Instructions Recormon solution for injection 2000 IU syringe-tube 0.3 ml with needles 27 g1/2 No. 6
Composition
active ingredient: epoetin beta;
1 pre-filled syringe (0.3 ml solution) contains epoetin beta 2000 IU (16.6 mcg);
excipients: urea; sodium chloride; polysorbate 20; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; calcium chloride, dihydrate; glycine; L-leucine; L-isoleucine; L-threonine; L-glutamic acid; L-phenylalanine; water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: colorless, transparent to slightly opalescent solution.
Pharmacotherapeutic group
Antianemic drugs.
ATX code B03X A01.
Pharmacological properties
Pharmacodynamics
Erythropoietin is a glycoprotein that is a mitosis-stimulating factor and differentiation hormone that promotes the formation of erythrocytes from precursor cells.
Epoetin beta, the active ingredient of the drug Recormon®, obtained by genetic engineering, is identical in its amino acid and carbohydrate composition to erythropoietin isolated from the urine of patients with anemia.
The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo. After administration, epoetin beta increases the number of erythrocytes, reticulocytes and hemoglobin levels, as well as the rate of 59Fe incorporation into cells, specifically stimulating erythropoiesis without affecting leukopoiesis.
No cytotoxic effect of epoetin beta on human bone marrow or skin cells has been detected.
Erythropoietin is a growth factor that primarily stimulates the production of red blood cells. Erythropoietin receptors can also be expressed on the surface of various tumor cells.
Very rarely, neutralizing antibodies to erythropoietin with or without pure red cell aplasia have been observed during therapy with erythropoiesis-stimulating agents.
Pharmacokinetics
Absorption
When the drug is administered subcutaneously to patients with uremia, prolonged absorption provides a plateau in serum concentrations of the drug, and the maximum concentration is reached on average after 12–28 hours. The bioavailability of epoetin beta when administered subcutaneously is 23–42% compared to intravenous administration.
Distribution
The volume of distribution is equal to or twice the volume of circulating plasma.
Breeding
In healthy volunteers and uremic patients, the elimination half-life of intravenously administered epoetin beta is 4–12 hours. The terminal phase half-life after subcutaneous administration is longer than after intravenous administration, averaging 13–28 hours.
Pharmacokinetics in special groups
The pharmacokinetics of epoetin beta in patients with hepatic impairment have not been studied.
Indication
Treatment of symptomatic anaemia associated with chronic renal failure in adults and children. Prevention of anaemia in premature infants born weighing 750-1500 g up to 34 weeks of gestation. Treatment of symptomatic anaemia in patients with non-myeloid malignancies receiving chemotherapy. Increasing the volume of autologous blood intended for subsequent autologous transfusion. The reported risk of thromboembolic events should be taken into account. Use in this indication is only indicated in patients with moderate anaemia (haemoglobin 100-130 g/l (6.21-8.07 mmol/l) without iron deficiency), if blood conservation procedures are unavailable or inadequate, and if elective major surgery may require a larger volume of blood (≥ 4 units for women or ≥ 5 units for men).
Contraindication
Hypersensitivity to epoetin beta or to any component of the drug. Poorly controlled arterial hypertension. Myocardial infarction or stroke within the previous month before the start of treatment, unstable angina, increased risk of deep vein thrombosis (with a history of venous thromboembolism) - when prescribed to increase the volume of autologous blood for subsequent autohemotransfusion.
Interaction with other medicinal products and other types of interactions
The data obtained to date have not revealed any interactions of epoetin beta with other drugs.
In experimental animal studies, epoetin beta did not increase the myelotoxicity of cytotoxic drugs such as etoposide, cisplatin, cyclophosphamide, fluorouracil.
Application features
Caution should be exercised when prescribing Recormon® to patients with refractory anemia with blast-transformed cells, patients with thrombocytosis, epilepsy and chronic liver failure. Vitamin B12 and folic acid deficiency should be excluded before starting treatment with epoetin beta, since their deficiency reduces the effectiveness of Recormon®.
Severe aluminum overload resulting from treatment for renal failure may reduce the effectiveness of Recormon®.
