Marcain 0.25% with adrenaline (epinephrine) 1:400,000 10mL injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

bupivacaine hydrochloride, Quantity: 2.5 mg/mL (Equivalent: bupivacaine hydrochloride monohydrate, Qty 2.64 mg/mL); adrenaline (epinephrine) acid tartrate, Quantity: 4.5 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 2.5 microgram/mL)

Disponible depuis:

Aspen Pharmacare Australia Pty Ltd

forme pharmaceutique:

Injection, solution

Composition:

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

Mode d'administration:

Intramuscular, Infiltration, Subcutaneous, Epidural

Unités en paquet:

10mL x 5

classe:

Medicine Registered

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

INDICATIONS AS AT 4 APRIL 2000: MARCAIN solutions are 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 4 strengths, 0.125%, 0.25%, 0.375% and 0.5%, makes it possible to vary the degree of motor blockade.

Descriptif du produit:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

1991-07-31

Résumé des caractéristiques du produit

MARCAIN AND MARCAIN WITH ADRENALINE Product Information
1(21)
AUSTRALIAN PRODUCT INFORMATION
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride and Adrenaline (Epinephrine) (as Acid
Tartrate)
(MARCAIN
® AND MARCAIN
® WITH ADRENALINE)
(Injection solutions for the production of local or regional
anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
Bupivacaine hydrochloride with or without adrenaline (epinephrine)
acid tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MARCAIN solutions are available with or without adrenaline.
MARCAIN 0.125% EPIDURAL INFUSION
bupivacaine hydrochloride 1.25 mg/mL
MARCAIN 0.25%
bupivacaine hydrochloride 2.5 mg/mL
MARCAIN 0.25% WITH ADRENALINE 1:400,000
bupivacaine hydrochloride 2.5 mg/mL with adrenaline (epinephrine) 2.5
(as acid
tartrate) microgram/mL
MARCAIN 0.375%
bupivacaine hydrochloride 3.75 mg/mL
MARCAIN 0.5%
bupivacaine hydrochloride 5 mg/mL
MARCAIN 0.5% WITH ADRENALINE 1:200,000
bupivacaine hydrochloride 5 mg/mL with adrenaline (epinephrine) 5 (as
acid
tartrate) microgram/mL
MARCAIN solutions for injection are sterile, isotonic aqueous
solutions of
bupivacaine hydrochloride 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.
MARCAIN with adrenaline solutions for injection are sterile, isotonic
aqueous
solutions of bupivacaine hydrochloride in Water for Injections BP. The
pH of the
solution is adjusted with sodium hydroxide or hydrochloric acid to
remain between
3.3 - 5.0.
MARCAIN AND MARCAIN WITH ADRENALINE Product Information
2(21)
MARCAIN with adrenaline also contains sodium metabisulfite as an
antioxidant.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless solution for injection or infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MARCAIN solutions are indicated for the production of local or
regional
anaesthesia and analgesia in individuals as