natgillin/translations-raw huggingface dataset:
The active substance in Ariclaim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Zdravilna učinkovina zdravila Ariclaim, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
How does Ariclaim work?
Kako zdravilo Ariclaim deluje?
What is Ariclaim used for?
Za kaj se zdravilo Ariclaim uporablja?
How has Ariclaim been studied?
Kako je bilo zdravilo Ariclaim raziskano?
What is Ariclaim?
Kaj je zdravilo Ariclaim?
How is Ariclaim used?
Kako se zdravilo Ariclaim uporablja?
Medicinal product no longer authorised
Zdravilo nima več dovoljenja za promet
MA (EU) Number (Invented) Name
(Izmišljeno) ime
Pharmaceutical Form Route of Administration
Jakost Farmacevtska oblika
Progress through Tanner stages appeared appropriate.
Napredek glede na stadije po Tannerju se je pokazal kot ustrezen.
Historical controls did not show change over time.
Zgodovinski kontrolni podatki niso pokazali sprememb v času.
An aseptic technique should be used.
Uporabiti je treba aseptično tehniko.
You are now ready to inject the correct dose.
Zdaj ste pripravljeni injicirati pravilni odmerek.
Always follow the instructions provided by your doctor.
Vedno upoštevajte navodila zdravnika.
SN {number}
SN {številka} NN {številka}
Pay attention not to hurt yourself with the needle.
Bodite pozorni, da se z iglo ne poškodujete.
Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Strensiq ne segrevajte na noben drug način (na primer, ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
These effects were restricted to injection sites and were partially or completely reversible.
Ti učinki so bili omejeni na mesta injiciranja in so bili delno ali povsem reverzibilni.
Craniosynostosis can lead to increased intracranial pressure.
Kraniosinostoza lahko povzroči povečan intrakranialni tlak.
The patients were randomly assigned to treatment group for the primary treatment period.
Bolniki so bili naključno razporejeni v skupino zdravljenja za primarno obdobje zdravljenja.
For more information, please consult:
Za več informacij glejte:
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:
• The dose you receive is based on your body weight.
• Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase.
Annually within annual reassessment
vsako leto v okviru vsakoletne ponovne ocene zdravila
Read section 3 carefully to know the injection recommendations.
Skrbno preberite poglavje 3, da se seznanite s priporočili za injiciranje.
Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research.
Nomenklatura, simboli in enote so sledili priporočilom Ameriškega združenja za raziskovanje kosti in mineralov (American Society for Bone and Mineral Research).
Rotation of injection sites may help to minimize these reactions.
Menjavanje mesta injiciranja lahko pomaga kar najbolj zmanjšati te reakcije.
These reference data were drawn from a representative sample of healthy children and are not specific for children with special health care needs: they have been used in the absence of growth charts for children with hypophosphatasia.
Ti referenčni podatki so bili izdelani iz reprezentativnega vzorca zdravih otrok in niso specifični za otroke s posebnimi potrebami v zvezi z zdravstveno oskrbo; uporabljajo se, kadar ni na voljo tablic rasti za otroke s hipofosfatazijo.
After opening the vial, the product should be used immediately (within 3 hours maximum).
Po odprtju viale morate zdravilo takoj uporabiti (v roku največ 3 ur).
There is potential for immunogenicity.
Obstaja možnost imunogenosti.
It is not intended for intravenous or intramuscular injection.
Ni namenjeno za intravensko ali intramuskularno injiciranje.
The adolescent (and adult) patients in this study did not display apparent height-gain.
Bolniki mladostniki (in odrasli bolniki) v tej študiji niso kazali navidezne rasti.
Of these 11 patients, 9 patients had their doses increased specifically to improve clinical response.
Od teh 11 bolnikov so 9 bolnikom odmerke zvečali posebej zato, da bi izboljšali klinični odziv.
Always use a new syringe contained in a protective plastic.
Vedno uporabite novo brizgo, priloženo v zaščitni plastiki.
Alexion Pharma International Operations Unlimited Company College Business and Technology Park, Blanchardstown Dublin 15
Alexion Pharma International Operations Unlimited Company College Business and Technology Park, Blanchardstown
Chemical and physical in-use stability has been demonstrated for up to 3 hours at a temperature between 23°C to 27°C.
