MARCAINE 0.5% WITH ADRENALINE INJECTION

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

BUPIVACAINE HYDROCHLORIDE; ADRENALINE ACID TARTRATE

Inapatikana kutoka:

Aspen Medical Products Malaysia Sdn Bhd

INN (Jina la Kimataifa):

BUPIVACAINE HYDROCHLORIDE; ADRENALINE ACID TARTRATE

Vitengo katika mfuko:

20ml mL

Viwandani na:

Recipharm Monts

Tabia za bidhaa

1
MARCAINE 0.50 PER CENT (100 mg/20 ml) ADRENALINE,
injectable solution.
QUALITATIVE AND QUANTITATIVE COMPOSITION Anhydrous bupivacaine hydrochloride 100.00 mg
(in the form of bupivacaine hydrochloride)
Adrenaline 0.10 mg
Sodium chloride 160.00 mg
Sodium metabisulphite 10.00 mg
Hydrochloric acid/sodium hydroxide qs.pH = 3.3 to
5.0 Water for injectable preparations qsp 20 ml
PHARMACEUTICAL FORM
Bupivacaine is classed as a membrane stabilising agent and is a local anaesthetic of the
amide type. Marcain s olutions are available with or without adrenaline, contain no
antimicrobial agent and should be used only once and any residue discarded.
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. They contain sodium
metabisulfite as an antioxidant.
CLINICAL PARTICULARS
INDICATIONS
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).
DOSAGE AND ADMINISTRATION
Marcain with Adrenaline should only be used by clinicians with experience of regional
anaesthesia or under their supervision. The lowest possible dose for adequate
anaesthesia should be used.
In order to prevent inadvertent intravascular injections, it is important that great caution be