Depakine

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

DEPAKINE

400 mg (400 mg/4 ml), powder and solvent for solution for injection
Sodium valproate
▼ This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

WARNING

The Depakine medicine (sodium valproate) used during pregnancy can seriously harm the unborn child. Women of childbearing age should use effective contraception (birth control) without interruption throughout the entire period of using the Depakine medicine. The doctor will discuss this with the patient, and the patient should also follow the recommendations presented in section 2 of this leaflet.
Patients should contact their doctor immediately if they plan to become pregnant or suspect they are pregnant.
The Depakine medicine should not be discontinued unless the doctor recommends it, as the patient's condition may worsen.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically to one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Depakine and what is it used for
• 2. Important information before using Depakine
• 3. How to use Depakine
• 4. Possible side effects
• 5. How to store Depakine
• 6. Contents of the packaging and other information

1. What is Depakine and what is it used for

Depakine is a powder for solution for injection and contains the active substance sodium valproate. Sodium valproate belongs to a group of antiepileptic medicines. It has antiepileptic effects in various types of epilepsy in humans.
Depakine is used:

• in epileptic states where benzodiazepines administered intravenously are ineffective;
• in cluster seizures;
• in the treatment of seizure attacks when oral treatment is temporarily impossible due to the state of consciousness or inability to swallow, especially if the patient was previously effectively treated with oral sodium valproate. This applies to generalized and partial seizures;
• prophylactically in connection with neurosurgical head operations, when there is a possibility of seizures.

2. Important information before using Depakine

When not to use Depakine:

Do not use the medicine in the following cases:

• if the patient is allergic to the active substance sodium valproate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has acute and chronic hepatitis,
• if the patient has had severe hepatitis, especially drug-induced or if the patient's family history indicates severe hepatitis,
• if the patient has porphyria (a very rare metabolic disorder),
• concomitant use with mefloquine.
• if the patient has a genetic disorder causing mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome),
• if the patient has metabolic disorders, such as disorders of the urea cycle,
• if the patient has a carnitine deficiency (a very rare metabolic disorder) that is not being treated,
• epilepsy:
• if the patient is pregnant, unless no other therapy is effective,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the entire treatment period with Depakine. Do not discontinue Depakine or contraception without discussing it with your doctor. The doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Warnings and precautions

Before starting to take Depakine, the patient should discuss it with their doctor.

THE PATIENT MUST IMMEDIATELY INFORM THEIR DOCTOR:

• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes) or recurrence of seizures, especially during the first 6 months of treatment, the patient should immediately inform their doctor.
• Depakine may cause severe liver damage, sometimes resulting in death. Before starting treatment and during the first 6 months of treatment, the patient should periodically undergo laboratory tests to check liver function. The risk of liver damage increases if Depakine is used in children under 3 years of age, people taking other antiepileptic medicines, or people with other neurological or metabolic disorders, as well as in people with severe epilepsy. Children under 3 years of age should not be given sodium valproate concomitantly with salicylates due to the risk of toxic effects on the liver.
• In case of acute abdominal pain, the patient should immediately inform their doctor. Depakine can very rarely cause severe pancreatitis, sometimes resulting in death.
• If the patient or their child taking Depakine experiences balance and coordination problems, drowsiness, or decreased alertness, vomiting, they should immediately inform their doctor. This may be caused by increased ammonia levels in the blood.
• A small number of people taking antiepileptic medicines, including sodium valproate, have thought about harming or killing themselves. If such thoughts ever occur to the patient, they should immediately contact their doctor.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with valproate use. If the patient notices any symptoms related to these severe skin reactions, as described in section 4, they should immediately consult their doctor.

