natgillin/translations-raw huggingface dataset:
Fiasp dose
Odmerek zdravila Fiasp
• you start being sick (vomiting)
• siljenje na bruhanje (bruhanje),
Fiasp 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Fiasp 100 enot/ml raztopina za injiciranje v vložku raztopina za injiciranje (Penfill)
• feeling or being sick (nausea or vomiting).
• siljenje na bruhanje ali bruhanje.
Median total bolus insulin dose at trial end was similar for mealtime Fiasp, postmeal Fiasp and mealtime NovoRapid (change from baseline to end of trial: mealtime Fiasp: 0.33→0.39 units/kg/day;
Mediani skupni odmerek bolusnega insulina ob koncu preskušanja je bil podoben pri uporabi zdravila Fiasp v času obroka, uporabi zdravila Fiasp po obroku in pri uporabi zdravila NovoRapid v času obroka (sprememba od izhodišča do konca preskušanja: zdravilo Fiasp v času obroka:
NovoRapid mealtime + insulin detemir
Zdravilo NovoRapid v času obroka + insulin detemir
Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Pred injiciranjem insulina s števcem in kazalnikom odmerka vedno preverite, koliko enot ste izbrali.
The pen can dial up to a maximum of 80 units.
Z injekcijskim peresnikom lahko izberete največ 80 enot.
Contents of the pack and other information What Fiasp contains
Shranjevanje zdravila Fiasp Vsebina pakiranja in dodatne informacije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (Pre-filled pen (FlexTouch) - with blue box)
ŠKATLA ZA SKUPNO PAKIRANJE (Napolnjen injekcijski peresnik (FlexTouch) - z modrim okencem)
If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Če želite spremeniti običajno prehrano, se najprej posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
Solution for injection Penfill
POSTOPEK UPORABE Penfill
• Pre-dinner dose should be adjusted according to the bedtime SMPG the previous day
• Odmerek pred večerjo je treba prilagoditi glede na vrednost SMPG pred spanjem prejšnjega dne.
Fiasp administered at mealtime provided significantly lower 1-hour and 2-hour postmeal glucose increment compared to NovoRapid administrated at mealtime.
Pri uporabi zdravila Fiasp v času obroka je bila koncentracija glukoze 1 uro in 2 uri po obroku statistično značilno manjša kot pri uporabi zdravila NovoRapid v času obroka.
Pack sizes of 1, 5 or a multipack with 2 x 5 pre-filled pens of 3 mL.
Pakiranja z 1 vialo z 10 ml, s 5 vialami z 10 ml ali skupno pakiranje, ki vsebuje 5 pakiranj po 1 vialo z
Fiasp 100 units/mL solution for injection in vial insulin aspart
Fiasp 100 enot/ml raztopina za injiciranje v viali insulin aspart
Keep the cartridge in the carton in order to protect from light.
Vložek shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Fiasp 100 units/mL solution for injection in vial
Fiasp 100 enot/ml raztopina za injiciranje v viali
Use only clear, colourless solution
Raztopino uporabite le, če je bistra in brezbarvna.
Injection site reactions (including rash, redness, inflammation, pain and bruising) were reported in patients treated with Fiasp (1.3% vs. 1.0% in comparator).
Pri bolnikih, ki so se zdravili z zdravilom Fiasp, so poročali o pojavu reakcij na mestu injiciranja, vključno z izpuščajem, rdečino, vnetjem, bolečinami in modricami (1,3 % med prejemniki zdravila
Please read these instructions carefully before using your FlexTouch pre-filled pen.
Pred uporabo napolnjenega injekcijskega peresnika FlexTouch natančno preberite ta navodila.
Can be stored in the refrigerator (2°C8°C).
Pred prvo uporabo: shranjujte v hladilniku (2 °C - 8 °C).
What to do if you get low blood sugar
Ukrepanje v primeru nizkega krvnega sladkorja
• Push the needle straight onto the pen.
• Iglo potisnite naravnost na injekcijski peresnik in jo trdno privijte.
Fiasp can be used for CSII in pumps suitable for insulin infusion and will cover both the bolus insulin requirement (approximately 50%) and basal insulin.
Pri takšni uporabi zdravilo pokriva tako potrebo po bolusnem insulinu (približno 50 %) kot bazalnem insulinu.
In the paediatric population lipodystrophy was reported with a frequency of 2.1% for Fiasp vs. 1.6% for NovoRapid.
