natgillin/translations-raw huggingface dataset:
Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicinal products known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
CYP3A4 (npr. ketokonazol in drugi imidazolni antimikotiki, eritromicin, fluoksetin, gemfibrozil,
• Bruising
fenitoin)
All formulations
Vse formulacije
MUPS and capsules
MUPS in kapsule
The MAH commits to update the dossier according to the various regulations and the EU Directive 2001/83/EC.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil dokumentacijo v skladu z različnimi uredbami in Direktivo EU 2001/83/ES.
CONDITIONS OF THE MARKETING AUTHORISATIONS
DODATEK IV POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM
The MAH commits to respond to the following unresolved quality issues by discussing and implementing as relevant in the context of an update of the CTD documentation in May 2010.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo odgovoril na naslednja nerešena vprašanja glede kakovosti, tako da bo o njih razpravljal in jih upošteval, kakor je treba, v okviru posodobitve dokumentacije CTD maja 2010.
The MAH commits to conduct an epidemiological study on the risk of falls and fractures and to provide the results of this study by Q2 of 2011.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvedel epidemiološko študijo tveganja padcev in zlomov ter da bo predložil rezultate te študije do drugega četrtletja leta 2011.
The MAH commits to update the document 'P3-03 Description of Manufacturing Process and Process Controls for Drug Product'
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil dokument „P3-03 Description of Manufacturing Process and Process Controls for Drug Product (P3-03 Opis postopka izdelave in kontrol postopka izdelave zdravila)“.
The MAH commits to investigate, justify and introduce the limits for impurities in accordance with the guideline ICH Topic Q3B: Impurities in new Drug Products
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo proučil, utemeljil in uvedel omejitve nečistoč v skladu s smernico ICH Topic Q3B: Impurities in new Drug Products (ICH tema Q3B: Nečistoče v novih zdravilih).
Capsules and solution for injection and solution for infusion
Kapsule in raztopina za injiciranje ter raztopina za infundiranje
The MAH commits to investigate, justify and introduce limits for a number of degradation products.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo proučil, utemeljil in uvedel omejitve za številne razgradne produkte.
The MAH commits to update the specifications with the test uniformity of dosage units.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil specifikacije ob upoštevanju enotnosti preskušanj enot odmerjanja.
The MAH commits to clarify the activities of the drug product manufacturer.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo pojasnil dejavnosti proizvajalca zdravila.
The MAH commits to provide the supporting documents regarding TSE (Transmissible Spongiform Encephalopathies) safety.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede varnosti v zvezi s TSE (transmisivna spongiformna encefalopatija).
The MAH commits to amend the product information as relevant based on the outcome of the study.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo na podlagi rezultata študije po potrebi spremenil informacije o zdravilu.
The MAH commits to provide stability data for the intermediate/bulk product.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil podatke o stabilnosti vmesnih/osnovnih izdelkov.
Solution for injection and solution for infusion
Raztopina za injiciranje in raztopina za infundiranje
The MAH commits to provide the supporting documents and data regarding the stability of the modification of the drug substance omeprazole magnesium and omeprazole.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo in podatke o stabilnosti modifikacije zdravilnih učinkovin omeprazol magnezij in omeprazol.
The MAH commits to provide the supporting documents regarding bioequivalence to the biobatch.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo o biološki enakovrednosti glede biološke serije.
The MAH commits to develop and introduce a second identification method for the drug substance omeprazole.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo oblikoval in uvedel drugo metodo identifikacije zdravilne učinkovine omeprazol.
The MAH commits to provide the supporting documents regarding the limits of quantifications of the drug product
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede omejitev kvantifikacij zdravila.
The MAH commits to provide the supporting documents regarding the shelflife specification of the finished product.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede specifikacije roka uporabnosti končnega zdravila.
Strength Pharmaceutical Form
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
More information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine.
Več informacij o zdravilu Myalepta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine.
This might result in the patient receiving too much or too little of the active substance.
Posledično lahko bolnik prejme preveč ali premalo učinkovine.
Information for patients and their parents or carers
Informacije za bolnike in njihove starše ali negovalce
It will be adjusted by your doctor according to your response to treatment.
Vaš zdravnik ga bo prilagodil glede na vaš odziv na zdravljenje.
