ALFENTANIL-HAMELN alfentanil (as hydrochloride) 1 mg/2 mL solution for injection ampoule

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

alfentanil hydrochloride, Quantity: 1.0876 mg (Equivalent: alfentanil, Qty 1 mg)

Saadav alates:

Hameln Pharma Pty Ltd

Ravimvorm:

Injection, solution

Koostis:

Excipient Ingredients: sodium chloride; dilute hydrochloric acid; water for injections

Manustamisviis:

Intravenous

Ühikuid pakis:

5 ampoules, 10 ampoules

Retsepti tüüp:

(S8) Controlled Drug

Näidustused:

Alfentanil-hameln is indicated for intravenous use by specialist anaesthetists and their trainees as:,? an analgesic supplement given by incremental intravenous boluses or continuous infusion; and,? an anaesthetic induction agent where in patients undergoing in-patient surgery, when endotracheal intubation and controlled ventilation are to be used.,Because of its rapid onset and short duration of action, intravenous Alfentanil-hameln is particularly suited as a narcotic analgesic for short procedures and outpatients, provided that the patients are maintained under appropriate post-operative surveillance. However, intravenous Alfentanil-hameln is also useful as an analgesic supplement for procedures of medium to long duration, since periods of very painful stimuli can be easily overcome by administration of small increments of Alfentanil-hameln or by adapting the infusion rate.

Toote kokkuvõte:

Visual Identification: clear and colourless solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Registered

Loa andmise kuupäev:

2023-03-17

Infovoldik

ALFENTANIL-HAMELN v0.3 0802223 tw
1
ALFENTANIL-HAMELN INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI
on the next page has more details. If you are worried about using this
medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN ALFENTANIL-HAMELN?
Alfentanil-hameln contains the active ingredient alfentanil
hydrochloride. Alfentanil-hameln is used to relieve pain and
produce anaesthesia.
For more information, see Section 1. Why am I being given
Alfentanil-hameln
? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN ALFENTANIL-HAMELN?
Do not use if you have ever had an allergic reaction to alfentanil,
other opioids or any of the ingredients listed at the end of the
CMI.
For more information, see Section 2. What should I know before I am
given Alfentanil-hameln
? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines, including medicines you can buy without a prescription
from a pharmacy, supermarket or health food store,
may interfere with Alfentanil-hameln and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO WILL I BE GIVEN ALFENTANIL-HAMELN?
•
Your doctor will decide the appropriate dose for you.
•
Alfentanil-hameln must only be administered by injection by a
specially trained anaesthetist.
Follow the instructions given to you by your doctor or pharmacist
exactly.More instructions can be found in
Section 4. How will
I be given Alfentanil-hameln? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALFENTANIL-HAMELN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Alfentanil-hameln
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you
relax, anything that contains alcohol (like cough syrup) or other
medicines that treat pain
•
If you become pregnant while being given this

Toote omadused

AUSTRALIAN PRODUCT INFORMATION – ALFENTANIL-HAMELN
(ALFENTANIL HYDROCHLORIDE) INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, alfentanil
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 _
Alfentanil 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 alfentanil. 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 on alfentanil.
1
NAME OF THE MEDICINE
Alfentanil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Alfentanil-hameln contains alfentanil hydrochloride
equivalent to 0.5 mg alfentanil with 9.0 mg
sodium chloride in water for injection to 1 mL.
3
PHARMACEUTICAL FORM
Alfentanil-