Skip to Content

VESIERRA 5 MG/ML SOLUTION FOR INJECTION

Active substance(s): ESKETAMINE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

inks on file

Process structure
Black

Vesierra 5 mg/ml solution for injection/infusion
Vesierra 25 mg/ml solution for injection/infusion
RECTO

Esketamine

PAA101702
323

Package leaflet: Information for the patient
Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• 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.
What is in this leaflet
1. What Vesierra is and what it is used for
2. What you need to know before you are given Vesierra solution for injection/infusion
3. How Vesierra solution for injection/infusion is given
4. Possible side effects
5. How to store Vesierra solution for injection/infusion
6. Contents of the pack and other information

1. What Vesierra is and what it is used for
• Vesierra belongs to one of a group of medicines called anaesthetic agents, which are
used to put you to sleep during an operation.
• Vesierra can be given alone or in combination with other anaesthetic agents.
• Vesierra can be given as a pain relief/anaesthesia in emergency situations.
• Vesierra can be used for supplementing regional or local anaesthesia.

2. What you need to know before you are given Vesierra solution for
injection/infusion
You should not be given Vesierra solution for injection/infusion
• if you are allergic to esketamine or any of the other ingredients of this medicine (listed in section 6)
• if high blood pressure or increased pressure in the brain (intracranial pressure) is a serious risk for you
• if you have chest pain (angina) and/or cardiac diseases (in such case, Vesierra solution for
injection/infusion should not be given as the only anaesthetic)
• if you have a condition called eclampsia or pre-eclampsia (which is a complication of pregnancy
that causes high blood pressure)
• in combination with xanthine derivatives and ergometrine (used to induce labour).
If any of the above applies to you, you should not be given this medicine.
Warnings and precautions
Talk to your doctor or nurse before Vesierra solution for injection/infusion is given to
you if any of the following apply to you, to help them decide if Vesierra solution for
injection/infusion is suitable for you:
• if you have a weak heart (cardiac insufficiency) and untreated high blood pressure
• if you have chest pain
• if you have increased pressure in the brain and damage or disease of the central nervous system.
Raised pressure around the brain or spinal cord has been seen in people given ketamine (a similar
product) as an anaesthetic.
• if you need an eye examination or eye surgery in which pressure in the eye must not be increased
• if you are under the influence of alcohol
• if you have or have had severe psychiatric problems
• if you have an overactive thyroid (insufficiently treated hyperthyroidism)
• situations during childbirth which require relaxed uterus muscle (e.g., threat of a uterus rupture,
prolapsed umbilical cord)
• if you have liver disease
• if you have a history of drug abuse or addiction.
Out-patient treatment
You should be accompanied home after out-patient anaesthesia and you should not drink alcohol
within the next 24 hours.
Other medicines and Vesierra
Tell your doctor or pharmacist if you are using or have recently used or might use any other
medicines.
• Sympathomimetics (for example adrenaline or noradrenaline), thyroid hormones and vasopressin
may lead to an increase in blood pressure and in heart rate or heart rhythm disorders.
• Xanthine derivatives (for example aminophylline, theophylline) which may lead to fits or convulsions
and therefore these combinations should be avoided.
• Hypnotics (sleeping pills), benzodiazepines (for example diazepam) or neuroleptics used for mental
disorders, as the duration of effect of Vesierra may be prolonged.
• Barbiturates and opiates (such as morphine) given together with Vesierra may prolong the recovery
phase after the anaesthetic.
• The anaesthetic effect of some gas anaesthetics (for example halothane, isoflurane, desflurane,
sevoflurane) is increased by administration of Vesierra so lower doses may be needed.
• The effect of muscle relaxants such as pancuronium-type suxamethonium –type may be prolonged
due to the use of Vesierra.
• Vesierra should not be used in combination with ergometrine (used to induce labour).
• Vesierra used with drugs that may inhibit CYP3A4 enzyme activity may require a decrease in dose
of Vesierra
• Vesierra used with drugs that may induce CYP3A4 enzyme activity may require an increase in dose
of Vesierra
Vesierra with food, drink and alcohol
As with all general anaesthetics you will be asked to fast for 4 to 6 hours before you are due to
receive Vesierra solution for injection/infusion.
You should not drink alcohol within 24 hours of having this anaesthetic.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine will not be used during pregnancy unless your doctor has advised you that there is no
safer alternative. It could cause problems with the baby’s breathing rate if used during delivery.
Breast-feeding
This medicine can pass into breast-milk however it is unlikely to affect the baby when it is used at the
recommended doses.
Driving and using machines
You should not drive or operate machinery for at least 24 hours after receiving this medicine. Vesierra
results in reduced response times which are important in situations requiring special alertness, e.g.,
when driving a car.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.

