natgillin/translations-raw huggingface dataset:
In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2- inhibitor) informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular (CV) events.
Septembra 2004 je imetnik dovoljenja za promet z rofekoksibom (selektivnim zaviralcem Cox- 2) obvestil Evropsko agencijo za zdravila, da so podatki iz novega kliničnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za trombotične kardiovaskularne dogodke.
These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišč umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja glede kardiovaskularne varnosti drugih zaviralcev Cox- 2.
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/ 83/ EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) and valdecoxib (Bextra/ Valdyn), which were started in November 2004.
Postopka sta se začela novembra 2004.
On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Podjetje je soglašalo tudi, da po vsem svetu ustavi prodajo in trženje zdravila Bextra do nadaljnje razprave o neugodnem razmerju med tveganjem in koristjo v zvezi s podatki o hudih kožnih reakcijah.
- the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk
- novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki
of thrombotic CV events,
kažejo tveganje za trombotične kardiovaskularne dogodke,
- the data on celecoxib presented in the APC study, which suggested a dose-related
- podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih
increased risk of serious CV events,
kardiovaskularnih dogodkov, ki so odvisni od odmerka,
- the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass
- podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft)
Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/ valdecoxib treatment arm compared to the group of patients receiving placebo,
in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/ valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo,
- the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials,
- podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih
which suggested an association with a higher thrombotic risk than naproxen,
kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom,
- the data on lumiracoxib in the Target study, which suggested a small increase in
- podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje
thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
1 vsi dostopni podatki kažejo povečano tveganje neželenih kardiovaskularnih reakcij pri skupini zaviralcev Cox- 2 in soglašal, da obstaja povezava med trajanjem jemanja in odmerki ter verjetnostjo pojava kardiovaskularne reakcije.
1 Further to the assessment of the data on serious skin reactions, parecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in post-marketing surveillance.
Po vrednotenju podatkov o hudih kožnih reakcijah je parekoksib povezan z zelo redkim pojavljanjem hudih kožnih reakcij, kakor je razvidno iz postmarketinškega nadzora.
The changes of the Product Information related to the CV can be summarised as follows:
Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi:
- Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based
- dodana je izjava, da mora odločitev o uvedbi selektivnega zaviralca COX- 2 temeljiti na
on an assessment of the individual patient's overall risks,
vrednotenju celotnega tveganja za posameznega bolnika,
- Addition of the contraindications Established ischaemic heart disease and/ or cerebrovascular
- dodani sta kontraindikaciji Potrjena ishemična srčna bolezen in/ ali cerebrovaskularno
disease and Peripheral arterial disease,
obolenje ter Periferna arterijska bolezen,
- Addition of a warning for patients with risk factors for heart disease, such as hypertension,
- dodano je opozorilo za bolnike z dejavniki tveganja za srčne bolezni, kot so hipertenzija,
hyperlipidaemia (high cholesterol levels), diabetes and smoking,
hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje,
- Addition of a warning for prescribers to consider discontinuation of therapy if during
- dodano je opozorilo za predpisovalce zdravila, naj preučijo možnost prekinitve zdravljenja, če
treatment, patients deteriorate in any of the organ system functions described,
se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov,
- Addition of a warning for prescribers not to discontinue antiplatelet therapies,
- dodano je opozorilo za zdravnike, da se ne sme prekiniti antiagregacijsko zdravljenje.
The changes of the Product Information related to the SCAR can be summarised as follows:
Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi:
- Addition of a contra-indication for patients with a history of any drug allergy,
- dodana je kontraindikacija za bolnike z anamnezo alergije na katerokoli zdravilo,
- Addition of a warning to report that the onset of skin reactions occur in the majority of cases
- dodano je opozorilo k poročilu, da se kožne reakcije v večini primerov pojavijo v prvem
within the first month of treatment,
mesecu zdravljenja,
- Addition of a warning for prescribers to monitor any serious skin reactions, which could occur
- dodano je opozorilo za zdravnike, naj spremljajo vse hude kožne reakcije, ki se utegnejo
during the treatment,
pojaviti med zdravljenjem,
- Addition of a warning for patients to immediately report any emergent skin condition to their
- dodano je opozorilo za bolnike, da morajo zdravnika takoj obvestiti o vsaki novonastali kožni
physician.
spremembi.
