Symptoms:
The symptoms of overdosage after submucosal injection of Oily Phenol are not known, but are likely to be similar to symptoms observed after excessive exposure to phenol in other preparations. Absorption of phenol after application of dilute phenol solutions to extensive wounds has resulted in abdominal pains, dizziness, methaemoglobinaemia, haemoglobinurea, cyanosis, cardiac arrhythmias, ECG abnormalities, and may result in respiratory failure, circulatory failure, coma and death.
Treatment: There is no specific antidote for actute phenol overdose. Treatment of overdose is symptomatic and supportive. If the product has been swallowed, empty the stomach by aspiration and lavage, taking care to avoid perforation, before carrying out the above procedure.
3 years (36 month) when packaged in glass ampoules
18 month when packaged in glass vials with rubber caps and aluminium crimps.
Oily Phenol Injection, BP is contraindicated in patients who are hypersensitive to phenol, nuts and in particular almond oil or any component of the product. It should not be used over large areas, since sufficient amounts may be absorbed to give rise to toxic symptoms. Oily Phenol Injection, BP is also contraindicated in neonates and children.
None stated
Almond oil BP
Injection.
General disorders and administration site conditions:
Pyrexia
Pain
Discomfort
Irritation
Ulcer
Tissue necrosis
Immune system disorders:
Hypersensitivity
Nervous system disorders:
Dizziness
Hepatobiliary disorders:
Hepatitis
Infections and infestations:
Abscess
Prostatic abscess
Necrotizing fasciitis
Retroperitoneal sepsis
Renal and urinary disorders:
Dysuria
Urinary incontinence
Reproductive system and breast disorders:
Impotence
Not applicable
Analgesic sclerosing agent in the treatment of internal haemorrhoids
The injection produces submucosal fibrosis, fixing the mucosa to the underlying muscle.
Not applicable
17/06/2010
Oily Phenol Injection 5% w/v.
Macarthys Laboratories Limited
T/A Martindale Pharmaceuticals
Martindale Pharmaceuticals
Bampton Road, Romford, RM3 8UG.
Not applicable
Clear glass ampoules containing 2 ml or 5 ml of product. 10 ampoules are packed into cartons. Glass vials containing 25 ml of product closed with rubber bungs sealed with aluminium caps.
PL 01883/6153R
Each ml of solution contains 50 mg Phenol BP.
For submucosal injection only. Not for intrathecal use. Care should also be taken to avoid accidental intravenous injection. The injection may cause severe pain if it is too close to the anal verge. Complications of therapy can include local ulceration and sterile abscess formation. These complications may be serious following a misplaced injection (eg prostatic abscess). Care in choosing the correct site of injection is mandatory.
Not applicable
By submucosal injection
Adults and the elderly
2 - 3 ml injected at the base of the haemorrhoid. Several sites may be injected but the maximum total at any one time is 10 ml.
Children
The use of oily phenol injection BP is contraindicated in children and neonates.
None
First authorised: 22nd June, 1989
Last renewal:18th October, 1994
