Depo-Medrol with Lidocaine

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Lidocaine hydrochloride monohydrate 10 mg/mL;  ; Methylprednisolone acetate 40 mg/mL

제공처:

Pfizer New Zealand Limited

INN (국제 이름):

Lidocaine hydrochloride monohydrate 10 mg/mL

복용량:

40 mg/mL

약제 형태:

Injection (depot)

구성:

Active: Lidocaine hydrochloride monohydrate 10 mg/mL   Methylprednisolone acetate 40 mg/mL

패키지 단위:

Vial, 1 mL, 1 dose unit

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Moehs Catalana SL

치료 징후:

Depo-Medrol with Lidocaine by intra-synovial of soft tissue administration (including periarticular and intrabursal) 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 gouty arthritis · Epicondylitis · Acute nonspecific tenosynovitis · Post-traumatic osteoarthritis · Acute and subacute bursitis

제품 요약:

Package - Contents - Shelf Life: Vial, 1 mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C

승인 날짜:

1978-01-24

제품 특성 요약

Version: pfddepli10718
Supersedes: pfddepli10218
Page 1 of 25
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DEPO-MEDROL
®
with
Lidocaine
(methylprednisolone
acetate
(40
mg/mL),
lidocaine
hydrochloride monohydrate (10 mg/mL)) (depot)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
1
mL
vial
contains
40
mg/mL
methylprednisolone
acetate and 10 mg/mL lidocaine
hydrochloride.
_EXCIPIENT WITH KNOWN EFFECT _

benzyl alcohol.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Injection (depot): white, aqueous, sterile suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Depo-Medrol
with
Lidocaine
by
intra-articular
or
soft
tissue
administration
(including
periarticular and intrabursal) 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 gouty arthritis

Epicondylitis

Acute nonspecific tenosynovitis

Post-traumatic osteoarthritis

Acute and subacute bursitis

Depo-Medrol with Lidocaine may also be useful in cystic tumours of an
aponeurosis or
tendon (ganglia).
Version: pfddepli10718
Supersedes: pfddepli10218
Page 2 of 25
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
Because complications of treatment with glucocorticoids are dependent
on the size of the dose
and the duration of treatment, a risk/benefit decision must be made in
each individual case as to
dose and duration of treatment and as to whether daily or intermittent
therapy should be used.
The lowest possible dose of corticosteroid should be used to control
the condition under treatment
and when reduction in dosage is possible, the reduction should be
gradual.
Because of possible physical incompatibilities, Depo-Medrol with
Lidocaine sterile aqueous
suspension (methylprednisolone acetate) should not be diluted or mixed
with other solutions.
When multidose vials are used, special care to prevent contamination
of the contents is essential
(see SECTION 4.4).
Parenteral drug products