Ifem

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IFEEM

Composition:

Active substance: meropenem;

1 vial contains meropenem trihydrate equivalent to 1000 mg of anhydrous meropenem;

Excipient: anhydrous sodium carbonate.

Dosage form. Powder for solution for injection.

Main physicochemical properties: crystals or crystalline powder, colorless to white or light yellow.

Pharmacotherapeutic group. Antimicrobial agents for systemic use. Carbapenems. ATC code J01D H02.

Pharmacological Properties

Pharmacodynamics

Meropenem exerts a bactericidal effect by inhibiting bacterial cell wall synthesis in both Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).

As with other beta-lactam antibacterial agents, time above the minimum inhibitory concentration (T > MIC) has shown a high degree of correlation with efficacy. In preclinical models, meropenem demonstrated activity when plasma concentrations exceeded the MIC for the infecting microorganisms for approximately 40% of the dosing interval. This target value has not been clinically established.

Bacterial resistance to meropenem may arise due to: (1) reduced permeability of the outer membrane in Gram-negative bacteria (due to decreased porin production), (2) reduced affinity for target PBPs, (3) increased expression of efflux pump components, and (4) production of beta-lactamases capable of hydrolyzing carbapenems.

In the European Union (EU), outbreaks of infection caused by carbapenem-resistant bacteria have been reported.

Cross-resistance between meropenem and medicinal products belonging to the quinolone, aminoglycoside, macrolide, and tetracycline classes, with respect to target microorganisms, is absent. However, bacteria may exhibit resistance to more than one class of antibacterial agents when the underlying mechanism involves reduced membrane permeability and/or the presence of efflux pump(s).

The MIC breakpoints established during clinical trials by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) can be found at the following link: https://www.ema.europa.eu/documents/other/minimum-inhibitory-concentration-mic-breakpoints_en.xlsx

The prevalence of acquired resistance may vary geographically and over time for individual species; therefore, it is advisable to refer to local information on microbial resistance, especially when treating severe infections. If necessary, when local resistance prevalence renders the benefit of the medicinal product questionable, at least for certain types of infections, expert consultation should be sought.

The following lists pathogenic microorganisms based on clinical experience and therapeutic treatment guidelines.

Commonly susceptible species

Gram-positive aerobes

Enterococcus faecalis $

Staphylococcus aureus (methicillin-susceptible) £

Staphylococcus species (methicillin-susceptible), including Staphylococcus epidermidis

Streptococcus agalactiae (Group B)

Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius)

Streptococcus pneumoniae

Streptococcus pyogenes (Group A)

Gram-negative aerobes

Citrobacter freundii

Citrobacter koseri

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Haemophilus influenzae

Klebsiella oxytoca

Klebsiella pneumoniae

Morganella morganii

Neisseria meningitidis

Proteus mirabilis

Proteus vulgaris

Serratia marcescens

Gram-positive anaerobes

Clostridium perfringens

Peptoniphilus asaccharolyticus

Peptostreptococcus species (including P. micros, P. anaerobius, P. magnus)

Gram-negative anaerobes

Bacteroides caccae

Bacteroides fragilis group

Prevotella bivia

Prevotella disiens

Species for which acquired resistance may be a problem

Gram-positive aerobes

Enterococcus faecium $,†

Gram-negative aerobes

Acinetobacter species

Burkholderia cepacia

Pseudomonas aeruginosa

Inherently resistant microorganisms

Gram-negative aerobes

Stenotrophomonas maltophilia

Legionella species

Other microorganisms

Chlamydophila pneumoniae

Chlamydophila psittaci

Coxiella burnetii

Mycoplasma pneumoniae

$ Species exhibiting natural intermediate susceptibility.

£ All methicillin-resistant staphylococci are resistant to meropenem.

† Resistance rate > 50% in one or more EU countries.

Glanders and melioidosis: the use of meropenem in humans is based on in vitro susceptibility data for B. mallei and B. pseudomallei and limited available human use data. Physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis.

