Ropivacaine hydrochloride Altan Pharma

Patient Information Leaflet: Information for the User

Ropivacaine Hydrochloride Altan Pharma 2 mg/ml infusion solution

ropivacaine hydrochloride
Equivalent medicinal product
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Ropivacaine Hydrochloride Altan Pharma is and what it is used for
2. What you need to know before using Ropivacaine Hydrochloride Altan Pharma
3. How to use Ropivacaine Hydrochloride Altan Pharma
4. Possible side effects
5. How to store Ropivacaine Hydrochloride Altan Pharma
6. Contents of the pack and other information

1. What Ropivacaine Hydrochloride Altan Pharma is and what it is used for

Ropivacaine Hydrochloride Altan Pharma contains ropivacaine hydrochloride, which belongs to a group of medicines called amide-type local anaesthetics.
Ropivacaine Hydrochloride Altan Pharma is used in adults and children of all ages for the treatment of acute pain. It numbs (anaesthetizes) parts of the body, for example after surgery.

2. What you need to know before using Ropivacaine Hydrochloride Altan Pharma

Do not use Ropivacaine Hydrochloride Altan Pharma
if you are allergic to ropivacaine, to other local anaesthetics of the amide type (such as lidocaine or
bupivacaine), or to any of the other ingredients of this medicine (listed in section 6).
in case of intravenous regional anaesthesia (injection into a blood vessel to anaesthetize a
specific area of your body), or paracervical obstetrical anaesthesia (injection into the cervix
to relieve pain during childbirth).
if you have been told you have reduced blood volume (hypovolemia), as you may develop low blood pressure.
If you are unsure whether any of the above conditions apply to you, consult your doctor before being administered Ropivacaine Hydrochloride Altan Pharma.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ropivacaine Hydrochloride Altan Pharma:

• if you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine.
• if you or anyone in your family has ever been diagnosed with a rare blood pigment disorder called "porphyria". Your doctor may need to administer a different anaesthetic medicine.
• about any medical conditions or illnesses you currently have.

Children and adolescents
The use of Ropivacaine Hydrochloride Altan Pharma has not been studied in premature newborns.
Special caution is required with Ropivacaine Hydrochloride Altan Pharma:
in newborns, as they are more sensitive to ropivacaine hydrochloride.
in children up to and including 12 years of age, as certain types of regional injections have not been established in younger children.
Other medicines and Ropivacaine Hydrochloride Altan Pharma
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines you can buy without a prescription and herbal medicines. This is because Ropivacaine Hydrochloride Altan Pharma may affect how some medicines work, and some medicines may affect Ropivacaine Hydrochloride Altan Pharma.
In particular, inform your doctor if you are taking any of the following medicines:
other local anaesthetics
strong painkillers, such as morphine or codeine.
medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and
mexiletine.
Your doctor needs to know about these medicines in order to determine the correct dose of Ropivacaine Hydrochloride Altan Pharma for you.
Also inform your doctor if you are taking any of the following medicines:
Medicines for depression (such as fluvoxamine)
Antibiotics used to treat bacterial infections (such as enoxacin).
This is because your body takes longer to eliminate Ropivacaine Hydrochloride Altan Pharma if you are taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine Hydrochloride Altan Pharma should be avoided.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before being administered this medicine.
Ropivacaine Hydrochloride Altan Pharma must not be used during pregnancy or breastfeeding unless clearly necessary, as determined by your doctor.
It is not known whether ropivacaine hydrochloride has effects on pregnancy or passes into breast milk.
Driving and using machines
Ropivacaine Hydrochloride Altan Pharma may cause drowsiness and affect reaction speed. After receiving Ropivacaine Hydrochloride Altan Pharma, you must not drive or operate tools or machinery until the following day.
Ropivacaine Hydrochloride Altan Pharma contains sodium
This medicine contains 3.34 mg of sodium (a key component of table salt) per ml. This corresponds to 0.17% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Ropivacaine Hydrochloride Altan Pharma

Route of administration
Ropivacaine hydrochloride Altan Pharma will be administered to you by a doctor or, occasionally, by a nurse under medical supervision.

Dosage
The dose your doctor administers will depend on the type of pain relief you require, as well as your body size, age, and physical condition.

