Instructions Meloxicam-Teva solution for injection 15 mg/1.5 ml ampoule 1.5 ml No. 5
Composition
active ingredient: meloxicam;
1 ampoule (1.5 ml) contains 15 mg of meloxicam;
excipients: meglumine, glycofurol, poloxamer 188, sodium chloride, glycine, sodium hydroxide, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent solution of yellow with a greenish tint, practically free of foreign inclusions, in ampoules made of colorless glass.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Oxycodone. ATX code M01A C06.
Pharmacological properties
Pharmacodynamics
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) from the oxicam group of substances with anti-inflammatory, analgesic and antipyretic properties associated with selective inhibition of the COX-2 isoenzyme. The selectivity coefficient IC50 for meloxicam is 2.
Pharmacokinetics
Absorption: Meloxicam is almost completely absorbed from the gastrointestinal tract. Absolute oral bioavailability is 89%. After a single oral dose, peak plasma levels are reached after 5-6 hours (tablets). After repeated dosing, steady state is reached after 3-5 days from the start of meloxicam administration.
When taking 7.5 or 15 mg of meloxicam orally once a day in a stationary mode, the plasma concentration reaches 0.4-1.0 mg/l (7.5 mg) or 0.8-2.0 mg/l (15 mg) (Cmin-Cmax).
In the case of long-term treatment, the plasma concentration under steady-state conditions does not change. Gastric absorption is not affected by simultaneous food intake.
Distribution: Meloxicam is highly protein bound, mainly to albumin (99%). Meloxicam enters the synovial fluid, where its concentration is half that in plasma.
The volume of distribution is on average 11 L. Individual fluctuations are approximately
30-40%.
Biotransformation: Meloxicam is metabolized by hepatic enzymes. Four different pharmacologically inactive metabolites of meloxicam have been identified in the urine. The main metabolite 5'-carboxymeloxicam (60%) is formed by oxidation of the intermediate metabolite 5'-hydroxymethylmeloxicam. The amount of unchanged 5'-hydroxymethylmeloxicam excreted is 9%. In vitro, it has been established that the initial step of this transformation is carried out mainly by CYP2C9 with a minor contribution of CYP 3A4. The formation of two other metabolites (16% and 4% of the administered dose) is associated with the action of peroxidase.
Elimination: Meloxicam is excreted mainly in the form of metabolites, in equal parts with urine and feces. Meloxicam is found in small amounts in urine ("traces"). The average half-life is about 20 hours. Total plasma clearance is on average 8 ml/min.
Linearity: Meloxicam exhibits linear pharmacokinetics when administered orally at therapeutic doses (7.5 mg and 15 mg).
Special patient groups
Liver/kidney failure
Neither mild nor moderate hepatic or renal insufficiency has a significant effect on the pharmacokinetics of meloxicam. In end-stage renal failure, an increase in the volume of distribution may lead to higher concentrations of free meloxicam, therefore a daily dose of 7.5 mg should not be exceeded.
Elderly patients
The mean plasma clearance in the plateau phase in elderly patients was slightly lower than that reported in younger patients.
Indication
Short-term symptomatic treatment of acute attacks of rheumatoid arthritis and ankylosing spondylitis when oral and rectal routes of administration cannot be used.
Contraindication
- Hypersensitivity to meloxicam or to any of the excipients of the product, or to active substances with similar effects, such as NSAIDs, aspirin. Meloxicam should not be prescribed to patients who have experienced asthma symptoms, nasal polyps, angioedema or urticaria after taking aspirin or other NSAIDs;
- 3rd trimester of pregnancy (see section "Use during pregnancy or breastfeeding");
- patient's age is up to 18 years;
- history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
- history of active or recurrent peptic ulcer/bleeding (two or more separate confirmed episodes of ulceration or bleeding);
- severe liver failure;
- severe renal failure without dialysis;
- gastrointestinal bleeding, history of cerebrovascular bleeding or other blood clotting disorders;
- hemostasis disorders or concomitant use of anticoagulants (contraindications related to the route of administration);
- severe heart failure;
- treatment of perioperative pain during coronary artery bypass grafting (CABG).
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions.
Other nonsteroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid ≥ 3 g/dose.
