BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA bupivacaine HCl 100 mg/20 mL with adrenaline 100 microgram/20 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bupivacaine hydrochloride monohydrate, Quantity: 105.54 mg (Equivalent: bupivacaine hydrochloride, Qty 100 mg); adrenaline (epinephrine) acid tartrate, Quantity: 182 microgram (Equivalent: adrenaline (epinephrine), Qty 100 microgram)

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Subcutaneous, Epidural, Infiltration

Units in package:

5 x 20 mL vials in sterile theatre pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra 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 ? Intermittent bolus epidural administration for analgesia in postoperative pain or labour pain ? Field block (minor nerve block and infiltration)

Product summary:

Visual Identification: A colourless or almost colourless solution; Container Type: Vial; 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

Authorization status:

Registered

Authorization date:

2022-10-07

Patient Information leaflet

Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra Injection V.01
1
BUPIVACAINE 0.5%
WITH ADRENALINE 1:200,000 PHEBRA INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY IS BUPIVACAINE WITH ADRENALINE INJECTION BEING USED ?
Bupivacaine with Adrenaline Injection contains the active ingredients
bupivacaine hydrochloride and adrenaline (epinephrine)
(as acid tartrate). Bupivacaine with Adrenaline Injection is used to
prevent or relieve pain, but it will not put you to sleep. It is
also used after surgery to relieve pain and to make childbirth less
painful.
For more information, see Section 1. Why is Bupivacaine with
Adrenaline Injection being used ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BUPIVACAINE WITH ADRENALINE INJECTION IS
USED?
Do not use if you have ever had an allergic reaction to Bupivacaine
with Adrenaline Injection or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
Bupivacaine with Adrenaline Injection is used? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bupivacaine with Adrenaline
Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS BUPIVACAINE WITH ADRENALINE INJECTION USED?
•
Bupivacaine with Adrenaline Injection will be injected by your doctor
into the skin, near a single nerve, or into an area that
contains a large number of nerves.
More instructions can be found in Section 4. How is Bupivacaine with
Adrenaline Injection used ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BUPIVACAINE WITH ADRENALINE INJECTION IS
BEING USED?
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery after you h

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra
Version 01
Page 1 of 18
BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA
[BUPIVACAINE HYDROCHLORIDE AND ADRENALINE (EPINEPHRINE)]
SOLUTION FOR INJECTION
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1
NAME OF THE MEDICINE
bupivacaine hydrochloride monohydrate
adrenaline (epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra solution for
injection contains bupivacaine hydrochloride
100 mg/20 mL with adrenaline (epinephrine) (as acid tartrate) 100
micrograms/20 mL.
The pH of the solution is between 3.0 - 5.5.
Excipient with known effect: contains sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra is a sterile, clear,
colourless, or almost colourless isotonic
aqueous solution for injection or infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra 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
• Intermittent bolus epidural administration for analgesia in
postoperative pain or labour pain
• Field block (minor nerve block and infiltration)
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Bupivacaine 0.25% with adrenaline (epinephrine) solution for
injection, and bupivacaine 0.125%, 0.25%, 0.375% _
_and 0.5% solutions for injection, are unavailable in this brand
however are available in other brands. _
_Where correct dosing requires a lower concentration of bupivacaine
with adrenaline (epinephrine), or a bupivacaine _
_solution without adrenaline (epinephrine), products from other
suppliers should be used. _
PRODUCT INFORMATION
BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA
Australian Product Information
Bupi