Phenobarbital Sodium 60mg/ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-05-2014
Summary of Product characteristics
(SPC)
08-02-2018
Active ingredient:
Phenobarbital sodium
Available from:
Martindale Pharmaceuticals Ltd
ATC code:
N03AA; N03AA02
INN (International Name):
Phenobarbital sodium
Dosage:
60 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Barbiturates and derivatives; phenobarbital
Authorization status:
Not marketed
Authorization date:
1994-05-16
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENOBARBITAL SODIUM INJECTION 15MG/ML, 30MG/ML, 60MG/ML OR 200MG/ML
Phenobarbital Sodium
(Referred to as Phenobarbital Injection in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Phenobarbital Injection is and what it is used for
2. Before Phenobarbital Injection is given
3. How Phenobarbital Injection will be given
4. Possible side effects
5. How to store Phenobarbital Injection
6. Further information
1. WHAT PHENOBARBITAL INJECTION IS AND WHAT IT IS USED FOR
Phenobarbital belongs to a group of drugs known as barbiturates.
Barbiturates have
antiepileptic properties which mean they help prevent some types of
epileptic seizures. They
can also make you feel sleepy.
Phenobarbital Injection is used in the treatment of most types of
epilepsy except absence
seizures (petit mal).
2. BEFORE PHENOBARBITAL INJECTION IS GIVEN
DO NOT USE PHENOBARBITAL INJECTION IF:
• You are allergic (hypersensitive) to any barbiturates or any of
the ingredients of this
medicine (see section 6)
• You suffer from acute intermittent porphyria (a type of blood
disorder)
• You suffer from severe breathing difficulties (respiratory
depression)
• You suffer from liver or kidney problems
If your problem is not severe your doctor may decide to give you the
medicine with caution.
Talk to your doctor, they will advise you on your particular
situation.
TAKE SPECIAL CARE WITH PHENOBARBITAL INJECTION IF:
• You have an alcohol or drug problem
• You are pregnant, planning to become pregnant or are
breast-feeding
• You are young,
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenobarbital Sodium 60mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 60mg of Phenobarbital sodium.
Each ml of solution contains 0.934g of propylene glycol
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
An anti-convulsant for the treatment of all forms of epilepsy except
absence seizures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration
By intramuscular, subcutaneous or, after dilution with 10 times its
own volume of Water for Injection, by slow
intravenous administration.
Adults
50-200mg as a single dose by intramuscular, subcutaneous or, after, by
intravenous injection. Repeated, if necessary,
after 6 hours.
Maximum daily intake 600mg.
Elderly
The use of phenobarbital must be the subject of a clinical
risk/benefit assessment. Dose schedules may need to be
reduced.
Children
3-5mg per kilogram body weight as a single dose by the intramuscular
route.
4.3 CONTRAINDICATIONS
Acute intermittent porphyria.
Severe renal, hepatic or respiratory dysfunction.
Known hypersensitivity to barbiturates or any of the ingredients.
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4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sui
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