natgillin/translations-raw huggingface dataset:
Common side effects (may affect up to 1 in 10 people): - Anxiety - Dizziness, feeling of dizziness or “spinning” (vertigo)
- omotica, občutek omotice ali “vrtenja” (vertigo); - občutek tresenja (tremor);
Baseline (kg)
(DMC).
Uncommon side effects (may affect up to 1 in 100 people): - Hives (uticaria) - Hypersensitivity - Abnormal dreams, - Feeling nervous, feeling spacey, tension, agitation, mood swings, Tremor of the head or a limb which increases when trying to perform a particular function (intention tremor) - Balance disorder - Loss of memory (amnesia), Tingling or numbness of the hands or feet - Motion sickness - Burping - Abdominal discomfort - Indigestion - Inflammation of the gallbladder (cholecystitis) - Increased creatinine levels in the blood (indicating loss of kidney function) - Increased liver enzymes and bilirubin levels, liver disorders - Difficulty in getting or keeping an erection - Feeling abnormal, weakness (asthenia) - Thirst, feeling hot - Chest pain - Increased appetite, weight gain
- občutek živčnosti, občutek odsotnosti, napetost, agitacija, nihanje razpoloženja; - tremor glave ali okončine, ki se okrepi, kadar poskušate narediti kako dejanje (intencijski tremor); - motnje ravnotežja; - izguba spomina (amnezija);
Committee for Human Medicinal Products.
1 Odbor za zdravila za uporabo v humani medicini.
Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party.
Vprašanja in odgovori: stališča v zvezi z določenimi vprašanji, postavljenimi delovni skupini za farmakokinetiko.
The company wanted the authorisation to be recognised in Germany (the ‘concerned Member State').
Družba je želela, da se dovoljenje za promet z zdravilom prizna v Nemčiji (zadevni državi članici).
The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
Odbor je prav tako izpostavil, da je predlagatelj te študije opravil pred objavo zadnje posodobljene smernice1 za to vrsto zdravil.
On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal.
Evropska agencija za zdravila je 25. julija 2013 zaključila arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve dovoljenja za promet z zdravilom Methylphenidate Hexal.
Why was Methylphenidate Hexal reviewed?
Zakaj je bilo zdravilo Methylphenidate Hexal pregledano?
Methylphenidate Hexal is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Methylphenidate Hexal je generično zdravilo na osnovi „referenčnega zdravila“ Concerta, ki je odobreno v vseh državah članicah EU.
Questions and answers on Methylphenidate Hexal (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg)
Vprašanja in odgovori v zvezi z zdravilom Methylphenidate Hexal (metilfenidatijev klorid, tableta s podaljšanim sproščanjem, 18, 36 in 54 mg)
What is Methylphenidate Hexal?
Kaj je zdravilo Methylphenidate Hexal?
As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation.
Ker je v informacijah o zdravilu navedeno, da se lahko tableta vzame s hrano ali brez nje, je bila za odobritev dovoljenja za promet z zdravilom potrebna študija o biološki enakovrednosti pri jemanju na poln želodec.
Hexal A/S submitted Methylphenidate Hexal for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Ireland.
Družba Hexal A/S je predložila vlogo za pridobitev dovoljenja za promet z zdravilom Methylphenidate Hexal po postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet z zdravilom, izdanega 29. marca 2012 na Danskem in prav tako veljavnega na Irskem v skladu z decentraliziranim postopkom.
It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Na voljo je od petdesetih let 20. stoletja v obliki tablet s takojšnjim sproščanjem in kapsul, ki takoj sprostijo metilfenidat, ter tablet s prirejenim sproščanjem, ki sprostijo del ali celotno zdravilno učinkovino počasneje, v več urah.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Hexal and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Na podlagi razpoložljivih podatkov in znanstvene razprave znotraj odbora je ta ugotovil, da biološke enakovrednosti med zdravilom Methylphenidate Hexal in referenčnim zdravilom v fazi s takojšnjim sproščanjem ni bilo mogoče dokazati zaradi razlik med bolniki glede učinkov obroka z veliko vsebnostjo maščob na to, kako telo obdela zdravila, in ne zaradi razlik v formulacijah teh dveh zdravil, zato je sklenil, da je bila biološka enakovrednost referenčnemu zdravilu dokazana.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Methylphenidate Hexal večje od z njim povezanih tveganj ter da se lahko dovoljenje za promet, izdano na Danskem, odobri v drugih državah članicah EU.
