PACKAGE LEAFLET INFORMATION FOR THE PATIENT Sodium Valproate 100mg/ml Solution for Injection or Infusion

▼This medicine is subject to additional monitoring.

This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

WARNING

Valproate can cause birth defects and problems with early development of the child if it is given during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.

Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Sodium Valproate Injection is and what it is used for

2.    What you need to know before you are given Sodium Valproate Injection

3.    How Sodium Valproate Injection is given

4.    Possible side effects

5.    How to store Sodium Valproate Injection

6.    Contents of the pack and other information

1. WHAT SODIUM VALPROATE INJECTION IS AND WHAT IT IS USED FOR

What Sodium Valproate Injection is

The name of your medicine is Sodium Valproate 100mg/ml Solution for Injection or Infusion (called Sodium Valproate Injection in this leaflet).

What Sodium Valproate Injection contains

Sodium Valproate Injection contains a medicine called sodium valproate. This belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down.

What Sodium Valproate Injection is used for Sodium Valproate Injection is used to treat epilepsy (fits) in adults and children. The injection is given when it is not possible to have your medicine by mouth.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM VALPROATE INJECTION

Do not have Sodium Valproate Injection and tell your doctor or nurse if:

•    you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Sodium Valproate Injection (listed in see section 6)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    you have liver problems or you or your family have a history of liver problems

•    you have a rare illness called porphyria.

•    you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Sodium Valproate Injection.

Warnings and precautions

A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Check with your doctor or nurse before you are given this medicine if:

•    you have diabetes. This medicine may affect the results of urine tests

•    you have kidney problems. Your doctor may give you a lower dose

•    you have fits (epilepsy), brain disease or a metabolic condition affecting your brain

•    you have a ‘urea cycle disorder' where too much ammonia builds up in the body

•    you have an illness called ‘systemic lupus erythematosus (SLE)'

- a disease of the immune system which affects skin, bones, joints and internal organs

•    you know that there is a genetic problem caused by a mitochondrial disorder in your family.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Sodium Valproate Injection Weight gain

Having Sodium Valproate Injection may make you put on weight. Talk to your doctor about how this will affect you.

Blood tests

Your doctor may wish to do blood tests before you start having Sodium Valproate Injection and during your treatment.

Other medicines and Sodium Valproate Injection

Tell your doctor or nurse if you are taking or have recently taken

any other medicines. This includes medicines you buy without a

prescription, including herbal medicines. This is because Sodium

Valproate Injection can affect the way some other medicines work.

Also some medicines can affect the way Sodium Valproate Injection

work.

The following medicines can increase the chance of you getting side effects, when taken with Sodium Valproate Injection:

•    Some medicines used for pain and inflammation (salicylates) such as aspirin

•    Some other medicines used to treat fits (epilepsy) - see Section 3: “Patients taking other medicines for ‘fits.'” This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, topiramate, lamotrigine and felbamate

Sodium Valproate Injection may increase the effect of the following medicines:

•    Medicines used for thinning the blood (such as warfarin)

•    Zidovudine used to treat HIV infection

•    Temozolomide used to treat cancer

•    Medicines for depression

•    Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid

•    Medicines used to calm emotional and mental conditions such as diazepam and olanzapine.

The following medicines can affect the way Sodium Valproate Injection works:

•    Some medicines used for the prevention and treatment of malaria such as mefloquine and chloroquine

•    Cimetidine used for stomach ulcers

•    Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem, meropenem, rifampicin and erythromycin. The combination of Sodium Valproate Injection and carbapenems should be avoided because it may decrease the effect of your medicine.

•    Colestyramine used to lower blood fat (cholesterol) levels. Sodium Valproate Injection with food, drink and alcohol Alcohol intake is not recommended during treatment.

Pregnancy, breast feeding and fertility

Important advice for women

•    Valproate can be harmful to unborn children when given to a woman during pregnancy.

•    Valproate carries a risk if given during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.

•    It can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.

•    If you are given valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. Because valproate has been used for many years we know that in women who are given valproate around

10 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women who don't have epilepsy.

•    It is estimated that up to 30-40% of preschool children whose mothers received valproate during pregnancy may have problems with early childhood development. Children affected can be slow to walk and talk, intellectually less able than other children, and have difficulty with language and memory.

•    Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

•    If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.

•    Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst having valproate. If you decide later you want to have a child you should not stop having your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.

•    Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

FIRST PRESCRIPTION

If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant. Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

•    Make sure you are using an effective method of contraception.

