NEOSTIGMINE Sterile injection (2021)
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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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