Kenalog Intramuscular 80mg/2ml suspension for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triamcinolone acetonide

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC code:

H02AB08

INN (International Name):

Triamcinolone acetonide

Dosage:

40mg/1ml

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

PATIENT INFORMATION LEAFLET
KENALOG™
INTRA-ARTICULAR / INTRAMUSCULAR INJECTION 40 MG/ML
TRIAMCINOLONE ACETONIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
•
KENALOG IA/IM 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 TAKING THIS MEDICINE without talking to your doctor –
you may need to
reduce the dose gradually.
•
KENALOG IA/IM 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 taking
your tablets, 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 TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET 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 Kenalog IA/IM Injection is and what it is used for
2. What you need to know before you are given Kenalog IA/IM Injection
3. Receiving Kenalog IA/IM Injection
4. Possible side effects
5. How to store Kenalog IA/IM Injection
6. Content of the pack and other information
1. WHAT KENALOG IA/IM INJECTION IS AND WHAT IT IS USED FOR
The name of this medicine is Kenalog IA/IM Injec

Summary of Product characteristics

OBJECT 1
KENALOG INTRA-ARTICULAR / INTRAMUSCULAR INJECTION
Summary of Product Characteristics Updated 08-Dec-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
Kenalog Intra-articular / Intramuscular Injection
2. Qualitative and quantitative composition
Kenalog Intra-articular / Intramuscular Injection contains
triamcinolone acetonide 40 mg per ml of sterile
suspension.
Excipient(s) with known effect: 15 mg/ml Benzyl alcohol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile aqueous suspension for injection.
4. Clinical particulars
4.1 Therapeutic indications
Intra-articular use: for alleviating the joint pain, swelling and
stiffness associated with rheumatoid
arthritis and osteoarthrosis, with an inflammatory component; also for
bursitis, epicondylitis, and
tenosynovitis.
Intramuscular use: Where sustained systemic corticosteroid treatment
is required: _Allergic states_, e.g.
bronchial asthma, seasonal or perennial allergic rhinitis. In seasonal
allergies, patients who do not respond
to conventional therapy may achieve a remission of symptoms over the
entire period with a single
intramuscular injection (see section 4.2); _Endocrine disorders, _e.g.
primary or secondary adrenocortical
insufficiency. _Collagen disorders_, e.g. during an exacerbation of
maintenance therapy of selected cases of
SLE or acute rheumatic carditis; _Dermatological diseases_, e.g.
pemphigus, severe dermatitis and Stevens
Johnson Syndrome; _Rheumatic, Gastrointestinal or Respiratory
disorders_ - as an adjunctive, short-term
therapy; _Haematological disorders_, e.g. acquired (autoimmune)
haemolytic anaemia; _Neoplastic diseases_,
e.g. palliative management of leukaemia and lymphomas; _Renal
disease_, such as acute interstitial
nephritis, minimal change nephrotic syndrome or lupus nephritis.
4.2 Posology and method of administration
Kenalog is for Intra-articular/Intramuscular injection ONLY. The
safety and efficacy of administration by
other routes has yet to be established (se