Before starting to take this medicine, the patient should discuss it with their doctor:

• Valproate should not be used in women with epilepsy who are planning to become pregnant, unless other treatments are ineffective or not tolerated. The benefits of using the medicine should be weighed against the risks before the first prescription or when a woman treated with valproate is planning to become pregnant. Women of childbearing age must use effective contraception during treatment.
• Before starting treatment, including before surgery and in case of bruising or spontaneous bleeding, laboratory tests are recommended (blood morphology test, including platelet count, bleeding time, and coagulation tests).
• Caution should be exercised when using Depakine in patients with impaired renal function. The doctor may recommend a lower dose of the medicine.
• Depakine should be used with caution in patients with systemic lupus erythematosus.
• If the patient is suspected to have any metabolic disorder, especially congenital enzyme deficiencies, such as "urea cycle disorders", due to the risk of increased ammonia levels in the blood.
• Weight gain may occur in patients treated with sodium valproate.
• If the patient has a rare disorder called "carnitine palmitoyltransferase II deficiency" due to the increased risk of muscle disorders.
• Concomitant use of carbapenem antibiotics with valproic acid is not recommended (see "Depakine and other medicines").
• Sodium valproate is mainly excreted by the kidneys, partly in the form of ketone bodies, so in diabetic patients, the test for ketone bodies may give a false-positive result.
• If there is a family history of mitochondrial disorders or if the doctor suspects such a disorder, due to the risk of liver damage.
• As with other antiepileptic medicines, the severity or frequency of seizures may increase during treatment with this medicine. If the patient experiences an increase in seizures, they should immediately consult their doctor.
• If the patient has inadequate carnitine intake, found in meat and dairy products, especially in children under 10 years of age.
• If the patient has a carnitine deficiency and is taking carnitine.
• If the patient has ever experienced a severe skin rash or exfoliative dermatitis after taking valproate.

Depakine and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of sodium valproate, and valproate may affect the action of other medicines.
These include:

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• medicines used to treat depression, MAO inhibitors;
• benzodiazepines, used to treat insomnia and anxiety disorders;
• other medicines used to treat epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate, rufinamid;
• kanabidiol (used to treat epilepsy and other indications);
• certain anti-infective medicines that contain pivampicillin (such as pivampicillin, adefovir dipivoxil);
• methotrexate (used to treat cancer and inflammatory diseases);
• zydovudine, ritonavir, and lopinavir (used to treat HIV infection and AIDS);
• mefloquine (used to treat and prevent malaria);
• salicylates (acetylsalicylic acid);
• anticoagulants;
• cimetidine (used to treat stomach ulcers);
• erythromycin, rifampicin;
• carbapenems (antibiotics used to treat bacterial infections);
• cholestyramine (used to lower cholesterol levels in the blood);
• propofol (used for general anesthesia);
• nimodipine;
• medicines containing estrogen (including some contraceptive measures);
• metamizole (used to treat pain and fever);
• clozapine (used to treat mental illnesses).

These medicines may affect the action of sodium valproate and vice versa. The patient may need to adjust the dose of individual medicines or use other medicines. The doctor will inform the patient about these changes in treatment.
The doctor will also provide additional information about medicines that should be used with caution or avoided during treatment with Depakine.

Depakine with food, drink, and alcohol

It is not recommended to drink alcohol during treatment with valproate.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important note for women

• Do not use Depakine if the patient is pregnant, unless no other therapy is effective.
• If the patient is of childbearing age, they should not take Depakine unless they use effective contraception (birth control) throughout the entire treatment period with Depakine. Do not discontinue Depakine or contraception without discussing it with the doctor. The doctor will provide further guidance.

