Sanergy

Package leaflet: Information for the patient

Sanergy 5 mg/ml injectable solution

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

Contents of this leaflet

1. What Sanergy is and what it is used for
2. What you need to know before you are given Sanergy
3. How Sanergy is administered
4. Possible side effects
5. How to store Sanergy
6. Contents of the pack and other information

1. What Sanergye is and what it is used for

Sanergye is a local anaesthetic (agents with numbing effect at the site of application), for single use only.
Sanergye is used to numb (anaesthetize) certain parts of the body during surgical procedures and also to relieve pain. The main methods of use are listed below:

• to numb the part of the body where the surgical procedure will be performed;
• to relieve pain after surgery or following an acute injury.

Sanergye is used to numb (anaesthetize) certain parts of the body during surgical procedures in adults and children of all ages.
Sanergye is administered in the lower part of the spine when numbing of the legs or lower parts of the body is required.
Sanergye works by temporarily preventing nerve fibres in the numbed area from transmitting sensations of pain, heat, or cold. However, it is still possible to perceive pressure and touch. A surgical procedure will be performed on the numbed part of the body. In many cases, nerve fibres in the numbed area do not transmit impulses to the muscles, resulting in weakened or temporarily non-functioning muscles.

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

Sanergy must not be administered to you:

• if you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Inform your doctor if you are allergic to other similar local anesthetics, as the risk of allergy to Sanergy is increased;
• if you have blood clotting disorders or if you are taking medicines used to prevent blood clots;
• if you have other medical conditions for which your doctor has determined that you should not receive Sanergy.

If any of the above conditions apply to you, your doctor must not administer this medicine to you.
If you have any doubts, ask your doctor before this medicine is administered to you.
Warnings and precautions
Talk to your doctor before being given Sanergy if you have heart, kidney, or liver disease,
as your doctor may need to adjust the dose of the medicine.
Children and adolescents
This medicine is suitable for children of all ages.
Other medicines and Sanergy
Inform your doctor if you are taking, have recently taken, or might take any other medicines,
for example, other local anesthetics or medicines used to correct irregular heartbeat, as these may affect
the correct dose of Sanergy.
Your doctor must have a complete overview of all other medicines you are taking in order to calculate the correct required dose.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a
pregnancy, consult your doctor before this medicine is administered to you.
It has not been shown that Sanergy has a harmful effect on pregnancy.
Breastfeeding
Inform your doctor about breastfeeding before this medicine is administered to you.
It has not been shown that Sanergy has a harmful effect on the infant during breastfeeding.
Driving and using machines
After administration of Sanergy, your reaction ability may be delayed and muscle coordination reduced. After receiving Sanergy, you must not drive or operate vehicles, machinery, or tools until the following day.
Sanergy contains sodium chloride
This medicine contains less than 1 mmol of sodium (12.59 mg) per vial, i.e. essentially “sodium-free”.

3. How Sanery is administered to you

Your doctor will administer the medicine to you. The required dose will be calculated by your doctor based on clinical need and your physical condition.
Use in children and adolescents
An anaesthetist experienced in anaesthetic techniques for children will slowly administer the anaesthetic solution into the spinal canal (the part of the vertebral column that contains the spinal cord). The dose size depends on the patient's age and body weight and is always determined by an anaesthetist.
If you are given more Sanery than you should
Serious adverse effects due to excessive administration of Sanery are very rare and require special treatment. The doctor administering this medicine is prepared to manage such situations.
Rare side effects associated with this type of anaesthesia include high or total block. Elderly patients or women in advanced stages of pregnancy should be given a lower dose to avoid this side effect. Excessive block manifests as difficulty breathing, decreased blood pressure, and reduced cardiac activity.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Severe allergic reactions (may affect up to 1 in 1,000 people)

• If you experience a severe allergic reaction, contact your doctor immediately. Signs may include sudden onset of:
  swelling of the face, lips, tongue and throat. This may make swallowing difficult.
  severe or sudden swelling of hands, feet and ankles.
  difficulty breathing.
  severe skin itching (with blisters).

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

• decrease in blood pressure;
• slowing of heart rate;
• feeling unwell.

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

• headache;
• vomiting;
• difficulty urinating;
• involuntary loss of urine (incontinence).

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

• skin tingling sensation;
• partial paralysis;
• unusual perceptual sensation;
• muscle weakness;
• back pain.

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

• temporary anaesthesia of arms, legs and respiratory muscles;
• bilateral paralysis;
• paralysis;
• nervous system disorders;
• arachnoiditis (inflammation of the arachnoid);
• cardiac arrest.

Contact your doctor immediately if you feel unusually well during treatment with Sanergynon.
Side effects in children are similar to those in adults.

Reporting of side effects
If you experience any side effect, including any not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly via the reporting system at https://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 Sanergy

Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after "Exp". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Your doctor or hospital usually stores Sanergy. The staff are responsible for the proper storage, handling, and use of this medicine.

6. Package contents and other information

What Sanergy contains
The active substance is bupivacaine hydrochloride.
Each ml of injectable solution contains 5 mg of bupivacaine hydrochloride.
One vial (4 ml) contains 20 mg of bupivacaine hydrochloride.

• The other components are: sodium chloride, sodium hydroxide or hydrochloric acid, concentrated (for pH adjustment), water for injections.

Description of the appearance of Sanergy and the package contents
Clear, colourless liquid, practically free from visible particles.
4 ml of injectable solution in a 5 ml colourless borosilicate glass vial, hydrolytic class I, with a break ring or pre-scored point.
5 vials are packaged in a polyvinyl chloride film container.
1 container is packaged in a cardboard box.

Marketing Authorization Holder
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia

Manufacturer
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: SANERGY SPINAL
Netherlands: Bupivacaïne HCl Grindeks Spinaal 5 mg/ml oplossing voor injectie
Romania: SANERGY SPINAL 5 mg/ml soluţie injectabilă
Slovakia: SANERGY SPINAL 5 mg/ml injekčný roztok
Austria: Bupivacain Grindeks Spinal 5 mg/ml Injektionslösung
Bulgaria: Санерджи Спинал 5 mg/ml инжекционен разтвор
Germany: Sanergy 5 mg/ml Injektionslösung
Hungary: Sanergy Spinal 5 mg/ml oldatos injekció
Italy: Sanergy
Slovenia: Sanergy Spinal 5 mg/ml raztopina za injiciranje