VITA-C 2000

VITA-C 2000

Professional information for VITA-C 2000

 

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

VITA-C 2000

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each scoop (2,5 g) contains:

Ascorbic acid (vitamin C, buffered)                                               1 000 mg

ß-carotene 1 %                                                                                      25 mg

Citrus bioflavonoids 35 %                                                               12,5 mg

Contains sweetener:  Acesulfame K.

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL FORM

Powder.

White to off-white orange flavoured powder.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Contributes to normal function of the immune system, helps in connective tissue formation and contributes to wound healing.

Contributes to normal cell division and to the reduction of tiredness and fatigue.

Safe for people suffering from acidic conditions.

 

4.2             Posology and method of administration

One level scoop dissolved in a glass of water or fruit juice, or as perscribed by your healthcare provider. Efficacy is enhanced when taken on an empty stomach.

 

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 VITA-C 2000 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 VITA-C 2000 if you are taking medication or suffering from any medical condition.

 

4.6             Fertility, pregnancy and lactation

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

Consult your healthcare provider before taking VITA-C 2000 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 VITA-C 2000 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 VITA-C 2000 are known.

 

4.8             Undesirable effects

VITA-C 2000 is well-tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of VITA-C 2000 is important.  It allows continued monitoring of the benefit/risk balance of VITA-C 2000. 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 C is readily absorbed from the gastrointestinal tract and is widely distributed in the body. The main route of elimination is through urine.

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

Some ingested ß -carotene is converted to vitamin A in the intestinal mucosa or liver. Carotenoids are mainly carried in the blood on low-density lipoproteins (LDLs). ß-carotene is excreted in the faeces.

 

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Acesulfame K

Aerosil

Citric acid

Malic acid

Maltodextrin

Orange flavour.

 

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

The powder is packed in a white PP securitainer with a orange LDPE lid.

 

6.6             Special precautions for disposal and other handling

None.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

Royal Square 428 Investments (Pty) Ltd

P.O. 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 VITA-C 2000

 

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

VITA-C 2000

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke maatlepel (2,5 g) bevat:

Askorbiensuur (gebufferde vitamien C)                      1 000 mg

ß-karoteen 1 %                                                               25 mg

Sitrusbioflavonoïede 35 %                                            12,5 mg

Bevat versoeter:  Asesulfaam K.

Vir die volledige lys van onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Poeier.

Wit tot naaswit lemoengegeurde poeier.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Dra by tot normale werking van die immuunstelsel, help met die vorming van bindweefsel en dra by tot wondgenesing.

Dra by tot normale seldeling en om moegheid en uitputting te verlig.

Veilig vir mense wat ly aan toestande waar te veel suur ’n probleem is.

 

4.2             Posologie en metode van toediening

Een gelykvol maatlepel opgelos in ’n glas water of vrugtesap, of soos wat deur jou gesondheidsorgverskaffer voorgeskryf is. Dit werk meer doeltreffend wanneer dit op ’n leë maag geneem word.

 

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 jy VITA-C 2000 neem indien jy medikasie gebruik of aan enige mediese toestand ly.

 

4.5             Interaksies met ander medisyne en ander vorms van interaksie

Konsulteer jou gesondheidsorgverskaffer voordat jy VITA-C 2000 neem indien jy medikasie gebruik 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 VITA-C 2000 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 VITA-C 2000 ’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 VITA-C 2000 is.

 

4.8             Ongewenste effekte

VITA-C 2000 word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat VITA-C 2000 goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van VITA-C 2000. 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 C word geredelik uit die spysverteringskanaal geabsorbeer en wyd in die liggaam versprei. Dit word hoofsaaklik in die urine uitgeskei.

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

Party van die ß-karoteen wat ingeneem word, word na vitamien A in die dermslymvliese of lewer omgeskakel. Karotenoïede word hoofsaaklik op laedigtheidslipoproteïene (LDL’s) in die bloed vervoer. ß-karoteen word in ontlasting (feses) uitgeskei.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Asesulfaam K

Aerosil

Sitroensuur

Appelsuur

Maltodekstrien

Lemoengeursel.

 

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

Die poeier word in ’n wit PP-sekuriteitshouer met ’n oranje 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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