natgillin/translations-raw huggingface dataset:
Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors with these medicines can be found in the guidance on risk minimisation strategies for high-strength and fixed-combination insulin products.
Več informacij o varni uporabi teh zdravil in drugih načinih zmanjševanja morebitnih tveganj za napake pri zdravljenju s temi zdravili je na voljo v navodilu o strategijah zmanjševanja tveganja za insulinska zdravila z veliko jakostjo in v fiksnih kombinacijah.
Guidance on prevention of medication errors with highstrength insulins
Navodilo za preprečevanje napak pri zdravljenju z insulini velike jakosti
The strength of the insulin formulation should also be always included in the prescription.
Jakost insulinskega pripravka je treba vedno vključiti v recept.
• During the switch to high-strength insulin and in the weeks after the switch you should measure your blood sugar levels more frequently.
• Med prehodom na insulin velike jakosti in v tednih po prehodu si morate krvni sladkor meriti pogosteje.
• If different short-and long-acting insulins are being prescribed together, the differences in appearance and use between the two pen devices must be highlighted.
• Če so skupaj predpisani kratko- in dolgodelujoči insulini, je treba poudariti razlike med videzom in uporabo obeh peresnikov.
Read the instructions in your package leaflet carefully before using this medicine.
Pred uporabo tega zdravila natančno preberite navodilo za uporabo.
Medicines containing high-strength insulin may allow patients to receive a high dose in a single injection, and help meet an increasing need for higher doses of insulin.
Zdravila, ki vsebujejo insulin velike jakosti, omogočajo bolnikom večji odmerek v eni sami injekciji in jim pomagajo pri pokrivanju naraščajoče potrebe bo večjih odmerkih insulina.
• Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the insulin pen device.
• Slepe ali slabovidne bolnike je treba poučiti, naj vedno poiščejo pomoč nekoga, ki dobro vidi in je usposobljen za uporabo insulinskega peresnika.
The dose counter of the pen device displays the number of units of insulin irrespective of strength.
Števec odmerkov na peresniku prikazuje število enot insulina, ne glede na jakost.
• Always prescribe the insulin dose in units (“units” to be spelled out and stated in lower case) and include the dose frequency.
• Odmerek insulina vedno predpisujte v enotah („enote“ je treba izpisati in navesti z malimi črkami) in določite pogostnost odmerjanja.
A high-strength insulin is a medicine that contains insulin at a concentration of more than the standard 100 units/ml, which for many years has been the only strength available across the EU.
Insulin velike jakosti je zdravilo, ki vsebuje insulin v koncentraciji, ki presega standardnih 100 enot/ml, kar je bila dolgo let edina možna jakost, na voljo v EU.
• Ensure that electronic and paper systems used to prescribe and dispense these medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
• Poskrbite, da elektronski in papirnati sistemi, ki jih uporabljate za predpisovanje in izdajanje teh zdravil, omogočajo pravilno izbiro zdravila in preprečujejo zamenjavo z drugimi zdravili.
Patients and healthcare professionals are therefore advised to take extra care when using highstrength insulin medicines and to carefully follow the recommendations given below.
Bolnikom in zdravstvenim delavcem zato svetujemo, da so pri uporabi insulina velike jakosti posebno previdni in da skrbno upoštevajo spodaj navedena priporočila.
Examples of high-strength insulin formulations are Tresiba (200 units/ml insulin degludec) and Humalog (insulin lispro 200 units/ml).
Primera insulinskih pripravkov velike jakosti sta Tresiba (200 enot/ml insulina degludek) in Humalog (200 enot/ml insulina lispro).
• If the concentration of insulin stated on your medicine pack is higher than 100 units/ml, you are using high-strength insulin.
• Če je koncentracija insulina, navedena na ovojnini zdravila, večja od 100 enot/ml, uporabljate insulin velike jakosti.
Toujeo (insulin glargine 300 units/ml), although it is also a high-strength insulin, is not bioequivalent to insulin glargine 100 units/ml (such as Lantus) which means that these insulins are not interchangeable.
Toujeo (insulin glargin 300 enot/ml) je sicer tudi insulin velike jakosti, vendar ni bioekvivalenten insulinu glarginu 100 enot/ml (kot je Lantus), kar pomeni, da ta insulina nista zamenljiva.
• Ensure that storage arrangements for combination insulin medicines facilitate correct selection of the medicine and avoid confusion with other medicines.
• Poskrbite, da način shranjevanja kombiniranih insulinskih zdravil omogoča pravilno izbiro zdravila in preprečuje zamenjavo z drugimi zdravili.