V pediatrični populaciji je bila pogostnost lipodistrofije z zdravilom Fiasp
EU/1/16/1160/007 1 vial of 10 mL EU/1/16/1160/008 5 vials of 10 mL
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1160/007 1 viala z 10 ml
Fiasp 100 units/mL solution for injection in pre-filled pen Fiasp 100 units/mL solution for injection in cartridge Fiasp 100 units/mL solution for injection in vial
6.5 Vrsta ovojnine in vsebina Fiasp 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
• Pre-lunch dose should be adjusted according to the pre-dinner SMPG the previous day
• Odmerek pred kosilom je treba prilagoditi glede na vrednost SMPG pred večerjo prejšnjega dne.
• Pre-breakfast dose should be adjusted according to the pre-lunch SMPG the previous day
• Odmerek pred zajtrkom je treba prilagoditi glede na vrednost SMPG pred kosilom prejšnjega dne.
Fiasp 100 units/mL solution for injection in vial Solution for injection.
Fiasp 100 enot/ml raztopina za injiciranje v viali raztopina za injiciranje
Hold the dose button down until the dose counter shows 0.
Pritisnite na potisni gumb in ga držite, dokler se števec odmerka ne vrne na 0.
Changes in median total basal insulin dose from baseline to end of trial were comparable for Fiasp
Mediani skupni odmerek bolusnega insulina ob koncu preskušanja je bil podoben pri zdravilu Fiasp in zdravilu NovoRapid (sprememba od izhodišča do konca preskušanja: zdravilo Fiasp:
5 x 3 mL 10 x 3 mL
Penfill 5 x 3 ml
Fiasp is a mealtime insulin.
Zdravilo Fiasp je insulin za uporabo v času obroka.
Fiasp 100 units/mL solution for injection insulin aspart
Fiasp 100 enot/ml raztopina za injiciranje v vložku insulin aspart
If you do not check the flow, you may get too little insulin or no insulin at all.
Če pretoka ne boste preverili, lahko injicirate premajhno količino insulina ali celo nič, posledično pa se lahko koncentracija krvnega sladkorja zviša.
Solution for injection FlexTouch
Aplikacija z napolnjenim injekcijskim peresnikom (FlexTouch)
Keep the cartridge in the outer carton in order to protect from light.
Injekcijski peresnik shranjujte pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
Renal and hepatic impairment
Okvara ledvic in jeter
Time to maximum concentration and total insulin aspart exposure were all comparable between the abdomen, upper arm and the thigh.
Pri injiciranju zdravila v predelu trebuha, nadlakti ali stegna sta čas do največje koncentracije in skupna izpostavljenost insulinu primerljivi.
No statistical significant difference was shown between postmeal Fiasp and mealtime NovoRapid.
Med uporabo zdravila Fiasp po obroku in uporabo zdravila NovoRapid v času obroka ni bilo statistično pomembne razlike.
Fiasp 100 units/mL solution for injection in pre-filled pen insulin aspart
Fiasp 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (VIAL)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• cold sweat
• suha usta,
Excipients
NovoRapid.
• Never share your pen or your needles with other people.
• Injekcijskega peresnika in igel si ne smete deliti z drugimi.
Examples
Primera:
Pharmacotherapeutic group: Drugs used in diabetes.
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje s hitrim delovanjem.
Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter.
V času prehoda in še nekaj tednov po prehodu z drugih insulinov, ki se jih uporablja v času obroka, priporočamo skrbno spremljanje koncentracije glukoze.
EU/1/16/1160/010 5 cartridges of 3 mL EU/1/16/1160/011 10 cartridges of 3 mL
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1160/010 5 vložkov s 3 ml
NAME OF THE MARKETING AUTHORISATION HOLDER Dompé Biotec S.p.A.
Imetnik dovoljenja za promet je družba Dompé Biotec S.p.A.
Parareg should be taken with or shortly after food.
Zdravilo Parareg se jemlje s hrano ali takoj po zaužitju obroka.
Take special care with Parareg:
Druge informacije o zdravilu Parareg:
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The dosage of Parareg should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Odmerek zdravila Parareg je treba povečevati vsakih dva do štiri tedne do vrednosti 90 mg tri- ali štirikrat dnevno, kolikor je potrebno za znižanje ravni kalcija v krvi na normalno raven.
Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa vsakih en do tri mesece.
• DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
Zdravila Parareg ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) cinakalcet ali katero koli drugo sestavino zdravila.
Parareg is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Na voljo je v obliki svetlozelenih ovalnih tablet (30, 60 ali 90 mg).
• to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.
• za zmanjšanje hiperkalciemije (visokih ravni kalcija v krvi) pri bolnikih s paratiroidnim karcinomom (rakom obščitnic) ali pri bolnikih s primarnim hiperparatiroidizmom, pri katerih odstranitev obščitnic ni možna, ali za katere zdravnik meni, da odstranitev obščitnic zanje ni primerna.
