Parecoxib-AFT parecoxib (as sodium) 40 mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

parecoxib sodium, Quantity: 42.36 mg (Equivalent: parecoxib, Qty 40 mg)

Disponível em:

AFT Pharmaceuticals Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: sodium hydroxide; dibasic sodium phosphate; phosphoric acid

Via de administração:

Intravenous, Intramuscular

Unidades em pacote:

10 vials

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

For a single peri-operative dose for the management of post-operative pain

Resumo do produto:

Visual Identification: Parecoxib-AFT is a white to off-white sterile lyophilised cake or powder in a single use vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2023-06-02

Folheto informativo - Bula

Parecoxib-AFT
1
PARECOXIB-AFT
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 USING PARECOXIB-AFT
Parecoxib-AFT contains the active ingredient parecoxib sodium.
Parecoxib-AFT is used for the prevention and treatment of
pain. It can be used to relieve pain and reduce inflammation (swelling
and soreness) which may occur after surgery.
Although Parecoxib-AFT can relieve the symptoms of pain and
inflammation, it will not cure your condition.
For more information, see Section 1. Why am I using Parecoxib-AFT? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PARECOXIB-AFT?
Do not use if you have ever had an allergic reaction to Parecoxib-AFT
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 I use
Parecoxib-AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Parecoxib-AFT 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 DO I USE PARECOXIB-AFT?
Your doctor will decide how much Parecoxib-AFT you need. The usual
recommended dose is a single 40 mg injection. Your
doctor may adjust the dosage you are given depending on your
condition.
Parecoxib-AFT will be given to you by your doctor. It is diluted and
given by injection into a vein through an intravenous line or
into a muscle.
More instructions can be found in Section 4. How do I use
Parecoxib-AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PARECOXIB-AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Parecoxib-AFT.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medication unless your doctor is aware of it.
DRIVING OR USING
MACHINES
•
T

Características técnicas

AUSTRALIAN PRODUCT INFORMATION-PARECOXIB-AFT (PARECOXIB)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Parecoxib (as sodium).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Parecoxib-AFT contains 40 mg parecoxib (as 42.36 mg
parecoxib sodium).
EXCIPIENT WITH KNOWN EFFECT
When reconstituted in sodium chloride solution (0.9% w/v),
Parecoxib-AFT powder for injection contains
0.
45
mEq of sodium per 40 mg vial.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for Injection
Parecoxib-AFT is a white to off-white sterile lyophilised cake or
powder in a single use vial.
The reconstituted solution is clear and colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For a single peri-operative dose for the management of post-operative
pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual recommended dose is a single 40 mg dose administered
intravenously (IV) or intramuscularly
(IM). The IV bolus injection may be given rapidly and directly into a
vein or into an existing IV line. The
IM injection should be given slowly and deeply into the muscle.
For intravenous (IV) or intramuscular (IM) administration,
Parecoxib-AFT powder for injection should be
reconstituted with 2 mL sodium chloride solution (0.9% w/v), or a
suitable alternative.
Reconstitute Parecoxib-AFT powder for injection with 2 mL sodium
chloride solution (0.9% w/v) using
aseptic technique. The ONLY other acceptable diluents for
reconstitution are:
•
5% Glucose Intravenous Infusion
•
0.45% Sodium Chloride and 5% Glucose Injection.
Use of Sterile Water for Injections is NOT recommended, as the
resulting solution is not isotonic.
Use of Lactated Ringer’s or 5% Glucose in Lactated Ringer’s for
reconstitution will cause the medicine to
precipitate from solution and therefore is not recommended.
This product is for single use in one patient only. Discard any
residue.
After reconstitution, Parecoxib-AFT should be inspected visually for
particulate matter and discolouration
prior to administration.