MARCAIN SPINAL 0.5% HEAVY bupivacaine hydrochloride anhydrous 20mg/4mL injection ampoule

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

bupivacaine hydrochloride, Quantity: 5 mg/mL

থেকে পাওয়া:

Aspen Pharmacare Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide; glucose monohydrate

প্রশাসন রুট:

Intrathecal

প্যাকেজ ইউনিট:

4mL x 5

শ্রেণী:

Medicine Registered

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Indications as at 6 April 2004: Marcain 0.5% and Marcain Spinal 0.5% Heavy are indicated for the production of spinal anaesthesia. Marcain 0.5% is suitable for lower limb surgery lasting 3 - 4 hours where muscle relaxation is desired or needed. Marcain Spinal 0.5% Heavy is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.

পণ্য সারাংশ:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

1991-07-31

তথ্য লিফলেট

MARCAIN
®
0.5% AND MARCAIN SPINAL 0.5% HEAVY INJECTION
1
MARCAIN
®
0.5% AND
MARCAIN SPINAL 0.5%
HEAVY INJECTION
_Bupivacaine hydrochloride _
CONSUMER PRODUCT INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Marcain 0.5% and Marcain Spinal
0.5% Heavy. It does not contain all
the information that is known about
Marcain 0.5% and Marcain Spinal
0.5% Heavy.
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 being given
Marcain 0.5% or Marcain Spinal
0.5% Heavy against the benefits they
expect it will have for you.
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 MARCAIN 0.5%
AND MARCAIN SPINAL
0.5% HEAVY ARE FOR
Marcain 0.5% and Marcain Spinal
0.5% Heavy are used to prevent or
relieve pain, before surgery of the
lower abdomen and lower limbs.
They will not put you to sleep.
Marcain 0.5% and Marcain Spinal
0.5% Heavy can also be used to
make childbirth less painful.
Marcain 0.5% and Marcain Spinal
0.5% Heavy belong to a group of
medicines called spinal local
anaesthetics. They are injected into
the spinal fluid where they make the
nerves unable to pass messages to the
brain.
Depending on the amount used,
Marcain 0.5% and Marcain Spinal
0.5% Heavy will either totally stop
pain or will cause a partial loss of
feeling.
Your doctor will have explained why
you are being treated with Marcain
0.5% or Marcain Spinal 0.5% Heavy
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 another use. Ask your
doctor if you want more information.
Marcain 0.5% and Marcain Spinal
0.5% Heavy are not addictive.
BEFORE YOU ARE GIVEN
MARCAIN 0.5% OR
MARCAIN SPINAL
0.5% HEAVY
_WHEN YOU MUST NOT HAVE IT _
DO NOT USE MARCAIN 0.5% OR
MARCAIN

পণ্য বৈশিষ্ট্য

Marcain Spinal 0.5% and Marcain Spinal 0.5% Heavy Product Information
1 (14)
AUSTRALIAN PRODUCT INFORMATION
Bupivacaine hydrochloride
(MARCAIN
®
SPINAL 0.5% AND MARCAIN
®
SPINAL 0.5% HEAVY)
(Injection solutions for the production of spinal anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
Bupivacaine hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MARCAIN SPINAL 0.5% HEAVY contains bupivacaine hydrochloride 0.5% w/v
(5
mg/mL) with glucose monohydrate 8% w/v (80 mg/mL).
MARCAIN SPINAL 0.5% HEAVY solution for injection is a sterile,
hyperbaric, isotonic
aqueous solution of bupivacaine hydrochloride in Water for Injections
BP. It has a
specific gravity of 1.026 at 20°C. The pH of the solution is adjusted
with sodium
hydroxide or hydrochloric acid to remain between 4.0 - 6.0 during the
approved shelf-
life.
MARCAIN SPINAL 0.5% contains bupivacaine hydrochloride 0.5% (5 mg/mL).
MARCAIN SPINAL 0.5% solution for injection is a sterile, isobaric,
isotonic aqueous
solution bupivacaine hydrochloride and sodium chloride in Water for
Injections BP.
The pH of the solution is adjusted with sodium hydroxide or
hydrochloric acid to
remain between 4.0 - 6.5 during the approved shelf-life.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MARCAIN SPINAL 0.5% and MARCAIN SPINAL 0.5% HEAVY are indicated for
the
production of spinal anaesthesia.
MARCAIN SPINAL 0.5% is suitable for lower limb surgery lasting 3 - 4
hours where
muscle relaxation is desired or needed.
Marcain Spinal 0.5% and Marcain Spinal 0.5% Heavy Product Information
2 (14)
MARCAIN SPINAL 0.5% HEAVY is suitable for abdominal surgery lasting 45
- 60
minutes and urological and lower limb surgery lasting 2 - 3 hours.
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