DIKON Injection 75 /3

Pays: Tanzanie

Langue: anglais

Source: Tanzania Medicinces & Medical Devices Authority

Ingrédients actifs:

Diclofenac

Disponible depuis:

Abacus Pharma Africa Limited, TANZANIA

Code ATC:

Topical products for joint and muscular pain, anti

DCI (Dénomination commune internationale):

Diclofenac

Dosage:

75 /3

forme pharmaceutique:

Injection

Fabriqué par:

Reyoung Pharmaceutical Co., Ltd, CHINA

Descriptif du produit:

Physical description: Almost colorless and clear solution; Local technical representative: Abacus Pharma Africa Limited (8473)

Statut de autorisation:

Registered/Compliant

Date de l'autorisation:

2021-06-03

Résumé des caractéristiques du produit

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1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium Injection 75mg/3ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution for injection contains 25mg of diclofenac
sodium for full
list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for intramuscular injection or concentrate for solution for
infusion. Almost
colorless and clear solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Intramuscular use:
Diclofenac injection is effective in acute forms of pain, including
renal colic, exacerbations of
osteo- and rheumatoid arthritis, acute back pain, acute gout, acute
trauma and fractures,
and post-operative pain.
Intravenous infusion:
For treatment or prevention of post-operative pain in the hospital
setting.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4 Special
warnings and precautions
for use).
ADULTS
Diclofenac injection (given im or iv) should not be given for more
than two days; if necessary,
treatment can be continued with Diclofenac tablets or suppositories.
_Intramuscular injection: _The following directions for intramuscular
injection must be adhered to
in order to avoid damage to a nerve or other tissue at the injection
site. One ampoule once
(or in severe cases twice) daily intramuscularly by deep intragluteal
injection into the upper
outer quadrant. If two injections daily are required it is advised
that the alternative buttock be
used for the second injection. Alternatively, one ampoule of 75mg can
be combined with
other dosage forms of Diclofenac (tablets or suppositories) up to the
maximum daily dosage
of 150mg.
Renal colic: One 75mg ampoule intramuscularly. A further ampoule may
be administered
after 30 minutes if necessary. The recommended maximum daily dose of
Diclofenac is
150mg.
_Intravenous _
_Infusion_:
Immediately
before
initiating
an
intravenous
infusi