What is Imipenem/Cilastatin Kabi used for?

Recarbrio is indicated for: • Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1). • Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. • Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1). Consideration should be given to official guidance on the appropriate use

What is the active ingredient in Imipenem/Cilastatin Kabi?

Imipenemum + Cilastatinum (Cilastatinum, Imipenemum)

What pharmaceutical form is Imipenem/Cilastatin Kabi available in?

Imipenem/Cilastatin Kabi: Proszek do sporządzania roztworu do infuzji 500 mg + 500 mg (dożylna)

Is Imipenem/Cilastatin Kabi OTC or prescription only?

Imipenem/Cilastatin Kabi requires a doctor's prescription.

What are the side effects of Imipenem/Cilastatin Kabi?

Summary of the safety profile The most frequently occurring adverse reaction (≥ 2 %) in patients receiving imipenem/cilastatin plus relebactam in pooled Phase 2 trials of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis (N = 431) was diarrhoea. The most frequently occurring adverse reactions (≥ 2 %) in patients receiving Recarbrio in a Phase 3 trial of HAP or VAP (N = 266) were diarrhoea, alanine aminotransferase increased, a

Who should NOT take Imipenem/Cilastatin Kabi?

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, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins, cephalosporins or monobactams) (see section 4.4).

Does Imipenem/Cilastatin Kabi interact with other medications?

Ganciclovir Generalised seizures have been reported in patients who received ganciclovir concomitantly with imipenem/cilastatin, components of Recarbrio. Ganciclovir should not be used concomitantly with Recarbrio unless the potential benefits outweigh the risks. Valproic acid Case reports in the literature have shown that co‑administration of carbapenems, including imipenem/cilastatin (components of Recarbrio), to patients receiving valproic acid or divalproex sodium results in a reduction in v

Can Imipenem/Cilastatin Kabi be used during pregnancy?

Pregnancy There are no adequate and well-controlled studies for the use of imipenem, cilastatin, or relebactam in pregnant women. Animal studies with imipenem/cilastatin have shown reproductive toxicity in monkeys (see section 5.3). The potential risk for humans is unknown. Animal studies with relebactam do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Recarbrio should be used during pregnancy only if the potential benefit justifies the

Who manufactures Imipenem/Cilastatin Kabi?

Fresenius Kabi Polska Sp. z o.o. (Włochy)

What ATC class does Imipenem/Cilastatin Kabi belong to?

Imipenem/Cilastatin Kabi: ATC J01DH51. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Imipenem/Cilastatin Kabi

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH56 Mechanism of action The bactericidal activity of imipenem results from the inhibition of penicillin binding proteins (PBPs) leading to inhibition of peptidoglycan cell wall synthesis. Cilastatin limits the renal metabolism of imipenem and does not have antibacterial activity. Relebactam is a non-beta lactam inhibitor of Ambler class A and class C beta-lactamases, including class A Klebsiella pneumoniae carbapenemase (KPC) and extended‑spectrum beta‑lactamases (ESBLs), and class C (AmpC-type) beta‑lactamases including Pseudomonas-Derived Cephalosporinase (PDC). Relebactam does not inhibit class B enzymes (metallo-beta-lactamases) or class D carbapenemases. Relebactam has no antibacterial activity. Resistance Mechanisms of resistance in Gram-negative bacteria that are known to affect imipenem/relebactam include the production of metallo-beta-lactamases or oxacillinases with carbapenemase activity. Expression of certain alleles of the class A beta-lactamase Guiana extended-spectrum beta-lactamase (GES) and overexpression of PDC coupled with loss of imipenem entry porin OprD may confer resistance to imipenem/relebactam in P. aeruginosa . The expression of efflux pumps in P. aeruginosa does not affect activity of either imipenem or relebactam. Mechanisms of bacterial resistance that could decrease the antibacterial activity of imipenem/relebactam in Enterobacterales include porin mutations affecting outer membrane permeability. Antibacterial activity in combination with other antibacterial agents In vitro studies have demonstrated no antagonism between imipenem/relebactam and amikacin, azithromycin, aztreonam, colistin, gentamicin, levofloxacin, linezolid, tigecycline, tobramycin, or vancomycin. Susceptibility testing breakpoints MIC (minimum inhibitory concentration) interpretive criteria for susceptibility testing have been established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for imipenem-relebactam and are listed here: https://www.ema.europa.eu/documents/other/minimum-inhibitory-concentration-mic-breakpoints_en.xlsx. Pharmacokinetic/pharmacodynamic relationship Time that unbound plasma concentrations of imipenem exceed the imipenem/relebactam minimum inhibitory concentration (% f T > MIC) has been shown to best correlate with efficacy. The ratio of the 24 - hour unbound plasma relebactam AUC to imipenem/relebactam MIC ( f AUC / MIC) has been determined to be the index that best predicts activity of relebactam. Clinical efficacy against specific pathogens Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to imipenem and relebactam in vitro : Hospital-acquired pneumonia, including ventilator-associated pneumonia Gram-negative micro-organisms • Escherichia coli • Haemophilus influenzae • Klebsiella pneumoniae • Pseudomonas aeruginosa • Serratia marcescens In vitro studies suggest that the following pathogens would be susceptible to imipenem and relebactam in the absence of acquired mechanisms of resistance: Gram-negative aerobic micro-organisms • Acinetobacter calcoaceticus-baumannii complex • Citrobacter spp. (including C. freundii and C. koseri ) • Enterobacter spp. (including E. asburiae and E. cloacae) • Escherichia coli • Klebsiella spp. (including K. aerogenes, K. oxytoca and K. pneumoniae ) • Pseudomonas aeruginosa • Serratia marcescens Gram-negative anaerobic micro-organisms • Bacteroides spp. (including B. fragilis ) • Fusobacterium spp. (including F. nucleatum and F. necrophorum ) • Prevotella spp. (including P. melaninogenica, P. bivia, and P. buccae ) Gram‑positive aerobic micro-organisms • Enterococcus faecalis • Staphylococcus aureus (methicillin susceptible isolates only) • Viridans group streptococci (including S. anginosus and S. constellatus) In vitro studies indicate that the following species are not susceptible to imipenem and relebactam: Gram-negative aerobic micro-organisms • Legionella spp. • Stenotrophomonas maltophilia Paediatric population The European Medicines Agency has deferred the obligation to submit the results of studies with Recarbrio in one or more subsets of the paediatric population in the treatment of Gram-negative bacterial infections (see section 4.2 for information on paediatric use).