For daily doses > 1.5 mg - 5 mg (0.3 - 1.0 mL)
Za dnevne odmerke > 1,5 mg-5 mg (0,3-1,0 ml)
Maximum daily dose (injection volume)
Največji dnevni odmerek (volumen za injiciranje)
Your pharmacist will give you detailed instructions on how to do this.
Vaš farmacevt vas bo o tem natančno poučil.
The size of the syringe depends on the dose prescribed and is determined as follows:
Velikost brizge je odvisna od predpisanega odmerka in se določi, kot sledi:
They must however always prepare and give the first dose under supervision of the doctor or nurse.
Vsekakor morajo prvi odmerek vedno pripraviti in dati pod nadzorom zdravnika ali medicinske sestre.
The dose should be prescribed in both milligrams and milliliters:
Odmerek je treba predpisati tako v miligramih kot tudi v mililitrih:
• The dose depends on your body weight and may be different for men than women.
• Odmerek je odvisen od vaše telesne mase in se lahko razlikuje za moške in ženske.
Patients should be reviewed every 6 months to ensure that their injection technique is correct.
Vsakih 6 mesecev je treba preverjati, da je bolnikova tehnika injiciranja pravilna.
Females > 40 kg
Ženske > 40 kg
0.3 mL 100 UI insulin
0,3 ml 100 IE insulina
Any remaining solution should be discarded.
Morebitno preostalo raztopino zavrzite.
Using the wrong syringe to make up the medicine or not withdrawing the correct dose could cause dosing errors.
Če uporabite napačno brizgo za pripravo zdravila ali ne odvzamete pravilnega odmerka, lahko pride do napak pri odmerjanju.
A second syringe to inject the dose.
drugo brizgo za injiciranje odmerka.
Water for injection to reconstitute the powder (2.2 ml of water for injection are needed);
vodo za injekcije za rekonstitucijo praška (potrebna sta 2,2 ml vode za injekcije);
Material will include training video on how to prepare and give medicine
Gradivo bo vključevalo učni videoposnetek o pripravi in dajanju zdravila
Weight of child
Telesna masa otroka
It is important that you follow the instructions given to you by your doctor, pharmacist or nurse.
Pomembno je, da upoštevate navodila zdravnika, farmacevta ali medicinske sestre.
In order to convert the dose for the 0.3 mL U100 insulin syringe the following table should be used:
Za pretvorbo odmerka za 0,3mililitrsko insulinsko brizgo U100 je treba uporabiti naslednjo preglednico:
• You must then inject the medicine under the skin.
• Zdravilo nato injicirajte pod kožo.
In addition giving the medicine in the muscle instead of under the skin could lead to the medicine being absorbed faster than recommended which can change the effects of the medicine.
Poleg tega se lahko zdravilo absorbira hitreje, kot je priporočeno, če se namesto pod kožo da v mišico, kar lahko povzroči spremembe učinkov zdravila.
Myalepta is a medicine used to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Zdravilo Myalepta je zdravilo, ki se uporablja za zdravljenje lipodistrofije, pri kateri imajo bolniki premalo maščobnega tkiva pod kožo in kopičijo maščobo drugje v telesu, na primer v jetrih in mišicah.
Healthcare professionals must carefully explain to the patient or carer how the solution for injection is prepared and how the prescribed dose should be measured (in ml or units).
Zdravstveni delavci morajo bolniku ali negovalcu skrbno razložiti, kako se pripravi raztopina za injiciranje in kako se meri predpisani odmerek (v ml ali enotah).
To avoid medication errors, healthcare professionals and patients will be given educational material with detailed instructions on how to prepare the solution and how to inject the correct dose.
V izogib napakam pri zdravljenju bodo zdravstveni delavci in bolniki prejeli izobraževalno gradivo s podrobnimi navodili o pripravi raztopine in injiciranju pravilnega odmerka.
• Patients, their parents or carers can inject the medicine once they have been trained.
• Bolniki, njihovi starši ali negovalci lahko po ustreznem usposabljanju zdravilo injicirajo sami.
The recommended daily dose depends on the patient's bodyweight and sex, which the doctor can then adjust based on the patient's response to treatment.
Priporočeni dnevni odmerek je odvisen od telesne mase in spola bolnika, zdravnik pa ga lahko nato prilagaja glede na bolnikov odziv na zdravljenje.
