Expiration date: 04/2025
The composition and form of issue:
Powder for preparation of intravenous solution 1 vials contains active substance:
Meropenem trihydrate 570 mg
(equivalent to anhydrous Meropenem — 500 mg)
excipients: sodium carbonate (anhydrous) — 104 mg
in vials of glass with a capacity of 10 or 20 ml, closed with a rubber stopper, compressed with an aluminum ring and a plastic lid in a cardboard bundle with the control of the first opening of 10 vials.
Powder for preparation of intravenous solution 1 vial contains active substance:
Meropenem trihydrate 1140 mg
(equivalent to anhydrous Meropenem — 1000 mg)
excipients: sodium carbonate (anhydrous) - 208 mg
in bottles of glass with a capacity of 30 ml, closed with a rubber stopper, compressed with an aluminum ring and a plastic lid in a cardboard bundle with the control of the first opening of 10 bottles.
Description of dosage form:
Powder from white to light yellow color.
Indications:
Meronem is indicated for the treatment of children (over 3 months) and adults of the following infectious and inflammatory diseases caused by one or more pathogens sensitive to Meronem:
- pneumonia, including nosocomial pneumonia
- infections of the urinary system
- infection of the abdominal cavity
- infectious and inflammatory diseases of the pelvic organs, such as endometritis
- infections of the skin and its structures
- meningitis
- septicaemia.
Empirical treatment of adult patients with suspected infection with symptoms of febrile neutropenia in monotherapy or in combination with antiviral or antifungal drugs.
The efficacy of Meronem has been proven both in monotherapy and in combination with other antimicrobials in the treatment of polymicrobial infections.
Contraindications:
- hypersensitivity to Meropenem or other carbapenem group drugs in history
- expressed hypersensitivity (anaphylactic reactions, severe skin reactions) to any antibacterial agent having a beta-lactam structure (ie, penicillins or cephalosporins)
- children up to 3 months.
Precautions: concurrent use with potentially nephrotoxic drugs to patients with complaints of the gastrointestinal tract (diarrhea), especially for people who have colitis.
Application during pregnancy and breast-feeding:
Pregnancy
The safety of the drug Meronem in women during pregnancy has not been studied. Animal studies have not shown any adverse effects on the developing fetus.
Meronem should not be used during pregnancy, except when the potential benefit to the mother from its use exceeds the possible risk to the fetus. In each case, the drug should be used under strict medical supervision.
Lactation
Meropenem is defined in breast milk of animals in very low concentrations. Meronem should not be used during breast-feeding, except in those cases where the potential benefit to the mother from the use of the drug outweighs the potential risk to the child. Having estimated advantage for mother, it is necessary to make the decision on the termination of breastfeeding or cancellation of reception of a preparation Meronem.
Side effect:
In General, the event is characterized by good portability. In rare cases, side effects led to the cancellation of therapy. Serious adverse reactions are rare.
The frequency of adverse reactions is given below as the following gradation: very often (&ge1/10) often (&ge1/100, <1/10) infrequently (&ge1/1000, <1/100) rarely (&ge1/10000, <1/1000) very rarely (<1/10000).
Hematopoietic system*: often-thrombocytosis infrequently-eosinophilia, thrombocytopenia rarely-leukopenia, neutropenia, agranulocytosis very rarely-hemolytic anemia.
Nervous system: rarely — headache, paresthesia, syncope**, hallucinations**, depression**, anxiety**, anxiety** insomnia** rare — convulsions.
Gastrointestinal tract: often-nausea, vomiting, diarrhea, increased activity of hepatic transaminases, schf, LDG and concentration of bilirubin in serum infrequently — constipation**, cholestatic hepatitis** very rarely — pseudomembranous colitis.
Skin and subcutaneous tissue: rare — rash, urticaria, pruritus very rare erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Immune system: very rarely — angioedema, manifestations of anaphylaxis.
CCC: infrequent heart failure**, cardiac arrest**, tachycardia**, bradycardia**, myocardial infarction**, reduction or increase in blood PRESSURE**, thromboembolism of pulmonary artery branches**.
Kidneys and urinary tract: infrequently — increasing the concentration of creatinine in the blood, increasing the concentration of urea in the blood.
Respiratory tract: rarely — dyspnea**.
Other: often-local reactions (inflammation, thrombophlebitis, pain at the injection site) rarely — vaginal candidiasis and candidiasis of the oral mucosa.
*There were reported cases of positive direct or indirect Coombs test samples, as well as cases of reduction in partial thromboplastin time.
** Causation with the administration of Meronem has not been established. Side effects were observed in a study that included 2904 immunocompetent adult patients receiving therapy with Meronem (500 or 1000 mg every 8 hours) due to infections that do not affect the Central nervous system. In 36 patients, therapy was discontinued due to adverse events. In 5 cases, it is possible to link the fatal outcome with the therapy. Against the background of the serious condition of patients, numerous diseases and multiple concomitant therapy with other drugs, it was not possible to conclude that the side effect was associated with therapy with Meronem.
Method of application and doses:
Adults.
The dosage and duration of therapy should be set depending on the type and severity of the infection and the patient's condition.
The following daily doses are recommended:
500 mg / V every 8 h in the treatment of pneumonia, urinary tract infections, gynecological infections such as endometritis, skin infections and skin structures
1 g / in every 8 hours in the treatment of nosocomial pneumonia, peritonitis, suspected bacterial infection in patients with symptoms of neutropenia, as well as septicemia.
In the treatment of meningitis, the recommended dose is 2 g every 8 hours.
Safety dose 2 g in the form of bolus injection is not sufficiently studied.
Dose in adult patients with impaired renal function
In patients with Cl creatinine less than 51 ml/min dose should be reduced as follows:
| Creatinine clearance, ml/ min | Dose (based on a unit dose of 500 mg, 1 g, 2 g) | Frequency of administration |
| 26–50 | one dose unit | every 12 h |
| 10–25 | 0.5 dose unit | every 12 h |
| <10 | 0.5 dose unit | every 24 h |
Meropenem is excreted in hemodialysis. If long-term treatment with Meronem is required, it is recommended that a dose unit (based on the type and severity of the infection) be administered at the end of the hemodialysis procedure to restore the effective plasma concentration.
Currently no data about the use of drug Meronem for administration to patients under peritoneal dialysis.
Dosing in adult patients with impaired liver function
In patients with liver failure there is no need of dose adjustment (see section "Special instructions").
Elderly patient
In elderly patients with normal renal function or creatinine Cl more than 50 ml / min do not require dose adjustment.
Children
For children aged 3 months to 12 years, the recommended dose for on/in administration is 10-20 mg/kg every 8 hours, depending on the type and severity of infection, the sensitivity of the pathogen and the patient's condition. In children weighing more than 50 kg should be used doses for adults.
With meningitis, the recommended dose is 40 mg / kg every 8 hours.
The safety of doses of 40 mg/kg in a bolus injection is not sufficiently studied.
There is no experience in the use of the drug in children with impaired liver and kidney function.
Method of administration
Meronem for/in use may be administered in/in the bolus injection for at least 5 minutes or as in/in infusion during 15-30 min, using appropriate dilutions of infusion fluid.
The possibility of using meropenema in extended infusion mode (up to 3 hours) is based on pharmacokinetic and pharmacodynamic parameters. To date, clinical and safety data supporting this regimen have been limited.
If you decide to treat the patient by prolonged infusion, you should pay attention to the data on the stability of compatible infusion fluids (see table below).
Meronem for I/V bolus injection should be diluted with sterile water for injection (5 ml per 250 mg Meropenem), while the concentration of solution is about 50 mg/ml. the resulting solution is a clear, colorless or pale yellow liquid.
Meronem for I/V infusion may be diluted with compatible infusion fluid (50 to 200 ml).
Meronem should not be mixed or added to other drugs.