Pharmacokinetics

In healthy volunteers, the mean plasma elimination half-life (t½) is approximately 1 hour; the mean volume of distribution is about 0.25 L/kg (11–27 L); and the mean clearance is 287 mL/min following a 250 mg dose, decreasing to 205 mL/min with a 2 g dose. After administration of 500, 1000, and 2000 mg doses as 30-minute infusions, mean Cmax values were approximately 23, 49, and 115 µg/mL, respectively; corresponding AUC values were 39.3, 62.3, and 153 µg×h/mL. Following 5-minute infusions, Cmax values were 52 and 112 µg/mL after 500 and 1000 mg doses, respectively. With multiple dosing every 8 hours in patients with normal renal function, accumulation of meropenem was not observed.

In a study involving 12 patients receiving 1000 mg meropenem every 8 hours after surgery for intra-abdominal infections, Cmax and t½ values were similar to those in healthy subjects, but a larger volume of distribution (27 L) was observed.

Distribution

The mean extent of plasma protein binding of meropenem is approximately 2% and is independent of drug concentration. After rapid administration (5 minutes or less), pharmacokinetics are biexponential, but this is much less evident after a 30-minute infusion. Meropenem has been shown to penetrate well into certain body fluids and tissues, including lungs, bronchial secretions, bile, cerebrospinal fluid, female genital tissues, skin, fascia, muscle, and peritoneal exudates.

Metabolism

Meropenem is metabolized via hydrolysis of the beta-lactam ring, forming a microbiologically inactive metabolite. In vitro, meropenem demonstrates reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem, and therefore does not require co-administration with a DHP-I inhibitor.

Elimination

Meropenem is primarily eliminated unchanged by the kidneys; approximately 70% (50–75%) of the dose is excreted unchanged within 12 hours. An additional 28% is excreted as the microbiologically inactive metabolite. Fecal excretion accounts for only about 2% of the dose. Measured renal clearance and probenecid effects indicate that meropenem undergoes both glomerular filtration and tubular secretion.

Renal impairment

Impaired renal function leads to higher plasma AUC values and a prolonged elimination half-life of meropenem. AUC increased 2.4-fold in patients with moderate renal impairment (creatinine clearance (CrCl) 33–74 mL/min), 5-fold in patients with severe renal impairment (CrCl 4–23 mL/min), and 10-fold in patients undergoing hemodialysis (CrCl < 2 mL/min), compared to healthy volunteers (CrCl > 80 mL/min). AUC values of the microbiologically inactive open-ring metabolite were also significantly increased in patients with renal impairment. Dose adjustment is recommended for patients with moderate and severe renal impairment (see section "Dosage and administration").

Meropenem is removed by hemodialysis, with a clearance during dialysis approximately 4 times higher than in patients with anuria.

Hepatic impairment

Studies in patients with alcoholic cirrhosis of the liver show no influence of liver disease on meropenem pharmacokinetics after repeated dosing.

Adult patients

Pharmacokinetic studies in patients have not revealed significant pharmacokinetic differences compared to healthy volunteers with similar renal function. A population model developed from data in 79 patients with intra-abdominal infection or pneumonia showed dependence of key parameters on body weight, creatinine clearance, and age.

Children

Pharmacokinetic studies in infants and children with infection receiving doses of 10, 20, and 40 mg/kg demonstrated Cmax values approaching those observed in adults after 500, 1000, and 2000 mg doses, respectively. Pharmacokinetic profiles were consistent across dose levels, with elimination half-lives similar to those in adults, except in the youngest patients (< 6 months, t½ 1.6 hours). Mean meropenem clearance values were 5.8 mL/min/kg (6–12 years), 6.2 mL/min/kg (2–5 years), 5.3 mL/min/kg (6–23 months), and 4.3 mL/min/kg (2–5 months). Approximately 60% of the dose was excreted in urine as meropenem and an additional 12% as metabolite within 12 hours. Meropenem concentrations in cerebrospinal fluid in children with meningitis are approximately 20% of simultaneously measured plasma levels, although considerable inter-individual variability exists.

