PROMIXIN Powder for nebuliser solution (2019)
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Περιεχόμενα
1. Name of the medicinal product
Promixin, 1 million International Units (IU) Powder for Nebuliser Solution.
2. Qualitative and quantitative composition
Each vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of colistimethate sodium.
3. Pharmaceutical form
Powder for nebuliser solution. The powder is white to off-white.
4.1. Therapeutic indications
Promixin is indicated for the management in adult and paediatric of chronic pulmonary infections due to <em>Pseudomonas aeruginosa</em> in patients with cystic fibrosis (see section 5.1). Consideration ...
4.2. Posology and method of administration
It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use. Posology The dosage can be adjusted depending on the ...
4.3. Contraindications
Promixin is contraindicated in patients with known hypersensitivity to colistimethate sodium or other polymyxins. Colistimethate sodium is known to reduce the amount of acetylcholine released from the ...
4.4. Special warnings and precautions for use
Bronchospasm Nebulisation of colistimethate sodium may induce coughing or bronchospasm. It is advisable to administer the first dose under medical supervision. Pre-dosing with a bronchodilator is recommended ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to the effects of colistimethate sodium on the release of acetylcholine, non-depolarising muscle relaxants should be used with extreme caution in patients receiving Promixin as their effects could ...
4.6. Pregnancy and lactation
Safety in human pregnancy has not been established. Animal studies do not indicate a teratogenic potential. However there is evidence that colistimethate sodium crosses the placenta and consequently there ...
4.7. Effects on ability to drive and use machines
Neurotoxicity, characterised by dizziness, confusion or visual disturbances have been reported following parenteral administration of colistimethate sodium. If these effects occur patients should be warned ...
4.8. Undesirable effects
The commonest undesirable effects following nebulisation of colistimethate sodium are coughing and bronchospasm (indicated by chest tightness which may be detected by a decrease in FEV1) in approximately ...
4.9. Overdose
Overdosage may cause apnoea, muscle weakness, vertigo, transient facial paraesthesia, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and renal insufficiency. No antidote ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> other antibacterials, Polymyxins <b>ATC code:</b> J01XB01 General properties Mode of action Colistimethate sodium is a prodrug of colistin, a polymyxin antibiotic , (belonging ...
5.2. Pharmacokinetic properties
Absorption Gastrointestinal absorption is negligible hence the swallowing of colistimethate sodium deposited in the nasopharynx is unlikely to add to the systemic exposure. Absorption following lung administration ...
5.3. Preclinical safety data
Animal studies with colistimethate do not indicate adverse effects on fertility or embryo-foetal development. Peri-postnatal studies have not been conducted. Data on potential genotoxicity and carcinogenicity ...
6.1. List of excipients
None
6.2. Incompatibilities
The addition of other antibiotics to solutions of Promixin may lead to precipitation. This medicinal product should not be mixed with other medicinal products except those mentioned in section 6.6.
6.3. Shelf life
<u>Unopened:</u> 3 years. <u>After reconstitution:</u> Chemical and physical in-use stability of solution reconstituted in the original vial has been demonstrated for up to 24 hours at 2 to 8°C. Patients ...
6.4. Special precautions for storage
Promixin may be reconstituted to produce a clear colourless to pale yellow solution,with either Water for Injections (WFI) to produce a hypotonic solution, a 50:50 mixture of WFI and 0.9% sodium chloride ...
7. Marketing authorization holder
Zambon S.p.A., Via Lillo del Duca 10, 20091 Bresso (MI) - Italy
8. Marketing authorization number(s)
PL 31654/0008
9. Date of first authorization / renewal of the authorization
20 February 2003/13<sup>th</sup> August 2008
10. Date of revision of the text
10/09/2019
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