Instructions for Euroceftaz powder for solution for injection 1000 mg + 125 mg vial No. 1
Composition
active ingredients: ceftriaxone, tazobactam;
1 vial contains ceftriaxone sodium equivalent to anhydrous ceftriaxone 1000 mg and tazobactam sodium equivalent to tazobactam 125 mg.
Dosage form
Powder for injection.
Main physicochemical properties: white or almost white crystalline powder.
Pharmacotherapeutic group
Antibacterials for systemic use. Cephalosporins. Ceftriaxone, combinations. ATX code J01D D54.
Pharmacological properties
Pharmacodynamics.
Ceftriaxone is a third-generation cephalosporin antibiotic for parenteral administration. It has a bactericidal effect against many gram-positive and gram-negative bacteria.
Ceftriaxone is resistant to beta-lactamases. It is also active against strains resistant to other cephalosporins.
The following strains are highly sensitive to ceftriaxone: Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus, S. epidermidis, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus ducrey, Yersinia pestis, Borrelia burgdorferi, Treponema pallidum, Serratia marcescens, Peptostreptococcus spp., Proteus mirabilis, Proteus vulgaris.
Enterobacteriaceae species (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Morganella morganii, Klebsiella spp., Enterobacter spp., Providencia spp.) are also susceptible to ceftriaxone, except for strains that produce beta-lactamases.
Ceftriaxone is not effective against Acinetobacter spp., P. aeruginosa, Campylobacter jejuni, Bacteroides fragilis, Clostridium difficile, Listeria monocytogenes, Enterococcus faecalis and methicillin-resistant staphylococci.
Mycoplasma, mycobacteria, and chlamydia are resistant to cephalosporins.
Tazobactam, a sulfonic derivative of triazolylmethylpenicillanic acid, is an inhibitor of many beta-lactamases, including plasmid and chromosomal enzymes, which often cause resistance to penicillins and cephalosporins, including third-generation cephalosporins. Tazobactam has only minor antibacterial activity. The presence of tazobactam in the combination drug Euroceftaz enhances and broadens the antimicrobial spectrum of ceftriaxone, including bacteria that produce beta-lactamases, which are usually insensitive to it and other beta-lactam antibiotics.
Pharmacokinetics.
Ceftriaxone is well absorbed after intramuscular administration and reaches high serum concentrations. The bioavailability of the drug is 100%.
Ceftriaxone rapidly penetrates into tissue fluid and is characterized by a high volume of distribution in most tissues and body fluids. In meningitis in children, ceftriaxone penetrates into the cerebrospinal fluid during inflammation of the meninges, while its concentration in the cerebrospinal fluid is 17% of the concentration in blood plasma. In adult patients, 2-24 hours after the administration of a single dose of 50 mg/kg body weight, the concentration of ceftriaxone in the cerebrospinal fluid exceeds the minimum concentration for the most common pathogens of meningitis.
Due to the long half-life (on average 8 hours, and in patients over 75 years of age - twice as long), the concentration of ceftriaxone 24 hours after administration is higher than the minimum inhibitory concentration for most microorganisms that cause various infections.
Approximately 50-60% of administered ceftriaxone is excreted unchanged in the urine by the kidneys, the remainder by the liver. Ceftriaxone apparently reduces the rate of elimination of tazobactam.
Indication
Treatment of infections whose pathogens are sensitive to the components of the drug:
respiratory tract infections, especially pneumonia, as well as infections of the ENT organs;
infections of the abdominal organs (peritonitis, infections of the biliary tract and gastrointestinal tract);
urinary tract infections;
genital infections, including gonorrhea;
sepsis;
infections of bones, joints, soft tissues, skin, as well as wound infections;
infections in patients with weakened immune systems;
meningitis;
disseminated Lyme borreliosis (early and late stages of the disease).
Preoperative prophylaxis of infections during surgical interventions on the gastrointestinal tract, biliary tract, urinary tract and during gynecological procedures, but only in cases of potential or known contamination.
When prescribing Euroceftaz, official recommendations for antibiotic therapy, including recommendations for the prevention of antibiotic resistance, should be followed.