The decision to use Recormon® in patients with nephrosclerosis who are not receiving dialysis should be made on an individual basis, as the possibility of accelerating the progression of renal failure cannot be completely ruled out.
Pure red cell aplasia
Pure red cell aplasia caused by neutralizing antibodies to erythropoietin may be associated with erythropoietin therapy, including Recormon®. These antibodies cross-react with all erythropoietic proteins. It is not recommended to switch patients to Recormon® therapy if neutralizing antibodies to erythropoietin are suspected or confirmed (see section 4.8).
Pure red cell aplasia in patients with hepatitis C
If a paradoxical decrease in hemoglobin occurs and severe anemia associated with a low reticulocyte count develops, epoetin beta treatment should be discontinued and anti-erythropoietin antibodies should be determined. Such cases have been reported in patients with hepatitis C who were treated concomitantly with interferon, ribavirin, and epoetins. Epoetins are not approved for the treatment of anemia associated with hepatitis C.
Blood pressure monitoring
In patients with chronic renal failure, episodes of increased blood pressure or worsening of existing arterial hypertension may occur, especially with increasing hematocrit. Increased blood pressure can be corrected with medication. In the absence of effect from drug therapy, a temporary break in treatment with Recormon® is necessary. It is recommended to regularly monitor blood pressure (especially at the beginning of treatment), including between dialysis sessions.
Hypertensive crisis with signs of encephalopathy may occur, requiring immediate medical attention and intensive care. Special attention is required in the event of sudden acute migraine-like headache.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported with epoetin therapy (see section 4.8). More severe cases have been observed with long-acting epoetins. Patients should be informed of the symptoms of such reactions when prescribing the drug and patients should be closely monitored for the development of skin reactions. If signs suggestive of such reactions appear, Recormon® should be discontinued immediately and alternative treatment should be considered. If a patient develops a severe skin reaction such as SJS or TEN due to Recormon®, treatment with erythropoiesis-stimulating agents (ESIs) should not be re-administered to that patient.
Chronic renal failure
In patients with chronic renal failure, during treatment with Recormon®, especially with intravenous administration of the drug, a dose-dependent moderate increase in the platelet count within the normal range may be observed, followed by a spontaneous return to normal. Therefore, regular monitoring of platelets is required during the first 8 weeks of treatment.
Hemoglobin concentration
In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin level of 120 g/l (7.5 mmol/l). In clinical trials, an increased risk of death and serious cardiovascular and cerebrovascular complications, including stroke, has been observed when erythropoiesis-stimulating agents are used to achieve haemoglobin levels above 120 g/l (7.5 mmol/l).
Controlled clinical trials have not shown any significant benefit from the use of epoetins when hemoglobin levels exceed those required to control symptoms of anemia and avoid blood transfusions.
Premature infants may experience a slight increase in platelet count, especially on days 12–14 of life, so platelet counts should be monitored regularly.
Effect on tumor growth
Epoetins are growth factors that primarily stimulate the production of red blood cells. Erythropoietin receptors can be expressed on the cell surface of various tumors. Therefore, like other growth factors, epoetins can stimulate tumor growth. Several controlled trials have not shown that epoetins improve overall survival or reduce the risk of tumor progression in patients with tumor-associated anemia.
reduced time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when hemoglobin levels exceed 140 g/L (8.7 mmol/L); reduced overall survival and increased mortality due to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when hemoglobin levels reach 120–140 g/L (7.5–8.7 mmol/L); increased risk of death when hemoglobin levels reach 120 g/L (7.5 mmol/L) in patients with active malignant disease not receiving chemotherapy or radiotherapy. Erythropoiesis-stimulating agents are not indicated for use in this patient population.
Therefore, in some clinical situations, blood transfusions should be preferred for the treatment of anemia in patients with malignant neoplasms. The decision to prescribe recombinant erythropoietins should be based on an assessment of the benefit-risk ratio for each patient. This should take into account the clinical situation, the type of tumor and its stage, the degree of anemia, the expected life expectancy, the environment in which the patient receives treatment, and the patient's preferences.
