SELENIVITE

SELENIVITE

Proposed professional information for SELENIVITE

 

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

SELENIVITE

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

FoodMatrix® carrot, tomato and spinach extracts                    322 mg

d-α-tocopherol succinate                                                                12,32 mg

providing d-α-tocopherol (vitamin E)                           10 mg

Selenium (as amino acid chelate)                                                 100 µg

Sodium selenite                                                                                68,19 µg

providing selenium                                                         28,5 µg

Sugar free.

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL FORM

Tablets.

A white round biconvex tablet.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Antioxidant for maintenance of good health, immune system, normal hair and nails.

Contributes to the protection of cells from oxidative stress.

 

4.2             Posology and method of administration

Adults: Take two tablets daily or as prescribed by your healthcare provider. Do not take more than two tablets daily.

 

4.3             Contraindications

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

Not indicated for children.

 

4.4             Special warnings and precautions for use

Consult your healthcare provider before taking SELENIVITE 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 SELENIVITE 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.

 

4.7             Effects on ability to drive and use machines

It is not known if SELENIVITE 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 SELENIVITE are known.

 

4.8             Undesirable effects

SELENIVITE is well-tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of SELENIVITE is important.  It allows continued monitoring of the benefit/risk balance of SELENIVITE. 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.

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

Vitamin E is mostly absorbed in the small intestines by passive diffusion and is excreted mainly unchanged via the faeces.

 

  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

60 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

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 SELENIVITE

 

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

SELENIVITE

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke tablet bevat:

FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte                                    322 mg

d-α-tokoferolsuksinaat                                                                                       12,32 mg

verskaf d-α-tokoferol (vitamien E)                                                 10 mg

Seleen (as aminosuurchelaat)                                                                         100 µg

Natriumseleniet                                                                                                  68,19 µg

verskaf seleen                                                                                  28,5 µg

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Tablette.

’n Wit, ronde, bikonvekse tablet.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Antioksidant vir die instandhouding van goeie gesondheid, die immuunstelsel, en normale hare en naels.

Dra by om selle teen oksidatiewe stres te beskerm.

 

4.2             Posologie en metode van toediening

Volwassenes: Neem twee tablette daagliks of soos wat deur jou gesondheidsorgverskaffer aangedui is. Moenie meer as twee tablette daagliks neem nie.

 

4.3             Kontra-indikasies

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

Nie aangedui vir kinders nie.

 

4.4             Spesiale waarskuwings en voorsorgmaatreëls vir gebruik

Konsulteer jou gesondheidsorgverskaffer voordat jy SELENIVITE 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 SELENIVITE neem indien jy medikasie gebruik of aan enige mediese toestand ly.

 

4.6             Vrugbaarheid, swangerskap en borsvoeding

Veiligheid en effektiwiteit tydens swangerskap en borsvoeding is nie vasgestel nie.

 

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

Dit is onbekend of SELENIVITE ’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 SELENIVITE is.

 

4.8             Ongewenste effekte

SELENIVITE word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat SELENIVITE goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van SELENIVITE. Gesondheidsorgverskaffers moet asseblief enige vermoedelike newe-effekte aan 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.

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

Vitamien E word hoofsaaklik deur middel van passiewe diffusie uit die dunderm geabsorbeer en word grootliks onveranderd via die feses uitgeskei.

 

  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

60 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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