The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Hexal was bioequivalent for the immediate-release phase to its reference product.
Podlaga za napotitev so bili pomisleki Nemčije in Nizozemske, ki sta menili, da študija biološke enakovrednosti pri jemanju na poln želodec ni pokazala, da je faza takojšnjega sproščanja pri zdravilu Methylphenidate Hexal biološko enakovredna referenčnemu zdravilu.
The CHMP therefore concluded that the benefits of Methylphenidate Hexal outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Zato je sklenil, da koristi zdravila Methylphenidate Hexal odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom odobri v zadevnih državah članicah.
A: We recommend no longer than one hour.
O: Priporočamo, da ne dlje kot eno uro.
Repeat steps 8 and 9 until it appears.
Ponavljajte koraka 8 in 9, dokler se ne pojavi.
Be patient.
Bodite potrpežljivi.
Do not use alcohol.
Ne uporabljajte alkohola.
The results of both studies were similar.
Rezultati obeh študij so bili podobni.
Part IV: Commonly Asked Questions
IV. del: Pogosto zastavljena vprašanja
Date of first authorisation: 16 February 2001 Date of latest renewal: 16 February 2006
Datum prve odobritve: 16. februar 2001 Datum zadnjega podaljšanja: 16. februar 2006
Personality changes or abnormal behaviour.
Osebnostne spremembe ali nenormalno vedenje.
Always use the needles recommended.
Vedno uporabljajte priporočene igle.
Thus, the risk for humans is unknown.
Tveganje za ljudi tako ni znano.
The greatest risk is at the beginning of treatment.
Tveganje je največje na začetku zdravljenja.
This happens generally in patients who grow rapidly.
To se običajno zgodi pri bolnikih, ki hitro rastejo.
No animal data are available.
Podatki pri živalih niso na voljo.
• Do not use the same needle for more than one person.
• Posamezne igle ne uporabljajte za več kot eno osebo.
See also section “warning and precautions”.
Glejte tudi poglavje “Opozorila in previdnostni ukrepi”.
• if you have an active tumour (cancer).
• če imate aktivni tumor (raka).
(Be careful not to touch the rubber seal.)
(Pazite, da se ne dotaknete gumijaste zapore.)
If you travel outside the European Union, make sure you take enough needles for the duration of your stay.
Če potujete zunaj Evropske unije, poskrbite, da boste imeli s seboj dovolj igel za ves čas bivanja zunaj EU.
No data for other races are available.
Podatki za druge rase niso na voljo.
A drop of blood may appear.
Pokaže se lahko kapljica krvi.
Part I: Preparing and Injecting
I. del: Priprava in injiciranje
Protect from intense light.
Zaščitite pred močno svetlobo.
This can start during adult life or continue from when you were a child.
Stanje se lahko začne v odrasli dobi ali pa nadaljuje iz otroštva.
The maximum recommended daily dose should not be exceeded (see section 4.2).
Največjega priporočenega dnevnega odmerka se ne sme preseči (glejte poglavje 4.2).
Tell your doctor if you have or have had an active tumour.
Obvestite zdravnika, če imate ali ste imeli aktivni tumor.
• Use needles only once.
• Iglo uporabite samo enkrat.
• in particular, inform your doctor if you are taking or have recently taken any of the following medicines.
• Še posebej pa zdravnika obvestite, če jemljete ali ste pred kratkim jemali katero koli od naslednjih zdravil.
Q: What does a blinking “bt‟ mean in the LCD?
V: Kaj pomeni utripajoč ‘bt' na prikazovalniku LCD?
• if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na somatropin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The improvements in growth were not accompanied by undue advancement of bone age, which would jeopardise future growth potential.
Izboljšanje rasti ni spremljalo čezmerno napredovanje kostne starosti, ki bi ogrozilo prihodnjo rast.
Small bubbles may remain and will not affect the dose.
