natgillin/translations-raw huggingface dataset:
Treatment with Naglazyme showed improvement, or lack of worsening, of facial dysmorphism. 
Ob zdravljenju z Naglazymom je bilo opaziti izboljšanje oz. ni prišlo do poslabšanja kraniofacialnega dismorfizma.
• Increased heart rate 
• hitrejši srčni utrip
If you experience any reaction like this, please tell your doctor immediately. 
Če opazite take reakcije, o tem takoj obvestite zdravnika.
Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction. 
Hudi neželeni učinki so vključevali edem grla, apnejo, pireksijo, urtikarijo, dihalno stisko, angioedem, astmo in anafilaktoidno reakcijo.
METHOD OF ADMINISTRATION Read the package leaflet before use 
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo
Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. 
Naglazyma se da bolniku v ustrezni klinični ustanovi, ki je opremljena z ustrezno opremo za nudenje nujne medicinske pomoči.
• Pain (including ear, abdominal, joint, chest pain) 
• bolečine (vključno z bolečino v ušesih,
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated-dose toxicity or on general reproductive performance or embryo-foetal development in rats or rabbits. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti posameznega odmerka, toksičnosti ponavljajočih se odmerkov ali vpliva na splošno sposobnost razmnoževanja ali razvoj zarodka/ploda pri podganah ali kuncih niso pokazali posebnega tveganja za ljudi.
The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Volumen Naglazyma je treba počasi dodajati infuzijski raztopini natrijevega klorida 9 mg/ml (0,9%).
• Decreased heart rate 
• upočasnjen srčni utrip
Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80 
Natrijev hidrogenfosfat monohidrat, Natrijev dihidrogenfosfat heptahidrat, Polisorbat 80,
• Cough 
• kašelj
If not used immediately, in-use storage times and conditions are the responsibility of the user and must normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at room temperature (23C - 27C) during administration. 
Praviloma shranjevanje ne sme presegati 24 ur pri temperaturi 2 C - 8 C in nadaljnjih 24 ur pri sobni temperaturi (23 C27 C) v fazi dajanja zdravila.
Very common adverse reactions are those with a frequency of 1/10. 
Neželeni učinki so našteti v skladu s dogovorom o navedbi pogostnosti po MedDRA. Zelo pogosti neželeni učinki so tisti, ki se pojavijo pri 1/10 bolnikov.
GAG results approached the normal range for age in the Naglazyme treatment group. 
Rezultati GAG so se v skupini, zdravljeni z zdravilom Naglazyme, približali normalnim vrednostim za določeno starost.
Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells. 
Galsulfaza je rekombinantna oblika humane Nacetilgalaktozamin-4-sulfataze, ki jo pridobijo iz gensko spremenjenih ovarijskih celic kitajskega hrčka (CHO).
Subjects enrolled in the program will have urinary glycosaminoglycan and samples for total antibodies routinely collected as specified in the Schedule of Activities. 
Kot je določeno v seznamu aktivnosti, se bodo bolnikom, vključenim v program, redno jemali vzorci glikozaminoglikana v urinu in vzorci za skupna protitelesa.
Angioeodema1, rash1, urticaria, pruritus Very Common Erythema 
Bolezni kože in podkožja angioedem1, izpuščaj1, urtikarija, pruritus zelo pogosti eritem pogosti
With administration of Naglazyme it is recommended that patients be administered pre-treatment medicinal products (antihistamines with or without antipyretics) approximately 30-60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs. 
Ob aplikaciji Naglazyma je približno 30 - 60 minut pred pričetkom infuzije za zmanjšanje tveganja za razvoj IAR priporočljiva premedikacija bolnikov (antihistaminiki z ali brez antipiretikov).
• Bulging belly button 
• zamašen nos • izbokel popek
Preparation of the Naglazyme Infusion (Use Aseptic Technique) 
Priprava Naglazyme raztopine za infundiranje (po aseptičnem postopku)
Musculoskeletal and Connective Tissue Disorders 
Bolezni mišično-skeletnega sistema artralgija zelo pogosti
• Low blood-oxygen 
• nizka raven kisika v krvi
Do not take Naglazyme if it contains visible particles. 
Ne vzemite zdravila Naglazyme, če opazite vidne delce.
• When new information is received that may impact on the current Safety 
• ob prejemu novih informacij, ki bi lahko vplivale na trenutno varnostno spedifikacijo , farmakovigilančni načrt ali dejavnosti za zmanjšanje tveganja;
Before dilution, each vial is to be inspected for particulate matter and discolouration. 
