Instructions for use: Vomenda solution for injection 2 mg/ml, 4 ml vial No. 5
Composition
active ingredient: ondansetron;
1 ml of solution contains ondansetron hydrochloride dihydrate, equivalent to 2 mg of ondansetron;
Excipients: sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent, colorless solution.
Pharmacotherapeutic group
Antiemetics and antinausea drugs. Serotonin 5HT3 receptor antagonists.
ATX code A04A A01.
Pharmacological properties
Pharmacodynamics
Ondansetron is a potent, highly selective serotonin (5HT3) receptor antagonist. The mechanism of action of ondansetron in nausea and vomiting is not fully understood. During radiotherapy and the use of cytostatic drugs in the small intestine, serotonin (5HT) is released and the afferent endings of the vagus nerve are excited by the activation of 5HT3 receptors, which triggers the peripheral mechanism of the vomiting reflex. Ondansetron blocks the initiation of this reflex. Activation of the afferent endings of the vagus nerve, in turn, can cause the release of 5HT in the posterior field of the fourth ventricle (area postxema), and this can trigger the central mechanism of the vomiting reflex. Thus, ondansetron's suppression of chemo- and radio-induced nausea and vomiting is likely due to its antagonistic effect on 5HT3 receptors of neurons located both in the periphery and in the central nervous system.
The mechanism of action of the drug in postoperative nausea and vomiting is not clear, but is likely to be similar to that in cytotoxic nausea and vomiting. Ondansetron does not affect plasma prolactin concentrations.
The role of ondansetron in opiate-induced vomiting is not fully understood.
Pharmacokinetics
The distribution of ondansetron is similar after oral, intramuscular and intravenous administration in adults, with a terminal half-life of 3 hours and a steady-state volume of distribution of 140 L. Equivalent systemic exposure is achieved after intramuscular and intravenous administration of ondansetron.
The maximum concentration of the drug in the blood is achieved after intravenous infusion of 4 mg of ondansetron after 5 minutes and within 10 minutes after intramuscular injection.
Ondansetron is moderately bound to plasma proteins (70–76%). Ondansetron is eliminated from the systemic circulation primarily by hepatic metabolism involving multiple enzyme systems. Less than 5% of the drug is excreted unchanged in the urine. The absence of the CYP2D6 isoenzyme (sparteine-debrisoquine polymorphism) does not affect the pharmacokinetics of ondansetron. The pharmacokinetic parameters of ondansetron remain unchanged after repeated administration.
Special patient groups
Sex
The pharmacokinetics of ondansetron are gender-dependent. Women have a higher rate and extent of oral absorption and a lower systemic clearance and volume of distribution (weight-adjusted) than men.
Children aged 1 month to 17 years
In a study, the area under the pharmacokinetic curve (AUC) after oral and intravenous administration in children and adolescents was similar to that in adults, except in infants aged 1 to 4 months. The volume of distribution was age-dependent and was lower in adults than in children. Creatinine clearance was weight-dependent but not age-dependent (except in infants aged 1 to 4 months). It is difficult to draw a definitive conclusion as to whether there was an additional decrease in ondansetron clearance in infants aged 1 to 4 months or whether the decrease was due to natural variability due to the small number of patients studied in this age group. Since infants under 6 months of age received only a single dose of the drug for postoperative nausea and vomiting, the decrease in clearance is unlikely to be clinically relevant.
Elderly patients
Based on the obtained data on the concentration of ondansetron in the blood plasma, as well as the results of modeling the dependence of clinical response on exposure, a more pronounced effect on the QTcF interval is expected in patients aged 75 years and older than in younger patients. For patients aged 65 years and older than 75 years, special recommendations for the selection of the intravenous dose are provided (see section "Method of administration and dosage").
Patients with renal impairment
In patients with renal impairment (creatinine clearance 15-60 ml/min), systemic clearance and volume of distribution are reduced after intravenous administration of ondansetron, resulting in a small, clinically insignificant increase in half-life (5.4 hours). Studies in patients with severe renal impairment requiring regular hemodialysis have shown no change in the pharmacokinetics of ondansetron after intravenous administration.
