Diazepam 2 ml. 10 ampoules
Diazepam Sofarma injection contains active substance diazepam, which refers to the drug known as benzodiazepine anxiolytics. Its main effect is removing the feeling of anxiety and fear. Induces relaxation of skeletal muscle (muscle relaxant effect) suppresses seizures and causes a condition similar to sleep. It is used to eliminate the states of anxiety and agitation; suppression of arousal delirium tremens (alcohol dependence syndrome); to address the status epilepticus and other seizure disorders; for treatment of muscle spasms and tetanus. Diazepam Sofarma also be used for sedation during preoperative preparation and other painful therapeutic and diagnostic procedures.
2. What you need to know before you are given Diazepam Sopharma
You should not be given Diazepam Sopharma:
if you are allergic to diazepam, benzodiazepines or any of the other ingredients of this medicine (listed in section 6);
if you have a disease such as myasthenia gravis (ongoing weakness and rapid fatigue of muscles);
if you have severe liver, kidney or respiratory problems, incl. etc. sleep apnea syndrome (sudden cessation of breathing during sleep);
if you have data on mental health problems in the past, including depressive or manic states; chronic psychoses;
in infants (contains benzyl alcohol).
Warnings and Precautions
Before you are given Diazepam Sopharma, tell your doctor:
if you are elderly, have a brain disease associated with poor circulation; impaired respiratory or hepatic function. If treatment of these patients with Sopharma Diazepam injection may be necessary to reduce the dosage. As a rule, in patients with mild renal impairment do not need dosage adjustment;
as diazepam causes depression of the central nervous system, they should not be administered concomitantly with other drugs with similar function, such as alcohol, sedatives, narcotic analgesics, and means for general anesthesia. And other similar Diazepam Sofarma drugs, it can cause drug dependency, if used for a long time and in higher doses as well as in patients with a history of drug addiction to diazepam or other drugs. With abrupt discontinuation of treatment, these patients may occur etc. "Withdrawal syndrome" which is characterized by the following symptoms: tremors, convulsions, abdominal and muscle cramps, vomiting, sweating, restlessness, irritability. In order to avoid the emergence of drug addiction, treatment with Diazepam Sofarma must be short, and in the lowest possible dose;
Upon intravenous administration of Diazepam Sofarma is necessary to inject the solution slowly, to minimize the risk of local irritation, phlebitis, or thrombosis.
Other medicines and Diazepam Sopharma
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Due to risk of enhanced depressant effect on the central nervous system during the treatment with Diazepam Sofarma should not use other drugs with such action, general anesthetics, hypnotics, drugs for the treatment of depression (antidepressants), for the treatment of psychoses (neuroleptics ), narcotic pain killers, classic antiallergic agents (antihistamines), drugs with anticonvulsant action and some drugs that lower blood pressure. If concomitant administration of Diazepam Sopharma narcotic painkillers, it is recommended to be administered after the analgesic dose and be carefully defined. Effects of Diazepam Sopharma significantly increases when administered concomitantly with medicines called MAO inhibitors used most often to treat Parkinson's disease and depression. Sopharma Diazepam should not be coadministered with drugs that have a depressing or stimulating effect on liver enzymes that break down drugs. When concomitant administration of Diazepam Sopharma with such drugs its effects can be strengthened or weakened. In this regard, should be avoided taking the following medicines: cimetidine; omeprazole (used to treat stomach ulcers); isoniazid, rifampicin (to treat tuberculosis); ritonavir (for HIV); birth control; phenytoin (used to treat seizures); theophylline (for treating bronchial asthma and other diseases occurring with bronchospasm).
Diazepam Sopharma with food, drinks and alcohol
Alcohol potentiates the suppressive effects of diazepam on the central nervous system, and therefore treatment with Diazepam Sofarma it should not be consumed.
Smoking may reduce the effectiveness of Diazepam Sofarma because of the accelerated its degradation in these cases.
Pregnancy, lactation and fertility
Ask your doctor or pharmacist before taking any medicine.
Not recommended for use Diazepam Sopharma during pregnancy (especially in the first and third quarter) due to insufficient data on safety on the fetus. Not recommended for use during breast-feeding because diazepam passes into breast milk and may cause adverse effect in infants.
Driving and using machines
Testimony, in which the Diazepam Sopharma off drive and use machines.
Sopharma diazepam injection contains ethanol (alcohol) 22.14 vol.%, Ie up to 1,8 g per dose (10 mg). Its presence in the medicinal product, even in small quantities, may present a risk to patients suffering from alcoholism, in pregnant and breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Diazepam Sofarma injection contains 157 mg benzyl alcohol per dose (10 mg), and is contraindicated its use in infants. Can cause toxic and allergic reactions in infants and children up to 3 years old. Sopharma diazepam injection contains benzoic acid and sodium benzoate, which can increase the risk of jaundice in newborns.
Sopharma diazepam injection contains propylene glycol, which can cause symptoms of alcohol intoxication.
3. How to use Diazepam Sopharma
The dose and duration of treatment prescribed by the doctor depending on the indication.
