IMMUNE PROFESSIONAL INFORMATION

SCHEDULING STATUS:

SO

PROPRIETARY NAME AND DOSAGE FORM

Immune Capsules

COMPOSITION

Ingredients

Amount per 1 Capsule

Panax ginseng (Panax Ginseng)

[Root]

299,9 mg

Curcuma longa (Turmeric)

[Rhizome]

280 mg

Ascorbic Acid (Vitamin C)

120 mg

Astragalus membranaceus (Astragalus)

[Root]

50 mg

Selenium

0,1 mg

Excipients: veggie capsule.

Sugar Free

 

CATEGORY AND CLASS

Category D: Complementary Medicine

Class 33.7 Combination Product

PHARMACOLOGICAL ACTION

Pharmacological Action

The Pharmacological action is achieved by the combination of ingredients to promote and maintain a healthy immune system.

 

Pharmacokinetic Properties

The active ingredients in this formulation are well known. Pharmacokinetic studies have not been conducted on the Immune.

INDICATIONS

  • Used in Herbal Medicine to help maintain a healthy immune system.
  • Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress.
  • An antioxidant for the maintenance of good health.
  • Source of antioxidants.

WARNINGS AND SPECIAL PRECAUTIONS

Consult a health care practitioner prior to use:

  • if you are pregnant or breastfeeding
  • if you have an autoimmune disorder.
  • if you have diabetes
  • if you are taking antidepressant medication, blood thinners or digoxin
  • if you have gall stones
  • if you have a bile duct obstruction
  • if you have stomach ulcers or excess stomach acid

Consult a health care practitioner if symptoms persist or worsen.

Not suitable for children under the age of 18 years.

In general, health supplements should not be intended for supply to any children under the age of seven (7) months old unless where supplementation is medically warranted.

INTERACTIONS

Antidepressant medication, blood thinners or digoxin

HUMAN REPRODUCTION

Consult a health care practitioner prior to use if you are pregnant, intending on becoming pregnant or breastfeeding.

DOSAGE AND DIRECTIONS FOR USE

Take one capsule once daily or as directed by a health care practitioner.

Consult a health care practitioner for use beyond 3 months.

SIDE EFFECTS

Adverse reactions are listed below by system organ class and by frequency. Frequencies are defined as: Very common (≥1/10), common (≥ 1/100, < 1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000), according to the MedDRA frequency convention and system organ classification.

Immune system disorders

Frequency unknown

Hypersensitivity reaction (such as rash)

Insomnia, anxiety or headaches

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

CONTRAINDICATIONS

  • Hypersensitivity/allergy to any of the ingredients, in which case, discontinue use.
  • Children under the age of 18 years
  • Pregnant and Breastfeeding individuals
  • Autoimmune disorders
  • Diabetes
  • Antidepressant medication, blood thinners or digoxin
  • Gall stones
  • Bile duct obstructions
  • Stomach ulcers or excess stomach acid

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT

See section Warnings and Special Precautions and Side Effects.

In overdose, side effects can be precipitated and/or be of increased severity.

Treatment should be symptomatic and supportive.

IDENTIFICATION

Clear, size 00 veggie capsule filled with orange/brown powder.

PRESENTATION

Clear, glass jar with aluminium screw lid.

STORAGE INSTRUCTIONS

Store in a dark, dry place at or below 25˚C.

REGISTRATION NUMBER

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

DATE OF PUBLICATION

February 2022

AFRIKAANS

SKEDULERINGSTATUS:

S0

BENAMING EN DOSISVORM:

Immune kapsules

SAMESTELLING:

Bestanddele

Hoeveelheid per 1 kapsule

Panax ginseng (Panax Ginseng)

[Wortel]

299,9 mg

Curcuma longa (Borrie)

[Risoom]

280 mg

Askorbiensuur (Vitamine C)

120 mg

Astragalus membranaceus (Astragalus)

[Wortel]

50 mg

Selenium

0,1 mg

Hulpstowwe: groente-kapsule.

Suikervry

KATEGORIE EN KLAS

Kategorie D: Aanvullende medisyne

Klas 33.7 Kombinasieproduk

FARMAKOLOGIESE AKSIE

Farmakologiese aksie

Die farmakologiese werking word bewerkstellig deur die kombinasie van bestanddele om ‘n gesonde immuunstelsel te bevorder en te handhaaf.

