Ropivacaine Kabi, 10 mg/ml, solution for injection, 10 ml, 5 pcs.

Ropivacaine Kabi, 10 mg/ml, solution for injection, 10 ml, 5 pcs.

Ropivacaine Kabi should only be administered by specialists with sufficient experience in administering local anesthesia or under their supervision, with equipment and medications available for resuscitation.

Solution for injection, 5 mg/ml

For perineural administration (spinal and conduction anesthesia)

IV catheters should be installed before large blockades can be performed.

Ropivacaine Kabi is administered slowly or by increasing sequential doses of the drug at a rate of 25–50 mg/min.

To prevent the anesthetic from entering the vessel, an aspiration test must be performed before and during the administration of the drug. Accidental intravascular injection is recognized by a temporary increase in heart rate.

The following table provides dosage guidelines for intrathecal blockade, acute pain relief, and peripheral nerve blockade. The minimum dosage sufficient to produce an effective blockade should be used. When deciding on a dose, the experience of the clinical specialist and knowledge of the patient's physical condition are important.

Recommendations for dosing of the drug Ropivacaine Kabi for adults and children over 12 years of age

(see table 2)

table 2

Recommendations for dosing of the drug Ropivacaine Kabi for children from 1 year to 12 years

(see table 3)

Table 3

The doses indicated in the table are considered sufficient to achieve a reliable blockade and are indicative when using the drug in adults, because There is individual variability in the speed of development of the block and its duration.

The intrathecal route of administration of ropivacaine hydrochloride has not been studied for anesthesia for caesarean section.

There are individual differences in the onset of the blockade and its duration.

The values ​​in the Dose column reflect the expected average range of dosages required. To obtain information about the factors influencing the blockade technique and the individual characteristics of patients, you should refer to standard manuals.

Due to the lack of sufficient clinical observations, it is not recommended to use Ropivacaine Kabi in children under 1 year of age.

Solution for injection, 2 mg/ml, 7.5 mg/ml, 10 mg/ml

For epidural and perineural administration (conduction and infiltration anesthesia and analgesia)

Adults and children over 12 years old.

In general, anesthesia for surgical interventions requires higher doses and more concentrated solutions of the drug than when using an anesthetic for pain relief. For analgesia (eg, epidural administration to suppress acute pain), lower concentrations and doses are recommended and a dose of 2 mg/mL is generally recommended. For intra-articular administration, a dose of 7.5 mg/ml is recommended. Ropivacaine Kabi 10 mg/ml is recommended for epidural anesthesia when complete motor blockade is necessary for surgery.

The following tables provide dosage guidelines for more commonly used blocks. The minimum dosage sufficient to produce an effective blockade should be used. When deciding on a dose, the experience of the clinical specialist and knowledge of the patient's physical condition are important.

Recommendations for dosing of the drug Ropivacaine Kabi for adults and children over 12 years of age

(see table 4)

The dosages given in Table 4 are considered sufficient for successful blockade and should serve as a guide for use in adult patients, because There are individual deviations in the timing of the blockade and its duration. The values ​​in the Dose column reflect the expected range of average doses required.

Table 4

1 The dosage for regional anesthesia should be adjusted according to the site of application and the patient's condition. Scalene and supraclavicular brachial plexus blocks may result in a higher incidence of adverse reactions, regardless of the local anesthetic used.

2 Cases of chondrolysis have been reported with postoperative extended intra-articular infusion of local anesthetics. Ropivacaine Kabi should not be used for long-term intra-articular administration.

3 If Ropivacaine Kabi was additionally used for other types of anesthesia, the maximum dose should not exceed 225 mg.

4 Stepped dosing should be used, with an initial dose of approximately 100 mg (97.55 mg = 13 mL, 105 mg = 14 mL) administered over 3–5 min. Two additional doses, totaling an additional 50 mg, may be administered as needed.

Standard guidelines should be used to understand the factors influencing the method of performing individual blocks and the requirements for specific patient groups.

To prevent the anesthetic from entering the vascular bed, it is imperative to carry out an aspiration test before and during the administration of the drug. If it is necessary to administer a large dose of the drug, it is recommended to administer a test dose of 3–5 ml of lidocaine with epinephrine. Accidental intravascular injection is recognized by a temporary increase in heart rate, and accidental intrathecal injection is recognized by signs of spinal block. If toxic symptoms occur, administration of the drug should be stopped immediately.

