Xomolix 2.5 mg/ml solution for injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Droperidol

Fáanlegur frá:

Kyowa Kirin Holdings B.V.

ATC númer:

N05AD; N05AD08

INN (Alþjóðlegt nafn):

Droperidol

Skammtar:

2.5 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Butyrophenone derivatives; droperidol

Leyfisstaða:

Marketed

Leyfisdagur:

2008-02-29

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
XOMOLIX 2.5 MG/ML SOLUTION FOR INJECTION
Droperidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 Xomolix is and what it is used for
2.
What you need to know before you are given Xomolix
3.
How you will be given Xomolix
4.
Possible side effects
5.
How to store Xomolix
6.
Contents of the pack and other information
1.
WHAT XOMOLIX IS AND WHAT IT IS USED FOR
Xomolix is a solution for injection containing the active substance
droperidol, which belongs to a
group of antipsychotics called butyrophenone derivatives. Xomolix is
used to prevent you feeling sick
(nausea) or vomiting when you wake up after an operation or when you
receive morphine based
painkillers after an operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN XOMOLIX
YOU SHOULD NOT BE GIVEN XOMOLIX IF YOU:

are allergic to droperidol, or any of the other ingredients of this
medicine (listed in section 6).

are allergic to a group of medicines used to treat psychiatric
disorders, called butyrophenones
(e.g. haloperidol, triperidol, benperidol, melperone, domperidone)

or anyone in your family have an abnormal electrocardiogram (ECG)
heart tracing

have low levels of potassium or magnesium in your blood

have a pulse rate of less than 55 beats per minute (the doctor or
nurse will check this), or are
taking any medicines that could cause this to happen

have a tumour in your adrenal gland (phaeochromocytoma)

are in a coma

have Parkinson’s disease

have severe depression
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Xomolix:

if you have epilepsy, or a history of epilepsy

if you

Vara einkenni

Health Products Regulatory Authority
09 November 2020
CRN00C0T5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xomolix 2.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of the solution contains 2.5 mg droperidol.
Excipient with known effect: sodium < 23 mg per ml (see section 4.4
for further details).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution, free from visible particles.
The pH of droperidol solution for injection is 3.0 – 3.8 and has an
osmolarity of approximately 300 millimosmol /kg water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xomolix is indicated in:

Prevention and treatment of post-operative nausea and vomiting (PONV)
in adults and, as second line, in children
(2 to 11 years) and adolescents (12 to 18 years).

Prevention of nausea and vomiting induced by morphine and derivatives
during post-operative patient controlled
analgesia (PCA) in adults.
Certain precautions are required when administering droperidol: see
sections 4.2, 4.3, and 4.4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prevention and treatment of post-operative nausea and vomiting (PONV).
_Adults_: 0.625 mg to 1.25 mg (0.25 to 0.5 ml).
_Elderly (over 65 years): _0.625 mg (0.25 ml)
_Renal/hepatic impairment:_ 0.625 mg (0.25 ml)
_Paediatric population_
_Children (2 to 11 years) and adolescents (12 to 18 years): _10 to 50
microgram/kg (up to a maximum of 1.25 mg).
_Children (below the age of 2 years):_not recommended.
Administration of droperidol is recommended 30 minutes before the
anticipated end of surgery. Repeat doses may be given
every 6 hours as required.
The dosage should be adapted to each individual case. The factors to
be considered here include age, body weight, use of
other medicinal products, type of anaesthesia and surgical procedure.
Prevention of nausea and vomiting induced by morphine and derivatives
during post-operative patient controlled analgesia