133 mg / 10 ml, 266 mg / 20 ml solution for injection , prolonged-release dispersion 
bupivacaine

1. What EXPAREL liposomal is and what it is used for

EXPAREL liposomal is a local anesthetic that contains the active substance bupivacaine.

EXPAREL liposomal is used in adult patients to reduce pain in a specific part of the body or small to medium-sized surgical wounds after surgery (such as surgery to remove hemorrhoids, hallux valgus, or knee or shoulder surgery).

What you need to know before you are given EXPAREL liposomal

You must NOT be given this medicine:

  • if you are allergic to bupivacaine (or any other similar local anesthetic) or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
  • if you are pregnant and need to get local anesthetics injected into the top of your vagina via the cervix. Bupivacaine can cause serious harm to the unborn child if used for this purpose.
  • in a blood vessel or the joints.

Warnings and cautions

EXPAREL liposomal should not be used in major surgeries in the abdomen, blood vessels, or chest.

Talk to your doctor or nurse before giving EXPAREL liposomal:

  • if you have heart problems
  • if you have liver or kidney problems.

EXPAREL liposomal may cause temporary loss of sensation or movement. You may notice a change in your ability to feel things or move normally for up to 5 days after receiving the medicine.

The following conditions have sometimes been reported with the use of other local anesthetics:

  • Allergic reactions
    Allergic reactions may in rare cases occur after you have been given local anesthetics. Signs of allergic reactions you should be aware of: hives or skin rash, swelling around the eyes, face, lips, mouth, or throat, shortness of breath or difficulty breathing, dizziness or fainting, or fever. Seek medical attention immediately if you notice any of these symptoms after receiving EXPAREL liposomal as these reactions may in rare cases be life-threatening (see also section 4 of this leaflet).
  • Neurological conditions
    Toxicity in the central nervous system may also occur occasionally. Early signs of this include restlessness, anxiety, difficulty speaking, unsteadiness, nausea or vomiting, numbness and tingling in the mouth and lips, metallic taste, tinnitus(ringing in the ears), dizziness, blurred vision, tremors or twitching, depression, drowsiness. Seek medical attention immediately if you notice any of these symptoms after receiving EXPAREL liposomal. More serious side effects, if you have received too much bupivacaine, include convulsions (convulsions), unconsciousness, and heart attack (see also section 4 of this leaflet).
  • Cardiovascular problems
    Cardiovascular problems can sometimes also occur after the use of local anesthetics. Signs to be aware of are abnormal/irregular heartbeat, low blood pressure, fainting, dizziness or feeling unsteady, fatigue, shortness of breath, or chest pain. Myocardial infarction can also occur occasionally. Seek medical attention immediately if you notice any of these symptoms after receiving EXPAREL liposomal (see also section 4 of this leaflet).
  • Methemoglobinemia
    Methemoglobinemia is a disorder of the blood that affects the red blood cells. The condition can occur immediately or a few hours after the use of local anesthetics. Signs and symptoms to be aware of include: pale or gray/blue skin, shortness of breath, feeling unsteady or fainting, seizures, palpitations, or chest pain. Seek medical attention immediately if you notice any of these symptoms after receiving EXPAREL liposomal. Occasionally, methemoglobinemia can cause more severe symptoms such as irregular heartbeat, convulsions, coma, and even death (see also section 4 of this leaflet).
  • Chondrolysis
    Controls (degradation of cartilage in the joints) have been noted in patients receiving intra-articular infusions (joint injections) of local anesthetics. EXPAREL liposomal must not be used for intra-articular infusion.

Children and young people

EXPAREL liposomal should not be used in children and adolescents under 18 years of age. This medicine has not been studied in this age group.

Other medicines and EXPAREL liposomal

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

It can be dangerous to take certain medicines together. This is especially true if you take any of the following:

  • Nitrates/nitrites – nitroglycerin, nitroprusside, nitric oxide, nitrous oxide
  • Local anesthetics – benzocaine, lidocaine , bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articles, ropivacaine
  • Antiarrhythmics – medicines used to treat irregular heartbeats ( arrhythmias ) such as lidocaine and mexiletine
  • Cytotoxic drugs are – cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea
  • Antibiotics – dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid
  • Antimalarial drugs – chloroquine, printmaking
  • Antiepileptics – phenytoin, sodium valproate, phenobarbital
  • Other medicines – acetaminophen ( paracetamol ), metoclopramide (for stomach problems and nausea), sulfasalazine (for inflammatory diseases), poividonion (local antiseptic )

Ask your doctor if you are unsure about any of these medicines.

Pregnancy and breastfeeding

EXPAREL liposomal is NOT recommended for pregnant women and women of childbearing potential not using contraception. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

EXPAREL liposomal passes into breast milk at very low concentrations and can cause serious side effects in the baby. Consult a doctor before breastfeeding your baby. She/he decides if you should stop breastfeeding your baby or if you should not be given this medicine.

Driving and using machines

EXPAREL liposomal may affect your ability to feel things or move normally for up to 5 days after receiving the medicine. You should not drive or use any tools or machines if you experience any of these side effects.

EXPAREL liposomal contains sodium

This product contains 21 mg sodium (the main ingredient in saline/table salt) per vial by 10 mL and 42 mg per vial by 20 mL. This corresponds to 1.1% and 2.1% respectively of the highest recommended daily intake of sodium for adults.

How to take EXPAREL liposomal

You will receive EXPAREL liposomal from your doctor during the operation.

The recommended dose that you receive will be determined by your doctor. It depends on the type of pain relief you need and in which part of the body the medicine is to be administered. It also depends on the size of the operating area and your physical condition.

You will receive EXPAREL liposomal as an injection. Your doctor will inject EXPAREL liposomal at one of the following sites:

  • The area of ​​operation;
  • close to the nerves that supply the area of ​​the body that has been operated on.

If you take more EXPAREL liposomal than you should

EXPAREL liposomal is for use by trained doctors who will check your blood pressure, heart rate, respiratory rate, level of consciousness and monitor for any signs that you have been given too much bupivacaine hydrochloride after receiving EXPAREL liposomal.

Seek medical attention immediately if you notice any of the side effects listed below after receiving EXPAREL liposomal (see also section 4 of this leaflet). These are signs that you have been given too much bupivacaine.

  • convulsions (convulsions);
  • unconsciousness;
  • restlessness or anxiety;
  • speech difficulties;
  • dizziness or instability;
  • nausea or vomiting;
  • numbness and tingling in the mouth and on the lips;
  • changes in vision, hearing, or taste;
  • shaking or twitching;
  • drowsiness, confusion, or not completely alert;
  • increased or decreased blood pressure;
  • increased or decreased heart rate.

If you miss a dose of EXPAREL liposomal

You are not likely to miss a dose. You will only get EXPAREL liposomal once from your doctor (during surgery).

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

4. Possible side effects

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

Seek medical attention immediately if you experience any of the following serious side effects that have been reported with the use of other local anesthetics (see section 2):

  • abnormal/irregular heartbeat, low blood pressure, fainting, dizziness or unsteadiness, fatigue, shortness of breath, chest pain, or cardiac arrest (symptoms of cardiovascular reaction).
  • restlessness, anxiety, difficulty speaking, feeling unsteady, nausea or vomiting, numbness and tingling in the mouth and lips, metallic taste, tinnitus (ie ringing in the ears), dizziness, blurred vision, tremors or twitching, depression, drowsiness, cramps (symptoms of a reaction in the central nervous system ).
  • hives or skin rash, swelling around the eyes, face, lips, mouth, or throat, shortness of breath or difficulty breathing, rapid heartbeat, nausea, vomiting, dizziness or fainting, or fever (symptoms of an allergic reaction ).
  • pale or gray/blue skin, shortness of breath, instability or fainting, confusion, palpitations, chest pain, irregular heartbeat, convulsions, or coma (symptoms of methemoglobinemia).

Other side effects may include:

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

  • taste disorders;
  • constipation;
  • nausea or vomiting;
  • lack of sensation in the mouth.

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

  • feeling of warmth;
  • general bruising or fall;
  • abnormal blood test results;
  • joint pain;
  • impaired mobility or involuntary/uncontrolled body movements;
  • injury, pain, spasm, twitching, or weakness in the muscles;
  • burning sensation;
  • headache;
  • loss of sensation;
  • itchy skin or skin irritation.

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

  • abdominal discomfort, bloating, or indigestion;
  • diarrhea;
  • dry mouth, difficulty swallowing or pain when swallowing;
  • itching on the inside of the mouth;
  • excess saliva in the mouth;
  • overindulge;
  • pain (in the abdomen, wound area, muscles, groin, hands, or feet);
  • swelling of the ankles, feet, legs, or joints;
  • stiffness in the joints;
  • abnormal ECG;
  • fresh blood from the rectum, usually with the stool;
  • feeling tired:
  • partial paralysis;
  • difficulty breathing;
  • redness on the skin or around the wound area;
  • complications (eg redness, swelling, pain) in the wound area;
  • heavy sweating;
  • discoloration of nails.

Has been reported (occurs in an unknown number of users)

  • inability to urinate (ie empty the bladder completely or partially);
  • Exparel liposomal does not work.

5. How to store EXPAREL liposomal

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 vial label after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

EXPAREL liposomal can also be stored at room temperature (maximum 25 ° C) for up to 30 days in sealed, unopened vials. Vials should not be returned to the refrigerator.

After the first opening

Chemical and physical in-use stability of EXPAREL liposomal withdrawn from vials and transferred to polypropylene syringes has been demonstrated for 48 hours when stored in a refrigerator (2 ° C to 8 ° C) or 6 hours when stored at room temperature (maximum 25 ° C).

From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and should not be longer than 24 hours at 2 ° C to 8 ° C unless opened under controlled and validated aseptic conditions.

After dilution

Chemical and physical stability when using the liposomal EXPAREL mixture with other formulation is bupivacaine have been demonstrated for 24 hours at room temperature (above 25 ° C). When mixed with 9 mg/ml (0.9%) sodium chloride or lactated Ringer’s solution, chemical and physical in-use stability have been demonstrated for 4 hours when stored in a refrigerator (2 ° C to 8 ° C) or at room temperature (maximum 25 ° C). ). From a microbiological point of view, unless the dilution method eliminates the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.

6. Contents of the packaging and other information

Content declaration

The active substance is bupivacaine. Each ml contains 13.3 mg of liposomal bupivacaine in an injection, depotdispersion.

Each vial with 10 ml injection, depotdispersion containing 133 mg and 266 mg bupivacaine free base.

Each vial with 20 ml injection, depotdispersion containing 266 mg bupivacaine free base.

The other ingredients are dierucoyl phosphatidylcholine(DEPC), dipalmitoyl phosphatidylglycerol (DPPG), cholesterol for parenteral use, tricaprylin, sodium chloride, phosphoric acid, and water for injections.

What the medicine looks like and the contents of the pack

EXPAREL liposomal is a white to off-white solution for injection.

It is available in 10 ml or 20 ml, disposable glass vials with a gray butyl rubber stopper with a surface of ethylene tetrafluoroethylene and a flip-tear-up seal of aluminum/polypropylene.

Each pack contains 4 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pacira Ireland Ltd

Unit 13

Classon House

Dundrum Business Park

Dundrum,

Dublin 14

D14W9Y3

Ireland

Manufacturer

Millmount Healthcare Limited

Block-7, City North Business Campus

Stamullen, Co. Meath

K32 YD60

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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