MiBiotix BABY DROPS BD PILL

MIBIOTIX BD DROPS 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix BD Drops.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix BD Drops

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

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

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix BD Drops 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 BD DROPS CONTAINS: 

10 drops contains: 2 Billion CFU’s of: Bifidobacterium lactis Howaru, Bifidobacterium longum Bl-05, Bifidobacterium infantis Bi-26, Lactobacillus salivarius Ls-33, Lactobacillus rhamnosus Howaru, Lactobacillus acidophilus Howaru, L. reuteri 1E1, L. casei Lc-11.

 

2. WHAT MIBIOTIX BD DROPS 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 BD Drops 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 BD DROPS:

Do NOT take/use MiBiotix BD Drops: 

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

Take special care with MiBiotix BD Drops:
MiBiotix BD Drops 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.

Important information about some of the ingredients of MiBiotix BD Drops:

All inactive ingredients added on the formulation of MiBiotix BD Drops are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix BD Drops:

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

 

4. HOW TO TAKE/ USE MIBIOTIX BD DROPS:
The usual dose is:
Take 10 drops once daily after breakfast or a bottle of milk.
Always take MiBiotix BD Drops 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 healthcare practitioner.
If you take/ use/ more MiBiotix BD Drops than you should:
Do not use more than recommended dose. (See Package Insert). In the event of overdosage, consult your doctor or pharmacist. 
If you forget to take /miss a dose of MiBiotix BD Drops:

Always take MiBiotix BD Drops 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 BD Drops”). 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 BD Drops. 

MiBiotix BD Drops can have side effects.

Not all side effects reported for MiBiotix BD Drops are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MiBiotix BD Drops, 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 BD DROPS:

Store all medicines 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 BD Drops if you notice any visible signs of deterioration. 

Return all unused medicine to your pharmacist/supplier.

Do not dispose of unused medicines in drains or sewage systems (e.g. toilets).

 

7. PRESENTATION OF MIBIOTIX BD DROPS:

MiBiotix BD Drops is packed in 30ml, amber bottle with a white cap in an outer carton.

 

8. IDENTIFICATION OF MIBIOTIX BD DROPS:

Containing a transparent MCT oil.

 

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 babies 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 BD DROPS 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix BD Drops.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix BD Drops 

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

MiBiotix BD Drops is beskikbaar sonder die voorskrif van ‘n dokter. U moet egter steeds MiBiotix BD Drops versigtig gebruik om die beste resultate daarmee te verkry.

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix BD Drops 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 BD DROPS BEVAT:

10 druppels bevat: 2 Biljion CFU’s van: Bifidobacterium lactis Howaru, B. longum Bl-05, B.infantis Bi-26, Lactobacillus salivarius Ls-33, L. rhamnosus Howaru, L. acidophilus Howaru, L. reuteri 1E1, L. casei Lc-11.

 

2. WAARVOOR  MIBIOTIX BD DROPS 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 BD DROPS sal die mikroflorabalans in jou dermkanaal en jou algemene gesondheid ondersteun. Onthou om “Altyd by jou dermkanaal te begin”.

 

3. VOORDAT U MIBIOTIX BD DROPS NEEM:

Moenie MiBiotix BD Drops gebruik as:

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

Neem Spesiale sorg met MiBiotix BD Drops:
MiBiotix BD Drops 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.

Belangrike inligting oor sommige van die bestanddele van MiBiotix BD Drops:

Al die onaktiewe bestanddele wat in die formulering van MiBiotix BD Drops gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix BD Drops:

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

 

4. HOE OM MIBIOTIX BD DROPS TE GEBRUIK 

Die gewone dosis is:

Neem 10 drupples, daagliks na ontbyt.

Neem MiBiotix BD Drops 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 u meer MiBiotix BD Drops gebruik as wat u behoort:

Moenie meer as aanbevole dosis gebruik nie. (Sien pakketinvoegsel)

In die geval van ’n oordosis, raadpleeg u dokter of apteker. As jy vergeet om ‘n dosis MiBiotix BD Drops te neem:

Neem MiBiotix BD Drops 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 BD Drops 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 BD Drops geneem word nie.

MiBiotix BD Drops kan newe-effekte hê.

Nie alle newe-effekte wat vir MiBiotix BD Drops gemeld is, is in hierdie inligtingstuk vervat nie. Indien u algemene gesondheid agteruitgaan of u ongewenste wisselwerkings ervaar terwyl MiBiotix BD Drops 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 BD DROPS:

Bewaar alle medisyne 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 BD Drops gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte medisyne na u apteker / verskaffer terug.

Moet nie ongebruikte medisyne in riool- of rioolstelsels gooi  nie (byvoorbeeld toilette).

 

7. AANBIEDING VAN MIBIOTIX BD DROPS:

MiBiotix BD Drops is verpak in 30ml bottle, met ‘n wit dop en in ‘n buitenste karton.

 

8. IDENTIFIKASIE VAN MIBIOTIX BD DROPS:

Deursigtige MCT olie.

 

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.mybiotix.co.za

 

11. DATUM VAN PUBLIKASIE:

April 2019; PI.065.1.04.19