MARCAIN POLYAMP STERIPACK Solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Marcain Polyamp Steripack 0.5%.
Qualitative and quantitative composition
Bupivacaine Hydrochloride BP 5.28 mg/ml equivalent to bupivacaine hydrochloride anhydrous 5.0 mg/ml. Excipient(s) with known effect: Each millilitre (ml) of Marcain Polyamp Steripack contains 3.15 mg of ...
Pharmaceutical form
Injection.
Therapeutic indications
Marcain 0.25% and 0.5% solutions are used for the production of local anaesthesia by percutaneous infiltration, peripheral nerve block(s) and central neural block (caudal or epidural), that is, for specialist ...
Posology and method of administration
Posology Adults and children above 12 years of age The following table is a guide to dosage for the more commonly used techniques in the average adult. The figures reflect the expected average dose range ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bupivacaine hydrochloride solutions are contra-indicated in patients with hypersensitivity to local anaesthetic ...
Special warnings and precautions for use
There have been reports of cardiac arrest during the use of bupivacaine for epidural anaesthesia or peripheral nerve blockade where resuscitative efforts have been difficult, and were required to be prolonged ...
Interaction with other medicinal products and other forms of interaction
Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. certain anti-arrhythmics, such as lidocaine ...
Pregnancy and lactation
Pregnancy There is no evidence of untoward effects in human pregnancy. In large doses there is evidence of decreased pup survival in rats and an embryological effect in rabbits if Marcain is administered ...
Effects on ability to drive and use machines
Marcain Polyamp Steripack has minor influence on the ability to drive and use machines. Besides the direct anaesthetic effect, local anaesthetics may have a very mild effect on mental function and co-ordination ...
Undesirable effects
Accidental sub-arachnoid injection can lead to very high spinal anaesthesia possibly with apnoea and severe hypotension. The adverse reaction profile for Marcain is similar to those for other long acting ...
Overdose
Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic toxicity appears later (15-60 ...
Pharmacodynamic properties
Phamacotherapeutic group (ATC code): N01BB51 Bupivacaine hydrochloride (Marcain) is a long acting local anaesthetic of the amide type with both anaesthetic and analgesic effects. At high doses it produces ...
Pharmacokinetic properties
Bupivacaine has a pKa of 8.2 and a partition coefficient of 346 (25°C n-octanol/phosphate buffer pH 7.4). The metabolites have a pharmacological activity that is less than that of bupivacaine. The plasma ...
Preclinical safety data
Bupivacaine hydrochloride is a well established active ingredient.
List of excipients
Sodium chloride (tonicity contributor) Sodium hydroxide/hydrochloric acid (pH adjustment to 4.0-6.5) Water for injections
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
Store below 30°C. Do not freeze.
Nature and contents of container
10 ml and 20 ml polypropylene ampoules Polyamp<sup>R</sup>. Cartons contain 5 or 10 ampoules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For single use only. Discard any unused solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0079
Date of first authorization / renewal of the authorization
4<sup>th</sup> June 2002
Date of revision of the text
April 2021
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