In patients with severe hepatic impairment, the systemic clearance of ondansetron is sharply reduced with an increase in the half-life to 15–32 hours.
Indication
Adults
- Nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy.
- Prevention and treatment of postoperative nausea and vomiting.
Children
- Nausea and vomiting induced by cytotoxic chemotherapy in children aged 6 months and older, and prevention and treatment of postoperative nausea and vomiting in children aged 1 month and older.
Contraindication
The use of ondansetron with apomorphine hydrochloride is contraindicated because
Cases of severe hypotension and loss of consciousness have been observed during their simultaneous use.
Hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
Ondansetron does not accelerate or inhibit the metabolism of other drugs when used simultaneously with it. Special studies have shown that ondansetron does not interact with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lidocaine, thiopental or propofol.
Ondansetron is metabolized by various hepatic cytochrome P450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the diversity of ondansetron metabolizing enzymes, inhibition or reduction of the activity of one of them (e.g. genetic deficiency of CYP2D6) is normally compensated by the other enzymes and will have no or negligible effect on total creatinine clearance.
Ondansetron should be used with caution in combination with drugs that prolong the QT interval and/or cause electrolyte imbalance (see section "Special warnings and precautions for use").
The use of ondansetron with other drugs that prolong the QT interval may cause additional prolongation of this interval. Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines (doxorubicin, daunorubicin) or trastuzumab), antibiotics (erythromycin), antifungals (ketoconazole), antiarrhythmics (amiodarone) and beta-blockers (atenolol or timolol) increases the risk of arrhythmia (see section "Special instructions").
Serotonergics (e.g., SSRIs and SNRIs)
Serotonin syndrome (including mental status changes, autonomic instability and neuromuscular disorders) has been described following concomitant use of ondansetron and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) (see section 4.4).
Apomorphine
The use of ondansetron with apomorphine hydrochloride is contraindicated, as cases of severe hypotension and loss of consciousness have been observed during concomitant use.
Phenytoin, carbamazepine, and rifampicin
In patients treated with potential CYP3A4 inducers (e.g. phenytoin, carbamazepine and rifampicin), the clearance of ondansetron is increased and its blood concentration is decreased.
Tramadol
According to a small number of clinical studies, ondansetron may reduce the analgesic effect of tramadol.
Application features
Hypersensitivity reactions have been observed in patients with hypersensitivity to other selective 5HT3 receptor antagonists.
Respiratory reactions are treated symptomatically. Healthcare professionals should pay special attention to them as they are signs of drug hypersensitivity reactions.
Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). Additionally, post-marketing reports of ventricular fibrillation (torsade de pointes) have been reported with ondansetron. Ondansetron should be avoided in patients with congenital long QT syndrome. Ondansetron should be used with caution in patients who have or may develop QT prolongation, including patients with electrolyte imbalance, congestive heart failure, bradyarrhythmias, or patients receiving other drugs that may prolong the QT interval or electrolyte imbalance.
Myocardial ischemia has been reported in patients receiving ondansetron. In some patients, especially when administered intravenously, symptoms have occurred immediately after administration of ondansetron. Patients should be advised of the signs and symptoms of myocardial ischemia.
Hypokalemia and hypomagnesemia should be corrected before starting use.
Since ondansetron reduces intestinal motility, careful monitoring of patients with signs of subacute intestinal obstruction is necessary during the use of the drug.
In patients undergoing adenotonsillar surgery, the use of ondansetron for the prevention of nausea and vomiting may mask the occurrence of bleeding. Therefore, such patients should be carefully monitored after the use of ondansetron.
One injection of the drug contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially sodium-free.
Children
Children receiving ondansetron with hepatotoxic chemotherapeutic agents should be closely monitored for possible liver dysfunction.
Dosage regimens
When calculating the dose according to body weight and using three doses with an interval of 4 hours, the total daily dose will be higher than when using a single dose of 5 mg/m2 and a single oral dose. The comparative efficacy of these two dosing regimens has not been evaluated in clinical studies. Comparison of the results of different studies indicates similar efficacy of both dosing regimens.
Use during pregnancy or breastfeeding
Women of reproductive age
Women of reproductive age should use contraception.