Contraindication
Hypersensitivity to ceftriaxone or to any other cephalosporin. History of severe hypersensitivity reactions (e.g. anaphylactic reactions) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
Ceftriaxone is contraindicated:
premature newborns aged ≤ 41 weeks, taking into account the term of intrauterine development (gestational age + age after birth)*;
full-term newborns (age ≤ 28 days):
with hyperbilirubinemia, jaundice, hypoalbuminemia, or acidosis, as bilirubin binding is likely to be impaired in these conditions*;
* In vitro studies have shown that ceftriaxone may displace bilirubin from serum albumin, leading to a possible risk of bilirubin encephalopathy in such patients.
Before intramuscular administration of ceftriaxone, it is essential to exclude contraindications to the use of lidocaine when used as a diluent (see section "Method of administration and dosage"). See the instructions for medical use of lidocaine, especially contraindications.
Ceftriaxone solutions containing lidocaine should never be administered intravenously.
Interaction with other medicinal products and other types of interactions
Under no circumstances should Euroceftaz be used with calcium-containing solutions (e.g. Ringer's solution). Calcium-containing solutions should not be administered within 48 hours of the last ceftriaxone administration.
No renal dysfunction was observed with the simultaneous use of high doses of Euroceftaz and potent diuretics such as furosemide. There is no evidence that Euroceftaz increases the renal toxicity of aminoglycosides. No disulfiram-like effects were observed after drinking alcohol immediately after taking ceftriaxone.
Ceftriaxone does not contain the N-methylthiotetrazole group, which could cause ethanol intolerance and bleeding, which are characteristic of some other cephalosporins. Probenecid does not affect the excretion of Euroceftaz.
Antagonism between chloramphenicol and ceftriaxone has been identified.
Diluents containing calcium, such as Ringer's solution or Hartmann's solution, should not be used to dissolve Euroceftaz in vials or to dilute the reconstituted solution for intravenous administration due to the possibility of precipitation of ceftriaxone calcium salts. The occurrence of precipitates of ceftriaxone calcium salts may also occur when Euroceftaz is mixed with solutions containing calcium in the same intravenous infusion system. Euroceftaz should not be administered intravenously simultaneously with solutions containing calcium, including long-term infusions containing calcium, such as parenteral nutrition, using a Y-line (see section "Method of administration and dosage"). However, in other patients, except newborns, ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the system is thoroughly flushed with a compatible fluid between infusions. In vitro studies using adult and neonatal cord blood plasma have shown that neonates are at increased risk of precipitation of ceftriaxone calcium.
There is conflicting evidence regarding the potential for increased renal toxicity of aminoglycosides when used with cephalosporins. In such cases, the recommendations for monitoring aminoglycoside levels (and renal function) in clinical practice should be carefully followed.
According to literature data, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycosides.
Do not use solutions that contain bicarbonates.
Bacteriostatic agents may interfere with the bactericidal effect of cephalosporins.
Ceftriaxone may reduce the effectiveness of hormonal oral contraceptives. Therefore, it is recommended to use additional (non-hormonal) methods of contraception during treatment and for 1 month after treatment.
There are no reports of interactions between ceftriaxone and oral calcium-containing products, and no interactions between ceftriaxone given intramuscularly and calcium-containing products (intravenously or orally).
Ceftriaxone should not be mixed with solutions of other antimicrobial agents.
With simultaneous use of cephalosporins and cyclosporins, the plasma levels and toxicity of the latter may increase.
Diclofenac stimulates the excretion of the drug into the bile and reduces total urinary clearance.
Concomitant use of the drug with oral anticoagulants may increase the antivitamin K effect and the risk of bleeding. It is recommended to frequently check the international normalized ratio and adjust the dose of the antivitamin K agent appropriately both during and after ceftriaxone therapy.
Application features
As with other cephalosporins, fatal anaphylactic reactions have been reported with Euroceftaz, even in the absence of a detailed medical history. Hypersensitivity reactions may also progress to Kounis syndrome, a serious allergic reaction that may lead to myocardial infarction (see section 4.8). If allergic reactions occur, Euroceftaz should be discontinued immediately and appropriate treatment should be initiated. Ceftriaxone should be administered with caution to patients with known hypersensitivity to penicillins due to possible cross-allergenicity.