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

CONTINUING TREATMENT AND NOT TRYING FOR A BABY

If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

•    Make sure you are using an effective method of contraception

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY

If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop having your valproate or taking your contraceptive medicine until you have discussed this with your prescriber. You should talk to your doctor well before you become pregnant so that you can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.

Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.

If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.

Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

Key messages:

•    Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy is controlled and the risks to your baby are reduced.

•    Tell your doctor at once when you know or think you might be pregnant.

UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating. If you are having valproate and you think you are pregnant or might be pregnant contact your doctor at once.

Do not stop having your medicine until your doctor tells you to.

Ask your doctor about taking folic acid. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.

However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

Key messages:

•    Tell your doctor at once if you know you are pregnant or think you might be pregnant.

•    Do not stop having valproate unless your doctor tells you to. Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.

Breast-feeding

Very little Sodium Valproate Injection gets into breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor or nurse for advice before taking any medicine.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY im Valproate 100mg/ml Solution lor Injection or Infusion

e refer to the Summary of Product Characteristics (SmPC) for further details on this product.

Each ml of solution contains 100 mg sodium valproate. Each 4 ml ampoule contains 400 mg sodium valproate. Each 10 ml ampoule contains 1000^ mgsidium valproate. ^

Pharmaceutical Fom

Solution for injection or infusion. A clear, colourless solution.

Sodium Valproate 100mg/ml Solution for Injection or Infusion

Please refer to the Summary of Product Characteristics (SmPC) for further details on this product.

separate in

Dosage requirements vary according to age and body weight. Each vial of sodium valproate injection is for single dose injection only. For instructions on preparation and dilution of sodium valproate injection before administration see section 6.6. Special precautions for disposal and other handling of the SmPC.

Patients already satisfactorily treated with oral sodium valproate may be continued at their current dosage using continuous or repeated infusion. Other patients may be given a slow intravenous injection minutes, usually 400-800mg depending on body weight (up to 10mg/kg) followed by continuous or repeated infusion up to a maximum of 2500mg/day.

Sodium valproate injection should not be administered via the same IV line as other IV additives.

The intravenous solution is suitable for infusion by PVC, polyethylene or glass containers.

Sodium valproate injection should be replaced by oral valproate therapy as soon as practicable.

Use with Children:Daily requirement for children is usually in the range 20 - 30mg/kg body weight per day and method of administration is as above. Where adequate control is not achieved within this range, the dose may be increased to 40 mg/kg/day but only in patients in whom plasma valproic acid levels can be monitored. Above 40 mg/kg/day clinical chemistry and haematological parameters should be monitored.

Use in elderly:Although the pharmacokinetics of sodium valproate are modified in the elderly, they have limited clinical significance and dosage should be determined by seizure control. The volume of distribution is increased in the elderly and because of decreased binding to serum albumin, the proportion of free drug is increased. This will affect the clinical interpretation of plasma valproic acid levels.

In patients with renal insufficiency: It may be necessary to decrease dosage. Dosage should be adjusted according to clinical monitoring since monitoring of plasma concentrations may be misleading (see section 5.2 Pharmacokinetic Properties of the SmPC).

In patients with hepatic insufficiency: Salicylates should not be used concomitantly with sodium valproate since they employ the same metabolic pathway (see section 4.4 Special Warnings and Precautions for Use and 4.8 Undesirable Effects of the SmPC).

Liver dysfunction, including hepatic failure resulting in fatalities, has occurred in patients whose treatment included valproic acid (see section 4.3 Contraindications and 4.4 Special Warnings and Precautions for Use of the SmPC).

Salicylates should not be used in children under 16 years (see aspirin/salicylate product information on Reye's syndrome). In addition in conjunction with sodium valproate, concomitant use in children under 3 years can increase the risk of liver toxicity (see section 4.4 Special Warnings of the SmPC). Female children, female adolescents, women of childbearing potential and pregnant women:

Sodium valproate injection should be initiated and supervised by a specialist experienced in the management of epilepsy. Treatment should only be initiated if other treatments are ineffective or not tolerated (see sections 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews. Preferably sodium valproate should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma concentrations. The daily dose should be divided into at least two single doses.

Driving and using machines

You may feel sleepy after having Sodium Valproate Injection. If this happens to you, do not drive or use any tools or machines. Taking other medicines used to treat fits or calm emotional and mental health problems may increase sleepiness.

3. HOW SODIUM VALPROATE INJECTION IS GIVEN

Sodium Valproate Injection is always given to you by a doctor or nurse. This is because it needs to be given as a slow injection or infusion into the vein. If you are not sure why you are being given Sodium Valproate Injection or have any questions about how much Sodium Valproate Injection is being given to you, speak to your doctor or nurse.

