MIBIOTIX DK DAILYBIOTIC KIDS CHEWS 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix DK DAILYBIOTIC KIDS CHEWS.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix DK DAILYBIOTIC KIDS CHEWS (chewable tablets).

Read all of this leaflet carefully because it contains important information for you.

MiBiotix DK DAILYBIOTIC KIDS CHEWS are available without a doctor’s prescription. Nevertheless, you still need to use MiBiotix DK DAILYBIOTIC KIDS CHEWS carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix DK DAILYBIOTIC KIDS CHEWS with any other person.
  • Ask your pharmacist if you need more information or advice.
  • You must see a doctor if your symptoms worsen or do not improve.

1. WHAT MIBIOTIX DK DAILYBIOTIC KIDS CHEWS CONTAINS: 

4 Billion CFUs consisting of: 

500 Million CFU Lactobacillus acidophilus Howaru

500 Million CFU Lactobacillus rhamnosus Howaru

100 Million CFU Lactobacillus reuteri KP1E1,

500 Million CFU Lactobacillus Salivarius LS-33

500 Million CFU Bifidobacterium Lactis Howaru, 

500 Million CFU Lactobacillus gasseri Lg-36

500 Million CFU Bifidobacterium longum Bl-05,

500 Million CFU Bifidobacterium bifidum Bb-05,

500 Million CFU Bacillus subtilis HU58

 

2. WHAT MIBIOTIX DK DAILYBIOTIC KIDS CHEWS ARE USED FOR:

The bacteria found in the gut have many functions that are essential to general health and wellbeing of your child.

All health and wellbeing starts with the gut. When taken on a regular basis MiBiotix DK DAILYBIOTIC KIDS CHEWS will support the microflora balance in the gut and general health.

Remember to “Always start with your gut”.

 

3. BEFORE YOU TAKE/ USE/ ARE GIVEN/ ADMINISTERED MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

Do NOT take/use MiBiotix DK DAILYBIOTIC KIDS CHEWS: 

  • If you are known to be hypersensitive (allergic) to (active ingredient) or any of the inactive ingredients. 

Take special care with MiBiotix DK DAILYBIOTIC KIDS CHEWS:
MiBiotix DK DAILYBIOTIC KIDS CHEWS does not intend to prevent or cure any form of illness or disease and should not replace any medication. If you suffer from a chronic medical condition, consult your healthcare practitioner before using this product. Do not exceed the recommended dose.

Driving and using machinery:

No studies on the effect on the ability to drive or use machinery have been performed. It is unlikely that MiBiotix DK DAILYBIOTIC KIDS CHEWS would affect your ability to drive or use machinery. However, please exercise care until you are certain that your ability to perform such activities is not affected.

Important information about some of the ingredients of MiBiotix DK DAILYBIOTIC KIDS CHEWS:

All inactive ingredients added on the formulation of MiBiotix DK DAILYBIOTIC KIDS CHEWS are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix DK DAILYBIOTIC KIDS CHEWS:

Always tell your healthcare professional if you are taking other medicines. (This includes complementary or traditional medicine). The use of MiBiotix DK DAILYBIOTIC KIDS CHEWS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice

 

4. HOW TO TAKE/ USE MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:
The usual dose is:
Take one MiBiotix DB DAILYBIOTIC Kids Chew once daily after breakfast. 
Always take MiBiotix DK DAILYBIOTIC KIDS CHEWS exactly as per recommendation of the Package Insert or by your health care provider and if you are unsure. If the symptoms worsen or persist, please consult your If you forget to take /miss a dose of MiBiotix DK DAILYBIOTIC KIDS CHEWS:
Always take MiBiotix DK DAILYBIOTIC KIDS CHEWS as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule (see “HOW TO TAKE MiBiotix DK DAILYBIOTIC KIDS CHEWS”). Do not take a double dose to make up for forgotten individual doses.

