Esketamine Sintetica 5 mg/ml solution for injection/infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

ESKETAMINE HYDROCHLORIDE

Διαθέσιμο από:

Sintetica GmbH

Φαρμακολογική κατηγορία (ATC):

N01AX14

INN (Διεθνής Όνομα):

ESKETAMINE HYDROCHLORIDE

Φαρμακοτεχνική μορφή:

Solution for injection/infusion

Θεραπευτική περιοχή:

esketamine

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2020-10-02

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESKETAMINE SINTETICA 5 MG/ML SOLUTION FOR INJECTION/INFUSION
ESKETAMINE SINTETICA 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.
-
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 Esketamine Sintetica is and what it is used for
2.
What you need to know before you are given Esketamine Sintetica
3.
How to use Esketamine Sintetica
4.
Possible side effects
5.
How to store Esketamine Sintetica
6.
Contents of the pack and other information
1.
WHAT ESKETAMINE SINTETICA AND WHAT IT IS USED FOR
Esketamine Sintetica belongs to one of a group of medicines called
general anaesthetics, which is used
to put you to sleep during an operation.
Esketamine Sintetica is used:
-
to initiate and perform general anaesthesia, as the only anaesthetic
or possibly in combination with
sleeping pills (hypnotics),
-
to supplement regional anaesthesia (local anaesthesia),
-
for anaesthesia and pain relief (analgesia) in emergency situations,
-
for pain control in artificial respiration (intubation).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ESKETAMINE SINTETICA
ESKETAMINE SINTETICA MUST NOT BE USED:
-
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 is a serious
risk for you,
if you have poorly controlled or untreated high blood pressure,
-
if you have a condition called eclampsia or pre-eclampsia (which is a
complication of pregnancy
that causes high blood pressure),
-
if you have an overactive thyroid (insufficiently treated
hyperthyroidism),
-
in situations during childbirth which require relaxed

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
28 June 2023
CRN00CNQT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esketamine Sintetica 5 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 28.83 mg esketamine hydrochloride.
1 vial of 20 ml solution for injection/infusion contains 100 mg of
esketamine as 115.40 mg esketamine hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
pH 3.0 – 4.0.
Osmolality = 270 – 310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Induction and maintenance of general anaesthesia, as the only
anaesthetic or possibly in combination with hypnotics.
- Supplementation of regional or local anaesthesia.
- Anaesthesia and pain relief (analgesia) in emergency medicine.
- Pain control in artificial respiration (intubation).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Esketamine should be administered only by specialist of
anaesthesiology or emergency medicine.
Esketamine is for hospital use only.
As aspiration cannot be completely excluded and due to the possibility
of respiratory depression, intubation and ventilation
equipment must be available.
Posology
For induction of general anaesthesia 0.5 to 1 mg/kg of esketamine is
given intravenously or 2 to 4 mg/kg intramuscularly, half
the initial dose is re-injected as needed, generally every 10 to 15
minutes.
As an alternative to injection, esketamine can be administered as a
continuous infusion at a dose of 0.5 to 3 mg
esketamine/kg/h. In case of multiple injuries (polytrauma) and in
patients with poor general condition a dose reduction may be
necessary.
For analgesic supplementation of regional and local anaesthesia 0.125
to 0.25 mg esketamine/kg/h is administered as
intravenous infusion.
For analgesi