Blood pressure may increase, which can be controlled with medication. Therefore, blood pressure monitoring is recommended, especially in the initial phase of treatment in patients with malignant tumors.
Patients with cancer should also have their platelet count and hemoglobin levels monitored regularly at regular intervals.
Patients preparing to donate blood for subsequent autotransfusion may have an increased platelet count, mostly within the normal range. Therefore, such patients should have their platelet count monitored at least weekly. If their increase is more than 150 × 109/l compared to the initial value or above the norm, treatment with Recormon® should be discontinued.
In premature infants, the potential risk of retinopathy due to erythropoietin use cannot be excluded, and caution should be exercised. Decisions regarding the treatment of premature infants should be made based on the potential benefit/risk of the drug and the available alternative treatment options.
Patients with chronic renal failure often require an increase in heparin dose during hemodialysis due to an increase in hematocrit. Occlusion of the dialysis system is possible with inadequate heparinization.
Early shunt revision and timely thrombosis prophylaxis (e.g., acetylsalicylic acid) are recommended in patients with chronic renal failure at risk of shunt thrombosis.
During treatment with Recormon®, serum potassium and phosphate levels should be monitored periodically. Elevated potassium levels have been reported in a few uremic patients receiving Recormon®, although a causal relationship has not been established. If potassium levels are elevated or increasing, consideration should be given to temporarily discontinuing Recormon® until potassium levels normalize.
If Recormon® is prescribed before autologous blood donation, the following recommendations regarding the donation procedure should be followed:
Blood can only be collected from patients with a hematocrit value ≥ 33% (hemoglobin level of at least 110 g/l (6.83 mmol/l)); special care should be taken with patients weighing less than 50 kg; the volume of blood collected at one time should not exceed 12% of the patient's estimated blood volume.
Treatment with Recormon® is indicated only for those patients for whom it is most important to avoid homologous blood transfusion, taking into account the risk-benefit ratio of using homologous transfusion.
Incorrect use of the drug by medical professionals may lead to an excessive increase in hematocrit, which, in turn, may lead to life-threatening cardiovascular complications.
Impurities
Each pre-filled syringe contains up to 0.3 mg of phenylalanine. This should be taken into account in patients with severe phenylketonuria.
Each pre-filled syringe contains up to 1 mmol sodium (23 mg), i.e. this medicine is considered to be essentially sodium-free.
To improve the tracking of erythropoiesis-stimulating agents, the name of the erythropoiesis-stimulating agent should be clearly stated in the patient's medical record.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles or operate other mechanisms.
Use during pregnancy or breastfeeding
Fertility
The results of animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal/fetal development, childbirth, or postnatal development.
Pregnancy
There are no clinical data on the use of epoetin beta in pregnant women. The drug should be prescribed with caution during pregnancy.
Breast-feeding
It is not known whether epoetin beta is excreted in human milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Recormon® should be made taking into account the benefit of epoetin beta therapy for the mother and the benefit of breast-feeding for the child.
Method of administration and doses
Recormon® therapy should be prescribed by a physician experienced in the treatment of this indication. Since anaphylactoid reactions have been observed in isolated cases, the first dose of the drug should be administered under medical supervision.
Treatment of symptomatic anemia in adults and children with chronic renal failure.
Symptoms and complications of anemia vary depending on the patient's age, gender, and disease. A physician's assessment of the clinical course of the disease and the patient's general condition is necessary.
The drug is administered subcutaneously or intravenously to achieve a hemoglobin level that should not exceed 120 g/l (7.5 mmol/l).
In patients not requiring hemodialysis, subcutaneous administration is preferred to avoid puncture of peripheral veins. For intravenous administration, e.g. in patients undergoing hemodialysis, the drug should be administered over 2 minutes through an arteriovenous shunt at the end of the dialysis session.
Due to individual variability, occasional changes in hemoglobin levels above and below the expected level are possible. In case of variability in hemoglobin levels, the dose of the drug should be adjusted, keeping in mind the target hemoglobin range of 100–120 g/l (6.2–7.5 mmol/l). A sustained increase in hemoglobin levels above 120 g/l (7.5 mmol/l) should be avoided. Recommendations for dose adjustment for hemoglobin levels exceeding 120 g/l (7.5 mmol/l) are given below.