⚠️ Warnings

Recarbrio is supplied as a dry powder in a single‑dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion as outlined below: • To prepare the infusion solution, contents of the vial must be transferred to 100 mL of an appropriate infusion solution (see sections 6.2 and 6.3): 9 mg/mL (0.9 %) sodium chloride. In exceptional circumstances where 9 mg/mL (0.9 %) sodium chloride cannot be used for clinical reasons 5 % glucose may be used instead. • Withdraw 20 mL (10 mL times 2) of diluent from the appropriate infusion bag and constitute the vial with 10 mL of the diluent. The constituted suspension must not be administered by direct intravenous infusion. • After constitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag. • Add the additional 10 mL of infusion diluent to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution before administering. Agitate the resulting mixture until clear. • Constituted solutions of Recarbrio range from colorless to yellow. Variations of color within this range do not affect the potency of the product. • For patients with renal insufficiency, a reduced dose of Recarbrio will be administered according to the patient's CrCl, as determined from Table 7. Prepare 100 mL of infusion solution as directed above. Select the volume (mL) of the final infusion solution needed for the appropriate dose of Recarbrio as shown in Table 7. Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if discoloration or visible particles are observed. Table 7: Preparation of Recarbrio doses Creatinine Clearance (mL/min) Dosage of Recarbrio (imipenem/cilastatin/relebactam) (mg) Volume (mL) of Solution to be Removed and Discarded from Preparation Volume (mL) of Final Infusion Solution Needed for Dosage Greater than or equal to 90 500/500/250 N/A 100 Less than 90 to greater than or equal to 60 400/400/200 20 80 Less than 60 to greater than or equal to 30 300/300/150 40 60 Less than 30 to greater than or equal to 15 or ESRD on haemodialysis 200/200/100 60 40 Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Compatible medicinal products The physical compatibility of Recarbrio with selected injectable medicinal products was evaluated in two commonly available diluents at a Y-infusion site. Compatible medicinal products with the corresponding compatible diluent (i.e., 5 % Dextrose Injection or 0.9 % Sodium chloride Injection) are listed below. Recarbrio should not be co‑administered through the same intravenous line (or cannula), with other medicinal products not listed below, as no compatibility data are available. Refer to the respective prescribing information of the co-administered medicinal product(s) to confirm compatibility of simultaneous co‑administration. This medicinal product must not be mixed with other medicinal products except those mentioned below. List of Compatible Injectable Medicinal Products for use with 5 % Dextrose or 0.9 % Sodium chloride Injection as Diluents • dexmedetomidine • dopamine • epinephrine • fentanyl • heparin • midazolam • norepinephrine • phenylephrine Compatible intravenous bags and infusion set materials Recarbrio is compatible with the following intravenous container bags and infusion set materials. Any intravenous bags or infusion set materials not listed below should not be used. Intravenous Container Bag Materials Polyvinyl chloride (PVC) and polyolefin (polypropylene and polyethylene) Intravenous Infusion Set Materials (with tubing) PVC + Di‑(2-ethylhexyl)phthalate (DEHP) and polyethylene (PE)‑lined PVC Incompatible medicinal products Recarbrio for solution for infusion is physically incompatible with propofol in 5 % Dextrose (also named Glucose) or 0.9 % Sodium chloride.

Imipenem/Cilastatin Kabi

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