2.5 mg / ml, 5 mg / ml injection solution 
bupivacaine hydrochloride

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 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 Bupivacaine Accord is and what it is used for 
2. What you need to know before you take Bupivacaine Accord 
3. How to use Bupivacaine Accord 
4. Possible side effects 
5. How to store Bupivacaine Accord 
6. Contents of the packaging and other information 

1. What Bupivacaine Accord is and what it is used for

Bupivacaine Accord contains the active substance bupivacaine hydrochloride. It belongs to a group of medicines called amide-type local anesthetics.

Bupivacaine Accord is used to numb parts of the body. It is used to prevent pain or to provide pain relief. It can be used to:

  • numb parts of the body during surgery in adults and children from 12 years of age
  • relieve pain during childbirth
  • relieve pain in adults, infants, and children from 1 year of age.

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

2. What you need to know before taking Bupivacaine Accord

Do not use Bupivacaine Accord:

Bupivacaine Accord should not be given:

  • if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to any other local anesthetic in the same class (eg lidocaine or ropivacaine)
  • if you have a skin infection near the place where you should get the injection one
  • if you have something called a cardiogenic shock (a condition that means that the heart cannot transport enough blood to the body)
  • if you have something called hypovolemic shock (very low blood pressure leading to collapse)
  • if you have problems with blood clotting (coagulation disorder) or ongoing treatment with blood thinners
  • if you have diseases of the brain or spine meningitis ( meningitis ), polio, or ryggkotsinflammation (spondylitis)
  • if you have a severe headache due to bleeding in the brain ( intracranial hemorrhage)
  • if you have spinal cord problems due to anemia ( anemia )
  • if you have sepsis ( septicemia )
  • if you have recently suffered an injury, tuberculosis, or tumor in your spine
  • if you get obstetric paracervical blockage (a type of anesthesia during childbirth)

You should not receive a Bupivacaine Accord if any of the above apply to you. If you are not sure, talk to your doctor or nurse before getting Bupivacaine Accord.

Warnings and Precautions

Tell your doctor or nurse before you are given Bupivacaine Accord:

  • if you have heart, kidney, or liver problems. This is because your doctor may need to adjust the dose of a Bupivacaine Accord
  • if you have a swollen stomach due to more fluid than normal
  • if you have a tumor in your stomach
  • if you have been told that you have reduced blood volume in your body ( hypovolemia )
  • if you have fluid in your lungs
  • if you have epilepsy
  • if you are to receive adrenaline-containing bupivacaine for special techniques (eg, penis-blocked, colon-blocked) to numb parts of the body where areas of the arteries are affected.

Children

  • For children under 12 years of age: Some injections of Bupivacaine Accord used to numb parts of the body during surgery have not been established in younger children. The use of Bupivacaine Accord has not been established in children under 1 year of age.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Bupivacaine Accord.

Other medicines and Bupivacaine Accord

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter ones and herbal medicines. This is because Bupivacaine Accord may affect the way some medicines work and some medicines may affect the way Bupivacaine Accord works.

This is especially true if you are taking any of the following medicines:

  • Drugs used to treat irregular heartbeats ( arrhythmia ) such as lidocaine, mexiletine, or amiodarone.
  • Drugs used to prevent blood clotting ( anticoagulants ).

Your doctor needs to know that you are taking these medicines in order to calculate the correct dose of Bupivacaine Accord for you.

Pregnancy, breastfeeding, and fertility

Pregnancy

There are no or limited amount of data from the use of Bupivacaine Accord in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breast-feeding

Bupivacaine Accord passes into breast milk. Discuss options with your doctor if you are breast-feeding.

Fertility

There are no data on the effect of bupivacaine hydrochloride on human fertility.

Driving and using machines

Bupivacaine Accord may make you feel tired and affect your ability to react. Once you have received the Bupivacaine Accord, do not drive or use any tools or machines until the following day.

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

Bupivacaine Accord contains sodium

1 ml Bupivacaine Accord 0.25% w / v solution for injection contains 0.15 mmol (3.4 mg) sodium . 1 ml Bupivacaine Accord 0.5% w / v solution for injection contains 0.14 mmol (3.2 mg) sodium . This should be considered in patients prescribed a low-salt diet.

3. How to use Bupivacaine Accord

You get Bupivacaine Accord from a doctor. Your doctor has knowledge of the correct administration of this medicine.

The dose that your doctor gives you depends on the type of pain relief you need and in which part of your body the medicine is to be administered. It also depends on your body size, age, and physical condition. Usually, one dose is enough, but several doses can be administered if the operation takes a long time.

You will receive the Bupivacaine Accord as an injection or infusion . In which part of the body you get the injection one depends on why you are getting Bupivacaine Accord. Your doctor may give you Bupivacaine Accord in the following places:

  • Close to the part of the body to be anesthetized.
  • In an area that is not close to the part of the body that is to be anesthetized. This is the case when you get an epidural injection (an injection around the spinal cord).

When Bupivacaine Accord is injected into the body in one of these ways, it leads to the nerves not being able to send pain messages to the brain. The effect slowly disappears when the procedure is completed.