2 leti Kemijska in fizikalna stabilnost med uporabo je bila dokazana za največ 3 ure pri temperaturi med 23 °C
The safety and efficacy of Strensiq in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.
Varnost in učinkovitost zdravila Strensiq pri bolnikih z ledvično ali jetrno okvaro ni bila ovrednotena, zato specifičnih režimov odmerjanja za te bolnike ni mogoče priporočati.
Age at treatment initiation in the study was between 0.5 to 35 months.
Starost ob začetku zdravljenja v študiji je bila med 0,5 in 35 mesecev.
NOTE: do not use any areas in which you feel lumps, firm knots, or pain; talk to your doctor about anything you find.
OPOMBA: ne uporabljajte predelov, v katerih čutite zatrdline, čvrste vozliče ali bolečino; o vsem, kar opazite, se pogovorite z zdravnikom.
Dietary supervision is recommended.
Priporoča se nadzor prehrane.
Strensiq may cause some tests to show wrongly higher or lower results.
Zdravilo Strensiq lahko povzroči, da nekateri testi nepravilno pokažejo višje ali nižje rezultate.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Če niste prepričani, kaj so spodaj navedeni neželeni učinki, prosite zdravnika, da vam jih razloži.
• You may experience a reaction at the injection site.
• Morda boste doživeli reakcijo na mestu injiciranja.
It is expected that pharmacokinetic exposures will increase with body weight.
Pričakuje se, da se bo farmakokinetika izpostavljenosti s telesno maso povečala.
Most suitable areas for injection are marked grey in the picture.
Najprimernejša mesta za injiciranje so na sliki sivo označena.
Do not inject this medicine yourself unless you have received training and you understand the procedure.
Tega zdravila si ne injicirajte sami, če o tem niste bili ustrezno poučeni in če ne razumete postopka.
Data from post-marketing cases suggests that the development of antibodies may affect clinical efficacy.
Podatki iz primerov v obdobju trženja zdravila kažejo, da bi razvoj protiteles lahko vplival na klinično učinkovitost.
As a consequence, your doctor may ask you to take supplements of calcium and oral vitamin D if needed.
Zato vam lahko zdravnik naroči, da jemljite kalcij in peroralni vitamin D, če je treba.
Pack sizes of 1 or 12 vials.
Velikosti pakiranja 1 ali 12 vial.
The MAH should set up an observational, longitudinal, prospective, long-term registry of patients with HPP to collect information on the epidemiology of the disease, including clinical outcomes and quality of life, and to evaluate safety and effectiveness data in patients treated with Strensiq.
MAH mora vzpostaviti opazovalen, longitudinalen, prospektiven, dolgoročen register bolnikov s HPP za zbiranje informacij o epidemiologiji bolezni, vključno s kliničnimi izidi in kvaliteto življenja, in za ocenjevanje podatkov o varnosti in učinkovitosti pri bolnikih, zdravljenih z zdravilom Strensiq.
Some patients required oral vitamin D supplements during the study (see sections 4.4 and 4.8).
Pri nekaterih bolnikih so bili med študijo potrebni peroralni dodatki vitamina D (glejte poglavji 4.4 in 4.8).
If you need to undergo laboratory tests (giving blood for testing), tell your doctor that you are treated with Strensiq.
Če je pri vas treba opraviti laboratorijske teste (če boste dali kri za preiskave), povejte zdravniku, da se zdravite z zdravilom Strensiq.
In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety (see section 5.2).
V kliničnih preskušanjih se je pokazalo, da razvoj protiteles ne vpliva na klinično učinkovitost ali varnost (glejte poglavje 5.2).
The antibody response (with or without presence of neutralizing antibodies) was time variant in nature.
Odziv protiteles (s prisotnostjo nevtralizirajočih protiteles ali brez nje) se je spreminjal s časom.
Fluctuation in height-gain was apparent and may reflect the more severe disease and higher rate of morbidity in these younger patients.
Fluktuacija pri pridobivanju višine je bila očitna in lahko kaže težjo bolezen in višjo stopnjo obolevnosti pri teh mladih bolnikih.
Adult patients Efficacy and safety data in patients with hypophosphatasia >18 years old are limited.
Odrasli bolniki Podatki o učinkovitosti in varnosti zdravila pri bolnikih s hipofosfatazijo, starih > 18 let, so omejeni.
It is used for long-term enzyme replacement treatment to manage symptoms.
