GLYCONEO 0.5/2.5 glycopyrronium bromide (glycopyrrolate) 0.5 mg/neostigmine methylsulfate 2.5 mg in 1 mL solution for injection ampoule

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

neostigmine methylsulfate, Quantity: 2.5 mg; glycopyrronium bromide, Quantity: 0.5 mg

Beschikbaar vanaf:

KSJ Pharmatech

farmaceutische vorm:

Injection, solution

Samenstelling:

Excipient Ingredients: water for injections; citric acid; sodium hydroxide; dibasic sodium phosphate dodecahydrate

Toedieningsweg:

Intravenous

Eenheden in pakket:

10 x 1 mL ampoules

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Reversal of residual non-depolarising (competitive) neuromuscular block.

Product samenvatting:

Visual Identification: A clear, colourless, sterile solution free from visible particles and fibres; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2022-07-21

Bijsluiter

GLYCONEO 0.5/2.5
1
_ _
GLYCONEO 0.5/2.5
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.
1.
WHY AM I USING GLYCONEO 0.5/2.5?
GLYCONEO 0.5/2.5 contains the active ingredients glycopyrronium
bromide (glycopyrrolate) and neostigmine methylsulfate.
GLYCONEO 0.5/2.5 is used at the end of an operation to reverse the
effects of some of the medicines used during surgery such
as anesthetics and muscle relaxants.
For more information, see Section 1. Why am I using GLYCONEO 0.5/2.5?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLYCONEO 0.5/2.5?
Do not use if you have ever had an allergic reaction these
ingredients; glycopyrronium bromide (glycopyrrolate), neostigmine
methylsulfate, dibasic sodium phosphate dodecahydrate, citric acid and
sodium hydroxide.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
GLYCONEO 0.5/2.5? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GLYCONEO 0.5/2.5 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 I USE GLYCONEO 0.5/2.5?
GLYCONEO 0.5/2.5 will be given to you by injection by a doctor or a
specially trained nurse.
Your doctor will know how much GLYCONEO 0.5/2.5 you should be given.
The need for more doses will depend on how well
your body responds to the treatment. The doctor will decide how many
injections you receive, and how often you should receive
them
More instructions can be found in Section 4. How do I use GLYCONEO
0.5/2.5? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLYCONEO 0.5/2.5?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist, or any healthcare professional
you visit that you are using
GLYCONEO 0.5/2.5.
THINGS YOU
SHOULD NOT DO
•

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION –GLYCONEO 0.5 /2.5
(GLYCOPYRRONIUM BROMIDE AND NEOSTIGMINE
METHYLSULFATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Glycopyrronium bromide [glycopyrrolate] and neostigmine methylsulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of solution for injection contains 500 micrograms (0.5 mg)
of glycopyrronium bromide
(glycopyrrolate) and 2.5 mg of neostigmine methylsulfate.
Excipients with known effect:
Each 1 mL contains 3 mg (0.13 mmol) sodium.
For the full list of excipients, see Section 6.1 List of excipients.
The solution is preservative free and sulfite free.
3
PHARMACEUTICAL FORM
Clear, colourless sterile solution for injection free of any visible
particles or fibres intended for
parenteral intravenous administration
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Reversal of residual non-depolarising (competitive) neuromuscular
block.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
This fixed-dose combination product contains a 0.5 mg:2.5 mg/1 mL of
glycopyrronium bromide
(glycopyrrolate): neostigmine in a fixed 1:5 ratio. If other ratios of
these agents are required, these
should be prepared using available monotherapy products.
_Adults:_
0.2 mg glycopyrronium bromide (glycopyrrolate) per 1 mg neostigmine
intravenously.
Alternatively, a dose of 0.016 mL/kg intravenously, equivalent to
0.008 mg/kg glycopyrronium bromide
(glycopyrrolate) with 0.04 mg/kg neostigmine.
_Children (1 month to 12 years):_
0.016 mL/kg intravenously, equivalent to glycopyrronium bromide
(glycopyrrolate) 0.008 mg/kg and neostigmine 0.04 mg/kg.
Total doses in excess of 2 mL are not recommended as this dose of
neostigmine may produce
depolarising neuromuscular block.
2
Method of administration
This medicine is for intravenous administration.
It contains no antimicrobial preservative and is for use in one
patient on one occasion only. Discard any
residue.
GLYCONEO 0.5 /2.5 should be administered when the first twitch
response is substantially greater
than 10 % of baseline, or when a second