Pregnancy
Based on experience in humans and epidemiological studies, there is suspicion of the development of maxillofacial defects when ondansetron is used in the first trimester of pregnancy.
In one cohort study involving 1.8 million pregnancies, use of ondansetron in the first trimester of pregnancy was associated with an increased risk of oral clefts (3 additional cases per 10,000 women treated; adjusted relative risk, 1.24 (95% CI 1.03–1.48)).
Epidemiological studies on congenital heart defects have shown conflicting results. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Ondansetron should not be used during the first trimester of pregnancy.
The safety of the drug during pregnancy in humans has not been established. In experimental studies in animals, ondansetron did not disrupt the development of the embryo or fetus and did not affect the course of pregnancy, peri- and postnatal development. However, since animal studies are not always predictive of humans, the drug is not recommended for use during pregnancy.
Breast-feeding
In experimental studies, it has been shown that ondansetron passes into breast milk in animals. If necessary, breastfeeding should be discontinued.
Fertility
There is no information on the effect of ondansetron on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Psychomotor tests have shown that ondansetron does not affect the ability to drive and does not have a sedative effect, but the side effect profile of the drug should be kept in mind when deciding
questions about the ability to drive a vehicle or work with other mechanisms.
Method of administration and doses
Nausea and vomiting caused by chemotherapy and radiation therapy
Adults
The emetogenic potential of cancer therapy varies depending on the dose and combination of chemotherapy and radiotherapy regimens. The choice of dosage regimen depends on the severity of the emetogenic effect. The dose of the drug (range 8 to 32 mg per day) and the route of administration are selected according to the information below.
Emetogenic chemotherapy and radiation therapy
Ondansetron, depending on the dosage form, can be administered orally, intravenously, or intramuscularly.
For most patients, the recommended intravenous or intramuscular dose of the drug is 8 mg as a slow intravenous injection over at least 30 seconds or as an intramuscular injection immediately before treatment, followed by 8 mg orally every 12 hours.
To prevent delayed or prolonged vomiting after the first 24 hours, oral administration of ondansetron is recommended for no more than 5 days after the end of the course of treatment.
Highly emetogenic chemotherapy (e.g. high-dose cisplatin)
For these patients, ondansetron can be administered orally, intravenously, or intramuscularly. Ondansetron has been shown to be equally effective in the following dosing regimens during the first 24 hours of chemotherapy:
A single dose of 8 mg may be administered immediately before chemotherapy as a slow intravenous injection (over at least 30 seconds) or intramuscular injection.
· the initial maximum dose of more than 8 mg (up to 16 mg) can be used only as an intravenous infusion in 50-100 ml of 0.9% sodium chloride solution or another suitable diluent (see below "Instructions for use"); the infusion should last at least 15 minutes immediately before chemotherapy. The initial dose of the drug 8 mg can be administered in two additional intravenous (not less than 30 seconds) or intramuscular injections with an interval of 4 hours between injections.
A single dose of more than 16 mg should not be used, as the risk of QT prolongation increases with increasing dose (see section "Special warnings and precautions for use").
The choice of dosage regimen depends on the severity of the emetogenic effect. The effectiveness of the drug in highly emetogenic chemotherapy can be increased by additional single intravenous administration of dexamethasone sodium phosphate at a dose of 20 mg before chemotherapy.
To prevent delayed or prolonged vomiting after the first 24 hours, oral administration of the drug is recommended for no more than 5 days after the end of the course of treatment.
Children aged 6 months and older and adolescents
The dose of the drug can be calculated based on the child's body surface area or body weight.
In pediatric practice, the drug should be administered by intravenous infusion in 25–50 ml of 0.9% sodium chloride solution or other suitable diluent (see “Instructions for Use” below) over 15 minutes.
The total daily dose calculated based on body weight is higher compared to the total daily dose calculated based on body surface area.
The drug should be diluted with 5% dextrose solution or 0.9% sodium chloride solution, or other suitable infusion solution, and administered by intravenous infusion over at least 15 minutes.
There are no data from controlled clinical trials on the use of the drug for the prevention of delayed or prolonged chemotherapy-induced nausea and vomiting. There are no data from controlled clinical trials on the use of the drug for the treatment of radiotherapy-induced nausea and vomiting in children.
