B. BRAUN PARACETAMOL paracetamol 100 mg/10 mL solution for infusion ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 0.1 g

Available from:

B Braun Australia Pty Ltd

INN (International Name):

Paracetamol

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: water for injections; glacial acetic acid; mannitol; sodium citrate dihydrate

Administration route:

Intravenous

Units in package:

20 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

B. Braun Paracetamol 10 mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

Product summary:

Visual Identification: Clear and colourless to slightly pinkish-orangish solution. Perception may vary.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-08-01

Patient Information leaflet

B. BRAUN PARACETAMOL CMI – Version 1.0 (13-9-2023)
Page 1 of 4
B. BRAUN PARACETAMOL
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 AM I BEING GIVEN B. BRAUN PARACETAMOL?
B. BRAUN PARACETAMOL contains the active ingredient paracetamol. B.
BRAUN PARACETAMOL is used to relieve pain or
reduce fever when intravenous administration is clinically necessary.
For more information, see Section 1. Why am I being given B. BRAUN
PARACETAMOL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN B. BRAUN PARACETAMOL?
You must not be given B. BRAUN PARACETAMOL if you have ever had an
allergic reaction to paracetamol 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 being
given B. BRAUN PARACETAMOL?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with B. BRAUN PARACETAMOL 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 B. BRAUN PARACETAMOL GIVEN?
This medicine will be given to you by your doctor who will decide what
dose is right for you and for how long it will be given
to you.
More instructions can be found in Section 4. How is B. BRAUN
PARACETAMOL given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN B. BRAUN PARACETAMOL?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or any health professionals you visit
that you were given B. BRAUN
PARACETAMOL.
•
Tell your doctor immediately if you develop a rash or other symptom of
an allergic reaction.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines, including any medicines, vitamins or
supplements without
checking with your doctor first.
DRIVING OR USING
MACHINES
•
Be careful be

Summary of Product characteristics

PRODUCT INFORMATION
B. BRAUN PARACETAMOL SOLUTION FOR INFUSION
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
CHEMICAL STRUCTURE
DESCRIPTION
PHARMACOLOGY
PHARMACODYNAMICS
FIGURE 2
INFANTS AND CHILDREN >6 MONTHS OF AGE
SPECIAL POPULATIONS
≤
≤
CLINICAL TRIALS
EFFICACY OF IV PARACETAMOL FOR THE TREATMENT OF POSTOPERATIVE PAIN
FOLLOWING ORTHOPAEDIC
SURGERY.
Inj.
APAP
n = 50
Pbo
n= 52
p value
APAP/Pbo
TOTPAR
Mean
SD
6.6
5.9
2.2
3.8
0.0001
SPID
Mean
SD
2.3
3.6
-0.6
3.5
0.0001
SPAID
Mean
SD
104.7
112.9
-27.7
92.4
0.0001
SPRID
Mean
SD
9.0
8.7
1.6
6.2
0.0001
MAXPR
Mean
SD
2.0
1.4
0.9
1.1
0.0001
MAXPID
Mean
SD
1.0
0.8
0.4
0.8
0.0001
MAXPAID
Mean
SD
36.6
23.4
11.9
20.0
0.0001
MAXPRID
Mean
SD
3.0
2.1
1.3
1.8
0.0001
Median time to rescue
medication (hr)
[95% CI]*
3.0
[1.4;4.0]
0.8
[0.6;1.1]
0.0001
*CI - Confidence interval; Inj. APAP – injectable acetaminophen; Pbo
–
placebo
INJ APAP
1G
PBO
P-VALUE
APAP/PBO
QUANTITY OF RESCUE MEDICATION (MG OF EQUIVALENT MORPHINE DOSE) OVER
24H
N
48
52
Mean
38.33
57.41
0.0007
SD
35.14
52.3
NUMBER OF REQUESTED ADMINISTRATIONS OF RESCUE MEDICATION OVER 24H
N
48
51
Mean
47.4
89.3
0.0003
SD
39.1
94.5
ACTUAL NUMBER OF ADMINISTRATIONS OF RESCUE MEDICATION OVER 24H
N
48
52
Mean
27.8
42.3
0.0001
SD
20.2
26.0
MPI (TO-T24HR)
N
46
47
Mean
1.4
1.6
0.0202
SD
0.5
0.6
MPAI (T0-T24HR)
N
46
47
Mean
31.6
39.6
0.0006
SD
17.0
18.5
COMPOSITE ENDPOINT MPI (T0-T24HR)
N
45
47
Mean
-20.2
33.1
0.0004
SD
94.6
95.4
COMPOSITE ENDPOINT MPAI (T0-T24HR)
N
45
47
Mean
-25.3
37.8
0.0001
SD
91.7
91.4
PATIENT’S GLOBAL EVALUATION ADJUSTED FOR RESCUE MEDICATION USE (AT
24HR)
N
49
52
Mean
81.6
61.8
0.0019
SD
42.8
37.3
EFFICACY OF IV PARACETAMOL FOR THE TREATMENT OF POSTOPERATIVE PAIN
FOLLOWING ORAL (POST DENTAL)
SURGERY.
ANALGESIA - CHILDREN
EFFICACY OF IV PARACETAMOL WITH POSTOPERATIVE PAIN (HERNIA REPAIR)
≤
TABLE 5
_ _
MEAN SCORES OF PAIN INTENSITY DIFFERENCES (PID) – VAS (INVESTIGATOR)
– ITT POPULATION _TREATMENT_
_TREATMENT _
_T15 MIN _
_T30 MIN _
_T1 H _
_T2H _
_T3H _
_T4H _
_T5H _
_T6H _
_PATIENT _
_NUMBER _
45