Ceftriaxone may increase prothrombin time. Therefore, if vitamin K deficiency is suspected, prothrombin time should be determined.
Clostridium difficile-associated diarrhea, which can range from mild to fatal, can occur with nearly all antibacterial agents, including ceftriaxone. Antibacterial agents alter the normal flora of the large intestine, leading to overgrowth of Clostridium difficile. Clostridium difficile produces toxins A and B, which cause Clostridium difficile-associated diarrhea. Strains of Clostridium difficile that overproduce toxins cause increased morbidity and mortality, as these infections may be resistant to antimicrobial agents and require colectomy. Clostridium difficile-associated diarrhea should be excluded in all patients receiving antibiotics. A detailed medical history should be taken, as Clostridium difficile-associated diarrhea can occur up to two months after discontinuation of antibacterial agents.
If Clostridium difficile-associated diarrhea is suspected or confirmed, antibiotic therapy that is not effective against Clostridium difficile should be discontinued. Appropriate fluid and electrolyte replacement, protein supplementation, antibiotic therapy to which Clostridium difficile is sensitive, and surgical evaluation should be considered as clinically indicated.
During prolonged use of Euroceftaz, it may be difficult to control non-susceptible microorganisms. Therefore, careful monitoring of patients is necessary. If superinfection occurs, appropriate measures should be taken.
After the use of ceftriaxone, usually in doses exceeding the standard recommended ones, shadows may be observed during ultrasound examination of the gallbladder, which are mistaken for stones. These are precipitates of the calcium salt of ceftriaxone, which disappear after the completion or discontinuation of therapy with the drug Euroceftaz. Such changes are rarely accompanied by any symptoms. But even in such cases, only conservative treatment is recommended. If these phenomena are accompanied by clinical symptoms, the decision to cancel the drug is made by the doctor.
Isolated cases of pancreatitis, possibly secondary to biliary obstruction, have been reported in patients receiving ceftriaxone. Most of these patients had risk factors for biliary obstruction, such as previous treatment, severe illness and total parenteral nutrition. However, a role for biliary precipitates formed by Euroceftaz cannot be excluded.
The safety and efficacy of ceftriaxone in neonates, infants and children have been established at the doses described in the section “Method of administration and dosage”. Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from its association with serum albumin.
Ceftriaxone is contraindicated in premature and full-term neonates at risk of bilirubin encephalopathy (see Contraindications).
For patients with impaired renal function, provided that liver function is normal, the dose of Euroceftaz does not need to be reduced. In renal failure (creatinine clearance below 10 ml/min), the daily dose of ceftriaxone should not exceed 2 g.
In patients with impaired liver function, provided that renal function is preserved, there is no need to reduce the dose of Euroceftaz.
In cases of concomitant severe liver and kidney disease, the concentration of ceftriaxone in the blood serum should be regularly monitored. In patients undergoing hemodialysis, there is no need to change the dose of the drug after this procedure.
Caution should be exercised when administering Euroceftaz to patients with renal insufficiency who are concurrently receiving aminoglycosides and diuretics.
Cases of kidney stones have been reported, which resolved after discontinuation of ceftriaxone. If symptoms are present, an ultrasound examination should be performed. The decision to use the drug in patients with a history of kidney stones or hypercalciuria should be made by the physician based on the results of a benefit-risk assessment of the individual case.
In case of severe renal and hepatic insufficiency, careful clinical monitoring of the safety and efficacy of the drug is recommended.
Immune-mediated hemolytic anemia has been observed in patients receiving cephalosporins, including Euroceftaz. Cases of severe hemolytic anemia, including fatal cases, have been reported in adults and children. If anemia develops during the use of ceftriaxone, anemia caused by ceftriaxone should be excluded and the drug should be discontinued until the etiology of the anemia is established.
During long-term treatment, blood counts should be monitored regularly.
