DEKAS PLUS LIQUID

Glavne informacije

  • Zaščiteno ime:
  • DEKAs Plus Liquid, 60 ml
  • Farmacevtska oblika:
  • peroralna raztopina
  • Enote v paketu:
  • plastenka s 60 ml peroralne raztopine
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • DEKAs Plus Liquid, 60 ml
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • Druge kombinacije hranil

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Živilo
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

DEKAs® Plus Liquid, 60 ml

Dietno (dietetično) živilo za posebne zdravstvene namene s sladili

Kratek povzetek informacij o izdelku

Izdelek DEKAs® Plus Liquid je živilo za posebne zdravstvene namene, ki se uporablja za dietetsko uravnavanje

motnje absorbcije vitaminov D, E, K in A.

DEKAs® Plus Liquid multivitaminsko-mineralno živilo za posebne zdravstvene namene , ki se specifično

uporablja kot prehranski dodatek pri pacientih s cistično fibrozo in tistih, ki s prehrano ne dobijo dovolj v

maščobi topnih vitaminov zaradi insuficience trebušne slinavke in zmanjšanega pretoka žolča. DEKAs Plus

Liquid so formulirane skladno z nutricionističnimi smernicami ter zadnjimi znanstvenimi študijami na področju

cistične fibroze, ki priporočajo povišane vsebnosti vitamina D in K.

DEKAs Plus uporabljajo klinično dokazano dostavno tehnologijo z namenom povečanja absorpcije v maščobah

topnih vitaminov in mikrohranil, kar izboljša stanje teh pacientov.

Vsi DEKAs izdelki so brez glutena, brez kazeina, brez gensko spremenjenih organizmov, ne vsebujejo umetnih

barvil.

Farmakologija

Cistična fibroza, insuficienca trebušne slinavke in znižan nivo žolčnih kislin vodi do motnje absorpcije ter

znižanja nivoja v maščobi topnih vitaminov ko so vitamin D, E, K in A.

Dostavna tehnologija izdelka DEKAs je bila klinično dokazana, da poveča absorpcijo v maščobi topnih vitaminov

in drugih lipofilnih komponent v primerih malabsorpcije kot je pri cistični fibrozi in holestazni jetrni bolezni.

Sestava:

1 ml izdelka

vsebuje povprečno

%PDV

2 ml izdelka vsebuje

povprečno

% PDV

Vitamin A (87% beta-

karoten in 13%

palmitat)

225 mcg retinola, 3

mg beta-karotena

450 mcg retinola, 6

mg beta-karotena

Vitamin C (kot natrijev

askorbat in

askorbinska kislina)

45 mg

90 mg

Vitamin D (kot

holekalciferol)

19 mcg

38 mcg

Vitamin E (kot d-alfa-

tokoferol in d-alfa

tokoferil polietilen

glikol 1000 sukcinat)

34 mg

Tiamin (tiamin

hidroklorid)

0,6 mg

1,2 mg

Riboflavin (kot natrijev

riboflavin 5-fosfat

0,6 mg

1,2 mg

Niacin (kot

niacinamid)

6 mg

12 mg

Vitamin B6 (kot

piridoksin hidroklorid)

0,6 mg

1,2 mg

Biotin

15 mcg

30 mcg

Pantotenska kislina

(kot kalcijev d-

pantotenat)

3 mg

6 mg

Cink (kot cinkov

glukonat)

5 mg

10 mg

Vitamin K (kot

500 mcg

1000 mcg

fitonadion)

Selen (kot natrijev

selenit)

10 mcg

18,18

20 mcg

36,36

Koencim Q10

2 mg

4 mg

Sestavine:

Voda, ekstrakt bogat s tokoferolom (antioksidant), naravne in umetne arome, sukraloza (sladilo), kalijev sorbat

(konzervans) in natrijev benzoat (konzervans)

Pomembno opozorilo:

Končni izdelek je varno zaprt. Ne uporabljajte v primeru predrtja embalaže.

Shranjevati nedosegljivo otrokom.

Živilo se uporablja izključno pod zdravniškim nadzorom.

Vitamin K moti delovanje antikoagulantne terapije. Če jemljete antikoagulantna zdravila se pred

uporabo posvetujte z zdravnikom.

Ob znani občutljivosti ali alergiji na katerokoli sestavino izdelka ne zaužijte.

Navodila za uporabo:

Pred vsako uporabo plastenko (vsebino) dobro pretresemo.

Priporočeni odmerki:

0-12 mesecev starosti ............1 ml dnevno

1-3 let starosti ........................2 ml dnevno

ali kot priporočeno iz strani lečečega zdravnika.

Pakiranje: 60 ml plastenka z oranžno obarvano tekočino z merilno kapalko

Način shranjevanja: Izdelek hranite na sobni temperaturi, po odprtju v hladilniku.

Uporabno najmanj do konca: odtisnjeno na plastenki

IRIS, Mednarodna trgovina, d.o.o.,

Cesta v Gorice 8, 1000 Ljubljana

tel.: 01 200 66 50, fax: 01 200 66 60

poreklo: ZDA

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-8-2018

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

4-6-2018

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.

FDA - U.S. Food and Drug Administration

25-5-2018

Brands Unlimited Trading Inc. recalls Laura Secord Mason Glass Mugs

Brands Unlimited Trading Inc. recalls Laura Secord Mason Glass Mugs

The glass mason mug may crack or break upon contact with hot or boiled liquid, posing a burn or laceration hazard to consumers.

Health Canada

10-5-2018

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

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FDA - U.S. Food and Drug Administration

1-5-2018

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

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FDA - U.S. Food and Drug Administration

1-5-2018

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

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Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

FDA - U.S. Food and Drug Administration

29-6-2018

EU/3/18/2031 (Air Liquide SantE (International))

EU/3/18/2031 (Air Liquide SantE (International))

EU/3/18/2031 (Active substance: Argon) - Orphan designation - Commission Decision (2018)4176 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/18

Europe -DG Health and Food Safety

4-6-2018

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports-  https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

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FDA - U.S. Food and Drug Administration