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Doripenem (Powder) Instructions for Use

ATC Code

J01DH04 (Doripenem)

Active Substance

Doripenem (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the carbapenem group

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; carbapenems

Pharmacological Action

A synthetic broad-spectrum antibiotic from the carbapenem group, structurally similar to other beta-lactam antibiotics. Doripenem is active in vitro against aerobic and anaerobic gram-positive and gram-negative bacteria. Compared to imipenem and meropenem, it is 2-4 times more active against Pseudomonas aeruginosa.

Doripenem exerts a bactericidal effect by disrupting bacterial cell wall biosynthesis. It inactivates a large number of important penicillin-binding proteins (PBPs), leading to impaired synthesis of the bacterial cell wall and subsequent death of bacterial cells. Doripenem has the highest affinity for PBPs of Staphylococcus aureus. In Escherichia coli and Pseudomonas aeruginosa cells, Doripenem binds tightly to PBPs involved in maintaining the shape of the bacterial cell.

In vitro experiments have shown that Doripenem slightly reduces the activity of other antibiotics; other antibiotics do not reduce the activity of doripenem. Additive activity or weak synergy has been described with amikacin and levofloxacin against Pseudomonas aeruginosa, as well as with daptomycin, linezolid, levofloxacin, and vancomycin against gram-positive bacteria.

Mechanisms of resistance to doripenem include inactivation of the drug by mutant or acquired carbapenem-hydrolyzing enzymes (PBPs), reduced permeability of the outer membrane, and active efflux of doripenem from bacterial cells. Doripenem is resistant to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-positive and gram-negative bacteria; an exception are the relatively rare β-lactamases capable of hydrolyzing Doripenem.

The prevalence of acquired resistance of individual species may vary in different geographic regions and at different times, so it is very important to have information on the local resistance structure, especially when treating severe infections. If necessary, consultation with microbiologists should be sought if the local resistance structure is such that the advisability of using a particular drug, at least for some types of infection, is in doubt.

Active against aerobic gram-positive bacteria Enterococcus faecalis, Staphylococcus aureus (methicillin-susceptible strains), Staphylococcus epidermidis (methicillin-susceptible strains), Staphylococcus haemolyticus (methicillin-susceptible strains), Streptococcus agalactiae (including macrolide-resistant strains), Staphylococcus saprophyticus, Streptococcus intermedius, Streptococcus constellatus, Streptococcus pneumoniae (including penicillin- or ceftriaxone-resistant strains), Streptococcus pyogenes, Streptococcus viridans (including penicillin-intermediate and resistant strains); aerobic gram-negative bacteria Acinetobacter baumannii, Acinetobacter calcoaceticus, Aeromonas hydrophila, Citrobacter diversus, Citrobacter freundii (including ceftazidime-resistant strains), Enterobacter aerogenes, Enterobacter cloacae (including ceftazidime-resistant strains), Haemophilus influenzae (including beta-lactamase-producing strains, or ampicillin-resistant strains that do not produce beta-lactamases), Escherichia coli (including levofloxacin-resistant strains and extended-spectrum beta-lactamase-producing strains), Klebsiella pneumonia (including beta-lactamase-producing strains), Klebsiella oxytoca, Morganella morganii, Proteus mirabilis (including ESBL-producing strains), Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa (including ceftazidime-resistant strains), Salmonella spp., Serratia marcescens (including ceftazidime-resistant strains), Shigella spp.; anaerobic bacteria : Bacteroides fragilis, Bacteroides caccae, Bacteroides ovatus, Bacteroides uniformis, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bilophila wadsworthia, Clostridium spp., Peptostreptococcus magnus, Peptostreptococcus micros, Porphyromonas spp., Prevotella spp., Suterella wadsworthia.

Resistant aerobic gram-positive bacteria methicillin-resistant staphylococci, Enterococcus faecium; aerobic gram-negative bacteria Stenotrophomonas maltophila; Burkholderia cepacia may also have acquired resistance.

Pharmacokinetics

In the dose range from 500 mg to 1 g with IV infusion over 1 or 4 hours, Cmax and AUC change linearly.

In patients with normal renal function, no signs of doripenem accumulation were found after multiple IV infusions of 500 mg or 1 g every 8 hours for 7-10 days.

The binding of doripenem to plasma proteins averages 8.1% and does not depend on its concentration in plasma. Vd is approximately 16.8 L, which is close to the volume of extracellular fluid in humans (18.2 L). Doripenem penetrates well into the tissues of the uterus, prostate gland, gallbladder and urine, as well as retroperitoneal fluid, achieving concentrations there that exceed the MIC.