Risk of taking valproate during pregnancy (regardless of the disease being treated with valproate)

• The patient should immediately consult their doctor if they plan to become pregnant or are pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free, even when valproate is used in combination with other antiepileptic medicines.
• Valproate may cause serious birth defects and affect the physical and mental development of the child after birth.
• The most common birth defects include: spina bifida (when the bones of the spine are not properly developed); developmental abnormalities of the face and skull; developmental abnormalities of the heart, kidneys, urinary tract, and genital organs; limb abnormalities; and many related developmental abnormalities affecting several organs and body parts. Birth defects can cause disability, which can be significant.
• Children exposed to valproate in the womb have been reported to have hearing problems or deafness.
• Children exposed to valproate in the womb have been reported to have eye development abnormalities, often in combination with other birth defects. Eye development abnormalities can affect vision.
• In a group of children born to mothers taking valproate, about 11 out of 100 children will have birth defects. For comparison, such defects are found in 2-3 out of 100 children born to women without epilepsy.
• It is estimated that up to 30-40% of preschool-age children whose mothers took valproate during pregnancy may exhibit early developmental problems. Children with the condition may start walking and talking later, be less intellectually gifted than other children, have language problems, and have memory problems.
• Children exposed to valproate in the womb are more likely to be diagnosed with various autism spectrum disorders. Some evidence suggests that these children may have an increased risk of developing attention deficit hyperactivity disorder (ADHD).
• Before prescribing this medicine, the doctor will explain to the patient what may threaten the child if the patient becomes pregnant while taking valproate. If the patient taking this medicine decides to have a child, they should not stop taking the medicine or contraception without discussing it with their doctor.
• Some contraceptive measures (estrogen-containing oral contraceptives) may decrease valproate levels in the blood. The patient should discuss their contraception method with their doctor.
• Parents or guardians of girls treated with valproate should contact the doctor when their child starts menstruating.
• The patient should ask their doctor about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Choose the situation that applies to the patient and read the information:

• STARTING TREATMENT WITH DEPAKINE
• CONTINUING TREATMENT WITH DEPAKINE WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH DEPAKINE WHILE TRYING TO CONCEIVE

• BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE

STARTING TREATMENT WITH DEPAKINE

If Depakine is prescribed for the first time, the doctor will explain the risks to the unborn child if the patient becomes pregnant. Women of childbearing age should ensure that they use effective contraception throughout the entire treatment period with Depakine.
If the patient needs advice on contraception, they should consult their doctor or a family planning clinic.

Important information

• The patient should use effective contraception (birth control) throughout the entire treatment period with Depakine.
• The patient should discuss their contraception method with their doctor. The doctor will provide information on preventing pregnancy and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist experienced in treating epilepsy. During this check-up, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• If the patient plans to become pregnant, they should inform their doctor.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their doctor.

CONTINUING TREATMENT WITH DEPAKINE WITHOUT TRYING TO CONCEIVE

If the patient continues to take Depakine and does not plan to become pregnant, they must ensure that they use effective contraception without interruption throughout the entire treatment period with Depakine.
If the patient needs advice on contraception, they should consult their doctor or a family planning clinic.

Important information

• The patient should use effective contraception (birth control) throughout the entire treatment period with Depakine.
• The patient should discuss their contraception method with their doctor. The doctor will provide information on preventing pregnancy and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist experienced in treating epilepsy. During this check-up, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• If the patient plans to become pregnant, they should inform their doctor.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their doctor.

CONTINUING TREATMENT WITH DEPAKINE WHILE TRYING TO CONCEIVE

If the patient plans to become pregnant, they should first schedule a visit with their doctor.
Do not stop taking Depakine or contraception without discussing it with the doctor. The doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high risk of birth defects and developmental problems that can significantly impair the child. The doctor will refer the patient to a specialist experienced in treating epilepsy to assess alternative treatment options. The specialist may take steps to ensure the best possible outcome of the pregnancy and minimize the risk to the mother and unborn child.
The specialist may decide to change the dose of Depakine, switch to another medicine, or discontinue Depakine treatment long before the patient becomes pregnant - to ensure that the disease is stable.
The patient should ask their doctor about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information

• Do not stop taking Depakine unless the doctor decides to do so.
• Do not stop using contraception before discussing it with the doctor and developing a plan to ensure control of the patient's condition and minimize risks to the child.
• First, the patient should schedule a visit with their doctor. During this visit, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• The doctor may try to switch to another medicine or discontinue Depakine treatment.
• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their doctor.

