骨敏捷注射液 15公絲/1.5公撮

Pays: Taïwan

Langue: chinois

Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Ingrédients actifs:

MELOXICAM

Disponible depuis:

台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)

Code ATC:

M01AC06

forme pharmaceutique:

注射劑

Composition:

MELOXICAM (9200038100) MG

Unités en paquet:

盒裝

classe:

製　劑

Type d'ordonnance:

限由醫師使用

Fabriqué par:

BOEHRINGER INGELHEIM ESPANA S.A. PRAT DE LA RIBA, 50, 08174 SANT CUGAT DEL VALLES (BARCELONA), SPAIN ES

Domaine thérapeutique:

meloxicam

indications thérapeutiques:

用於類風濕性關節炎及骨關節炎之短期及急性之症狀治療。

Descriptif du produit:

有效日期: 2028/06/20; 英文品名: MOBIC INJECTION 15MG/1.5ML

Date de l'autorisation:

2003-06-20

Notice patient

in these trials ranged from 3 weeks to one year
(most patients were enrolled in one-month
studies). Almost all patients participated in trials
that permitted enrolment of patients with a prior
history of gastro-intestinal perforation, ulcer or
bleed. The incidence of clinically significant
upper gastro-intestinal perforation, obstruction,
or bleed (POB) was assessed retrospectively
following independent blinded review of cases.
Results are shown in the following table.
CUMULATIVE RISK OF POBS FOR MELOXICAM 7.5 MG
AND 15 MG FROM BI CLINICAL TRIALS COMPARED TO
DICLOFENAC AND PIROXICAM (KAPLAN-MEIER ESTIMATES)
TREATMENT
Daily
dose
Interval
(days)
Patients at
interval
midpoint
POBs
within
interval
Risk (%)
95%
confidence
interval
Meloxicam
7.5 mg
15 mg
1 - <30
30 - <91
1 - <30
30 - <91
91 - <182
182 - <365
9636
551
2785
1683
1090
642
2
1
3
5
1
0
0.02
0.05
0.12
0.40
0.50
0.50
0.00 – 0.05
0.00 – 0.13
0.00 – 0.25
0.12 – 0.69
0.16 – 0.83
Diclofenac
100 mg
1 - <30
30 - <91
5110
493
7
2
0.14
0.55
0.04 – 0.24
0.00 – 1.13
Piroxicam
20 mg
1 - <30
30 - <91
5071
532
10
6
0.20
1.11
0.07 – 0.32
0.35 – 1.86
PHARMACOKINETICS
_ABSORPTION_
Meloxicam is completely absorbed after i.m.
administration. Relative bioavailability as compared
to oral administration routes amounts almost 100%.
Dose-adjustment switching from i.m. to oral
treatment is therefore not necessary.
Following a 15 mg i.m. injection, peak plasma
concentrations of about 1.6 - 1.8 µg/mL are
reached in about 1 - 1.6 hours.
Following i.m. administration dose linearity was
demonstrated in the therapeutic dose range of
7.5 to 15 mg.
_DISTRIBUTION_
Meloxicam is very strongly bound to plasma
proteins, essentially albumin (99%).
Meloxicam penetrates into synovial fluid to give
concentrations approximately half of those in
plasma.
Volume of distribution is low, i.e. approx. 11 L after
i
.m. or i.v. administration, and shows interindividual
variation in the order of 7 - 20%.
The volume of distribution following
administration of mulitple oral doses of
meloxicam