natgillin/translations-raw huggingface dataset:
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease.
Pri bolnikih z akutnim koronarnim sindromom (acute coronary syndrome, ACS), ki je zdravljen s PCI, lahko predhodna prekinitev kakršnegakoli zdravila proti trombocitom, vključno z zdravilom Efient,
A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Priporoča se zdravljenje do 12 mesecev, razen, če je prekinitev zdravila Efient klinično indicirana
Heparin:
Digoksin:
e ICH=intracranial haemorrhage.
e ICH=intracranial haemorrhage, intrakranialna krvavitev.
Vascular Disorders Haematoma Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa hemoptiza
Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Bolezni prebavil gastrointestinalna krvavitev retroperitonealna krvavitev rektalna krvavitev hematohezija krvavitev iz dlesni
+ASA (N = 6741)
+ASK (N=6716)
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI.
V kliničnem preskušanju bolnikov z NSTEMI (študija ACCOAST), v kateri je bila za bolnike predvidena koronarna angiografija v obdobju 2 do 48 ur po randomizaciji, je polnilni odmerek prasugrela, dan v povprečju 4 ure pred koronarno angiografijo, povečal tveganje za večjo ali manjšo krvavitev ob postopku v primerjavi s polnilnim odmerkom prasugrela v času perkutane koronarne intervencije.
+ASA (N = 1740)
+ASK (N=1736)
In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving Efient, there was no relevant effect of genetic variation in CYP3A5, CYP2B6, CYP2C9, or CYP2C19 on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
zaradi genetske variacije CYP3A5, CYP2B6, CYP2C9 ali CYP2C19 ni bilo pomembnega učinka na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Efient 10 mg filmsko obložene tablete Efient 5 mg filmsko obložene tablete
f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
f Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl vendar < 5 g/dl.
The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Učinkovitost prasugrela je bila neodvisna od odmerka ASK (75 mg do
Effects of Efient on other medicinal products Digoxin:
Učinki zdravila Efient na druga zdravila
There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Terapevtske izkušnje pri bolnikih z blago in zmerno okvaro jeter so omejene (glejte poglavje 4.4).
Talk to your doctor before taking Efient.
Pred začetkom jemanja zdravila Efient se posvetujte z zdravnikom.
Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Po zdravljenju, v 7 do 9 dneh po dajanju enkratnega 60 mg polnilnega odmerka prasugrela in v 5 dneh po prekinitvi vzdrževalnega odmerjanja v stanju dinamičnega ravnovesja, se je agregacija trombocitov postopno vrnila na osnovne vrednosti.
* ICH=intracranial haemorrhage.
d ICH=intracranial haemorrhage, intrakranialna krvavitev.
3.0% (0.5% fatal)
3,0 % (0,5 % smrtno)
c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
c Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 5 g/dl.
2.2% (0.2% fatal) a
2,2 % (0,2 % smrtno) a
3.8% (0.2% fatal)
3,8 % (0,2 % smrtno)
Efient contains lactose
Zdravilo Efient vsebuje laktozo.
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
Titanov dioksid (E171)
Bleeding
Krvavitev
Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
V obdobju 7 dni po prekinitvi prasugrela se pri bolnikih, ki so imeli kirurški poseg aortokoronarnega obvoda (Coronary Artery Bypass Graft, CABG), lahko pojavita povečana pogostnost (3-krat) in resnost krvavitve (glejte poglavje 4.8).
In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg.
približno 19 % višji pri kitajskih, japonskih in korejskih preiskovancih, v primerjavi z AUC pri belcih, zlasti zaradi višje izpostavljenosti pri azijskih osebah < 60 kg. Razlik v izpostavljenosti pri kitajskih, japonskih in korejskih preiskovancih ni bilo.
How to store Efient
Shranjevanje zdravila Efient
Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
V študiji TRITON je pogostnost bolnikov, ki so imeli krvavitev, nepovezano s CABG, prikazana v
• Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
• Alergijske reakcije (izpuščaj, srbenje, otekle ustnice/jezik ali težko dihanje) • Spontana krvavitev iz očesa, danke, dlesni ali v trebuh okrog notranjih organov
The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Pri bolnikih, pri katerih srčna anatomija ni določena in je možen nujni CABG, je treba skrbno razmisliti o koristih in tveganjih prasugrela.
• Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
• Hematom (podkožna krvavitev na mestu injiciranja ali v mišico, ki povzroča oteklino) • Nizek hemoglobin ali nizko število rdečih krvnih celic (anemija)
This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2).
Zdravilo Efient moramo dati kot enkratni 60 mg polnilni odmerek in nato nadaljevati s 5 mg odmerkom enkrat na dan. 10 mg vzdrževalni odmerek ni priporočljiv, in sicer zaradi večje izpostavljenosti aktivnemu presnovku prasugrela in povečanemu tveganju za krvavitev ob prejemanju 10 mg odmerka enkrat na dan pri bolnikih, ki tehtajo < 60 kg, v primerjavi z bolniki ≥ 60 kg (glejte poglavja 4.4, 4.8 in 5.2).
Prasugrel must not be used in patients with severe hepatic impairment (see section 4.
Prasugrela ne smemo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
e Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl vendar < 5 g/dl.
1.6% (0.2% fatal)
1,6 % (0,2 % smrtno)
QUALITATIVE AND QUANTITATIVE COMPOSITION Efient 10 mg:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Immune system disorders
Organski sistem Pogosti
The maximum inhibition by prasugrel of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition of platelet aggregation by 1 hour.
Maksimalno zaviranje agregacije trombocitov, inducirane z ADP, s prasugrelom je 83 % pri 5 µM ADP in 79 % pri 20 µM ADP.
Nonfatal stroke
Okvara ledvic
Rare side effects (may affect up to 1 in 1,000 people)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • Nizko število trombocitov
Each tablet contains 10 mg prasugrel (as hydrochloride).
Ena tableta vsebuje 10 mg prasugrela (v obliki klorida).
Clopidogrelb +ASA (N = 6716)
prasugrelb +ASK (N=6741)
This effect is likely to be of clinical concern only when prasugrel is co-administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
CYP2B6 in imajo ozko terapevtsko širino (npr. ciklofosfamid, efavirenz).
Clopidogrelb +ASA (N = 1736)
prasugrelb +ASK (N=1740)
Bleeding risk
Smrtno nevarnac
2.9% (0.1% fatal)
2,9 % (0,1 % smrtno)
6.9% (0.1% fatal)
6,9 % (0,1 % smrtno)
Each tablet contains 5 mg prasugrel (as hydrochloride).
Ena tableta vsebuje 5 mg prasugrela (v obliki klorida).
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih udarnina post-operativna krvavitev podkožni hematom
bAny intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
b Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 5 g/dl.
6.5% (0.3% fatal)
6,5 % (0,3 % smrtno)
Prasugrel
Dojenje
Efient 5 mg: Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other.
Rumene tablete v obliki dvojne puščice, z vtisnjenim “5 MG” na eni strani in “4760” na drugi strani.
NAME OF THE MEDICINAL PRODUCT Efient 5 mg film-coated tablets prasugrel
IME ZDRAVILA Efient 5 mg filmsko obložene tablete prasugrel
3.3% (0.1% fatal)
3,3 % (0,1 % smrtno)
2.6% (0.3% fatal)
2,6 % (0,3 % smrtno)
Haematuria
pvrednost
Adults
Bolniki
4.2% (0.3% fatal)
4,2 % (0,3 % smrtno)
Efient 5 mg film-coated tablets.
PRETISNI OMOT 5 mg FILMSKO OBLOŽENIH TABLET
The usual dose of Efient is 10 mg per day.
Običajen odmerek zdravila Efient je 10 mg na dan. Vaše zdravljenje boste začeli z enkratnim odmerkom 60 mg.
Prasugrel should be used with caution in patients ≥ 75 years of age due to the potential risk of bleeding in this population
Prasugrel moramo uporabljati previdno pri bolnikih ≥ 75 let,
CABG-related bleeding
Krvavitev, povezana z aortokoronarrnim obvodom (CABG)
1.4% (0.1% fatal)
1,4 % (0,1 % smrtno)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Subcutaneous haematoma
Žilne bolezni hematom
Efient 10 mg: Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other.
Bež tablete v obliki dvojne puščice, z vtisnjenim “10 MG” na eni strani in “4759” na drugi strani.
