NUTRIVITE

NUTRIVITE

Professional information for NUTRIVITE

 

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.

 

SCHEDULING STATUS

S0

 

  1. NAME OF THE MEDICINE

NUTRIVITE

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

FoodMatrix® carrot, tomato and spinach extracts     197 mg

Calcium carbonate                                                                           166,62 mg

providing calcium                                                           66,67 mg

Magnesium oxide                                                                             82,92 mg

providing magnesium                                                    50 mg

Ascorbic acid (vitamin C)                                                                50 mg

Calcium D-pantothenate                                                                 8,7 mg

providing pantothenic acid (vitamin B5)                     4 mg

Iron lactate                                                                                        5,03 mg

providing iron                                                                  0,87 mg

Nicotinamide (vitamin B3)                                                               4,2 mg

Citrus bioflavonoids                                                                         4,17 mg

Zinc oxide                                                                                          4,11 mg

providing zinc                                                                  3,3 mg

Thiamine mononitrate                                                                     3,27 mg

providing thiamine (vitamin B1)                                   2,3 mg

Riboflavin (vitamin B2)                                                                    2,7 mg

Manganese sulphate                                                                       2,28 mg

providing manganese                                                    0,83 mg

Pyridoxine hydrochloride                                                                2,07 mg

providing pyridoxine (vitamin B6)                                1,7 mg

Boric acid                                                                                           0,97 mg

providing boron                                                               0,17 mg

Copper (as amino acid chelate)                                                     0,2 mg

Vanadium sulphate                                                                          286 µg

providing vanadium                                                        25 µg

Folic acid                                                                                           130 µg

Chromium polynicotinate                                                                56 µg

providing chromium                                                       17 µg

Biotin                                                                                                  33 µg

Molybdate                                                                                          28 µg

providing molybdenum                                                  17 µg

Selenium (as amino acid chelate)                                                 17 µg

Cyanocobalamin (vitamin B12)                                                      4 µg

Vitamin A acetate                                                                             955 IU

providing retinol (vitamin A)                                          833 IU

Cholecalciferol (vitamin D3)                                                           40 IU

d-α-tocopherol (vitamin D5)                                                            15 IU

Sugar free.

For the full list of excipients, see section 6 .1.

 

  1. PHARMACEUTICAL FORM

Tablets.

An off-white speckled round convex tablet.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Multivitamin and mineral supplement for the maintenance of good health.

Contributes to the maintenance of immune function, bones, cartilage, teeth, gums, and wound healing.

Contains antioxidants.

 

4.2             Posology and method of administration

Adults and children older than 12 years:

Take three tablets per day.

 

Children under 12 years:

Take one tablet per day.

 

4.3             Contraindications

Hypersensitivity to any of the active ingredients or excipients (see sections 2 and 6.1).

 

4.4             Special warnings and precautions for use

Consult your healthcare provider before taking NUTRIVITE if you are taking medication or suffering from any medical condition.

 

4.5             Interaction with other medicines and other forms of interaction

Consult your healthcare provider before taking NUTRIVITE if you are taking medication or suffering from any medical condition.

 

4.6             Fertility, pregnancy and lactation

Safety and efficacy have not been established in pregnancy and lactation.

Consult your healthcare provider before taking NUTRIVITE if you are pregnant, planning to get pregnant or if you are breastfeeding.

 

4.7             Effects on ability to drive and use machines

It is not known if NUTRIVITE has an effect on the ability to drive or use machines. Caution is advised before driving a vehicle or operating machinery until the effects of NUTRIVITE are known.

 

4.8             Undesirable effects

NUTRIVITE is well tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of NUTRIVITE is important. It allows continued monitoring of the benefit/risk balance of NUTRIVITE. Healthcare providers are asked to report any suspected adverse reactions to NRF HEALTH via https://www.nrfhealth.co.za

 

4.9             Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). Overdose treatment is symptomatic and supportive.