Pred redčenjem se je treba za vsako vialo prepričati, da ne vsebuje vidnih delcev in da ni razbarvana.
Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities. 
Vzorci bolnikov, pri katerih se ugotovi stalna porast vrednosti GAG v urinu in visoke ravni protiteles, se bodo ocenili v zvezi z nevtralizacijo učinka zdravila.
A brief update will be submitted as part of the Annual Reassessments. 
Kratko poročilo bo predloženo v letnem poročilu o ponovni oceni.
If you have missed a Naglazyme infusion, please contact your doctor. 
Če ste pozabili priti na infuzijo zdravila Naglazyme, se posvetujte s svojim zdravnikom.
Evaluate the safety and efficacy of Naglazyme in 10 children less than 
Za ocenitev varnosti in učinkovitosti zdravila Naglazyme bo 10 otrok,
Very common symptoms of these infusion reactions were pyrexia, chills/rigors, rash, urticaria and dyspnoea. 
Zelo pogosti simptomi teh reakcij na infundiranje so bili pireksija, mrzlica/tresavica, izpuščaj, urtikarija in dispneja.
The most common symptoms of infusion associated reactions include fever, chills, rash, hives and shortness of breath. 
Najbolj pogosti simptomi reakcij, povezanih z infundiranjem, so vključevali zvišano telesno temperaturo, mrzlico, izpuščaj, koprivnico in zasoplost.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Samo za enkratno uporabo
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. 
Koncentrat za raztopino za infundiranje mora biti po aseptičnem postopku razredčen z izotonično raztopino natrijevega klorida 9 mg/ml (0,9%) za infundiranje.
A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added. 
Iz 250 ml vsebnika z raztopino natrijevega klorida 9 mg/ml (0,9%) za infundiranje se potegne in zavrže takšen volumen raztopine natrijevega klorida 9 mg/ml (0,9%), kot znaša celoten, na telesno maso bolnika preračunani volumen Naglazyma.
Apnoea1, cough, respiratory distress, asthma, bronchospasm 
zelo pogosti apneja1, kašelj, dihalna stiska, astma, bronhospazem pogosti edem grla, hipoksija, tahipneja neznana
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase 
IME ZDRAVILA IN POT(I) UPORABE Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje galsulfaza
The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below. 
To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena spodaj.
• Poor hearing 
• poslabšan sluh
• Wheezing • Skin redness 
• zasoplost • rdečina kože
A clear to slightly opalescent, and colourless to pale yellow solution. 
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina
One ml of Naglazyme contains 1 mg galsulfase. 
Vsak ml raztopine vsebuje 1 mg galsulfaze.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 1 mg galsulfase. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak ml raztopine vsebuje 1 mg galsulfaze.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use. 
V skladu s smernicami CHMP o sistemih za obvladovanje tveganja za zdravila za humano uporabo mora imetnik dovoljenja za promet predložiti posodobljen načrt RMP.
NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion 
IME ZDRAVILA Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje
Management of compromised airways 
Obravnava prizadetih dihalnih poti
• Sore throat 
• vnetje žrela
The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea. 
Najpogostejši neželeni učinki so bili pireksija, izpuščaj, pruritus, urtikarija, mrzlica/tresavica, navzea, glavobol, bolečina v trebuhu, bruhanje in dispneja.
Overall, one case of sleep apnoea was experienced from all clinical studies. 
Med klinično študijo so opazili 1 primer apneje v spanju.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Dyspnoea1, nasal congestion1 
Očesne bolezni konjunktivitis1, motnost roženice1
4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
• Skin paleness 
• modrikava koža
Table 1: Frequency of adverse drug reactions with Naglazyme 
Preglednica 1: Pogostnost neželenih učinkov na zdravilo Naglazyme Organski sistem po MedDRA Priporočeni izraz po MedDRA Pogostnost Bolezni imunskega sistema anafilaksa, šok neznana
PACKAGE LEAFLET: INFORMATION FOR THE USER Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase 
NAVODILO ZA UPORABO Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje galsulfaza
There is no evidence for special considerations when Naglazyme is administered to the paediatric population. 
Ni dokazov za posebne pomisleke v zvezi z uporabo zdravila Naglazyme pri otrocih.