The active substance is biotransformed into a microbiologically inactive metabolite mainly under the action of dehydropeptidase-I.

In vitro, metabolism of doripenem was observed under the action of CYP450 system isoenzymes and other enzymes, both in the presence and absence of NADPH.

Doripenem is excreted primarily by the kidneys unchanged. In healthy young adults, the terminal T1/2 of doripenem is about 1 hour, and plasma clearance is approximately 15.9 L/h. The mean renal clearance is 10.3 L/h. The value of this indicator, along with a significant decrease in the elimination of doripenem when administered simultaneously with probenecid, indicates that Doripenem undergoes both glomerular filtration and renal secretion. In healthy young adults, after a single dose of doripenem 500 mg, 71% of the dose was found in the urine as unchanged doripenem and 15% as the ring-opened metabolite, respectively. After administration of a single dose (500 mg) of radioactively labeled doripenem to healthy young adults, less than 1% of the total radioactivity was found in the stool.

After a single dose of doripenem 500 mg in patients with impaired renal function, AUC increases compared to AUC in healthy people with normal renal function (CrCl ≥80 ml/min).

Compared to young adults, in elderly patients the AUC of doripenem was increased by 49%. These changes are mainly explained by age-related changes in CrCl.

Indications

Hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia; complicated intra-abdominal infections; complicated urinary tract infections, including complicated and uncomplicated pyelonephritis, including cases with concomitant bacteremia.

ICD codes

ICD-10 code Indication
A40 Streptococcal sepsis
A41 Other sepsis
B95.3 Streptococcus pneumoniae as the cause of diseases classified to other chapters
B95.6 Staphylococcus aureus as the cause of diseases classified to other chapters
B96.1 Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified in other chapters
B96.3 Haemophilus influenzae [H.influenzae] as the cause of diseases classified to other chapters
J15 Bacterial pneumonia, not elsewhere classified
J15.1 Pneumonia due to Pseudomonas
K65.0 Acute peritonitis (including abscess)
K81.0 Acute cholecystitis
K81.1 Chronic cholecystitis
K83.0 Cholangitis
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
ICD-11 code Indication
1B5Y Other specified staphylococcal or streptococcal diseases
1G40 Sepsis without septic shock
CA40.05 Pneumonia caused by Pseudomonas aeruginosa
CA40.0Z Bacterial pneumonia, unspecified
DC12.0Z Acute cholecystitis, unspecified
DC12.1 Chronic cholecystitis
DC13 Cholangitis
DC50.0 Primary peritonitis
DC50.2 Peritoneal abscess
DC50.Z Peritonitis, unspecified
GB50 Acute tubulo-interstitial nephritis
GB51 Acute pyelonephritis
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB5Z Renal tubulo-interstitial diseases, unspecified
XN1P6 Haemophilus influenzae
XN3PW Streptococcus pneumoniae
XN6BM Staphylococcus aureus
XN741 Klebsiella pneumoniae

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Powder

Administered intravenously as an infusion. A single dose is 500 mg. The interval between administrations is 8 hours. The duration of therapy is 5-14 days.

In patients with moderate renal impairment (CrCl from ≥30 to ≤50 ml/min), the drug is administered at a dose of 250 mg every 8 hours. In patients with severe renal impairment (CrCl from >10 to <30 ml/min), the drug is administered at a dose of 250 mg every 12 hours.

Adverse Reactions

Most common headache (10%), diarrhea (9%) and nausea (8%).

From the central nervous system : very common – headache.

From the cardiovascular system: common – phlebitis.

From the digestive system: common – nausea, diarrhea, increased activity of liver enzymes; sometimes – Clostridium difficile-associated colitis.

Dermatological reactions common – itching, rash.

Allergic reactions sometimes – anaphylactic shock; very rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome.

From the hematopoietic system : sometimes – neutropenia, thrombocytopenia.

Other: common – oral candidiasis, vaginal candidiasis.

Contraindications

Childhood and adolescence under 18 years; hypersensitivity to doripenem; hypersensitivity to other drugs of the carbapenem group, as well as to beta-lactam antibiotics.

Use in Pregnancy and Lactation

When using doripenem in a small number of pregnant women, no negative effects on pregnancy, or on the health of the fetus and newborn were observed. If use during pregnancy is necessary, caution is required, as well as an assessment of the ratio of the expected benefit of therapy for the mother and the potential risk to the fetus.