2.2% (0.3% fatal)
2,2 % (0,3 % smrtno)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 10 mg FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 10 mg FILMSKO OBLOŽENIH TABLET
A delayed and decreased exposure to oral P2Y12 inhibitors, including prasugrel and its active metabolite, has been observed in patients with acute coronary syndrome treated with morphine.
Pri bolnikih z akutnim koronarnim sindromom, zdravljenih z morfinom, so opazili zakasnjeno in zmanjšano izpostavljenost peroralnim zaviralcem P2Y12, vključno s prasugrelom in njegovim aktivnim presnovkom.
Tabulated summary of adverse reactions
V preglednici predstavljeni neželeni učinki
Patients < 60 kg Non-CABG-related TIMI major or minor bleeding rates:
Stopnje večjih in manjših krvavitev po TIMI, nepovezanih s CABG:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 5mg FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 5 mg FILMSKO OBLOŽENIH TABLET
Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed on one side and “4760” on the other.
Efient 5 mg: Tablete so rumene barve, v obliki dvojne puščice, z vtisnjenim “5 MG” na eni strani in
Prasugrel is not detected in plasma following oral administration.
Po peroralnem dajanju prasugrela v plazmi ni zaznati.
1.3% (0.1% fatal)
1,3 % (0,1 % smrtno)
Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) - body weight of less than 60 kg.
- nedavni kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) - nedavna ali ponovna krvavitev iz želodca ali črevesja (npr. želodčni ulkus ali polipi debelega črevesja)
NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets prasugrel
IME ZDRAVILA Efient 10 filmsko obložene tablete prasugrel
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN
Prasugrel 10 mg
Efient 10 mg:
Class
SERIJE
Efient 10 mg: The tablets are beige and double-arrow-shaped, with “10 MG” debossed on one side and “4759” on the other.
Efient 10 mg: Tablete so bež barve, v obliki dvojne puščice, z vtisnjenim “10 MG” na eni strani in
This is usually only short-lasting.
To je običajno le kratkotrajno.
You may then hear or feel a click.
Pri tem lahko slišite ali začutite klik.
This is normal and does not affect your dose.
To je normalno in ne vpliva na odmerek.
more than 108
več kot 108
less than 71
manj kot 71
This is especially important if you take more than one type of insulin.
To je še posebej pomembno, če uporabljate več kot le eno vrsto insulina.
The reactions usually disappear after a few days.
Reakcije običajno minejo po nekaj dneh.
Signs of a serious allergic reaction may include:
Znaki resne alergijske reakcije lahko vključujejo:
These may be signs of a very serious condition called ketoacidosis.
To so lahko znaki zelo resnega stanja, ki ga imenujemo ketoacidoza.
30 months.
30 mesecev
Detailed instructions for use are provided on the other side of this leaflet.
Podrobna navodila za uporabo se nahajajo na drugi strani tega navodila.
This could be dangerous to yourself or others.
S tem lahko ogrozite sebe ali druge.
This may constitute a risk in situations where these abilities are of special importance (e.g., driving a car or using machines).
To lahko predstavlja tveganje pri dejavnostih, pri katerih so takšne sposobnosti še posebej pomembne (npr. vožnja vozil ali upravljanje strojev).
What others need to do if you pass out
Kaj morajo storiti drugi, če se onesvestite
Make sure you select the full dose you need.
Poskrbite, da boste izbrali celoten odmerek, ki ga potrebujete.
• not give you any food or drink because you may choke.
• ne smejo pa vam dajati hrane ali pijače, saj se lahko zadušite.
Date of first authorisation: 09 January 2017
Datum prve odobritve: 09.01.2017
Unit No adjustment
Enota Brez prilagoditve
This is normal, but you must still check the insulin flow.
To je normalno, vendar pa morate kljub temu še preveriti pretok insulina.
Be especially aware of the following:
Še posebej pozorni bodite na:
Travelling between time zones
Potovanja med različnimi časovnimi pasovi
Once empty, it must be disposed of.
Ko je prazen, ga morate zavreči.
The observed effects and the safety profiles were comparable between all age groups.
Opaženi učinki in varnostne značilnosti so bile v vseh starostnih skupinah primerljive.
