PRIMACOR Solution for injection (2019)
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Περιεχόμενα
1. Name of the medicinal product
Primacor 1 mg/ml Solution for Injection.
2. Qualitative and quantitative composition
Each ampoule contains 1 mg/ml of the active substance Milrinone. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow liquid.
4.1. Therapeutic indications
Primacor 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, ...
4.2. Posology and method of administration
For intravenous administration. Adults Primacor Injection should be given as a loading dose of 50 µg/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated ...
4.3. Contraindications
Hypersensitivity to milrinone or any of the excipients listed in section 6.1. Severe hypovolaemia.
4.4. 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). Primacor Injection is not recommended ...
4.5. 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 ...
4.6. Pregnancy and lactation
Pregnancy Although animal studies have not revealed evidence of drug-induced fetal damage or other deleterious effects on reproductive function, the safety of milrinone in human pregnancy has not yet been ...
4.7. Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8. 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, ...
4.9. Overdose
Overdose of intravenous Primacor may produce hypotension (because of its vasodilatory effect) and cardiac arrhythmia. If this occurs, Primacor Injection administration should be reduced or temporarily ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Cardiac therapy; Phosphodiesterase inhibitor <b>ATC code:</b> C01CE02 Milrinone is a positive inotrope and vasodilator, with little chronotropic activity. It also improves ...
5.2. Pharmacokinetic properties
Following intravenous injections of 12.5-125 µg/kg to congestive heart failure patients, Primacor Injection had a volume of distribution of 0.38 L/kg/hr, a mean terminal elimination half-life of 2.3 hours, ...
5.3. 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 fetal rats. Postnatal ...
6.1. List of excipients
Lactic acid Glucose anhydrous Water for injection Sodium hydroxide (for pH adjustment)
6.2. Incompatibilities
Furosemide or bumetanide should not be administered in intravenous lines containing Primacor Injection since precipitation occurs on admixture. Sodium Bicarbonate Intravenous infusion should not be used ...
6.3. Shelf life
36 months when unopened. A diluted solution of Primacor Injection should be used within 24 hours.
6.4. Special precautions for storage
Store below 25°C. Do not freeze.
6.5. Nature and contents of container
Type 1 colourless, glass ampoules 10ml or 20ml packed in lots of 10. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Infusion solutions diluted as recommended with 0.45% saline, 0.9% saline or 5% glucose should be freshly prepared before use. Parenteral drug products should be examined visually and should not be used ...
7. Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK
8. Marketing authorization number(s)
PL 04425/0646
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 October 1989 Date of latest renewal: 7 April 2004
10. Date of revision of the text
17/09/2019
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