natgillin/translations-raw huggingface dataset:
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
Pri bolnikih s sladkorno boleznijo tipa 2 so med uporabo odmerkov od 0,5 do 4 mg repaglinida dokazali od odmerka odvisno znižanje glukoze v krvi.
- The other ingredients are: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate anhydrous, colloidal silicon dioxide anhydrous, polacrilin potassium, maize starch, magnesium stearate, indigo carmine aluminium (E132) (0.5 mg tablet only), iron oxide yellow (E172) (1 mg tablet only), iron oxide red (E172) (2 mg tablet only)
- Pomožne snovi so: mikrokristalna celuloza (E460), meglumin, poloksamer 188, povidon K-30, brezvodni kalcijev hidrogenfosfat, brezvodni koloidni silicijev dioksid, polakrilin kalij, koruzni škrob, magnezijev stearat, indigotin (E132)(samo v 0,5 mg tabletah), rumeni železov oksid (E172) (samo v 1 mg tabletah), rdeči železov oksid (samo v 2 mg tabletah)
After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.
Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina: 20-39 ml/min) so rezultati po 5-dnevnem zdravljenju z repaglinidom
What you need to know before you take Repaglinide Teva
Kaj morate vedeti, preden boste vzeli zdravilo Repaglinid Teva Ne jemljite zdravila Repaglinid Teva
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.
Kombinacija z insulinom NPH (Neutral Protamine Hagedorn) ali s tiazolidindioni Preskušanja s kombiniranim zdravljenjem z NPH insulinom ali s tiazolidindioni so bila izvedena, vendar je treba profil koristi in tveganja še ugotoviti v primerjavi z drugimi kombiniranimi zdravljenji.
The resulting increased calcium influx induces insulin secretion from the β-cell.
Vdor kalcija v celico se zato zveča in to sproži izločanje insulina iz celice β.
The safety and efficacy of repaglinide in children below 18 years have not been established.
Uporaba repaglinida ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in/ali učinkovitosti.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na presnovo repaglinida lahko vplivajo številna zdravila, zato mora zdravnik upoštevati možne interakcije:
• If you have a severe liver disease.
• če imate težave z jetri.
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
Če je sočasna uporaba obeh zdravil nujna, je potrebno pazljivo spremljati vrednosti glukoze v krvi in bolnika natančno klinično spremljati.
Marketing Authorisation Holder Teva B.V.
Imetnik dovoljenja za promet z zdravilom: Teva B.V.
Warnings and precautions Talk to your doctor before taking Repaglinide Teva:
Pred začetkom jemanja zdravila Repaglinid Teva se posvetujte z zdravnikom:
In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
V študiji pri zdravih prostovoljcih se je pri sočasni uporabi repaglinida (enkratni odmerek po 0,25 mg) in ciklosporina (večkratni odmerki po 100 mg) AUC repaglinida zvečala za približno 2,5-krat in njegova Cmax za približno 1,8-krat.
Co-administration of 200 mg ketoconazole increased the repaglinide (AUC and Cmax) by 1.2-fold with profiles of blood glucose concentrations altered by less than 8% when administered concomitantly (a single dose of 4 mg repaglinide).
AUC in Cmax repaglinida 1,2-krat ob manj kot 8% spremenjenih profilih koncentracije glukoze v krvi, če sta bila aplicirana hkrati (repaglinid v enkratnem odmerku 4 mg).
EU/1/09/530/011 30 tablets EU/1/09/530/012 90 tablets EU/1/09/530/013 120 tablets EU/1/09/530/014 270 tablets EU/1/09/530/015 360 tablets
EU/1/09/530/011 30 tablet EU/1/09/530/012 90 tablet EU/1/09/530/013 120 tablet EU/1/09/530/014 270 tablet EU/1/09/530/015 360 tablet
One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
zdravljenih z repaglinidom, v primerjavi z bolniki, zdravljenimi z derivati sulfonilsečnine (glejte poglavji 4.4 in 4.8).
• If you take other medicines or suffer from liver or kidney problems (see other sections of
• uporabljate druga zdravila ali imate težave z jetri ali ledvicami (glejte ostale dele poglavja 2 Kaj morate vedeti, preden boste vzeli zdravilo Repaglinid Teva).
• Stomach pain
• bolečine v želodcu
Your blood sugar may get too high (hyperglycaemia).
Če se vam sladkor v krvi preveč zviša Sladkor v krvi se vam lahko preveč zviša (to imenujemo hiperglikemija).
EU/1/09/530/006 30 tablets EU/1/09/530/007 90 tablets EU/1/09/530/008 120 tablets EU/1/09/530/009 270 tablets EU/1/09/530/010 360 tablets
EU/1/09/530/006 30 tablet EU/1/09/530/007 90 tablet EU/1/09/530/008 120 tablet EU/1/09/530/009 270 tablet EU/1/09/530/010 360 tablet
Repaglinide Teva 0.5 mg tablets Each tablet contains 0.5 mg of repaglinide.
Repaglinid Teva 0,5 mg tablete Ena tableta vsebuje 0,5 mg repaglinida.
Repaglinide Teva 1 mg tablets Each tablet contains 1 mg of repaglinide.
Repaglinid Teva 1 mg tablete Ena tableta vsebuje 1 mg repaglinida.
Repaglinide Teva 2 mg tablets Each tablet contains 2 mg of repaglinide.
Repaglinid Teva 2 mg tablete Ena tableta vsebuje 2 mg repaglinida.
In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values.
kot CYP3A4, ter repaglinida (enkratni odmerek 0,5 mg) sistemska izpostavljenost (AUC) repaglinidu povečala za 2,3-krat (90-odstotni interval zaupanja [2,03-2,63]) kontrolne vrednosti, vrednost Cmax povečala za 1,6-krat (90-odstotni interval zaupanja [1,42-1,84]), vrednost glukoze v krvi pa nekoliko pomembno zmanjšala.
EU/1/09/530/001 30 tablets EU/1/09/530/002 90 tablets EU/1/09/530/003 120 tablets EU/1/09/530/004 270 tablets EU/1/09/530/005 360 tablets
EU/1/09/530/001 30 tablet EU/1/09/530/002 90 tablet EU/1/09/530/003 120 tablet EU/1/09/530/004 270 tablet EU/1/09/530/005 360 tablet
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Sočasna uporaba gemfibrozila (600 mg dvakrat dnevno) zaviralca CYP2C8, in repaglinida (enkratni odmerek 0,25 mg), je pri zdravih prostovoljcih zvečalaAUC repaglinida za 8,1-krat inCmax za 2,4-krat.
NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets
IME ZDRAVILA Repaglinid Teva 0,5 mg tablete Repaglinid Teva 1 mg tablete Repaglinid Teva 2 mg tablete
INFORMATION IN BRAILLE Repaglinide Teva 0.5 mg tablets
PODATKI V BRAILLOVI PISAVI Repaglinid Teva 0,5 mg tablete
In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
V študiji interakcij na zdravih prostovoljcih je sočasna uporaba 250 mg klaritromicina, ki močno zavira encimski mehanizem CYP3A4, AUC repaglinida nekoliko zvečala za 1,4-krat in Cmax za 1,7-krat,
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmavcevtom.
See section 4.
4.4 in 4.5.
), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t½) as compared to patients with normal renal function.
(t1/2) v primerjavi z bolniki z normalnim delovanjem ledvic.
NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 2 mg tablets Repaglinide
IME ZDRAVILA Repaglinid Teva 2 mg tablete repaglinid
INFORMATION IN BRAILLE Repaglinide Teva 1 mg tablets
PODATKI V BRAILLOVI PISAVI Repaglinid Teva 1 mg tablete
NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide
IME ZDRAVILA Repaglinid Teva 0,5 mg tablete repaglinid
INFORMATION IN BRAILLE Repaglinide Teva 2 mg tablets
PODATKI V BRAILLOVI PISAVI Repaglinid Teva 2 mg tablete
NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 1 mg tablets Repaglinide
IME ZDRAVILA Repaglinid Teva 1 mg tablete repaglinid
Repaglinide should not be used in breast-feeding women.
Študij o uporabi repaglinida pri doječih materah ni. Doječe matere repaglinida ne smejo uporabljati.
Povidone K-30
CYP3A4.
Frequency not known
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low.
Če se vam sladkor v krvi preveč zniža, lahko doživite hipo (hipa je okrajšava za hipoglikemijo in pomeni simptome nizkega sladkorja v krvi).
Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets Repaglinide
Navodilo za uporabo Repaglinid Teva 0,5 mg tablete Repaglinid Teva 1 mg tablete Repaglinid Teva 2 mg tablete repaglinid
You should not take Repaglinide Teva if you are breast-feeding.
Ne jemljite zdravila Repaglinid Teva, če dojite.
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).
Če je sočasna uporaba nujna, je treba bolnika skrbno klinično spremljati in nadzirati vrednosti glukoze v krvi (glejte poglavje 4.4).
