Tenoxicam

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Tenoxicam 20mg (+10% overage)

可用日期:

Devatis Limited

剂量:

20 mg

药物剂型:

Powder for injection

组成:

Active: Tenoxicam 20mg (+10% overage) Excipient: Ascorbic acid Disodium edetate Hydrochloric acid Mannitol Sodium hydroxide Trometamol

处方类型:

Prescription

疗效迹象:

Tenoxicam Devatis is indicated in adults for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system: - rheumatoid arthritis; - osteoarthritis; - arthrosis; -ankylosing spondylitis; - extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of shoulders (shoulder-hand syndrome) or hips, strains and sprains; - post-operative pain.

產品總結:

Package - Contents - Shelf Life: Vial, glass, - 20 mg - 24 months from date of manufacture stored at or below 30°C protect from light

授权日期:

2018-04-12

资料单张

TENOXICAM
DEVATIS
POWDER FOR INJECTION, 20 MG
MODULE 1.3.2 CONSUMER MEDICINE INFORMATION (CMI)
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 8
Version: NZ-V05/June 2022
TENOXICAM DEVATIS POWDER FOR INJECTION, 20 MG
DEVATIS
_Tenoxicam _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using TENOXICAM
Devatis.
This leaflet answers some common questions about TENOXICAM Devatis. It
does not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given TENOXICAM
Devatis against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TENOXICAM DEVATIS IS USED FOR
TENOXICAM Devatis contains 20 mg tenoxicam as active substance, which
is a medicine that belongs to a
group called non-steroidal anti-inflammatory drugs (NSAIDs).
The injection will be given to you by a doctor or nurse into your
muscles or veins.
TENOXICAM Devatis relieves pain and reduces inflammation (swelling,
redness and soreness) that may
occur in:

different types of arthritis, including rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis. As
with other NSAID medicines, TENOXICAM Devatis will not cure your
arthritic condition, but it may
help to control pain, swelling and stiffness.

muscle and bone injuries such as sprains, strains and tendonitis such
as tennis elbow

pain or swelling in or near a joint (bursitis)

inflammation surrounding the shoulders (shoulder-hand syndrome) or
hips

degenerative joint disease (arthrosis)

following surgery
Your doctor may have prescribed TENOXICAM Devatis for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TENOXICAM DEVATIS
HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with a doctor’s p

产品特点

TENOXICAM
DEVATIS
POWDER FOR INJECTION, 20 MG
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly Confidential
Page 1/11
Version: NZ-V05/July 2022
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
TENOXICAM Devatis Powder for Injection, 20 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each vial contains 20 mg Tenoxicam
.
Reconstituted Tenoxicam Devatis solution contains 10 mg/ml tenoxicam.
EXCIPIENT(S)
:
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vial containing lyophilized powder for injection
Yellow-green colored lyophilized mass
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tenoxicam Devatis is indicated in adults for the symptomatic treatment
of the following painful inflammatory
and degenerative disorders of the musculoskeletal system:

rheumatoid arthritis

osteoarthritis

arthrosis

ankylosing spondylitis

extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of
shoulders (shoulder-hand syndrome) or
hips, strains and sprains

post-operative pain
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY/FREQUENCY AND DURATION OF ADMINISTRATION
Undesirable effects may be minimized by using the lowest effective
dose for the shortest possible duration
necessary to control symptoms (see section 4.4).
For all indications except post-operative pain, a daily single dose of
20 mg should be administered at the same
time of day.
For post-operative pain the recommended dose is 40 mg daily for 5
days.
In treatment of chronic disorders the therapeutic effect of tenoxicam
is evident early in treatment and there is
a progressive increase in response over time. In chronic disorders,
daily doses higher than 20 mg are not
recommended
since
this
would
increase
the
frequency
and
intensity
of
unwanted
reactions
without
significantly increasing efficacy.
For patients needing long-term treatment a reduction to a daily oral
dose of 10 mg may be tried for maintenance
(this cannot be achieved using this product, i.e. a tablet
presentation should be us