Bupivacaine Hydrochloride 0.5% w/v Solution for Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Bupivacaine hydrochloride

זמין מ:

Mercury Pharmaceuticals (Ireland) Ltd

קוד ATC:

N01BB; N01BB01

INN (שם בינלאומי):

Bupivacaine hydrochloride

כמות:

0.5 percent weight/volume

טופס פרצבטיות:

Solution for injection

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Amides; bupivacaine

מצב אישור:

Marketed

תאריך אישור:

1988-01-21

עלון מידע

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

מאפייני מוצר

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