BUPIVACAINE-BAXTER bupivacaine hydrochloride (as monohydrate) 50 mg/10 mL solution for injection vial

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

bupivacaine hydrochloride, Quantity: 5 mg/mL (Equivalent: bupivacaine hydrochloride monohydrate, Qty 5.28 mg/mL)

Fáanlegur frá:

Baxter Healthcare Pty Ltd

INN (Alþjóðlegt nafn):

bupivacaine hydrochloride

Lyfjaform:

Injection, solution

Samsetning:

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

Stjórnsýsluleið:

Epidural, Infiltration

Einingar í pakka:

5 vials, 10 vials

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

INDICATIONS ,BUPIVACAINE-BAXTER is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: ,Surgical anaesthesia ,Epidural block for surgery ,Field block (minor and major nerve blocks and infiltration). ,Analgesia ,Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. ,Field block (minor nerve block and infiltration).

Vörulýsing:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2015-04-20

Upplýsingar fylgiseðill

BUPIVACAINE-CLARIS
_Bupivacaine hydrochloride 0.25% and 0.5% Solution for injection_
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
Bupivacaine-Claris. It does not
contain all the information that is known about Bupivacaine-Claris. It
does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking
Bupivacaine-Claris against the benefits they expect it will 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 BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT BUPIVACAINE-CLARIS IS USED FOR
Bupivacaine-Claris is used to prevent or relieve pain, but it will not
put you to sleep.
Bupivacaine-Claris is also used after surgery to relieve pain. It can
also be used to make childbirth
less painful.
Bupivacaine-Claris belongs to a group of medicines called local
anaesthetics.
When injected, it makes the nerves nearby unable to pass messages to
the brain and will therefore
prevent or relieve pain.
Depending on the amount used, Bupivacaine-Claris will either totally
stop pain or will cause a partial
loss of feeling.
Your doctor will have explained why you are being treated with
Bupivacaine-Claris and told you what
dose you will be given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may
differ from the information
contained in this leaflet.
Your doctor may prescribe this medicine for uses other than those
listed above. Ask your doctor if
you want more information.
Bupivacaine-Claris is not addictive
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT:_
ASK YOUR DOCTOR ABOUT THE RISKS AND BENEFITS OF BEING GIVEN
BUPIVACAINE-CLARIS WHILE

Vara einkenni

Bupivacaine-Baxter (Bupivacaine Hydrochloride)
Version 1.0
1 of 15
AUSTRALIAN PRODUCT INFORMATION
BUPIVACAINE-BAXTER (BUPIVACAINE
HYDROCHLORIDE) SOLUTION FOR INJECTION
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1
NAME OF THE MEDICINE
Bupivacaine hydrochloride (as monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine hydrochloride (as monohydrate) 2.5 mg/mL or 5 mg/mL,
solution for injection.
Bupivacaine-Baxter is a clear, colourless, sterile, isotonic,
preservative-free solution
containing Bupivacaine hydrochloride (as monohydrate) 2.5 or 5 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bupivacaine-Baxter is indicated for the production of local or
regional anaesthesia and
analgesia in individuals as follows:
SURGICAL ANAESTHESIA
•
Epidural block for surgery.
•
Field block (minor and major nerve blocks and infiltration).
ANALGESIA
•
Continuous
epidural
infusion
or
intermittent
bolus
epidural
administration
for
analgesia in postoperative pain or labour pain.
•
Field block (minor nerve block and infiltration).
The choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary
the degree of motor
blockade.
Bupivacaine-Baxter (Bupivacaine Hydrochloride)
Version 1.0
2 of 15
4.2
DOSE AND METHOD OF ADMINISTRATION
As with all local anaesthetics, the dosage varies and depends upon the
area to be anaesthetised,
the vascularity of the tissues, the number of neuronal segments to be
blocked, the depth of
anaesthesia and degree of muscle relaxation required, individual
tolerance, the technique of
anaesthesia, and the physical condition of the patient.
The lowest dosage that results in effective anaesthesia should be
used. In general, surgical
anaesthesia requires the use of higher concentrations and doses than
those required for
analgesia. The volume of the drug used will affect the extent of
spread of anaesthesia.
The presentations of Bupivacaine-Baxter are inte