If it is necessary to use doripenem during lactation, breastfeeding should be discontinued.

Special Precautions

In patients receiving beta-lactam antibiotics, serious, sometimes fatal, hypersensitivity reactions (anaphylactic reactions) may occur. Before starting treatment with doripenem, the patient should be questioned in detail about whether they have previously had hypersensitivity reactions to other carbapenems or to beta-lactam antibiotics. If a hypersensitivity reaction to Doripenem occurs, it should be discontinued immediately and appropriate treatment should be administered. Serious hypersensitivity reactions (anaphylactic shock) require emergency therapy, including the administration of corticosteroids and pressor amines (epinephrine), as well as other measures including oxygen therapy, intravenous fluids, and, if necessary, administration of antihistamines and maintenance of airway patency.

Pseudomembranous colitis caused by Clostridium difficile can occur with treatment with almost all antibacterial drugs and can range from mild to life-threatening. Therefore, it is necessary to be aware of this complication if a patient receiving Doripenem develops diarrhea.

Long-term use of doripenem should be avoided to prevent overgrowth of microorganisms resistant to it.

Before using doripenem, it is recommended to conduct a bacteriological study. In this case, appropriate samples should be taken for bacteriological testing to isolate pathogens, identify them and determine their sensitivity to doripenem. In the absence of such data, the empirical choice of drugs should be based on local epidemiological data and the local susceptibility pattern of microorganisms.

Drug Interactions

Probenecid competes with doripenem for renal tubular secretion and reduces the renal clearance of doripenem. Probenecid increases the AUC of doripenem by 75% and plasma T1/2 by 53%. This combination is not recommended.

In healthy volunteers, Doripenem reduced the plasma concentration of valproic acid to a subtherapeutic level (AUC value decreased by 63%), which is also consistent with the results obtained for other carbapenems. The pharmacokinetics of doripenem did not change. With the simultaneous use of doripenem and valproic acid or sodium valproate, the concentration of the latter should be monitored and the possibility of prescribing another treatment should be considered.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial 1, 5 or 10 pcs.
Powder for solution for infusion 500 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion 1 vial
Doripenem 250 mg

Vials (1) – cardboard packs.
Vials (5) – cardboard packs.
Vials (10) – cardboard packs.

Powder for solution for infusion 1 vial
Doripenem 500 mg

Vials (1) – cardboard packs.
Vials (5) – cardboard packs.
Vials (10) – cardboard packs.

Marketing Authorization Holder

Lekvalis, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Doripenem Powder for concentrate for solution for infusion 500 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for concentrate for solution for infusion from white to almost white with a slightly yellowish tint.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

Glass vials with a volume of 20 ml (1) – cardboard packs.
Glass vials with a volume of 20 ml (5) – cardboard packs.
Glass vials with a volume of 20 ml (10) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Doripenem Powder for solution for infusion 500 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion white or yellowish in color.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

500 mg – vials with a capacity of 10 ml (1) – cardboard packs.
500 mg – vials with a capacity of 10 ml (5) – cardboard packs.
500 mg – vials with a capacity of 10 ml (10) – cardboard packs.
500 mg – vials with a capacity of 20 ml (1) – cardboard packs.
500 mg – vials with a capacity of 20 ml (5) – cardboard packs.
500 mg – vials with a capacity of 20 ml (10) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion white or yellowish in color; reconstituted solution – when 5 ml of water for injections or 0.9% sodium chloride solution is added to the vial contents, a homogeneous white or yellowish suspension is formed, which passes freely through a needle No. 0840.

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

250 mg – vials with a capacity of 10 ml (1) – cardboard packs.
250 mg – vials with a capacity of 10 ml (5) – cardboard packs.
250 mg – vials with a capacity of 10 ml (10) – cardboard packs.

Marketing Authorization Holder

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion finely crystalline, white or white with a yellowish tint.

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

250 mg – colorless glass vials (1) – cardboard packs.
250 mg – colorless glass vials (from 10 to 50 pcs.) – cardboard packs (for hospitals).

Powder for solution for infusion finely crystalline, white or white with a yellowish tint.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

500 mg – colorless glass vials (1) – cardboard packs.
500 mg – colorless glass vials (from 10 to 50 pcs.) – cardboard packs (for hospitals).