Pharmacokinetics of meropenem in neonates receiving antibacterial treatment showed higher clearance in neonates with greater chronological or gestational age, with an overall mean elimination half-life of 2.9 hours. Monte Carlo simulations based on the population pharmacokinetic model indicated that with a dosing regimen of 20 mg/kg every 8 hours, 60% T > MIC for P. aeruginosa was achieved in 95% of preterm neonates and 91% of term neonates.

Elderly patients

Pharmacokinetic studies in healthy elderly subjects (65–80 years) showed reduced plasma clearance, correlating with age-related reduction in creatinine clearance, as well as a slight decrease in non-renal clearance. Dose adjustment is not required in elderly patients unless moderate or severe renal impairment is present.

Clinical characteristics.

Indications.

The medicinal product is indicated for the treatment of the following infections in adults and children aged 3 months and older:

• pneumonia, including community-acquired and hospital-acquired pneumonia;
• bronchopulmonary infections in cystic fibrosis;
• complicated urinary tract infections;
• complicated intra-abdominal infections;
• infections during childbirth and postpartum infections;
• complicated skin and soft tissue infections;
• acute bacterial meningitis.

Meropenem may be used for the treatment of patients with neutropenia and fever suspected to be caused by a bacterial infection.

Treatment of patients with bacteremia associated or potentially associated with any of the above-mentioned infections.

Official recommendations regarding appropriate use of antibacterial agents should be taken into account.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Hypersensitivity to any other antibacterial agent of the carbapenem group.

Severe hypersensitivity (e.g., anaphylactic reactions, severe skin reactions) to any other type of beta-lactam antibacterial agent (e.g., penicillins or cephalosporins).

Interaction with other medicinal products and other forms of interaction.

Studies on interaction of the medicinal product with other medicinal products, except probenecid, have not been conducted.

Probenecid competes with meropenem for active tubular secretion and thus inhibits renal excretion of meropenem, resulting in an increased elimination half-life and elevated plasma concentrations of meropenem. Caution should be exercised when probenecid is administered concomitantly with meropenem.

The potential effect of meropenem on protein binding or metabolism of other drugs has not been studied. However, since protein binding is so low, interactions with other compounds via this mechanism are not expected.

Decreased serum levels of valproic acid have been reported when administered concomitantly with carbapenems, resulting in a 60–100% reduction in valproic acid levels within approximately 2 days. Due to the rapid onset and extent of this reduction, concomitant administration of valproic acid/sodium valproate/valpromide and carbapenems is considered uncorrectable; therefore, such interaction should be avoided (see section "Special precautions").

Oral anticoagulants

Concomitant use of antibiotics with warfarin may enhance its anticoagulant effect. Numerous reports have documented increased anticoagulant effect of oral anticoagulants, including warfarin, in patients receiving antibiotics concomitantly. The risk may vary depending on the type of underlying infection, age, and general condition of the patient, thus making it difficult to assess the contribution of antibiotics to the increase in INR (International Normalized Ratio). Frequent monitoring of INR levels is recommended during and immediately after concomitant use of antibiotics with oral anticoagulants.

Children

All drug interaction studies have been conducted in adults only.

Special precautions for use.

When selecting meropenem as a therapeutic agent, consideration should be given to the appropriateness of using a carbapenem-class antibacterial agent, taking into account factors such as the severity of infection, prevalence of resistance to other appropriate antibacterial agents, and the risk of selecting for carbapenem-resistant bacteria.

Resistance in Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter

In the European Union, resistance to penems among Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter varies. When prescribing this medicinal product, local resistance patterns of these bacteria to penems should be taken into account.

