GLYCOPYRROLATE ACCORD glycopyrrolate 0.6 mg/3 mL injection ampoules

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

glycopyrronium bromide, Quantity: 0.2 mg/mL

Tilgjengelig fra:

Accord Healthcare Pty Ltd

INN (International Name):

glycopyrronium bromide (glycopyrrolate)

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Intramuscular, Intravenous

Enheter i pakken:

10 x 1 mL, 5 x 1 mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

1. As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents.,2. As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra- operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.,3. To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.

Produkt oppsummering:

Visual Identification: A clear, colourless solution practically free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-06-06

Informasjon til brukeren

Version 4.0
Page 1 of 3
GLYCOPYRROLATE ACCORD INJECTION
_Glycopyrronium bromide (glycopyrrolate), solution for injection, 0.2
mg/1 mL and 0.6 mg/3 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glycopyrrolate
Accord. 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 taking Glycopyrrolate Accord
against the benefits they expect it will
have for you.
If you have any concerns about taking
this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT GLYCOPYRROLATE
ACCORD INJECTION IS
USED FOR
_WHEN YOU MUST NOT BE _
_GIVEN IT _
Do not have Glycopyrrolate Accord if:
You are allergic to Glycopyrrolate
Accord or any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an allergic
reaction may include rash, itching,
hives on the skin, swelling of the face,
lips, tongue or other parts of the body,
shortness of breath, wheezing or
troubled breathing.
You are breastfeeding or plan to
breastfeed.
Medicines like Glycopyrrolate Accord
may reduce your milk supply. It is not
known if Glycopyrrolate Accord is
found in breast milk.
Do not have Glycopyrrolate Accord if
the packaging is torn or shows signs of
tampering.
Do not have Glycopyrrolate Accord
after the expiry date (EXP.) printed on
the pack.
If you have it after the expiry date has
passed, it may not work as well.
_BEFORE YOU ARE GIVEN IT _
YOU MUST TELL YOUR DOCTOR IF:
1.
YOU HAVE ANY ALLERGIES TO:
•
any other medicines
•
any other substances, such as
foods, preservatives or dyes
2.
YOU ARE PREGNANT OR PLAN TO
BECOME PREGNANT.
Your doctor will discuss the risks and
benefits of receiving Glycopyrrolate
Accord during pregnancy.
3.
YOU HAVE OR HAVE HAD ANY OTHER
MEDICAL CONDITIONS INCLUDING:
•
asthma
•
glaucoma, which is an increased
pressure in your eyes
•
diarrhoea
•
proble

Preparatomtale

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
GLYCOPYRROLATE ACCORD (GLYCOPYRRONIUM BROMIDE
(GLYCOPYRROLATE)) INJECTION
1
NAME OF THE MEDICINE
Glycopyrronium bromide (glycopyrrolate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 0.2 mg glycopyrronium bromide (glycopyrrolate).
1 ampoule of 1 mL solution for injection contains 0.2 mg
glycopyrronium bromide (glycopyrrolate).
1 ampoule of 3 mL solution for injection contains 0.6 mg
glycopyrronium bromide (glycopyrrolate).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Glycopyrrolate Accord is supplied as a clear, colourless sterile
solution for injection, practically free
from visible particles, with a pH of 2.0 - 3.0.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Glycopyrrolate Accord is indicated for:
•
As a preoperative antimuscarinic to reduce salivary, tracheobronchial
and pharyngeal secretions,
and to reduce the acidity and volume of the gastric contents.
•
As
a
preoperative
or
intra-operative
antimuscarinic
to
attenuate
or
prevent
intra-operative
bradycardia associated with the use of suxamethonium or due to cardiac
vagal reflexes.
•
To protect against the peripheral muscarinic actions (e.g. bradycardia
and excessive secretions) of
anticholinesterases such as neostigmine or pyridostigmine given to
reverse neuromuscular blockade
produced by non-depolarising muscle relaxants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For intramuscular or intravenous administration.
Glycopyrrolate Accord contains no antimicrobial preservative and is
for single use in one patient on one
occasion only. Discard any remaining residue.
PRE-ANAESTHETIC USE
_ADULTS _
0.2 mg to 0.4 mg intravenously or intramuscularly before the induction
of anaesthesia.
Alternatively, a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4
mg may be used. Larger doses
may result in profound and prolonged antisialogogue effect, which may
be unpleasant for the patient.
_CHILDREN _
(see
SECTION 4.3 CONTRAINDICATIONS
)
1 month to 12 years of age 0.0