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Doripenem Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion from white or almost white to slightly yellowish, crystalline; reconstituted solution: when the vial contents are dissolved in 10 ml of water for injections, a homogeneous white or almost white suspension is formed, which passes freely into a syringe through a needle No. 0840.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

Colorless glass vials with a capacity of 20 ml (1) – cardboard packs.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion from white to light yellow, crystalline; reconstituted solution: clear, from white to light yellow.

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

250 mg – glass vials with a capacity of 10 ml (1) – cardboard packs.

Powder for solution for infusion from white to light yellow, crystalline; reconstituted solution: clear, from white to light yellow.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

500 mg – glass vials with a capacity of 20 ml (1) – cardboard packs.

Marketing Authorization Holder

Pharmnovations, LLC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Primary Packaging

Ruzpharma, LLC (Russia)

Secondary Packaging

Ruzpharma, LLC (Russia)

Or

Altegra, JSC (Russia)

Quality Control Release

Ruzpharma, LLC (Russia)

Or

Altegra, JSC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial
Powder for solution for infusion 500 mg: vial

Dosage Form, Packaging, and Composition

Powder for solution for infusion in the form of a finely crystalline powder, white or white with a yellowish tint.

1 vial
Doripenem monohydrate 260.7 mg*,
   Equivalent to doripenem content 250 mg

250 mg – vials with a capacity of 10 ml (1) – cardboard packs.

* the actual amount of mg of doripenem monohydrate in the vial depends on the content of the active substance and water in the doripenem monohydrate substances.

Powder for solution for infusion in the form of a finely crystalline powder, white or white with a yellowish tint.

1 vial
Doripenem monohydrate 521.4 mg*,
   Equivalent to doripenem content 500 mg

500 mg – vials with a capacity of 20 ml (1) – cardboard packs.

* the actual amount of mg of doripenem monohydrate in the vial depends on the content of the active substance and water in the doripenem monohydrate substances.

Marketing Authorization Holder

Euroservice Firm, JSC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Powder for solution for infusion 250 mg: vial
Powder for solution for infusion 500 mg: vial

Dosage Form, Packaging, and Composition

Powder for solution for infusion white or white with a yellowish tint, crystalline.

1 vial
Doripenem (as doripenem monohydrate) 250 mg

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 20 ml (1) – cardboard packs.

Powder for solution for infusion white or white with a yellowish tint, crystalline.

1 vial
Doripenem (as doripenem monohydrate) 500 mg

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 20 ml (1) – cardboard packs.

Marketing Authorization Holder

Elfa SPC, JSC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Doripenem Elfa Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion white or white with a yellowish tint.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

Glass vials with a capacity of 20 ml (1) – cardboard packs.

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Or

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem J Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion from white or almost white to yellowish; reconstituted suspension – when 10 ml of water for injections or 0.9% sodium chloride solution is added to the vial contents, a homogeneous suspension from white or almost white to yellowish is formed, which passes freely through a needle No. 0840 or No. 21 on the Gauge scale.

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

250 mg – colorless glass vials (type I) (1) – cardboard packs.
250 mg – colorless glass vials (type I) (5) – cardboard boxes (for hospitals).
250 mg – colorless glass vials (type I) (10) – cardboard boxes (for hospitals).
250 mg – colorless glass vials (type I) (50) – cardboard boxes (for hospitals).

Powder for solution for infusion from white or almost white to yellowish; reconstituted suspension – when 10 ml of water for injections or 0.9% sodium chloride solution is added to the vial contents, a homogeneous suspension from white or almost white to yellowish is formed, which passes freely through a needle No. 0840 or No. 21 on the Gauge scale.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

500 mg – colorless glass vials (type I) (1) – cardboard packs.
500 mg – colorless glass vials (type I) (5) – cardboard boxes (for hospitals).
500 mg – colorless glass vials (type I) (10) – cardboard boxes (for hospitals).
500 mg – colorless glass vials (type I) (50) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Manufactured By

Omutninskaya Scientific Experimental-Industrial Base, JSC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Kronofarm Powder for solution for infusion 250 mg: vial 1 or 10 pcs.
Powder for solution for infusion 500 mg: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion crystalline, from white to almost white or slightly yellowish.

1 vial
Doripenem (as monohydrate) 250 mg

250 mg – vials (1) – cardboard packs with insert.
250 mg – vials (10) – cardboard packs with insert.

Powder for solution for infusion crystalline, from white to almost white or slightly yellowish.

1 vial
Doripenem (as monohydrate) 500 mg

500 mg – vials (1) – cardboard packs with insert.
500 mg – vials (10) – cardboard packs with insert.

