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NEOSTIGMINE Sterile injection (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Neostigmine Methylsulfate Injection BP 2.5mg in 1ml.

Qualitative and quantitative composition

Each ml contains 2.5mg of Neostigmine Methylsulfate. 1 ampoule with 1 ml contains 2.5 mg Neostigmine Methylsulfate. Excipients with known effect: This medicinal product contains approximately 3.54 mg sodium ...

Pharmaceutical form

Sterile Injection.

Therapeutic indications

Myasthenia Gravis, antagonist to non-depolarizing neuromuscular blockade, Paralytic Ileus, Post-operative Urinary Retention; Paroxysmal Supraventricular Tachycardia.

Posology and method of administration

Posology Recommended doses are present by indication below but may be varied according to the individual needs of the patient. Myasthenia Gravis Patient population Recommended dose (via subcutaneous or ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Neostigmine should not be administered to patients with mechanical obstruction of gastrointestinal or urinary ...

Special warnings and precautions for use

Neostigmine should be used with extreme caution in patients with asthma as the parasympathomimetic action of neostigmine may cause bronchoconstriction. Bradycardia, with the potential for progression to ...

Interaction with other medicinal products and other forms of interaction

Neuromuscular Blocking Agents Neostigmine effectively antagonises the effect of Non-depolarizing muscle relaxants (e.g. Tubocurarine, Gallamine or Pancuronium) and this interaction is used to therapeutic ...

Pregnancy and lactation

The use of Neostigmine Methylsulfate during pregnancy or lactation has not been established. Although the possible hazards to mother and child must be weighed against the potential benefits in every case. ...

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Adverse effects of Neostigmine are chiefly those of exaggerated response to parasympathetic stimulation. System Organ Class Adverse reaction Frequency <b>Immune system disorders</b> Hypersensitivity, ...

Overdose

Symptoms Neostigmine Methylsulfate overdosage may include Cholinergic Crisis, which is characterised by nausea, vomiting, diarrhoea, excessive salivation and sweating, increased bronchial secretions, miosis, ...

Pharmacodynamic properties

Neostigmine inhibits cholinesterase activity and prolongs and intensifies the muscarinic and nicotinic effects of acetylcholine. The anticholinesterase actions of Neostigmine are reversible. It is used ...

Pharmacokinetic properties

Neostigmine is a quaternary ammonium compound and is poorly absorbed from the gastrointestinal tract. Following parenteral administration as the methylsulfate, neostigmine is metabolised partly by hydrolysis ...

Preclinical safety data

No further information other than that which is included in the Summary of Product Characteristics.

List of excipients

Sodium chloride Water for Injections

Incompatibilities

Neostigmine may be diluted with Water for Injections. Stability of the injection cannot be guaranteed once it has been diluted.

Shelf life

36 Months.

Special precautions for storage

Protect from light and store at less than 25°C.

Nature and contents of container

1ml glass ampoules hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.

Special precautions for disposal and other handling

Use as directed by a physician. If only part used discard the remaining solution.

Marketing authorization holder

hameln pharma limited, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom

Marketing authorization number(s)

PL 01502/0023

Date of first authorization / renewal of the authorization

5<sup>th</sup> February 1979 / 27<sup>th</sup> August 2001

Date of revision of the text

13/05/2021

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