5mg / ml injection solution
bupivacaine hydrochloride

Read all of this leaflet carefully before you are given this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Hevicain Spinal Tung is and what it is used for
2. What you need to know before you use Hevicain Spinal Tung
3. How to use Hevicain Spinal Tung
4. Possible side effects
5. How to store Hevicain Spinal Tung
6. Contents of the pack and other information

1. What Hevicain Spinal Tung is and what it is used for

Hevicain Spinal Tung is a local anesthetic used to numb (remove the sensation) parts of the body. The anesthetic is used to block or relieve pain.

Hevicain Spinal Tung is used in surgeries for adults and children of all ages.

Hevicain Spinal Tongue is injected into the lower back of the spine when the lower abdomen, legs, or lower part of the body need to be anesthetized before the operation (eg hip surgery) or in connection with childbirth (cesarean section) or urinary tract surgery.

Hevicain Spinal Tongue blocks the nerve signals in the area where it is injected, which means that you cannot feel pain, cold, or heat. However, you can still feel pressure and touch.

Bupivacaine hydrochloride contained in Hevicain Spinal Tung may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Hevicain Spinal Tung

Do not use Hevicain Spinal Tongue

  • if you are allergic to bupivacaine hydrochloride, other amide-type local anesthetics or any of the other ingredients of this medicine (listed in section 6).
  • if you are to be sedated (by injection into a vein)
  • if you have acute active disease of the central nervous system , such as meningitis , tumors , polio, increased pressure or suspicion of increased pressure or bleeding in the head
  • if you have active disease and narrowing of the spinal canal or a nerve root (eg vertebral inflammation, tuberculosis , tumor ) or recent injury
    (eg fracture ) of a vertebra
  • if you have sepsis ( septicemia )
  • if you have acute anemia ( anemia ) in combination with degeneration (breakdown) of the spinal cord
  • if you have cardiovascular disease or heart failure
  • if you have an infection at or near the injection site
  • if your blood does not clot (coagulate) normally or if you are taking medicines that prevent the blood from clotting (exception: low dose heparin )
  • if you have cardiovascular disease in the heart muscle and the operation requires spreading the anesthesia all the way to vertebra T6.

Warnings and cautions

Talk to your doctor or nurse before giving Hevicain Spinal Tung.

Your doctor and healthcare professional will be extra careful when you are being treated for Hevicain Spinal Tung:

  • if you have a heart rhythm disorder ( AV block ) or other heart disease
  • if you have advanced liver disease
  • if you have impaired kidney function
  • if the blood’s ability to coagulate is impaired or if you are taking blood-thinning medicines
  • if you have anemia ( anemia )
  • if you have a nerve disease, e.g. multiple sclerosis (tissue changes in the brain and spinal cord), hemiplegia (unilateral paralysis), paraplegia (bilateral paralysis) or other muscle nerve disease
  • if you are older and your general condition is impaired
  • if you are in a late stage of pregnancy.

Other medicines and Hevicain Spinal Tung

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Tell your doctor

  • if you are taking other topical painkillers
  • if you are taking propofol (short-term anesthetic)
  • if you are taking medicines for heart rhythm disorders, such as lidocaine or amiodarone
  • if you are taking verapamil (medicines for arrhythmias and heart attacks)
  • if you are taking ACE inhibitors (medicines for high blood pressure )
  • if you are taking blood-thinning medicines
  • if you are taking cimetidine (medicine for stomach acid).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You can be treated with Hevicain Spinal Tongue during pregnancy.

Dose one should be reduced during later stages of pregnancy. Talk to your doctor.

Breast-feeding

You can be treated with Hevicain Spinal Tongue during breastfeeding. Breastfed babies are unlikely to be affected. Talk to your doctor.

Driving and using machines

You should not drive or use machines on the day of surgery as Hevicain Spinal Tung may affect your ability to react and muscle coordination.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hevicain Spinal Tung contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free.

3. How to use Hevicain Spinal Tongue

Hevicain Spinal Tongue will be given to you as a slow injection into the spinal cord by healthcare professionals trained in anesthesiology (anesthesia), who will also be available throughout the procedure. There will also be resuscitation equipment available.

Your dose will be determined by your doctor and it will be based on your illness, your general condition, and if you are pregnant. Only the doctor can change the dose.

Use for children and adolescents

Hevicain Spinal Tung is given as a slow injection into the spinal cord by an anesthesiologist (experienced anesthetist) with experience in anesthesia of children. Dose one depends on age and weight and will be determined by the anesthesiologist.

If you use more Hevicain Spinal Tung than you should 

It is very rare for side effects to occur due to overdose. The care staff is trained to handle such situations.

Signs of an overdose with Hevicain Spinal Tongue include low blood pressure, slow heartbeat, irregular heartbeat, or central nervous system effects. Tell your doctor immediately if you notice any of these signs.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

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

Serious side effects are

Uncommon (may affect up to 1 in 100 people)

  • paralysis or muscle weakness (paresis) 

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

  • heart failure
  • pain and sensory disturbances due to nerve inflammation
  • inflammation of the membrane surrounding the spinal cord (arachnoiditis). Symptoms of arachnoiditis may include drowsiness, joint pain, fever, rapid breathing
  • movement paralysis
  • bilateral paralysis, often in the lower part of the body or in both legs (paraplegia)
  • unintentional blockage of nerves in the spine (spinal block)
  • weak breathing. Blue staining of lips and nails. Contact a doctor immediately.
  • sudden skin rash and fainting (within minutes to hours) due to hypersensitivity (anaphylactic shock ), can be life-threatening. Contact a doctor immediately. 

Other side effects are

Very common (may affect more than 1 user in 10)

  • dizziness, possible fainting due to low blood pressure
  • nausea
  • slow pulse . Can get serious. If you experience a very slow pulse or feel sick or faint, consult a doctor. Contact a doctor immediately. 

Common (may affect up to 1 in 10 people)

  • headache
  • vomiting
  • difficulty urinating
  • accidental urination 

Uncommon (may affect up to 1 in 100 people)

  • muscle weakness
  • back pain
  • stinging sensation or loss of sensation in the skin
  • painful or abnormal sensation in the skin

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

  • allergic reactions

Additional side effects in children and adolescents

Side effects in children and adolescents are similar to those in adults.

Reporting of side effects ar

If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly via the details below. By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Hevicain Spinal Tung

No special storage instructions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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 packaging and other information

Content declaration

  • The active substance is bupivacaine hydrochloride.
  • The other ingredients are glucose monohydrate, sodium hydroxide, water for injections.

What the medicine looks like and contents of the pack

Colorless glass ampoules in blisters: 5 x 4 ml

Marketing Authorization Holder and Manufacturer

EQL Pharma AB
Stortorget 1

222 23 Lund

This medicinal product is authorized under the European Economic Area under the names:

Denmark: Hevicain Spinal Tung 5 mg/ml, solution for injection

Norway: Hevicain Spinal Tung 5 mg/ml, solution for injection

Sweden: Hevicain Spinal Heavy 5 mg/ml injection solution

Finland: Hevicain Spinal Tung 5 mg / ml, injection test, liuos

Muhammad Nadeem

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