Kenalog 40 Mg/Ml Injection
PATIENT INFORMATION LEAFLET
KENALOG® 40 mg/ml INJECTION
(triamcinolone acetonide)
This medicine is available as the above name but will be referred to as Kenalog Injection throughout the following leaflet.
Please read this leaflet carefully before you are given your medicine. It provides a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.
• Kenalog 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 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 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 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.
In this leaflet:
1. What Kenalog Injection is and what it is used for
2. Before you are given your medicine
3. Receiving your medicine
4. Possible side effects
5. How to store your medicine
6. Further information
11. WHAT KENALOG INJECTION IS AND WHAT IT IS USED FOI
The name of this medicine is Kenalog Injection. Each injection contains triamcinolone acetonide 40mg/ml as the active ingredient. Triamcinolone acetonide belongs to a group of medicine called corticosteroids (steroids). Kenalog injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis.
It is also for the treatment of various allergic disorders including asthma, seasonal allergies, blood disorders, hormone problems, rheumatic fever, and problems associated with digestive system, kidneys, lungs or skin.
|2. BEFORE YOU ARE GIVEN YOUR MEDICINEl
Do not receive Kenalog Injection if:
• You have had an allergic reaction to a similar medicine or any of the ingredients in this medicine. See Section 6 for full list of ingredients
• You are suffering from an infection unless your doctor has also prescribed a treatment for the infection
Kenalog Injection is not recommended for children under 6 years.
You must tell your doctor if:
• You have had any recent infection [including tuberculosis (TB)]
• You have had recent bowel surgery
• You have, or have had a bowel disorder or stomach ulcer
• You have an infection or inflammation of the veins in your legs
• You have had any mental disorders or epilepsy
• You have had any kidney, liver or thyroid (gland in the neck) problems as the dose of Kenalog may need to be adjusted
• You have recently suffered from any form of cancer
• You have thin or brittle bones (osteoporosis)
• You have myasthenia gravis (a disease which causes weak muscles)
• You have high blood pressure or heart failure
• You or someone in your family has glaucoma (increased pressure in your eyes).
• You are diabetic as your insulin dose may need to be changed
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 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 Injection.
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 as soon as possible. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any vaccination without consulting your doctor. You must take care not to over-use a joint which feels better after you receive Kenalog Injection. The joint will still need to recover from the inflammation which caused your symptoms.
Taking other medicines with Kenalog Injection
Always tell your doctor about any medicines you are taking, or have recently taken, including those obtained without a prescription.
This is especially important if you are taking:
• Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as corticosteroids can increase the chance of bleeding from the gut.
• Any antifungals (e.g. ketoconazole, amphotericin)
• Warfarin or other medicines to thin the blood
• Oral contraceptive pill or hormone replacement therapy (HRT)
• Human growth hormone
• A medicine called ciclosporin
• A medicine called rifampicin or medicines to treat:
• High blood pressure or irregular heart beat (e.g. digoxin)
• Myasthenia gravis (a disease which causes weak muscles)
• Epilepsy or other sorts of fits (e.g. phenytoin)
• tuberculosis (TB)
• diabetes
• thyroid problems
If you are taking any of these medicines, or are not sure, please consult your doctor.
If you are due to have surgery
Before surgery and anaesthesia (even at the dentist) you should tell the doctor or dentist that you are being treated with Kenalog Injection.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or if you are breast-feeding you should make sure you discuss this with your doctor as soon as possible before receiving Kenalog Injection.
Driving or operating machinery
This medicine does not usually affect your ability to drive or operate machinery but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or problems with your vision.
Steroid Treatment Card
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 medicine
Optician - it is advisable to have regular eye tests
Important information about the ingredients of Kenalog Injection
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.
|3. RECEIVING YOUR MEDICINEl
The effect of the injection will vary from patient to patient and further injections may be given to you when symptoms return and not at regular intervals.
The usual doses are:
Use in inflammatory joint disorders:
The dose of injection into a joint or tendon sheath depends upon the size of the joint to be treated and the severity of 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 usually give relief of symptoms.
This medicine should not be used for injection into the Achilles tendon.
Use in allergic disorders:
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.
Your doctor will advise you whether it is wise for you to have further injections.
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.
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.
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.
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.
Mental problems while taking Kenalog Injection
Mental health problems can happen while taking steroids like Kenalog 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.
. POSSIBLE SIDE EFFECTSl
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious effects: tell a doctor straight away
Steroids including Kenalog 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 Injection:
• Mood changes, mental disorders, feeling dependent on the medicine, trouble sleeping, fits or epilepsy, fainting and dizziness
• 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.
Serious cases of anaphylactic reactions (i.e. a serious allergic reaction) and anaphylactic shock including death have been reported. If you notice any of the following, contact your doctor immediately:
• Swelling of the face, lips or throat
• Breathing difficulties
• Skin itching, redness or a rash
• As these may be signs of an allergic reaction
Common side effects (may affect up to 1 in 10 people)
• Increased risk of infection
• Injection site reactions
• Headache
• Joint pain
Uncommon side effects (may affect up to 1 in 100 people)
• Changes in blood chemicals, fluid retention, heart failure or irregular heart beat
• Weak or fragile bones or muscles, poor healing of broken bones or destruction of the ends of bones, decrease in muscle mass, muscle pain, muscular weakness/discomfort, fracture
• Thin/fragile skin, rashes, stretch marks, bruising, sweating, flushing and increased hair growth, itchy bumps, loss/darkening of skin colour
• Indigestion, stomach pain, stomach ulcers, bloating, increased appetite and weight loss, inflammation of the pancreas/oesophagus, perforation of stomach ulcer,stomach bleeding
• Eye problems including glaucoma and cataracts, blindness, bulging of the eye, damage to the cornea
• Infection of the nose
• Irregular periods/ postmenopausal women may also experience vaginal bleeding
• Fungal eye infections
• Viral eye infections
• Yeast infections e.g. thrush
• Tiredness and tingling, Increased pressure in the brain
• Inadequately controlled diabetes mellitus, high blood sugar
• Pain and worsening of the pain in the injected joint
• Impaired healing
• High body temperature
• Treatment with steroids can stop the body from producing some hormones and may slow or stop children's growth.
• Hormone production by certain glands may be increased or decreased.
• Vertigo
• High/low blood pressure
• Abnormal blood clots
• Longstanding chronic infections such as tuberculosis could be made worse Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
|5. HOW TO STORE YOUR MEDICINEl
• Keep out of the sight and reach of children.
• Kenalog Injection will be kept in the pharmacy until it is given to you by your doctor or nurse.
• It should not be used after the expiry date shown on the outer packaging. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in upright position.
|6. FURTHER INFORMATION
What Kenalog Injection contains
Each 1 ml of aqueous suspension contains 40 mg of triamcinolone acetonide.
In addition, Kenalog injection contains the following inactive ingredients: Other ingredients: benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water for injection.
Kenalog 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 Injection) is an effective way to treat various illnesses involving inflammation in the body. Kenalog 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.
What Kenalog Injection looks like and contents of the pack
Kenalog Injection is a sterile aqueous suspension for injection supplied in a 1 ml glass ampoule.
Pack size: 5 ampoules.
PL No: 15814/1098 pOM|
Manufactured by Bristol-Myers Squibb, S.r.l., Anagni, Italy.
Procured from within the Eu and repackaged by the Product Licence holder: O.P.D. Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref): 29.09.2015.
Kenalog is a registered trademark of Bristol-Myers Squibb Pharmaceuticals Limited, UK.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.