Aspiration should be performed before and during administration of the main dose, which should be administered slowly or stepwise at a level of 25–50 mg/min, while closely monitoring the patient's vital signs and maintaining verbal contact with the patient.

A single dose of Ropivacaine Kabi for epidural blockade for surgery at a dose of up to 250 mg is usually well tolerated by patients.

When brachial plexus block is used with 40 ml of Ropivacaine Kabi 7.5 mg/ml, maximum plasma concentrations of ropivacaine hydrochloride in some patients can reach values ​​characterized by mild symptoms of CNS toxicity. Therefore, the use of a dose higher than 40 ml of Ropivacaine Kabi 7.5 mg/ml (300 mg ropivacaine hydrochloride) is not recommended.

When using long-term blockade, either by continuous infusion or repeated bolus administration, the risks of achieving toxic plasma concentrations or causing local nerve damage must be taken into account. Administration of ropivacaine hydrochloride over 24 hours at a dose of up to 800 mg in total during surgical interventions and for postoperative pain relief, as well as prolonged epidural infusion after surgery at a rate of up to 28 mg/h for 72 hours, is well tolerated by adult patients.

To relieve postoperative pain, the following method is recommended: if an epidural catheter was not installed during surgery, after its installation, an epidural blockade is performed with a bolus injection of the drug Ropivacaine Kabi 7.5 mg/ml. Analgesia is maintained by infusion of the drug Ropivacaine Kabi 2 mg/ml. In most cases, for the management of moderate to severe postoperative pain, infusion at a rate of 6–14 ml/h (12–28 mg/h) provides adequate analgesia with minimal non-progressive motor blockade (a significant reduction in the need for opioid analgesics has been observed using this technique ). For postoperative pain relief, Ropivacaine Kabi 2 mg/mL can be administered continuously as an epidural infusion over 72 hours without or in combination with fentanyl (1–4 mcg/mL). Ropivacaine Kabi 2 mg/ml (6–14 ml/hour) provided adequate pain relief in most patients. The combination of the drug Ropivacaine Kabi and fentanyl led to improved pain relief, while causing side effects inherent in narcotic analgesics.

The use of Ropivacaine Kabi concentrations greater than 7.5 mg/ml during caesarean section has not been studied.

Kidney failure

As a rule, when administering a single dose or short-term therapy to patients with impaired renal function, no dose adjustment is required.

Liver failure

Ropivacaine is metabolized in the liver and, as a result, should be used with caution in patients with serious liver disease. Repeated doses may need to be reduced due to delayed elimination.

Patients suffering from hypovolemia

Patients who are hypovolemic for any reason may develop acute and severe hypotension during epidural anesthesia, regardless of the use of local anesthetic.

Recommendations for dosing of the drug Ropivacaine Kabi for children from 0 to 12 years

(see table 5)

Table 5

1 Lower doses of the suggested dosing range are recommended for thoracic and epidural blocks, whereas larger doses are recommended for lumbar and caudal epidural blocks.

2 Recommended for lumbar epidural blocks. It is reasonable to reduce the bolus dose in case of analgesia at the thoracic level.

The dosages in Table 5 should be considered a guide to the use of the drug in pediatric practice. At the same time, there is individual variability in the speed of development of the block and its duration. In children with increased body weight, a gradual reduction in the dose of the drug is often required, and the patient's ideal body weight should be taken as a basis. For factors influencing specific block techniques and individual patient requirements, the data provided in standard guidelines must be taken into account. The volume for a single caudal block and the volume for epidural bolus dosages should not exceed 25 mL in any patient.

Careful aspiration is recommended before and during injection to prevent intravascular injection. During the administration of the drug, it is necessary to carefully monitor the patient's vital functions. If toxic symptoms occur, the infusion should be stopped immediately. A single caudal epidural injection of ropivacaine hydrochloride at a dose of 2 mg/ml (at a rate of 2 mg/kg, solution volume 1 ml/kg) produces adequate postoperative analgesia below the T12 level in most patients.

Children over 4 years of age tolerate doses of 3 mg/kg well. The volume of epidural solution administered at the caudal level can be varied to achieve varying degrees of sensory block, as described in specialized guidelines.

