Remifentanil-AFT, remifentanil (as hydrochloride) 1 mg, powder for injection, glass vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

remifentanil hydrochloride, Quantity: 1.097 mg (Equivalent: remifentanil, Qty mg)

Saadav alates:

AFT Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Remifentanil hydrochloride

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: hydrochloric acid; glycine

Manustamisviis:

Intravenous

Ühikuid pakis:

5 vials

Klass:

Medicine Registered

Retsepti tüüp:

(S8) Controlled Drug

Näidustused:

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 procedures but not cardiac procedures in children aged 1 to 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 drugs, 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.

Toote kokkuvõte:

Visual Identification: White to off-white lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Volitamisolek:

Registered

Loa andmise kuupäev:

2013-03-20

Infovoldik

REMIFENTANIL-AFT
Remifentanil (as the hydrochloride) 1mg, 2 mg and 5 mg, Powder for
Injection
WARNING
LIMITATIONS OF USE
Remifentanil-AFT should only be used when your doctor decides that
other treatment
options are not able to effectively manage your pain or you cannot
tolerate them.
HAZARDOUS AND HARMFUL USE
Remifentanil-AFT poses risks of abuse, misuse and addiction which can
lead to overdose
and death. Your doctor will monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
Remifentanil-AFT can cause life-threatening or fatal breathing
problems (slow, shallow,
unusual or no breathing) even when used as recommended. These problems
can occur at
any time during use, but the risk is higher when first starting
Remifentanil-AFT and after a
dose increase, if you are older, or have an existing problem with your
lungs. Your doctor
will monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING REMIFENTANIL-AFT
USING REMIFENTANIL-AFT WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL
DROWSY SUCH AS
SLEEPING TABLETS (E.G. BENZODIAZEPINES), OTHER PAIN RELIEVERS,
ANTIHISTAMINES,
ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND
PREGABALIN),
CANNABIS AND ALCOHOL MAY RESULT IN SEVERE DROWSINESS, DECREASED
AWARENESS,
BREATHING PROBLEMS, COMA AND DEATH. Your doctor will minimise the dose
and duration of
use; and monitor you for signs and symptoms of breathing difficulties
and sedation. You
must not drink alcohol while using Remifentanil-AFT.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Remifentanil-AFT. 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 Remifentanil-AFT 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

Toote omadused

REMIFENTANIL-AFT
AUSTRALIAN PI
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids,
Remifentanil-AFT 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-AFT 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-AFT. 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 not to drink alcohol while
taking Remifentanil-AFT.
1
NAME OF THE MEDICINE
Remifentanil-AFT.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remifentanil-AFT Powder for Injection is a sterile, nonpyrogenic,
preservative-free white to off-white
lyophilised powder for intravenous administration.
The product is formulated in glycine and requires reconstitution and
dilution before use.
Three strengths are available:
Remifent