Triamcinolone hexacetonide 20mg/1ml suspension for injection ampoules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Triamcinolone hexacetonide

Disponível em:

Esteve Pharmaceuticals Ltd

Código ATC:

H02AB08

DCI (Denominação Comum Internacional):

Triamcinolone hexacetonide

Dosagem:

20mg/1ml

Forma farmacêutica:

Suspension for injection

Via de administração:

Intraarticular; Periarticular

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 10010202; GTIN: 5039021006116

Folheto informativo - Bula

NOW READ THE REST OF THIS LEAFLET.
THIS LEAFLET WAS LAST
UPDATED ON 23/10/2017.
WHAT IS IN THIS LEAFLET:
1. WHAT TRIAMCINOLONE HEXACETONIDE IS AND
WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN TRIAMCINOLONE HEXACETONIDE
YOU SHOULD NOT BE GIVEN TRIAMCINOLONE HEXACETONIDE
WARNINGS AND PRECAUTIONS
THEREFORE YOU MUST TELL YOUR DOCTOR BEFORE ADMINISTRATION
OF TRIAMCINOLONE HEXACETONIDE IF YOU HAVE ANY OF THE
FOLLOWING CONDITIONS:
CHECK WITH YOUR DOCTOR FIRST:
IF YOU HAVE EVER HAD SEVERE DEPRESSION
TALK TO A DOCTOR BEFORE
TRIAMCINOLONE HEXACETONIDE IS GIVEN TO YOU.
CONTACT YOUR DOCTOR IF YOU EXPERIENCE BLURRED VISION OR
OTHER VISUAL DISTURBANCES.
MENTAL HEALTH PROBLEMS WHILE TAKING TRIAMCINOLONE
HEXACETONIDE
CHILDREN AND ADOLESCENTS
OTHER MEDICINES AND TRIAMCINOLONE HEXACETONIDE
AMPHOTERICIN B INJECTION AND POTASSIUM DEPLETING AGENTS:
ANTICHOLINESTERASES (ACHEI):
ANTICHOLINERGICS (E.G. ATROPINE):
ANTI BLOOD CLOTTING TABLETS (ANTICOAGULANTS, ORAL):
BLOOD SUGAR LOWERING DRUGS (ANTIDIABETICS, E.G. SULFONYL
UREA DERIVATIVES, AND INSULIN):
BLOOD PRESSURE LOWERING DRUGS (ANTIHYPERTENSIVES,
INCLUDING DIURETICS):
DRUGS TO TREAT TUBERCULOSIS, E.G. ISONIAZID:
IMMUNE SUPPRESSING DRUGS (CYCLOSPORIN):
HEART FAILURE MEDICINES (DIGITALIS GLYCOSIDES):
DRUGS THAT INCREASE THE AMOUNT OF SPECIAL LIVER ENZYMES
HUMAN GROWTH HORMONE (SOMATROPIN):
DRUGS TO TREAT FUNGAL INFECTIONS (KETOCONAZOLE):
PROTEASE INHIBITORS TO TREAT HIV INFECTION (RITONAVIR):
NON DEPOLARISING MUSCLE RELAXANTS:
It includes other important
information on the safe and effective use of this medicine that
might be especially important to you.
1.
What Triamcinolone hexacetonide is and what it is used for
2.
What you need to know before you are given Triamcinolone
hexacetonide
3.
How Triamcinolone hexacetonide is given
4.
Possible side effects
5.
How to store Triamcinolone hexacetonide
6.
Contents of the pack and other information
Triamcinolone hexacetonide 20 mg/ml suspension for injection
contains a steroid medicine. Triamcinolone hexacetonide belongs

Características técnicas

OBJECT 1
TRIAMCINOLONE HEXACETONIDE 20 MG/ML SUSPENSION
FOR INJECTION
Summary of Product Characteristics Updated 19-Oct-2017 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Triamcinolone Hexacetonide 20 mg/ml suspension for injection
2. Qualitative and quantitative composition
1 ml suspension for injection contains 20 mg triamcinolone
hexacetonide.
Excipients with known effect:
Contains 9 mg benzyl alcohol per ml and 455 mg sorbitol (E 420) per
ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection
Milky white suspension, easily resuspendable.
4. Clinical particulars
4.1 Therapeutic indications
TRIAMCINOLONE HEXACETONIDE is indicated for intraarticular,
intrasynovial or periarticular use
in adults and adolescents for the symptomatic treatment of subacute
and chronic inflammatory joint
diseases including:
• Rheumatoid arthritis
• Juvenile Idiopathic Arthritis (JIA)
• Osteoarthritis and post-traumatic arthritis
• Synovitis, tendinitis, bursitis and epicondylitis
TRIAMCINOLONE HEXACETONIDE may also be used for the intraarticular use
in children aged 3 –
12 years with Juvenile Idiopathic Arthritis (see Posology below).
4.2 Posology and method of administration
POSOLOGY
_INTRAARTICULAR INJECTION (DOSAGE FOR ADULTS AND ADOLESCENTS) FOR ALL
INDICATIONS_
The dose 2-20 mg is determined individually according to the size of
the joint and the amount of articular
fluid. Large joints (e.g. hip, knee, shoulder) generally require 10-20
mg (0.5-1 ml), medium-sized joints
5-10 mg (0.25-0.5 ml), and smaller joints 2-6 mg (0.1-0.3 ml). If
there is a lot of articular fluid, it can be
aspirated prior to administration of the drug. The next dose and the
number of injections depend on the
progress of the clinical condition. Because TRIAMCINOLONE HEXACETONIDE
is long-acting,
administration of injections into individual joints more frequently
than at 3-4 week intervals is not
recommended. Accumulation of the drug at the injection site must be
avoided, because it