Phenobarbital 30mg/1ml solution for injection ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Phenobarbital sodium

Disponibil de la:

Martindale Pharmaceuticals Ltd

Codul ATC:

N03AA02

INN (nume internaţional):

Phenobarbital sodium

Dozare:

30mg/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Intramuscular; Intravenous; Subcutaneous

Clasă:

Schedule 3 (CD No Register Phenobarbital)

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04080100; GTIN: 5014124170278

Prospect

WHAT IS IN THIS LEAFLET
1. What Phenobarbital Injection is and what it is used for
2. What you need to know before you are given
Phenobarbital Injection
3. How Phenobarbital Injection will be given
4. Possible side effects
5. How to store Phenobarbital Injection
6. Contents of the pack and other 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
also have hypnotic properties which mean they can make you
feel sleepy.
Phenobarbital Injection is used in the treatment of most types of
epilepsy except absence seizures (petit mal).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
PHENOBARBITAL INJECTION
YOU SHOULD NOT BE GIVEN 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.
IF YOU DEVELOP A RASH OR THE FOLLOWING SKIN SYMPTOMS, SEEK
IMMEDIATE ADVICE FROM A DOCTOR AND TELL HIM THAT YOU ARE
TAKING THIS MEDICINE:
• Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported
with the use of Phenobarbital Injection appearing initially
as reddish target-like spots or circular patches often with
central blisters on the trunk. Additional signs to look for
include ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These potentially life-
threatening skin rashes are often accompanied by flu-like
symptoms. The rash may progress to widespread blistering
or peeling of the skin. The highest risk for occur

Caracteristicilor produsului

OBJECT 1
PHENOBARBITAL SODIUM 30MG/ML INJECTION
Summary of Product Characteristics Updated 23-Jan-2018 | Martindale
Pharma
1. Name of the medicinal product
Phenobarbital Sodium 30mg/ml Injection
2. Qualitative and quantitative composition
Each ml of solution contains 30mg of Phenobarbital Sodium
Excipient with known effect
Propylene Glycol: 90.000%v/v
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection
Clear, colourless, solution practically free from particles
pH = 10.0 – 11.0
4. Clinical particulars
4.1 Therapeutic indications
An anti-convulsant for the treatment all forms of epilepsy except
absence seizures.
4.2 Posology and method of administration
Posology
Adults
50 - 200mg as a single dose by intramuscular, subcutaneous or, after
dilution 1 in 10 with Water for
Injection, by intravenous injection, repeated, if necessary, after 6
hours.
Paediatric population
3 - 5mg per kg body weight as a single dose by intramuscular
injection.
Method of administration
Intramuscular, subcutaneous or intravenous injection
4.3 Contraindications
Hypersensitivity to phenobarbital, other barbiturates or to any of the
excipients listed in section 6.1
Severe respiratory depression.
Acute intermittent porphyria.
Severe impairment of renal or hepatic function.
4.4 Special warnings and precautions for use
Suicidal ideation and behaviour have been reported in patients treated
with anti-epileptic agents in several
indications. A meta-analysis of randomised placebo controlled trials
of anti-epileptic drugs has also
shown a small increased risk of suicidal ideation and behaviour. The
mechanism of this risk is not known
and the available data do not exclude the possibility of an increased
risk for Phenobarbital Sodium.
Therefore patients should be monitored for signs of suicidal ideation
and behaviours and appropriate
treatment should be considered. Patients (and caregivers of patients)
should be advised to seek medical
advice should signs of suicidal ideation or behaviour emerge.
Steven-Johnso