Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: GlaxoSmithKline Consumer Healthcare South Africa (Pty) Limited, 39 Hawkins avenue, Epping Industria 1, Cape Town, 7460
Voltaren Emulgel 12 hour (2% gel).
| Pharmaceutical Form |
|---|
|
Gel. White to practically white, soft, homogeneous, cream-like gel. |
Diethylamine-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
1 g of Voltaren Emulgel 12 Hour contains 23,2 mg of the active substance diclofenac diethylamine, which corresponds to 20 mg diclofenac sodium.
Excipients: Propylene glycol (50 mg/g gel), Buthylhydroxytoluene (0.2 mg/g gel), Isopropyl alcohol (175 mg/g gel).
Anti-oxidant: Buthylhydroxytoluene (0,2 mg/g gel).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms. |
| List of Excipients |
|---|
|
Butylhydroxytoluene |
Aluminium laminated tube [low density polyethylene/aluminium/high density polyethylene (internal layer)] fitted with a high-density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap, incorporating a moulded feature used to insert, twist and remove the seal before first use. 30 g and 50 g Laminated aluminium tube with white cap 100 g Laminated aluminium tube with white cap or Laminated aluminium tube with white triangular cap
Pack sizes: 50 g and 100 g.
Not all pack sizes may be marketed.
GlaxoSmithKline Consumer Healthcare South Africa (Pty) Limited, 39 Hawkins avenue, Epping Industria 1, Cape Town, 7460
46/3.1/0649
The date of registration of the medicine: 15 December 2020
| Drug | Countries | |
|---|---|---|
| VOLTAREN | Albania, Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.