Educational materials will be provided to patients and healthcare professionals to ensure that the medicine Myalepta (metreleptin) is prepared and injected correctly, and to prevent the risk of medication errors.
Izobraževalno gradivo bo na voljo bolnikom in zdravstvenim delavcem, da se zagotovita pravilna priprava in injiciranje zdravila Myalepta (metreleptina) ter prepreči tveganje napak pri zdravljenju.
• Your pharmacist will also give you a second syringe (the size of syringe to use varies depending on the dose prescribed and is either 0.3 mL, 1.0 mL or 2.5 mL ) that you must use to give the injection.
• Od farmacevta boste prejeli še eno brizgo (njena velikost je odvisna od predpisanega odmerka in je lahko 0,3 ml, 1,0 ml ali 2,5 ml ), ki jo uporabite za dajanje injekcije.
Rounded amount of solution
Zaokrožena količina raztopine
The pharmacist must also dispense the corresponding needles, alcohol swabs and sharps bin.
Farmacevt mora zagotoviti tudi ustrezne igle, alkoholne krpice in vsebnik za ostre predmete.
You will need to use the 3 ml syringe to withdraw the water from the vial or ampoule and transfer it into the vial containing Myalepta powder.
Slednjo boste uporabili, da odvzamete vodo iz viale ali ampule in jo prenesete v vialo, ki vsebuje prašek Myalepta.
A 3 ml syringe (21 gauge and 40 mm) to draw up the water for injection and reconstitute the powder.
3-mililitrsko brizgo (dimenzije 21 in 40 mm) za odvzem vode za injekcije in rekonstitucijo praška;
Patients, their parents or carers can inject the medicine once they have been trained by their doctor or nurse.
Bolniki, njihovi starši ali negovalci lahko sami injicirajo zdravilo, potem ko jih zdravnik ali medicinska sestra ustrezno pouči.
• The recommended daily dose depends on the patient's bodyweight and sex as shown in the following table, and is adjusted based on the patient's response to treatment.
• Priporočeni dnevni odmerek je odvisen od telesne mase in spola bolnika, kot prikazuje spodnja preglednica, in se prilagaja glede na bolnikov odziv na zdravljenje.
Starting daily dose
Začetni dnevni odmerek
With every prescription of Myalepta the pharmacist should dispense:
Za vsako predpisano zdravilo Myalepta farmacevt zagotovi tudi naslednje:
‘Unit' measurement volume in 0.3 mL syringe to inject
„Enota“ volumna za injiciranje v 0,3mililitrski brizgi
Dose of Myalepta in mg
Odmerek zdravila Myalepta v mg
This includes written training materials as well as a video with instructions on how to prepare the solution for injection and how to inject it.
To vključuje pisno gradivo ter videoposnetek z navodili o pripravi raztopine za injiciranje in postopku injiciranja.
Males > 40 kg
Moški > 40 kg
Dose of Myalepta in mL
Odmerek zdravila Myalepta v ml
With each vial of Myalepta the pharmacist will dispense an ampoule or vial of water for injection to prepare the solution as well as two syringes (one to make up the medicine and one to give it) and needles.
Skupaj z vialo z zdravilom Myalepta vam bo farmacevt dal tudi ampulo ali vialo z vodo za injekcije, s katero pripravite raztopino, ter dve brizgi z iglama (eno za pripravo zdravila in drugo za dajanje).
• Myalepta (metreleptin), used treat lipodystrophy, is given as a daily subcutaneous injection in the abdomen, thigh or upper arm.
• Zdravilo Myalepta (metreleptin), ki se uporablja za zdravljenje lipodistrofije, se daje enkrat dnevno s subkutano injekcijo v abdomen, stegno ali nadlahet.
Myalepta is given as a daily injection under the skin of the abdomen (belly), thigh or upper arm.
Zdravilo Myalepta se daje enkrat na dan v obliki injekcije pod kožo abdomna (trebuha), stegna ali nadlahti.
• Together with the vial containing Myalepta powder, your pharmacist will give you a vial or ampoule of water for injection as well as a 3 ml syringe.
• Farmacevt vam bo skupaj z vialo, v kateri je prašek Myalepta, dal tudi vialo ali ampulo z vodo za injekcijo in 3-mililitrsko brizgo.
