Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
VELTEX is indicated in:
Rheumatoid arthritis.
Ankylosing spondylitis.
Osteoarthritis and spondyloarthritis.
Painful musculoskeletal conditions.
Non-articular rheumatism.
Acute attacks of gout.
Painful post-operative and post-traumatic inflammation and swelling.
Pain following dental surgery.
Symptomatic treatment of primary dysmenorrhoea.
VELTEX AMPOULES are specifically used as initial therapy for inflammatory and degenerative rheumatic disease, as well as for painful conditions due to the inflammation of non-rheumatic origin and acute attacks of gout.
The initial daily dosage is 100 to 150 mg.
In milder cases as well as for maintenance therapy 75 to 100 mg is usually sufficient.
The maximal daily dose is 150 mg. This dosage is usually administered in two to three fractional doses.
When used as an analgesic, the daily dosage should be adjusted to the individual need of the patient and special circumstance, e.g. for the treatment of primary dysmenorrhoea or post-operative pain. In these cases the dosage is 75 to 150 mg and the treatment should commence with the first symptoms, and depending on the severity, continued for a few days.
In cases where the symptoms are most pronounced during the night or in the early morning, VELTEX CR 100 capsules should be taken preferably in the evening.
Use the lowest effective dose for the shortest possible duration of treatment.
Recommended daily dose of 1 to 3 mg per kg body weight in children able to swallow capsules.
The directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site. After inserting the needle, the plunger should be pulled back to avoid inadvertent intra-arterial injection.
NOT TO BE ADMINISTERED BY INTRAVENOUS INJECTION.
The usual adult dose is 75 mg (3 ml) by deep intra-gluteal injection into the upper outer quadrant once daily. This dose may be repeated after a few hours if required in severe or hospitalised patients. Each injection must be administered at a different site.
Parenteral administration should not be continued for more than two days. Treatment may be continued with oral therapy.
Deep intra-gluteal injection.
For oral use.
The capsule should be swallowed intact with some fluid.
The pellets should never be chewed.
There is no known antidote.
Treatment should be symptomatic and supportive.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating VELTEX because of its extensive protein binding rate and metabolism.
VELTEX 75 CR capsules: 36 months.
VELTEX 100 CR capsules: 24 months.
VELTEX AMPOULES: 24 months.
VELTEX 75 CR and VELTEX 100 CR capsules:
Store at or below 25°C.
Protect from light and moisture.
VELTEX AMPOULES:
Protect from heat and light.
Store between 15°C and 25°C.
Do not refrigerate.
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.
No special requirements.
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