Sopharma diazepam administered slowly intravenously or intramuscularly only healthcare facility by a qualified medical practitioner, as dosage is strictly individual, depending on the indication and the patient's condition.
If you have any further questions on the use of this product, ask your doctor.
If you think that you are given more than you should Diazepam Sopharma
The product is administered by a qualified medical person and rarely shows symptoms of overdose, but if you think that you are given a higher dose, contact your doctor.
Management of overdose is done in a medical facility, as events are held for vital functions.
If you think you missed diazepam Sopharma
If you think you missed diazepam Sopharma, contact your doctor.
Discontinuation of Diazepam Sopharma gradually under medical supervision.
4. Possible side effects
Like all medicines, Sopharma Diazepam injection may cause side effects, although not everybody gets them.
Tell your doctor if you develop any of the following effects and they worry you.
More often can be observed: somnolence, headache, dizziness, fatigue, weakness; application site - local pain and inflammation of the vein (thrombophlebitis).
Are possible, though rare, the following side effects: disturbances in coordination and speech, shaking hands (tremor), seizures, visual disturbances, double vision, nausea, vomiting, constipation, hiccups, dry mouth, confusion, anxiety, aggressiveness, hallucinations, lethargy, development of drug dependency, lethargy, depression, memory disorders, lowering of blood pressure and body temperature, urinary retention, changes in the menstrual cycle and sexual desire, breast enlargement in men, yellowing of eyes and skin , skin rash, itching, hives, allergic skin reactions, increased risk of falls and fractures in the elderly, eating disorders of psychological basis (anorexia), slow heart rate, muscle weakness, reduced number of blood cells , increased liver enzymes, respiratory depression in high doses.
In case of abdominal or muscle spasms, tremors, convulsions, sweating, vomiting, is necessary to reduce the dose of the drug or discontinuing it.
If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet.
5. How to store Diazepam Sopharma
Store in original container, protected from light.
Do not store above 25 ° C.
Do not freeze!
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Diazepam Sopharma
The active substance is 5 mg diazepam in 1 ml of solution for injection.
Other ingredients are: ethanol (96%), benzoic acid (E210), sodium benzoate (E211), propylene glycol, benzyl alcohol, water for injections.
How does Diazepam Sopharma and contents of the pack
Diazepam Sopharma is a clear, pale yellow to yellow solution.
Brown glass vials holding 2 ml, with markings for opening the ampoule - point above the neck of the ampoule.
10 ampoules in PVC foil, 1 or 10 blisters in a cardboard box together with a leaflet.
The opening of the ampoules is done by pressing the thumb on the mark (point) over the neck of the ampoule.
Before applying the solution it should be inspected visually for sludge solids or change in clarity.
Marketing Authorisation Holder and Manufacturer:
Sopharma AD, Bulgaria.
Date of last revision of the leaflet March 2012.
The following information is intended for healthcare professionals only:
Medicinal product is injected intramuscularly or intravenously slowly only in a healthcare facility by a qualified medical practitioner, as dosage is strictly individual, depending on the indication and the patient's condition.
In severe or violating employability states of anxiety and agitation and muscle spasms dose is 10 mg intramuscularly or intravenously, can be repeated after 4 hours if necessary;
Tetanus initial dose is from 0.1 to 0,3 mg / kg weight intravenously and may be repeated at intervals of 1 to 4 hours;
In delirium tremens dose is 10-20 mg intramuscularly or intravenously. Dosages may be higher depending on the severity of symptoms;
In status epilepticus and other seizures, the dose is 10-20 mg intravenously or intramuscularly, it may be repeated after 30-60 minutes to a maximum dose of 30 mg. This dose can be followed by slow intravenous infusion (up to 3 mg / kg weight per 24 hours);
Preoperative medication or premedication in diagnostic and therapeutic procedures: the dose is 10-20 mg (0,1-0,2 mg / kg weight) intramuscularly or intravenously 10-30 minutes before the procedure or surgery.
In status epilepticus and other seizures slowly intravenously or intramuscularly at a dose of 0.2 to 0,3 mg / kg of weight;
Preoperative medication or premedication in diagnostic and therapeutic procedures: the dose is 0,2 mg / kg weight.
Sopharma diazepam injection is not recommended for infants.
The product contains the excipient benzyl alcohol, which is contraindicated in neonates and premature, as it may cause toxic effects.
Patients over 65 years of age
The dose should then be reduced by half the recommended adult dose.
Patients with hepatic and / or renal impairment
It is recommended to reduce the dose in these patients.
Method of administration
Administered slowly intravenously, intramuscularly, or by intravenous infusion, the dose is strictly individual and depends on the therapeutic response, the age and weight of the patient.
In order to reduce side effects of treatment with intravenous drug its introduction should be done very slowly (1 ml for 1 minute).
Treatment should be carried out with the lowest possible dose under close medical supervision.
After entering all of the medication is desirable that the patient be lying down for about 1 hour.
In urgent cases it is necessary to be ready to resuscitation measures.
After drug administration the patient should be accompanied to the house, he should not drive or operate machinery for 24 hours.
The content of the vial must be diluted. An exception is made in the slow drip infusion administration when diluted with isotonic NaCl solution and dextrose solution.