Meronem is compatible with the following infusion fluids:
0, 9% sodium chloride solution
5 or 10% dextrose solution
5% dextrose with 0, 02% a solution of sodium bicarbonate
0, 9% sodium chloride solution and 5% dextrose solution
5% dextrose solution with 0, 225% sodium chloride solution
5% dextrose solution with 0, 15% potassium chloride solution
2, 5 or 10% solution of mannitol.
Dilution of the drug Meronem should follow the standard mode of asepsis. It is necessary to shake the diluted solution before administration.
All vials are intended for single use only.
For the on/in the injections and infusions is recommended to use a freshly prepared solution of the drug Meronem
The Meronem, diluted as described above, retains its effectiveness when stored at room temperature (below 25 °C) or when stored in a refrigerator (up to 4 °C) for the time specified in the following table:
| Solvent | The duration of storage, h | |
| at 15-25 °C | at 4 °C | |
The drug is diluted with water for injection, intended for bolus injection | 8 | 24 |
solutions (1-20 mg/ml) prepared using: | ||
| 0, 9% sodium chloride | 8 | 48 |
| 5% dextrose | 3 | 14 |
| 5% dextrose and 0, 225% sodium chloride | 3 | 14 |
| 5% dextrose and 0, 9% sodium chloride | 3 | 14 |
| 5% dextrose and 0, 15% potassium chloride | 3 | 14 |
| 2, 5% dextrose or 10% mannitol for in / in infusions | 3 | 14 |
| 10% dextrose | 2 | 8 |
| 5% dextrose and 0, 02% sodium bicarbonate for in/in infusion | 2 | 8 |
The solution of the drug Meronem should not be frozen.
Overdose:
Accidental overdose is possible during treatment, especially in patients with impaired renal function.
Treatment: symptomatic. Normally, there is a rapid elimination of the drug through the kidneys. In patients with impaired renal hemodialysis effectively removes Meropenem and its metabolite.
Special instruction:
Experience in the use of the drug in pediatric patients with neutropenia or with primary or secondary immunodeficiency is not.
As with the use of other antibiotics in the application of meropenema in monotherapy in patients in critical condition with an infection of the lower respiratory tract caused by Pseudomonas aeruginosa or suspected it is recommended to conduct a regular sensitivity test.
In rare cases, the use of the drug Meronem, as with virtually all antibiotics, there is the development of pseudomembranous colitis, which can vary in severity from mild to life-threatening forms. It is important to remember the possibility of the development of pseudomembranous colitis in the event of diarrhea on the background of the drug Meronem.
There are clinical and laboratory signs of cross allergic reactions between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. There have been rare cases of hypersensitivity reactions (including fatal) for the drug Meronem, as well as other beta-lactam antibiotics (see section "Side effects"). Before starting therapy with Meropenem, it is necessary to carefully interview the patient, paying special attention to the hypersensitivity reaction to beta-lactam antibiotics in the history. Meronem should be used with caution in patients with a history of such phenomena. If there is an allergic reaction to the event, it is necessary to stop the introduction of the drug and take appropriate measures.
The use of the drug Meronem in patients with liver diseases should be carefully monitored transaminaz activity and concentration of bilirubin.
As in the case of other antibiotics, excessive growth of insensitive microorganisms is possible, which requires constant monitoring of the patient.
The prevalence of acquired antibiotic resistance of various pathogens may vary depending on the region and time, it is desirable to have up-to-date information about the resistance of common pathogens in a particular region, especially in the treatment of severe infections. If the resistance is such that the effectiveness of the drug against at least some infections becomes questionable, you should consult an expert.
It is not recommended to receiving medication Meronem drugs and valproic acid.
The use of the drug in infections caused by methicillin-resistant Staphylococcus aureus, is not recommended.
Influence on the ability to drive and work with equipment. There were no studies of the effect of Meronem on the ability to drive a car and other equipment. However, it should be taken into account that when taking Meronem may experience headache, paresthesia and convulsions.
Comment:
Before using the drug, read the instructions for use.