Whereas, the CHMP
Ob upoštevanju, da je CHMP
- is of the Opinion that the benefit/ risk balance of Dynastat in the short-term treatment of
- mnenja, da razmerje med koristjo in tveganjem za zdravilo Dynastat pri kratkotrajnem
postoperative pain remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics and Package Leaflet (attached in Annex I and IIIB, respectively of the CHMP Opinion),
zdravljenju pooperacijske bolečine ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženih mnenju CHMP v Dodatku III),
- concluded that the cardiovascular safety and serious skin reactions should be continuously and
- zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in
carefully monitored and assessed,
natančno spremljati in vrednotiti,
- recommended follow-up measures to further investigate the safety of parecoxib.
- priporočil nadaljnje ukrepe za dodatno raziskovanje varnosti parekoksiba.
It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.
Na voljo je v obliki praška za pripravo raztopine za injiciranje, ki se nahaja v vialah z 20 ali 40 mg parekoksiba, z vehiklom ali brez njega.
Dynastat is used for the short-term treatment of pain after an operation.
Zdravilo Dynastat se uporablja za kratkotrajno zdravljenje bolečine po operaciji.
Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day.
Zdravilo Dynastat se daje v odmerku 40 mg, kateremu sledita nadaljnja odmerka po 20 ali 40 mg, glede na potrebo, vsakih šest do 12 ur, vendar ne več kot 80 mg na dan.
The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
Injekcijo se lahko daje hitro in neposredno v veno ali v obstoječo intravensko linijo (tanko cevko, ki teče v veno) ali pa počasi in globoko v mišico.
Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
Zdravilo Dynastat se lahko daje sočasno z opioidnimi zdravili proti bolečinam (zdravili, ki so povezana z morfinom).
As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with higher doses and longer durations of Dynastat treatment.
Kot pri drugih zdravilih v isti skupini, v katero spada zdravilo Dynastat, se lahko tveganje za težave s srcem in krvnimi žilami poveča z višjimi odmerki in daljšim trajanjem zdravljenja z zdravilom Dynastat.
For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg.
Starejše bolnike, ki tehtajo manj kot 50 kg, in bolnike z zmernimi jetrnimi težavami je treba zdraviti s polovico običajno priporočenega odmerka zdravila Dynastat, pri čemer pa je najvišji dovoljeni dnevni odmerek 40 mg.
Dynastat must not be used in patients with severe liver problems.
Zdravilo Dynastat se ne sme uporabljati pri bolnikih s hudimi jetrnimi težavami.
In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient’ s kidneys should be monitored closely.
Pri bolnikih s hudimi ledvičnimi težavami ali tistih, pri katerih lahko pride do zastajanja tekočine, je treba zdravljenje začeti z najnižjim odmerkom, pri čemer je treba skrbno spremljati delovanje bolnikovih ledvic.
Dynastat is not recommended for children or adolescents.
Zdravilo Dynastat ni priporočeno za uporabo pri otrocih ali mladostnikih.
The active substance in Dynastat, parecoxib, is a ‘ prodrug ’ of valdecoxib.
Zdravilna učinkovina v zdravilu Dynastat je parekoksib, ki je „ predzdravilo “ valdekoksiba.
Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Valdekoksib je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino zdravil, imenovanih zaviralci ciklooksigenaze- 2 (COX- 2).
By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
Z zaviranjem encima COX- 2 povzroči zmanjšanje nastajanja prostaglandinov, snovi, ki sodelujejo pri vnetnem procesu.
The effectiveness of Dynastat in treating pain after an operation has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
Učinkovitost zdravila Dynastat pri preprečevanju bolečin po operaciji je bila raziskana pri 2 582 odraslih bolnikih, ki so prestali različne kirurške posege, vključno z zobozdravstvenimi, ortopedskimi (kostnimi), ginekološkimi posegi ali operacijo koronarnega (srčnega) obvoda.
Some of the studies also looked at the impact of giving Dynastat on the patient ’ s use of morphine for additional pain relief after surgery.
V nekaterih študijah so opazovali tudi vpliv uporabe zdravila Dynastat ob sočasni uporabi morfina pri bolnikih za dodatno lajšanje bolečine po kirurškem posegu.
It was generally more effective than placebo and as effective as other painkillers.
Zdravilo je bilo na splošno učinkovitejše od placeba in enako učinkovito kot druga zdravila proti bolečinam.
Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.
Za zdravilo Dynastat so dokazali tudi, da zmanjša potrebo po morfinu, vendar pa temu zmanjšanje ni sledilo zmanjšanje neželenih učinkov, ki so povezani z morfinom.