An increase in haemoglobin of more than 20 g/l (1.25 mmol/l) in 4 weeks should be avoided. If this occurs, the dose should be adjusted. If the rate of increase in haemoglobin exceeds 20 g/l (1.25 mmol/l) in 1 month or if the haemoglobin level increases to 120 g/l (7.45 mmol/l), the dose should be reduced by approximately 25%. If the haemoglobin level continues to increase, treatment should be discontinued until the haemoglobin level begins to decrease. At this point, treatment should be resumed at a dose approximately 25% lower than the previous dose.
Patients should be closely monitored to ensure that the lowest approved dose of Recormon® is used to provide adequate control of symptoms of anemia.
In patients with arterial hypertension, cardiovascular, cerebrovascular and peripheral vascular diseases, the weekly increase in hemoglobin level and the target hemoglobin level should be determined individually, depending on the clinical picture.
Treatment is carried out in two stages.
Correction stage
When administered subcutaneously, the initial dose is 20 IU/kg body weight 3 times a week. If the hemoglobin level does not increase sufficiently (< 2.5 g/l per week), the dose can be increased every 4 weeks by 20 IU/kg body weight 3 times a week. The total weekly dose of the drug can also be divided into daily administrations in smaller doses.
When administered intravenously, the initial dose is 40 IU/kg body weight 3 times a week. After 4 weeks, the dose can be increased to 80 IU/kg body weight 3 times a week. If further dose increases are necessary, the dose should be increased by 20 IU/kg body weight 3 times a week at monthly intervals.
Regardless of the method of administration, the maximum dose should not exceed 720 IU/kg body weight per week.
Stage of maintenance therapy
To maintain hemoglobin levels at 100–120 g/l, the dose should initially be reduced by half of the previous dose. Subsequently, the maintenance dose is adjusted individually, at intervals of one or two weeks (maintenance dose).
When administered subcutaneously, the weekly dose can be administered as a single injection per week or divided into 3 or 7 injections per week. When the condition stabilizes on the background of a single injection per week, it is possible to switch to a single injection with a two-week interval, in which case an increase in the dose may be necessary.
As shown by the results of clinical studies, as a rule, the younger the child, the higher the dosage of the drug is required. However, since it is impossible to predict the individual response to the drug, it is advisable to adhere to the recommended dosage regimen.
Treatment with Recormon® is usually long-term. If necessary, it can be interrupted at any time. Data on the once-weekly dosing regimen are based on the results of clinical studies with a treatment duration of 24 weeks.
Prevention of anemia in premature newborns
The drug is administered subcutaneously at a dose of 250 IU/kg body weight 3 times a week. In premature newborns who have been transfused before starting treatment with Recormon®, the effect of treatment may be less pronounced than in premature newborns who have not been transfused. The recommended duration of treatment is 6 weeks.
Treatment of symptomatic anemia induced by chemotherapy in patients with cancer.
The drug is administered subcutaneously to patients with anemia (hemoglobin level ≤ 100 g/L (6.2 mmol/L)). Symptoms and complications of anemia vary depending on the age, gender of the patient and the nosology. The physician's assessment of the clinical course of the disease and the general condition of the patient is necessary.
Due to individual variability, occasional haemoglobin values above and below the desired level may occur. In case of haemoglobin variability, the dose should be adjusted, keeping in mind the target haemoglobin range of 100–120 g/l (6.2–7.5 mmol/l). A sustained increase in haemoglobin above 120 g/l (7.5 mmol/l) should be avoided. Recommendations for dose adjustment for haemoglobin levels above 120 g/l (7.5 mmol/l) are given below.
If the hemoglobin level increases by at least 10 g/l (0.62 mmol/l) after 4 weeks, therapy should be continued at the same dose. If the hemoglobin level increases by less than 10 g/l (0.62 mmol/l) after 4 weeks, the dose should be doubled. If the hemoglobin level does not increase by at least 10 g/l (0.62 mmol/l) after 8 weeks, treatment should be discontinued, since the response to therapy with Recormon® is unlikely.