In addition, healthcare professionals are encouraged to take the following precautions when storing and dispensing high strength insulins:
Poleg tega zdravstvenim delavcem priporočamo tudi, da pri shranjevanju in izdajanju insulinov velike jakosti upoštevajo naslednje previdnostne ukrepe:
1 In exceptional cases your dose may need to be changed because of differences in the way the high-strength and standard strength solutions are taken up into the body - your doctor will advise you if this is needed.
1 V izjemnih primerih bo morda treba vaš odmerek spremeniti, ker telo raztopino z veliko in raztopino s standardno jakostjo privzema drugače.
However, there are differences in the way high-strength insulin products are used compared with existing insulin formulations of standardstrength and there is therefore a risk of medication errors and accidental mix-ups.
Vendar pa se zdravila z insulinom velike jakosti uporabljajo drugače kot obstoječi insulinski pripravki standardne jakosti, zato obstaja tveganje za napake pri zdravljenju in nenamerne zamenjave.
Therefore, when switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approx. 10-18%) may be needed to achieve target ranges for plasma glucose level.
Zato se pri prehodu z insulina glargina 100 enot/ml na zdravilo Toujeo lahko ohrani enako število enot, vendar bo za doseganje ciljnih razponov ravni glukoze v plazmi morda potreben večji odmerek zdravila Toujeo (približno 10-18 %).
• Explain differences in the design of the package and the pre-filled pen for high-strength insulins and standard-strength insulins, especially if the patient has been transferred from standardstrength insulin to high-strength insulin.
• Pojasnite razlike v zasnovi pakiranja in napolnjenega peresnika med insulini velike jakosti in insulini standardne jakosti, zlasti če je bolnik prešel z insulina standardne jakosti na insulin velike jakosti.
• If you are using other types of insulin alongside your high-strength insulin, always check the strength on the packaging and the label of each type of insulin before every injection to avoid mixing them up.
• Če poleg insulina velike jakosti uporabljate še druge vrste insulina, pred vsakim injiciranjem na ovojnini in nalepki vedno preverite jakost vsake vrste insulina, da jih ne zamenjate.
• When switching patients from standard-strength insulin to an insulin formulation that is not bioequivalent (such as Toujeo, insulin glargine 300 units/ml), switching can be done on a unit to unit basis, but the dose may need to be adjusted to achieve target ranges for plasma glucose level.
• Kadar bolniki preidejo z insulina standardne jakosti na insulinski pripravek, ki ni bioekvivalenten (kot je Toujeo, insulin glargin 300 enot/ml), se pri prehodu lahko ohrani enako število enot, morda pa bo treba odmerek prilagoditi tako, da se doseže ciljno območje ravni glukoze v plazmi.
• Pharmacists are encouraged to check that patients and carers are able to read the strength of insulin and the dose counter of the pen device before dispensing the medicine.
• Farmacevtom priporočamo, da pred izdajo zdravila preverijo, ali bolniki in negovalci lahko odčitajo jakost insulina in števec odmerkov na peresniku.
• If you are being transferred from standard-strength insulin to a high-strength insulin you will usually be using the same number of units that you were when using the standard-strength insulin.1 This also applies if you are being transferred from a high-strength to a standard-strength insulin.
• Če preidete z insulina standardne jakosti na insulin velike jakosti, boste običajno uporabljali enako število enot, kot ste jih pri insulinu standardne jakosti.1 To velja tudi, če preidete z insulina velike jakosti na insulin standardne jakosti.
• The insulin is supplied in a pre-filled pen and it should only be used with this device.
• Insulin je na voljo v napolnjenem peresniku in ga morajo tudi uporabljati samo s peresnikom.
Healthcare professionals must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose can result.
Zdravstveni delavci insulina nikoli ne smejo z brizgo potegniti iz napolnjenega peresnika, saj lahko pride do resnega prevelikega odmerjanja.
• You must never use a syringe to withdraw insulin from a pre-filled pen otherwise severe overdose may result.
• Insulina nikoli ne potegnite z brizgo iz napolnjenega peresnika, saj lahko pride do resnega prevelikega odmerjanja.
• If you are being transferred from standard strength insulin to high-strength insulin, your healthcare professional will highlight any differences in design between your high-strength insulin pen and other standard-strength insulin pens.
• Če preidete z insulina standardne jakosti na insulin velike jakosti, vam bo zdravstveni delavec pojasnil razlike v zasnovi med peresnikom za insulin velike jakosti in drugimi peresniki za insuline standardne jakosti.
• The high-strength insulin is supplied in a pre-filled pen and it should only be used with this device.
• Insulin velike jakosti je na voljo v napolnjenem peresniku in ga morate tudi uporabljati samo s peresnikom.