 

5. POSSIBLE SIDE EFFECTS:

There has not been a case of any side effects reported when taking MiBiotix DK DAILYBIOTIC KIDS CHEWS. 

MiBiotix DK DAILYBIOTIC KIDS CHEWS can have side effects.

Not all side effects reported for MiBiotix DK DAILYBIOTIC KIDS CHEWS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MiBiotix DK DAILYBIOTIC KIDS CHEWS, please consult your healthcare provider for advice. Please report/ inform your doctor or pharmacist if you notice any side effects not mentioned in this leaflet. 

 

6. STORAGE AND DISPOSING OF MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

Store all MiBiotix DK DAILYBIOTIC KIDS CHEWS out of reach of children.

Store in a cool, dry place below or at 25 0 C.

Keep the container in the original packaging and in an outer carton.

Protect from light.

Do not store in a bathroom.

Do not use after expiry date stated on the label/carton and on the bottle.

Do not use MiBiotix DK DAILYBIOTIC KIDS CHEWS if you notice any visible signs of deterioration. 

Return all unused MiBiotix DK DAILYBIOTIC KIDS CHEWS to your pharmacist/supplier.

Do not dispose of unused MiBiotix DK DAILYBIOTIC KIDS CHEWS in drains or sewage systems (e.g. toilets).

 

7. PRESENTATION OF MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

MiBiotix DK DAILYBIOTIC KIDS CHEWS is packed in 30’s, in a white plastic bottle with a white cap in an outer carton.

 

8. IDENTIFICATION OF MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

White chewable tablet

 

9. REGISTRATION NUMBER:

Will be allocated by Council upon registration.

This unregistered medicine has not been evaluated by the SAHPRA for

its quality, safety or intended use.

 

10. NAME AND ADDRESS OF REGISTRATION HOLDER:

Kenza Health (Pty) Ltd Suite 177, Private Bag X7, Northriding 2162
For professional information go to www.mibiotix.co.za


11. SCIENTIFIC SUPPORT

Lactoba­cilli are among the dominant bacterial species in the microflora of the small intestine, while bifidobacteria are one of the dominant species in the colon. Admin­istering probiotic strains from both of these genera al­lows colonization and improvement of the microflora balance in both the upper and lower digestive tracts. Lactobacillus and Bifidobacterium  are well-doc­umented probiotic strains and, collectively, have been shown to benefit both digestive and immune health and to meet the microflora needs of toddlers through to teenagers.

12. REFERENCES

Sui J, et al. J Appl Microbiol. 2002;93(5):907-912. 

Varcoe J, et al. J Appl Microbiol. 2002;93(5):900-906. 

Ouwehand AC, et al. Microbiological and Functional Aspects. New York: Marcel Dekker; 2004:375-395. 

Kim HS, et al. J Dairy Sci. 1983;66(5):959-966. 

Montes RG, et al. J Dairy Sci. 1995;78:1657-1664.

Prasad J, et al. Int Dairy J. 1998;8(12):993-1002. 

Gopal PK, et al. Nutr Res. 2003;23(10):1313-1328. 

Gopal PK, et al. Int J Food Microbiol. 2001;67(3):207-216. 

FAO/WHO Working Group. Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics in Food. http://www.who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf. April 30 and May 1, 2002. 

Borriello SP, et al. Clin Infect Dis. 2003;36(6):775-780. 

Gueimonde M, et al. Scand J Nutr. 2004;48(1):42-48. 

 

MIBIOTIX DK DAILYBIOTIC KIDS CHEWS 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix DK DAILYBIOTIC KIDS CHEWS.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix DK DAILYBIOTIC KIDS CHEWS (koutablet).

Lees die hele blaadjie sorgvuldig deur, want dit bevat belangrike inligting vir u.

MiBiotix DK DAILYBIOTIC KIDS CHEWS is beskikbaar sonder die voorskrif van ‘n dokter. U moet egter steeds MiBiotix DK DAILYBIOTIC KIDS CHEWS versigtig gebruik om die beste resultate daarmee te verkry.