In rare cases, patients may experience false-positive Coombs' test results during treatment with Euroceftaz. Like other antibiotics, Euroceftaz may cause false-positive results in galactosemia tests. False-positive results may also be obtained in the determination of glucose in urine, therefore, during the use of the drug, glycosuria, if necessary, should be determined only by the enzymatic method.
Encephalopathy
Encephalopathy has been reported with ceftriaxone (see section 4.8), particularly in elderly patients with severe renal impairment or central nervous system disorders. If ceftriaxone-related encephalopathy is suspected (e.g., decreased level of consciousness, altered mental status, myoclonus, convulsions), discontinuation of ceftriaxone should be considered.
Jarish-Herxheimer reaction.
At the beginning of ceftriaxone treatment, some patients with spirochetosis may develop a Jarisch-Herxheimer reaction. This reaction is usually self-limiting, or symptomatic treatment may be required. Antibiotic treatment should not be discontinued if a Jarisch-Herxheimer reaction occurs.
Use during pregnancy or breastfeeding
There are no reliable data on the use of the combination of ceftriaxone and tazobactam in pregnant women. Therefore, the use of the drug is contraindicated during pregnancy.
Ceftriaxone passes into breast milk. The concentration of tazobactam in breast milk has not been studied. Therefore, the use of Euroceftaz during breastfeeding is contraindicated. If necessary, breastfeeding should be discontinued.
Fertility.
Reproductive studies have shown no evidence of adverse effects on male or female fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with ceftriaxone, side effects such as dizziness may occur, which may affect the ability to drive or operate machinery (see section "Adverse reactions"). Patients should be careful when driving or operating other machinery.
Method of administration and doses
Euroceftaz injections are intended for intravenous or intramuscular administration only.
Adults and children over 12 years of age: usually 1000/125 mg - 2000/250 mg of Euroceftaz should be prescribed once a day (every 24 hours). In severe infections or infections whose pathogens are only moderately sensitive to ceftriaxone, the daily dose can be increased to 4000/500 mg. The daily dose should not exceed 4000 mg of ceftriaxone.
Children aged 2 to 12 years: 20-80 mg/kg body weight (as ceftriaxone) once daily. The daily dose should not exceed 2000 mg ceftriaxone.
Children weighing more than 50 kg should be given adult doses.
Intravenous doses of 50 mg/kg (as ceftriaxone) or higher should be administered by infusion over at least 30 minutes.
Elderly patients
Elderly patients do not need dose adjustment.
Duration of treatment
The duration of treatment depends on the course of the disease. As with other antibiotics, patients should continue to take Euroceftaz for at least 48-72 hours after the temperature has returned to normal and tests show the absence of pathogens. Usually the total duration of treatment is 4-14 days.
Combination therapy
Synergism exists between ceftriaxone and aminoglycosides against many gram-negative bacteria. Although increased efficacy of such combinations cannot always be predicted, it should be considered in the presence of severe, life-threatening infections caused by Pseudomonas aeruginosa. Due to the physical incompatibility of ceftriaxone and aminoglycosides, they should be administered separately at the recommended doses.
Dosage in special cases
Meningitis
For bacterial meningitis in children aged 2 to 12 years, treatment should be initiated at a dose of 100 mg/kg (ceftriaxone), not to exceed 4000/500 mg once daily. Once the pathogen has been identified and its sensitivity determined, the dose can be reduced accordingly. The best results have been achieved with the following duration of treatment:
Neisseria meningitidis Haemophilus influenzae Streptococcus pneumoniae | 4 days 6 days 7 days |
Lyme borreliosis: adults and children - at the rate of 50 mg/kg of ceftriaxone (highest daily dose - 2 g of ceftriaxone) once a day for 14 days.
Gonorrhea
For the treatment of gonorrhea (caused by strains that produce or do not produce penicillinase), a single dose of 250 mg of ceftriaxone intramuscularly is recommended.
For the prevention of postoperative infections in surgery, it is recommended – depending on the degree of risk of infection – to administer a single dose of 1-2 g (ceftriaxone) of Euroceftaz 30-90 minutes before the start of the operation. In operations on the colon and rectum, simultaneous (but separate) administration of Euroceftaz and one of the 5-nitroimidazoles, for example ornidazole, has proven itself well.