Ropivacaine hydrochloride Altan Pharma will be administered as an infusion. The site of administration will depend on the reason for which Ropivacaine hydrochloride Altan Pharma is being given. Your doctor will administer Ropivacaine hydrochloride Altan Pharma at one of the following sites:

• The part of the body that needs to be anesthetized.
• The area near the part of the body that needs to be anesthetized.
• An area distant from the part of the body that needs to be anesthetized. This occurs when an epidural or infusion injection is performed (into the area surrounding the spinal cord).

When Ropivacaine hydrochloride Altan Pharma is used in any of the ways described above, it prevents nerves from transmitting pain signals to the brain. You will not feel pain, heat, or cold sensations, but you may still perceive other sensations such as pressure or touch.

Your doctor will determine the appropriate method of administration.

If you receive more Ropivacaine hydrochloride Altan Pharma than you should
Serious adverse effects due to an overdose of Ropivacaine hydrochloride Altan Pharma require special treatment, and your doctor is able to manage these situations. The first signs of an overdose of Ropivacaine hydrochloride Altan Pharma are usually the following:

• Feeling dizzy or mentally confused.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing disturbances.
• Visual disturbances (vision problems).

To reduce the risk of serious adverse effects, your doctor will stop administering Ropivacaine hydrochloride Altan Pharma as soon as any of these signs appear. Therefore, if you experience any of the above symptoms, or if you think you have received too much Ropivacaine hydrochloride Altan Pharma, you must inform your doctor immediately.

The most serious adverse effects resulting from an overdose of Ropivacaine hydrochloride Altan Pharma include speech difficulties, muscle spasms, tremors, shaking, epileptic seizures (fits), and loss of consciousness.

If any of these symptoms occur, or if you think you have received too much Ropivacaine hydrochloride Altan Pharma, inform your doctor or healthcare personnel immediately.

In cases of acute toxicity, healthcare staff will immediately take appropriate corrective measures.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Important side effects to be aware of:
Sudden, life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, occurring in 1 to 10 patients out of 10,000. Possible symptoms include sudden onset of rash, itching or rash with swelling (urticaria); swelling of the face, lips, tongue or other body parts; shortness of breath, wheezing or difficulty breathing; feeling faint or loss of consciousness. If you think Ropivacaine hydrochloride Altan Pharma is causing an allergic reaction, inform your doctor immediately.

Other possible side effects:

Very common • Low blood pressure (hypotension). This may cause dizziness or
(affects more than 1 mental confusion.
patient in 10) • Feeling unwell (nausea).

Common: • Headache.
(affects 1 to 10 • Tingling or abnormal sensation (paresthesia).
patients in 100) • Dizziness.

• Slow or fast heartbeat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• Nausea (vomiting).
• Difficulty urinating (urinary retention).
• High temperature (fever) or tremors (chills).
• Back pain.

Uncommon • Anxiety.
(affects 1 to 10 • Some symptoms may occur if the injection is accidentally given
patients in 1,000) into a blood vessel or if an excessive dose of Ropivacaine hydrochloride
Altan Pharma has been administered (see also section 3 ‘If you receive
more Ropivacaine hydrochloride Altan Pharma than you should’, above).
These include epileptic seizures (convulsions), dizziness or mental
confusion, numbness of the lips and around the mouth, numbness of the
tongue, hearing problems, vision problems, speech difficulties, muscle
rigidity and tremor).

• Reduced sense of touch (hypoesthesia).
• Fainting (syncope).
• Difficulty breathing (dyspnea).
• Low body temperature (hypothermia).

Rare • Heart attack (cardiac arrest).
(affects 1 to 10 • Irregular heartbeat (arrhythmia).
patients in 10,000)

Not known • Horner’s syndrome
(frequency cannot be (the frequency cannot be determined from the available data)
determined from the
available data)

Other possible side effects include:
Numbness due to nerve irritation caused by the needle or injection. This usually does not last long.
Involuntary muscle movements (dyskinesia).

Possible side effects observed with other local anaesthetics, which could also be caused by
Ropivacaine hydrochloride Altan Pharma include:
Nerve damage. Rarely (affects 1 to 10 patients out of 10,000), this may cause permanent problems.
If an excessive dose of Ropivacaine hydrochloride Altan Pharma is administered into the spinal fluid, it may cause the entire body to become numb (anaesthetized).
Receiving an epidural injection (an injection into the space around the spinal nerves) may interrupt the nerve pathway from the brain to the head and neck, particularly in pregnant women, which may sometimes lead to a condition called Horner’s syndrome. This is characterized by a reduction in pupil size, drooping of the upper eyelid, and inability of the sweat glands to produce sweat. It will resolve on its own once treatment is stopped.