Dose calculation according to the child's body surface area
The drug should be administered immediately before chemotherapy by a single intravenous injection at a dose of 5 mg/m². The intravenous dose should not exceed 8 mg.
After 12 hours, oral administration of the drug can be started, which can last up to 5 days. The total daily dose of ondansetron (divided into several doses) should not exceed the adult dose of 32 mg.
| Body surface area | Day 1(a,b) | Day 2-6(b) |
| 2 | 5 mg/m2 intravenously, then 2 mg syrup after 12 hours | 2 mg syrup every 12 hours |
| ≥ 0.6 m2 and ≤ 1.2 m2 | 5 mg/m2 intravenously, then 4 mg syrup or tablet every 12 hours | 4 mg syrup or tablet every 12 hours |
| > 1.2 m2 | 5 mg/m2 or 8 mg intravenously, followed by 8 mg syrup or tablet 12 hours later | 8 mg syrup or tablet every 12 hours |
a Intravenous dose should not exceed 8 mg.
b The total daily dose, divided into several doses, should not exceed the adult dose (32 mg).
Dose calculation according to the child's body weight
The total daily dose calculated based on body weight is higher compared to the total daily dose calculated based on body surface area.
The drug should be administered immediately before chemotherapy by a single intravenous injection at a dose of 0.15 mg/kg. The intravenous dose should not exceed 8 mg. Subsequently, two intravenous injections may be administered with an interval of 4 hours. After 12 hours, oral administration of the drug can be started, which can last up to 5 days. The total daily dose of ondansetron (divided into several doses) should not exceed the adult dose of 32 mg.
| Body weight | Day 1(a,b) | Day 2-6(b) |
| ≤ 10 kg | up to 3 doses of 0.15 mg/kg intravenously every 4 hours | 2 ml of syrup every 12 hours |
| > 10 kg | up to 3 doses of 0.15 mg/kg intravenously every 4 hours | 5 ml of syrup every 12 hours |
a Intravenous dose should not exceed 8 mg.
b The total daily dose, divided into several doses, should not exceed the adult dose (32 mg).
Elderly patients
For patients aged 65 to 74 years, the initial dose of ondansetron is 8 mg or 16 mg. All doses for intravenous injection should be dissolved in 50–100 ml of 0.9% sodium chloride solution or another suitable diluent (see “Instructions for Use” below) and administered over 15 minutes.
For patients aged 75 years and older, the initial intravenous injection of ondansetron should not exceed 8 mg. All doses for intravenous injection should be dissolved in 50–100 ml of 0.9% sodium chloride solution or other suitable diluent (see “Instructions for Use” below) and administered over 15 minutes. After an initial dose of 8 mg, administration may be continued with 2 doses of 8 mg, which should be administered by infusion over 15 minutes with an interval of at least 4 hours between administrations.
Patients with renal insufficiency
There is no need to change the dosage regimen or route of administration in patients with renal impairment.
In patients with moderate to severe hepatic impairment, the clearance of ondansetron is significantly reduced and the serum half-life is increased. For such patients, the maximum daily dose should not exceed 8 mg.
Patients with impaired metabolism of sparteine/debrisoquine
The half-life of ondansetron in patients with impaired metabolism of sparteine and debrisoquine is not altered. In such patients, after repeated administration, the drug concentration is the same as in patients with intact metabolism. Therefore, a change in dosage or frequency of administration is not required.
Postoperative nausea and vomiting
Adults
For the prevention of postoperative nausea and vomiting, the recommended dose of ondansetron is 4 mg as a single intramuscular or slow intravenous injection during induction of anesthesia.
For the treatment of postoperative nausea and vomiting, the recommended single dose of ondansetron is 4 mg as an intramuscular or slow intravenous injection.
Children from 1 month of age and adolescents
For the prevention and treatment of postoperative nausea and vomiting in children undergoing surgery under general anesthesia, the drug can be administered at a dose of 0.1 mg/kg body weight (maximum 4 mg) by slow intravenous injection (at least 30 seconds) before, during, after induction of anesthesia or after surgery.
