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VESIERRA 25 MG/ML SOLUTION FOR INJECTION

Active substance(s): ESKETAMINE HYDROCHLORIDE / ESKETAMINE HYDROCHLORIDE / ESKETAMINE HYDROCHLORIDE

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Package leaflet: Information for the patient
(Invented) name 5 mg/ml solution for injection/infusion
(Invented) name 25 mg/ml solution for injection/infusion
Esketamine
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 (Invented) name is and what it is used for
2.
What you need to know before you are given (Invented) name solution for injection/infusion
3.
How (Invented) name solution for injection/infusion is given
4.
Possible side effects
5.
How to store (Invented) name solution for injection/infusion
6.
Contents of the pack and other information
1.

What (Invented) name is and what it is used for






(Invented) name belongs to one of a group of medicines called anaesthetic agents, which are
used to put you to sleep during an operation.
(Invented) name can be given alone or in combination with other anaesthetic agents.
(Invented) name can be given as a pain relief/anaesthesia in emergency situations.
(Invented) name can be used for supplementing regional or local anaesthesia.

2.

What you need to know before you are given (Invented) name solution for injection/infusion

You should not be given (Invented) name 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, (Invented) name 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 (Invented) name solution for injection/infusion is given to you if
any of the following apply to you, to help them decide if (Invented) name 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 (Invented) name
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 (Invented) name may be prolonged.



Barbiturates and opiates (such as morphine) given together with (Invented) name 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 (Invented) name 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 (Invented) name.



(Invented) name should not be used in combination with ergometrine (used to induce labour).



(Invented) name used with drugs that may inhibit CYP3A4 enzyme activity may require a decrease in
dose of (Invented) name



(Invented) name used with drugs that may induce CYP3A4 enzyme activity may require an increase in
dose of (Invented) name

(Invented) name 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
(Invented) name 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. (Invented)
name results in reduced response times which are important in situations requiring special alertness, e.g.,
when driving a car.
(Invented) name 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 (Invented) name solution for injection/infusion is given

(Invented) name 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 national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store (Invented) name 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.
(Invented) name 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.
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 (Invented) name contains

The active substance is esketamine
(Invented) name 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.
(Invented) name 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 (Invented) name 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
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
Manufacturer
Pfizer Manufacturing Belgium NV,
Puurs,
Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium

Vesierra 5/25 mg/ml solution injectable/pour perfusion/oplossing voor injectie/infusie/
Injektions-/ Infusionslösung
Estonia
Esketamine Pfizer 5/25 mg/ml solution for injection
Finland
Ketanest-S
France
Esketamine Pfizer 5/25 mg/ml, solution injectable
Latvia
Esketamine Pfizer 5/25 mg/ml solution for injection
Luxembourg Vesierra 5/25 mg/ml solution injectable/pour perfusion/oplossing voor
injectie/infusie/Injektions-/ Infusionslösung
Norway
Ketanest
Portugal
Ketanest
Slovenia
Ketanest 5/25 mg/ml raztopina za injiciranje
Sweden
Ketanest
UK
Vesierra 5/25 mg/ml solution for injection
This leaflet was last revised in <{month YYYY}>.

-----------------------------------------------------------------------------------------------------------------------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.
Parenteral products should be inspected visually for particulate matter and discolouration prior to
administration, whenever solution and container permit.

Expand Transcript

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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