Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
VELTEX 75 CR 75 mg capsules.
VELTEX 100 CR 100 mg capsules.
VELTEX AMPOULES 75 mg injections.
| Pharmaceutical Form |
|---|
CapsulesVELTEX 75 CR: Size 2 hard gelatin capsule with opaque light blue cap and opaque light blue body. VELTEX 100 CR: Size 2 hard gelatin capsule with opaque red cap and opaque ivory body. InjectionVELTEX AMPOULES: 3 ml amber labelled ampoule. |
Each VELTEX 75 CR capsule contains diclofenac 75 mg as diclofenac sodium.
Each VELTEX 100 CR capsule contains diclofenac 100 mg as diclofenac sodium.
Excipients with known effect: VELTEX 75 CR capsules contain 105,93 mg and VELTEX 100 CR 141,25 mg sugar (sucrose).
Each VELTEX AMPOULES ampoule contains diclofenac 75 mg as diclofenac sodium in 3 ml.
Excipients with known effect: Preservative: Benzyl alcohol 4% m/v.
Contains sodium metabisulphite (antioxidant).
Contains sugar: D-mannitol 18 mg.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Diclofenac |
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 |
|---|
List of excipients for VELTEX 75 CR and VELTEX 100 CREudragit "RS"100 Composition of the hard capsule: VELTEX 75 CR: Indigotine VELTEX 100 CR: Eritrosine List of excipients for VELTEX AMPOULED-mannitol |
VELTEX 75 CR capsules: Amber glass bottles of 6, 10 and 30 capsules.
VELTEX 100 CR capsules: Amber glass bottles of 30 capsules.
VELTEX AMPOULES: Packs of 5 × 3 ml and 50 × 3 ml ampoules.
Not all pack sizes/types are necessarily marketed.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
VELTEX 75 CR: 27/3.1/0321
VELTEX 100 CR: W/3.1/329
VELTEX AMPOULES: 29/3.1/0394
Date of registration: 10/12/1992
Date of approval: 29 May 2023
| Drug | Countries | |
|---|---|---|
| VELTEX | South Africa |
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