DICLOFENAC INJECTION UNIMED

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Unimed Healthcare (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 3,0 ml AMPOULE CONTAINS DICLOFENAC SODIUM 75,0 mg

Authorization status:

Registered

Authorization date:

2001-07-05

Patient Information leaflet

APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Diclofenac Injection Unimed
DOSAGE FORM AND STRENGTH: Each 3,0 ml Ampoule contains Diclofenac
Sodium 75 mg
Injection
26.05.2023 (v1) Page 1 of 17
Initials:
PATIENT INFORMATION LEAFLET (PIL)
FOR MEDICINES FOR HUMAN USE
DICLOFENAC INJECTION UNIMED (INJECTION)
SCHEDULING STATUS: S3
DICLOFENAC INJECTION UNIMED (75 MG/3 ML) INJECTION
DICLOFENAC SODIUM
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN DICLOFENAC
INJECTION UNIMED
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
DICLOFENAC INJECTION UNIMED has been prescribed for you personally and
you
should not share your medicine with other people. It may harm them,
even if their
symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1. What DICLOFENAC INJECTION UNIMED is and what it is used for
2. What you need to know before you take DICLOFENAC INJECTION UNIMED
3. How to take DICLOFENAC INJECTION UNIMED
4. Possible side effects
5. How to store DICLOFENAC INJECTION UNIMED
6. Contents of the pack and other information
APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Diclofenac Injection Unimed
DOSAGE FORM AND STRENGTH: Each 3,0 ml Ampoule contains Diclofenac
Sodium 75 mg
Injection
26.05.2023 (v1) Page 2 of 17
Initials:
1. WHAT DICLOFENAC INJECTION UNIMED IS AND WHAT IT IS USED FOR
DICLOFENAC INJECTION UNIMED belongs to a group of medicines called
non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
DICLOFENAC INJECTION UNIMED is used as an intramuscular injection to
relieve pain,
reduce swelling and ease inflammation in conditions affecting the
joints, muscles, and tendons
including:
•
Rheumatoid arthritis, osteoarthritis, (pain, stiffness and swelling of
the joints especially
in the hands, hips and knees), ankylosing spondylitis (form of spinal
arthritis) and
spondylarthritis.
•
Painful musculoskeletal conditions such as backache, sprains and
strains, soft tissue
spo

Summary of Product characteristics

APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Diclofenac Injection Unimed
DOSAGE FORM AND STRENGTH: Each 3,0 ml Ampoule contains Diclofenac
Sodium 75 mg,
Injection
25.05.2023
(v1)
Page 1 of 29
Initial:
PROFESSIONAL INFORMATION (PI)
FOR MEDICINES FOR HUMAN USE
DICLOFENAC INJECTION UNIMED (INJECTION)
SCHEDULING STATUS:
1.
NAME OF THE MEDICINE
DICLOFENAC INJECTION UNIMED (75 MG/3 ML)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains:
Diclofenac sodium 75 mg
Benzyl alcohol 4 % _m/v_ as preservative
Sodium metabisulphite 0,1 % _m/v_ as an antioxidant
Sugar free
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Injection
Ampoules 75 mg / 3 ml: Clear, colourless to pale yellow solution free
from fibers and particulate
matter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
S3
APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Diclofenac Injection Unimed
DOSAGE FORM AND STRENGTH: Each 3,0 ml Ampoule contains Diclofenac
Sodium 75 mg,
Injection
25.05.2023
(v1)
Page 2 of 29
Initial:
•
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing
spondylitis, osteoarthrosis and spondylarthritis.
•
Painful musculoskeletal conditions.
•
Non-articular rheumatism.
•
Acute attacks of gout.
•
Painful post-operative and post-traumatic inflammation and swelling,
pain following
dental surgery.
•
Symptomatic treatment of primary dysmenorrhoea.
DICLOFENAC INJECTION UNIMED is suitable as initial therapy for
inflammatory and
degenerative rheumatic diseases, as well as for the treatment of
painful conditions due to
inflammation of non-rheumatic origin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment.
ADULTS:
For adults the dosage is generally one DICLOFENAC INJECTION UNIMED
ampoule daily.
DICLOFENAC INJECTION UNIMED should not be mixed with other injection
solutions. By way
of exception, in severe cases, two injections separated by an interval
of a few hours can be
gi