However, the benefit risk profile remains to be established when comparing to other combination therapies.
Tveganje za pojav hipe se lahko poveča, če jemljete druga zdravila.
Repaglinide Teva 1 mg tablet is a yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and “211” on the other side of the tablet.
Zdravilo Repaglinid Teva 1 mg tablete je rumena do svetlo rumena tableta v obliki kapsule, z vgraviranim napisom “93” na eni strani in “211” na drugi strani tablete.
Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Sočasna aplikacija trimetoprima (160 mg dvakrat dnevno), srednje močnega zaviralca CYP2C8, in repaglinida (v enkratnem odmerku 0,25 mg) je povečala AUC, Cmax int1/2 repaglinida (1,6-krat,
• Deferasirox (used to reduce chronic iron overload).
• deferasiroks (uporabljamo ga za zdravljenje kronične preobremenitve z železom), • klopidogrel (zdravilo, ki preprečuje nastajanje krvnih strdkov),
• If you have an infection or a fever.
• ste vzeli premalo zdravila Repaglinid Teva, • imate okužbo ali zvišano telesno temperaturo,
How to store Repaglinide Teva
Shranjevanja zdravila Repaglinid Teva
• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
• če imate hudo bolezen jeter, • če jemljete gemfibrozil (zdravilo za zdravljenje zvišanih maščob v krvi).
Repaglinide Teva 2 mg tablet is a mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side of the tablet.
Zdravilo Repaglinid Teva 2 mg tablete je tableta lisasto breskove barve v obliki kapsule, z vgraviranim napisom “93” na eni strani in “212” na drugi strani tablete.
Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
Variabilnost pri posameznem bolniku je majhna do zmerna (35 %),
Metabolism and nutrition disorders
Kombinacija z metforminom
A number of medicinal products are known to influence repaglinide metabolism.
- Zdravilna učinkovina je repaglinid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg of repaglinide.
Ena tableta vsebuje 0,5 mg repaglinida.
Repaglinide Teva 2 mg tablets Microcrystalline cellulose (E460) Meglumine
Repaglinid Teva 2 mg tablete mikrokristalna celuloza (E460) meglumin poloksamer 188 povidon K-30 brezvodni kalcijev hidrogenfosfat brezvodni koloidni silicijev dioksid polakrilin kalij koruzni škrob magnezijev stearat rdeči železov oksid (E172)
Repaglinide Teva 0.5 mg tablet is a light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side of the tablet.
Izgled zdravila Repaglinid Teva in vsebina pakiranja Zdravilo Repaglinid Teva 0,5 mg tablete je svetlo modra do modra tableta v obliki kapsule, z vgraviranim napisom “93” na eni strani in “210” na drugi strani tablete.
Be aware that the desired effect is not achieved if you stop taking Repaglinide Teva.
Vedite, da s prenehanjem jemanja zdravila Repaglinid Teva izgubite željeni učinek na znižanje sladkorja v krvi.
At such times diabetic control may be lost.
V takšnih okoliščinah lahko vaša sladkorna bolezen postane neurejena;
Repaglinide Teva 1 mg tablets Microcrystalline cellulose (E460) Meglumine
Repaglinid Teva 1 mg tablete mikrokristalna celuloza (E460) meglumin poloksamer 188 povidon K-30 brezvodni kalcijev hidrogenfosfat brezvodni koloidni silicijev dioksid polakrilin kalij koruzni škrob magnezijev stearat rumeni železov oksid (E172)
• ACE-inhibitors (used to treat heart conditions).
• zaviralce angiotenzinske konvertaze (zaviralce ACE; uporabljajo se za zdravljenje bolezni srca),
Repaglinide Teva 2 mg tablets Mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side.
Tableta lisasto breskove barve v obliki kapsule, z vgraviranim napisom “93” na eni strani in “212” na drugi strani tablete.
Repaglinide Teva 1 mg tablets Yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and “211” on the other.
Rumena do svetlo rumena tableta v obliki kapsule, z vgraviranim napisom “93” na eni strani in “211” na drugi strani tablete.
Bear in mind that you could endanger yourself or others.
Vedite, da lahko to ogrozi vas in druge (ljudi okoli vas).
Please see If you get a hypo on what a hypo is and how to treat it.
Za razlago in navodila za odpravo hipe prosim glejte odstavek V primeru pojava hipe.
