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This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

To get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Information line on 0800 198 5000.

The product codes for this leaflet are: PL 00034/5045R, PL 00034/5045R, PL 00034/5045R

 

Kenalog Intra-Articular/Intramuscular Injection

Company Details

E. R. Squibb & Sons Limited


Uxbridge Business Park Sanderson RoadUxbridgeMiddlesexUB8 1DH
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The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

PATIENT INFORMATION LEAFLET

KENALOG

INTRA-ARTICULAR/INTRAMUSCULAR INJECTION 40 mg/ml

Triamcinolone Acetonide

  • 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.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

Your doctor has prescribed Kenalog injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

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Q. WHAT IS IN KENALOG INTRA-ARTICULAR/INTRA-MUSCULAR INJECTION?

A. Kenalog IA/IM Injection belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Kenalog IA/IM Injection) is an effective way to treat various illnesses involving inflammation in the body. Kenalog IA/IM Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. The injection contains triamcinolone acetonide 40mg/ml and is supplied in 1.0ml or 2.0ml ready-filled syringes and in the U.K., also in 1.0ml glass vials.

The 1ml containers each contain 40mg triamcinolone acetonide and the 2ml syringe contains 80mg triamcinolone acetonide.

The injection can be given as an intra-articular or intramuscular injection but the needle provided with the ready-filled syringes is only for deep intramuscular injection into the large muscle of the buttock.

The other ingredients are benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water.

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UK PRODUCT LICENCE

Held by:

E.R. Squibb & Sons Limited
Uxbridge
Middlesex
UB8 1DH
Tel. No.:0800 7311736
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IRISH PRODUCT AUTHORISATION

Held by:

Bristol-Myers Squibb Pharmaceuticals Ltd
Swords
County Dublin
Tel:1-800-749-749
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MANUFACTURER

Bristol-Myers Squibb Srl
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
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Q. WHAT IS THIS MEDICINE FOR?

A. Kenalog injection is for the treatment of various inflammatory and/or allergic disorders. These include asthma, seasonal allergies, arthritis, blood disorders, hormone problems, rheumatic fever, problems with kidneys, lungs or skin.

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BEFORE RECEIVING YOUR MEDICINE

Q. Should I be receiving Kenalog Injection?

A. You should not receive this medicine if you have ever had an allergic reaction to similar medicines or to any of the medicines or to any of the ingredients in Kenalog injection. You should not receive this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Q. Is there anything else I should discuss with my doctor before receiving Kenalog injection?

A. Check with your doctor before receiving Kenalog injection if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer, blood clots, cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Check with your doctor first:

  • If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Kenalog IA/IM Injection.
  • If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Kenalog IA/IM Injection.

If you are receiving long-term intramuscular treatment with Kenalog injection your doctor may advise you to eat more protein. This should help to reduce the gradual loss of weight that can sometimes occur with long-term treatment.

Q. What if I am in contact with someone who has an infectious disease such as Chickenpox, Shingles or Measles?

A. Steroid medicines suppress your body's natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor promptly.

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant?
What if I am planning to become pregnant?
What if I am breast-feeding?

A. You should make sure you discuss this with your doctor as soon as possible before receiving Kenalog injection.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Kenalog may need to be adjusted.

Q. Can I take other medicines?

A. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Kenalog if you are taking ibuprofen or another NSAID.

Always tell your doctor about all other medicines you are taking, even those you have bought at a pharmacy or other places, e.g. supermarket.

Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Kenalog. On the other hand, Kenalog can affect the action of some medicines used to treat diabetes, high blood pressure, to slow the heart or to thin the blood.

Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, medicines for treating fungal infections or if you are to be vaccinated or to be given an anaesthetic.

Q. Is it all right to take exercise?

A. You must take care not to over-use a joint which feels better after you receive Kenalog injection as the joint will still need to recover from the inflammation which caused your symptoms.

Q. Is it all right to drive?

A. This medicine does not usually affect your ability to drive but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A. There is no known interaction between Kenalog and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed.

Q. Who should I tell that I have received this injection?

A. Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any new treatment is prescribed.

Dentist - before having any dental surgery

Pharmacist - before buying any medicines

Optician - it is advisable to have regular eye tests.