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE

Do not stop taking Depakine unless the doctor decides to do so, as the patient's condition may worsen.
If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their doctor. The doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high risk of birth defects and developmental problems that can significantly impair the child.
The patient will be referred to a specialist experienced in treating epilepsy to assess alternative treatment options.
In exceptional cases, when Depakine is the only available treatment option during pregnancy, the patient will be closely monitored, both in terms of the underlying disease and fetal development. The patient and their partner will receive counseling and support regarding valproate-exposed pregnancy.
The patient should ask their doctor about taking folic acid. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information

• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their doctor.
• Do not stop taking Depakine unless the doctor decides to do so.
• The patient should ensure that they have been referred to a specialist experienced in treating epilepsy to assess the need for alternative treatment methods.
• The patient must receive counseling on the risks of taking Depakine during pregnancy, including its teratogenic effects (causing birth defects) and physical and mental developmental disorders in children. The patient should ensure that they have been referred to a specialist for prenatal monitoring to detect any developmental abnormalities. In newborns of mothers who took Depakine during pregnancy, bleeding disorders, hypoglycemia, hypothyroidism, and withdrawal symptoms such as irritability, restlessness, hyperactivity, tremors, seizures, and feeding problems may occur.

The patient should read the patient guide provided by their doctor.

The doctor will discuss the annual confirmation form regarding the risks and ask the patient to sign and keep it. The patient will also receive a patient card from the pharmacist to remind them of the risks associated with taking valproate during pregnancy.

Important note for male patients

Possible risk associated with taking valproate in the 3 months before conception
A study suggests a possible risk of motor disorders and developmental delays (problems with development in early childhood) in children whose fathers were treated with valproate in the 3 months before conception. In this study, such disorders occurred in about 5 out of 100 children whose fathers were treated with valproate, compared to about 3 out of 100 children of men treated with lamotrigine or levetiracetam (other medicines that may be used to treat the patient's condition). The risk to children whose fathers stopped taking valproate at least 3 months (the time needed to produce new sperm) before conception is unknown. The study has limitations, and therefore, it is not clear whether the suggested increased risk of developmental delays is caused by valproate. The study was not large enough to show what specific types of motor disorders and developmental delays are associated with this risk.
As a precaution, the doctor will discuss with the patient:

• the possible risk to children whose fathers were treated with valproate;
• the need to consider using effective contraception (birth control) by the patient and their partner during treatment and for 3 months after its completion;
• the need to consult a doctor when planning to conceive and before stopping contraception;
• the possibility of using alternative treatment methods for the patient's condition, depending on the individual situation.

The patient should not donate sperm while taking valproate and for 3 months after stopping it.
If the patient is planning to have children, they should discuss it with their doctor.
If the patient's partner becomes pregnant while the patient is taking valproate in the 3 months before conception and the patient has questions about it, they should contact their doctor. The patient should not stop taking the medicine without consulting their doctor. If the patient stops taking the medicine, their symptoms may worsen.
The patient should regularly visit their doctor. During such a visit, the doctor will discuss the precautions associated with taking valproate and the possibility of using alternative treatment methods for the patient's condition, depending on the individual situation.
The patient should read the patient guide provided by their doctor. The patient will also receive a patient card from the pharmacist to remind them of the possible risk associated with taking valproate.

Breastfeeding

Valproate is excreted in small amounts into breast milk. The patient should consult their doctor about whether they can breastfeed while taking the medicine.

Driving and using machines

In some patients, drowsiness may occur during treatment, especially when taking several antiepileptic medicines or when taking benzodiazepines concomitantly. Before driving or using machines, the patient should make sure how they react to the treatment.