Hypersensitivity reactions

As with other beta-lactam antibiotics, serious, and sometimes fatal, hypersensitivity reactions have been reported (see sections "Contraindications" and "Side effects").

Patients with a history of hypersensitivity to carbapenems, penicillins, or other beta-lactam antibiotics may also be at increased risk of hypersensitivity to meropenem. A thorough patient history regarding previous hypersensitivity reactions to beta-lactam antibiotics should be obtained prior to initiating meropenem therapy.

If a severe allergic reaction occurs, administration of the drug should be discontinued immediately and appropriate measures should be initiated.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), erythema multiforme, and acute generalized exanthematous pustulosis, have been reported in patients receiving meropenem therapy (see section "Side effects"). If signs or symptoms suggestive of these reactions occur, meropenem should be discontinued immediately and alternative therapy considered.

Hypersensitivity reactions with other beta-lactam antibiotics have been reported to progress to Koebner’s phenomenon (acute allergic coronary artery spasm, which may lead to myocardial infarction) (see section "Side effects").

Antibiotic-associated colitis

Cases of antibiotic-associated colitis, including pseudomembranous colitis, have been reported with the use of nearly all antibacterial agents, including meropenem, with severity ranging from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after meropenem therapy (see section "Side effects"). Consideration should be given to discontinuing meropenem and initiating specific therapy directed against Clostridium difficile. Medicinal products that inhibit intestinal motility should not be administered.

Seizures

Seizures have been reported rarely during treatment with carbapenems, including meropenem (see section "Side effects").

Liver function monitoring

Due to the risk of hepatotoxicity (liver function abnormalities with cholestasis and cytolysis) during meropenem therapy, liver function should be closely monitored (see section "Side effects").

Use in patients with liver disease: liver function should be carefully monitored in patients with pre-existing liver disease during meropenem therapy. Dose adjustment is not required (see section "Dosage and administration").

Seroconversion in the direct antiglobulin test (Coombs test)

Treatment with meropenem may result in a positive direct and/or indirect Coombs test.

Concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

This medicinal product contains 90.2 mg of sodium per dose. Caution should be exercised when administering this product to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of meropenem in pregnant women are lacking or limited.

Animal studies have not shown direct or indirect effects of reproductive toxicity. As a precautionary measure, it is advisable to avoid the use of meropenem during pregnancy.

Breastfeeding

It has been reported that a small amount of meropenem passes into human breast milk. Meropenem may be used during lactation only if the expected benefit to the mother outweighs the potential risk to the infant.

Ability to influence the ability to drive and use machines.

Studies on the effect of the medicinal product on the ability to drive vehicles or operate machinery have not been conducted.

When driving vehicles or operating machinery, particular caution is recommended, considering the possibility of headache, paresthesia, or seizures, which have been reported during meropenem therapy.

Method of administration and dosage.

Dosage

The tables below provide general recommendations regarding dosage of the medicinal product.

The dose of meropenem and duration of treatment depend on the causative pathogen, severity of the infection, and the patient's response to therapy.

Meropenem administered at a dose of up to 2 g three times daily in adults and children with body weight over 50 kg, and up to 40 mg/kg three times daily in children, may be particularly appropriate for the treatment of certain infections caused by less susceptible bacterial species (e.g., Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter) or in cases of very severe infections.

Additional dosage recommendations must be followed when treating patients with renal impairment (see below).

Table 1

Recommended doses for adults and children with body weight over 50 kg

Infection	Single dose administered every 8 hours
Pneumonia, including community-acquired and hospital-acquired	500 mg or 1 g
Respiratory tract infections in cystic fibrosis	2 g
Complicated urinary tract infections	500 mg or 1 g
Complicated intra-abdominal infections	500 mg or 1 g
Infections during childbirth and postpartum infections	500 mg or 1 g
Complicated skin and soft tissue infections	500 mg or 1 g
Acute bacterial meningitis	2 g
Treatment of patients with febrile neutropenia	1 g

Meropenem should be administered as an intravenous infusion lasting from 0.25 to 0.5 hours. Additionally, doses up to 1 g may be given as an intravenous bolus injection over approximately 5 minutes. Safety data supporting administration of a 2 g dose as an intravenous bolus injection in adults are limited.