• Tell patients to closely monitor their blood sugar levels when starting high-strength insulin and in the weeks after.
• Bolnikom povejte, naj ob prehodu na insulin velike jakosti in v tednih za tem skrbno spremljajo krvni sladkor.
Call your doctor immediately.
Nemudoma pokličite zdravnika.
Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
Datum prve odobritve: 15. maj 2009 Datum zadnjega podaljšanja: 15. maj 2014
In a small number of cases, these may be signs of a second degree burn and need urgent attention.
V manjšem številu primerov, so lahko to znaki opeklin druge stopnje in zahtevajo nujno pozornost.
Do not touch the patch with your hands.
Ne dotikajte se obliža z rokami.
• Risk Management Plan (RMP)
o Načrt za obvladovanje tveganj (RMP)
Sensory function
Senzorična funkcija
For all three aetiologies efficacy was maintained throughout the 12-week study period.
Pri vseh treh etiologijah se je učinkovitost ohranila vseh 12 tednov trajanja študije.
Cleansing gel contains:
Čistilni gel vsebuje:
Latex gloves should NOT be worn as they do not provide adequate protection.
Rokavice iz lateksa NISO primerne, saj ne zagotavljajo zadostne zaščite.
No more than 4 patches should be used at the same time.
Hkrati se lahko uporabijo največ 4 obliži.
o Frequency not known: frequency cannot be estimated from the available data
o neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Remove anaesthetic.
Odstranite anestetik.
Do not touch your eyes, mouth or other sensitive areas.
Ne dotikajte se oči, ust ali drugih občutljivih predelov.
For instructions on handling and disposal of the treatment materials see section 6.6.
Za navodila o rokovanju in odstranjevanju materialov za zdravljenje glejte poglavje 6.6.
Do not attempt to remove the patch yourself.
Ne poskušajte sami odstraniti obliža.
• administration of capsaicin should only be done under medical supervision
• aplikacija kapsaicina lahko poteka samo pod zdravniškim nadzorom
Cleansing gel
Čistilni gel
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca
Monitoring and management of application site reactions
Spremljanje in obvladovanje reakcij na mestu uporabe
Disposal of used and unused Qutenza patches.
Odstranjevanje uporabljenih in neuporabljenih obližev Qutenza.
Herpes zoster
Občasni herpes zoster
Increased blood pressure
Zvišanje krvnega tlaka
However, caution should be exercised when prescribing to pregnant women.
Kljub temu je pri predpisovanju zdravila nosečnicam potrebna previdnost.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake „EXP“.
This educational programme will include: - recommendations regarding the general handling and disposal measures for Qutenza
Izobraževalni program vključuje: - priporočila o splošnem rokovanju z zdravilom Qutenza in ukrepih za njegovo odstranjevanje,
TUBE OF CLEANSING GEL - LABEL
TUBA ČISTILNEGA GELA - NALEPKA
The use of a mask and protective glasses is recommended, see section 4.2.
Priporočljiva je uporaba maske in zaščitnih očal, glejte poglavje 4.2.
A carcinogenicity study performed in mice indicates that capsaicin is not carcinogenic.
Študija karcinogenosti, ki je bila izvedena na miših, dokazuje, da kapsaicin ni karcinogen.
These later-stage effects of capsaicin are frequently referred to as “desensitization” and are thought to underlie the pain relief.
Ti učinki kapsaicina v kasnejši fazi se pogosto imenujejo „desenzitizacija“ in naj bi vplivali na lajšanje bolečine.
The cutaneous patch should be applied to the most painful skin areas (using up to a maximum of 4 patches).
Dermalni obliž je treba aplicirati na najbolj boleče predele kože (skupno največ 4 obliže).
For this case a relationship with Qutenza could not be excluded.
Za ta primer povezave z zdravilom Qutenza niso mogli izključiti.
• because of the risk of accidental exposure, the use of nitrile gloves, a mask and protective glasses are recommended
• zaradi tveganja nenamerne izpostavljenosti zdravilu je priporočena uporaba nitrilnih rokavic, maske in zaščitnih očal
If you experience very severe pain, ask your doctor to remove the patch.
Če občutite zelo hudo bolečino, prosite vašega zdravnika, da vam obliž odstrani.
According to the EC Scientific Committee on Food, the average European oral intake of capsaicin is 1.5 mg/day (0.025 mg/kg/day for a 60 kg person) and the highest dietary exposure is 25 to 200 mg/day (up to 3.3 mg/kg/day for a 60 kg person).