Repaglinide Teva 0.5 mg tablets Microcrystalline cellulose (E460) Meglumine
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Repaglinid Teva 0,5 mg tablete mikrokristalna celuloza (E460) meglumin poloksamer 188 povidon K-30 brezvodni kalcijev hidrogenfosfat brezvodni koloidni silicijev dioksid polakrilin kalij koruzni škrob magnezijev stearat indigotin (E132)
Tell your doctor what happened.
Povejte zdravniku, kaj se je zgodilo.
*See next section below
*Glejte naslednje poglavje spodaj.
Date of first authorisation: 31 August 2010 Date of latest renewal: 17 July 2015
Datum prve odobritve: 31. avgust 2010 Datum zadnjegapodaljšanja: 17. julij 2015
Repeat step 5 three times.
Korak 5 ponovite trikrat.
The patient should be instructed how to do this correctly.
Bolnik mora biti poučen o tem, kako naj to pravilno stori.
It is very important to follow your doctor's instructions.
Zelo pomembno je, da se ravnate po zdravnikovih navodilih.
One hundred of these patients continued treatment for up to 26 months in an extension phase.
Sto od teh bolnikov je nadaljevalo zdravljenje v fazi podaljšanja do 26 mesecev.
• not knowing where you are (disorientated)
• ne veste, kje ste (dezorientiranost),
This should clear any blockage.
To bi moralo odstraniti blokado.
• Information on the correct indication
• informacije o pravilni indikaciji;
Abuse potential and tolerance
Možnost zlorabe in toleranca
How much to use
Koliko uporabiti
The relevance of these findings to humans is unknown.
Pomen teh izsledkov za ljudi ni znan.
Clinical signs and symptoms may be manifest from these hormonal changes.
Lahko so vidni klinični znaki in simptomi zaradi teh hormonskih sprememb.
This is called ‘priming'.
To se imenuje aktiviranje.
• Do not change the dose yourself.
• Odmerka ne spreminjajte sami.
Sit down with your head upright.
Sedite z glavo pokonci.
• You will NOT hear a click when you press down .
• Pri pritiskanju NE boste slišali klika.
Bottles contain:
Steklenice vsebujejo:
This will tilt the bottle slightly (Figure 5).
S tem boste steklenico rahlo nagnili (slika 5).
Your doctor will tell you how many sprays (1 or 2) you should use to treat your breakthrough pain episode.
Zdravnik vam bo povedal, koliko vpihov (1 ali 2) morate uporabiti za zdravljenje svoje epizode prebijajoče bolečine.
Elderly (older than 65 years)
Posebne populacije Starejši bolniki (starejši od 65 let)
Patients should be carefully monitored until an effective dose is reached.
Bolnike moramo skrbno spremljati, dokler ne dosežemo učinkovitega odmerka.
Never try to fix the nasal spray yourself or take it apart.
Nikoli ne poskušajte sami popraviti pršila za nos ali ga razstaviti.
• you suffer a severe blow to the head
• ste doživeli močan udarec v glavo;
Its primary therapeutic actions are analgesia and sedation.
Njegova primarna terapevtska učinka sta analgezija in sedacija.
The main pharmacokinetic parameters are shown in the following table.
Glavni farmakokinetični parametri so prikazani v naslednji preglednici.
Less than 7 % of an administered dose of fentanyl is excreted unchanged in the urine and only about 1 % is excreted unchanged in the faeces.
Manj kot 7 % danega odmerka fentanila se izloči nespremenjenega v urinu in samo okrog 1 % se ga izloči nespremenjenega v blatu.
• Breakthrough pain comes on suddenly.
• Prebijajoča bolečina se pojavi nenadoma.
• seeing or hearing things that are not really there (hallucinations/delirium), feeling confused
• vidite ali slišite stvari, ki jih v resnici ni (halucinacije/delirij), zmedenost,
If your doctor has prescribed a second spray, repeat steps 5 to 9, using the other nostril.
Če vam je zdravnik predpisal še drugi vpih, ponovite korake 5 do 9 in uporabite drugo nosnico.
Of the 355 patients treated in the open-label treatment phase, 90 % required no increase in dose.
Od 335 bolnikov, zdravljenih v odprti fazi zdravljenja, jih 90 % ni potrebovalo zvečanja odmerka.
This leaflet was last revised Other sources of information
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
Once you have found the right dose
Ko najdete pravi odmerek
The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Tveganje neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi ali antipsihotiki.
Other side effects (frequency not known (frequency cannot be estimated from the available data))
Drugi neželeni učinki (neznana pogostnost; ni mogoče oceniti iz razpoložljivih podatkov):
Blow your nose if you feel you need to.
