ATROPINE JUNO atropine sulfate monohydrate 600 microgram/1mL injection BP ampoule

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Download Vara einkenni (SPC)
05-07-2022
Download Opinber matsskýrsla (PAR)
11-07-2022

Virkt innihaldsefni:

atropine sulfate monohydrate, Quantity: 600 microgram/mL; sodium hydroxide

Fáanlegur frá:

Juno Pharmaceuticals Pty Ltd

Lyfjaform:

Injection, solution

Samsetning:

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

Stjórnsýsluleið:

Subcutaneous, Intramuscular, Intravenous

Einingar í pakka:

1mL x 50, 1mL x 10

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

INDICATIONS AS AT 30 SEPTEMBER 2003:Surgery : Atropine may be given as a pre-anaesthetic medication to inhibit excessive salivary and bronchial secretions and to diminish the risk of vagal inhibition of the heart. The use of atropine as an antisialogogue is rarely necessary since the introduction of halothane and similar anaesthetics in place of ether anaesthesia. After surgery atropine may also be administered concurrently with anticholinesterase agents (e.g. neostigmine, physostigmine) when used to terminate curarisation to counteract the adverse muscarinic effects of these drugs. Cardiopulmonary resuscitation : Atropine may be used during cardiopulmonary resuscitation to treat sinus bradycardia and associated hypotension, and increased ventricular irritability. Anticholinesterase Poisoning : Atropine Juno is also used in the treatment of sinus bradycardia induced by organophosphate pesticides, Amanita muscaria mushrooms or other compounds with anticholinesterase activity. A cholinesterase reactivator, e.g. pralidoxime iodide, may be given concurrently.

Vörulýsing:

Visual Identification: Clear, colourless, particle-free solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Registered

Leyfisdagur:

2022-07-05

Upplýsingar fylgiseðill

                                _ _
1
ATROPINE JUNO INJECTION BP
_(Atropine sulfate monohydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Atropine Juno Injection. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking Atropine
Juno Injection against the
benefits this medicine is
expected to have for you.
This medicine is likely to be
used while you are at the clinic
or in hospital. If possible, please
read this leaflet carefully before
this medicine is given to you. In
some cases this leaflet may be
given to you after the medicine
has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ATROPINE JUNO
INJECTION IS USED FOR
Atropine sulfate monohydrate
belongs to a group of medicines
called antimuscarinic agents.
Atropine Juno Injection is given
before anaesthesia to decrease
mucus secretions, such as saliva.
During anaesthesia and surgery,
atropine is used to help keep the
heart beat normal. Atropine
sulfate monohydrate is also used
to block or reverse the adverse
effects caused by some
medicines and certain type of
pesticides.
Atropine Juno Injection may be
used for the management of
other conditions that are not
mentioned above. Your doctor
will be able to tell you about the
specific condition for which you
have been prescribed Atropine
Juno Injection.
This medicine is available only
with a doctor's prescription.
BEFORE YOU ARE
GIVEN ATROPINE
JUNO INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE ATROPINE JUNO
INJECTION IF YOU HAVE AN ALLERGY
OR HAVE HAD AN UNUSUAL
REACTION TO ATROPINE OR ANY OF
THE ANTICHOLINERGIC MEDICINES
SUCH AS HYOSCYAMINE AND
BELLADONNA.
DO NOT USE ATROPINE JUNO
INJECTION IF YOU HAVE OR HAVE
HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
•
severe and chronic
inflammation of the large
intestine and r
                                
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Vara einkenni

                                Juno Pharmaceuticals Pty Ltd
Australian Product Information
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
ATROPINE JUNO
(ATROPINE SULFATE MONOHYDRATE 600 MICROGRAM / 1 ML)
_ _
1 NAME OF THE MEDICINE
Atropine sulfate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.6 mg/mL injection: a clear, colourless, sterile solution containing
0.6 mg/mL atropine sulphate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Clear colourless particle free solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SURGERY
Atropine Juno may be given as a pre-anaesthetic medication to inhibit
excessive salivary and
bronchial secretions and to diminish the risk of vagal inhibition of
the heart. The use of
Atropine Juno as an antisialagogue is rarely necessary since the
introduction of halothane
and similar anaesthetics in place of ether anaesthesia.
Atropine
Juno
may
be
administered
concurrently
with
anticholinesterase
agents
(e.g.
neostigmine, physostigmine) to block the adverse muscarinic effects
when they are used after
surgery to terminate curarisation.
CARDIOPULMONARY RESUSCITATION
It may be used in the management of patients with sinus bradycardia
who have associated
hypotension and increased ventricular irritability.
ANTICHOLINESTERASE POISONING
Atropine Juno is also used in the treatment of sinus bradycardia
induced by organophosphate
pesticides, _ Amanita muscaria_ mushrooms or other compounds with
anticholinesterase
activity. A cholinesterase reactivator, e.g. pralidoxime iodide, may
be given concurrently.
4.2 DOSE AND METHOD OF ADMINISTRATION
Atropine Juno may be administered by subcutaneous (SC), intramuscular
(IM) or direct
intravenous (IV) injection. Atropine Juno contains no antimicrobial
agent. It should be used
only once in one patient only and any residue discarded. Atropine Juno
should not be added
to any IV infusion solution.
Juno Pharmaceuticals Pty Ltd
Australian Product Information
PI v 1.0
Page | 2
SURGERY
Adults:
300-600 µg of atropine sulfate IM or SC, 
                                
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