Drobni mehurčki lahko ostanejo in ne bodo vplivali na odmerek.
EXP: {date}
EXP: {številka}
If you are using the passive shield (or no shield) proceed to step 13.
Če uporabljate pasivni ščitnik (ali ščitnika ne uporabljate), nadaljujte s korakom 13.
Doses used in these US based studies are consistent with the US approved dose regimen.
Odmerki, uporabljeni v teh študijah, izvedenih v ZDA, so v skladu z odobrenim režimom odmerjanja v ZDA.
Your doctor or nurse will show you how to do this.
Zdravnik ali medicinska sestra vam bosta pokazala, kako to storiti.
Continue with your usual dosage the next day and tell your doctor at your next appointment.
Nadaljujte z uporabo običajnega odmerka naslednji dan in pri naslednjem pregledu o tem obvestite svojega zdravnika.
The average change in height SDS after 5 years of treatment was close to 2 standard deviations (SDs).
Povprečna sprememba vrednosti SDS telesne višine po 5 letih zdravljenja je blizu 2 standardnih odklonov (SD).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Scoliosis may progress in any child during rapid growth.
Skolioza lahko napreduje pri vsakem otroku s hitro rastjo.
The needle is only sterile on the first use.
Igla je sterilna samo ob prvi uporabi.
If you cannot dial the full dose, either start a new cartridge (as described in Part I), or inject the partial dose.
Če ne morete nastaviti polnega odmerka, lahko bodisi načnete nov vložek (kot je opisano v I. delu) bodisi injicirate delni odmerek.
If you accidentally turn it too far, go back one click (0.1 mg).
Če ga pomotoma preveč zasučete, pojdite en klik (0,1 mg) nazaj.
DO NOT INJECT THE MEDICINE UNTIL YOUR DOCTOR OR NURSE HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUES.
NE INJICIRAJTE ZDRAVILA, DOKLER VAS ZDRAVNIK ALI MEDICINSKA SESTRA TEMELJITO NE NAUČITA PRAVILNEGA POSTOPKA.
• You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use.
• Injekcijski peresnik in vložek lahko vzamete iz hladilnika do 45 minut pred uporabo.
In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse.
Pri bolnikih s predhodno maligno boleznijo je treba posebno pozornost nameniti znakom in simptomom relapsa.
If necessary, remove the empty cartridge and discard it properly.
Če je potrebno, odstranite prazni vložek in ga pravilno zavrzite.
• Avoid excessive temperatures.
• Izogibajte se izjemnim temperaturam.
Q: Why do I keep my medication in the refrigerator?
V: Zakaj moram zdravilo hraniti v hladilniku?
In general, the lowest efficacious dose should be administered.
Praviloma je treba uporabljati najmanjši učinkoviti odmerek.
Reporting of suspected adverse reactions after authorization of the medicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Warning and Precautions
Opozorila in previdnostni ukrepi
• If you have had a tumour (cancer) in the past, specially a tumour affecting the brain, your doctor should pay special attention and examine you regularly for a possible return of the tumour.
• Če ste v preteklosti imeli tumor (raka), posebej tumor, ki je vplival na možgane, vam mora zdravnik posvetiti posebno pozornost in vas redno pregledovati glede morebitne ponovitve tumorja.
< PC: {number} SN: {number} NN: {number}
PC: {številka} SN: {številka}
Patients under 11 years of age were also randomised to receive oestrogen therapy, either in late (aged 15 years) or early (aged 12 years) adolescence.
Bolnice, mlajše od 11 let, so bili randomizirane tudi na zdravljenje z estrogenom, bodisi v pozni (pri starosti 15 let) ali zgodnji (pri starosti 12 let) adolescenci.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
Each study had a two year treatment period which included a placebo arm, followed by an open label uncontrolled extension in which all patients received somatropin.
Vsaka študija je imela še dveletno obdobje zdravljenja, ki je vključevalo skupino s placebom, sledil pa je odprt nenadzorovan podaljšek, v katerem so vsi bolniki prejemali somatropin.
Press the white reset button.
Pritisnite beli nastavitveni gumb.
The solution for multidose use is clear and colourless.
