natgillin/translations-raw huggingface dataset:
Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen (see section 5.1).
4.1 Terapevtske indikacije Zdravilo Trogarzo je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, okuženih z virusom HIV-1, odpornim proti več zdravilom, za katere sicer ni mogoče izdelati supresivnega protivirusnega režima (glejte poglavje 5.1).
Both subjects were discontinued from ibalizumab treatment.
Oba preiskovanca sta prekinila zdravljenje z ibalizumabom.
By Week 16, i.e. prior to the possible switching of patients in the Placebo arm to the 15 mg/kg dose of ibalizumab every 2 weeks and/or to change in OBR for all patients, mean viral load decrease was 1.07 log10 copies/mL in Arm A, 1.33 log10 copies/mL in Arm B and 0.26 log10 copies/mL in the Placebo arm (p=0.002 vs Arm A, p<0.001 vs Arm B).
Do 16. tedna, tj. pred možnim prehodom bolnikov iz skupine s placebom na odmerek 15 mg/kg ibalizumaba na vsaka 2 tedna in/ali spremembo OBR pri vseh bolnikih, je bilo povprečno zmanjšanje virusne obremenitve 1,07 log10 kopij/ml v skupini A, 1,33 log10 kopij/ml v skupini B in 0,26 log10 kopij/ml v skupini s placebom (p = 0,002 v primerjavi s skupino A, p < 0,001 v primerjavi s skupino B).
If a maintenance dose (800 mg) of ibalizumab is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible.
Izpuščeni odmerek Če vzdrževalni odmerek (800 mg) ibalizumaba izpustimo za 3 dni ali več po predvidenem dnevu odmerjanja, je treba čim prej dati polnilni odmerek (2.000 mg).
- One vial contains 200 mg of ibalizumab in 1.33 mL of solution.
- Ena viala vsebuje 200 mg ibalizumaba v 1,33 ml raztopine.
How to store Trogarzo 6.
Shranjevanje zdravila Trogarzo 6.
Subjects with baseline CD4 counts < 50 cells/mm3 were less likely to achieve a HIV-1 RNA of < 200 copies/mL (or < 50 copies/mL) than subjects with > 50 cells/mm3.
je bilo manj verjetno, da bi dosegle HIV-1 RNK < 200 kopij/ml (ali < 50 kopij/ml), kot pri preiskovancih z > 50 celic/mm3.
All patients must be observed during and for 1 hour after completion of ibalizumab administration for at least the first infusion.
Vse bolnike je treba vsaj ob prvi infuziji ibalizumaba opazovati med infundiranjem in še eno uro po zaključku infundiranja.
Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Med zdravljenjem z ibalizumabom so poročali o omotici, navzei, utrujenosti in glavobolu (glejte poglavje 4.8).
The recommended dose of ibalizumab is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.
Priporočeni odmerek ibalizumaba je enkratni polnilni odmerek 2.000 mg, ki mu sledi vzdrževalni odmerek 800 mg vsaka 2 tedna.
There are no data on the effects of ibalizumab on human fertility.
Podatkov o učinku ibalizumaba na plodnost pri človeku ni.
At Baseline, median [Min - Max] viral load and CD4+ T cell counts were 35,350 [304 - 743,000] copies/mL and 73 [0 - 676] cells/mm3, respectively.
virusna obremenitev 35.350 [304-743.000] kopij/ml in število T-celic CD4+ 73 [0-676] celic/mm3.
Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Obvestite zdravnika ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established.
Varnost in učinkovitost ibalizumaba pri starejših bolnikih (starih ≥ 65 let) še nista bili dokazani.
It is unknown whether ibalizumab/metabolites are excreted in human milk.
Ni znano, ali se ibalizumab/presnovki izločajo v materino mleko.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (Contains 2 vials of 200 mg)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (vsebuje 2 200-mg viali)
• feeling hot
• občutek vročine
This epitope is positioned on the surface of CD4 opposite to the site in domain 1 that is required for CD4 binding of the MHC class II molecules and, therefore, does not interfere with CD4-mediated immune functions.
nasproti mestu v domeni 1, ki je potrebno za vezavo molekul MHC razreda II na CD4, in zato ne moti imunskih funkcij, ki jih posreduje CD4.
Each vial contains 200 mg of ibalizumab (in 1.33 mL of solution).
Ena viala vsebuje 200 mg ibalizumaba (v 1,33 ml raztopine).
If you miss a dose of Trogarzo
Če niste prejeli odmerka zdravila Trogarzo
signs of a new infection (called ‘immune reconstitution inflammatory syndrome') Tell your doctor or nurse straight away if you get any of the above (for more information see ‘Serious side effects' in section 4).
Takoj obvestite zdravnika ali medicinsko sestro, če dobite kaj od zgoraj navedenega (za več informacij glejte „Resni neželeni učinki“ v poglavju 4).
Ibalizumab should not be administered as an intravenous push or bolus.
Ibalizumab se ne sme dajati v obliki intravenskega potiska ali bolusa.
How Trogarzo works
Kako zdravilo Trogarzo deluje
A tabulated list of adverse reactions is presented in Table 1.
Seznam neželenih učinkov je prikazan v preglednici 1.
See the table below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Glejte spodnjo preglednico za ustrezno število vial, ki so potrebne za pripravo polnilnega odmerka 2.000 mg in vzdrževalnih odmerkov 800 mg.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 2 viali
Phase 3 trial TMB-301 was a single arm, multicenter clinical trial conducted in 40 heavily treatment-experienced HIV-infected subjects with multidrug resistant HIV-1.
Tretja faza preskušanja TMB-301 je bilo multicentrično klinično preskušanje z enim krakom, v katero je bilo vključenih 40 preiskovancev, okuženih s HIV-1, odpornim proti več zdravilom, ki so prejemali obsežno protiretrovirusno zdravljenje.
Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Tel. št.: + 35319201427 regulatoryaffairs@theratech.com
Only one subject was found to have anti-ibalizumab antibodies.
Samo za enega preiskovanca je bilo ugotovljeno, da ima protitelesa proti ibalizumabu.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
Ibalizumab dose
Odmerek ibalizumaba
The pack size is 2 glass vials per carton.
Velikost pakiranja je 2 stekleni viali na škatlo.
Ibalizumab vials (Total volume to be withdrawn)
Viale ibalizumaba (skupna prostornina, ki se odvzame)
Week 25
31. oktober 2025
(see Annex I: Summary of Product Characteristics, section 4.2).
(glejte spodaj in poglavje 4.4)
Other intravenous diluents must not be used to prepare the ibalizumab solution for infusion.
Za pripravo raztopine ibalizumaba za infundiranje se ne smejo uporabljati druga intravenska razredčila.
Non-clinical data reveal no special hazard for humans based on conventional studies of in vitro and in vivo safety assessments.
Predklinični podatki na osnovi običajnih študij o varnosti in vitro in in vivo ne kažejo posebnega tveganja za človeka.
2 mL vial (Type I borosilicate glass) sealed with a stopper (butyl rubber) and an aluminum crimp cap.
6.5 Vrsta ovojnine in vsebina 2-ml viala (borosilikatno steklo tipa 1), ki je zatesnjena z zamaškom (butilna guma) in aluminijastim pokrovčkom.
Diluted ibalizumab solution should be administered by a healthcare professional.
Razredčeno raztopino ibalizumaba mora dati zdravstveni delavec.
There were no ibalizumab-related adverse effects (maternal, foetal, or infant) at 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
Pri 110 mg/kg (raven brez opaženih negativnih učinkov (NOAEL - No-Observed-Adverse-Effect Level) ni bilo neželenih učinkov, povezanih z ibalizumabom (pri materii, plodu ali mladičih).
See Table 4 below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
V preglednici 4 je navedeno ustrezno število vial, ki so potrebne za pripravo polnilnega odmerka 2.000 mg in vzdrževalnih odmerkov 800 mg.
Ibalizumab should be administered as an intravenous infusion.
Ibalizumab je treba dajati kot intravensko infuzijo.
Ibalizumab has a minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Ibalizumab ima blag vpliv na sposobnost vožnje in upravljanja strojev.
No relevant remaining effect of ibalizumab is expected in cases of resistance development.
V primerih razvoja odpornosti ni pričakovati nobenega ustreznega preostalega učinka ibalizumaba.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trogarzo 200 mg sterile concentrate ibalizumab
IME ZDRAVILA IN POT(I) UPORABE Trogarzo 200 mg sterilen koncentrat ibalizumab i.v.