Po podatkih Znanstvenega odbora za hrano Evropske skupnosti je pri Evropejcih povprečen peroralni vnos kapsaicina 1,5 mg/dan (0,025 mg/kg/dan za osebo, težko 60 kg), največja izpostavljenost s prehrano pa je 25 do 200 mg/dan (do 3,3 mg/kg/dan za osebo, težko 60 kg).
Damaged nerves in your skin may occur as a result of a variety of diseases such as shingles, HIV infection, diabetes, certain medicines and other conditions.
Poškodovani živci v koži so lahko posledica številnih bolezni, na primer pasovca, okužbe s HIV, sladkorne bolezni, določenih zdravil in drugih okoliščin.
Keep in place for 30 or 60 minutes depending on the location of treatment.
Pustite učinkovati 30 ali 60 minut, odvisno od mesta zdravljenega predela.
There is no antidote to capsaicin.
Antidot za kapsaicin ne obstaja.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Because of the pain, your blood pressure may go up and therefore, your doctor will measure your blood pressure several times during your treatment.
Zaradi bolečine se vam lahko zviša krvni tlak, zato bo zdravnik med uporabo zdravila krvni tlak večkrat izmeril.
• to monitor blood pressure during the treatment procedure
• spremljanju krvnega tlaka med postopkom zdravljenja;
In general, the proportions of PHN patients with systemic exposure to capsaicin increased with larger treatment areas and with longer treatment durations.
V splošnem se je delež bolnikov s PHN pri sistemski izpostavljenosti kapsaicinu povečeval z večanjem zdravljene površine in s podaljševanjem trajanja zdravljenja.
The painful area should be determined by the physician and marked on the skin.
Boleči predel mora določiti zdravnik in ga označiti na koži.
Supportive measures should be taken as clinically needed.
Če se izkaže za klinično potrebno, je treba izvajati podporne ukrepe.
No formal interaction studies with other medicinal products have been performed as only transient low levels of systemic absorption have been shown to occur with Qutenza.
Formalne študije medsebojnega delovanja z drugimi zdravili niso bile izvedene, saj se je izkazalo, da se zdravilo Qutenza le prehodno nizko sistemsko absorbira.
Your doctor or nurse will remove it for you.
Namesto vas ga bo odstranil zdravnik ali medicinska sestra.
Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain.
Zdravljenje z zdravilom Qutenza je mogoče ponavljati vsakih 90 dni, glede na vztrajnost ali ponovitev bolečine.
Qutenza acts locally on your skin and is not expected to influence other medicines.
Zdravilo Qutenza učinkuje lokalno na kožo in ni pričakovati, da bi vplivalo na druga zdravila.
Following hair removal and washing, the skin should be thoroughly dried.
Po odstranitvi dlak in umivanju je treba kožo temeljito osušiti.
Blood pressure should be monitored during the treatment procedure.
Med postopkom zdravljenja je treba nadzirati krvni tlak.
Delays in skeletal ossification (reductions in ossified metatarsals) were observed in a rat teratology study at dose levels higher than human therapeutic levels; the significance of this finding for humans is unknown.
Zakasnjena okostenitev skeleta (zmanjšanje okostenelih metatarzusov metatarzal) je bila opažena v študiji teratogenosti na podganah pri odmerkih, višjih od terapevtskih odmerkov pri ljudeh; pomen tega izsledka za ljudi ni znan.
As the amount of capsaicin released from the patch per hour is proportional to the surface area of application, this amounts to an estimated total maximum possible dose for a 1000 cm2 area of application of approximately 7 mg.
Ker je količina kapsaicina, ki se vsako uro sprosti iz obliža, sorazmerna površini mesta aplikacije, je ocenjen skupni maksimalni možni odmerek za mesto aplikacije v velikosti 1000 cm2 približno 7 mg.
Treatment-related discomfort
Z zdravljenjem povezane neprijetnosti
EXP Use the patch within 2 hours of opening the sachet.
EXP Obliž uporabite v 2 urah po odprtju vrečke.
There is no data in humans available on fertility.
Podatkov o vplivu na plodnost pri ljudeh ni na voljo.
Therefore, overdosing is unlikely to occur.
Preveliko odmerjanje je zato zelo malo verjetno.
Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1).
Kapsaicin oz. N-[(4-hidroksi-3-metoksifenil) metil]-8-metil (6E) nonenamid, je visoko selektivni agonist vaniloidnega receptorja 1 (ionski kanal prehodnega receptorskega potenciala) (TRPV1transient receptor potential vanilloid 1 receptor).
Qutenza therapy may be repeated at 90-day intervals, if necessary.
Zdravljenje z zdravilom Qutenza je po potrebi mogoče ponavljati v 90-dnevnih intervalih.