Once you have made up the solution you must draw the amount prescribed by your doctor (this may be in units or in ml depending on the syringe) using the second syringe.
Ko pripravite raztopino, morate z drugo brizgo odvzeti količino, ki vam jo je predpisal zdravnik (v enotah ali ml, odvisno od brizge).
• Myalepta is available as a vial of powder to which water for injection is added to make a solution for injection.
• Zdravilo Myalepta je na voljo v obliki viale s praškom, kateremu se doda voda za injekcije, da nastane raztopina za injiciranje.
• You should speak to your doctor, pharmacist or nurse if you have any questions about your treatment.
• V primeru kakršnih koli vprašanj o zdravljenju se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The medicine comes as a vial of powder to which water is added to make a solution for injection.
Zdravilo je na voljo v obliki viale s praškom, kateremu se doda voda, da nastane raztopina za injiciranje.
It is available as a vial that contains a powder that is made into a solution for injection.
Na voljo je kot viala s praškom, s katerim se pripravi raztopina za injiciranje.
Myalepta dose range to be administered daily
Velikost dnevnega odmerka zdravila Myalepta
Needle gauge and length
Premer in dolžina igle
The potential risk to humans is unknown.
Potencialno tveganje za ljudi ni znano.
To date, no other relevant epidemiological data are available.
Do danes drugih pomembnih epidemioloških podatkov ni.
There is no data available to support use in this age group.
Ni razpoložljivih podatkov za podporo uporabe v tej starostni skupini.
Patient comfort in various social and work settings was also improved.
Izboljšalo se je tudi počutje bolnikov v različnih družabnih in delovnih okoljih.
No improvement / worse * At end of therapy (Week 24).
Izboljšanje Ni izboljšanja/slabše * Ob koncu terapije (24 teden).
Special population Elderly: (> 65 years) no dosage adjustment is necessary.
Posebne populacije Starejši: (> 65 let) prilagajanje odmerka ni potrebno.
It is important to continue using the cream.
Pomembno je, da nadaljujete z uporabo te kreme.
Date of first authorisation: 20 March 2001 Date of latest renewal: 07 March 2011
Datum pridobitve dovoljenja za promet: 20 Marec 2001 Datum zadnjega podaljšanja dovoljenja za promet: 07 Marec 2011
The frequency of possible side effects listed below is defined using the following convention:
Pogostost možnih neželenih učinkov, navedenih spodaj, je opredeljena z uporabo sledeče konvencije:
Excessive growth of hair may be a result of underlying diseases.
Prekomerna rast dlak je lahko posledica nekaterih bolezni.
For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Pri bolnikih, ki so prenehali z zdravljenjem, so se zadnja opažanja prenesla do 24. tedna.
If you stop using it your original hair growth may return within 8 weeks.
Če prenehate uporabljati to kremo, se lahko prvotna rast dlak povrne v 8 tednih.
Ronda General Mitre, 151 08022 Barcelona Spain.
Ronda General Mitre, 151 08022 Barcelona Španija
It may harm them,
prečiščena voda;
MedDRA conventions for frequency are 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), or not known (cannot be estimated from the available data) including isolated reports.
konvencija za pogostnost pojavljanja: zelo pogosto (≥1/10), pogosto (≥1/100 do <1/10), občasno (≥1/1.000 do <1/100), redko (≥1/10.000 do <1/1.000), zelo redko (<1/10.000), ali neznana (ni mogoče oceniti iz razpoložljivih podatkov) vključno s posamičnimi primeri.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
• When using on the face, avoid contact with your eyes or the inside of your nose or mouth.
• Pri uporabi na obrazu se izogibajte stiku z očmi ali notranjostjo nosu ali usti.
Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Višji odmerki so povzročili maternalno in fetusno toksičnost brez dokazov za teratogenost.
• if you are allergic to eflornithine or any of the other ingredients of this medicine listed in section 6.
• če ste alergični na eflornitin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
• tell your doctor of any other medical problems you may be experiencing (especially related to your kidneys or liver).
• Obvestite o vaših morebitnih drugih zdravstvenih težavah (predvsem povezanih z jetri ali ledvicami).
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Zaradi majhne penetracije eflornitina skozi kožo (glejte poglavje 5.2) je preveliko odmerjanje malo verjetno.
