Remifentanil APOTEX remifentanil (as hydrochloride) 1 mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

remifentanil hydrochloride, Quantity: 1.097 mg

Disponível em:

Apotex Pty Ltd

DCI (Denominação Comum Internacional):

Remifentanil hydrochloride

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: hydrochloric acid; glycine

Via de administração:

Intravenous Infusion

Unidades em pacote:

5 x 1 mg

Tipo de prescrição:

(S8) Controlled Drug

Indicações terapêuticas:

Remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.

Resumo do produto:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2016-01-06

Folheto informativo - Bula

REMIFENTANIL APOTEX
1
REMIFENTANIL APOTEX
_Remifentanil (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about remifentanil. It does
not contain all 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Remifentanil APOTEX powder for
injection. It contains the active
ingredient remifentanil (as
hydrochloride).
Remifentanil 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.
Remifentanil may also be used for
patients in the Intensive Care Unit to
maintain sedation and relieve pain.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Remifentanil 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.
As with other opioids, remifentanil
can be addictive. This is unlikely to
happen when remifentanil is only
used during your operation.
_USE IN CHILDREN _
This medicine should not be used in
children less than 1 year old.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT RECEIVE _
_IT _
YOU MUST NOT RECEIVE THIS MEDICINE
IF YOU ARE HYPERSENSITIVE TO, OR
HAVE HAD AN ALLERGIC

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION
REMIFENTANIL APOTEX (REMIFENTANIL
HYDROCHLORIDE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Remifentanil (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg, 2 mg or 5 mg remifentanil (as hydrochloride).
EXCIPIENTS WITH KNOWN EFFECT
Glycine
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Remifentanil
APOTEX powder for injection
should only be used in patients for whom other treatment options,
including non-opioid analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of pain (see
section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
HAZARDOUS AND HARMFUL USE
Remifentanil APOTEX powder for injection poses risks of hazardous and
harmful use which can lead
to overdose and death. Assess the patient’s risk of hazardous and
harmful use before prescribing and
monitor the patient regularly during treatment (see section 4.4.
SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of Remifentanil
APOTEX powder for injection. Be aware of situations which increase the
risk of respiratory
depression, modify dosing in patients at risk and monitor patients
closely, especially on initiation or
following a dose increase (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS,
INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Limit
dosages and durations to the minimum required; and monitor patients
for signs and symptoms of
respiratory depression and sedation. Caution patients no