Recommended ibalizumab dose and number of vials per administration Ibalizumab dose
Priporočeni odmerek ibalizumaba in število vial na dajanje Odmerek ibalizumaba
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Tabulated summary of adverse reactions associated with ibalizumab System organ class
Povzetek neželenih učinkov, povezanih z ibalizumabom, v obliki preglednice
Subjects on a failing ART regimen continued to receive their failing regimen in addition to the loading dose of ibalizumab.
Preiskovanci z neuspešnim zdravljenjem z ART so poleg polnilnega odmerka ibalizumaba nadaljevali tudi neuspešno zdravljenje.
Ibalizumab contains less than 1 mmol sodium (23 mg) in each loading dose of 2,000 mg or maintenance dose of 800 mg and therefore is essentially sodium-free.
Ibalizumab vsebuje v enem polnilnem odmerku 2.000 mg ali v vzdrževalnem odmerku 800 mg manj kot 1 mmol natrija (23 mg), kar bistvu pomeni „brez natrija“.
At Week 2, the mean viral load decrease was 0.87 log10 copies/mL in Arm A, 1.15 log10 copies/mL in Arm B and 0.38 log10 copies/mL in the Placebo arm (p=0.003 vs Arm A, p<0.001 vs Arm B).
1,15 log10 kopij/ml v skupini B in 0,38 log10 kopij/ml v skupini s placebom (p = 0,003 proti skupini A, p < 0,001 proti skupini B).
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC ODGOVOREN ZA SPROŠČANJE SERIJ
Recommended ibalizumab dose and number of vials per administration
Priporočeni odmerek ibalizumaba in število vial na dajanje
No. of subjects achieving <200 HIV-1 RNA copies/mL (n/N)
Št. preiskovancev, ki dosegajo < 200 kopij/ml (n/N) HIV-1 RNK
No. of subjects achieving <50 HIV-1 RNA copies/mL (n/N)
Št. preiskovancev, ki dosegajo < 50 kopij/ml (n/N) HIV-1 RNK
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Sledljivost
Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Trogarzo 200 mg koncentrat za raztopino za infundiranje ibalizumab
What Trogarzo is used for
Za kaj uporabljamo zdravilo Trogarzo
What Trogarzo is and what it is used for
Kaj je zdravilo Trogarzo in za kaj ga uporabljamo Kaj je zdravilo Trogarzo
Laboratory abnormalities
Nenormalni rezultati laboratorijskih testov
Hepatic impairment
• nenormalen srčni utrip
How to store Trogarzo
Kako prejeti zdravilo Trogarzo
Headache, feeling dizzy, feeling sick (nausea) or feeling tired are common side effects of Trogarzo and can affect your ability to drive or use machines.
Glavobol, omotičnost, siljenje na bruhanje (navzea) ali utrujenost so pogosti neželeni učinki zdravila
Ibalizumab is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
), potem ko razredčimo ustrezno število vial v 250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Sodium chloride Polysorbate 80
saharoza natrijev klorid polisorbat 80 histidin klorovodikova kislina voda za injekcije
Trogarzo 200 mg concentrate for solution for infusion
IME ZDRAVILA Trogarzo 200 mg koncentrat za raztopino za infundiranje
Talk to your doctor or nurse about how to avoid infecting other people.
O tem, kako preprečiti okužbo drugih ljudi, se posvetujte se z zdravnikom ali medicinsko sestro.
No formal studies were conducted to examine the effects of renal impairment on the pharmacokinetics of ibalizumab.
Formalnih študij za preučitev učinkov ledvične okvare na farmakokinetiko ibalizumaba niso izvedli.
• Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of sodium chloride 9 mg/mL (0.9%) solution for injection.
(OPOMBA: v viali lahko ostane majhna količina preostanka, zavrzite neporabljeni del) ter to prenesite v 250-ml vrečko z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Resume maintenance dosing (800 mg) every 2 weeks thereafter.
Po 2 tednih je treba nadaljevati zdravljenje z vzdrževalnim odmerkom (800 mg).
• tremor
• tresenje
outcomes are shown in Table 3.
25. tedna so prikazani v preglednici 3.
Serious side effects Talk to your doctor or nurse straight away if you get any of the following serious side effects: Signs of a new infection, changes in your immune system, can happen when you start using HIV medicines.