Corticosteroids (e.g. glucocorticoids): Concomitant use with corticosteroids requires caution due to increased risk of gastrointestinal bleeding or ulceration.
Anticoagulants or heparin used in geriatric practice or in therapeutic doses
. The risk of bleeding is significantly increased due to inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs may enhance the effects of anticoagulants such as warfarin (see section "Special precautions for use"). The concomitant use of NSAIDs and anticoagulants or heparin is not recommended in geriatric practice or in therapeutic doses (see section "Special precautions for use").
In other cases, heparin should be used with caution due to the increased risk of bleeding. Careful monitoring of the INR (international normalized ratio) is necessary if the combination is proven to be unavoidable.
Thrombolytic and antiplatelet drugs: Increased risk of bleeding due to inhibition of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and angiotensin II antagonists.
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of ACE inhibitors or angiotensin II antagonists and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter (see section 4.4).
Other antihypertensive drugs (e.g. beta-blockers). As with the following drugs, the antihypertensive effect of beta-blockers may be reduced (due to inhibition of vasodilating prostaglandins).
Calcineurin inhibitors (e.g. cyclosporine, tacrolimus). Nephrotoxicity of calcineurin inhibitors may be potentiated by NSAIDs due to mediation of renal prostaglandin effects. Renal function should be monitored during treatment. Close monitoring of renal function is recommended, especially in elderly patients.
Intrauterine contraceptives. NSAIDs reduce the effectiveness of intrauterine contraceptives. It has been previously reported that the effectiveness of intrauterine contraceptives is reduced by NSAIDs, but this requires further confirmation.
Pharmacokinetic interaction: the effect of meloxicam on the pharmacokinetics of other drugs.
Lithium.
There are data on NSAIDs that increase the level of lithium in the blood plasma (due to a decrease in renal excretion of lithium), which can reach toxic values. The simultaneous use of lithium and NSAIDs is not recommended (see section "Special instructions"). If combination therapy is necessary, careful monitoring of lithium plasma levels is necessary at the beginning of treatment, during dose adjustment and when discontinuing treatment with meloxicam.
Methotrexate.
NSAIDs may reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, concomitant use of NSAIDs is not recommended in patients receiving high doses of methotrexate (more than 15 mg/week) (see section "Special instructions"). The risk of interaction between NSAIDs and methotrexate should also be considered in patients receiving low doses of methotrexate, in particular in patients with impaired renal function. If combined treatment is necessary, blood counts and renal function should be monitored. Caution should be exercised if NSAIDs and methotrexate are taken for 3 consecutive days, as plasma levels of methotrexate may increase and toxicity may increase. Although the pharmacokinetics of methotrexate (15 mg/week) were not affected by concomitant treatment with meloxicam, it should be considered that the haematological toxicity of methotrexate may be increased by treatment with NSAIDs (see information above) (see section "Adverse reactions").
Pharmacokinetic interaction: the effect of other drugs on the pharmacokinetics of meloxicam.
Cholestyramine. Accelerates the elimination of meloxicam due to impaired intrahepatic circulation, so the clearance of meloxicam increases by 50% and the half-life decreases to 13±3 hours. This interaction is clinically significant.
No clinically significant pharmacokinetic interaction was found when co-administered with antacids, cimetidine, and digoxin.
Application features
The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, nor should additional NSAIDs be used, as this may increase toxicity while the therapeutic benefit has not been proven. The concomitant use of meloxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Meloxicam is not used to treat patients requiring relief of acute pain.
If there is no improvement after several days, the clinical benefit of treatment should be reassessed.
Attention should be paid to a history of esophagitis, gastritis and/or peptic ulcer in order to ensure that they are completely cured before starting therapy with meloxicam. Patients treated with meloxicam and patients with a history of such cases should be regularly monitored for possible recurrence.
Gastrointestinal disorders.
As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur at any time during treatment with or without previous symptoms or a history of serious gastrointestinal disease.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly complicated by bleeding or perforation (see section 4.3), and in elderly patients. In such patients, treatment should be initiated at the lowest effective dose. Combination therapy with protective agents (such as misoprostol or proton pump inhibitors) should be considered for such patients, as well as for patients who require concomitant use of low-dose aspirin or other agents that increase gastrointestinal risks (see information below and section 4.5).