The most common side effects with Dynastat (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), agitation, insomnia (difficulty sleeping), hypoaesthesia (reduction in the sense of touch), high or low blood pressure, pharyngitis (sore throat), respiratory insufficiency (difficulty breathing), alveolar osteitis (inflammation after a tooth extraction), dyspepsia (indigestion), flatulence (wind), pruritus (itching), back pain, oliguria (low urine output), peripheral oedema (swelling, usually of the legs) and increase in blood creatinine levels (a marker of kidney problems).
Najpogostejši neželeni učinki zdravila Dynastat (opaženi pri 1 do 10 bolnikih izmed 100) so anemija (nizko število rdečih krvničk), hipokaliemija (nizka raven kalija v krvi), agitiranost, nespečnost, hipestezija (zmanjšanje občutka dotika), visok ali nizek krvni tlak, faringitis (vneto žrelo), respiracijska insuficienca (težave z dihanjem), alveolarni osteitis (vnetje po izdrtju zoba), dispepsija (prebavne motnje), flatulenca (vetrovi), pruritus (srbenje), bolečine v hrbtu, oligurija (izloča se manj urina kot ponavadi), periferni edem (otekanje, navadno nog) in povišana raven kreatinina v krvi (znamenje ledvičnih težav).
For the full list of all side effects reported with Dynastat, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dynastat, glejte navodilo za uporabo.
Dynastat should not be used in people who may be hypersensitive (allergic) to parecoxib or any of the other ingredients.
Zdravila Dynastat ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) parekoksib ali katero koli drugo sestavino zdravila.
Dynastat must not be used in patients with:  a history of serious allergic reactions to medicines, especially skin reactions;  stomach ulcers or bleeding in the stomach or gut;  allergic-type reactions such as asthma, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;  severe liver disease;  inflammatory bowel disease;  heart failure (an inability of the heart to pump enough blood around the body), heart disease, peripheral artery disease (obstruction of the arteries in the arms or legs), or cerebrovascular disease (problems affecting the blood vessels in the brain).
Zdravila Dynastat ne smejo uporabljati bolniki z:  anamnezo hudih alergijskih reakcij na zdravila, še posebno v primeru kožnih reakcij;  ranami v želodcu ali krvavitvami v želodcu oziroma črevesu,  alergijskimi reakcijami, kot so astma, prehladu podobni simptomi, polipi v nosu, otekanje obraza ali izpuščaji po zaužitju aspirina ali nesteroidnih protivnetnih zdravil, vključno z drugimi zaviralci COX- 2;  hudimi boleznimi jeter;  vnetnimi boleznimi črevesja;  srčnim popuščanjem (nezmožnostjo srca črpati dovolj krvi po telesu), srčno boleznijo, boleznijo perifernih arterij (zaporo arterij v rokah in nogah) ali cerebrovaskularno boleznijo (težavami, ki vplivajo na krvne žile v možganih).
Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Zdravilo Dynastat se ne sme dajati nosečnicam v zadnjem tromesečju ali doječim materam.
It must not be used after coronary bypass surgery.
Zdravilo se ne sme uporabljati po obvodni operaciji koronarnih arterij.
The Committee for Medicinal Products for Human Use (CHMP) decided that Dynastat’ s benefits are greater than its risks for the short-term treatment of postoperative pain.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Dynastat pri kratkotrajnem zdravljenju pooperacijske bolečine večje od z njim povezanih tveganj.
The Committee recommended that Dynastat be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Dynastat odobri dovoljenje za promet.
The marketing authorisation holder is Pfizer Limited.
Imetnik dovoljenja za promet je družba Pfizer Limited.
The marketing authorisation was renewed on 22 March 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 22. marca 2007.
The full EPAR for Dynastat is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dynastat je na voljo tukaj.
This summary was last updated in 02-2009.
Povzetek je bil nazadnje posodobljen 02- 2008.
Dynastat 20 mg powder for solution for injection
Dynastat 20 mg prašek za raztopino za injiciranje
Each vial contains 20 mg parecoxib (present as 21.18 mg parecoxib sodium) for reconstitution.
Vsaka 20- mg viala vsebuje 20 mg parekoksiba v obliki natrijeve soli (21, 18 mg natrijevega parekoksibata) za pripravo raztopine.
After reconstitution, the final concentration of parecoxib is 20 mg/ ml.
Končna koncentracija parekoksiba po pripravi raztopine je 20 mg/ ml.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.22 mEq of sodium per vial.