Renal and hepatic failure
In patients with impaired liver function, there is no need to reduce the dose if renal function remains normal. Only in the case of pre-terminal renal failure (creatinine clearance less than 20 ml/min) the daily dose of ceftriaxone should not exceed 2 g. In patients with impaired liver function, there is no need to reduce the dose if renal function remains normal. Patients on hemodialysis do not need additional administration of the drug after dialysis. However, the concentration of ceftriaxone in the blood serum should be monitored for possible dose adjustment, since the rate of excretion may be reduced in such patients. The daily dose of Euroceftaz in patients on hemodialysis should not exceed 2 g (for ceftriaxone).
Preparation of solutions
Prepare solutions immediately before use.
Intramuscular injection
For intramuscular injection, dissolve 1 g in 3.5 ml of 1% lidocaine solution; inject deeply into the gluteal muscle. It is recommended to inject no more than 1 g into one buttock. Before using lidocaine, perform a skin test for sensitivity. Solutions containing lidocaine should not be administered intravenously.
Intravenous injection
For intravenous injection, dissolve 1 g of Euroceftaz in 10 ml of sterile water for injection; administer intravenously slowly (2-4 minutes).
Intravenous infusion
Intravenous infusion should last at least 30 minutes. To prepare the infusion solution, dissolve 2 g of Euroceftaz in 40 ml of one of the following calcium-free infusion solutions: 0.9% sodium chloride, 0.45% sodium chloride + 2.5% glucose, 5% glucose, 10% glucose, 6% dextran in 5% glucose solution, 6-10% hydroxyethyl starch, water for injection. Due to possible incompatibility, solutions containing ceftriaxone and tazobactam should not be mixed with solutions containing other antibiotics, both during preparation and during administration.
Diluents containing calcium, such as Ringer's solution or Hartmann's solution, should not be used to dissolve Euroceftaz in vials or to dilute the reconstituted solution for intravenous administration due to the possibility of precipitation of ceftriaxone calcium salts. The occurrence of precipitation of ceftriaxone calcium salts may also occur when Euroceftaz is mixed with solutions containing calcium in the same intravenous infusion system. Euroceftaz should not be administered intravenously simultaneously with solutions containing calcium, including long-term infusions containing calcium, such as parenteral nutrition (see section "Interaction with other medicinal products and other forms of interaction").
Children.
Use for children over 2 years of age.
Overdose
Overdose may cause nausea, vomiting, diarrhea. Overdose of cephalosporin antibiotics can lead to symptoms of brain irritation, which may result in convulsions. In case of overdose, hemodialysis or peritoneal dialysis will not reduce the concentration of the drug. There is no specific antidote. Treatment of overdose is symptomatic.
Side effects
Euroceftaz is usually well tolerated. The following side effects are possible when using it.
Infections and infestations: candidomycosis, common - genital mycosis, secondary fungal infections and infections caused by resistant microorganisms, pseudomembranous colitis, superinfections.
From the blood and lymphatic system: common - eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, increased prothrombin time; rare - increased serum creatinine; very rare - coagulation disorders. Very rare cases of agranulocytosis (<500/mm3) have been observed, mainly after a total dose of 20 g or more. During long-term treatment, the blood picture should be regularly monitored. A slight prolongation of prothrombin time has been recorded.
On the part of the hepatobiliary system: very common - pseudocholelithiasis of the gallbladder, precipitates of calcium salt of ceftriaxone in the gallbladder with corresponding symptoms in children, reversible cholelithiasis in children (these phenomena were rarely observed in children); common - increased levels of liver enzymes in the blood serum (AST, ALT, alkaline phosphatase); frequency unknown - kernicterus, hepatitis (usually reversible upon discontinuation of ceftriaxone), cholestatic hepatitis (section "Special instructions").
Skin and subcutaneous tissue disorders: common - rash, allergic dermatitis, itching, urticaria, swelling, exanthema, angioedema; very rare - exudative erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) (see section "Special warnings and precautions for use").