Raztopina za večkratno uporabo je bistra in brezbarvna.
Pack sizes of 1, 3 and 6 cartridges.
Velikost pakiranja: 1, 3 ali 6 vložkov.
Somatropin should not be used for growth promotion in patients with closed epiphyses.
Somatropina se ne sme uporabljati za spodbujanje rasti pri bolnikih z zaprtimi epifizami.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Ker so bila poročila o teh neželenih učinkih pridobljena spontano iz populacije neznane velikosti, njihove pogostnosti ni mogoče zanesljivo oceniti.
• in children if the bones have already stopped growing.
• pri otrocih, če je rast kosti že končana.
Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Ženske lahko potrebujejo večje odmerke kot moški, pri čemer se občutljivost za IGF-I pri moških s časom povečuje.
Now you are ready to administer the dose.
Zdaj ste pripravljeni za injiciranje odmerka.
A: This ensures that the plunger push rod completely resets itself back to the starting position.
O: To zagotovi, da se potisni nosilec bata popolnoma vrne na začetni položaj.
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use.
Diagnozo in zdravljenje s somatropinom morajo začeti ter nadzorovati zdravniki, ki so ustrezno usposobljeni in izkušeni za diagnosticiranje in vodenje bolnikov z navedenimi terapevtskimi indikacijami.
Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Večjega pokrovčka ne vrzite proč, ker ga boste potrebovali za pravilno odstranitev in zavrženje igle.
Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Lumbar spine BMD had statistically significant increases in both treated groups, and the increase was dose dependent.
BMD ledvene hrbtenice se je statistično pomembno povečala v obeh skupinah zdravljenja, povečanje pa je bilo odvisno od odmerka.
Under the proposed indications, the use of somatropin is not expected to result in an unacceptable risk to the environment.
Uporaba somatropina v skladu s predlaganimi indikacijami ne predstavlja nesprejemljivega tveganja za okolje.
The clicks are only audible confirmation that the black dose knob has been moved.
Kliki so le slišna potrditev, da se je črni odmerni gumb premaknil.
Overall, 171 patients were exposed to somatropin for an average of 3.5 or 2.8 years.
Somatropinu je bilo tako izpostavljenih 171 bolnikov, in sicer v povprečju za 3,5 oziroma 2,8 let.
If the medicine does not appear within a few seconds, you may need to push the reset button again.
Če se zdravilo ne pojavi v nekaj sekundah, boste morali še enkrat pritisniti nastavitveni gumb.
Body composition
Telesna sestava
Your doctor may need to adjust the dose of NutropinAq or of the other medicines: - Oestrogen taken orally or other sex hormones
Zdravnik bo morda moral prilagoditi odmerek zdravila NutropinAq ali drugih zdravil: - Estrogen, ki se ga jemlje peroralno, ali drugi spolni hormoni.
This leaflet was last revised in <{Month/YYYY}>
Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}
Batteries typically last 24 months and have a 4-week life from the time the „bt‟ first starts blinking.
Baterije praviloma trajajo 24 mesecev; od trenutka, ko začne prvič utripati oznaka ‘bt', pa trajajo še 4 tedne.
If you stop using NutropinAq too early or for too long, the results will not be as expected.
Če zdravilo NutropinAq prenehate uporabljati prezgodaj ali ga predolgo ne uporabljate, ne bodo doseženi pričakovani rezultati zdravljenja.
Follow the instructions in this section if you are using the pen for the first time or are replacing an empty cartridge.
Navodila v tej točki upoštevajte, če injekcijski peresnik uporabljate prvič ali če menjate prazen vložek.
Diabetes mellitus can lead to increased urination, thirst and hunger.
Sladkorna bolezen lahko povzroči pogostejše uriniranje, žejo in lakoto.
Metabolic alterations in these patients include normalisation of IGF-I serum levels.
Presnovne spremembe pri teh bolnikih vključujejo normalizacijo koncentracije IGF-I v serumu.
The incidence of these AEs was also high in the placebo groups.
Pojavnost teh neželenih učinkov je bila visoka tudi v skupini, ki je prejemala placebo.
Benefits if using this medicine
Koristi uporabe tega zdravila
Absorption The absolute bioavailability of recombinant human growth hormone after subcutaneous administration is about 80%.