Renal impairment

Table 2

Recommended doses of the drug for adults and children with body weight over 50 kg when patients' creatinine clearance is less than 51 ml/min

Creatinine clearance (ml/min)	Single dose (see Table 1)	Frequency
26–50	full single dose	every 12 hours
10–25	half the single dose	every 12 hours
< 10	half the single dose	every 24 hours

Data supporting the use of the doses of the drug indicated in Table 2, adjusted to a 2 g unit dose, are limited.

Meropenem is removed by hemodialysis and hemofiltration; therefore, the required dose of the drug should be administered after completion of the hemodialysis procedure.

There are no recommendations regarding established dosing for patients receiving peritoneal dialysis.

Hepatic impairment

Dose adjustment of the drug is not required in patients with hepatic impairment (see section "Special warnings and precautions for use").

Dosage in elderly patients

Dose adjustment is not required in elderly patients with normal renal function or with creatinine clearance values above 50 ml/min.

Children under 3 months of age

There are no data on the safety and efficacy of meropenem use in children under 3 months of age, and the optimal dosing regimen has not been established. There are limited pharmacokinetic data justifying the use of a meropenem dose of 20 mg/kg every 8 hours (see section "Pharmacokinetics").

Table 3

Recommended doses of the drug for children aged from 3 months to 11 years and with body weight below 50 kg

Infection	Single dose to be administered every 8 hours
Pneumonia, including community-acquired and hospital-acquired	10 or 20 mg/kg body weight
Respiratory tract infections in cystic fibrosis	40 mg/kg body weight
Complicated urinary tract infections	10 or 20 mg/kg body weight
Complicated intra-abdominal infections	10 or 20 mg/kg body weight
Complicated skin and soft tissue infections	10 or 20 mg/kg body weight
Acute bacterial meningitis	40 mg/kg body weight
Treatment of patients with febrile neutropenia	20 mg/kg body weight

Children with body weight more than 50 kg

The dose should be used as for adult patients.

There is no experience with use of the drug in children with impaired renal function.

Method of administration

Meropenem is usually administered by intravenous infusion over 15 to 30 minutes. Additionally, meropenem doses up to 20 mg/kg may be administered by intravenous bolus injection over approximately 5 minutes. Safety data supporting administration of meropenem at a dose of 40 mg/kg by intravenous bolus injection in children are limited.

Administration of intravenous bolus injection

The solution for bolus injection should be prepared by dissolving the medicinal product in water for injections to obtain a concentration of 50 mg/ml.

Chemical and physical stability of the prepared bolus injection solution has been demonstrated for 3 hours at temperatures up to 25 °C or for 12 hours when stored refrigerated (2–8 °C).

From a microbiological standpoint, if the method of opening/reconstitution/dilution does not exclude the risk of microbial contamination, the medicinal product should be used immediately.

If the medicinal product is not used immediately, the storage period and conditions of the prepared solution should be carefully controlled.

Administration of intravenous infusion

The infusion solution should be prepared by dissolving the medicinal product in 0.9% sodium chloride solution for infusion or in 5% glucose (dextrose) solution for infusion to obtain a concentration of 1–20 mg/ml.

Chemical and physical stability of the prepared infusion solution using 0.9% sodium chloride solution has been demonstrated for 3 hours at 25 °C or for 24 hours when stored refrigerated (2–8 °C). From a microbiological standpoint, the medicinal product should be used immediately. If the medicinal product is not used immediately, the storage period and conditions of the prepared solution should be carefully controlled.

The solution prepared with 5% glucose (dextrose) solution should be used immediately.

