vidjeti dio 4.3).
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
pioglitazon, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) glimepirid/pioglitazonklorid, metformin/pioglitazon, pioglitazon nepromijenjen, uz predložene izmjene informacija o lijeku.
Some medicinal products that can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDS, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
NSAIL-ovi, uključujući selektivne inhibitore ciklooksigenaze (COX) II, angiotenzin-konvertirajućeg enzima (ACE) inhibitore, antagoniste receptora angiotenzina II i diuretike, osobito diuretike Henleove petlje.
Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia)
Manje često (može se javiti u do 1 na 100 osoba) - upala sinusa (sinusitis) - vjetrovi
1 Post-marketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
1 Nakon stavljanja lijeka na tržište, kod bolesnika liječenih pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
dehidraciju (dodatne informacije vidjeti niže), tegobe s jetrom i sva zdravstvena stanja u kojima dio tijela ima smanjenu opskrbu kisikom (kao što je akutna teška srčana bolest).
Therapy with Competact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Competact 15 mg/850 mg film-coated tablets
Competact 15 mg/850 mg filmom obložene tablete
Competact should be discontinued if any deterioration in cardiac status occurs.
Ako nastupi bilo kakvo pogoršanje srčanog statusa, primjenu lijeka Competact treba prekinuti.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Kad je funkcija bubrega oštećena, bubrežni klirens je snižen proporcionalno klirensu kreatinina i stoga je poluvijek eliminacije produljen, što dovodi do povišenja razine metformina u plazmi.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
U kontroliranim kliničkim ispitivanjima, zabilježena incidencija zatajenja srca u skupinama liječenima pioglitazonom bila je jednaka kao i u skupinama koje su primale placebo, metformin ili sulfonilureju,
5 How to store Competact Contents of the pack and other information
Sadržaj pakiranja i druge informacije
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Zabilježeno je da istovremena primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) dovodi do sniženja AUC-a pioglitazona za 54%.
Titanium dioxide (E171).
Film ovojnica hipromeloza makrogol 8000 talk titanijev dioksid (E171)
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Prospektivno randomizirano (UKPDS) ispitivanje ustanovilo je dugotrajnu korist intenzivne kontrole glukoze u krvi kod šećerne bolesti tipa 2. Analiza rezultata za bolesnike s prekomjernom tjelesnom težinom koji su nakon neuspjeha liječenja samo dijetom bili liječeni metforminom pokazala je: - značajno sniženje apsolutnog rizika za sve komplikacije šećerne bolesti u skupini koja je primala metformin (29,8 događaja na 1000 bolesničkih godina) u odnosu na skupinu liječenu samo dijetom (43,3 događaja na 1000 bolesničkih godina), p = 0,0023, i kombinirane skupine na sulfonilureji i inzulinskoj monoterapiji (40,1 događaja na 1000 bolesničkih godina), p = 0,0034
Maximum daily dose is 45 mg
Bez prilagodbe doze Maksimalna dnevna doza iznosi 45 mg.
Competact may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Competact može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza,
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Zabilježeno je da istovremena primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) rezultira trostrukim porastom AUC-a pioglitazona.
Package leaflet: Information for the patient Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Uputa o lijeku: Informacije za bolesnika Competact 15 mg/850 mg filmom obložene tablete pioglitazon/metforminklorid
Posology
Primjenu
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Competact.
Manje često (može se javiti u do 1 na 100 osoba) se u bolesnika koji su uzimali Competact razvio karcinom mokraćnog mjehura.
Competact 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Competact 15 mg/850 mg tablete pioglitazon/metforminklorid
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD05.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Lijekovi za primjenu kod šećerne bolesti, kombinirani peroralni lijekovi za sniženje glukoze u krvi.
(ACE) inhibitors and angiotensin II receptor antagonists)
- određene lijekove za liječenje povišenog krvnog tlaka inhibitori angiotenzin-konvertirajućeg enzima (ACE) i antagonisti receptora angiotenzina II)
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
U razdoblju nakon stavljanja lijeka u promet, kod uzimanja tiazolidindiona, uključujući pioglitazon, zabilježeni su slučajevi novonastalog dijabetičkog makularnog edema sa smanjenjem oštrine vida.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Bolesnike, osobito one sa smanjenom srčanom rezervom, treba pratiti zbog moguće pojave znakova i simptoma zatajenja srca, povećanja tjelesne težine ili pojave otoka.
Thu.
C.
If you stop using Competact, your blood sugar may go up.
šećer u krvi Vam se može povisiti.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) rak mokraćnog mjehura manje često manje često
In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
liječnici koji propisuju lijek trebaju rutinski kontrolirati održanost koristi primjene pioglitazona (vidjeti dio 4.4).
Vitamin B12 absorption decreased2
Poremećaji metabolizma i prehrane snižena apsorpcija vitamina B122
Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Competact 15 mg/850 mg filmom obložene tablete pioglitazon/metforminklorid
At the initiation of the treatment abdominal pain, diarrhoea, loss of appetite, nausea and vomiting may occur, these reactions are very common but usually disappear spontaneously in most cases.
Na početku liječenja mogu se javiti bol u trbuhu, proljev, gubitak apetita, mučnina i povraćanje.
Decreased renal function in elderly patients is frequent and asymptomatic.
Stariji bolesnici često imaju smanjenu funkciju bubrega ali bez simptoma.
Weight gain
- povećanje tjelesne težine
Maximum daily dose is 2,000 mg.