Absolutna biološka uporabnost rekombinantnega humanega rastnega hormona po subkutani uporabi je okrog 80 %.
The growth rate decreased after the first year in both studies, but continued to be greater than pretreatment levels for up to 48 months treatment (7.1 cm/year).
Stopnja rasti se je v obeh študijah po prvem letu zmanjšala, vendar pa je bila do 48. meseca zdravljenja še vedno večja od stopnje pred zdravljenjem (7,1 cm/leto).
These side effects appear usually in adults early in treatment and are short-lived.
Ti neželeni učinki se običajno pojavijo pri odraslih kmalu po uvedbi zdravljenja in so kratkotrajni.
NutropininAq is a registered trademark of Genentech, Inc.
NutropinAq je registrirana blagovna znamka podjetja Genentech, Inc.
Tell your doctor immediately if you notice any change or increase in growth of birthmarks and/or moles (melanocytic naevus).
Nemudoma obvestite svojega zdravnika, če opazite kakršne koli spremembe ali povečano rast materinih in/ali drugih znamenj (melanocitni nevus).
Symptoms usually occur within the first eight weeks of the initiation of NutropinAq therapy.
Simptomi se ponavadi pojavijo v prvih osmih tednih po začetku zdravljenja z zdravilom NutropinAq.
Gather all of these components prior to use.
Pred uporabo pripravite vse te dele.
IGF-I levels increased from a baseline of 43 ng/ml to 252 ng/ml at 36 months, which approximate to the normal levels expected in children of this age.
Vrednosti IGF-I so se od izhodiščnih vrednosti 43 ng/ml povečale na 252 ng/ml v 36. mesecu, kar je približno normalna pričakovana vrednost pri otrocih te starosti.
When these antibodies were found in patients, it did not prevent them from growing.
Pri bolnikih, pri katerih so jih odkrili, protitelesa niso preprečila rasti.
This continued to increase in those patients treated for 36 and 48 months.
Povečevanje vrednosti se je nadaljevalo tudi pri tistih bolnikih, ki so se zdravili 36 in 48 mesecev.
Height gains were maintained in the patients treated for 36 or 48 months.
Pridobivanje telesne višine se je ohranilo pri bolnikih, ki so se zdravili 36 ali 48 mesecev.
Endogenous growth hormone production may also increase in some individuals with end-stage renal disease.
Endogeno nastajanje rastnega hormona se lahko pri nekaterih posameznikih s končnim stadijem ledvične bolezni tudi zveča.
It is unknown whether somatropin/metabolites are excreted in human milk.
Ni znano, če se somatropin/presnovki izločajo v materino mleko.
To guard against the spread of infection, follow these safety measures:
Za zaščito pred okužbo upoštevajte naslednje varnostne ukrepe:
In case of a tumour or re-growth of previous tumours (confirmed by your doctor), treatment with NutropinAq must be stopped immediately.
V primeru tumorja ali ponovne rasti prejšnjega tumorja (ki ga je potrdil zdravnik), je treba zdravljenje z zdravilom NutropinAq takoj prekiniti.
You should also check the pen to see that the black dose knob is moving up and down properly and that the LCD counter is working.
Preveriti morate tudi, če se črni odmerni gumb še pravilno premika navzgor in navzdol in ali LCD-števec deluje.
These changes were highly significant at the 12-month time point in both studies, and at the 24-month time point in the childhood-onset study.
Te spremembe so bile zelo pomembne pri 12-mesečni časovni točki v obeh študijah in v 24-mesečni časovni točki v študiji pri bolnikih z začetkom pomanjkanja v otroštvu.
On the basis of the scientific conclusions for somatropin the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing somatropin is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za somatropin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) somatropin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
When these alterations are coupled with the increase in total body water and bone mass, the overall effect of somatropin therapy is to modify body composition, an effect that is maintained with continued treatment.
Ko so te spremembe povezane z zvečanjem celotne količine telesne vode in kostne mase, je skupni učinek zdravljenja s somatropinom sprememba telesne sestave; učinek se med nadaljevanjem zdravljenja ohrani.