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be informed of any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment.
Caution should be exercised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, including heparin, as a radical therapy or in geriatric practice, anticoagulants such as warfarin, or other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid at anti-inflammatory doses (≥ 1 g single dose or ≥ 3 g total daily dose) (see section “Interaction with other medicinal products and other forms of interaction”).
If gastrointestinal bleeding or ulceration occurs in patients taking meloxicam, treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section "Adverse reactions").
Liver disorders.
In patients taking NSAIDs (including meloxicam), elevations of one or more liver function tests may occur. These laboratory abnormalities may progress, remain stable, or be transient with continued treatment. Elevations of ALT or AST (approximately three or more times the upper limit of normal) may occur. Rare cases of severe hepatic reactions, including jaundice and fulminant hepatitis, hepatic necrosis, and hepatic failure, some of which were fatal, have been reported.
Patients with symptoms and/or signs of hepatic dysfunction or who have had abnormal liver function tests should be evaluated for the development of symptoms of more severe hepatic insufficiency during meloxicam therapy. If clinical signs and symptoms are associated with the development of liver disease or if systemic manifestations of the disease (e.g. eosinophilia, rash, etc.) are observed, meloxicam should be discontinued.
Cardiovascular disorders.
Close monitoring is recommended in patients with hypertension and/or a history of mild to moderate congestive heart failure, as fluid retention and edema have been reported with NSAID therapy.
Clinical monitoring of blood pressure is recommended in patients with risk factors at the beginning of therapy, especially at the beginning of treatment with meloxicam.
Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a small increased risk of vascular thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for meloxicam.
NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which may be fatal. The increased risk is related to the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.
Skin disorders.
Serious skin reactions, some of which were fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with the use of NSAIDs (see section 4.8). The highest risk of such reactions was observed at the beginning of treatment, with the majority of such reactions occurring within the first month of treatment. Meloxicam should be discontinued at the first appearance of skin rash, mucosal lesions or other signs of hypersensitivity.
Anaphylactic reactions.
As with other NSAIDs, anaphylactic reactions may occur in patients with no known history of reaction to meloxicam. The drug should not be used in patients with the aspirin triad. This symptom complex has been observed in patients with asthma who have reported rhinitis with or without nasal polyps or who have experienced severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency care should be sought if an anaphylactoid reaction occurs.
Liver parameters and kidney function.
As with most NSAIDs, isolated cases of increased serum transaminases, serum bilirubin or other liver function parameters, as well as increases in serum creatinine, blood urea nitrogen and other laboratory abnormalities have been reported. In most cases, these abnormalities were minor and transient. If significant or persistent abnormalities occur, meloxicam should be discontinued and follow-up tests performed.
Functional renal failure.
NSAIDs, by inhibiting the vasodilatory effects of renal prostaglandins, may induce functional renal failure due to decreased glomerular filtration. This adverse effect is dose-dependent. At the beginning of treatment or after increasing the dose, careful monitoring of diuresis and renal function is recommended in patients with the following risk factors:
- old age;
- concomitant use with ACE inhibitors, angiotensin II antagonists, sartans, diuretics (see section "Interaction with other medicinal products and other types of interactions");
- hypovolemia (of any origin);
- congestive heart failure;
- renal failure;
- nephrotic syndrome;
- lupus nephropathy;
- severe hepatic dysfunction (serum albumin < 25 g/l or ≥ 10 according to the Child-Pugh classification).
In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome.
The dose of meloxicam for patients with end-stage renal disease on dialysis should not exceed 7.5 mg. In patients with mild to moderate renal impairment, the dose may not be reduced (creatinine clearance greater than 25 ml/min).
Sodium, potassium and water retention.
NSAIDs may increase sodium, potassium and water retention and may interfere with the natriuretic effects of diuretics. In addition, the antihypertensive effect of antihypertensive drugs may be reduced (see section 4.5). In connection with
in connection with this
In susceptible patients, oedema, heart failure or hypertension may be precipitated or exacerbated. Clinical monitoring is therefore recommended in patients at risk (see sections 4.2 and 4.3).