Following capsaicin exposure, cutaneous nociceptors become less sensitive to a variety of stimuli.
Po izpostavljenosti kapsaicinu postanejo kožni nociceptorji manj občutljivi za številne dražljaje.
Sensations from non TRPV1-expressing cutaneous nerves are expected to remain unaltered, including the ability to detect mechanical and vibratory stimuli.
Občutki iz kožnih živcev, ki ne izražajo TRPV1, bi morali ostati nespremenjeni, vključno s sposobnostjo zaznavanja mehanskih in vibracijskih dražljajev.
The MAH shall agree the details of an educational programme for health care practitioners with the National Competent Authorities and implement such programme nationally before launch.
Imetnik dovoljenja za promet z zdravilom se z nacionalnimi pristojnimi organi dogovori o podrobnostih izobraževalnega programa za zdravstvene delavce in implementira tak program na nacionalni ravni, preden da zdravilo v promet.
For painful diabetic peripheral neuropathy consistent and reproducible efficacy has been demonstrated with repeated treatments during a 52-week period.
Pri boleči diabetični periferni nevropatiji in HIV-AN so v 52-tedenskem obdobju s ponavljajočimi zdravljenji dokazali dosledno in ponovljivo učinkovitost.
Patients experiencing pain during and after patch application should be provided with supportive treatment (see section 4.4).
Bolnikom, ki doživljajo bolečino med uporabo obliža in po njej, je treba zagotoviti podporno zdravljenje (glejte poglavje 4.4).
The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the risk of aerosolisation of capsaicin.
Obliže Qutenza je treba odstraniti nežno in počasi, z zvijanjem navznoter, da se čimbolj zmanjša tveganje aerosolizacije kapsaicina.
Pharmacotherapeutic group: Anaesthetics, other local anaesthetics, ATC code: N01BX04
Farmakoterapevtska skupina: anestetiki, drugi lokalni anestetiki, oznaka ATC: N01BX04
Wait up to 60 minutes, or according to product's instructions for use.
Počakajte do 60 minut oz. kolikor je navedeno v navodilu za uporabo zdravila.
No data are available following 30-minute treatments.
Podatki za 30 minut trajajočo aplikacijo niso na voljo.
CARTON OF 1 OR 2 PATCHES
ŠKATLA Z 1 ALI 2 OBLIŽEMA
Lactating rats exposed to Qutenza daily for 3 hours showed measurable levels of capsaicin in the mothers' milk.
Pri podganah v laktaciji, ki so bile izpostavljene zdravilu Qutenza vsak dan 3 ure, so bile opažene merljive ravni kapsaicina v mleku samic.
Based on in vitro studies, approximately 1% of capsaicin is estimated to be absorbed into the epidermal and dermal layers of skin during one-hour applications.
Na osnovi študij in vitro se ocenjuje, da se med enourno aplikacijo v epidermalni in dermalni sloj kože absorbira približno 1 % kapsaicina.
Tell your doctor if the following side effects occur or get worse:
Obvestite zdravnika, če se pojavijo ali poslabšajo naslednji neželeni učinki:
• administration of Qutenza in a well ventilated area to reduce the risk of occupational exposure - instructions regarding the administration of Qutenza - warnings and precautions, including the need:
• uporaba zdravila Qutenza v dobro ventiliranem prostoru, da bi zmanjšali tveganje za poklicno izpostavljenost - navodila za aplikacijo obližev Qutenza, - opozorila in previdnostne ukrepe, vključno s potrebo po:
Do not use Qutenza on broken skin or open wounds.
Ne uporabljajte zdravila Qutenza na poškodovani koži ali odprtih ranah.
Qutenza contains capsaicin and belongs to a group of medicines called anaesthetics.
Zdravilo Qutenza vsebuje kapsaicin in spada v skupino zdravil, imenovanih anestetiki.
A mild sensitization was seen in a cutaneous sensitization study with guinea pigs.
Blaga preobčutljivost je bila opažena v študiji kožne preobčutljivosti na morskih prašičkih.
The safety and efficacy of Qutenza in children from birth to 18 years has not been established.
Varnost in učinkovitost zdravila Qutenza pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
The safety profile of Qutenza in diabetic patients was consistent with that seen in the non-diabetic population.
Varnostne značilnosti zdravila Qutenza pri sladkornih bolnikih se skladajo s tistimi, ki so ugotovljene v nediabetični populaciji.
The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm.
Topikalni anestetik je treba aplicirati tako, da prekrije celoten predel, kamor bo aplicirano zdravilo Qutenza, in 1 do 2 cm okrog tega predela.