• Ko začnete uporabljati zdravila za zdravljenje okužbe z virusom HIV, se lahko pojavijo znaki nove okužbe in spremembe v vašem imunskem sistemu.
It belongs to a group of medicines called ‘antiretrovirals'.
Spada v skupino zdravil, imenovanih
The median time to maximum serum concentration (Tmax) of 2,000 mg and 800 mg is 1 hr and 10 min, respectively.
2.000 mg je 1 ura, do koncentracije 800 mg pa 10 minut.
No formal studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of ibalizumab.
Formalnih študij za preučitev učinkov jetrne okvare na farmakokinetiko ibalizumaba niso izvedli.
Trogarzo contains the active substance ibalizumab.
Zdravilo Trogarzo vsebuje učinkovino ibalizumab.
Hepatic impairment is not anticipated to impact the pharmacokinetics of ibalizumab.
Ne pričakuje se, da bi okvara ledvic vplivala na farmakokinetiko ibalizumaba.
• diarrhoea feeling sick (nausea) or being sick (vomiting) dizziness headache feeling tired dry skin dermatitis - a type of eczema with dry itchy skin pain and feeling numb in hands, feet or legs
• dermatitis - vrsta ekcema s suho srbečo kožo
There is no known antidote to ibalizumab overdose.
4.9 Preveliko odmerjanje Ni znanega antidota za preveliko odmerjanje ibalizumaba.
Immune system disorders hypersensitivity, immune reconstitution inflammatory syndrome (see below and section 4.4)
bolezni imunskega sistema preobčutljivost, vnetni sindrom imunske obnove
Diluted solution
Razredčena raztopina
Subjects all received OBR plus 1 of the following regimens: alternating intravenous (IV) infusions of 15 mg/kg ibalizumab and placebo, weekly for the first 9 doses (through the Week 8 visit), then IV infusions of 15 mg/kg ibalizumab every 2 weeks (Arm A); 10 mg/kg ibalizumab IV infusions weekly for the first 9 doses (through the Week 8 visit), then IV infusions of 10 mg/kg ibalizumab every 2 weeks (Arm B); or weekly placebo IV infusions for the first 9 doses (through the Week 8 visit), then IV infusions of placebo every 2 weeks (Placebo arm).
infuzije 15 mg/kg ibalizumaba in placeba enkrat tedensko prvih 9 odmerkov (do obiska v 8. tednu), nato i.v.
2 vials
OVOJNINAH VIALA
NAME OF THE MEDICINAL PRODUCT Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Navodilo za uporabo Trogarzo 200 mg koncentrat za raztopino za infundiranje ibalizumab
What you need to know before you use Trogarzo
Kaj morate vedeti, preden boste uporabili zdravilo Trogarzo Zdravila Trogarzo ne smete prejeti:
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of ibalizumab
Ena viala vsebuje 200 mg ibalizumaba.
2 log10 reduction in viral load at Week 25.
preiskovancev pa za ≥ 2 log10.
Ibalizumab is administered as an IV infusion.
Ibalizumab se daje v obliki intravenske infuzije.
Uncommon
• omotica
How much Trogarzo you will be given The recommended dose of Trogarzo is: a single dose of 2,000 mg on the first occasion followed by a maintenance dose of 800 mg every 2 weeks.
• enkratni odmerek 2.000 mg ob prvi uporabi, • ki mu sledi vzdrževalni odmerek 800 mg vsaka 2 tedna
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Pred uporabo je treba to zdravilo vizualno pregledati, da ne vsebuje trdih delcev in ni spremenjene barve.
Adverse reaction frequency*
Pogostost*
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Zadnji veljavni Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo so končne verzije dosežene v postopku koordinacijske skupine.
Summary of product characteristics, labelling and package leaflet
Povzetek glavnih začilnosti zdravila, označevanje in navodilo za uporabo
84 vials + 88 ampoules
84 vial + 88 ampul
84 vials + 88 ampoules + 1 Altera Nebuliser Handset
84 vial + 88 ampul + 1 komplet z nebulatorjem Altera
These changes do not have any clinical significance.
Te spremembe nimajo bistvenega kliničnega pomena.
Date of first authorisation: 19 June 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 19. junij 2015
Therefore, there is no evidence of efficacy in this paediatric patient population.
Zato v tej populaciji pediatričnih bolnikov ni dokazov za učinkovitost.