Hyperkalemia.
Hyperkalemia may be caused by diabetes mellitus or concomitant use of medicinal products that increase potassium levels (see section 4.5). In such cases, potassium levels should be monitored regularly.
Other warnings and precautions.
Adverse reactions are often worse tolerated by elderly, frail or debilitated patients who require close monitoring. As with other NSAIDs, caution should be exercised in the elderly, who are more likely to have decreased renal, hepatic and cardiac function. Elderly patients have a higher incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Meloxicam, like any other NSAID, may mask the symptoms of infectious diseases.
Meloxicam may impair reproductive function and is not recommended in women attempting to conceive. Therefore, in women attempting to conceive or undergoing investigation of infertility, discontinuation of meloxicam should be considered (see section 4.6).
Masking inflammation and fever.
The pharmacological action of meloxicam to reduce fever and inflammation may complicate the diagnosis of suspected non-infectious pain conditions.
Meloxicam cannot be a likely substitute for corticosteroids in the treatment of corticosteroid insufficiency.
Hematological effects.
Anemia may occur in patients receiving NSAIDs, including meloxicam. This may be due to fluid retention, gastrointestinal bleeding of unknown origin, or macroscopic or incompletely described effects on erythropoiesis. Patients receiving long-term treatment with NSAIDs, including meloxicam, should have their hemoglobin or hematocrit monitored if they develop symptoms or signs of anemia.
NSAIDs inhibit platelet aggregation and may prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively smaller, short-lived, and reversible. Patients taking meloxicam who may have adverse effects related to changes in platelet function, including coagulation disorders, or patients receiving anticoagulants should be carefully monitored.
Use in patients with existing asthma.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Because of cross-reactivity, including bronchospasm, between aspirin and other NSAIDs, meloxicam should not be used in aspirin-sensitive patients and should be prescribed with caution in patients with pre-existing asthma.
Other.
As with other injectable NSAIDs, abscess and necrosis may develop at the injection site.
The drug contains a very small amount of sodium, i.e. it is virtually sodium-free.
Use during pregnancy or breastfeeding
Pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal development. Epidemiological data suggest an increased risk of miscarriage and of cardiac malformations and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiac malformations has increased from less than 1% to approximately 1.5%. This risk is thought to increase with increasing dose and duration of treatment.
During the first and second trimesters of pregnancy, meloxicam should not be used unless clearly necessary. If a woman is trying to become pregnant or is using meloxicam during the first and second trimesters of pregnancy, the dosage and duration of treatment should be kept to a minimum.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose a risk to the fetus:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- impaired renal function, which may develop into renal failure with oligohydramnios;
possible risks in the last stages of pregnancy for the mother and newborn:
- possibility of prolongation of bleeding time, anti-aggregation effect even at very low doses;
- suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, meloxicam is contraindicated during the third trimester of pregnancy.
Breastfeeding: Although there are no specific data for meloxicam, NSAIDs are known to pass into breast milk. Therefore, use is not recommended in women who are breastfeeding.
Fertility: Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may have an adverse effect on reproductive function and is not recommended in women attempting to conceive. Therefore, in women planning pregnancy or undergoing investigation of infertility, discontinuation of meloxicam should be considered.
The ability to influence the reaction speed when driving or working with other mechanisms
There are no specific studies on the effects of the drug on the ability to drive or use machines. However, based on the pharmacodynamic profile and the observed adverse reactions, it can be assumed that meloxicam is likely to have no or negligible influence on these activities. However, patients who have experienced visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, are advised to refrain from driving or using machines.
Method of administration and doses
Meloxicam should be administered by intramuscular injection.
One injection of 15 mg once daily.
Do not exceed a dose of 15 mg/day.
Treatment should be limited to a single injection at the beginning of therapy with a maximum duration of up to 2-3 days in justified exceptional cases (e.g. when oral and rectal routes of administration are not possible).
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section "Special warnings and precautions for use").
The patient's need for symptomatic relief and response to treatment should be assessed periodically.
Special patient groups
Elderly patients and patients at increased risk of developing adverse reactions.
The recommended dose for elderly patients is 7.5 mg/day. Patients at increased risk of adverse reactions should start treatment with 7.5 mg/day (half a 1.5 ml ampoule) (see section "Special instructions").