Uporablja se za dolgotrajno encimsko nadomestno zdravljenje za zdravljenje simptomov.
• Should you experience anaphylactic reaction, or an event with similar symptoms, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision.
• Če pri vas pride do anafilaktične reakcije ali stanja s podobnimi simptomi, se bo zdravnik z vami pogovoril o naslednjih korakih in možnosti, da začnete ponovno jemati zdravilo Strensiq pod zdravniškim nadzorom.
If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated.
Če se pojavijo te reakcije, se priporoča takojšnja prekinitev zdravljenja in uvedba ustreznega zdravljenja.
Step 5: Disposing of supplies
5. korak: Odstranjevanje odpadnega materiala
Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.
Bolnike je treba spremljati glede ponovnega pojava znakov in simptomov resne preobčutljivostne reakcije.
You may need to use several vials to withdraw the complete amount needed to reach the correct dose.
Morda boste morali uporabiti več vial, da izvlečete celotno količino, potrebno za pravilni odmerek.
Pack sizes: cartons of 1 or 12 vials Not all pack sizes may be marketed.
Velikosti pakiranja: škatle z 1 vialo ali 12 vialami Na trgu morda ni vseh navedenih pakiranj.
The current medical standards for emergency treatment should be observed.
Upoštevati je treba najnovejše zdravstvene standarde za zdravljenje v urgentnih primerih.
• When injecting regularly, the injection site should be changed between different areas of the body to help reduce potential pain and irritation
• Pri rednem injiciranju morate mesto injiciranja menjavati med različnimi predeli telesa, da zmanjšate morebitno bolečino in draženje.
If you are allergic to asfotase alfa (see section ‘Warnings and precautions' below) or any of the other ingredients of this medicine (listed in section 6).
Če ste alergični na asfotazo alfa (glejte poglavje "Opozorila in previdnostni ukrepi" spodaj) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Frequency category
Stopnja pogostnosti
Before injecting Strensiq, please read the following instructions carefully
Pred injiciranjem zdravila Strensiq natančno preberite naslednja navodila
Other medicines and Strensiq Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Druga zdravila in zdravilo Strensiq Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The MAH shall ensure that in each Member State where Strensiq is marketed all patients/parents or caregivers who are expected to use Strensiq are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Strensiq trži, vsi bolniki in njihovi starši ali skrbniki, za katere se pričakuje, da bodo uporabljali zdravilo Strensiq, prejeli naslednji paket izobraževalnih gradiv:
The average ± SD elimination half-life following subcutaneous administration was 2.28 ± 0.58 days.
Povprečni razpolovni čas izločanja ± SD po subkutanem dajanju je bil 2,28 ± 0,58 dni.
Doses will need to be adjusted regularly by your doctor as the body weight changes.
Odmerek bo zdravnik redno prilagajal glede na spreminjanje telesne mase.
Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months).
Osemintrideset bolnikov so zdravili vsaj 2 leti (24 mesecev), 6 bolnikov pa so zdravili vsaj 5 let (60 mesecev).
Therefore another type of test may need to be used if you are treated with Strensiq.
Zato bo morda treba uporabiti drugo vrsto testa, če se zdravite z zdravilom
Patients can self-inject only if they have properly been trained on administration procedures.
Bolniki si lahko zdravilo samoinjicirajo le, če so bili ustrezno poučeni o postopkih dajanja.
If you experience any of these symptoms, discontinue Strensiq and seek medical help immediately.
Če opazite katerega koli od teh simptomov, nehajte jemati zdravilo Strensiq in takoj poiščite medicinsko pomoč.
The effects of asfotase alfa on x-ray appearance
Učinek asfotaze alfa na izgled rentgenskih posnetkov
4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.
Pri 4 bolnikih je bilo na voljo premalo podatkov za presojo, pri 1 bolniku pa se ni bilo mogoče z gotovostjo odločiti.
Your doctor will advise you on the possible injection sites.
Zdravnik vam bo svetoval o možnih mestih injiciranja.
* produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
* izdelano s tehnologijo rekombinantne DNA v sesalskih celičnih kulturah ovarijskih celic kitajskega hrčka (CHO, Chinese Hamster Ovary).
• Injection guide for parents or caregivers with infant patients
• Vodnik za injiciranje za starše ali skrbnike otroških bolnikov.