Depakine contains sodium

Depakine contains 55.35 mg of sodium (the main component of table salt) per 400 mg of sodium valproate. This corresponds to 2.8% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Depakine

The medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor.
Girls and women of childbearing age
Treatment with Depakine should be started and supervised by a doctor specializing in the treatment of epilepsy.
Male patients
It is recommended that the use of Depakine be started and supervised by a specialist with experience in the treatment of epilepsy - see section 2 "Important note for male patients".
For patients who have been successfully treated with oral Depakine, the current dose can be used in continuous intravenous infusion or multiple injections; for example, if the patient was taking 25 mg/kg/day, treatment can be continued for 2-3 days with a continuous infusion at a rate of 1 mg/kg/hour. The dose and duration of administration are interdependent.
For other patients, the medicine can be administered initially in a slow intravenous injection (over 3 minutes), usually 15 mg/kg, and then continued as an intravenous infusion at a rate of usually 1 to 2 mg/kg/hour, adjusted according to clinical response.

General notes

The daily dose is determined based on age and body weight, but individual sensitivity should be taken into account.
The optimal dose is determined based on clinical response to treatment; measuring valproate levels in the blood should be considered an additional element of monitoring, necessary only when clinical control of seizures is inadequate or adverse reactions have occurred. The average effective concentration is usually 50-120 mg/liter (375-840 µmol/liter).
Depakine can be administered intravenously through direct slow injection or continuous infusion. If other medicines are used concomitantly, Depakine should be administered through a separate catheter.
When possible, treatment should be continued with the oral form of the medicine in the generally recommended doses.
Duration of treatment
The medicine should be used for as long as the doctor recommends.
If the patient feels that the effect of Depakine is too strong or too weak, they should consult their doctor.
Patients with impaired renal function
The doctor may decide to modify the dose in the patient.

Using a higher dose of Depakine than recommended

Clinical symptoms of severe overdose include: coma, decreased muscle tone, decreased reflexes, pinpoint pupils, and respiratory disorders. Metabolic acidosis, hypotension, and acute cardiovascular failure may also occur. Other symptoms may also occur; seizures have been reported in cases of very high valproate levels in the blood.
The presence of sodium in valproate formulations may lead to increased sodium levels in the blood in case of overdose.
Hospital treatment for overdose is symptomatic; it should involve monitoring cardiovascular and respiratory function.
In severe cases, hemodialysis or even exchange transfusion may be necessary.
In individual cases, the use of naloxone has been effective.
If a higher dose of the medicine than recommended is used, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Depakine

The patient should not take two doses of the medicine at the same time or at short intervals. The patient should continue taking the medicine as directed by their doctor.
In case of missing several doses of the medicine, the patient should immediately contact their doctor.

Stopping treatment with Depakine

Without consulting the doctor, the patient should not stop taking Depakine or change the dose of the medicine. If the patient stops taking the medicine without consulting the doctor, their condition may worsen.

4. Possible side effects

Like all medicines, Depakine can cause side effects, although not everybody gets them. Patients may need appropriate treatment in case of some side effects.

If the patient experiences any of the following serious side effects, they should immediately contact their doctor, as they may need urgent medical attention:

