Ultiva 2mg powder for solution for injection vials

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Remifentanyl hydrochloride

から入手可能:

Aspen Pharma Trading Ltd

ATCコード:

N01AH06

INN（国際名）:

Remifentanyl hydrochloride

投薬量:

2mg

医薬品形態:

Powder for solution for injection

投与経路:

Intravenous

クラス:

Schedule 2 (CD)

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 15010100; GTIN: 5000123311897

情報リーフレット

[ASPEN]
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ULTIVA FOR INJECTION
REMIFENTANIL HYDROCHLORIDE
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 Ultiva is and what it is used for
2
What you need to know before you are given Ultiva
3
How Ultiva is given
4
Possible side effects
5
How to store Ultiva
6
Contents of the pack and other information
1
WHAT ULTIVA IS AND WHAT IT IS USED FOR
Ultiva contains a medicine called remifentanil. This belongs to a
group of medicines
known as opioids.
Ultiva is used together with other medicines called anaesthetics
•
to help put you to sleep BEFORE an operation
•
to keep you asleep and stop you feeling pain DURING an operation
•
to make you feel sleepy and stop you feeling pain while you receive
treatment in
an Intensive Care Unit.
2
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ULTIVA
DO NOT HAVE ULTIVA IF:
•
you are allergic (hypersensitive) to remifentanil or any of the other
ingredients of
Ultiva (listed in section 6)
•
you are allergic (hypersensitive) to any other pain-relieving
medicines which are
similar to fentanyl and which are related to the class of medicines
known as
opioids.
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or
nurse before you are given Ultiva.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before you are given Ultiva if:
•
you are allergic (hypersensitive) to any other opioid medicines, such
as morphine
or codeine
•
you are over 65 years of age
•
you are dehydrated or have lost a lot of blood
•
you have been feeling weak or unwell
•
if you are overweight
If you are not sure if any of the above

製品の特徴

OBJECT 1
ULTIVA (REMIFENTANIL HYDROCHLORIDE) FOR INJECTION
2 MG
Summary of Product Characteristics Updated 15-Aug-2017 | Aspen
1. Name of the medicinal product
Ultiva (remifentanil hydrochloride) for Injection 2 mg
2. Qualitative and quantitative composition
Ultiva is a sterile, endotoxin-free, preservative-free, white to off
white, lyophilised powder, to be
reconstituted before use.
When reconstituted as directed, solutions of Ultiva are clear and
colourless and contain 1 mg/ml of
remifentanil base as remifentanil hydrochloride.
Ultiva for injection is available in glass vials containing 1 mg, 2 mg
or 5 mg of remifentanil base.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Lyophilised powder for reconstitution for intravenous (IV)
administration.
4. Clinical particulars
4.1 Therapeutic indications
Ultiva is indicated as an analgesic agent for use during induction
and/or maintenance of general
anaesthesia under close supervision.
Ultiva is indicated for provision of analgesia and sedation in
mechanically ventilated intensive care
patients 18 years of age and over.
4.2 Posology and method of administration
ULTIVA SHOULD BE ADMINISTERED ONLY IN A SETTING FULLY EQUIPPED FOR THE
MONITORING AND SUPPORT OF
RESPIRATORY AND CARDIOVASCULAR FUNCTION AND BY PERSONS SPECIFICALLY
TRAINED IN THE USE OF
ANAESTHETIC DRUGS AND THE RECOGNITION AND MANAGEMENT OF THE EXPECTED
ADVERSE EFFECTS OF POTENT
OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION. SUCH
TRAINING MUST INCLUDE THE
ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED
VENTILATION.
Continuous infusions of Ultiva must be administered by a calibrated
infusion device into a fast flowing
IV line or via a dedicated IV line. This infusion line should be
connected at, or close to, the venous
cannula and primed, to minimise the potential dead space (_see section
6.6_ for additional information,
including tables with examples of infusion rates by body weight to
help titrate Ultiva to the patient's
anaesthetic needs).
Ultiva may also b