Useknite se, če se vam zdi, da je treba.
• Do not drive or use tools or machines until you know how this medicine makes you feel.
• Ne vozite in ne uporabljajte orodij ali strojev, dokler ne veste, kako to zdravilo vpliva na vaše počutje.
If this occurs, patients should be advised to discontinue their decongestant.
Če se to zgodi, bolnikom svetujemo, naj ukinejo dekongestiv.
Make sure that you use the strength that your doctor has prescribed for you.
Prepričajte se, da uporabljate jakost, ki vam jo je predpisal zdravnik.
Your doctor may need to check the dose.
Vaš zdravnik bo moral mogoče preveriti odmerek.
PecFent is not approved for use in children under 18 years of age.
Zdravilo PecFent ni odobreno za uporabo pri otrocih, mlajših od 18 let.
This may occur within the recommended dose (see section 4.5).
Pojavi se lahko znotraj priporočenega odmerka (glejte poglavje 4.5).
micrograms micrograms micrograms micrograms micrograms
mikrogramov mikrogramov mikrogramov mikrogramov mikrogramov
PecFent with food, drink and alcohol
Zdravilo PecFent skupaj s hrano, pijačo in alkoholom
This medicine should only be used by patients taking other opioids.
To zdravilo smejo uporabljati samo bolniki, ki jemljejo druge opioide.
The safety and efficacy of PecFent in children and adolescents aged below 18 years have not yet been established.
Varnost in učinkovitost zdravila PecFent pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
This is because it may cause breathing problems in your baby.
Lahko namreč povzroči težave z dihanjem pri vašem otroku.
If you have not been using these medicines you must not use PecFent, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Če niste uporabljali teh zdravil, ne smete uporabljati zdravila PecFent, saj lahko poviša tveganje, da postane dihanje nevarno počasno in/ali plitko ali se celo ustavi;
• After the first spray, number 1 will appear in the counting window.
• Po prvem vpihu se bo v okencu števca pokazalo število 1.
Dose increase should be undertaken with caution.
Zvečanja odmerka se moramo lotiti previdno.
Note: You may not feel anything happen in your nose at all - do not trust this to mean the spray did not operate - rely on the click and number counter.
Opozorilo: Mogoče sploh ne boste imeli občutka, da se je v nosu kaj zgodilo - ne mislite, da to pomeni, da pršilo ni delovalo - verjemite kliku in števcu.
• The counter will stay on the number “8”.
• Števec bo ostal na številu “8”.
Of the patients entering the titration phase, only 7 (6.1 %) were unable to be titrated to an effective dose due to lack of efficacy and 6 (5.3 %) withdrew due to adverse events.
Od bolnikov, ki so se vključili v fazo titracije, jih samo 7 (6,1 %) ni bilo mogoče titrirati do učinkovitega odmerka zaradi neučinkovitosti, 6 (5,3 %) pa jih je izstopilo iz študije zaradi neželenih učinkov.
Therefore it is not possible to definitively separate the effects of PecFent alone.
Zato ni mogoče dokončno ločiti učinkov zdravila PecFent samega.
Dose required (micrograms)
Potrebni odmerek (mikrogrami)
The efficacy of a given dose should be assessed over the ensuing 30 minute period.
Učinkovitost danega odmerka moramo ocenjevati v obdobju 30 minut po odmerku.
Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Zdravnik bo ocenil, ali potrebujete zdravilo, ki bo ublažilo ali odpravilo odtegnitvene simptome.
After first use: 60 days
Po prvi uporabi: 60 dni.
• Do not use PecFent if you are pregnant or might get pregnant, unless your doctor has told you to.
• Ne uporabljajte zdravila PecFent, če ste noseči ali bi lahko zanosili, razen če vam je to naročil zdravnik.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signficant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Call an ambulance or ask someone else to call one straight away if you:
Takoj pokličite rešilca ali prosite nekoga, naj ga takoj pokliče:
• PecFent that has passed the expiry date or is no longer required may still contain enough medicine to be harmful to other people, especially children.
• Zdravilo PecFent, ki mu je potekel rok uporabnosti ali ga ne potrebujete več, lahko še vedno vsebuje dovolj zdravila, da je lahko škodljivo za druge ljudi, predvsem otroke.
• you have not been taking the same dose of your daily opioid medicine for your constant pain for some time
• že nekaj časa ne jemljete enakega odmerka svojega vsakodnevnega opioidnega zdravila za svojo stalno bolečino;
General introduction
Splošen uvod