Do not freeze prepared solutions.

Children.

The drug is administered to children aged from 3 months.

Overdose.

Relative overdose is possible in patients with impaired renal function if the dose of the drug is not adjusted as described in the section "Dosage and administration". Limited post-marketing experience with the drug suggests that adverse reactions occurring after overdose are consistent with the profile of the adverse reactions listed in the section "Adverse reactions", and are generally mild in severity and resolve after discontinuation of the drug or dose reduction. Symptomatic treatment should be considered as necessary.

In individuals with normal renal function, the drug is rapidly eliminated by the kidneys.

Meropenem and its metabolites are removed from the body during hemodialysis.

Adverse Reactions

In the course of reviewing data from 4872 out of 5026 patients regarding the impact of meropenem treatment, the most commonly reported adverse reactions associated with meropenem use were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%), and injection site inflammation (1.1%). The most frequently reported laboratory abnormalities associated with meropenem use were thrombocytosis (1.6%) and elevated liver enzymes (1.5–4.3%).

The adverse reactions listed in the table below are classified by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data). Within each frequency grouping, adverse reactions are listed in order of decreasing seriousness.

Infections and infestations:
Uncommon – oral and vaginal candidiasis.

Blood and lymphatic system disorders:
Common – thrombocytosis;
Uncommon – eosinophilia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia.

Immune system disorders:
Uncommon – angioedema, anaphylactic reaction (see sections "Contraindications" and "Special warnings and precautions for use").

Psychiatric disorders:
Rare – delirium.

Nervous system disorders:
Common – headache;
Uncommon – paresthesia;
Rare – seizures (see section "Special warnings and precautions for use").

Gastrointestinal disorders:
Common – diarrhea, vomiting, nausea, abdominal pain;
Uncommon – antibiotic-associated colitis (see section "Special warnings and precautions for use").

Hepatobiliary disorders:
Common – increased transaminase levels, increased alkaline phosphatase levels in blood, increased lactate dehydrogenase levels in blood;
Uncommon – increased bilirubin levels in blood.

Skin and subcutaneous tissue disorders:
Common – rash, pruritus;
Uncommon – urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme (see section "Special warnings and precautions for use");
Frequency not known – drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (see section "Special warnings and precautions for use").

Renal and urinary disorders:
Uncommon – increased blood creatinine levels, increased blood urea levels.

General disorders and administration site conditions:
Common – inflammation, pain;
Uncommon – thrombophlebitis, injection site pain.

Limited available data do not indicate an increased risk of adverse events in children. All reported cases corresponded to adverse reactions observed in adult patients.

Cojanu Syndrome

Acute coronary syndrome associated with allergic reaction (Cojanu syndrome) has been reported with the use of other beta-lactam antibiotics (see section "Special warnings and precautions for use").

Reporting of adverse reactions

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C. Keep out of reach of children. Do not freeze.

Each vial is for single use only.

Standard aseptic techniques should be used during reconstitution and administration of the solution.

The solution should be shaken before use.

Any unused product or waste material must be disposed of in accordance with local requirements.

Incompatibilities.

Meropenem must not be mixed or combined with other medicinal products.

Meropenem intended for intravenous bolus injection should be reconstituted with sterile water for injection.

Meropenem in vials intended for intravenous infusion may be directly reconstituted with 0.9% sodium chloride solution or 5% glucose solution for infusion.

Packaging. Powder in a glass vial sealed with a rubber stopper and an aluminum cap with a "flip-off" component, one vial per carton.

Prescription status. Prescription only.

Manufacturer.

Brooks Sterisience Limited.

Manufacturer's address and location of operations.

Block No. Survey No. 61/62, Manglaj Village, Naresar Road, Karjan Taluka, Vadodara, 391243, India.

Marketing Authorization Holder.

Ananta Medikare Ltd.

Address of the Marketing Authorization Holder and/or its representative.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.