For patients who have little fat under the skin or thin skin, a 45º angle may be preferable.
Pri bolnikih, ki imajo malo podkožne maščobe ali tanko kožo, je morda boljši kot 45°.
Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.
Nekateri bolniki, pri katerih so potrdili pozitivno prisotnost protiteles proti zdravilu, so imeli reakcije na mestu injiciranja (injection site reactions - ISR) in/ali preobčutljivost, vendar ni bilo doslednega trenda v pogostnosti teh reakcij v času, ki bi ga opazili med bolniki, ki so bili kdaj ADA-pozitivni, in bolniki, ki so bili vedno ADA-negativni.
Driving and using machines This medicine is not expected to have any effect on the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ne pričakuje se, da bi to zdravilo vplivalo na sposobnost vožnje ali upravljanja strojev.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from asfotase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z asfotazo alfa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
If more than 1 ml is required, you need to do multiple injections immediately one after the other.
Če je treba uporabiti več kot 1 ml, morate dati več injekcij takoj eno za drugo.
The dose of asfotase alfa was increased for 11 patients during the study.
Odmerek asfotaze alfa so med študijo zvečali 11 bolnikom.
Thirteen patients were enrolled, 12 completed, and 1 discontinued (discontinuation early in the study due to a previously planned elective scoliosis surgery).
12 bolnikov je študijo zaključilo, 1 bolnik pa jo je prekinil (prekinitev na začetku študije je bila posledica predhodno načrtovane elektivne operacije skolioze).
Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays.
Alkalna fosfataza (AF) se uporablja kot detekcijski reagent pri mnogih rutinskih laboratorijskih analizah.
If you experience any severe reaction at the injection site, tell your doctor immediately.
Če se pojavijo hude reakcije na mestu injiciranja, takoj povejte zdravniku.
The study employed historical controls from the same centres as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.
V študiji so uporabljeni zgodovinski kontrolni podatki istih raziskovalnih centrov kot za bolnike, ki so prejemali asfotazo alfa in ki so bili predmet podobnega protokola klinične obravnave.
X-ray changes from baseline were then rated using the Radiographic Global Impression of Change rating scale as follows: -3=severe worsening, -2=moderate worsening, -1=minimal worsening, 0=no change, +1=minimal healing, +2=substantial healing, +3= near-complete or complete healing.
Radiološke spremembe od izhodišča so ocenjevali s pomočjo Lestvice radiografskega globalnega vtisa sprememb RGI-C (Radiographic Global Impression of Change), kot sledi: -3=resno poslabšanje, -2=zmerno poslabšanje, -1=minimalno poslabšanje, 0=ni spremembe, +1=minimalno celjenje, +2=znatno celjenje, +3=skoraj popolno ali popolno celjenje.
• Each vial is for single use and should only be punctured once.
• Ena viala je samo za enkratno uporabo in jo je dovoljeno le enkrat prebosti.
Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Mesta injiciranja je treba menjavati in skrbno spremljati znake možnih reakcij (glejte poglavje 4.4).
cellulitis, scar, mass, extravasation, exfoliation and vesicles) are the most common adverse reactions observed in about 74% of the patients in clinical studies.
celulitisom, brazgotino, tvorbo, ekstravazacijo, eksfoliacijo in mehurčki na mestu injiciranja) so najpogostejši neželeni učinki, ki so jih v kliničnih študijah opazili pri približno 74 % bolnikov.
Your doctor, pharmacist or nurse will advise you on how you can obtain a sharps container.
Zdravnik, farmacevt ali medicinska sestra vam bodo svetovali, kje dobiti vsebnik za ostre odpadke.
This will help seal the punctured tissue and prevent any leakage.
To bo zatesnilo preluknjano tkivo in preprečilo izcejanje.
The impact of immunogenicity on asfotase alfa pharmacokinetic varied over time due to the time varying nature of immunogenicity and overall was estimated to decrease pharmacokinetic exposures by less than 20%.
Vpliv imunogenosti na farmakokinetiko asfotaze alfa je s časom nihal, ker tudi imunogenost s časom niha, celokupno pa je bilo ocenjeno, da farmakokinetično izpostavljenost zmanjša za manj kot 20 %.
Study ENB-010-10 was a controlled open-label study in 69 patients, aged 1 day to 72 months, with perinatal/infantile-onset HPP.
