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TRIESENCE 40 MG/ML SUSPENSION FOR INJECTION

Active substance(s): TRIAMCINOLONE ACETONIDE

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AAA2379 I TRIESN 1mL
Ross,Steve,FORT
WORTH,Alcon

K
NOTATIONS-DIE VINYL

H

04.22.2015
01:54 PM

By Ross,Steve,FORT WORTH,Alcon
2:39 pm, Apr 22, 2015

Package Leaflet: Information For The User

TRIESENCE® 40 mg/ml, suspension for injection
Triamcinolone acetonide
Read all of this leaflet carefully before you are given TRIESENCE 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.
• If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What TRIESENCE is and what it is used for
4. Possible side effects
2. What you need to know before you are
5. How to store TRIESENCE
given TRIESENCE
6. Contents of the pack and
3. How TRIESENCE is given
other information
1. What TRIESENCE is and what it is used for
TRIESENCE is a suspension that helps make the structures inside the eye more
visible during your eye surgery. This medicine is for diagnostic use only. It is not
used to treat any condition.
2. What you need to know before you are given TRIESENCE
You should NOT be given TRIESENCE
• if you are allergic (hypersensitive) to triamcinolone or any other ingredients in
TRIESENCE. Tell your doctor if you think that this may apply to you.
• If you have active herpes simplex infection in the eye
Warnings and precautions
Tell your doctor before you are given TRIESENCE
• if you have had a reaction to triamcinolone before. Another option might be
considered by your surgeon.
• if you have increased pressure in the eye.
• if you are diabetic please consult your doctor. The risk of corticosteroid-induced
increase of pressure in the eye and /or cataract formation (progressive cloudiness
of the normal eye lens) is increased in diabetic patients.
• if you have recent or ongoing infections in the eye.
If the above applies to you, or if you are not sure, please tell your doctor before
you are given TRIESENCE.
Children and adolescents
Do not give this medicine to children below the age of 18 years because the safety
and efficacy has not been established.
Other medicines and TRIESENCE
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy, breast feeding and fertility
Tell your doctor if you are pregnant or are planning to become pregnant. Little is
known about the use of TRIESENCE suspension in pregnant women. Your doctor will
carefully consider your condition and weigh the risks of using TRIESENCE suspension
against its benefits.
Tell your doctor if you are breast feeding. The safety and effectiveness of TRIESENCE
suspension in nursing mothers have not been established.
Driving and using machines
Eye surgery can temporarily affect your vision and your ability to drive or use
machines. Do not drive or use machinery until your vision has returned to normal.
3. How TRIESENCE is given
TRIESENCE will be given by your doctor. Depending on your condition your doctor
may modify the dose.
The usual dose is 1 to 4 mg of the medicine, given by injection inside your eye
during your surgery. The TRIESENCE is removed during the surgical procedure.
If you have any further questions about how TRIESENCE is given, ask your doctor.
4. 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 undertaken
with TRIESENCE:
Uncommon
(may affect up to 1 in 100 people)
Effects in the eye: Increased pressure in eye, injury to the back of the eye.
The following side-effects have also been observed during use:

Not known
(frequency cannot be estimated from the available data)
Effects in the eye: inflammation and pain with or without infection inside the eye,
reduced vision.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the national reporting system (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store TRIESENCE
• Keep out of the sight and reach of children.
Your doctor or nurse knows how to store TRIESENCE:
Do not use TRIESENCE after the expiry date which is stated on the label and outer
carton after ‘Exp’. The expiry date refers to the last day of that month.
Storage conditions:
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not use TRIESENCE if the vial is cracked or damaged in any way.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. Contents of the pack and other information
What TRIESENCE contains
The active substance is triamcinolone acetonide. 1 ml of suspension for injection
contains 40 mg triamcinolone acetonide. The other ingredients are sodium chloride,
carmellose sodium, polysorbate 80, potassium chloride, calcium chloride (dihydrate),
magnesium chloride (hexahydrate), sodium acetate (trihydrate), sodium citrate, water
for injection. Sodium hydroxide and hydrochloric acid are used to adjust the pH to
6.2 to 7.9.
What TRIESENCE looks like and contents of the pack
This medicinal product is a white suspension for injection. It is available in a pack
containing 1 vial of 1 ml suspension for injection.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
For any information about this medicine, please contact the local representative of
the Marketing Authorisation Holder:
Alcon Laboratories (UK) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR,
United Kingdom.
Manufacturer
S.A.Alcon-Couvreur N.V.
Rijksweg 14, B – 2870, Puurs
Belgium
This medicinal product is authorised in the following Member States under the name:
TRIESENCE 40 mg/ml suspension for injection: Belgium, Denmark, Finland, France,
Germany, Greece, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, United Kingdom
VISTREC 40 mg/ml suspension for injection: Netherlands
This leaflet was last revised in April 2015.
© 2011, 2014, 2015 Novartis

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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