Max Dura.pdf

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Record Summary 141243 MAX DURA

Sponsor Contract Manufacturing & Packaging Services Pty Ltd

Therapeutic Type Medicine

Product Category/ Class Listed

ARTG Start date 28/06/2007

Postal Address 1/38 Elizabeth Street,WETHERILL PARK, NSW, 2164

AustraliaBilling Address 1/38 Elizabeth Street, WETHERILL PARK, NSW, 2164

Australia

Export alias names ZoverRevitalDuramaxVIGORMAXDURAMax Dura Performance

Conditions

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine issub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall bekept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records tothe Office of Complementary Medicines, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those acceptedin relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Medicine Safety Monitoring, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports.Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Medicines SafetyMonitoring is notified of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicineoutside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the Head,Office of Complementary Medicines, Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monographPowdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27). This condition does not apply to powdered ordried leaf.

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Therapeutic Goods Act 1989, shall beonly those included in the list of 'Colourings permitted in medicines for oral use' available at , as amendedfrom time to time.

Manufacturers

Name Address Manufacturing steps

Contract Manufacturing &Packaging Services Pty Ltd

Unit 1 & 2 38 Elizabeth StreetWETHERILL PARK, NSW,

2164Australia

Manufacture of dosage formPackaging and labellingRelease for supplySecondary packagingTesting chemical and physicalTesting microbial

Vitex Pharmaceuticals Pty Ltd Unit 1 12 Weld StreetPRESTONS, NSW, 2170Australia

Packaging and labellingRelease for supply

Products

1.MAX DURA

Product Type Single Medicine Product Status Current

Effective date 28/06/2007

Warnings

CAFF Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

S If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

Aids, assists or helps in the maintenance of general well-being

Specific Indications

No Specific Indications included on Record

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The details contained in this copy of the Record Summary reflect the information held at the nominated date and time of printingThe currency and accuracy of the details can be confirmed at www.ebs.gov.au."


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Specific Conditions

No Specific Conditions included on Record

Pack Size information

Pack Size Not recorded

Poison information

Poison Not recorded

Additional Product information

Components

1.Medicine component

Dosage form Capsule, hard

Route of Administration Oral

Maximum daily dose 2

Maximum single dose 1

Weight of dividedpreparation

620mg

Formulations

Active Ingredients Category Quantity Units

Epimedium sagittatum AHN 50 mg

Concentration ratio 20:1

Carrier Qty Units

Silica - colloidal anhydrous 20 mg

Plant details (origin) Part Preparation

leaf Extract dry concentrate

Equivalent

Epimedium sagittatum(Dry) 1 g

Extract ingredient name Ratio Type

Epimedium sagittatum 20:1 CONCENTRATION

Extract step solvent Name %

Water - purified 40

Ethanol 60

Ginkgo biloba AHN 5 mg



leaf Extract dry concentrate

Equivalent

Ginkgo biloba(Dry) 250 mg


Ginkgo biloba 50:1 CONCENTRATION


Water - purified 50

Ethanol 50

Panax ginseng AHN 35 mg



root Extract dry concentrate

Equivalent

Panax ginseng(Dry) 105 mg


Panax ginseng 3:1 CONCENTRATION


Water - purified 30

Ethanol 70

Paullinia cupana AHN 100 mg


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Carrier Qty Units

Maltodextrin 20 mg


seed Extract dry concentrate

Equivalent

Paullinia cupana(Dry) 400 mg

Caffeine 10 mgExtract ingredient name Ratio Type

Paullinia cupana 4:1 CONCENTRATION


Water - purified 30

Ethanol 70

Tribulus terrestris AHN 150 mg



root and rhizome and stolon Extract dry concentrate

Equivalent

Tribulus terrestris(Dry) 7.5 g


Tribulus terrestris 50:1 CONCENTRATION


Water - purified 100

Excipient Ingredients Category Quantity Units

Calcium hydrogen phosphate AAN 80 mg

Cellulose - microcrystalline AAN 50 mg

Gelatin ABN 96.9 mg

Animal Details Part Preparation Country of Origin

Bovine Skin Not listed United States Of America

Magnesium stearate AAN 15 mg

Silica - colloidal anhydrous AAN 15 mg

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