Abdominal pain1, umbilical hernia1, vomiting, nausea 
Bolezni prebavil bolečina v trebuhu1, popkovna kila1, bruhanje, navzea zelo pogosti
Pain1, chest pain1, rigors1, malaise1, pyrexia 
Splošne težave in spremembe na mestu aplikacije bolečina1, bolečina v prsih1, tresavica1, splošno slabo počutje1, pireksija zelo pogosti
Concentrate for solution for infusion. 
Koncentrat za raztopino za infundiranje galsulfaza
Naglazyme is supplied as a concentrate for solution for infusion. 
Izgled zdravila Naglazyme in vsebina pakiranja Naglazyme je na razpolago kot koncentrat za raztopino za infundiranje.
• Inflammation of the eye 
• očesno vnetje
• Nausea 
• srbenje
What is Taxespira and what is it used for? 
Kaj je zdravilo Taxespira in za kaj ga uporabljamo
• breast cancer. 
• krvni strdki.
The full EPAR and risk management plan summary for Taxespira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu.
• non-small-cell lung cancer. 
Nedrobnocelični pljučni rak
For more information, see the summary of product characteristics. 
Za nadaljnje podrobnosti prosimo, glejte povzetek glavnih značilnosti trastuzumaba.
What measures are being taken to ensure the safe and effective use of Taxespira? 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
By keeping the skeleton intact the cells cannot divide and they eventually die. 
Če se v raztopini pojavijo kristali, raztopine ne smete več uporabiti in jo je treba zavreči.
Taxespira is used with cisplatin and 5-fluorouracil. 
Cisplatin in 5-fluorouracil
The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes. 
Docetaksel spada v skupino zdravil za zdravljenje raka, imenovanih taksoidi.
Taxespira is available as a concentrate for solution for infusion (drip) into a vein and is given as a onehour infusion every three weeks. 
Docetaksel apliciramo v enourni infuziji vsake tri tedne.
The full EPAR for the reference medicine can also be found on the Agency's website. 
To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
How is Taxespira used? 
Kako uporabljati zdravilo Taxespira
The company provided data from the published literature on docetaxel. 
Niso opazovali statistično značilnih učinkov prednizona na farmakokinetiko docetaksela.
Previously known as Docetaxel Hospira UK Limited. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Hospira UK Limited
Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines); 
V kombinaciji s cisplatinom in 5-fluorouracilom
Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). 
Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm
Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy. 
Docetaksel se sme uporabljati le v enotah, specializiranih za citotoksično kemoterapijo in samo pod nadzorom zdravnika, izkušenega na področju onkološke kemoterapije (glejte poglavje 6.6).
Other information about Taxespira 
Druga zdravila in zdravilo Taxespira
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects 
Tudi deksametazon ni vplival na vezavo docetaksela na beljakovine.
For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist. 
Če imate glede uporabe tega zdravila še kakšna vprašanja, vprašajte zdravnika ali bolnišničnega farmacevta.
EPAR summary for the public 
Povzetek varnostnih značilnosti za vse indikacije
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
BE / LX / NL Hospira Benelux BVBA Tél/Tel: + 32 3 231 90 09
It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated; 
Če se sočasni uporabi močnega zaviralca CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
A risk management plan has been developed to ensure that Taxespira is used as safely as possible. 
Za zmanjšanje tveganja za hematološke toksične učinke se lahko profilaktično uporabi G-CSF.
Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide. 
In vitro docetaksel dokazano zmoti celično mikrotubulno mrežje, nujno za mitotično in interfazno celično delovanje.
For more information about treatment with Taxespira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Če se pojavijo akutne težave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, težko dihanje/kratka sapa ali kašelj), takoj obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta.
An antiinflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxespira infusion. 
V študiji osrednjega pomena so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
The name of the medicine was changed to Taxespira on 12 October 2015. 
To zdravilo se imenuje Taxespira.
Further information can be found in the summary of the risk management plan. 
Opozorila so navedena v navodilu za uporabo.
Because Taxespira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
V celoti rezultati študije dokazujejo ugodno razmerje koristi in tveganja TAC v primerjavi s FAC.
• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). 
• 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom(predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer; 
Zdravilo Taxespirav kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
Taxespira contains the active substance docetaxel and is a ‘generic medicine'. 
En ml raztopine vsebuje 20 mg docetaksela (v obliki trihidrata).
For more information on generic medicines, see the question-and-answer document here. 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. 
Količina alkohola v tem zdravilu lahko spremeni učinke drugih zdravil.
This summary was last updated in 01-2016. 
