Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenobarbital sodium
Martindale Pharmaceuticals Ltd
N03AA02
Phenobarbital sodium
200mg/1ml
Solution for injection
Intravenous; Intramuscular; Subcutaneous
Schedule 3 (CD No Register Phenobarbital)
Valid as a prescribable product
BNF: 04080100; GTIN: 5014124170261
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 Preberite celoten dokument
OBJECT 1 PHENOBARBITAL SODIUM 200MG/ML INJECTION Summary of Product Characteristics Updated 23-Jan-2018 | Martindale Pharma 1. Name of the medicinal product Phenobarbital Sodium 200mg/ml Injection 2. Qualitative and quantitative composition Each ml of solution contains 200mg 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-Jo Preberite celoten dokument