In patients with severe renal insufficiency who are on dialysis, the dose should not exceed 7.5 mg/day (half a 1.5 ml ampoule).
No dose reduction is required in patients with mild to moderate renal impairment (i.e., patients with creatinine clearance above 25 mL/min). For patients with severe renal impairment not requiring dialysis, see section 4.3.
Liver failure.
No dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, see section "Contraindications".
Method of application.
The drug should be administered slowly, by deep intramuscular injection into the upper outer quadrant of the buttock, observing strict aseptic technique. In case of repeated administration, it is recommended to change the injection site (alternating between the left and right buttock). Before injection, it is important to check that the needle tip is not in a blood vessel.
The injection should be stopped immediately if severe pain occurs during the injection.
In the case of a hip replacement, the injection should be given in the other buttock.
Children
The drug is contraindicated in children (under 18 years of age).
Overdose
Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive therapy. Gastrointestinal bleeding may occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular failure, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic use of NSAIDs, which may also occur with overdose.
In case of NSAID overdose, symptomatic and supportive measures are recommended. Studies have shown that meloxicam elimination is accelerated by administration of
4 oral doses of cholestyramine 3 times a day.
Adverse reactions
Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a small increased risk of vascular thrombotic events (e.g. myocardial infarction or stroke) (see section "Special warnings and precautions for use").
Edema, hypertension, and heart failure have been observed with NSAID treatment.
Most of the observed side effects are of gastrointestinal origin. Peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, may occur (see section "Special instructions"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been observed after use (see section "Special instructions"). Gastritis has been observed less frequently.
Blood and lymphatic system disorders: Anemia, abnormal blood count (including changes in white blood cell count), leukopenia, thrombocytopenia. Very rare cases of agranulocytosis have been reported (see Description of selected serious and/or common adverse reactions).
Immune system disorders: allergic reactions, including anaphylactic shock, anaphylactoid reactions, anaphylactic reactions.
Mental disorders: confusion, mood swings, nightmares, insomnia, disorientation.
From the nervous system: dizziness, headache, drowsiness.
On the part of the organs of vision: visual function disorders, including blurred vision, conjunctivitis.
From the side of the organs of hearing and vestibular apparatus: dizziness, ringing in the ears.
Cardiac: palpitations, heart failure.
From the vascular system: increased blood pressure, hot flashes.
Respiratory system: patients with a history of allergic reactions to acetylsalicylic acid or other NSAIDs may experience asthma attacks, upper respiratory tract infections, and cough.
Gastrointestinal: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, occult or macroscopic gastrointestinal bleeding, gastroduodenal ulcer, esophagitis, stomatitis, constipation, flatulence, belching, gastrointestinal perforation, gastritis, colitis. Peptic ulcer, perforation or gastrointestinal bleeding may be severe and potentially fatal, especially in elderly patients.
Hepatobiliary disorders: abnormal liver function tests (e.g. increased transaminases or bilirubin), hepatitis, jaundice, liver failure.
Skin and subcutaneous tissue disorders: pruritus, rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, bullous dermatitis, erythema multiforme, photosensitivity, exfoliative dermatitis.
From the urinary system: sodium and water retention, hyperkalemia, impaired renal function (increased creatinine and/or urea in serum), acute renal failure, particularly in patients at high risk, urinary tract infections, urination disorders, including acute urinary retention.
General disorders and administration site conditions: injection site induration, injection site pain; edema, including edema of the lower extremities, influenza-like symptoms.
Description of selected serious and/or common adverse reactions.
Cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic drugs (see section "Interaction with other medicinal products and other forms of interaction").
Adverse reactions that have not previously been observed with this drug, but are characteristic of other drugs of this pharmacotherapeutic group.
Renal impairment up to renal failure: cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Incompatibility
The injection solution must not be mixed with other medicines in the same syringe.
Packaging
5 ampoules of 1.5 ml in a plastic container in a cardboard box.
Vacation category
According to the recipe.
Producer
Help S.A.
Location of the manufacturer and address of its place of business
Pedini Ioanninon, Ioannina, 45501, Greece.