 

  1. PHARMACOLOGICAL PROPERTIES

Category and class: D 34.12 Multiple substance formulation.

Vitamin A is a fat-soluble vitamin that is readily absorbed from the gastrointestinal tract and is excreted in the bile or urine.

Vitamin B1 is a water-soluble B vitamin and is absorbed by the proximal part of the small intestines. It occurs in the body as the metabolically active form thiamine diphosphate and is excreted in the urine.

Vitamin B2 is readily absorbed from the gastrointestinal tract and is widely distributed in the body. It is excreted in the urine.

Vitamin B3 is water-soluble and well absorbed and is excreted mainly via urine.

Vitamin B5 is an essential B vitamin. It is absorbed from the small intestines and widely distributed through the body. About 70 % is excreted unchanged in the urine, and 30 % in the faeces.

Vitamin B6 is passively absorbed from the upper gastrointestinal tract, converted in the liver to the coenzyme pyridoxal phosphate and excreted in the urine.

Vitamin B12 is an essential water-soluble vitamin. It is absorbed in the terminal ileum and is mainly stored in the liver. Vitamin B12 is excreted via urine, faeces and bile.

Vitamin C is readily absorbed from the gastrointestinal tract and is widely distributed in the body. The main route of elimination is through urine.

Vitamin D is a fat-soluble vitamin. It is well absorbed and requires hydroxylation in the body to form the active metabolite, calcitriol. Excretion occurs mainly through the bile and faeces, with small amounts appearing in urine.

Folic acid is rapidly absorbed from the gastrointestinal tract, mainly the jejunum, and enters portal circulation where it is converted to the metabolically active form 5-methyltetrahydrofolate in the plasma and liver. It is excreted mainly in the urine.

Biotin is completely absorbed after oral administration and is bound to plasma proteins. It is excreted in the urine as unmetabolised biotin or as metabolites.

Zinc is a biologically essential trace element that is absorbed in the small intestines and is distributed in the body in skeletal muscle and bone. It is mainly excreted through the faeces.

Copper is absorbed from the small intestines and rapidly taken up by the liver and incorporated into caeruloplasmin. It is excreted via bile into faeces, with small amounts excreted in urine.

Iron absorption is variable and is enhanced by the presence of ascorbic acid. Most of the iron absorbed is incorporated into haemoglobin and is mostly excreted in the faeces.

After absorption from the gastrointestinal tract, selenium is incorporated into the enzyme glutathione peroxidase. It is excreted mainly in the urine.

After absorption, boron is distributed to all tissues with the highest concentration in bone and lowest in adipose tissue. 90 % of the boron is excreted unchanged in the urine.

Calcium absorption is affected by several factors like age, race, environmental and dietary conditions. Dietary calcium absorption is inversely correlated with total dietary calcium, dietary fibre, alcohol intake and physical activity. Calcium is distributed in the bones and teeth and excreted via the urine and faeces.

Approximately 0,5 % to 2 % of chromium is absorbed and distributed to the kidney, heart, liver, brain, muscle, spleen and lungs. A small percentage of chromium that is absorbed is rapidly excreted in the urine.

Magnesium requires both parathyroid hormone and vitamin D for absorption. Magnesium is absorbed throughout the gastrointestinal tract, is distributed in the skeleton and soft tissue, and excreted primary via the kidneys.

Absorbed manganese stays in the blood for a short time, but accumulates in tissues, including bone, where it can remain for many years. Manganese is cleared hepatically.

Molybdenum is absorbed from the gastrointestinal tract and stored in several organs. 90 % of ingested molybdenum is excreted in the urine within a few hours.

Only about 5 % of ingested vanadium is absorbed. Vanadium is distributed to the liver, kidney and bone, and primarily excreted in the urine.

Citrus bioflavonoids are a source of antioxidants which helps to protect cells against free radicals.

 

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Magnesium stearate

Microcrystalline cellulose

Silicon dioxide

Talc.

