METOPROLOL IV VIATRIS metoprolol tartrate 5mg/5mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoprolol tartrate, Quantity: 5 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Metoprolol tartrate

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- Intravenous therapy: Disturbances of cardiac rhythm, in particular supraventricular tachyarrhythmias.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-07

Patient Information leaflet

METOPROLOL IV
VIATRIS
_metoprolol tartrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about METOPROLOL IV
VIATRIS. 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 being given
METOPROLOL IV VIATRIS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT METOPROLOL
IV VIATRIS IS USED FOR
Your medicine contains metoprolol
tartrate as the active ingredient. This
medicine belongs to a group of
medicines called beta-blockers.
Metoprolol tartrate is used to treat an
irregular heartbeat, also known as
arrhythmia, which means that there is
a disturbance of the heart's normal
rhythm or beat.
Arrhythmias may be caused by
numerous factors, including some
heart diseases, an overactive thyroid
gland or chemical imbalances. After
a heart attack there is also a chance
of developing an arrhythmia.
Metoprolol tartrate helps to restore
your heart beat to a more normal rate,
particularly if it is beating very fast.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
METOPROLOL IV
VIATRIS
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN
METOPROLOL IV VIATRIS IF:
•
you have any allergies to
metoprolol tartrate, any other
beta-blocker medicine, any of the
ingredients listed at the end of
this leaflet. Some of the
symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue
or other parts of the body; rash,
itching or hives on the skin or you
may feel faint.
•
you have asthma, wheezing,
difficulty breathing or other lung
problems, or ha

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
METOPROLOL IV VIATRIS
_metoprolol tartrate injection _
1
NAME OF THE MEDICINE
Metoprolol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL vial of METOPROLOL IV VIATRIS contains 5 mg of metoprolol
tartrate as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
METOPROLOL IV VIATRIS is a clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTRAVENOUS THERAPY
Disturbances of cardiac rhythm, in particular supraventricular
tachyarrhythmias.
4.2
DOSE AND METHOD OF ADMINISTRATION
INTRAVENOUS THERAPY
Initially, up to 5 mg is injected intravenously at a rate of 1 to 2 mg
per minute. This dose may be repeated at
5-minute intervals until a satisfactory effect is achieved. A total
dose of 10 to 15 mg will generally produce a
satisfactory effect. Doses of 20 mg or more are unlikely to result in
further therapeutic benefit. Blood pressure
and ECG should be monitored during the treatment.
Parenteral administration should be conducted by experienced staff
with suitable monitoring and resuscitating
equipment available.
This product contains no antimicrobial agent and is for single use in
one patient only. Discard any residue.
PAEDIATRICS
The safety and efficacy in children have not been established.
4.3
CONTRAINDICATIONS
•
Bronchospasm
Beta-adrenergic blockade of the smooth muscle of bronchi and
bronchioles may result in an increased airways
resistance. These drugs also reduce the effectiveness of asthma
treatment. This may be dangerous in
susceptible patients.
Therefore, beta-blockers are contraindicated in any patient with a
history of airways obstruction or a tendency
to bronchospasm. Use of cardioselective beta blockers can also result
in severe bronchospasm. If such therapy
must be used, great caution should be exercised. Alternative therapy
should be considered.
•
Allergic disorders (including allergic rhinitis) which may suggest a
predisposition to bronchospasm
•
Right ven