Salvudex

Patient information leaflet

Salvudex hyperbaric 5 mg/ml injectable solution

bupivacaine hydrochloride
Equivalent medicine
Please read 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 questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Salvudex is and what it is used for
2. What you need to know before you are given Salvudex
3. How Salvudex will be administered
4. Possible side effects
5. How to store Salvudex
6. Package contents and other information

1. What Salvudex is and what it is used for

Salvudex contains bupivacaine hydrochloride. It is a local anaesthetic used to numb
(anaesthetize) the lower parts of the body during surgical procedures in adults and children of all
ages. It is used, for example, to numb the legs prior to surgery, in urological or abdominal surgery.
The medicine temporarily blocks nerve signals in the area where it is injected and reduces or
eliminates sensation temporarily in certain parts of the body.

2. What you need to know before you are given Salvudex

Salvudex must not be administered if:

• you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to other local anaesthetics of the same class (e.g. mepivacaine, lidocaine). Intrathecal anaesthesia must not be administered if:
• you have active acute diseases of the brain or spinal cord, such as meningitis, poliomyelitis or spondylitis
• you have severe headache caused by internal bleeding in the head (intracranial haemorrhage)
• you have blood poisoning (septicaemia)
• you have purulent infections at or near the injection site
• you have recently suffered trauma (e.g. a spinal fracture)
• you have tuberculosis or a tumour of the spinal cord
• you have spinal stenosis (narrowing of the spinal canal)
• you have a severe condition in which the heart is unable to supply sufficient blood to the body (cardiogenic shock)
• you have very low blood pressure leading to collapse (hypovolemic shock)
• you have a heart condition (heart failure)
• your blood does not clot properly or you are taking medicines to prevent blood clots
• you have spinal cord problems due to anaemia.

Warnings and precautions
Talk to your doctor or nurse before you are given Salvudex if:
you have a cardiac arrhythmia called AV block II or III
you have liver disease
you have kidney disease
you are elderly or debilitated
you are pregnant, especially if in an advanced stage
Neurological disorders are not considered to be worsened by anaesthesia, but caution is required.

Other medicines and Salvudex
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Salvudex may interact with other medicines, such as:

• other local anaesthetics
• medicines structurally similar to Salvudex, for example medicines for cardiac arrhythmias (antiarrhythmics).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or nurse for advice before being given this medicine.
Salvudex may be used during pregnancy and breastfeeding. Your doctor will adjust the dose if the pregnancy is advanced.

Driving and operating machinery
On the day of the procedure, you must not drive or operate machinery, as Salvudex may affect your reaction ability and muscular coordination.

Salvudex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially "sodium-free".

3. How Salvudex will be administered to you

Salvudex will be administered by a doctor, who will determine the correct dose. The medicine
is injected into the lower part of the spinal column.
The dosage depends on the type of surgery, the patient's age and weight, and will be determined by
the doctor.
Use in children and adolescents
Salvudex is slowly injected into the spinal canal (lower part of the spine) by an anaesthetist experienced in paediatric anaesthetic techniques.
If you are given more Salvudex than you should
It is unlikely that you will receive an overdose of this medicine, as it is administered in a hospital setting by healthcare professionals. If you are concerned that you may have received too high a dose, or if you have any doubts about the dose administered, speak to your doctor or nurse.
The first signs of an overdose of Salvudex are usually the following:

• Low blood pressure
• Slow pulse
• Irregular heartbeat
• Feeling dizzy or lightheaded
• Numbness of the lips and mouth
• Numbness of the tongue
• Hearing problems
• Vision problems

To reduce the risk of serious side effects, your doctor will stop the administration of
Salvudex as soon as these signs appear.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
If you experience any of the following symptoms, stop treatment and contact a doctor immediately:

• Signs of central nervous system toxicity, such as numbness, tingling, loss of movement (paresis), muscle weakness, or dysesthesia (abnormal sensation) (uncommon side effects, may affect up to 1 in 100 people)
• Sudden stopping of the heartbeat and loss of consciousness (cardiac arrest) (rare side effect, may affect up to 1 in 1,000 people)
• Slow and shallow breathing (respiratory depression) (rare side effect, may affect up to 1 in 1,000 people)
• Severe allergic reaction with symptoms such as difficulty breathing, swelling of the lips, throat and tongue, and low blood pressure (anaphylactic shock) (rare side effect, may affect up to 1 in 1,000 people)

Other side effects
Very common: (may affect more than 1 in 10 people)

• Nausea
• Low blood pressure
• Slow heart rate (bradycardia)

Common: (may affect up to 1 in 10 people)

• Headache
• Vomiting
• Difficulty urinating (urinary retention)
• Involuntary urination (urinary incontinence)

Uncommon: (may affect up to 1 in 100 people)

• Back pain
• Tingling, burning sensation, or numbness of the skin (paresthesia)

Rare: (may affect up to 1 in 1,000 people)

• Involuntary blockage of spinal nerves (spinal block), which may cause temporary loss of sensation in the abdomen and/or lower part of the body, respiratory depression, and even loss of consciousness.
• Bilateral paralysis, often in the lower part of the body or both legs (paraplegia)
• Pain and sensory disturbances due to nerve inflammation (neuropathy)
• Loss of voluntary movement (paralysis)
• Inflammation of a membrane surrounding the spinal cord (arachnoiditis), which may cause pain in the lower back, or pain, numbness, or weakness in the legs.
• Allergic reactions

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salvudex

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Salvudex contains

• The active substance is bupivacaine hydrochloride. Each ml of solution contains 5 mg of bupivacaine hydrochloride (as anhydrous).
• The other ingredients are monohydrate glucose, sodium hydroxide (for pH adjustment), and water for injections.

Description of the appearance and contents of the pack
Clear borosilicate glass vials of hydrolytic class with a single-point cut. The vials are
packaged in a sleeve and placed in a cardboard box.
Pack: 5 vials.
Marketing Authorization Holder
AS GRINDEKS.
Krustpils iela 53,
Rīga LV-1057,
Latvia
Manufacturer
HBM Pharma s.r.o.
Sklabinska 30
036 80, Martin
Slovakia
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Sweden Bupivacaine Spinal Tung Grindeks
Austria Mofecet 5 mg/ml Injektionslösung
Bulgaria Бемевакс 5 mg/ml инжекционен разтвор
Bemevax 5 mg/ml solution for injection
Czech Republic Salvudex
Germany Bupivacain hyperbar Grindeks 5 mg/ml Injektionslösung
Estonia Bemevax
Hungary Salvudex 5 mg/ml oldatos injekció
Italy Salvudex
Latvia Bupivacaine Grindeks 5 mg/ml šķīdums injekcijām ar glikozi
Lithuania Mofecet 5 mg/ml injekcinis tirpalas
Netherlands Bupivacaine Grindeks Glucose 5 mg/ml oplossing voor injectie
Poland Sanergy Heavy
Romania Bemevax 5 mg/ml soluție injectabilă
Slovakia Salvudex 5 mg/ml injekčný roztok
Slovenia Mofecet 5 mg/ml raztopina za injiciranje

The following information is intended exclusively for physicians or healthcare professionals:
The solution must be used immediately after opening.
As with all parenteral medicinal products, the solution should be inspected before use. Only clear solutions free from visible particles may be used.
The addition of additives to spinal solutions is not recommended.
Do not dispose of medicines via wastewater or household waste.