ESMERON Solution for injection (2021)

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Περιεχόμενα

1. Name of the medicinal product

Esmeron 10 mg/ml solution for injection.

2. Qualitative and quantitative composition

Each ml Esmeron contains 10 mg rocuronium bromide. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection. pH: 3.8-4.2.

4.1. Therapeutic indications

Esmeron is indicated in adult and paediatric patients (from term neonates to adolescents [0 to <18 years]) as an adjunct to general anaesthesia to facilitate tracheal intubation during routine sequence ...

4.2. Posology and method of administration

Posology Like other neuromuscular blocking agents, Esmeron should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these drugs. As with ...

4.3. Contraindications

Hypersensitivity to rocuronium or to the bromide ion or to any of the excipients.

4.4. Special warnings and precautions for use

Since Esmeron causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this drug until adequate spontaneous respiration is restored. As with all neuromuscular ...

4.5. Interaction with other medicinal products and other forms of interaction

The following drugs have been shown to influence the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents. Effect of other drugs on Esmeron Increased effect: Halogenated ...

4.6. Pregnancy and lactation

Pregnancy For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...

4.7. Effects on ability to drive and use machines

Since Esmeron is used as an adjunct to general anaesthesia, the usual precautionary measures after a general anaesthesia should be taken for ambulatory patients.

4.8. Undesirable effects

Summary of the safety profile The most commonly occurring adverse drug reactions include injection site pain/reaction, changes in vital signs and prolonged neuromuscular block. The most frequently reported ...

4.9. Overdose

In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. There are two options for the reversal of neuromuscular block: (1) ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Muscle relaxants, peripherally acting agents ATC code: M03AC09 Mechanism of Action Esmeron (rocuronium bromide) is a fast onset, intermediate acting non-depolarising ...

5.2. Pharmacokinetic properties

After intravenous administration of a single bolus dose of rocuronium bromide the plasma concentration time course runs in three exponential phases. In normal adults, the mean (95% CI) elimination half-life ...

5.3. Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. There is no proper animal model ...

6.1. List of excipients

Esmeron contains the following excipients: Sodium acetate (E262) (for pH adjustment) Sodium chloride Acetic acid (E260) (for pH adjustment) Water No preservative has been added.

6.2. Incompatibilities

Physical incompatibility has been documented for Esmeron when added to solutions containing the following drugs: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, ...

6.3. Shelf life

Esmeron has a shelf life of 3 years, provided it is stored under the prescribed conditions (see section 6.4). The date mentioned on the carton and on the label of the vial is the expiry date; this is the ...

6.4. Special precautions for storage

Storage in the Refrigerator: Esmeron should be stored at 2°-8°C in the dark and used within the expiry date given on the pack. Storage out of the refrigerator: Esmeron can be stored outside ...

6.5. Nature and contents of container

Esmeron 25 mg in 2.5 ml (10mg/ml): Packaging of 10 vials each containing 25 mg rocuronium bromide. Esmeron 50 mg in 5 ml (10mg/ml): Packaging of 10 vials each containing 50 mg rocuronium ...

6.6. Special precautions for disposal and other handling

Compatibility studies with the following infusion fluids have been performed: In nominal concentrations of 0.5 mg/ml and 2.0 mg/ml Esmeron has been shown to be compatible with: 0.9% NaCl, 5% dextrose, ...

7. Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

8. Marketing authorization number(s)

PL 53095/0001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 15th July 1996 Date of latest renewal: 7th May 2002

10. Date of revision of the text

31 December 2021

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