DEPO MEDROL + LIDOCAINE

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

LIDOCAINE AS HYDROCHLORIDE; METHYLPREDNISOLONE ACETATE

Disponibil de la:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Codul ATC:

H02BX01

Forma farmaceutică:

SUSPENSION FOR INJECTION

Compoziție:

LIDOCAINE AS HYDROCHLORIDE 10 MG/ML; METHYLPREDNISOLONE ACETATE 40 MG/ML

Calea de administrare:

INTRASYNOVIAL, INTRABURSAL, CYST AND TENDON SHEATH INJECTION, INTRA-ARTICULAR

Tip de prescriptie medicala:

Required

Produs de:

PFIZER MANUFACTURING BELGIUM NV/SA

Grupul Terapeutică:

LIDOCAINE

Zonă Terapeutică:

METHYLPREDNISOLONE, COMBINATIONS

Indicații terapeutice:

Depo-Medrol with Lidocaine is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: - synovitis of osteoarthritis - rheumatoid arthritis - acute and subacute bursitis - acute gouty arthritis - epicondylitis - acute nonspecific tenosynovitis - post-traumatic osteoarthritis.

Data de autorizare:

2015-01-31

Prospect

injection site
for
each
joint
is
determined
by
that location where the synovial cavity is most
superficial and most free of large vessels
a n d
n e r v e s .
S u i t a b l e
s i t e s
f o r
i n t r a - a r t i c u l a r
injection are the knee, ankle, wrist, elbow,
shoulder,
phalangeal
and
hip
joints.
The
spinal joints, unstable joints and those devoid
of synovial space are not suitable. Treatment
failures
are
most
frequently
the
result
of
f a i l u r e
t o
e n t e r
t h e
j o i n t
s p a c e .
I n t r a - a r t i c u l a r
i n j e c t i o n s
s h o u l d
b e
m a d e
w i t h
c a r e
a s
follows:
ensure
correct
positioning
of
the
n e e d l e
i n t o
t h e
s y n o v i a l
s p a c e
a n d
a s p i r a t e
a
f e w
d r o p s
o f
j o i n t
f l u i d .
T h e
a s p i r a t i n g
s y r i n g e
s h o u l d
t h e n
b e
r e p l a c e d
b y
a n o t h e r
containing
Depo-Medrol
with
Lidocaine.
To
ensure
position of the needle synovial fluid should be
aspirated and the injection made.
After injection the joint is moved slightly to aid
mixing of the synovial fluid and the suspension.
Subsequent to therapy care should be taken
for the patient not to overuse the joint in
which benefit has been obtained. Negligence
in this matter may permit an increase in joint
deterioration
that
will
more
than
offset
the
beneficial effects of the steroid.
Intrabursal
injections
should
be
made
as
follows: the area around the injection site
is prepared in a sterile way and a wheal
at the site made with 1 percent procaine
h y d r o c h l o r i d e
s o l u t i o n .
A
2 0
t o
2 4
gauge
needle attached to a dry syringe is inserted
into the bursa and the fluid aspirated. The
needle
is
left
in
place
and
the
aspirating
syringe
changed
for
a
small
syringe
containing the desired dose. After injection,
the needle is withdrawn and a small dressing
applied.
In
the
treatment
of
tenosynovitis
and tendinitis, care should be taken to inject
Depo-Medrol with Lidocaine into the tendon
sheath rather than into the substance of the
tendon. Due to the absence of a true te

Caracteristicilor produsului

Depo Medrol
®
with Lidocaine LPD CC 120723
Page 1 of 19
2023-0083908
DEPO-MEDROL
®
WITH LIDOCAINE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DEPO-MEDROL
®
WITH LIDOCAINE.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylprednisolone acetate with lidocaine (as hydrochloride): (40 mg,
10 mg)/ml,
Methyprednisolone 4%, Lidocaine Hydrochloride 1%
Excipients with known effect:
Benzyl alcohol: 8.7 mg per ml.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for Injection.
White, sterile aqueous suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Depo-Medrol may be used by any of the following routes:
Intra-articular, Intrabursal,
Intrasynovial Cyst and Tendon Sheath injection.
It must not be used by the intrathecal or intravenous routes (see
section 4.3
CONTRAINDICATIONS)
The following routes of administration are not recommended; epidural,
intranasal, intraocular
and any other unapproved route of administration (see section 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE)
Methylprednisolone acetate with lidocaine is indicated as adjunctive
therapy for short-term
administration (to tide the patient over an acute episode or
exacerbation) in:
•
Synovitis of osteoarthritis
•
Rheumatoid arthritis
•
Acute and subacute bursitis
•
Acute gouty arthritis
•
Epicondylitis
•
Acute nonspecific tenosynovitis
•
Post-traumatic osteoarthritis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Because of possible physical incompatibilities, methylprednisolone
acetate with lidocaine
should not be diluted or mixed with other solutions. Parenteral drug
products should be
inspected visually for particulate matter and discoloration prior to
administration whenever
solution and container permit.
Depo Medrol
®
with Lidocaine LPD CC 120723
Page 2 of 19
2023-0083908
Therapy with methylprednisolone acetate with lidocaine does not
obviate the need for the
conventional measures usually employed. Although this method of
treatment will ameliorate
symptoms, it is in no sense a