Xomolix 0.5 mg/ml Solution for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Droperidol

可用日期:

Kyowa Kirin Holdings B.V.

ATC代码:

N05AD; N05AD08

INN（国际名称）:

Droperidol

剂量:

0.5 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

Not applicable

治疗领域:

Butyrophenone derivatives; droperidol

授权状态:

Not marketed

授权日期:

2019-01-11

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
XOMOLIX 0.5 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.

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 Xomolix is and what it is used for
2.
What you need to know before you use Xomolix
3.
How to use 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 of droperidol for injection, which is used to
prevent you feeling sick
(nausea) or vomiting when you wake up after an operation or in adults
when they receive
morphine based painkillers after an operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XOMOLIX
DO NOT USE XOMOLIX:

if you are allergic to droperidol, or any of the other ingredients of
this medicine (listed in
section 6).

if you are allergic to a group of medicines used to treat psychiatric
disorders, called
butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone,
domperidone)

if you or anyone in your family have an abnormal electrocardiogram
(ECG) heart tracing

if you have low levels of potassium or magnesium in your blood

if you 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

if you have a tumour in your adrenal gland (phaeochromocytoma)

if you are in a coma

if you have Parkinson’s disease

if you have severe depression
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before

产品特点

Health Products Regulatory Authority
09 November 2020
CRN00C0T5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xomolix 0.5 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains 0.5 mg droperidol (1.25 mg/2.5
ml).
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 Xomolix 0.5 mg/ml solution for injection is 3.0–3.8 and
has an osmolarity of approximately 10 milliosmol /kg water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
● 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
For intravenous use. Administer slowly (hypotonic solution).
Prevention and treatment of post-operative nausea and vomiting (PONV).
_Adults:_ 0.625 mg to 1.25 mg (1.25 to 2.5 ml).
_Elderly (over 65 years):_ 0.625 mg (1.25 ml).
_Renal/hepatic impairment:_ 0.625 mg (1.25 ml).
_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.
For prevention of PONV, antiemetics are indicated in patients at
moderate and high risk. The risk should be assessed using
standard accepted scales or scores, such as the Modified APFEL Score.
Administration of Xomolix is recommended 30 minutes before the
anticipated end of surgery. Repeat doses may be given
every 6 hours as required.
In adults, prevention of early vomiting and late nausea may be
improved by doses above 0.75 mg, but not greater than
1.25 mg.
In adults and children, higher doses are associated with increas