Študija ENB-010-10 je bila kontrolirana odprta študija pri 69 bolnikih, starih od 1 dan do 72 mesecev, s perinatalnim/infantilnim začetkom HPP.
Vial type used for injection
Vrsta viale, ki se uporablja za injekcijo
• Information on cold chain management for Strensiq during storage and travel
• informacije o zagotavljanju nepretrgane hladne verige za zdravilo Strensiq med shranjevanjem in potovanjem,
Most injection site reactions were mild and selflimiting, and the majority (> 99%) were reported as non-serious.
Največ reakcij na mestu injiciranja je bilo blagih in so izzvenele brez zdravljenja, o večini reakcij na mestu injiciranja (> 99 %) pa so poročali kot o neresnih.
Most of these reactions were non-serious, mild to moderate in intensity.
Reakcije so bile večinoma neresne in blage do zmerne po intenzivnosti.
Patients with hypophosphatasia have low levels of an enzyme called alkaline phosphatase that is important for various body functions, including the proper hardening of bones and teeth.
Bolniki s hipofosfatazijo imajo nizke ravni encima, imenovanega alkalna fosfataza, ki je pomemben za različne telesne funkcije, vključno s pravilno trdoto kosti in zob.
The European Medicines Agency has deferred the obligation to submit the results of studies with Strensiq in one or more subsets of the paediatric population in hypophosphatasia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Strensiq za eno ali več podskupin pediatrične populacije za hipofosfatazijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The improvement in rickets severity was maintained for at least 72 months of follow-up treatment (including at least 84 months in 4 patients), as measured by the RGI C.
Izboljšanje izraženosti rahitisa je trajalo vsaj 72 mesecev nadaljevalnega zdravljenja (vključno z vsaj 84 meseci pri 4 bolnikih), izmerjeno z RGI C.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of asfotase alfa.
Študij na živalih za ocenitev genotoksičnosti in kancerogenega potenciala asfotaze alfa niso izvedli.
Preclinical fertility studies were conducted and showed no evidence of effect on fertility and embryo-fetal development.
Izvedli so predklinične študije plodnosti, ki niso pokazale dokazov o vplivu na plodnost in razvoj zarodka in plodu.
Age at inclusion was from 13 to 66 years and was between 17 and 72 years at study completion.
Starost ob vključitvi je bila od 13 do 66 let, ob zaključku študije pa od 17 do 72 let.
• Detailed description on how Strensiq is injected using aseptic techniques
• natančen opis načina injiciranja zdravila Strensiq z uporabo aseptične tehnike,
Patients received STRENSIQ at 6 mg/kg per week for the first 4 weeks.
Bolniki so prejemali zdravilo STRENSIQ v odmerku 6 mg/kg na teden prve 4 tedne.
After removing the bubbles, check the dose of medication in the syringe to be sure you have drawn up the correct amount.
Potem, ko odstranite mehurčke, preverite odmerek zdravila v brizgi in se prepričajte, da je v brizgi pravilna količina zdravila.
Improvements in median RGI-C were maintained over the course of treatment, which ranged from 0.9 to 302.3 weeks, even if fewer patients were followed after Week 96 (a total of 29 patients were followed after Week 96 and ≤8 patients after Week 192).
Izboljšanja medianega RGIC so trajala ves čas zdravljenja z razponom od 0,9 do 302,3 tedna, tudi če so po 96. tednu sledili manj bolnikom (po 96. tednu so sledili skupaj 29 bolnikom, po 192. tednu pa ≤ 8 bolnikom).
The absolute bioavailability after the first and third subcutaneous administration ranged from 45.8 to 98.4%, with median Tmax ranging between 24.2 to 48.1 hours.
Absolutna biološka razpoložljivost po prvem in tretjem subkutanem dajanju je bila v območju od 45,8 do 98,4 %, mediani Tmax pa v območju od 24,2 do 48,1 ure.
The majority of the patients who received asfotase alfa moved to scores of +2 and +3 over the first 6 months of exposure and this was sustained with on-going treatment.
Večina bolnikov, ki so prejemali asfotazo alfa, se je premaknila na oceni +2 in +3 v prvih 6 mesecih izpostavljenosti, kar se je ohranilo med trajanjem zdravljenja.
Remove the plastic cap covering the syringe needle.
Odstranite plastični pokrovček, ki pokriva iglo brizge.