Your doctor will decide together with you:
Zdravnik bo skupaj z vami določil:
6 How much insulin is left?
6 Koliko insulina je še preostalo?
• In this case - you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
• V tem primeru niste prejeli nič zdravila, tudi če se je števec odmerka premaknil od začetnega odmerka, ki ste ga nastavili.
Three simple steps to avoid low or high blood sugar are:
Trije enostavni koraki, da se izognete nizkemu ali visokemu krvnemu sladkorju so:
These reactions are usually mild and transitory and they normally disappear during continued treatment.
Te reakcije so običajno blage in prehodne, med nadaljevanjem zdravljenja pa običajno izzvenijo.
Race and Ethnicity
Rasa in etnična pripadnost
Before travelling between different time zones, the patient should seek the doctor's advice.
Pred potovanjem med različnimi časovnimi pasovi se mora bolnik posvetovati z zdravnikom.
• losing your appetite
• izguba apetita,
• you suddenly feel unwell with sweating
• nenadno slabo počutje z znojenjem,
Suggested initial dose is 4 units at one or more meals.
Priporočeni začetni odmerek je 4 enote pri enem ali več obrokih.
Concomitant illness
Sočasne bolezni
Look through the insulin window.
Poglejte skozi insulinsko okence.
You should therefore monitor your blood sugar level more often than usual.
Koncentracijo krvnega sladkorja morate zato nadzirati pogosteje kot običajno.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Po porodu se potreba po insulinu običajno hitro vrne na vrednosti pred nosečnostjo.
6 Inject the insulin under the skin.
6 Insulin injicirajte pod kožo.
Reduce dose by 1 unit No dose adjustment more than 6.0
Odmerek zmanjšajte za 1 enoto Brez prilagoditve odmerka več kot 6,0
• turn you on your side to avoid choking
• položiti na bok, da se prepreči dušenje,
• urinating more often
• pogostejše uriniranje,
Dose counter stopped: 16 units left
števec odmerka se je ustavil: preostalo je še 16 enot
This is a build-up of acid in the blood because the body is breaking down fat instead of sugar.
To je kopičenje kisline v krvi, ker telo presnavlja maščobe namesto sladkorja.
The medicinal product must not be diluted or mixed with any other medicinal products except infusion fluids as described in section 4.2.
Zdravila ne smemo redčiti ali mešati z drugimi zdravili, razen z infuzijskimi tekočinami, kot je opisano v poglavju 4.2.
• Test your urine for ketones.
• Preverite ketone v urinu.
This must be considered when prescribing Fiasp.
To je treba upoštevati pri predpisovanju zdravila Fiasp.
• if the protective cap on the vial is loose or missing.
• če zaščitna zaporka na viali ni trdno pričvrščena ali manjka.
However, the dosage may need to be adjusted.
Kljub temu pa bo odmerek zdravila morda treba prilagoditi.
• difficulty in concentrating
• težave s koncentracijo,
• If you do not respond to a glucagon injection, you will have to be treated in a hospital.
• Če se na injekcijo glukagona ne boste odzvali, bo potrebno zdravljenje v bolnišnici.
• get medical help straight away
• nemudoma poiskati zdravniško pomoč,
Remove the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle.
Odstranite iglo, kot je opisano pod točko 5, in ponovite vse korake, začenši s točko 1, Pripravite injekcijski peresnik z novo iglo.
• Always carry products containing sugar with you.
• vedno imejte pri sebi živilo, ki vsebuje sladkor.
• Give a correction dose of insulin if you have been taught how to do this.
• Uporabite korekcijski odmerek insulina, če so vas o tem ustrezno poučili.
Never use a bent or damaged needle.
Nikoli ne uporabite zvite ali poškodovane igle.
Adverse reactions listed below (Table 2) are based on data from 6 completed therapeutic confirmatory trials in adults.
V nadaljevanju navedeni neželeni učinki (preglednica 2) temeljijo na podatkih iz 6 dokončanih terapevtskih potrditvenih preskušanj pri odraslih.
2 Remove the protective cap from the vial.
2 Odstranite zaščitno zaporko z viale.
2880 Bagsværd Denmark
2880 Bagsvaerd Danska
When using other medicines, ask your doctor if your treatment needs to be adjusted.