• Coma, encephalopathy (brain damage), lethargy (state of indifference and lack of reaction to stimuli), changes in behavior related or unrelated to increased frequency of seizures or their severity, especially when concomitantly using phenobarbital or during rapid dose escalation of Depakine
• Confusion, weakness, dizziness, nausea, vomiting, which may be caused by low sodium levels in the blood or a condition called "SIADH" (Syndrome of Inappropriate Secretion of ADH) or inappropriate antidiuretic hormone secretion
• Balance and coordination problems, drowsiness, or decreased alertness, accompanied by vomiting. This may be caused by increased ammonia levels in the blood (hyperammonemia)
• Increased number and severity of seizures
• Extreme fatigue, weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, severe abdominal pain, nausea, jaundice (yellowing of the skin and whites of the eyes), or increased frequency of seizures, or general malaise - these symptoms may indicate liver or pancreas damage
• Allergic reactions, which may manifest as:
• Blisters with skin exfoliation (blisters, peeling, or bleeding from various parts of the body, including the lips, eyes, mouth, nose, genitals, hands, or feet) with or without rash, sometimes with flu-like symptoms, such as fever, chills, or muscle pain - these may be symptoms of conditions called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• Rash or skin changes with a pink/red ring and pale center, which may be itchy, peeling, or fluid-filled. The rash may appear especially on the hands or soles of the feet. These may be symptoms of a condition called "erythema multiforme"
• Swelling caused by an allergic reaction with painful, itchy swelling (most often around the eyes, lips, throat, and sometimes hands and feet) - these may be symptoms of "angioedema"
• A syndrome with rash, fever, lymph node enlargement, and possible damage to other organs - these may be symptoms of a condition called "DRESS" or drug reaction with eosinophilia and systemic symptoms
• Blood coagulation disorders confirmed by tests, which may cause spontaneous bruising and bleeding
• Significant decrease in white blood cell count or bone marrow failure (myelodysplastic syndrome) shown in blood tests, sometimes manifested by fever and breathing difficulties
• Hypothyroidism, which may cause fatigue or weight gain
• Arthralgia, fever, fatigue, rash. These may be symptoms of systemic lupus erythematosus
• Tremors, gait disturbances, muscle stiffness, coordination disorders (parkinsonism, extrapyramidal disorders, ataxia)
• Muscle pain and weakness (rhabdomyolysis - breakdown of striated muscle)
• Breathing difficulties, chest pain or feeling of pressure, shortness of breath, and dry cough due to fluid accumulation around the lungs (pleural effusion)
• Kidney disease (renal failure, interstitial nephritis), which may manifest as decreased urine output

5. How to store Depakine

There are no special storage instructions.
The solution should be stored at a temperature of 2-8°C and used within 24 hours.
The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicinal products should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Depakine contains

1 vial of powder contains the active substance sodium valproate 400 mg.
1 ampoule contains solvent - 4 ml of water for injections.

What Depakine looks like and what the pack contains

Pack sizes:

• 1 vial of powder and 1 ampoule of solvent 4 ml,
• 4 vials of powder and 4 ampoules of solvent 4 ml each, in a cardboard box.

To obtain more detailed information on the medicinal product, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Manufacturer:

Sanofi S.r.l, Via Valcanello 4, 03012 Anagni, Italy

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Bulgaria, the country of export:9600303
Parallel import authorization number:93/21

Date of leaflet approval: 06.02.2025

A patient guide for women and a patient guide for men are available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website https://inpharm.pl/materialy-edukacyjne/#walproiniany
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Information intended exclusively for healthcare professionals:

Instructions for use – reconstitution and administration

To prepare the solution, the enclosed solvent should be injected, waited for dissolution, and the appropriate dose taken.
The concentration of the prepared solution is 100 mg/ml, resulting from the increase in solvent volume by sodium valproate.
Preparation of the intravenous form of Depakine should be done immediately before use, and the solution should be used within 24 hours.
The solution for intravenous infusion can be administered from a container made of polyvinyl chloride, polyethylene, or glass.
Physical and chemical compatibility has been demonstrated with the following solutions:

• -sodium chloride solution: 0.9 g in 100 ml
• -glucose: 5 g in 100 ml
• -glucose: 10 g in 100 ml
• -glucose: 20 g in 100 ml
• -glucose: 30 g in 100 ml
• -glucose: 2.55 g + NaCl: 0.45 g in 100 ml
• -sodium bicarbonate: 0.14 g in 100 ml
• -trometamol (THAM): 3.66 g + NaCl: 0.172 g in 100 ml with 400 mg of intravenous Depakine in 500 ml of each of the above solutions (except trometamol: 250 ml).