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix DK DAILYBIOTIC KIDS CHEWS met enige ander persoon deel nie.
    • Vra jou apteker as jy meer inligting of advies benodig.
    • U moet ’n dokter raadpleeg indien u simptome vererger of nie verbeter nie.
 

1. WAT MIBIOTIX DK DAILYBIOTIC KIDS CHEWS BEVAT:

4 Miljard KVEs bestaande uit: 

500 Miljoen KVE Lactobacillus acidophilus Howaru

500 Miljoen KVE Lactobacillus rhamnosus Howaru, 

100 Miljoen KVE Lactobacillus reuteri 1E1,

 

500 Miljoen KVE Lactobacillus Salivarius LS-33

500 Miljoen KVE Bifidobacterium Lactis Howaru

500 Miljoen KVE Lactobacillus Gasseri Lg-36, 

500 Miljoen KVE Bifidobacterium longum Bl-05,

500 Miljoen KVE Bifidobacterium bifidum Bb-05

500 Miljoen KVE Bacillus subtilis HU58

 

2. WAARVOOR  MIBIOTIX DK DAILYBIOTIC KIDS CHEWS GEBRUIK WORD:

Bakterieë in die dermkanaal het baie funksies wat

noodsaaklik is vir algemene gesondheid en welwees

van jou kind. Alle gesondheid en welwees begin by die dermkanaal.

Gereelde gebruik van MiBiotix DB DAILYBIOTIC KIDS CHEWS sal

die mikroflorabalans in jou dermkanaal en jou

algemene gesondheid ondersteun.

Onthou om “Altyd by jou dermkanaal te begin”.

 

3. VOORDAT U MIBIOTIX DK DAILYBIOTIC KIDS CHEWS NEEM:

Moenie MiBiotix DK DAILYBIOTIC KIDS CHEWS gebruik as:

  • jy bewus is daarvan dat jy hipersensitief (allergies) is vir (aktiewe bestanddeel) of enige van die bestanddele. 

Neem Spesiale sorg met MiBiotix DK DAILYBIOTIC KIDS CHEWS:
MiBiotix DK DAILYBIOTIC KIDS CHEWS beoog nie om enige ongesteldheid of siektetoestand te genees nie en moet nie enige medikasie vervang nie. Mense wat aan ’n chroniese mediese toestand ly moet hulle gesondheidspraktisyn raadpleeg voor hulle hierdie produk gebruik. Moenie die voorgeskrewe dosis oorskry nie.

Bestuur en die gebruik van masjinerie:

Geen navorsingstudies is uitgevoer oor die effek op die vermoë om te bestuur of masjinerie te hanteer nie. Dit is onwaarskynlik dat MiBiotix DK DAILYBIOTIC KIDS CHEWS die vermoë om te bestuur of masjinerie te gebruik sal beïnvloed. Wees egter versigtig tot u seker is u vermoë om hierdie aktiwiteite uit te voer word nie beïnvloed nie.

Belangrike inligting oor sommige van die bestanddele van MiBiotix DK DAILYBIOTIC KIDS CHEWS:

Al die onaktiewe bestanddele wat op die formulering van MiBiotix DK DAILYBIOTIC KIDS CHEWS gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix DK DAILYBIOTIC KIDS CHEWS:

Lig altyd u gesondheidpraktisyn in wanneer u medisyne neem. (Dit sluit in komplementêre of tradisionele medisyne). Die gebruik van MiBiotix DK DAILYBIOTIC KIDS CHEWS saam met hierdie medisyne mag ongewenste wisselwerkings veroorsaak. Raadpleeg asseblief u dokter, apteker of ander professionele gesondheidsorgwerker vir advies.