Treatment should be continued for 4 weeks after the end of chemotherapy.
The maximum dose of the drug should not exceed 60,000 IU per week.
When the required hemoglobin level, individual for each patient, is reached, the dose of the drug should be reduced by 25–50%, maintaining hemoglobin at this level. It is important to remember about the appropriate dose titration.
If the hemoglobin level exceeds 120 g/l (7.5 mmol/l), the dose of the drug should be reduced by approximately 25-50%. If the hemoglobin level exceeds 130 g/l (8.1 mmol/l), treatment with Recormon® should be temporarily discontinued. If the hemoglobin level decreases to 120 g/l (7.5 mmol/l) or below, treatment should be resumed at a dose approximately 25% lower than the previous dose.
If the hemoglobin level increases by more than 20 g/l (1.3 mmol/l) after 4 weeks, the dose of the drug should be reduced by 25–50%.
Patients should be closely monitored to ensure that the lowest approved dose of Recormon® is used to provide adequate control of symptoms of anemia.
Preparing patients for autologous blood collection for subsequent autohemotransfusion.
The drug is administered intravenously (over approximately 2 minutes) or subcutaneously 2 times a week for 4 weeks. In cases where the patient's hematocrit (≥ 33%) allows blood sampling, Recormon® is administered at the end of the procedure. During the entire course of treatment, the hematocrit should not exceed 48%.
The dose of the drug is determined by the surgical team individually for each patient, depending on the volume of blood that will be taken from the patient and what his erythrocyte reserve is:
1. The volume of blood to be withdrawn from the patient depends on the expected blood loss, the available blood conservation techniques and the general condition of the patient; it should be sufficient to avoid transfusion from another donor. The volume of blood to be withdrawn from the patient is expressed in units (one unit is equivalent to 180 ml of red blood cells).
2. The ability to donate depends mainly on the patient's blood volume and initial hematocrit. Both indicators determine the endogenous erythrocyte reserve, which can be calculated using the following formula:
Endogenous erythrocyte reserve = blood volume [ml] × (hematocrit – 33) : 100
Women: blood volume [ml] = 41 [ml/kg] × body weight [kg] + 1200 [ml]
Men: blood volume [ml] = 44 [ml/kg] × body weight [kg] + 1600 [ml] (for body weight ≥ 45 kg)
Indications for the use of Recormon® and its single dose are determined by nomograms based on the required volume of donor blood and endogenous erythrocyte reserve.
The single dose determined in this way is administered twice a week for 4 weeks. The maximum dose should not exceed 1600 IU/kg body weight per week for intravenous administration and 1200 IU/kg body weight per week for subcutaneous administration.
Instructions for use of the pre-filled syringe
The pre-filled syringe with Recormon® is ready for use. Only a colorless, clear or slightly opalescent solution, practically free from visible particles, should be used. Recormon® in the pre-filled syringe is sterile, but does not contain preservatives. Under no circumstances should more than one dose be administered from the pre-filled syringe.
You must wash your hands before injecting.
1. Remove 1 pre-filled syringe from the package and ensure that the solution is clear, colourless and practically free from visible particles. Remove the cap from the syringe.
2. Remove one needle from the package, put it on the syringe and remove the protective cap from the needle.
3. Remove air from the syringe and needle by holding the syringe vertically and gently pushing the plunger up. Press the plunger until the required dose of Recormon® remains in the syringe.
4. Wipe the skin at the injection site with an alcohol swab. Pinch the skin between your thumb and index finger. Holding the syringe body closer to the needle, insert it under the skin. Inject the Recormon® solution. Quickly remove the needle and press the injection site with sterile dry cotton.
The pre-filled syringe is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Children
Treatment of symptomatic anemia associated with chronic renal failure in children.
Prevention of anemia in premature newborns born with a body weight of 750–1500 g before the 34th week of pregnancy.
Overdose
The therapeutic index of Recormon® is very wide. Even at very high serum concentrations of the drug, no signs of overdose were observed.
Adverse reactions
Based on the results of clinical studies involving 1725 patients, adverse reactions during treatment with Recormon® are expected to occur in approximately 8% of patients.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported with epoetin treatment.
The description of adverse reactions is given in accordance with the terminology of the Medical Dictionary of Regulatory Activities MedDRA by system organ class and frequency category. By frequency, adverse reactions are divided into very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).
Patients with anemia associated with chronic renal failure
The most common adverse reaction during treatment with Recormon® is an increase in blood pressure or worsening of existing hypertension, especially with a rapid increase in hematocrit (see section "Special instructions"). Hypertensive crises with manifestations of encephalopathy (headache, confusion, sensorimotor disorders such as speech and gait disorders, up to tonic-clonic seizures) may occur in individual patients with normal or low blood pressure (see section "Special instructions").
Shunt thrombosis is possible, especially in patients with a tendency to hypotension or in patients who have developed complications from the arteriovenous fistula (stenosis, aneurysm) (see section "Special instructions for use"). In most cases, the increase in hematocrit is accompanied by a decrease in serum ferritin concentration (see section "Special instructions for use"). In isolated cases, a short-term increase in serum potassium and phosphate levels has been observed (see section "Special instructions for use").
Isolated cases of pure red cell aplasia with neutralizing antibodies to erythropoietin have been reported in association with Recormon® therapy. It is not recommended to switch patients to Recormon® therapy if a diagnosis of pure red cell aplasia mediated by the presence of neutralizing antibodies to erythropoietin is established (see section "Special instructions").
Adverse reactions associated with treatment with Recormon® observed in controlled clinical trials:
Vascular disorders: uncommon – hypertensive crisis; common – arterial hypertension.
Nervous system disorders: common – headache.
Blood and lymphatic system disorders: rare – shunt thrombosis; very rare – thrombocytosis.
Patients with malignant neoplasms
Headache and hypertension associated with epoetin beta treatment, which can be treated with medication, are common.
Decreased serum iron levels have been observed in some patients (see section "Special warnings and precautions for use").
In clinical trials, a higher incidence of thromboembolism was reported in patients with malignant neoplasms treated with Recormon® (7%) compared to the control group that did not receive treatment (4%) or received placebo. However, there was no increase in mortality from thromboembolism in the Recormon® treatment group compared to the control group.
Adverse reactions associated with treatment with Recormon® observed in controlled clinical trials:
Vascular disorders: common – arterial hypertension.
Blood and lymphatic system disorders: common – thromboembolic events.
Nervous system disorders: common – headache.
Patients who are scheduled for autologous donor blood collection
A slightly higher incidence of thromboembolic events was observed in patients receiving autologous blood donation. However, a clear causal relationship with Recormon® has not been established.
In placebo-controlled studies, iron deficiency was more pronounced in patients treated with Recormon® than in the placebo group (see section "Special instructions").
Adverse reactions associated with treatment with Recormon® observed in controlled clinical trials:
Nervous system disorders: common – headache.
Premature newborns
A very common decrease in serum ferritin levels was observed (see section 4.4).
Description of selected adverse reactions
Skin and subcutaneous tissue disorders: rarely - rash, itching, urticaria, injection site reactions.
Very rarely, especially at the beginning of therapy, flu-like symptoms associated with epoetin beta treatment, such as fever, chills, headache, pain in the extremities, malaise and/or bone pain, have been reported. These reactions were mild to moderate and resolved within a few hours to a few days.
In controlled clinical trials with epoetin alfa or darbepoetin alfa, stroke was reported with a frequency common (≥ 1/100 to < 1/10).
Expiration date
2 years.
Storage conditions
Keep out of reach of children. Store in the original packaging to protect from light at a temperature of 2–8 °C (in a refrigerator). If necessary, transportation may be carried out at a temperature of up to 25 °C, but not for more than 3 days.
Incompatibility
In the absence of compatibility studies, Recormon® should not be mixed with other drugs.
Packaging
2 contour blister packs (6 pre-filled syringes and 6 needles) in a cardboard box.
Vacation category
According to the recipe.
Producer
Roche Diagnostics GmbH.
Location of the manufacturer and its business address
Sandhoferstrasse 116, 68305 Mannheim, Germany
