Bridgewest ATROPINE INJECTION BP atropine sulfate monohydrate 1200 microgram/1 mL injection BP ampoule

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

atropine sulfate monohydrate, Quantity: 1.2 mg/mL

Fáanlegur frá:

Bridgewest Perth Pharma Pty Ltd

Lyfjaform:

Injection, solution

Samsetning:

Excipient Ingredients: water for injections; sodium chloride

Stjórnsýsluleið:

Intravenous, Subcutaneous, Intramuscular

Einingar í pakka:

1mL x 50

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

INDICATIONS AS AT 23 OCTOBER 2001: Preanaesthetic medication to reduce salivary secretions and bronchial secretions. To prevent cholinergic cardiac effects such as cardiac arrhythmias, hypotension and bradycardia. Management of patients with acute myocardial infarction and sinus bradycardia who have associated hypotension and increased ventricular irritability. Concurrent administration with anticholinesterase agents (eg. neostigmine, physostigmine) to block the adverse muscarinic effects of these agents following surgery to terminate curarisation. For poisoning by organophosphate pesticides, atropine may be used concomitantly with a cholinesterase reactivator such as pralidoxime to reverse muscarinic effects.

Vörulýsing:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

1991-08-13

Upplýsingar fylgiseðill

ATROPINE INJECTION BP
_(Atropine sulfate monohydrate )_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Atropine 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 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
INJECTION IS USED FOR
Atropine sulfate monohydrate
belongs to a group of medicines
called antimuscarinic agents.
Atropine 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 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
Injection.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ATROPINE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE ATROPINE 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 INJECTION IF
YOU HAVE OR HAVE HAD ANY MEDICAL
CONDITIONS, ESPECIALLY THE FOLLOWING:
•
severe and chronic inflammation
of the large intestine and rectum
•
gastrointestinal blockage and/or
diseases
•
en

Vara einkenni

Version : pfpatroi11021
Supersedes: pfpatroi10919
Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
ATROPINE
INJECTION
BP
(ATROPINE
SULFATE
MONONHYDRATE)
1.
NAME OF THE MEDICINE
Atropine sulfate monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atropine Injection BP is a sterile, isotonic, preservative free
solution containing 600 microgram
of atropine sulfate monohydrate in 1mL or 1.2 mg of atropine sulfate
monohydrate in 1 mL.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Preanaesthetic medication to reduce salivary secretions and bronchial
secretions
•
to prevent cholinergic cardiac effects such as cardiac arrhythmias,
hypotension and
bradycardia
•
management of patients with acute myocardial infarction and sinus
bradycardia who
have associated hypotension and increased ventricular irritability
•
concurrent
administration
with
anticholinesterase
agents
(e.g.
neostigmine,
physostigmine) to block the adverse muscarinic effects of these agents
following
surgery to terminate curarisation
•
for poisoning by organophosphate pesticides, atropine may be used
concomitantly with
a cholinesterase reactivator such as pralidoxime to reverse muscarinic
effects.
4.2
DOSE AND METHOD OF ADMINISTRATION
Parenteral drug products should be inspected visually for particulate
matter and discoloration
prior to administration, whenever solution and container permit. Do
not administer unless
solution is clear and seal is intact.
Atropine
Injection
may
be
given
by
subcutaneous
(SC),
intramuscular
(IM)
or
direct
intravenous (IV) injection.
Atropine Injection should not be added to any IV infusion solutions
for administration.
Atropine Injection contains no microbial agent. It should be used in
one patient on one
occasion only and any residue discarded.
Version : pfpatroi11021
Supersedes: pfpatroi10919
Page 2 of 12
CARDIOPULMONARY RESUSCITATION
The usual adult dose is 0.4 – 1 mg IV, which may be repeated at 5
minute intervals until the
desired heart rate is achieved. Th