TRIAMACORT Intravenous/Intramuscular Injection 40

Šalis: Tanzanija

kalba: anglų

Šaltinis: Tanzania Medicinces & Medical Devices Authority

Parsisiųsti Prekės savybės (SPC)
15-03-2023

Veiklioji medžiaga:

Triamcinolone Acetonide

Prieinama:

Lincoln Pharmaceuticals Limited, INDIA

ATC kodas:

Corticosteroids for systemic use/ plain

INN (Tarptautinis Pavadinimas):

Triamcinolone Acetonide

Dozė:

40

Vaisto forma:

Intravenous/Intramuscular Injection

Pagaminta:

LINCOLN PHARMACEUTICALS LIMITED, INDIA

Produkto santrauka:

Physical description: A white to off white colour suspension; Local technical representative: Heko Pharmacy Limited (7718)

Autorizacija statusas:

Registered/Compliant

Leidimo data:

2022-09-21

Prekės savybės

                                1.
NAME OF THE MEDICINAL PRODUCT
TRIAMACORT (Triamcinolone Acetonide Injection BP 40 mg/ml) solution
for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone Acetonide BP 40 mg/ml
Excipient(s) with known effect: Benzyl alcohol
For full list of Excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for Injection
A white to off white colour suspension.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
It is used for the treatment of joint pain, swelling and stiffness in
inflammatory disorders such
as rheumatoid arthritis. It is also for the treatment of various
allergic disorders including
asthma, blood disorders, hormone problems, rheumatic fever, and
problems associated with
digestive system, kidneys, lungs or skin.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Use only Intramuscular/Intra-articular injection. Do not used for
intravenous, intradermal or
intraocular.
The
strict
aseptic
precautions
taken.
The
duration
of
effect
is
variable,
subsequent doses should be given when symptoms recur and not at set
intervals. It should
not be physically mixed with other medicinal products.
INTRA-ARTICULAR INJECTION (I.A): It is recommended that injections
given into sheaths of short
tendons, bursae, Dose: may vary from 5-10 mg, smaller joints: (0.125 -
0.25 ml), larger
joints: up to 40 mg (1.0 ml), depending on the specific disease entity
being treated. Single
injections into several sites for multiple joint involvement, up to a
total of 80 mg given
without undue reactions. It should not be used in achilles tendon.
INTRAMUSCULAR INJECTION (I.M): To avoid the danger of subcutaneous fat
atrophy, it is
important to ensure that deep intramuscular injection given into the
gluteal site. The deltoid
should not be used. Alternate sides should be used for subsequent
injections.
Recommended dosage
Adults and children over 12 years: Initial dose is 40 mg (1.0 ml)
injected deeply into the
upper, outer quadrant of the gluteal muscle. Subsequent dosage depends
on the patient's
response and
                                
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