If you take more Bupivacaine Accord than you should

It is unlikely that you will get serious side effects if you get too much Bupivacaine Accord. They require special treatment and the doctor treating you is trained to deal with these situations. The first signs that you have received too much Bupivacaine Accord are usually the following:

  • You feel dizzy or unsteady
  • Numbness in the lips and around the mouth
  • Numbness in the tongue
  • Hearing problems
  • Vision problems

To reduce the risk of serious side effects, your doctor should stop giving you Bupivacaine Accord as soon as these signs occur. This means that if any of these affect you, or if you think you have been given too much Bupivacaine Accord, tell your doctor straight away.

More serious side effects that can occur if you have received too much Bupivacaine Accord are muscle twitching, seizures, and unconsciousness.

4. Possible side effects

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

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

In case of signs of a severe allergic reaction, contact a doctor immediately. These signs may include sudden onset of:

  • Swelling of face, lips, tongue, and throat. This can make it difficult to swallow
  • Severe or sudden swelling of the hands, feet, and ankles
  • Breathing difficulties
  • Severe itching of the skin (with raised lumps)

Other possible side effects:

Very common: may affect more than 1 user in 10

  • Low blood pressure. This can make you feel dizzy or unsteady
  • Nausea

Common: may affect up to 1 in 10 users

  • Nausea (vomiting)
  • Dizziness
  • Tingling and numbness
  • High blood pressure ( hypertension )
  • Slow heartbeat
  • Difficulty urinating

Less common; may affect up to 1 in 100 users

  • Feeling unsteady
  • Seizures
  • Numbness in the tongue or around the mouth
  • Earrings or sound sensitivity
  • Speech difficulties
  • Dimsyn
  • Unconsciousness
  • Tremors ( tremor )
  • Muscle twitches

Rare may affect up to 1 in 1,000 people

  • Double vision
  • Nerve damage can lead to sensory changes or muscle weakness ( neuropathy). This may include peripheral nerve damage (mainly in the arms and/or legs)
  • A condition called arachnoiditis ( inflammation of the membrane surrounding the spinal cord). Signs include stabbing or burning pain in the lower back or legs, and tingling, numbness, or weakness in the legs
  • Weak or paralyzed legs
  • Uneven heartbeat ( arrhythmia ). This can be life-threatening
  • Slow breathing or respiratory arrest or cardiac arrest. This can be life-threatening

Any side effects seen with other local anesthetics that may also be caused by the Bupivacaine Accord include:

  • Problem with liver enzymes. This may occur with long-term treatment with this medicine
  • Nerve damage. This can in rare cases become permanent
  • Non-permanent blindness or problems with the muscles of the eyes that are long-lasting. This can happen with certain injections given around the eyes

Do not worry about this list of possible side effects. You may not get any of them.

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 Bupivacaine Accord

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

Use before the expiry date which is stated on the ampoule, vial, and carton. The expiration date is the last day of the specified month.

Do not use this medicine if you notice that the contents are discolored in any way or if there are particles.

Store in a cold place. Do not freeze.

Bupivacaine Accord is usually stored by a doctor or hospital and they are responsible for the quality of the medicine once it has been opened unless used immediately. They are also responsible for not disposing of unused Bupivacaine Accord properly.

6. Contents of the packaging and other information

Content declaration

The active substance is bupivacaine hydrochloride.

Bupivacaine Accord 2.5 mg/ml solution for injection :

1 ml contains 2.5 mg bupivacaine hydrochloride (as monohydrate)

5 ml contains 12.5 mg bupivacaine hydrochloride (as monohydrate)

10 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)

20 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)

Bupivacaine Accord 5 mg/ml solution for injection :

1 ml contains 5 mg bupivacaine hydrochloride (as monohydrate)

2 ml contains 10 mg bupivacaine hydrochloride (as monohydrate)

4 ml contains 20 mg bupivacaine hydrochloride (as monohydrate)

5 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)

10 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)

20 ml contains 100 mg bupivacaine hydrochloride (as monohydrate)

The other ingredients are water for injections, sodium chloride, and sodium hydroxide (E524) (for pH adjustment).

What the medicine looks like and the contents of the pack

Bupivacaine Accord solution for injection is a clear, colorless, sterile solution for injection. It is available as a type I clear glass ampoule and type I clear glass vials with a rubber stopper and flip-off seal.

Bupivacaine Accord 2.5 mg/ml solution for injection :

5 ml vial s with a white band in packs of 5 and 10 ampoule s

10 ml vial s with green bands in packs of 5, 10, 15, and 20 ampoule s

20 ml vials with chlorobutyl rubber stopper and an orange flip-off seal are supplied in packs of 1 vial

Bupivacaine Accord 5 mg/ml solution for injection :

2 ml vial s with two orange rings in packs of 5 and 10 ampoule s

4 mL vial s with red tape in packs of 5 and 10 ampoule s

5 ml vial s with the blue band in packs of 5 and 10 ampoule s

10 ml vial s with yellow bands in packs of 5, 10, 15, and 20 ampoule s

20 ml vials with chlorobutyl rubber stopper and a red flip-off seal are supplied in packs of 1 vial

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4 HF

UK

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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