0.625 mg / ml and 1.25 mg / mL infusion solution 
levobupivacaine

Read all of this leaflet carefully before you start using 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, pharmacist 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 Chirocaine is and what it is used for 
2. What you need to know before you are given Chirocaine 
3. How to take Chirocaine 
4. Possible side effects 
5. How to store Chirocaine 
6. Contents of the packaging and other information 

What Chirocaine is and what it is used for

Chirocaine belongs to a group of medicines called local anesthetics. This type of medicine is used to numb or relieve a part of the body.

Chirocaine infusion solution must be used only in adults.

Chirocaine is used for pain relief:

  • after major surgeries
  • at births

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

Do not use Chirocaine

  • if you are allergic (hypersensitive) to levobupivacaine, to similar local anesthetics to any of the other ingredients of this medicine (listed in section 6)
  • if you have very low blood pressure
  • as a type of pain relief given by injection in the area around the cervix ( cervix ) during the opening stage of labor (paracervical blockade)
  • to numb an area by injecting Chirocaine into a vein

Warnings and cautions

Before treatment with Chirocaine, tell your doctor or nurse if you suffer from any of the conditions or any of the conditions listed below. You may need to be monitored more closely or you may need to be given a smaller dose.

  • if you have diseases of the nervous system
  • if you are weak or ill
  • if you are older
  • if you have liver disease.

Other drugs and Chirocaine

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines. Be especially careful to tell if you are taking medicines for:

  • irregular heartbeat (eg mexiletine)
  • fungal infections (eg ketoconazole ) as it may affect how long Chirocaine stays in the body
  • asthma (eg theophylline) because it can affect how long Chirocaine stays in the body

Pregnancy, breastfeeding, and fertility

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

Chirocaine must not be given as pain relief by injection in the area around the cervix ( cervix ) during childbirth (paracervical blockade).

The effect of Chirocaine on the baby during early pregnancy is unknown. Therefore, Chirocaine should not be used during the first three months of pregnancy unless your doctor considers it necessary.

It is not known if levobupivacaine is transferred to breast milk, but experience with a similar drug shows that only small amounts of levobupivacaine are expected to be transferred to breast milk. It is therefore possible to breastfeed after using Chirocaine as a local anesthetic.

Driving and using machines

Chirocaine can have significant effects on the ability to drive and use machines. You must not drive or use machines until all effects of Chirocaine and the immediate effects of the operation have ceased. Consult the doctor or nurse treating you before leaving the hospital.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 nurse.

Chirocaine contains sodium

This medicine contains 3.5 mg/ml sodium in an infusion bag or ampoule, which should be considered by patients on a low-salt diet.

3. How to get Chirocaine

The doctor gives Chirocaine through a small tube in the back (epidural). Your doctor and nurse will monitor you closely when you receive Chirocaine.

Dosage

Adults:

The amount and how often Chirocaine is given depends on why Chirocaine is used and on your health, age, and weight. The minimum dose that can generate anesthesia in the intended area will be used. Dosage one is carefully prepared by the doctor.

When Chirocaine is used for pain relief during childbirth, the dose should be monitored particularly carefully.

Children:

Not recommended.

If you take more Chirocaine than you should

If you are given too much Chirocaine, you may experience numbness of the tongue, dizziness, blurred vision, muscle twitching, severe difficulty breathing (including pauses in breathing), and seizures. Tell your doctor immediately if you notice any of these symptoms. In some cases, too much Chirocaine can cause low blood pressure, fast or slow heartbeat, and changes in heart rate. Your doctor may need to give you other medicines to relieve these symptoms.

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. Some side effects of Chirocaine can be serious.

If you notice any of the following side effects, contact your doctor or nurse immediately.

Very common: may affect more than 1 in 10 people

  • feelings of fatigue or weakness, shortness of breath, pallor (all of these are signs of anemia )

Common: may affect up to 1 in 10 people

  • complications (discomfort) for an unborn child

No known frequency: frequency can not be calculated from the available data

  • severe allergic reactions (hypersensitivity) that cause difficulty breathing, difficulty swallowing, rash, very low blood pressure, and swelling of the tongue or throat
  • respiratory arrest
  • heart block or cardiac arrest
  • unconsciousness
  • paralysis
  • seizures

Other side effects that may also occur:

Very common: may affect more than 1 in 10 people

  • low blood pressure
  • nausea

Common: may affect up to 1 in 10 people

  • dizziness
  • headache
  • vomiting
  • back pain
  • high body temperature (fever)
  • pain after surgery

No known frequency: frequency can not be calculated from the available data

  • allergic reactions (hypersensitivity) characterized by red, itchy skin, sneezing, profuse sweating, rapid heartbeat, fainting, or swelling of the face, lips, and mouth.
  • somnolence
  • dimsyn
  • localized knitting
  • numbness of the tongue
  • muscle weakness or muscle twitching
  • lost control of the bladder and intestines
  • tingling, numbness, or other abnormal sensations
  • prolonged erection of the penis which can be painful
  • nerve disease that may include drooping eyelids, small eye pupils, sunken eye socket, sweating, and/or unilateral redness of the face.

Rapid, slow, or irregular heartbeats and changes in heart rate that can be seen on an ECG have also been reported as side effects.

In rare cases, some side effects may be long-lasting or permanent.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Chirocaine

  • 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 label. The expiration date is the last day of the specified month.
  • This medicine is stored by your doctor.
  • The solution should be used immediately after opening the package.
  • The solution must not be used if there are visible particles in it.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is levobupivacaine (as hydrochloride).

Chirocaine 0.625 mg / ml solution for infusion : One ml contains 0.625 mg levobupivacaine (as hydrochloride).

Chirocaine 1.25 mg / ml solution for infusion : One ml contains 1.25 mg levobupivacaine (as hydrochloride).

The other ingredients are water for injections, sodium chloride, sodium hydroxide, and a small amount of hydrochloric acid.

What the medicine looks like and contents of the pack

Chirocaine is a clear, colorless solution in a soft polyester bag with an aluminum outer bag. Each bag contains 100 ml or 200 ml of solution. Chirocaine is delivered in packs of 5 bags with 100 ml or 200 ml solution, 24 or 60 bags with 100 ml solution, and 12 or 32 bags with 200 ml solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder

AbbVie AB 
Box 1523

171 29 Solna

Manufacturer

Baxter Healthcare SA, Moneen Road, Castlebar, Ireland

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

Chirocaine: Italy, Netherlands, France, UK, Ireland, Finland, Greece, Belgium, Luxembourg.

Chirocane: Spain

Muhammad Nadeem

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