- Approval Id
- 8de80d4eb7c1b0d3
- Drug Name
- REGIVELL SPINAL HEAVY INJECTION 0.5% W/V
- Product Name
- REGIVELL SPINAL HEAVY INJECTION 0.5% W/V
- Approval Number
- SIN16501P
- Approval Date
- 2022-05-24
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION</strong><br>
Route of administration: For Intrathecal Injection.<br>
As with all local anaesthetics, the dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anaesthesia and degree of muscle relaxation required, individual tolerance, the technique of anaesthesia, and the physical condition of the patient.<br>
The lowest dosage that results in effective anaesthesia should be used. In general, surgical anaesthesia requires the use of higher concentrations and doses than those required for analgesia. The presentations of Regivell injection solutions are for use in one patient on one occasion only. Any solution remaining from an opened container should be discarded.</p>
<p><strong>Spinal anaesthesia for surgery</strong><br>
2 – 4 mL Regivell (10 – 20 mg bupivacaine hydrochloride).<br>
When 3 mL Regivell was injected into the L3 – L4 interspace and patients were kept in the sitting position for 2 minutes before being placed supine, blockade spread to the T7 – T10 segment. When a similar injection was made in patients in the lateral position who were then immediately placed supine, blockade spread to the T4 – T7 segment.<br>
The effects of injections of Regivell exceeding 4 mL have not yet been studied and such volumes can therefore not be recommended.<br>
<strong>Note:</strong>-</p>
<p><strong>Hypotension</strong><br>
During spinal anaesthesia, a marked fall in blood pressure and/or intercostal paralysis may be seen, possibly due to the use of excessive doses or improper positioning of the patient.<br>
Hypotension and bradycardia may occur as a result of sympathetic blockade.<br>
Standard textbooks should be consulted with respect to techniques for administration of Regivell for spinal anaesthesia.</p>
<p><strong>Use in Children</strong><br>
The use of spinal anaesthesia in children requires a thorough knowledge of the differences between adults and children to enable the administration of adequate doses of the drug. Since a relatively high CSF volume is found in infants and neonates, proportionately larger doses per kg are required to produce the same level of block. In small children the nerves are less myelinated, allowing easier diffusion of the drug and a more rapid onset of anaesthesia, hence lower concentrations are needed to block nerve conduction. The hypotension usually seen following spinal block in adults is uncommon in children below the age of 8.<br>
The following doses of Regivell are recommended for use in children:<br>
0.4 – 0.5 mg/kg for infants up to 5 kg<br>
0.3 – 0.4 mg/kg for children weighing between 5 and 15 kg<br>
0.25 – 0.3 mg/kg for children weighing more than 15 kg<br>
The onset of anaesthesia is slower than with lignocaine and lasts for 60 – 120 minutes.</p>
<p><strong>Use in Pregnancy</strong><br>
It should be noted that the dose should be reduced in patients in the late stages of pregnancy.</p>
<p><strong>Use in Debilitated or Elderly Patients</strong><br>
The dose should be reduced in the elderly.</p>
- Route Of Administration
- INTRATHECAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
Spinal anaesthesia for surgery (urological and lower limb surgery lasting 2–3 hours, abdominal surgery lasting 45–60 minutes).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ol>
<li>Allergy or hypersensitivity to amide type local anaesthetics.<br>
Detection of suspected sensitivity by skin testing is of limited value.</li>
<li>Intravenous administration.</li>
<li>Diseases of the cerebrospinal system such as meningitis, tumours (primary or secondary), poliomyelitis, subacute combined degeneration of the spinal cord, cranial haemorrhage, demyelinating disease and raised intracranial pressure.</li>
<li>Certain conditions of the bones of the vertebral column such as tuberculosis, tumours and osteomyelitis.</li>
<li>Arthritis, spondylitis, spinal stenosis and other diseases of the vertebral column, or recent trauma due to fracture, rendering spinal puncture impossible.</li>
<li>Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension or coagulation disorders or in patients receiving anti-coagulant treatment.</li>
<li>Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection or in the presence of septicaemia.</li>
<li>Pernicious anaemia with subacute combined degeneration of the spinal cord.</li>
<li>Cardiogenic or hypovolaemic shock.</li>
</ol>
- Atc Code
- N01BB01
- Atc Item Name
- bupivacaine
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
