OSTEOVITE
OSTEOVITE
Professional information for OSTEOVITE
COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS
S0
- NAME OF THE MEDICINE
OSTEOVITE
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Calcium carbonate 332,1 mg
providing calcium 133 mg
FoodMatrix® carrot, tomato and spinach extracts 262 mg
Magnesium oxide 111,1 mg
providing magnesium 67 mg
Ascorbic acid (vitamin C) 50 mg
Colloidal silicon dioxide 4,5 mg
providing silicon 2,1 mg
Zinc oxide 3,4 mg
providing zinc 2,7 mg
Boric acid 2,7 mg
providing boron 0,5 mg
Manganese sulphate 1,84 mg
providing manganese 0,67 mg
Copper (as amino acid chelate) 0,17 mg
Vanadium sulphate 194,3 µg
providing vanadium 17 µg
Molybdate 61,6 µg
providing molybdenum 37 µg
Chromium polynicotinate 60,3 µg
providing chromium 18 µg
Cholecalciferol (vitamin D3) 34,7 IU
Sugar free.
For the full list of excipients, see section 6 .1.
- PHARMACEUTICAL FORM
Tablets.
An off-white round biconvex tablet.
- CLINICAL PARTICULARS
4.1 Therapeutic indications
Helps in the absorption and use of calcium and may reduce the risk of developing osteoporosis.
Helps to repair connective tissue, the development and maintenance of normal bones.
4.2 Posology and method of administration
Take 4 – 6 tablets per day, or as prescribed by your healthcare provider. Do not exceed the recommended dosage.
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 OSTEOVITE 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 OSTEOVITE 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 OSTEOVITE 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 OSTEOVITE 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 OSTEOVITE are known.
4.8 Undesirable effects
OSTEOVITE is well tolerated.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of OSTEOVITE is important. It allows continued monitoring of the benefit/risk balance of OSTEOVITE. 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.
- 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.
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.
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.
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.
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 form the gastrointestinal tract and stored in several organs. 90 % of ingested molybdenum is excreted in the urine within a few hours.
Silicon is primarily absorbed in the proximal small intestine, distributed and contained in connective tissue, and excreted via the kidneys.
Only about 5 % of ingested vanadium is absorbed. Vanadium is distributed to the liver, kidney and bone, and primarily excreted in the urine.
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.
- PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate
Microcrystalline cellulose
Polyethylene glycol
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.
- HOLDER OF CERTIFICATE OF REGISTRATION
Royal Square 428 Investments (Pty) Ltd
P.O. Box 1762
Randpark Ridge
2156
- REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Will be allocated by SAHPRA upon registration.
- DATE OF REVISION OF THE TEXT
November 2020.
Professionele inligting vir OSTEOVITE
KOMPLEMENTÊRE MEDISYNE: GESONDHEIDSAANVULLING
Hierdie ongeregistreerde medisyne is nie vir gehalte, veiligheid of beoogde gebruik deur SAHPRA geëvalueer nie.
SKEDULERINGSTATUS
S0
- NAAM VAN DIE MEDISYNE
OSTEOVITE
- KWALITATIEWE EN KWANTITATIEWE SAMESTELLING
Elke tablet bevat:
Kalsiumkarbonaat 332,1 mg
verskaf kalsium 133 mg
FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte 262 mg
Magnesiumoksied 111,1 mg
verskaf magnesium 67 mg
Askorbiensuur (vitamien C) 50 mg
Kolloïdale silikondioksied 4,5 mg
verskaf silikon 2,1 mg
Sinkoksied 3,4 mg
verskaf sink 2,7 mg
Boorsuur 2,7 mg
verskaf boor 0,5 mg
Mangaansulfaat 1,84 mg
verskaf mangaan 0,67 mg
Koper (as aminosuurchelaat) 0,17 mg
Vanadiumsulfaat 194,3 µg
verskaf vanadium 17 µg
Molibdaat 61,6 µg
verskaf molibdeen 37 µg
Chroompolinikotinaat 60,3 µg
verskaf chroom 18 µg
Cholekalsiferol (vitamien D3) 34,7 IE
Suikervry.
Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.
- DOSEERVORM
Tablette.
’n Naaswit, ronde, bikonvekse tablet.
- KLINIESE BESONDERHEDE
4.1 Terapeutiese indikasies
Help met die absorpsie en benutting van kalsium en mag die risiko om osteoporose te ontwikkel verlaag.
Help met die herstel van bindweefsel, en ontwikkelling en instandhouding van normale bene.
4.2 Posologie en metode van toediening
Neem 4 – 6 tablette per dag, of soos wat deur jou gesondheidsorgverskaffer aangedui is. Moenie die aanbevole dosering oorskry nie.
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 OSTEOVITE 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 OSTEOVITE 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.
Raadpleeg jou gesondheidsorgverskaffer voordat jy OSTEOVITE neem 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 OSTEOVITE ’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 OSTEOVITE is.
4.8 Ongewenste effekte
OSTEOVITE word goed verdra.
Rapportering van vermoedelike newe-effekte:
Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat OSTEOVITE goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van OSTEOVITE. 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.
- 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.
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.
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.
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.
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.
Silikon word hoofsaaklik uit die proksimale dunderm geabsorbeer, versprei en geberg in bindweefsel, en via die niere 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.
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.
- FARMASEUTIESE BESONDERHEDE
6.1 Lys van onaktiewe bestanddele
Magnesiumstearaat
Mikrokristallyne sellulose
Poliëtileenglikol
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.
- HOUER VAN DIE REGISTRASIESERTIFIKAAT
Royal Square 428 Investments (Edms.) Bpk.
Posbus 1762
Randparkrif
2156
- REGISTRASIENOMMER
Sal met registrasie deur SAHPRA toegeken word.
- DATUM VAN EERSTE MAGTIGING/HERNUWING VAN MAGTIGING
Sal met registrasie deur SAHPRA toegeken word.
- DATUM VAN HERSIENING VAN DIE TEKS
November 2020.