MILNIRONE Solution for injection / infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Milrinone 1mg/ml Solution for injection/infusion.
Qualitative and quantitative composition
Each 10 ml ampoule contains 10 mg milrinone. Each ml of solution contains 1 mg milrinone. Excipient with known effect: Sodium (this medicinal product contains less than 1 mmol sodium (23 mg) per dose). ...
Pharmaceutical form
Solution for injection/infusion. Clear, colourless to pale yellow solution, practically free from particles. The pH of the solution is 3.2-4.0 and the osmolality is 261–319 mOsm/Kg.
Therapeutic indications
Milrinone Injection is indicated for the short-term treatment of severe congestive heart failure unresponsive to conventional maintenance therapy, and for the treatment of patients with acute heart failure, ...
Posology and method of administration
For intravenous administration. Adults Milrinone Injection should be given as a loading dose of 50μg/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated ...
Contraindications
Hypersensitivity to milrinone or any of the excipients. Severe hypovolaemia.
Special warnings and precautions for use
The use of inotropic agents such as milrinone during the acute phase of a myocardial infarction may lead to an undesirable increase in myocardial oxygen consumption (MVO2). Milrinone Injection is not recommended ...
Interaction with other medicinal products and other forms of interaction
Furosemide or bumetanide should not be administered in intravenous lines containing milrinone lactate in order to avoid precipitation. Milrinone should not be diluted in sodium bicarbonate intravenous ...
Fertility, pregnancy and lactation
Pregnancy Although animal studies have not revealed evidence of drug-induced foetal damage or other deleterious effects on reproductive function, the safety of milrinone in human pregnancy has not yet ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
Adverse reactions have been ranked under heading of system-organ class and frequency using the following convention: very common (≥1/10); common (≥1/100, ≤1/10); uncommon (≥1/1,000, ≤1/100); rare (≥1/10,000, ...
Overdose
Overdose of intravenous milrinone may produce hypotension (because of its vasodilatory effect) and cardiac arrhythmia. If this occurs, Milrinone Injection administration should be reduced or temporarily ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy; Phosphodiesterase inhibitor ATC code: C01CE02 Milrinone is a positive inotrope and vasodilator, with little chronotropic activity. It also improves left ventricular ...
Pharmacokinetic properties
Following intravenous injections of 12.5 to 125mcg/kg to congestive heart failure patients, Milrinone Injection had a volume of distribution of 0.38 l/kg/hr, a mean terminal elimination half-life of 2.3 ...
Preclinical safety data
Juvenile animals A preclinical study was performed to clarify the ductus-dilating effects of PDE 3 inhibitors in near-term rat pups and their differential effects in near-term and preterm foetal rats. ...
List of excipients
(S)-Lactic acid Anhydrous glucose Water for injections Sodium hydroxide (for pH adjustment) Lactic acid (for pH adjustment)
Incompatibilities
Furosemide or bumetanide should not be administered in intravenous lines containing Milrinone Injection since precipitation occurs on admixture. Sodium Bicarbonate Intravenous infusion should not be used ...
Shelf life
3 years for the unopened product. After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C when diluted with 0.45% sodium chloride infusion, 0.9% sodium chloride ...
Special precautions for storage
Store below 25°C. Do not freeze. Store in the original package. For storage conditions of the medical product after dilution, please see section 6.3.
Nature and contents of container
Milrinone 1mg/ml Solution for Injection is presented in 10ml clear, neutral glass (PhEur, Type I) ampoules. The ampoules are packed in a PVC tray and cardboard box in packs of 10.
Special precautions for disposal and other handling
Instructions for dilution Infusion solutions should be freshly prepared before use. Parenteral drug products should be examined visually and should not be used if particulate matter or discolouration are ...
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom
Marketing authorization number(s)
PL 29831/0619
Date of first authorization / renewal of the authorization
01/08/2016
Date of revision of the text
14/06/2019
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