Falls were more common in the elderly (≥65 years old).
Padci so bili bolj pogostejši pri starejših (≥ 65 let).
• tinnitus (hearing sound in the ear when there is no external sound)
• tinitus (zvenjenje v ušesih, kljub temu da ni zunanjega zvoka)
Talk to your doctor if you do not feel better after 2 months.
Posvetujte se z zdravnikom, če se vaše počutje po dveh mesecih ne izboljša.
Use within 6 months after opening.
Po odprtju porabiti v 6 mesecih.
The safety results from this study were consistent with the known safety profile of duloxetine.
Rezultati varnosti iz te študije so bili skladni z znanim varnostnim profilom duloksetina.
• fast and/or irregular heart beat
• hitro in/ali nepravilno bitje srca
You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Pojav takšnih misli je verjetnejši, če: - ste že kdaj razmišljali o samomoru ali samopoškodovanju - ste mlajša odrasla oseba.
Opening date:…………
Datum odprtja:
Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Ocene pogostnosti: zelo pogosti ( 1/10), pogosti ( 1/100 do  1/10), občasni ( 1/1.000 do  1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs.
Poročali so o dolgotrajni spolni disfunkciji, pri kateri so se simptomi nadaljevali kljub prekinitvi zdravljenja s SSRI/SNRI.
In some cases, these symptoms have continued after stopping treatment.
V nekaterih primerih so se simptomi nadaljevali tudi po prekinitvi zdravljenja.
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Hrana podaljša čas, potreben za doseganje najvišje koncentracije, s 6 na 10 ur in mejno zmanjša obseg absorpcije (približno 11 %).
Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine.
Pri otrocih in mladostnikih, mlajših od 18 let, ki so se za depresijo zdravili s tem zdravilom, so ugotovili nekaj izgube telesne mase na začetku jemanja tega zdravila.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Ženskam je treba svetovati, naj obvestijo svojega zdravnika, če med zdravljenjem zanosijo ali načrtujejo nosečnost.
• headache, feeling sleepy
• glavobol, občutek zaspanosti
• menopausal symptoms, abnormal production of breast milk in men or women
• menopavzni simptomi, nenormalna tvorba mleka v dojkah pri moških ali ženskah
Some patients who stop taking Duloxetine Mylan suddenly have had symptoms such as:
Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo Duloksetin Mylan, so imeli simptome, kot so:
Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
Zdravnik ali babica morata vedeti, da jemljete duloksetin, tako da vam bosta lahko svetovala.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Mylan, you should see your doctor.
Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Duloksetin Mylan, obiščite zdravnika.
No studies on the effects on the ability to drive and use machines have been performed.
Študij vpliva na sposobnost vožnje in upravljanja strojev niso izvedli.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Epidemiološki podatki kažejo, da uporaba SSRI v nosečnosti, še posebej v pozni nosečnosti, lahko povečala tveganje za primarno pljučno hipertenzijo pri novorojenčkih (PPHN).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharaze-izomaltaze ne smejo jemati tega zdravila.
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
• prekomerna krvavitev iz nožnice kmalu po porodu (poporodna krvavitev)
Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Ne začnite jemati niti ne prenehajte jemati katerih koli zdravil, vključno s tistimi, ki ste jih kupili brez recepta, in zdravil rastlinskega izvora, ne da bi se pred tem posvetovali z zdravnikom.
Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Ugotavljali so farmakokinetične razlike med mlajšimi in starejšimi ženskami ( 65 let) (pri starejših bolnikih se AUC poviša za približno 25 %, razpolovni čas pa je daljši za približno 25 %), vendar obseg teh sprememb ni tolikšen, da bi upravičil prilagajanje odmerka.
The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Mylan.
Odmerek bo morda prilagojen do 120 mg na dan, glede na vaš odziv na zdravilo Duloksetin Mylan.
Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Zelo redki neželeni učinki (se lahko pojavijo pri največ 1 od 10.000 bolnikov) • vnetje krvnih žil v koži (kožni vaskulitis)
If your doctor has prescribed Duloxetine Mylan for a patient under 18 and you want to discuss this, please go back to your doctor.
Če je zdravnik predpisal zdravilo Duloksetin Mylan bolniku, mlajšemu od 18 let, in se želite o tem pogovoriti, se, prosimo, obrnite na zdravnika.