Your doctor will stop giving you Sodium Valproate Injection and change you to oral therapy (by mouth) as soon as possible.

Sodium Valproate Injection treatment must be started and supervised by a doctor specialised in the treatment of epilepsy How much will be given to you

•    Your doctor will decide how much Sodium Valproate Injection to give you depending on your illness. The amount of Sodium Valproate Injection given to you or your child will depend on you or your child's age or body weight

•    If you have been taking Sodium Valproate by mouth your doctor may decide to give you the same amount of Sodium Valproate Injection by continuous or repeated infusion.

If you have not had Sodium Valproate Injection before, the doctor will use the following doses:

Adults (including the elderly)

•    The starting dose is usually between 400mg and 800mg daily (up to 10mg per kilogram of body weight)

•    This is given as a slow intravenous injection over 3-5 minutes

•    This is followed by a continuous or repeated infusion, up to a maximum dose of 2500mg each day.

Children

•    The usual dose is between 20mg and 30mg for each kilogram of body weight each day

•    This may be increased to 40mg for each kilogram of body weight each day depending on your child's illness.

Patients with kidney problems

•    Your doctor may decide to adjust your or your child's dose Patients taking other medicines for ‘fits’ (epilepsy)

•    You or your child may be taking other medicines for epilepsy at the same time as Sodium Valproate Injection. If so, your doctor should gradually initiate treatment depending on you or your child's condition

•    Your doctor may increase the dose of Sodium Valproate Injection by 5 to 10mg for each kilogram of body weight each day depending on which other medicines you are taking.

If have more Sodium Valproate Injection than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor will be checking your progress and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

Having too much Sodium Valproate Injection can lead to the following symptoms: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.

If you forget to have Sodium Valproate Injection Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.

If you stop receiving Sodium Valproate Injection It is important for you to keep having Sodium Valproate Injection until your doctor decides to stop them. If you stop, your fits may come back. Tests

Make sure you or your child keep your regular appointments for a check-up. They are very important as your or your child's dose may need to be changed. Sodium Valproate Injection can change the levels of liver enzymes shown up in blood tests. This can mean that your or your child's liver is not working properly. If you or your child go into hospital or visit another doctor or a dentist, tell them you are having Sodium Valproate Injection.

If you have any further questions about receiving this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Sodium Valproate Injection can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

•    You have an allergic reaction. The signs may include: a rash, joint pain, fever (systemic lupus erythematosus), swallowing or breathing problems, swelling of your lips, face, throat or tongue. Hands, feet or genitals may also be affected. More severe allergic reactions can lead to lymph node enlargement and possible impairment of other organs.

•    Liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. This happens in a very small number of people having Sodium Valproate Injection. It includes feeling and being sick many times, being very tired, sleepy and weak, stomach pain including very bad upper stomach pain, jaundice (yellowing

of the skin or whites of the eyes), loss of appetite, swelling (especially of the legs and feet but may include other parts of the body), worsening of your fits or a general feeling of being unwell. Your doctor may stop giving you Sodium Valproate Injection immediately if you have these symptoms.

•    You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid.

The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme.'

•    Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome.'

•    Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis.'

•    Bruising more easily and getting more infections than usual. This could be a blood problem called ‘thrombocytopenia'. It can also be due to a fall in the number of white blood cells, bone marrow depression or another condition that affects red blood cells, white blood cells and platelets (pancytopenia) or how the blood clots.

•    Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.

•    Changes in mood, loss of memory, lack of concentration and deep loss of consciousness (coma).

•    Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism)

•    Breathing difficulty and pain due to inflammation of the lungs (pleural effusion)

Combined Therapy: When starting sodium valproate injection in patients already on other anticonvulsants these should be tapered slowly. Initiation of sodium valproate injection therapy should then be gradual, with target dose reached after about two weeks. In certain cases it may be necessary to raise the dose by 5 to 10mg/kg/day when used in combination with anticonvulsants which induce liver enzyme activity, e.g. phenytoin, phenobarbital and carbamazepine. Once known enzyme inducers have been withdrawn it may be possible to maintain seizure control on a reduced dose of sodium valproate injection.

When barbiturates are being administered concomitantly and particularly if sedation is observed (particularly in children) the dosage of barbiturates should be reduced.

N.B. In children requiring doses higher than 40 mg/kg/day clinical chemistry and haematological parameters should be monitored.

Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels is unnecessary. However, a method for measurement of plasma levels is available and may be helpful where there is poor control or side effects are suspected (see section 5.2 Pharmacokinetic Properties of the SmPC).

Pharmaceutical Particulars List of Excipients

Disodium hydrogen phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Phosphoric acid (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Water for injections

Incompatibilities

Sodium valproate Intravenous should not be administered via the same line as other IV additives. This medicinal product must not be mixed with other medicinal products except those mentioned in the section entitled ‘Special precautions for disposal and other handling'.

Shelf Life

Unopened: 3 years.

After dilution according to the directions detailed in the section entitled ‘Special precautions for disposal and other handling': Chemical and physical in-use stability has been demonstrated for seven days at 20 - 22°C. From a microbiological point of view, the product should be used immediately

Tell your doctor as soon as possible if you have any of the following side effects:

•    Changes in behaviour including being very alert, and sometimes also aggressive, hyperactive and unusual or

inappropriate behaviour.

This is more likely if other medicine to treat fits such as phenobarbital and topiramate are taken at the same time or if the Sodium Valproate Injection starting dose is high or has been suddenly increased.

•    Changes in the amount

of ammonia in the blood. Symptoms of this condition are being sick, problems with balance and co-ordination, feeling lethargic or less alert.

•    Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements

•    Feeling tired or confused with loss of consciousness sometimes accompanied by hallucinations or fits.

•    Blisters with the skin flaking away.

•    Rapid, uncontrollable movement of the eyes

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:

•    Feeling sick, stomach ache or diarrhoea, especially when starting treatment.

•    Fainting

•    Hearing loss

•    Skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine

•    Acne

•    Hair loss which is usually temporary. When it grows back it may be more curly than before

•    Hair, including body or facial hair grows more than normal in women

•    Skin rash caused by narrow or blocked blood vessels (vasculitis)

•    Changes in women's periods and increased hair growth in women

•    Breast enlargement in men

•    Swelling of the feet and legs (oedema)

•    Weight gain, leading to obesity in rare cases - as your appetite may be increased

•    Kidney problems, bedwetting or increased need to pass urine

•    Headache

•    Aggression, agitation, disturbance in attention, abnormal behaviour, restlessness/hyperactivity and learning disorder

•    Tingling or numbness of the hands or feet

•    Nail and nail bed disorders are common Bone Disorders

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

Blood tests

Sodium Valproate Injection can change levels of liver enzymes, salts or sugars shown up on blood and urine tests.

Male fertility

Sodium Valproate Injection can be a contributing factor in male infertility.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SODIUM VALPROATE INJECTION

This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.

Do not have this medicine if the expiry date on the carton has passed. The expiry date refers to the last day of that month.

Do not freeze. Only clear solutions free of particles should be used. The contents of the ampoule are for single use only.

Medicines should not be disposed of via 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 Sodium Valproate Injection contains

The active ingredient is sodium valproate 100mg per ml.

The other ingredients are Disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide and water for injections.

What Sodium Valproate Injection looks like and contents of the pack

Sodium Valproate Injection is a clear colourless solution. It is available in glass ampoules containing either 4ml (400mg sodium valproate) or 10ml (1000mg sodium valproate) of the solution for injection.

Each pack contains 1,5 or 10 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,

Wrexham Industrial Estate, Wrexham, LL13 9UF, UK Other sources of information:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name	Reference number
Sodium Valproate 100mg/ml Solution for Injection or Infusion	29831/0506

This is a service provided by the Royal National Institute of Blind People.

For Malta, please call +44 1978 661261.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom and Malta: Sodium Valproate 100mg/ml Solution

for Injection or Infusion

This leaflet was last revised in 06/2016

_l05857/5__________fwVCKHARDT

after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be not longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Special Precautions for Storage

Do not freeze.

Nature and contents of container

Clear glass 5ml-capacity ampoules (PhEur Type I, One Point Cut with black spot), containing 4ml of solution and clear glass 10ml-capacity ampoules (PhEur Type I, One Point Cut with red spot) containing 10ml of solution.

The ampoules are packed in a PVC tray and cardboard box in packs of 1,5 or 10 ampoules per pack. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

For infusion the product may be diluted in 0.9% saline or 5% dextrose. Tests with the recommended infusion solutions over seven days at 20 - 22°C show compatibility.

Prior to use sodium valproate solution for injection and the diluted solution should be visually inspected. Only clear solutions without particles should be used.

The contents of the ampoule are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK

Marketing Authorisation Number PL 29831/0506; MA 154/10201 Date of Revision of Text: 06/2016

105857/5    Twockhardt