This can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Posledica so lahko bolečine v kosteh in sklepih ter deformacije rok in nog.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 22 October 2004
Evropska komisija je dovoljenje za promet z zdravilom Parareg, veljavno po vsej Evropski uniji, odobrila dne 22. oktobra 2004.
If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Parareg is 30 mg (one tablet) twice per day.
Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom je priporočeni začetni odmerek zdravila Parareg za odrasle 30 mg dvakrat dnevno.
This medicine has been prescribed for you.
Zdravilo se dobi samo na recept.
Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Cinakalcet deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki se nahajajo na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Zmanjšanje ravni paratiroidnega hormona privede do znižanja ravni kalcija v krvi.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Ravni kalcija v krvi je treba meriti pogosto in v enem tednu po vsaki prilagoditvi odmerka zdravila Parareg.
Eighteen of 29 patients (62 %) with parathyroid carcinoma and 15 of 17 subjects (88 %) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Zdravilo Parareg je privedlo do znižanja ravni kalcija v krvi za več kot 1 mg/dl pri 62 % bolnikov z rakom (pri 18 bolnikih od 29) in pri 88 % bolnikov s primarnim hiperparatiroidizmom (pri 15 bolnikih od 17).
The recommended starting dose for adults is 30 mg once per day.
Pri sekundarnem hiperparatiroidizmu je priporočeni začetni odmerek za odrasle 30 mg enkrat dnevno.
The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
To je stanje, pri katerem obščitnice v vratu tvorijo preveč paratiroidnega hormona (PTH).
Parareg may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Uporablja se lahko kot del zdravljenja, ki vključuje vezalce fosfatov ali sterole vitamina D.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
Secondary Hyperparathyroidism
• za zdravljenje sekundarnega hiperparatiroidizma.
PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka in en do štiri tedne po vsaki prilagoditvi odmerka zdravila Parareg.
Parareg is a light green film-coated tablet.
Parareg je zdravilo, ki vsebuje zdravilno učinkovino cinakalcet.
The active substance is cinacalcet.
Zdravilna učinkovina v zdravilu Parareg, cinakalcet, je kalcimimetično sredstvo.
This leaflet was last approved in
Povzetek je bil nazadnje posodobljen 06-2008.
Very common side effects (seen in more than 1 in 10 people taking Parareg): • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Najpogostejša neželena učinka zdravila Parareg pri zdravljenju sekundarnega hiperparatiroidizma (opažena pri več kot 1 izmed 10 bolnikov) sta navzeja (slabost) in bruhanje.
In a key study,46 patients (29 with parathyroid carcinoma and 17 with primary HPT (who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
Zdravilo Parareg so preučevali tudi v študiji, ki je vključevala 46 bolnikov s hiperkalciemijo, od tega 29 bolnikov s paratiroidnim karcinomom in 17 bolnikov s primarnim hiperparatiroidizmom, pri katerih ni bilo mogoče odstraniti obščitnic ali pri katerih kirurška odstranitev obščitnic ni bila učinkovita.
The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Odmerek se prilagodi vsake dva do štiri tedne v skladu z bolnikovimi ravnmi paratiroidnega hormona do maksimalno 180 mg enkrat dnevno.
Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dl [2.1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Parareg večje od z njim povezanih tveganj pri zdravljenju sekundarnega hiperparatiroidizma pri dializnih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju in za zmanjšanje hiperkalciemije pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom, pri katerih bi bila kirurška odstranitev obščitnic indicirana na osnovi ravni kalcija v krvi, vendar pa taka odstranitev zanje ni klinično ustrezna ali je kontraindicirana.
Bottle: 4 years.
Študije so trajale šest mesecev.
What Parareg contains
Kaj je zdravilo Parareg?
In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
Pri dializnih bolnikih s hudim obolenjem ledvic je imelo približno 40 % bolnikov, ki so jemali zdravilo Parareg, ob koncu študije ravni paratiroidnega hormona pod 250 mikrogramov na liter, v primerjavi s 6 % bolnikov, ki so prejemali placebo.
For oral use Read the package leaflet before use.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Parareg, glejte navodilo za uporabo.
In this leaflet What Parareg is and what it is used for
Za kaj se zdravilo Parareg uporablja ?
B CONDITIONS OF THE MARKETING AUTHORISATION
Odbor je priporočil, da se za zdravilo Parareg odobri dovoljenje za promet.
PTH levels in Parareg clinical trials were measured at the end of the dosing interval.
Kakšne koristi je zdravilo Parareg izkazalo med študijami?
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Parareg je na voljo tukaj.
During treatment with Parareg, tell your doctor:
Zdravilo Parareg se uporablja pri odraslih in starostnikih:
In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Zdravilo Parareg je zmanjšalo ravni paratiroidnega hormona za 42 % v primerjavi s povečanjem za 8 % pri bolnikih, ki so jemali placebo.
Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1136).
Zdravilo Parareg so preučevali v treh glavnih študijah, ki so vključevale 1136 dializnih bolnikov s hudim obolenjem ledvic.
Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
To pomeni, da posnema učinkovanje kalcija v telesu.
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Rezultati dodatnih študij so podprli uporabo zdravila Parareg pri zdravljenju hiperkalciemije pri bolnikih s primarnim hiperparatiroidizmom.
Parareg should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Zdravilo Parareg se uporablja pri bolnikih s hudim obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi potrebujejo dializo.
Parareg has not been tested in pregnant women.
Kako je bilo zdravilo Parareg raziskano?
Cataracts are known to occur in rodents as a result of hypocalcaemia.
„Sekundarni“ pomeni, da hiperparatiroidizem nastane kot posledica drugega bolezenskega stanja.
The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli ob koncu študije raven paratiroidnega hormona pod 250 mikrogramov na liter.
Cinacalcet has been shown to cross the placental barrier in rabbits.
Cinakalcet s povečanjem občutljivosti teh receptorjev zmanjša tvorbo paratiroidnega hormona v obščitnicah.
Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT receiving dialysis.
Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom so neželeni učinki podobni tistim, opaženim pri bolnikih z dolgotrajnim obolenjem ledvic: najpogostejša neželena učinka sta navzeja (slabost) in bruhanje.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
To pomeni, da obstajajo podatki v literaturi z znanstvenimi dokazi o njihovi učinkovitosti in varnosti, če se uporabljajo, kot je navedeno, in ki v EU zajemajo obdobje vsaj 10 let.
It should be taken during the day at least half an hour to one hour before or after taking other medicines and not immediately before bedtime.
Jemati jo je treba čez dan, vsaj pol ure do eno uro pred ali po jemanju drugih zdravil, in ne neposredno pred spanjem.
The plant is cultivated or gathered to obtain the seeds for medicinal use.
Rastlino se goji ali nabira za pridobivanje semen za medicinsko uporabo.
EMA/HMPC/313600/2013
EMA/HMPC/313600/2013 Odbor za zdravila rastlinskega izvora (HMPC)
If constipation does not resolve after three days, a doctor or pharmacist should be consulted.
Če se zaprtosti ne odpravi v treh dneh, se je treba posvetovati z zdravnikom ali farmacevtom.
When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Pri uporabi pripravka v obliki praška je treba preprečiti vdihavanje praška, ker lahko to povzroči alergijsko občutljivost in morebitni razvoj alergij.
Studies that were carried out in patients with irritable bowel disease did not show an effect on the disease itself but showed benefits in those patients who were also suffering from constipation.
Študije, ki so bile izvedene na bolnikih z boleznijo razdražljivega črevesja, niso pokazale učinka na bolezen samo, vendar so zabeležili koristi pri bolnikih, ki so istočasno trpeli za zaprtostjo.
The HMPC conclusions on the use of ispaghula husk medicines are based on their ‘well-established use' in these conditions.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo semensko lupino jajčastega trpotca, temeljijo na njihovi „dobro uveljavljeni uporabi“ pri teh stanjih.
It can be used in adults and children above the age of 6 years for the treatment of constipation and to soften the stools but should only be used in adults and children over the age of 12 years when used to increase the fibre intake.
Za zdravljenje zaprtosti in omehčanje blata se lahko uporablja pri odraslih in otrocih, starejših od 6 let, , za povečanje vnosa vlaknin pa se lahko uporablja samo pri odraslih in otrocih, starejših od 12 let.
It should also not be used in patients with conditions that involve a narrowing of the stomach and gut, and patients who have difficulty swallowing or have problems with their throat.
Prav tako se jih ne sme uporabljati pri bolnikih s stanji, ki vključujejo zoženje želodca in črevesja, ter pri bolnikih, ki imajo težave s požiranjem ali z žrelom.
There is a risk of a build-up of hard, dry stool, particularly if Ispaghula husk is swallowed without enough liquid.
Obstaja tveganje za kopičenje trdega, suhega blata, zlasti kadar se lupina jajčastega trpotca ne zaužije z dovolj tekočine.
The way ispaghula husk works in reducing blood cholesterol levels is not fully understood.
Delovanje semenske lupine jajčastega trpotca pri zmanjšanju ravni holesterola v krvi ni povsem pojasnjeno.
Further information on the risks associated with ispaghula husk medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The use of ispaghula husk in hypercholesterolaemia always requires medical supervision.
Uporaba semenske lupine jajčastega trpotca pri hiperholesterolemiji mora vedno potekati pod zdravniškim nadzorom.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ispaghula husk.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semenske lupine jajčastega trpotca.