Regardless of the type of anesthesia, bolus administration of the calculated dose of the drug is recommended.

The use of the drug at concentrations above 5 mg/ml, as well as the intrathecal use of Ropivacaine Kabi, have not been studied in children.

Regardless of route of administration, ropivacaine hydrochloride has not been studied in premature infants.

Instructions for use of solution for injection 2 mg/ml, 5 mg/ml, 7.5 mg/ml, 10 mg/ml

The solution does not contain preservatives and is intended for single use only.

To be used immediately after opening the Friflex® ampoule or bag; the unused remainder of the drug is destroyed.

Before use, the medicinal product must be carefully examined.

The injection solution is only suitable if it is transparent, there are no visible mechanical particles, and the container is not damaged.

Any amount of solution remaining in the ampoule or container after use must be destroyed.

An unopened ampoule or container of solution should not be autoclaved.

Unopened blister packs provide sterility to the outer surface of the ampoule or container and are preferred for use in environments requiring sterility.

Ropivacaine

The drug is used for epidural, spinal, infiltration and conduction anesthesia.

Ropivacaine should only be used by specialists with sufficient experience in administering local anesthesia, or under their supervision, with equipment and medications available for resuscitation. Intravenous catheters must be placed before major blockades can be performed.

Adults and children over 12 years old

In general, anesthesia for surgical interventions requires higher doses and more concentrated solutions of the drug than when using an anesthetic for pain relief.

When using an anesthetic for pain relief, a dose of 2 mg/ml is usually recommended.

For intra-articular administration, a dose of 7.5 mg/ml is recommended.

Ropivacaine 10 mg/ml is recommended for epidural anesthesia when complete motor blockade is necessary for surgery.

The doses indicated in tables 1 and 2 are considered sufficient to achieve a reliable blockade and are indicative when using the drug in adults and children over 12 years of age, since there is individual variability in the rate of development of the blockade and its duration.

The data in Tables 1 and 2 are indicative guidelines for dosing the drug for the most commonly used blockades. When selecting the dose of the drug, it should be based on clinical experience taking into account the physical condition of the patient.

Table 1. Dosing recommendations for Ropivacaine for adults and children over 12 years of age at concentrations of 2 mg/ml, 7.5 mg/ml and 10 mg/ml:

*The dose for major plexus block should be adjusted according to the site of administration and the patient's condition. Brachial plexus blocks using the interscalene and supraclavicular approaches may be associated with a high incidence of serious adverse reactions, regardless of the local anesthetic used.

**Cases of chondrolysis have been reported with postoperative extended intra-articular infusion of local anesthetics. Ropivacaine should not be used for prolonged intra-articular infusion.

***If the drug Ropivacaine was additionally used for other types of anesthesia, the maximum dose should not exceed 225 mg.

Table 2. Recommendations for dosing of the drug Ropivacaine for adults and children over 12 years of age at concentrations of 5 mg/ml:

Standard guidelines should be used to understand the factors influencing the method of performing individual blocks and the requirements for specific patient groups.

To prevent the anesthetic from entering the vessel, an aspiration test must be performed before and during the administration of the drug. If you intend to use the drug in a high dose, it is recommended to administer a test dose of 3-5 ml of lidocaine with adrenaline.

Accidental intravascular injection is recognized by a transient increase in heart rate, and accidental intrathecal injection is recognized by signs of spinal block. If toxic symptoms appear, you should immediately stop administering the drug.

Before and during the administration of the drug Ropivacaine (which should be done slowly or by increasing sequentially administered doses of the drug at a rate of 25-50 mg/min), it is necessary to carefully monitor the patient's vital functions and maintain verbal contact with him.

A single dose of ropivacaine up to 250 mg for epidural blockade for surgical intervention is usually well tolerated by patients.

When brachial plexus block is used with 40 ml of ropivacaine 7.5 mg/ml, maximum plasma concentrations of ropivacaine in some patients may reach values ​​characterized by mild symptoms of CNS toxicity. Therefore, the use of a dose higher than 40 ml of ropivacaine 7.5 mg/ml (300 mg ropivacaine) is not recommended.