 

6.2             Incompatibilities

Not applicable.

 

6.3             Shelf life

2 years.

 

6.4             Special precautions for storage

Store at or below 25 °C.

Protect from light and moisture.

 

6.5            Nature and contents of container

90 tablets are packed in a white PP securitainer with a red LDPE lid.

 

6.6             Special precautions for disposal and other handling

None.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

Royal Square 428 Investments (Pty) Ltd

PO Box 1762

Randpark Ridge

2156

 

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF REVISION OF THE TEXT

November 2020.

Professionele inligting vir NUTRIVITE

 

KOMPLEMENTÊRE MEDISYNE: GESONDHEIDSAANVULLING

Hierdie ongeregistreerde medisyne is nie vir gehalte, veiligheid of beoogde gebruik deur SAHPRA geëvalueer nie.

 

SKEDULERINGSTATUS

S0

 

  1. NAAM VAN DIE MEDISYNE

NUTRIVITE

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke tablet bevat:

FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte                  197 mg

Kalsiumkarbonaat                                                                            166,62 mg

verskaf kalsium                                                               66,67 mg

Magnesiumoksied                                                                            82,92 mg

verskaf magnesium                                                        50 mg

Askorbiensuur (vitamien C)                                                            50 mg

Kalsium-D-pantotenaat                                                                   8,7 mg

verskaf pantoteensuur (vitamien B5)                          4 mg

Ysterlaktaat                                                                                       5,03 mg

verskaf yster                                                                    0,87 mg

Nikotienamied (vitamien B3)                                                          4,2 mg

Sitrus bioflavonoïede                                                                       4,17 mg

Sinkoksied                                                                                         4,11 mg

verskaf sink                                                                     3,3 mg

Tiamienmononitraat                                                                         3,27 mg

verskaf tiamien (vitamien B1)                                       2,3 mg

Riboflavien (vitamien B2)                                                                2,7 mg

Mangaansulfaat                                                                                2,28 mg

verskaf mangaan                                                            0,83 mg

Piridoksienhidrochloried                                                                  2,07 mg

verskaf piridoksien (vitamien B6)                                1,7 mg

Boorsuur                                                                                            0,97 mg

verskaf boor                                                                    0,17 mg

Koper (as aminosuurchelaat)                                                         0,2 mg

Vanadiumsulfaat                                                                              285,73 µg

verskaf vanadium                                                           25 µg

Foliensuur                                                                                          130 µg

Chroompolinikotinaat                                                                       55,82 µg

verskaf chroom                                                               16,67 µg

Biotien                                                                                                33,3 µg

Molibdaat                                                                                           0,028 mg

verskaf molibdeen                                                          0,017 mg

Seleen (as aminosuurchelaat)                                                       0,017 mg

Sianokobalamien (vitamien B12)                                                   4,2 µg

Vitamien A-asetaat                                                                          955 IE

verskaf retinol (vitamien A)                                           833 IE

Cholekalsiferol (vitamien D3)                                                         40 IE

d-α-tokoferol (vitamien D5)                                                             15 IE

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Tablette.

’n Naaswit, gespikkelde, ronde, konvekse tablet.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Multivitamien-en-mineraal-aanvulling om goeie gesondheid te onderhou.

Dra by tot die instandhouding van immuunfunksie, been, kraakbeen, tande, tandvleis, en wondgenesing.

Bevat antioksidante.

 

4.2             Posologie en metode van toediening

Volwassenes en kinders ouer as 12 jaar:

Neem drie tablette per dag.

 

Kinders jonger as 12 jaar:

Neem een tablet per dag.

 

4.3             Kontra-indikasies

Hipersensitiwiteit vir enige van die aktiewe of onaktiewe bestanddele (sien afdelings 2 en 6.1).

 

4.4             Spesiale waarskuwings en voorsorgmaatreëls vir gebruik

Konsulteer jou gesondheidsorgverskaffer voordat NUTRIVITE geneem word indien jy medikasie neem of aan enige mediese toestand ly.