 

4. HOE OM MIBIOTIX DK DAILYBIOTIC KIDS CHEWS TE GEBRUIK 

Die gewone dosis is:

Neem een MiBiotix DK DAILYBIOTIC Kids Chew, daagliks na ontbyt.

Neem MiBiotix DK DAILYBIOTIC KIDS CHEWS altyd volgens aanbevelings van die pakketinvoer of deur u gesondheidsorgverskaffer en indien u onseker is. As die simptome vererger of voortduur, raadpleeg ’n gesondheidsorgpraktisyn.

As jy vergeet om ‘n dosis MiBiotix DK DAILYBIOTIC KIDS CHEWS te neem:

Neem MiBiotix DK DAILYBIOTIC KIDS CHEWS altyd soos voorgeskryf. Indien u ’n dosis vergeet het, neem dit sou gou as wat u onthou. Indien u egter nie van die vergete dosis onthou voordat dit tyd is vir die volgende dosis is nie, slaan die vergete dosis oor en keer terug na u gewone doseringskedule (sien “HOE OM MiBiotix DK DAILYBIOTIC KIDS CHEWS TE GEBRUIK”). Moenie ’n dubbele dosis neem om te vergoed vir die oorgeslane individuele dosis nie.

 

5. MOONTLIKE NEWE EFFEKTE

Daar was nie gevalle van enige newe-effekte gerapporteer wanneer MiBiotix DK DAILYBIOTIC KIDS CHEWS geneem word nie.

MiBiotix DK DAILYBIOTIC KIDS CHEWS kan newe-effekte hê.

Nie alle newe-effekte wat vir MiBiotix DK DAILYBIOTIC KIDS CHEWS gemeld is, is in hierdie inligtingstuk vervat nie. Indien u algemene gesondheid agteruitgaan of u ongewenste wisselwerkings ervaar terwyl MiBiotix DK DAILYBIOTIC KIDS CHEWS gebruik, raadpleeg asseblief u gesondheidsorgvoorsiener vir advies. Lig asseblief u dokter of apteker in indien u enige newe-effekte opmerk wat nie in hierdie inligtingstuk genoem word nie.

 

6. BERGING EN WEGDOEN VAN MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

Bewaar alle MiBiotix DK DAILYBIOTIC KIDS CHEWS buite bereik van kinders.

Berg in ‘n koel, droë plek onder of by 25 ° C.

Hou die houer in die oorspronklike verpakking en in ‘n buitenste karton.

Beskerm teen lig.

Moenie in ‘n badkamer stoor nie.

Moet nie gebruik word na die vervaldatum wat op die etiket / karton en op die bottel aangedui word nie.

Moenie MiBiotix DK DAILYBIOTIC KIDS CHEWS gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte MiBiotix DK DAILYBIOTIC KIDS CHEWS na u apteker / verskaffer terug.

Moet nie ongebruikte MiBiotix DK DAILYBIOTIC KIDS CHEWS in riool- of rioolstelsels gooi  nie (byvoorbeeld toilette).

 

7. AANBIEDING VAN MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

MiBiotix DK DAILYBIOTIC KIDS CHEWS is verpak in 30’s, in ‘n wit plastiekbottel met ‘n wit dop en in ‘n buitenste karton.

 

8. IDENTIFIKASIE VAN MIBIOTIX DK DAILYBIOTIC KIDS CHEWS:

Wit kou tablette.

 

9. REGISTRASIENOMMER:

Sal deur die Raad toegeken word by registrasie.

Hierdie ongeregistreerde medisyne is nie deur die

SAHPRA geevalueer ten opsigte van kwaliteit,

veiligheid of beoogde gebruik nie.

 

10. NAAM EN ADRES VAN DIE HOUER VAN DIE REGISTRASIE:

Kenza Health (Edms) Bpk Suite 177, Private BagX7, Northriding 2162

Vir proffessionele inligting gaan na www.mibiotix.co.za

 

DATEOF PUBLICATION:

April 2019; PI.063.2.4.19