Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
LIDOCAINE AS HYDROCHLORIDE; METHYLPREDNISOLONE ACETATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
H02BX01
SUSPENSION FOR INJECTION
LIDOCAINE AS HYDROCHLORIDE 10 MG/ML; METHYLPREDNISOLONE ACETATE 40 MG/ML
INTRASYNOVIAL, INTRABURSAL, CYST AND TENDON SHEATH INJECTION, INTRA-ARTICULAR
Required
PFIZER MANUFACTURING BELGIUM NV/SA
LIDOCAINE
METHYLPREDNISOLONE, COMBINATIONS
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.
2015-01-31
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 Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot