Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Triamcinolone acetonide

Dostupné z:

Bristol-Myers Squibb Pharmaceuticals uc

ATC kód:

H02AB; H02AB08

INN (Medzinárodný Name):

Triamcinolone acetonide

Dávkovanie:

10 milligram(s)/millilitre

Forma lieku:

Suspension for injection

Typ predpisu:

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

Terapeutické oblasti:

Glucocorticoids; triamcinolone

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1978-04-01

Príbalový leták

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

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for
injection, 1 ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone acetonide 10 mg per ml (10 mg per 1 ml ampoule).
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.
If several sites are injected the total dosage administered should not