There are no data from studies on the use of the injectable form of ondansetron in children under 2 years of age for the prevention and treatment of postoperative nausea and vomiting.
Elderly patients
There is limited experience with the use of ondansetron for the prevention and treatment of postoperative nausea and vomiting in elderly patients, however, ondansetron was well tolerated in patients aged 65 years and older receiving chemotherapy.
Patients with renal insufficiency
There is no need to change the dosage regimen or route of administration for patients with renal impairment.
Patients with hepatic insufficiency
In patients with moderate to severe hepatic impairment, the clearance of ondansetron is significantly reduced and the serum half-life is prolonged. For such patients, the maximum daily dose should not exceed 8 mg.
Patients with impaired metabolism of sparteine/debrisoquine
The half-life of ondansetron in subjects with impaired metabolism of sparteine and debrisoquine is not altered. In such patients, after repeated administration, the drug concentration is the same as in patients with intact metabolism. Therefore, no change in dosage or frequency of administration is necessary.
Instructions for use
The vial does not contain preservatives and the solution should be used immediately after opening. Do not use the product if the solution is not clear or if a precipitate forms. Any remaining solution should be discarded. The vial should not be autoclaved.
After breeding
After dilution in compatible intravenous infusion solutions, the drug is stable under normal room lighting conditions or daylight for at least 24 hours; protection from light during infusions is not required.
Compatibility with other intravenous fluids
Only the recommended media may be used to prepare the Vomenda solution for infusion: 0.9% sodium chloride solution; 5% glucose solution; 10% mannitol solution; Ringer's solution; 0.3% potassium chloride solution with 0.9% sodium chloride solution; 0.3% potassium chloride solution with 5% glucose solution.
If prolonged storage of the drug is required, reconstitution should be carried out under appropriate aseptic conditions. Solutions for infusion should be prepared immediately before infusion or stored in a refrigerator at 2–8 °C for no more than 24 hours prior to use.
Ondansetron has been shown to be stable in polyethylene and glass vials. Ondansetron has been shown to be stable in polypropylene syringes when diluted with 0.9% sodium chloride or 5% glucose solution. Stability in polypropylene syringes has also been shown to be stable when diluted with other recommended solutions.
Compatibility with other drugs
Vomenda can be administered as an intravenous infusion at a rate of 1 mg/h. The drug as an infusion solution at an ondansetron concentration of 16–160 μg/ml (e.g. 8 mg/500 ml or 8 mg/50 ml, respectively) can be administered via a Y-line catheter with the following drugs:
- cisplatin at a concentration of up to 0.48 mg/ml (e.g. 240 mg/500 ml) for 1–8 hours;
- 5-fluorouracil at a concentration of up to 0.8 mg/ml (e.g. 2.4 g in 3 l or 400 mg in 500 ml) at a rate not exceeding 20 ml/h (500 ml in 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion solution may contain up to 0.045% magnesium chloride in addition to other compatible excipients;
- carboplatin at a concentration of 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in 100 ml) over 10–60 minutes;
- etoposide at a concentration of 0.14 mg/ml to 0.25 mg/ml (e.g., 72 mg in 500 ml to 250 mg in 1 l) over 30–60 minutes;
- cyclophosphamide in a dose of 100 mg to 1 g, diluted in water for injection (5 ml per 100 mg of cyclophosphamide), as an intravenous bolus injection over 5 minutes;
- doxorubicin in a dose of 10 mg to 100 mg, diluted in water for injection (5 ml per 10 mg of doxorubicin), as an intravenous bolus injection over 5 minutes;
- dexamethasone at a dose of 20 mg, as a slow intravenous injection over 2–5 minutes (with simultaneous administration of 8 mg or 16 mg of ondansetron dissolved in 50–100 ml of injection solution), for about 15 minutes. Since these drugs are compatible, they can be administered through a single dropper, while in the solution the concentrations of dexamethasone phosphate (in the form of sodium salt) will be from 32 μg to 2.5 mg per 1 ml, and ondansetron - from 8 μg to 1 mg per 1 ml.
Children.
