PRIMAXIN IV Powder for solution for infusion (2023)
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Περιεχόμενα
1. Name of the medicinal product
PRIMAXIN IV 500 mg/500 mg powder for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin. <u>Excipient with known effect:</u> Each vial contains 37.6 mg (1.6 ...
3. Pharmaceutical form
Powder for solution for infusion. White to light yellow powder.
4.1. Therapeutic indications
PRIMAXIN is indicated for the treatment of the following infections in adults and children 1 year of age and above (see sections 4.4 and 5.1): complicated intra-abdominal infections severe pneumonia including ...
4.2. Posology and method of administration
Posology The dose recommendations for PRIMAXIN represent the quantity of imipenem/cilastatin to be administered. The daily dose of PRIMAXIN should be based on the type of infection and given in equally ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Hypersensitivity to any other carbapenem antibacterial agent Severe hypersensitivity (e.g. anaphylactic reaction, ...
4.4. Special warnings and precautions for use
General The selection of imipenem/cilastatin to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the ...
4.5. Interaction with other medicinal products and other forms of interaction
Generalized seizures have been reported in patients who received ganciclovir and PRIMAXIN. These medicinal products should not be used concomitantly unless the potential benefit outweighs the risks. Decreases ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies for the use of imipenem/cilastatin in pregnant women. Studies in pregnant monkeys have shown reproductive toxicity (see section 5.3). The potential ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, there are some side effects (such as hallucination, dizziness, somnolence, and vertigo) associated with ...
4.8. Undesirable effects
In clinical trials including 1,723 patients treated with imipenem/cilastatin intravenous the most frequently reported systemic adverse reactions that were reported at least possibly related to therapy ...
4.9. Overdose
Symptoms of overdose that can occur are consistent with the adverse reaction profile; these may include seizures, confusion, tremors, nausea, vomiting, hypotension, bradycardia. No specific information ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use, carbapenems <b>ATC code:</b> J01DH51 Mechanism of action PRIMAXIN consists of two components: imipenem and cilastatin sodium in a 1:1 ...
5.2. Pharmacokinetic properties
Imipenem Absorption In normal volunteers, intravenous infusion of PRIMAXIN over 20 minutes resulted in peak plasma levels of imipenem ranging from 12 to 20 μg/ml for the 250 mg/250 mg dose, from 21 to ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity studies. Animal studies showed that the toxicity produced ...
6.1. List of excipients
Sodium bicarbonate
6.2. Incompatibilities
This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it can be administered into an I.V. system through which a lactate ...
6.3. Shelf life
2 years. <u>After reconstitution:</u> Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours. ...
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze the reconstituted solution. For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
20 ml Type I glass vials. The medicinal product is supplied in packs of 1 vial, 10 vials and 25 vials. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Each vial is for single use only. Reconstitution Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see sections 6.2 and 6.3): 0.9% sodium chloride. In exceptional ...
7. Marketing authorization holder
Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
8. Marketing authorization number(s)
PL 53095/0006
9. Date of first authorization / renewal of the authorization
Licence first granted: 30 June 1988 Licence last renewed: 8 March 2012
10. Date of revision of the text
24 August 2023
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