 

4.5             Interaksies met ander medisyne en ander vorms van interaksie

Konsulteer jou gesondheidsorgverskaffer voordat NUTRIVITE geneem word indien jy medikasie neem of aan enige mediese toestand ly.

 

4.6             Vrugbaarheid, swangerskap en borsvoeding

Die veiligheid en effektiwiteit tydens swangerskap en borsvoeding is nie vasgestel nie.

Konsulteer jou gesondheidsorgverskaffer voordat NUTRIVITE geneem word indien jy swanger is, beplan om swanger te raak of jou baba borsvoed.

 

4.7             Uitwerking op die vermoë om te bestuur en masjiene te gebruik

Dit is onbekend of NUTRIVITE ’n uitwerking het op die vermoë om te bestuur of masjiene te gebruik. Versigtigheid word aangeraai voordat ’n voertuig bestuur of masjinerie hanteer word, totdat bekend is wat die uitwerking van NUTRIVITE is.

 

4.8             Ongewenste effekte

NUTRIVITE word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat NUTRIVITE goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van NUTRIVITE. Gesondheidsorgverskaffers moet asseblief enige vermoedelike newe-effekte rapporteer aan NRF HEALTH via https://www.nrfhealth.co.za

 

4.9             Oordosering

Met oordosering kan newe-effekte gepresipiteer word en/of ernstiger wees (sien afdeling 4.8). Na oordosering moet simptomatiese en ondersteunende behandeling toegepas word.

 

  1. FARMAKOLOGIESE EIENSKAPPE

Kategorie en klas:  D 34.12 Formule met verskeie bestanddele.

Vitamien A is ’n vetoplosbare vitamien wat geredelik uit die spysverteringskanaal geabsorbeer word en in die gal of urine uitgeskei word.

Vitamien B1 is ’n wateroplosbare B-vitamien en word deur die proksimale deel van die dunderm geabsorbeer. Dit kom in die liggaam as die metabolies aktiewe vorm tiamiendifosfaat voor en word in die urine uitgeskei.

Vitamien B2 word geredelik uit die spysverteringskanaal geabsorbeer en word wyd versprei in die liggaam. Dit word in die urine uitgeskei.

Vitamien B3 is wateroplosbaar, word goed geabsorbeer en word hoofsaaklik via die urine uitgeskei.

Vitamien B5 is ’n essensiële B-vitamien. Dit word uit die dunderm geabsorbeer en wyd versprei deur die liggaam. Ongeveer 70 % word onveranderd in die urine uitgeskei, en 30 % in die feses.

Vitamien B6 word passief geabsorbeer uit die boonste spysverteringskanaal, in die lewer omgeskakel na die koënsiem piridoksaalfosfaat en in die urine uitgeskei.

Vitamien B12 is ’n essensiële, wateroplosbare vitamien. Dit word in die terminale ileum geabsorbeer, en word hoofsaaklik in die lewer opgeberg. Vitamien B word via urine, feses en gal uitgeskei.

Vitamien C word geredelik uit die spysverteringskanaal geabsorbeer en wyd in die liggaam versprei. Dit word hoofsaaklik in die urine uitgeskei.

Vitamien D is ’n vetoplosbare vitamien. Dit word goed geabsorbeer en word dan in die liggaam gehidroksileer om die aktiewe metaboliet kalsitriol te vorm. Dit word hoofsaaklik in gal en feses uitgeskei, met klein hoeveelhede in die urine.

Foliensuur word vinnig uit die spysverteringskanaal geabsorbeer, hoofsaaklik die jejunum, en gaan die portale sirkulasie in waar dit in die plasma en lewer na 5-metieltetrahidrofolaat omgeskakel word, wat metabolies aktief is. Dit word hoofsaaklik in die urine uitgeskei.