Še prisotno amenorejo so med spremljanjem, v študiji TAX316, zabeležili pri 121 od 202 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients. 
Za te reakcije je bil značilen izpuščaj, vključno z lokaliziranimi erupcijami, predvsem na dlaneh in stopalih (vključno z resnim roka/noga sindromom), pa tudi na rokah, obrazu in prsnem košu; pogosto jih je spremljalo srbenje.
Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines); 
Zdravilo Taxespiraje v kombinaciji s prednizonom ali prednizolonom indicirano za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere. 
Za kombinacijo docetaksel/karboplatin v primerjavi z referenčno terapevtsko kombinacijo VCis ni bilo mogoče dokazati niti enakovredne niti neinferiorne učinkovitosti.
No additional studies in humans were needed as Taxespira is a generic medicine that is given by infusion and contains the same active substance as Taxotere. 
Omejeni podatki iz ene same nekontrolirane študije so nakazovali interakcijo med docetakselom in karboplatinom.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 28 avgust 2015
Date of first authorisation: 04 December 1998 Date of latest renewal: 21 May 2008 
Datum prve odobritve: 04. december 1998 Datum zadnjega podaljšanja: 21. maj 2008
Not known (frequency cannot be estimated from the available data) 
Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov)
Population/Visit 
Skupina/obisk
Each bottle contains 250 capsules. 
Vsaka steklenica vsebuje 250 kapsul.
• The patch can be used in everyday situations, including bathing and during hot weather. 
• Obliž je mogoče uporabljati v vsakdanjih situacijah, tudi med kopanjem in v vročem vremenu.
During the course of the treatment your doctor may adjust the dose to suit your individual needs. 
Med potekom zdravljenja vam lahko zdravnik prilagodi odmerek, da bo ustrezal vašim osebnim potrebam.
The patient reminder card should contain the following key messages: 
Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
Frequency categories are defined using the following convention: 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); not known (cannot be estimated from the available data). 
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed. 
• Bat vlecite navzgor, dokler ne doseže prave oznake za odmerek, ki vam ga je prepisal zdravnik.
• To benefit from your medicine, take it every day. 
• Da vam bo zdravilo pomagalo, ga morate jemati vsak dan.
• Seeing things that are not really there (hallucinations) 
• vidna zaznava nečesa, česar v resnici ni tam (halucinacije)
Prometax can be used with food, drink and alcohol. 
Zdravilo Prometax lahko uporabljate skupaj s hrano, pijačo in alkoholom.
However, Prometax may be used in this patient population and close monitoring is necessary. 
Vendar se zdravilo Prometax v tej populaciji bolnikov lahko uporabi in potrebno je natančno spremljanje.
They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country. 
Pakirane so v pretisnih omotih, ki so na voljo v treh različnih velikostih pakiranj (28, 56 ali 112 kapsul) in v plastičnih steklenicah s po 250 kapsulami, vendar morda v vaši državi niso na voljo vsa navedena pakiranja.
• Bathing, swimming or showering should not affect the patch. 
- Kopanje, plavanje in prhanje ne bi smeli vplivati na obliž.
Source: Study D2340-Table 11-6 and Table 11-7 
Vir: Študija D2340-preglednici 11-6 in 11-7
• Urinary incontinence (inability to retain adequate urine) 
• urinska inkontinenca (nezmožnost zadrževanja urina)
You should only open the sachet when you are ready to apply the patch. 
Vrečko odprite šele, ko boste pripravljeni na nameščanje obliža.
• The previous day's patch must be removed before applying a new one every day (see section 4.9). 
• Vsak dan je treba pred nameščanjem novega obliža odstraniti obliž predhodnega dne (glejte poglavje 4.9).
If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time. 
Če ugotovite, da ste pozabili vzeti odmerek zdravila Prometax, počakajte in ob običajnem času vzemite naslednji odmerek.
• Hyperactivity (high level of activity, restlessness) 
• hiperaktivnost (povečana stopnja aktivnosti, nemir)
At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001 
Izboljšanje za vsaj 4 točke pri ADAS-Cog brez poslabšanja pri CIBIC-Plus in PDS *p<0,05, **p<0,01, ***p<0,001
Skin application site reactions 
Reakcije na mestu apliciranja na kožo
Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. 
Vzdrževalno zdravljenje lahko nadaljujemo, dokler ima bolnik od njega terapevtske koristi.
After using the syringe 
Po uporabi brizge