País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Bupivacaine hydrochloride
Mercury Pharmaceuticals (Ireland) Ltd
N01BB; N01BB01
Bupivacaine hydrochloride
0.5 percent weight/volume
Solution for injection
Product subject to prescription which may not be renewed (A)
Amides; bupivacaine
Marketed
1988-01-21
UNCOMMON (AFFECTS LESS THAN 1 IN 100 PEOPLE) • Feeling light-headed • Fits (seizures) • Numbness of the tongue or around mouth • Abnormal sensation of the skin • Ringing in the ears or being sensitive to sound • Difficulty in speaking • Blurred sight or double vision • Loss of consciousness • Shaking (tremors) • Twitching of your muscles. RARE (AFFECTS LESS THAN 1 IN 1,000 PEOPLE) • Nerve damage that may cause changes in sensation or muscles weakness (neuropathy). This may include peripheral nerve damage • A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal cord). The signs include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in the legs • Spinal cord injury (paraplegia) • Weak or paralysed legs • Double vision • Uneven heart beat or stopped heart beat. This could be life threatening • Slowed or stopped breathing or stopped heart beat. This could be life-threatening. POSSIBLE SIDE EFFECTS SEEN WITH OTHER LOCAL ANAESTHETICS WHICH MIGHT ALSO BE CAUSED BY BUPIVACAINE INJECTION INCLUDE: • Problems with your liver enzymes. This may happen if you have long-term treatment with this medicine • Collection of pus in the spinal cord • Loss of sensation • Deficiency in the amount of oxygen reaching body tissues (hypoxia) • More than normal level of carbon dioxide in blood (hypercarbia) • Increased acidity in the blood (acidosis) • Increased potassium levels in the blood (hyperkalemia) • Low levels of calcium in the blood (hypocalcaemia) • Damaged nerves. Rarely this may cause permanent problems • Drooping of the upper eyelid, sunk in eye, flushing of the face (Horner’s syndrome) are more commonly experienced in pregnant women • Blindness which is not permanent or problems with muscles of the eyes that are long-lasting. This may happen with some injections given around the eyes. ADDITIONAL SIDE EFFECTS IN CHILDREN AND ADOLESCENTS: • Adverse drug reactions in children are similar to those Llegiu el document complet
Health Products Regulatory Authority 17 October 2019 CRN0093HL Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bupivacaine Hydrochloride 0.5% w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10ml of sterile solution for injection contains Bupivacaine Hydrochloride equivalent to 50mg of Anhydrous Bupivacaine Hydrochloride (5 mg in 1 ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A colourless or almost colourless, sterile, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Surgical anaesthesia in adults and children above 12 years of age Acute pain management in adults, infants and children above 1 year of age The suggested dose and strength of solution appropriate for each indication are provided in Section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the technique of anaesthesia used. The lowest dosage needed to provide effective anaesthesia should be administered. For most indications, the duration of anaesthesia with Bupivacaine solutions is such that a single dose is sufficient. The maximum dosage must be determined by evaluating the size and physical status of the patient and considering the usual rate of systemic absorption from a particular injection site. Experience to date indicates a single dose of up to 150mg bupivacaine hydrochloride. Doses of up to 50mg 2-hourly may subsequently be used. A maximum dose of 2mg/kg should not be exceeded in any four hour period. When prolonged blocks are used, either by continuous infusion or by repeated bolus administration, the risks of reaching a toxic plasma concentration must be considered. The dosages in the following table are recommended as a guide for use in the average adult. Individual variations in onset and duration occur. For young, elderly or debil Llegiu el document complet