Q. Is there any important information about the ingredients of Kenalog that I need to know?

A. Kenalog injection contains 15mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Kenalog injection must not be given to premature or newly born babies.

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ADMINISTRATION OF YOUR MEDICINE

Q.How will Kenalog injection be given and how often?

A. The effect of the injection will vary from patient to patient and further injections may be given when symptoms return and not at regular intervals.

Use in inflammatory joint disorders:

The dose of injection into a joint or into a tendon sheath depends upon the size of the joint and the condition which is being treated. Doses of 5-10mg (0.125-0.25ml) for smaller joints and up to 40mg (1.0ml) for larger joints may be given. This medicine should not be used for injection into the Achilles tendon.

Use in allergic disorders:

Deep intramuscular injection must be given into the large muscles of the buttock and not into the upper arm or the thigh. This medicine should not be given into a vein.

The usual starting dose is 40mg (1.0ml) injected deeply into the upper outer area of the buttock. If you require a further injection, this should be made into the same area on the other buttock. Some patients with hay fever or pollen asthma find that one injection of 40-100mg lasts throughout the pollen season.

Children: Kenalog is not recommended for children under 6 years of age. It may be given to older children but the dose is adjusted according to their size and weight and is always kept as low as possible for the shortest possible time.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets, or, if they have recently finished a course of Kenalog injections, may need to start taking oral steroid tablets for a while.

Q. How long should I continue receiving Kenalog injection?

A. Your doctor will advise you whether it is wise for you to have further injections. Treatment with steroids is usually kept as short as possible and must not be stopped abruptly.

Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

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Mental problems while taking Adcortyl IA/ID injection

Mental health problems can happen while taking steroids like Kenalog IA/IM Injection (see also section 4 Possible Side Effects).

  • These illnesses can be serious.
  • Usually they start within a few days or weeks of starting the medicine.
  • They are more likely to happen at high doses.
  • Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

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UNDESIRABLE EFFECTS

Q. Are there any unwanted effects of Kenalog injection?

A. All medicines may cause some unwanted or "side" effects. Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach, severe pain in your abdomen or tarry black stools, facial swelling or an unexpected rash.

Steroid treatment may cause: Increased appetite, weight gain, indigestion, bloating feeling tired or weak.

Increased risk of infection;

Thinning of bones or tendons causing fractures or torn muscles and muscle wasting;

Wounds or broken bones may be slow to heal;

Water retention, changes in potassium, sodium and calcium levels, heart problems, irregular heart beat, high blood pressure or blood clots, increase in white blood cells;

Skin disorders, including bruising, rashes, redness, itching, itchy raised lumps (hives) and other serious skin conditions. Acne, increased hair growth, increased sweating, flushing and thinning of the skin, and eye problems, including glaucoma and cataracts, may occur.

Treatment with steroids can stop the body from producing some hormones and may slow or stop children's growth rate.

If you are female, your periods may stop or become irregular.

Elevation or depression of mood, feelings of dependence on the medicine, worsening of psychiatric conditions, sleeplessness, dizziness, fainting, convulsions, tingling, numbness, wheezing, breathing problems and severe headaches have been reported.

When Kenalog is injected into a joint you may notice some indentation or skin discolouration appearing after a while in the surrounding area. There may also be some temporary worsening of the pain, irritation and discomfort after the injection. These changes should disappear in time.

Occasionally, Kenalog given by deep intramuscular injection produces dimpling of the buttock, caused by loss of fat under the skin. Severe pain and changes in skin colour around the injection site can also occur.

Tell your doctor or pharmacist if you notice any other troublesome side effects.

Serious effects: tell a doctor straight away

Steroids including Kenalog IA/IM injection can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Kenalog IA/IM injection.

  • Feeling depressed, including thinking about suicide.
  • Feeling high (mania) or moods that go up and down.
  • Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
  • Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

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LOOKING AFTER YOUR MEDICINE

Kenalog injection will be kept in the pharmacy until it is given to you by your doctor or nurse. It should not be stored above 25°C nor should it be allowed to freeze. The container should be kept in the outer carton and this should be kept out of the reach and sight of children. It should not be used after the expiry date shown on the outer packaging.

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DATE OF LAST REVISION

April 2008

1041174A6


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