Oily Phenol Injection Bp 5%W/V
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oily Phenol Injection BP 5%w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol BP 5.00 % WV
3 PHARMACEUTICAL FORM
Sterile solution intended for parenteral use
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Scleropathy of haemorrhoids
4.2 Posology and method of administration
Injected into sub-mucosal layer at the base of the haemorrhoid ADULTS
2-3 ml of oily phenol injection into the sub-mucosal layer at the base of the pile; Several injections may be given at different sites but not more than a total volume of 10 ml should be used at any one time.
CHILDREN
Use of this product is not advised ELDERLY
No alternative dosage schedules have been suggested.
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
For submucosal injection only. Not for intrathecal use. 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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated
4.6 Pregnancy and lactation
Safety in pregnancy has not been established. The effects on the foetus are unknown, therefore Oily Phenol is not recommended for use during pregnancy.
It is not known whether Oily Phenol is excreted in breast milk. Since safety in infants has not been established, Oily Phenol injection is not recommended for use whilst breast-feeding.
4.7 Effects on ability to drive and use machines
Effects of phenol oily injection are not likely to affect the patient’s ability to drive and use machinery.
4.8 Undesirable effects
General disorders and administration site conditions:
Pyrexia
Pain
Discomfort
Ulcer
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
4.9 Overdose
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 acute phenol overdose. Treatment of overdose is symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Oily phenol injection acts as an analgesic and thrombotic agent by numbing the sensory nerve endings and precipitating proteins.
5.2 Pharmacokinetic properties
Phenol is absorbed from the gastro-intestinal tract and through skin and mucous membranes. It is metabolised to phenylglucoronide and phenylsulphate and small amounts are oxidised to catechol and quinol which are mainly conjugated. The metabolites are excreted in the urine; on oxidation to quinones they may tint the urine green.
Preclinical safety data
5.3
No data available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Almond oil
6.2 Incompatibilities
Incompatible with alkaline salts, acetanilide, phenazone, piperazine, quinine salts, phenacetin and iron salts. Phenol coagulates albumin and gelatinises collodion.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
5 ml neutral glass (type 1) ampoules supplied in cartons of 10.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
UCB Pharma Limited 208 Bath Road,
Slough,
Berkshire,
SL1 3WE,
UK
MARKETING AUTHORISATION NUMBER(S)
PL 0039/5690R
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20 March 1987 / 21 December 2002
DATE OF REVISION OF THE TEXT
23/09/2008
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