45-59 Maksimalna dnevna doza je 2000 mg
It is especially important to mention the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) - cimetidine (used to reduce stomach acid) - glucocorticoids (used to treat inflammation) - beta-2-agonists (used to treat asthma) - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (angiotensin-converting enzyme
- lijekove koji povećavaju stvaranje mokraće (diuretici) - lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib)
Mon. 2
Uto 2
Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Često (mogu se javiti u 1 na 10 osoba) - lokalizirano oticanje (edem)
Film coat
Prijelomi kostiju6
Mon. 1
Uto 1
Hepatic impairment
- poremećen vid
Competact must therefore not be used in women who are breast-feeding (see section 4.3).
Nije poznato bi li dojenje dovelo do izloženosti dojenčeta ovom lijeku pa se stoga Competact ne smije primjenjivati u dojilja (vidjeti dio 4.3).
Marketing authorisation holder
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Musculoskeletal and connective tissue disorders bone fracture6
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - Cardiac failure or history of cardiac failure (NYHA stages I to IV) - Current bladder cancer or a history of bladder cancer - Uninvestigated macroscopic haematuria - Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure,
- akutnom ili kroničnom bolešću koja može prouzročiti hipoksiju tikva, kao što je srčano ili respiratorno zatajenje, nedavni infarkt miokarda, šok
recent myocardial infarction, shock - Hepatic impairment - Acute alcohol intoxication, alcoholism - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR < 30 mL/min)
- bilo koja vrsta akutne metaboličke acidoze (kao što je laktacidoza, dijabetička ketoacidoza) - dijabetička predkoma
Talc
Čet
Tue. 1
Pon 1
• If this happens, you may be able to feel these pieces on your tongue.
• Ako se to dogodi, možda ćete osjetiti te komadiće na jeziku.
Otherwise, wait for your next dose.
U suprotnom, čekajte svoju sljedeću dozu.
Lift here to open.
Ovdje podići i otvoriti.
Take the other 3 capsules in the same way.
Uzmite preostale 3 kapsule na isti način.
Some people do not get this infection until later on in their lives, while others get it very young.
Neki ljudi tu infekciju dobiju kasnije u životu, dok je drugi dobiju vrlo mladi.
It should appear pierced and empty.
Trebala bi biti probušena i prazna.
You then start another course.
Zatim ćete započeti sljedeći ciklus.
The dose is the same for everyone aged 6 years and older.
Doza je jednaka za sve u dobi od 6 i više godina.
Talk to your doctor if you are concerned about this.
Obratite se svom liječniku ako ste zabrinuti zbog toga.
Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
If the capsule does not look pierced:
Ako kapsula ne izgleda probušeno:
• Disturbed sense of taste.
• Poremećen osjet okusa
Taking your capsules at the same time each day will help you remember when to take them.
Ako uzimate kapsule u isto vrijeme svakoga dana, lakše ćete zapamtiti kada ih trebate uzeti.
Repeat, starting at step 5, for the remaining three capsules of the dose.
15. Ponovite, počevši od 5-og koraka, za preostale tri kapsule koje su dio doze.
Wash and fully dry your hands.
Operite i dobro osušite ruke.
FOUR capsules are required for ONE complete dose.
ČETIRI kapsule su potrebne za JEDNU punu dozu.
Please check the order of medications with your doctor.
Molimo provjerite redoslijed sa svojim liječnikom.
Occasionally, very small pieces of the capsule can get past the screen and get into your mouth.
Povremeno vrlo mali komadići kapsule mogu proći kroz rešetku i ući Vam u usta.
You should check with your doctor if you are not sure.
Provjerite s liječnikom ako niste sigurni.
• Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
• Molimo pročitajte upute na kraju ove upute za više informacija o načinu uporabe inhalatora.
• 7 capsule cards (one card for each day of the week).
• 7 kartica s kapsulama (jedna kartica za svaki dan u tjednu).
Tell your doctor if you have ever had any of the following conditions:
Obratite se svom liječniku ako ste ikada imali bilo što od sljedećeg:
The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
Tvrde kapsule pakirane su u PVC/PA/Al/PVC- PET/Al blisterima.
In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population.
U aktivno kontroliranom ispitivanju obavljeno je audiološko testiranje u odabranim centrima u otprilike četvrtine ispitivane populacije.
Cough was not related to bronchospasm.
Kašalj nije bio povezan s bronhospazmom.
• You are now ready to inhale the capsule in 2 separate breaths (Steps 8 and 9).
• Sada ste spremni za inhalaciju kapsule u 2 zasebna udisaja (koraci 8 i 9).
Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016
Datum posljednje obnove odobrenja: 18. veljače 2016.
• Loss of voice
• Gubitak glasa
See sections 4.4 and 5.1 regarding data in different age groups.
Vidjeti dijelove 4.4 i 5.1 za podatke u različitim dobnim skupinama.
This means that TOBI Podhaler may not work as well as it should over time.
To znači da TOBI Podhaler možda s vremenom neće djelovati kako bi trebao.
• It is best to leave close to 12 hours between doses, but this must be at least 6 hours
• Najbolje je da prođe blizu 12 sati između doza, ali razmak mora biti najmanje 6 sati.
See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1.
Vidjeti također informacije o kliničkoj koristi i podnošljivosti u dijelovima 4.4, 4.8 i 5.1.
What is Pseudomonas aeruginosa
Što je Pseudomonas aeruginosa
This analysis did not show gender or age-related pharmacokinetic differences
Ta analiza nije pokazala farmakokinetičke razlike povezane sa spolom ili dobi.