On the part of the kidneys and urinary system: rarely - increased blood urea and creatinine, oliguria, hematuria, glycosuria; very rarely - cylindruria, interstitial nephritis, kidney stone formation, mainly in children aged 3 years and older who received large daily doses of the drug (≥80 mg/kg per day), or cumulative doses of more than 10 g, as well as who had additional risk factors (limited fluid intake, bed rest). The formation of kidney stones may be asymptomatic or manifest clinically, may cause renal failure, which resolves after discontinuation of treatment with the drug.
Neurological disorders: headache and dizziness, tremor, seizures, rarely - encephalopathy.
Cardiac disorders: increase or decrease in blood pressure, palpitations, Kounis syndrome with a frequency of "not known".
Respiratory, thoracic and mediastinal disorders: dyspnea, bronchospasm.
Immune system disorders: anaphylactic or anaphylactoid reactions, anaphylactic shock, hypersensitivity.
From the organs of hearing and balance: vertigo.
General disorders: rarely common - headache and dizziness, fever, chills, as well as serum sickness, edema, nosebleeds, weakness.
Local reactions: with intravenous administration - phlebitis, soreness, induration along the vein, in isolated cases inflammatory reactions of the vein wall were observed. They can be avoided by using a slow injection (2-4 minutes).
Intramuscular injection without the use of lidocaine is painful.
Impact on laboratory test results.
Increased blood creatinine levels. In rare cases, patients may experience false-positive Coombs test results during treatment with Euroceftaz. Like other antibiotics, Euroceftaz may cause false-positive results in galactosemia tests. False-positive results may also be obtained when determining glucose in the urine, therefore, during treatment with the drug, glycosuria, if necessary, should be determined only by the enzymatic method.
Cases of diarrhoea following ceftriaxone administration may be associated with Clostridium difficile. Adequate fluid and electrolyte replacement should be administered (see section 4.4).
Precipitates of ceftriaxone calcium salt.
Rare cases of serious adverse reactions, sometimes fatal, have been reported in premature and full-term neonates (<28 days of age) who received intravenous ceftriaxone and calcium preparations. Ceftriaxone calcium precipitates have been found in the lungs and kidneys at autopsy. The high risk of precipitate formation in neonates is due to their small blood volume and the longer half-life of ceftriaxone compared to adults (see sections 4.3 and 4.4).
Cases of renal precipitate formation have been reported, mainly in children aged 3 years and older who received high daily doses of the drug (≥80 mg/kg/day) or cumulative doses of more than 10 g, and who had additional risk factors (restricted fluid intake, bed rest). The risk of precipitate formation increases in patients who are immobile or dehydrated. Renal precipitate formation may be asymptomatic or clinically apparent, and may cause renal failure, which resolves after discontinuation of ceftriaxone treatment.
Cases of precipitation of calcium salt of ceftriaxone in the gallbladder have been reported, mainly in patients who received doses higher than the standard recommended dose. In children, according to prospective studies, the frequency of precipitation during intravenous administration of the drug was variable, in some studies exceeding 30%. With slow administration of the drug (over 20-30 minutes), the frequency of precipitation is apparently lower. Precipitation is usually asymptomatic, but in rare cases, clinical symptoms such as pain, nausea and vomiting have occurred. In such cases, symptomatic treatment is recommended. After discontinuation of ceftriaxone, the precipitate usually disappears (see section "Special instructions").
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility
The drug should never be added to infusion solutions containing calcium, such as Hartmann's or Ringer's solution, including parenteral nutrition solutions, due to the possibility of precipitation. Calcium-containing solutions should also not be used within 48 hours after the last administration of ceftriaxone. The drug is incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides, other antibiotics.
Do not mix with other solvents except those specified in the "Method of administration and dosage" section.
Packaging
1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
Swiss Parenterals Ltd.
Location of the manufacturer and address of its place of business.
Unit II, Plot 402, 412-414 Kerala Industrial Estate, GIDS, Near Bavla, Ahmedabad, Gujarat, 382220, India.
