40 mg/ml solution for injection, suspension
Triamcinolone acetonide
What Presence is and what it is used for
Presence is a suspension that helps make structures inside the eye more visible during eye surgery. This medicine is intended for diagnostic use only. It is not used to treat any disease.
Triamcinolone acetonide found in Triesence may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you are given Presence
You should NOT be given Triesence
- if you are allergic (hypersensitive) to triamcinolone or any other ingredient in Presence. Tell your doctor if you think this applies to you.
- if you have an active herpes simplex infection in the eye.
Warnings and precautions
Tell your doctor before you are given Triesence
- if you have reacted to triamcinolone before. Your surgeon may then consider another option.
- if you have increased pressure in the eye.
- if you are diabetic, you should consult your doctor. The risk of increased pressure in the eye and/or the development of cataracts ( progressive clouding of the lens in a normal eye) caused by corticosteroids is higher in patients with diabetes.
- if you have recently had or have an ongoing infection in your eye.
If the above applies to you or if you are not sure, tell your doctor before you are given Presence.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children and young people
Do not give this medicine to children under 18 years of age because safety and efficacy have not been established.
Other medicines and Presence
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Pregnancy, breastfeeding, and fertility
Tell your doctor if you are pregnant or plan to become pregnant. There is not enough information on the use of Triesence suspension in pregnant women. Your doctor will carefully consider your condition and weigh the risks of using Triesence suspension against the benefits.
Tell your doctor if you are breastfeeding. The safety and effectiveness of Triesence suspension in nursing mothers have not been established.
Driving ability and use of machinery
Eye surgery can temporarily affect your vision and your ability to drive or use machines. You must not drive or use machines until your vision has returned to normal.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How Triesence is given
Presence is administered by your doctor. Depending on your condition, the doctor may adjust the dose.
The normal dose is 1 to 4 mg of the drug, which is given by injection into your eye during surgery. Presence is removed during the surgical procedure.
If you have further questions about how Triesence is given, contact the doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed in clinical studies conducted for Presence:
Less common
(may affect up to 1 in 100 people)
Effects in the eye: Increased pressure in the eye.
The following side effects have also been observed during use:
No known frequency
(cannot be calculated from available data)
Effects in the eye: inflammation and pain with or without infection inside the eye, impaired vision, blurred vision.
How to store Presence
Keep this medicine out of the sight and reach of children.
Your doctor or nurse knows how to store Presence:
Use before the expiry date which is stated on the label and outer carton after EXP. The expiration date is the last day of the specified month.
Storage instructions
Do not freeze.
Store the vial in the outer carton. Light sensitive.
Do not use Triesence if the vial is cracked or damaged in any way.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is triamcinolone acetonide. 1 ml solution for injection, the suspension contains 40 mg triamcinolone acetonide.
- Other ingredients are sodium chloride, carmellose sodium, polysorbate 80, potassium chloride, calcium chloride (dihydrate), magnesium chloride (hexahydrate), sodium acetate (trihydrate), sodium citrate, and water for injections. Sodium hydroxide and hydrochloric acid are used to adjust the pH value to between 6.2 and 7.9.
Appearance and package sizes of the medicine
This medicine is a white suspension for injection. It is available in a pack containing 1 vial of 1 ml suspension for injection.
Manufacturer
SAAlcon-Couvreur NV
Rijksweg 14, B – 2870, Puurs
Belgium
This medicine is approved in the European Economic Area under the names:
Presence 40 mg/ml solution for injection, suspension:
Belgium
Denmark
Finland
France
Germany
Greece
Italy
Luxembourg
Norway
Portugal
Spain
Sweden
Vitric 40 mg/ml solution for injection , and suspension:
Netherlands