Biotien word volledig geabsorbeer na mondelikse inname, en is gebonde aan plasmaproteïene. Dit word in die urine as ongemetaboliseerde biotien of as metaboliete uitgeskei.

Sink is ’n biologies essensiële spoorelement wat uit die dunderm geabsorbeer word en na die skeletspiere en -bene versprei word. Dit word hoofsaaklik in die feses uitgeskei.

Koper word uit die dunderm geabsorbeer en vinnig in die lewer opgeneem, waar dit in seruloplasmien (ferroksidase) geïnkorporeer word. Dit word via gal in die feses uitgeskei, met klein hoeveelhede in die urine.

Ysterabsorpsie varieer en word bevorder deur die teenwoordigheid van askorbiensuur. Die meeste van die yster wat geabsorbeer word, word in hemoglobien geïnkorporeer, en word hoofsaaklik in die feses uitgeskei.

Seleen word in die ensiem glutatioonperoksidase geïnkorporeer nadat dit uit die spysverteringskanaal geabsorbeer is. Dit word hoofsaaklik in die urine uitgeskei.

Na absorpsie word boor na al die weefsels versprei, met die hoogste konsentrasie in been en die laagste in vetweefsel. 90 % van die boor word onveranderd in die urine uitgeskei.

Kalsiumabsorpsie word deur verskeie faktore beïnvloed, soos ouderdom, ras, omgewingstoestande en eetgewoontes. Absorpsie van kalsium uit die dieet is omgekeerd eweredig aan die hoeveelheid kalsium in die dieet, dieetvesel, alkoholinname en fisieke aktiwiteit. Kalsium word na die bene en tande versprei, en via die urine en feses uitgeskei.

Ongeveer 0,5 % tot 2 % van die chroom word geabsorbeer en na die niere, hart, lewer, brein, spiere, milt en longe versprei. ’n Klein persentasie van die chroom wat geabsorbeer word, word vinnig via die urine uitgeskei.

Magnesium benodig sowel paratiroïedhormoon as vitamien D vir absorpsie. Magnesium word uit die hele lengte van die spysverteringskanaal geabsorbeer, word na die skelet en sagteweefsel versprei, en hoofsaaklik via die niere uitgeskei.

Geabsorbeerde mangaan bly vir ’n kort rukkie in die bloed, maar akkumuleer in weefsel, insluitende been, waar dit vir baie jare kan bly. Mangaan word deur die lewer opgeruim.

Molibdeen word uit die spysverteringskanaal geabsorbeer en in verskeie organe opgeberg. 90 % van die molibdeen wat ingeneem word, word binne ’n paar uur in die urine uitgeskei.

Slegs sowat 5 % van die vanadium wat ingeneem word, word geabsorbeer. Vanadium word na die lewer, niere en been versprei, en hoofsaaklik in die urine uitgeskei.

Sitrusbioflavonoïede is ’n bron van antioksidante, wat help om selle teen vry radikale te beskerm.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Magnesiumstearaat

Mikrokristallyne sellulose

Silikondioksied

Talk.

 

6.2             Onverenigbaarhede

Nie van toepassing nie.

 

6.3             Rakleeftyd

2 jaar.

 

6.4             Spesiale voorsorgmaatreëls vir berging

Bêre by of onder 25 °C.

Beskerm teen lig en vog.

 

6.5           Aard en inhoud van die houer

90 tablette word in ’n wit PP-sekuriteitshouer met ’n rooi LDPE-deksel verpak.

 

6.6             Spesiale voorsorgmaatreëls vir wegdoening en ander hantering

Geen.

 

  1. HOUER VAN DIE REGISTRASIESERTIFIKAAT

Royal Square 428 Investments (Edms.) Bpk.

Posbus 1762

Randparkrif

2156

 

  1. REGISTRASIENOMMER

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN EERSTE MAGTIGING/HERNUWING VAN MAGTIGING

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN HERSIENING VAN DIE TEKS

November 2020.

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