Ultiva

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Remifentanil hydrochloride 1.1mg equivalent to 1 mg remifentanil;  

Beschikbaar vanaf:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Algemene Internationale Benaming):

Remifentanil hydrochloride 1.1 mg (equivalent to 1 mg remifentanil)

Dosering:

1 mg

farmaceutische vorm:

Powder for injection

Samenstelling:

Active: Remifentanil hydrochloride 1.1mg equivalent to 1 mg remifentanil   Excipient: Glycine Hydrochloric acid Sodium hydroxide Water for injection

Eenheden in pakket:

Vial, glass, (5 x 1mg), 5 mg

klasse:

Class B3 Controlled Drug

Prescription-type:

Class B3 Controlled Drug

Geproduceerd door:

Minakem High Potent SA

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, (5 x 1mg) - 5 mg - 18 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C

Autorisatie datum:

1995-10-04

Bijsluiter

_ _
1
ULTIVA
 INJECTION
_Remifantanil hydrochloride 1mg and 2mg vials_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
ULTIVA. It does not contain all
of the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given ULTIVA against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ULTIVA IS USED
FOR
ULTIVA is an anaesthetic used
with other anaesthetic medicines,
to produce and/or maintain heavy
sleep during your operation. If
you are a cardiac patient, it may
also be used to help relieve any
pain immediately following your
operation.
ULTIVA may also be used for
patients in the Intensive Care Unit
to maintain sedation and relieve
pain.
ULTIVA belongs to a group of
medicines called opioids. It
differs from other medicines in
this group by its very quick onset
and very short duration of action.
Your doctor may have prescribed
ULTIVA for another reason.
Ask your doctor if you have any
questions about why ULTIVA has
been prescribed for you.
As with other opioids, ULTIVA
can be addictive. This is unlikely
to happen when ULTIVA is only
used during your operation.
BEFORE YOU ARE GIVEN
ULTIVA
_WHEN YOU MUST NOT RECEIVE _
_ULTIVA _
•
YOU MUST NOT RECEIVE
ULTIVA IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO
REMIFENTANIL HYDROCHLORIDE
OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
•
YOU SHOULD NOT RECEIVE ULTIVA
IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO OTHER
PAIN-RELIEVING MEDICINES
WHICH ARE SIMILAR TO FENTANYL
AND WHICH ARE RELATED TO THE
CLASS OF MEDICINES KNOWN AS
OPIOIDS.
Symptoms of an allergic
reaction may be mild or severe.
They usually include some or
all of the following:
wheezing, swelling of the
lips/mouth, difficulty in
breathing, hayfever, lumpy
r

Productkenmerken

1
DATA SHEET
1. PRODUCT NAME ULTIVA
®
_REMIFENTANIL HYDROCHLORIDE FOR INJECTION1MG AND 2MG _
_(REMIFENTANIL BASE) VIALS _
_ _
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active substance –
Remifentanil hydrochloride – 1mg and 2 mg as remifentanil base
List of Excipients -
Glycine, Hydrochloric acid, Sodium hydroxide and water for injection
3. PHARMACEUTICAL FORM
ULTIVA, for injection, 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 1mg/mL of remifentanil base as remifentanil hydrochloride.
ULTIVA for injection is available as glass vials containing 1mg or 2mg
of
remifentanil base.
Lyophilized powder for reconstitution for intravenous 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 during surgical procedures
including
cardiac surgery. ULTIVA may also be used for continuation of analgesia
into
the immediate post-operative period under close supervision, during
transition
to longer acting analgesia.
ULTIVA is indicated for provision of analgesia and sedation in
mechanically
ventilated intensive care patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
When reconstituted as directed, solutions of ULTIVA are clear and
colourless
and contain 1mg/mL of remifentanil base as remifentanil hydrochloride.
2
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 medicines 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 f