Če uporabljate druga zdravila, se posvetujte z zdravnikom, če je treba zdravljenje kakor koli prilagoditi.
Inject the air into the vial.
Zrak iztisnite v vialo.
No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
Med starejšimi in mlajšimi bolniki niso opazili razlik v varnosti in učinkovitosti.
If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Če se kapljica še vedno ne pojavi, zamenjajte iglo in še enkrat ponovite korake od 2A do 2C.
• If you have ketones, seek medical help straight away.
• Če ugotovite prisotnost ketonov, nemudoma poiščite zdravniško pomoč.
The dose selector changes the number of units.
Izbirnik odmerka spreminja število enot.
The symptoms of hypoglycaemia usually occur suddenly.
Simptomi hipoglikemije se običajno pojavijo nenadoma.
Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Povejte jim kaj se lahko zgodi v primeru nizkega krvnega sladkorja, vključno s tveganjem, da se onesvestite.
Avoiding low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Preprečevanje nizkega krvnega sladkorja (hipoglikemije) je še posebej pomembno za zdravje otroka.
The 95% confidence interval is stated in ‘[]' A Meal test
95 % interval zaupanja je naveden v
The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0.5 and 1.0 unit/kg/day.
Skupna dnevna potreba po insulinu je pri posameznih odraslih, mladostnikih in otrocih lahko različna, običajno pa se giblje med 0,5 in 1,0 enote/kg/dan.
Use the injection technique advised by your doctor or nurse.
Uporabite tehniko injiciranja, ki sta vam jo svetovala zdravnik ali medicinska sestra.
The safety and efficacy of Fiasp have been established in elderly patients aged 65 to 75 years.
Varnost in učinkovitost zdravila Fiasp pri starejših bolnikih, starih od 65 do 75 let, sta bili dokazani.
• Do not leave the pen in a car or other place where it can get too hot or too cold.
• Injekcijskega peresnika ne puščajte v avtomobilu ali na drugem mestu, kjer bi lahko bil izpostavljen previsokim ali prenizkim temperaturam.
• you have been given an injection of glucagon
• ste prejeli injekcijo glukagona,
One (1) unit of Fiasp corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.
Ena (1) enota zdravila Fiasp ustreza 1 mednarodni enoti humanega insulina ali 1 enoti drugega hitrodelujočega insulinskega analoga.
• how much Fiasp you will need at each meal
• koliko zdravila Fiasp morate injicirati pri vsakem obroku,
• anabolic steroids - such as testosterone
• anabolne steroide (kot je testosteron),
Speak to your doctor if you need to inject your insulin by another method.
Pogovorite se z zdravnikom, če si morate insulin injicirati na drug način.
However, long-term glycaemic control decreases the risk of diabetic retinopathy and neuropathy.
Kljub temu pa se pri dolgoročni urejenosti glikemije zmanjša tveganje za diabetično retinopatijo in nevropatijo.
• High blood sugar (hyperglycaemia) frequency not known (cannot be estimated from the available data)
• Visok krvni sladkor (hiperglikemija) (neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti))
• you have had too low blood sugar a few times recently.
• ste pred kratkim imeli večkrat nizek krvni sladkor.
Before using Fiasp in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, high or low blood sugar or failure of the pump system.
Pred uporabo zdravila Fiasp v sistemu s črpalko morate dobiti izčrpna navodila o uporabi in informacije o tem, kako ukrepati v primeru bolezni, visokega ali nizkega krvnega sladkorja ali odpovedi sistema s črpalko.
Insulin treatment of the nursing mother presents no risk to the baby.
Zdravljenje doječe matere z insulinom ne predstavlja nobene nevarnosti za dojenega otroka.
If no drop appears, repeat steps 2A to 2C up to 6 times.
Če se kapljica ne pojavi, ponovite korake od 2A do 2C, vendar ne več kot 6-krat.
• when to check your blood sugar level and if you need a higher or lower dose.
• kdaj morate preveriti koncentracijo krvnega sladkorja in kdaj morate uporabiti večji ali manjši odmerek zdravila.
Push the air out of the syringe and check that the dose is correct.
Iz injekcijske brizge iztisnite zrak in preverite, če je odmerek pravilen.