When carrying out a long-term blockade by prolonged infusion or repeated bolus administration, the possibility of creating toxic concentrations of anesthetic in the blood and local nerve damage should be taken into account. The administration of ropivacaine over 24 hours at a dose of up to 800 mg in total during surgical interventions and for postoperative pain relief, as well as prolonged epidural infusion after surgery at a rate of up to 28 mg/h for 72 hours, is well tolerated by adult patients.

To relieve postoperative pain, the following regimen of drug use is recommended: if an epidural catheter was not installed during surgery, after its installation, an epidural blockade is performed with a bolus injection of the drug Ropivacaine (7.5 mg/ml)

Analgesia is maintained by infusion of the drug Ropivacaine (2 mg/ml).

In most cases, for the management of moderate to severe postoperative pain, infusion at a rate of 6-14 ml/h (12-28 mg/h) provides adequate analgesia with minimal non-progressive motor blockade (a significant reduction in the need for opioid analgesics has been observed using this technique ).

For postoperative pain relief, Ropivacaine (2 mg/ml) can be administered continuously as an epidural infusion for 72 hours without or mixed with fentanyl (1-4 mcg/ml). Ropivacaine 2 mg/ml (6-14 ml/hour) provided adequate pain relief in most patients.

The combination of ropivacaine and fentanyl led to improved pain relief, while causing the side effects associated with narcotic analgesics.

The use of ropivacaine in concentrations greater than 7.5 mg/ml during caesarean section has not been studied.

Kidney failure

As a rule, when administering a single dose or short-term therapy to patients with impaired renal function, no dose adjustment is required.

Liver failure

Ropivacaine is metabolized in the liver and, as a result, should be used with caution in patients with serious liver disease. Repeated doses should be reduced due to delayed release.

Patients suffering from hypovolemia

Patients who are hypovolemic for any reason may develop acute severe hypotension during epidural anesthesia, regardless of the use of local anesthetic.

Table 3. Recommendations for dosing of the drug Ropivacaine for children from 0 to 12 years old at a concentration of 2 mg/ml:

* Lower doses of the suggested range are recommended for thoracic epidural administration, while higher doses are recommended for lumbar and caudal epidural administration.

**Recommended for epidural administration at the lumbar level. It is reasonable to reduce the bolus dose for epidural analgesia at the thoracic level.

Table 4. Recommendations for dosing of the drug Ropivacaine for children from 1 year to 12 years at a concentration of 5 mg/ml:

The doses indicated in Tables 3 and 4 are guidelines for the use of the drug in pediatric practice. At the same time, there is individual variability in the speed of development of the block and its duration

In overweight children, a gradual reduction in the dose of the drug is often required; In this case, it is necessary to be guided by the “ideal” weight of the patient. Specific guidelines should be consulted for background information on the factors that influence individual block techniques and the requirements for specific patient groups. The caudal epidural solution volume and epidural bolus volume should not exceed 25 mL for any patient.

To prevent inadvertent intravascular injection of anesthetic, careful aspiration testing should be performed before and during administration of the drug. During administration of the drug, it is necessary to carefully monitor the patient's vital functions. If toxic symptoms appear, you should immediately stop administering the drug.

A single dose of ropivacaine 2 mg/ml (based on 2 mg/kg, solution volume 1 ml/kg) for postoperative caudal analgesia provides adequate pain relief below the Thxn level in most patients. Children over 4 years of age tolerate doses up to 3 mg/kg. The volume of epidural solution administered at the caudal level can be varied to achieve varying degrees of sensory block, as described in specialized guidelines.

Regardless of the type of anesthesia, bolus administration of the calculated dose of the drug is recommended.

The use of the drug at concentrations above 5 mg/ml, as well as intrathecal use of any concentrations of ropivacaine in children, has not been studied. The use of ropivacaine in premature infants has not been studied.

Instructions for using the solution

The solution does not contain preservatives and is intended for single use only. To be used immediately after opening the ampoule or vial (bottle/bottle), the unused remainder of the drug is destroyed. Before use, the medicinal product must be carefully examined.

The solution for injection is suitable only if it is transparent, there are no visible mechanical particles, and the container is not damaged.

Any amount of solution remaining in the ampoule or vial (bottle/bottle) after use must be destroyed.

Due to the lack of sufficient clinical observations, it is not recommended to use ropivacaine at a dosage of 5 mg/ml in children under the age of 1 year.