Adcortyl Intra-articular/Intradermal Injection 10 mg/ml, Suspension for Injection, 5ml

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Triamcinolone acetonide

Fáanlegur frá:

Bristol-Myers Squibb Pharmaceuticals uc

ATC númer:

H02AB; H02AB08

INN (Alþjóðlegt nafn):

Triamcinolone acetonide

Skammtar:

10 milligram(s)/millilitre

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Glucocorticoids; triamcinolone

Leyfisstaða:

Marketed

Leyfisdagur:

1978-04-01

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ADCORTYL INTRA-ARTICULAR / INTRADERMAL INJECTION 10 MG/ML SUSPENSION
FOR INJECTION
TRIAMCINOLONE ACETONIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
•
ADCORTYL IA/ID INJECTION IS A STEROID MEDICINE,
prescribed for many different conditions, including
serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
•
DON’T STOP USING THIS MEDICINE
without talking to your doctor – you may need to reduce the dose
gradually.
•
ADCORTYL IA/ID INJECTION CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4 below). Some problems such as mood changes (feeling
depressed or ‘high’), or stomach
problems can happen straight away. If you feel unwell in any way, keep
using your medicine,
BUT SEE
YOUR DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS.
These include weakness of arms and legs, or
developing a rounder face (read section 4 for more information).
•
IF YOU ARE GIVEN THIS MEDICINE FOR MORE THAN 3 WEEKS, YOU WILL BE
GIVEN A BLUE ‘STEROID CARD’:
always keep it with you and show it to any doctor or nurse treating
you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR SHINGLES,
if you have never had them. They could
affect you severely. If you do come into contact with chicken pox or
shingles,
SEE YOUR DOCTOR STRAIGHT
AWAY.
WHAT IS IN THIS LEAFLET
1.
What Adcortyl IA/ID Injection is and what it is used for
2.
What you need to know before you are given Adcortyl IA/ID Injection
3.
Receiving Adcortyl IA/ID Injection
4.
Possible side effects
5.
How to store Adcortyl IA/ID Injection
6.
Content of the pack and other information
1. WHAT ADCORTYL IA/ID INJECTION IS AND WHAT IT

Vara einkenni

Health Products Regulatory Authority
29 January 2024
CRN00DJ92
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adcortyl Intra-articular/Intradermal Injection 10 mg/ml, Suspension
for Injection, 5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone acetonide 10 mg per ml (50 mg per 5 ml vial).
Excipient(s) with known effect: Benzyl alcohol 15 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for Injection (Injection).
White, sterile aqueous suspension with a slight odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Intra-articular use:_
in the local management of inflammation involving joints, bursae or
tendon sheaths such as occurs in rheumatoid arthritis,
osteoarthritis, bursitis, synovitis, tendinitis, epicondylitis and
trauma.
_Intradermal use:_
for inflammatory dermal lesions such as lichen simplex, lichen planus,
psoriasis, granuloma annulare, keloids and for alopecia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adcortyl Injection is only for intra-articular or intra-dermal use and
should not be given by any other route. Strict aseptic
precautions should be observed. Since the duration of effect is
variable, subsequent doses should be given when symptoms
recur and not at set intervals.
Adcortyl Injection should only be given in an appropriate setting
where there is access to emergency medical care.
Adults:
The dose of Adcortyl Injection for intra-articular administration, and
injection into tendon sheaths and bursae, is dependent on
the size of the joint to be treated and on the severity of the
condition.
Doses of 2.5 - 5 mg (0.25 - 0.5 ml) for smaller joints and 5 - 15 mg
(0.5 - 1.5 ml) for larger joints usually alleviate the
symptoms. Triamcinolone acetonide 40 mg/ml (Kenalog) is available to
facilitate administration of larger doses. (see section
4.4 re Achilles tendon.)
Intradermal dosage is usually 2 - 3 mg (0.2 - 0.3 ml), depending on
the size of the lesion. No more than 5 mg (0.5 ml) should
be injected at any one site.