Use in children from 6 months of age (during chemotherapy) and from 1 month of age (for the prevention and treatment of postoperative nausea and vomiting).
Overdose
Symptoms and signs. There is limited information on overdose with ondansetron. In most cases, the symptoms are similar to those described in patients given the recommended doses (see section 4.8). Symptoms of overdose have included visual disturbances, severe constipation, hypotension, and vasovagal reactions with transient second-degree atrioventricular block. In all cases, these symptoms resolved completely.
Ondansetron prolongs the QT interval in a dose-dependent manner. ECG monitoring is recommended in case of overdose.
Children: Serotonin syndrome has been reported in infants and children aged 12 months to 2 years following accidental oral overdose (doses exceeding the recommended level of 4 mg/kg).
Treatment: There is no specific antidote, therefore, in cases of overdose, symptomatic and supportive therapy should be used.
Further management of patients should be based on clinical indications or, where possible, on the recommendations of the national poisons centre.
The use of ipecacuanha to treat ondansetron overdose is not recommended because its effect may not be due to the antiemetic effects of the drug.
Adverse reactions
The side effects listed below are classified by system organ class and frequency. The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100) and not known (cannot be estimated from the available data).
On the part of the immune system:
Rare: immediate hypersensitivity reactions, sometimes severe, up to anaphylaxis.
From the nervous system:
very common: headache;
uncommon: convulsions, movement disorders (including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia without lasting clinical consequences) (1);
Rare: dizziness, mainly during rapid intravenous administration of the drug.
On the part of the organs of vision:
Rare: transient visual disturbances (clouding of the eyes), mainly during intravenous administration;
very rare: transient blindness, mainly during intravenous administration (2).
From the heart:
uncommon: arrhythmias, chest pain (with or without ST segment depression), bradycardia;
Rare: QT prolongation (including ventricular fibrillation/flutter (torsade de pointes);
unknown: myocardial ischemia ⃰ (see section "Special warnings and precautions for use").
From the vascular side:
common: feeling of warmth or flushing;
uncommon: hypotension.
From the respiratory system and chest cavity organs:
uncommon: hiccups.
From the digestive tract:
Common: constipation.
From the hepatobiliary system:
uncommon: asymptomatic elevation of liver function tests (3).
Skin and subcutaneous tissue disorders:
Very rare: toxic rashes, including toxic epidermal necrolysis.
General disorders and local reactions:
Common: local reactions at the site of intravenous administration.
1 Observational studies lack definitive data on sustained clinical outcomes.
2 In most cases, transient blindness resolved within 20 minutes. Most patients were receiving chemotherapy agents containing cisplatin. Some cases of transient blindness of cortical origin have been reported.
3 These cases were observed mainly in patients receiving cisplatin-containing chemotherapy agents.
* These types of adverse reactions have been derived from post-marketing experience with ondansetron through spontaneous case reports and case literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency and are therefore classified as not known.
The following adverse reactions have been observed during post-marketing surveillance.
Cardiovascular system: chest pain and discomfort, extrasystoles, tachycardia, including ventricular and supraventricular tachycardia, atrial fibrillation, palpitations, syncope, ECG changes.
Hypersensitivity reactions: anaphylactic reactions, angioedema, bronchospasm, anaphylactic shock, itching, skin rashes, urticaria.
General disorders and local reactions: fever, pain, redness, burning at the injection site.
Other: hypokalemia.
Expiration date
2 years.
Storage conditions
Store in the original packaging to protect from light at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Incompatibility
The drug should not be used in the same syringe or infusion solution with other drugs. The drug in the form of injections can only be combined with recommended infusion solutions (see section "Method of administration and dosage").
Packaging
2 ml (4 mg) or 4 ml (8 mg) in a vial; 5 or 10 vials in a cardboard box.
Vacation category
According to the recipe.
Producer
Aspiro Pharma Limited.
Location of the manufacturer and address of its place of business
C.No.321, Biotech Park, Phase-III, Karkapatla Village, Markuk Mandal, Siddipet Dist-502281, Telangana State, India/
Sy.No.321, Biotech park, Phase-III, Karkapatla Village, Markook Mandal, Siddipet Dist-502281, Telangana State, India.
