Esketamine IDD 25 mg/ml, oplossing voor injectie/infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ESKETAMINEHYDROCHLORIDE 28,8 mg/ml SAMENSTELLING overeenkomend met ; ESKETAMINE 25 mg/ml

Beschikbaar vanaf:

International Drug Development 104 boulevard Auguste Blanqui 75013 PARIS (FRANKRIJK)

ATC-code:

N01AX14

INN (Algemene Internationale Benaming):

ESKETAMINEHYDROCHLORIDE 28,8 mg/ml SAMENSTELLING overeenkomend met ; ESKETAMINE 25 mg/ml

farmaceutische vorm:

Oplossing voor injectie of infusie

Samenstelling:

NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)

Toedieningsweg:

Intraveneus gebruik, Intramusculair gebruik

Therapeutisch gebied:

Esketamine

Autorisatie datum:

2019-02-11

Bijsluiter

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESKETAMINE IDD 5 MG/ML, OPLOSSING VOOR INJECTIE/INFUSIE
ESKETAMINE IDD 25 MG/ML, OPLOSSING VOOR INJECTIE/INFUSIE
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 IDD is and what it is used for
2.
What you need to know before you are given Esketamine IDD
3.
How to use Esketamine IDD
4.
Possible side effects
5.
How to store Esketamine IDD
6.
Contents of the pack and other information
1.
WHAT ESKETAMINE IDD AND WHAT IT IS USED FOR
Esketamine IDD belongs to one of a group of medicines called general
anaesthetics, which is used to
put you to sleep during an operation.
Esketamine IDD 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 IDD
_ _
ESKETAMINE IDD 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 uterus muscle,
(e.g. threat of a ute

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Esketamine IDD 5 mg/ml, oplossing voor injectie/infusie
Esketamine IDD 25 mg/ml, oplossing voor injectie/infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esketamine IDD 5 mg/ml, oplossing voor injectie/infusie
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.
Esketamine IDD 25 mg/ml, oplossing voor injectie/infusie
1 ml solution for injection/infusion contains 25 mg of esketamine as
28.83 mg of esketamine
hydrochloride.
1 ampoule of 2 ml solution for injection/infusion contains 50 mg of
esketamine as 57.66 mg of
esketamine hydrochloride.
1 ampoule containing 10 ml solution for injection/infusion contains
250 mg of esketamine as 288.30 mg
of esketamine hydrochloride.
1 vial of 10 ml solution for injection/infusion contains 250 mg of
esketamine as 288.3 mg of esketamine
hydrochloride.
1 vial of 50 ml solution for injection/infusion contains 1250 mg of
esketamine as 1441.5 mg of
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 po