Process Black

Vesierra solution for injection/infusion contains sodium
This medicinal product contains 3.2 mg sodium per ml (strength 5 mg/ml)
This medicinal product contains 1.2 mg sodium per ml (strength 25 mg/ml). Patients on a low-salt
diet should take this in consideration.

3. How Vesierra solution for injection/infusion is given

VERSO

Vesierra will only be given to you in a hospital or prehospital setting by or under the supervision of an
anaesthetist (a specialist in anaesthetics).
It is given as a slow injection into your vein (intravenous) or muscle (intramuscular). If necessary, the
injection can be repeated or the preparation can be given as an infusion.
If you have any further questions on the use of this product, ask your doctor, nurse or anaesthetist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually depend on the dose and speed of injection and usually get better without treatment.
Common (may affect up to 1 in 10 people)
• Recovery reactions after anaesthesia. These include vivid dreams, nightmares, dizziness and
restlessness.
• Blurred vision
• Temporary increase in heart beat, increase in blood pressure
• Effects on breathing during anaesthesia
• Nausea and vomiting, increased salivation.
Uncommon (may affect up to 1 in 100 people)
• Increased body movements (for example muscle twitching), which can resemble seizures, and
increased eye movements
• Double vision, increased pressure in the eye
• Rash
• Pain and/or redness at the injection site.
Rare (may affect up to 1 in 1,000 people)
• Severe allergic reactions
• Irregular heart beat or slower heart beat
• Low blood pressure
Unknown (frequency cannot be estimated from the available data)
• Hallucinations, dysphoria, anxiety and disorientation
• Abnormal liver function test results
• Liver injury
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 or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vesierra solution for injection/infusion
Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry
date refers to the last day of that month.
Vesierra 25 mg/ml solution for injection/infusion
It is recommended that the product is used as soon as possible after it is mixed with solvent,
although it may be stored if the instructions at the end of the leaflet are strictly followed.
Your doctor will check that the solution contains no particles and is not discoloured before using it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Vesierra contains
• The active substance is esketamine
Vesierra 5 mg/ml solution for injection/infusion
1 ml solution for injection/infusion contains 5 mg esketamine as 5.77 mg of esketamine hydrochloride
1 ampoule of 5 ml solution for injection/infusion contains 25 mg of esketamine as 28.85 mg of
esketamine hydrochloride.
Vesierra 25 mg/ml solution for injection/infusion
1 ml solution for injection/infusion contains 25 mg esketamine as 28.85 mg of esketamine
hydrochloride
1 ampoule of 2 ml solution for injection/infusion contains 50 mg of esketamine as 57.7 mg of
esketamine hydrochloride.
1 ampoule of 10 ml solution for injection/infusion contains 250 mg of esketamine as 288.5 mg of
esketamine hydrochloride.
• The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), water for
injections.
See section 2.
What Vesierra looks like and contents of the pack
The solution for injection/infusion is a clear solution for injection or infusion, contained in a clear glass
ampoule for single use only.
Pack sizes:
5 mg/ml: 10 x 5 ml; 10 x (10 x 5 ml) ampoules
25 mg/ml: 10 x 2 ml; 10 x (10 x 2 ml) ampoules
25 mg/ml: 5 x 10 ml; 5 x (5 x 10 ml) ampoules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing Belgium NV,
Puurs,
Belgium
This leaflet was last revised in 02/2018.
Ref: VE 6_0
--------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only. For full prescribing information
please refer to the SmPC.
Incompatibilities
Esketamine is chemically incompatible with barbiturates, diazepam and doxapram because of
precipitate formation. They are not to be administered with the same syringe and needle.
The medicinal product must not be mixed with other medicinal products except those mentioned in
”Special precautions for handling.”
Shelf life
3 years.
25 mg/ml:
The chemical and physical in–use stability has been demonstrated for 48 hours at 25°C for drug
product diluted with Dextrose 5% (glucose 50 mg/mL) or normal Saline (sodium chloride 9 mg/mL).
From a microbiological point of view, the diluted solution should be used immediately. If not used
immediately, in–use storage conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and
validated aseptic conditions.
Special precautions for handling
Esketamine can be mixed with glucose 50 mg/ml and sodium chloride 9 mg/ml.

Process Black

Parenteral products should be inspected visually for particulate matter and discolouration prior to
administration, whenever solution and container permit. The solution should not be used if
discoloured or cloudy or if particulate matter is observed.

PAA101702

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide