10 mg / ml injection solution 
rocuronium bromide

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 anesthetist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your anesthetist or another doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Esmeron is and what it is used for 
2. What you need to know before giving Esmeron 
3. How Esmeron is given 
4. Possible side effects 
5. How to store Esmeron 
6. Contents of the packaging and other information 

1. What Esmeron is and what it is used for

Esmeron belongs to a group of medicines called muscle relaxants. Esmeron is used in conjunction with anesthesia during surgery to provide skeletal muscle relaxation.

When undergoing certain types of surgeries, the muscles must be completely relaxed. This makes it easier for the surgeon to operate. Esmeron blocks the nerve impulses to the muscles, which gives the muscle a relaxing effect. When Esmeron is used, the respiratory muscles are also relaxed and then you get help with breathing in the form of artificial (mechanical) breathing during and after the operation. When you are anesthetized, a tube is inserted into the trachea and this is facilitated by the fact that you have received Esmeron. After surgery, the effects of Esmeron will subside so after a while you will no longer need help breathing. Sometimes, at the end of the operation, you will be given additional medication to speed this up.

2. What you need to know before giving Esmeron

Do not use Esmeron

  • if you are allergic to rocuronium, bromide, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Some diseases that you have or have had can affect how Esmeron is given to you. Therefore, tell your doctor if you have or have ever had any of the following:

  • allergy to any muscle relaxant
  • renal impairment or kidney disease
  • liver or bile disease
  • decreased circulation in heart disease, old age, or edema (fluid retention)
  • a disease affecting nerves or muscles
  • malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in the muscles)

Some conditions can affect the effect of Esmeron, for example:

  • low body temperature
  • low potassium levels in the blood (eg after severe vomiting, diarrhea, or treatment with diuretics )
  • high magnesium value in the blood
  • low calcium in the blood
  • low amount of protein in the blood
  • dehydration
  • too high acidity in the blood
  • too much carbon dioxide in the blood
  • poor general condition
  • burn
  • overweight

Tell your anesthetist if any of the above applies to you, it may be important when determining the dose of Esmeron.

Children and the elderly

Esmeron can be given to children (newborns – adolescents) and the elderly, but your doctor will first assess your medical history.

Other medicines and Esmeron

Tell your anesthetist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. It will help your doctor determine the right dose of Esmeron for you.

The following medicines may affect the effect of Esmeron:

Drugs that increase the effect of Esmeron:

  • certain medicines used to put you to sleep during surgery ( anesthetics )
  • long-term use of corticosteroids ( cortisone ) given for inflammation
  • certain medicines are given for bacterial infections ( antibiotics )
  • certain medicines used in bipolar disorder (lithium)
  • certain medicines used to treat heart disease or high blood pressure ( quinidine, calcium channel blockers, and beta-blockers )
  • certain medicines used to treat malaria (quinine)
  • diuretics ( diuretics )
  • magnesium salts
  • local anesthetics ( lidocaine, bupivacaine)
  • use of antiepileptic drugs during surgery ( phenytoin ).

Drugs that reduce the effect of Esmeron:

  • long-term treatment with antiepileptic drugs ( phenytoin and carbamazepine)
  • medicines for inflammation of the pancreas, for disorders of the blood’s ability to clot, or acute blood loss (so-called protease inhibitors; gabexat, ulinastatin)

Drugs that have varying effects on Esmeron:

  • other muscle relaxants

Esmeron may affect the effects of the following medicines:

  • local anesthetics ( lidocaine ), the effect can be enhanced.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your anesthetist if you are or suspect you may be pregnant or breast-feeding. You may still get Esmeron, but that needs to be discussed first.

Breast-feeding should be stopped for 6 hours after using this medicine.

Driving and using machines

Your doctor will tell you when it is safe to drive or use dangerous machines after receiving Esmeron during surgery.

Esmeron contains sodium

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

How Esmeron is given

Dosage

Your anesthetist will calculate the dose of Esmeron you need. You will be given Esmeron before and/or during surgery. The usual dose is 0.6 mg rocuronium bromide per kg body weight and the effect lasts 30-40 minutes. During the operation, it is checked that Esmeron still affects.

You can then, if necessary, receive an additional dose of the medicine. The dose chosen is dependent on several different factors, such as which other medicines will be given at the same time, how long the operation will take, your age, and your state of health.

How Esmeron is given

You will not administer Esmeron yourself. Esmeron solution is injected into a vein. It is given as an injection or as an infusion (drip).

A doctor or nurse should give the injections.

If you take more Esmeron than you should

Because your anesthetist will closely monitor your condition during surgery, it is unlikely that you will receive too much Esmeron. Should this happen, you will have artificial respiration until you can breathe on your own again. It is possible to counteract the effect of (too much) Esmeron by giving another medicine that cancels the effect of Esmeron.

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

4. Possible side effects

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

Side effects are less common or rare (seen in 1 to 100 people)

10,000 users):

  • palpitation
  • low blood pressure
  • absent, decreased, or increased effect of Esmeron
  • pain or local reaction at the injection site
  • prolongation of the muscle relaxing effect
  • delayed recovery after anesthesia.

Very rare side effects (seen in less than 1 user in 10,000):

  • hot flashes
  • hives, rash
  • swelling of the face, tongue, or throat ( angioedema )
  • respiratory problems due to respiratory cramps ( bronchospasm )
  • hypersensitivity reaction with effect on blood pressure or heart rate
  • muscle weakness or paralysis
  • long-term muscle problems are most commonly seen when Esmeron and corticosteroids (medicines for inflammation, cortisone ) are used together in seriously ill patients in an intensive care unit (so-called steroid myopathy)
  • respiratory complications after anesthesia.

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

  • Severe allergic reaction with cramps in the coronary arteries of the heart (Kounis syndrome) which causes chest pain (angina) or heart attack.

5. How to store Esmeron

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

Esmeron is kept in the hospital.

6. Contents of the packaging and other information

Content declaration

  • The active substance is rocuronium bromide. 1 ml solution for injection contains 10 mg rocuronium bromide.
  • The other ingredients are sodium acetate trihydrate, sodium chloride, acetic acid, and water for injections. One ml of Esmeron contains 1.64 mg of sodium. No preservative included.

What the medicine looks like and the contents of the pack

Esmeron is a solution for injection or infusion.

Pack sizes: Vials 5 ml in packs of 10 and 12 pieces.

10 ml vials in packs of 10 pieces.

The vials are fitted with a gray rubber membrane, which is a latex-free silicone closure made of bromobutyl.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer

NV Organon

Kloosterstraat 6

PO Box 20

NL-5340 BH Oss

Netherlands

Muhammad Nadeem

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