Farmakokinetiese eienskappe

Die aktiewe bestanddele in hierdie formulering is bekend. Farmakokinetiese studies is nie op die Immune uitgevoer nie.

AANWYSINGS

  • Word gebruik in Kruie Geneeskunde om ‘n gesonde immuunstelsel te handhaaf.
  • Word gebruik in Kruie Geneeskunde as ‘n adaptogeen om energie en weerstand teen spanning te verhoog.
  • ‘n Antioksidant vir die handhawing van goeie gesondheid.
  • Bron van antioksidante.

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

Raadpleeg ‘n geneesheer voor gebruik:

  • as u swanger is of borsvoed
  • as u ‘n outo-immuunversteuring het
  • as u diabetes het
  • as u ‘n antidepressant, bloedverdunner of digoksien neem
  • as u galstene het
  • as u ‘n obstruksie van die galbuis het
  • as u maagsere of oortollige maagsuur het

Raadpleeg ‘n geneesheer as die simptome voortduur of vererger.

Nie geskik vir kinders onder die ouderdom van 18 jaar nie.

Oor die algemeen moet gesondheidsaanvullings nie bedoel wees vir verskaffing aan kinders onder die ouderdom van sewe (7) maande nie, tensy dit medies geregverdig is om aanvulling te kry.

INTERAKSIES

Antidepressant medikasie, bloedverdunners of digoksien

MENSLIKE REPRODUKSIE-VERSLAE

Raadpleeg ‘n geneesheer voor gebruik as u swanger is, beoog om swanger te raak of borsvoed.

DOSERING EN AANWYSINGS VIR GEBRUIK

Neem een kapsule een keer per dag of soos aangedui deur ‘n geneesheer.

Raadpleeg ‘n gesondheidsorg-praktisyn vir gebruik langer as drie maande.

NEWE-EFFEKTE

Die newe-reaksies word hieronder gelys volgens die orgaanklas en volgens frekwensie. Frekwensies word gedefinieer as: Baie gereeld (≥1 / 10), algemeen (≥ 1/100, <1/10), ongewoon (≥1 / 1, 000, <1/100), skaars (≥1 / 10,000, <1/1, 000), baie skaars (<1/10,00000) volgens die MedDRA frekwensie-konvensie en stelselorgaanklassifikasie.

Immuunstelsel-afwykings

Frekwensie onbekend

Hipersensitiwiteitsreaksie (soos uitslag)

Slapeloosheid, angs of hoofpyn

Verslagdoening oor vermoedelike newe-reaksies

Dit is belangrik om vermoedelike newe-reaksies na die magtiging van die medisyne aan te meld. Dit laat voortgesette monitering van die voordeel / risiko-balans van die medisyne toe. Verskaffers van gesondheidsorg word gevra om enige vermoedelike nadelige reaksies by SAHPRA aan te meld via die “6.04 Nadelige medisynereaksie-verslagdoeningsvorm”, wat aanlyn gevind word onder SAHPRA se publikasies: https: //www.sahpra.org.za / Publikasies / Indeks / 8.

KONTRA-INDIKASIES

  • Oorgevoeligheid / allergie vir enige van die bestanddele, in welke geval die gebruik gestaak word.
  • Kinders jonger as 18 jaar
  • Swanger en borsvoedende individue
  • Outo-immuunafwykings
  • Diabetes
  • Antidepressant-medikasie, bloedverdunners of digoksien
  • Galstene
  • Galbuis-obstruksies
  • Maagsere of oortollige maagsuur

 

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING

Sien afdeling Waarskuwings en spesiale voorsorgmaatreëls en newe-effekte.

 By oordosis kan newe-effekte versnel word en / of vererger word.

Behandeling moet simptomaties en ondersteunend wees.

IDENTIFIKASIE

Helder, grootte 00 groente-kapsule gevul met oranje / bruin poeier.

AANBIEDING

Helder, glaskruik met aluminiumskroefdeksel.

BERGINGSINSTRUKSIES

Berg in ‘n donker, droë plek by of onder 25˚C

REGISTRASIENOMMER

Hierdie ongeregistreerde medisyne is nie deur die SAHPRA geëvalueer vir die kwaliteit daarvan, veiligheid of beoogde gebruik nie.

DATUM VAN PUBLIKASIE

Februarie 2022