Po pripravi z 9 mg/ ml (0, 9%) raztopino natrijevega klorida vsebuje Dynastat približno 0, 22 mEq natrija na vialo.
Powder for solution for injection White to off-white powder.
Bel ali belkast prašek.
For the short-term treatment of postoperative pain.
Za kratkotrajno zdravljenje pooperacijske bolečine.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
4. 2 Odmerjanje in način uporabe
The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/ day.
Priporočeni začetni odmerek je 40 mg, intravensko (i. v.) ali intramuskularno (i. m.), ter nato vsakih 6 do 12 ur 20 mg ali 40 mg, glede na potrebo, vendar ne več od 80 mg/ dan.
The IM injection should be given slowly and deeply into the muscle (see section 6.6 for instructions for reconstitution).
Intramuskularno injekcijo je treba dajati počasi in globoko v mišico (za navodila za pripravo glejte poglavje 6. 6).
Concomitant Use with Opioid Analgesics:
Sočasna uporaba opioidnih analgetikov:
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).
V vseh kliničnih ocenjevanjih so parekoksib uporabljali v določenih časovnih presledkih, opioide pa po potrebi (PP).
As the cardiovascular risk of cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Zato mora biti zdravljenje čim krajše in z najmanjšim učinkovitim dnevnim odmerkom.
Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection.
Če Dynastat kombiniramo v raztopini z drugimi zdravili, lahko pride do precipitacije, zato Dynastata ne smemo mešati z drugimi zdravili niti med pripravo niti med injiciranjem.
In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility.
Če se pri bolniku uporablja ista intravenska pot za injiciranje drugih zdravil, je treba pot pred injiciranjem Dynastata in po njem ustrezno sprati z raztopino, za katero je znano, da je kompatibilna.
IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering: sodium chloride 9 mg/ ml (0.9%) solution
0, 9% (9 mg/ ml) raztopina natrijevega klorida
2 glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
2 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje raztopina Ringerjevega laktata za injiciranje
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution.
Injiciranje v intravensko linijo, po kateri teče 50 g/ l (5%) glukoza v raztopini Ringerjevega laktata za injiciranje ali kakšna druga intravenska tekočina, ki ni navedena v tem poglavju, ni priporočljivo, ker lahko povzroči precipitacijo iz raztopine.
However, for elderly patients weighing less than 50 kg, initiate treatment with half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2).
Starejšim bolnikom (≥65 let) odmerka praviloma ni treba prilagajati; če pa tehtajo manj kot 50 kg, je treba zdravljenje začeti s polovičnim običajnim priporočenim odmerkom Dynastata, maksimalni dnevni odmerek pa zmanjšati na 40 mg (glejte poglavje 5. 2).
No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Bolnikom z blago jetrno okvaro (ocena od 5 do 6 po Child- Pughu) odmerka praviloma ni treba prilagajati.
Introduce Dynastat with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and reduce the maximum daily dose to 40 mg.
Pri bolnikih z zmerno jetrno okvaro (ocena od 7 do 9 po Child- Pughu) pa je treba zdravljenje začeti previdno in s polovičnim običajnim priporočenim odmerkom Dynastata; maksimalni dnevni odmerek je treba zmanjšati na 40 mg.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score ≥ 10), therefore its use is contraindicated in these patients (see sections 4.3 and 5.2).
Kliničnih izkušenj pri bolnikih s hudo jetrno okvaro (ocena > 10 po Child- Pughu) ni, zato je zdravilo pri njih kontraindicirano (glejte poglavji 4. 3 in 5. 2).
Renal Impairment:
Ledvična okvara:
On the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/ min.).
Glede na farmakokinetiko bolnikom z blago do zmerno okvaro ledvic (očistek kreatinina 30– 80 ml/ min) odmerka ni treba prilagoditi.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min.) or patients who may be predisposed to fluid retention parecoxib should be initiated at the lowest recommended dose and the patient ’ s kidney function closely monitored (see sections 4.4 and 5.2).
Bolnikom s hudo okvaro ledvic (očistek kreatinina < 30 ml/ min) ali bolnikom, nagnjenim k zastoju tekočine, je treba parekoksib uvesti v najmanjšem priporočenem odmerku, bolnikovo delovanje ledvic pa je treba natančno nadzirati (glejte poglavji 4. 4 in 5. 2).
There is no experience in children and adolescents.
Z uporabo pri otrocih in mladostnikih ni izkušenj.
Therefore, its use is not recommended in these patients.
Uporaba tega zdravila pri tej skupini bolnikov torej ni priporočljiva.