Marketing Authorization Holder

MD Trade, LLC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem MD Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion white or white with a yellowish tint, finely crystalline; when 10 ml of water for injections is added to the vial contents, a homogeneous white or almost white suspension is formed, which passes freely through a needle No. 0840.

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

Glass vials with a capacity of 20 ml (1) – cardboard packs.

Powder for solution for infusion white or white with a yellowish tint, finely crystalline; when 10 ml of water for injections is added to the vial contents, a homogeneous white or almost white suspension is formed, which passes freely through a needle No. 0840.

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

Glass vials with a capacity of 20 ml (1) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem Velpharm Powder for solution for infusion 250 mg
Powder for solution for infusion 500 mg

Dosage Form, Packaging, and Composition

Powder for solution for infusion

1 vial
Doripenem (as monohydrate) 250 mg

250 mg – vials – cardboard packs – By prescription
250 mg – vials (10 pcs.) – cardboard packs – By prescription
250 mg – vials (100 pcs.) – cardboard boxes – for hospitals
250 mg – vials (20 pcs.) – cardboard boxes – for hospitals
250 mg – vials (25 pcs.) – cardboard boxes – for hospitals
250 mg – vials (5 pcs.) – cardboard packs – By prescription
250 mg – vials (50 pcs.) – cardboard boxes – for hospitals

Powder for solution for infusion

1 vial
Doripenem (as monohydrate) 500 mg

250 mg – vials – cardboard packs – By prescription
250 mg – vials (10 pcs.) – cardboard packs – By prescription
250 mg – vials (100 pcs.) – cardboard boxes – for hospitals
250 mg – vials (20 pcs.) – cardboard boxes – for hospitals
250 mg – vials (25 pcs.) – cardboard boxes – for hospitals
250 mg – vials (5 pcs.) – cardboard packs – By prescription
250 mg – vials (50 pcs.) – cardboard boxes – for hospitals

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

Belarusian-Dutch Joint Venture "FARMLAND", LLC (Republic of Belarus)

Dosage Forms

Bottle Rx Icon Doripenem-Alvils Powder for solution for infusion 250 mg
Powder for solution for infusion 500 mg

Dosage Form, Packaging, and Composition

Powder for solution for infusion

1 vial
Doripenem (as monohydrate) 250 mg

260.7 mg – vials – cardboard packs – By prescription
260.7 mg – vials (10 pcs.) – cardboard packs – By prescription
260.7 mg – vials (5 pcs.) – cardboard packs – By prescription

Powder for solution for infusion

1 vial
Doripenem (as monohydrate) 500 mg

521.4 mg – vials – cardboard packs – By prescription
521.4 mg – vials (10 pcs.) – cardboard packs – By prescription
521.4 mg – vials (5 pcs.) – cardboard packs – By prescription

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Pharmconcept, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem-Binergia Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion from white to light yellow, crystalline; reconstituted solution: when 5 ml of water for injections or 0.9% sodium chloride solution is added to the vial contents, a homogeneous suspension from white to light yellow is formed, which passes freely through a needle No. 21 G (08×40 mm).

1 vial
Doripenem monohydrate 260.7 mg,
   Equivalent to doripenem content 250 mg

250 mg – 10 ml glass vials (1) – cardboard packs.
250 mg – 10 ml glass vials (10) – cardboard packs (for hospitals).
250 mg – 10 ml glass vials (50) – cardboard packs (for hospitals).

Powder for solution for infusion from white to light yellow, crystalline; reconstituted solution: when 10 ml of water for injections or 0.9% sodium chloride solution is added to the vial contents, a homogeneous suspension from white to light yellow is formed, which passes freely through a needle No. 21 G (08×40 mm).

1 vial
Doripenem monohydrate 521.4 mg,
   Equivalent to doripenem content 500 mg

500 mg – 20 ml glass vials (1) – cardboard packs.
500 mg – 20 ml glass vials (10) – cardboard packs (for hospitals).
500 mg – 20 ml glass vials (50) – cardboard packs (for hospitals).

Marketing Authorization Holder

Protek-SVM LLC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Doripenem-LEKSVM® Powder for solution for infusion 250 mg: vial 1 pc.
Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion fine-crystalline white or white with a yellowish tint.

1 vial
Doripenem 250 mg
(as monohydrate)

250 mg – colorless glass vials (1) – cardboard packs.

Powder for solution for infusion fine-crystalline white or white with a yellowish tint.

1 vial
Doripenem 500 mg

500 mg – colorless glass vials (1) – cardboard packs.

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