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Samoocenjevanje bolnikov je pokazalo pomembno zmanjšano psihološko nelagodje s svojim stanjem, ki so ga izmerili glede na odgovor na 6 vprašanj na vizualni analogni skali.
If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.
Če nenamerno zanesete zdravilo Vaniqa v oči, usta ali nos, dobro izperite z vodo.
very rare
zelo redki
Steady state was reached within four days.
Stanje dinamičnega ravnovesja se vzpostavi v štirih dneh.
About 12% of women in the clinical trials were postmenopausal.
12 % žensk je bilo postmenopavzalnih.
Animal studies have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje
• Use twice a day, at least 8 hours apart.
• Zdravilo uporabljajte dvakrat dnevno z vsaj osemurnim presledkom.
Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Najvišji varni odmerki v kliničnih raziskavah so do 30 gramov mesečno.
Shelf-life after first opening: 6 months.
3 leta Rok uporabnosti po prvem odprtju: 6 mesecev.
The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established.
Varnost in učinkovitost zdravila Vaniqa pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Eflornithine slows down the growth of hair through its effect on a specific enzyme (a protein in the body involved in the production of hair).
Eflornitin upočasni rast dlak z delovanjem na specifičen encim (protein v telesu, ki je udeležen pri izgradnji dlak).
Vaniqa is not recommended for use in anyone younger than 18 years of age.
Zdravila Vaniqa se ne priporoča za uporabo pri osebah mlajših od 18 let.
Treatment of facial hirsutism in women.
Zdravljenje obraznega hirsuitizma pri ženskah.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
Nadaljevanje zdravljenja izboljša učinek zdravila in je nujno za vzdrževanje ugodnega učinka zdravila.
Paediatric population The adverse reactions observed in adolescents are similar to the ones observed in adults.
Neželeni učinki, ki so jih opazili pri mladostnikih so podobni tistim, ki so jih opazili pri odraslih.
Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
V teh študijah je bilo z zdravilom Vaniqa zdravljenih 1.350 bolnikov 6 mesecev do 1 leta, medtem ko je le vehikel prejemalo nekaj več kot 200 bolnikov 6 mesecev.
Clear / almost clear
Čisto/skoraj čisto Očitno izboljšanje
To maintain the reduction of hair growth keep using Vaniqa continuously as indicated.
Za vzdrževanje zmanjšane rasti dlak še naprej neprekinjeno uporabljajte zdravilo Vaniqa kot je navedeno.
Cream 15 g 30 g 60 g
krema 15 g 30 g 60 g
Patient self-assessments were found to correlate with physician observations of efficacy.
Samoocenjevanje bolnikov je bilo sorazmerno povezano z zdravnikovo oceno učinkovitosti zdravljenja.
It is not known whether eflornithine/metabolites are excreted in human milk.
Ni znano, ali se eflornitin/presnovki izločajo v materino mleko.
The cream should be rubbed in thoroughly.
Kremo je treba dobro vtreti v kožo.
Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on the face of women older than 18 years of age.
Zdravilo Vaniqa se uporablja za zmanjšanje prekomerne poraščenosti (hirsuitizem) na obrazu žensk starejših od 18 let.
Vaniqa is not a depilatory cream, so you may need to continue with your hair removal method, for example by shaving or plucking.
Zdravilo Vaniqa ni depilacijska krema, zato boste morda morali nadaljevati z vašo metodo odstranjevanja dlak, na primer z britjem ali s puljenjem.
Do not use this medicine after the expiry date which is stated on the box and on the bottom of the tube after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na spodnji strani tube poleg oznake Uporabno do:.
If symptoms of overdose occur the use of the medicinal product should be stopped.
Če se pojavijo znaki prevelikega odmerjanja, je treba uporabo zdravila prekiniti.
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
1 gram kreme vsebuje 115 mg eflornitina (v obliki klorida monohidrata).
If you do not see any improvement after using it for 4 months contact your doctor.
V primeru, da po 4 mesecih uporabe ne opazite izboljšanja, se posvetujte z zdravnikom.
Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down's Syndrome to a 35 year old).
zdravih novorojenčkov, 5 elektivnih prekinitev nosečnosti, 4 spontane in 1 novorojenček z genetsko okvaro (Downov sindrom novorojenčka matere, stare 35 let).