Children
In children, side effects are the same as in adults, except that low blood pressure occurs less frequently in children (affects 1 to 10 children out of 100) and feeling unwell occurs more frequently in children (affects more than 1 child in 10).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropivacaine Hydrochloride Altan Pharma

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date stated on the carton or label,
after EXP. The expiry date refers to the last day of that month.
From a microbiological point of view, the product should be used immediately, unless the method of opening prevents the risk of microbial contamination. If not used immediately, the conditions and duration of storage are the responsibility of the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ropivacaine Hydrochloride Altan Pharma contains

• The active substance is ropivacaine hydrochloride. Each 100 ml bag contains 200 mg of ropivacaine hydrochloride. Each 200 ml bag contains 400 mg of ropivacaine hydrochloride.
• The excipients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Description of the appearance of Ropivacaine Hydrochloride Altan Pharma and contents of the pack
Ropivacaine Hydrochloride Altan Pharma is a clear, colourless solution for intravenous infusion.
Each container contains 5 bags of 100 ml or 5 bags of 200 ml with non-sterile outer surfaces.
Although the solution itself is sterile, procedures for using the product should take into account
the fact that the outside of the bag is not sterile within its overwrap. The removable overwrap provides
photoprotection and ensures mechanical and physical protection of the sterile solution.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain

The following information is intended for healthcare professionals only:
Dosage
Adults and adolescents over 12 years of age:
The table below provides guidance on recommended dosages for the most common types of block. The dose used should be the lowest required to achieve effective block. The dose to be administered should be selected based on the physician's experience and knowledge of the patient's clinical condition.

Route of administration
For perineural and epidural use.
To avoid intravascular injection, careful aspiration is recommended before and during injection. When a large dose must be administered, it is recommended to perform a test dose of 3–5 ml of lidocaine (lignocaine) with adrenaline (epinephrine). Accidental intravascular injection may be recognized by a transient increase in heart rate, while accidental intrathecal injection may be identified by signs of spinal block such as apnea and hypotension.
Aspiration must be performed before and during administration of the main dose, which should be injected slowly or in fractionated doses at a rate of 25–50 mg/minute, with close monitoring of the patient's vital signs and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.
When performing prolonged blocks, either by continuous infusion or repeated bolus injections, the potential risk of achieving toxic plasma concentrations or causing local neurotoxicity must be considered. Cumulative doses of up to 675 mg of ropivacaine administered over 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as have continuous postoperative epidural infusions at rates up to 28 mg/hour for 72 hours. Higher doses up to 800 mg/day have been administered in a limited number of patients with a relatively low incidence of adverse reactions.
For postoperative pain treatment, the following technique may be recommended: unless already established preoperatively, an epidural block using a concentration of 7.5 mg/ml is induced via an epidural catheter. Analgesia is maintained with infusion of Ropivacaine hydrochloride Altan Pharma 2 mg/ml.
Infusion rates of 6–14 ml (12–28 mg) per hour provide adequate analgesia with mild and non-progressive motor block in most cases of moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, careful monitoring of analgesic effect is required, and the catheter should be removed as soon as the pain condition allows. With this technique, a significant reduction in opioid requirements has been observed.
In clinical studies, epidural infusion of ropivacaine 2 mg/ml alone or mixed with fentanyl 1–4 μg/ml has been administered for postoperative pain management for up to 72 hours. The combination of ropivacaine and fentanyl provided improved pain relief but caused opioid-related adverse effects. The combination of ropivacaine and fentanyl has only been studied with ropivacaine 2 mg/ml.
When performing prolonged peripheral nerve blocks, either by continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neurotoxicity must be taken into account. In clinical studies, femoral nerve block was established with 300 mg of ropivacaine 7.5 mg/ml and interscalene block with 225 mg of ropivacaine 7.5 mg/ml, respectively, prior to surgery. Analgesia was maintained with ropivacaine 2 mg/ml. Infusion rates and intermittent injections of 10–20 mg/hour for 48 hours provided adequate analgesia and were well tolerated.
Epidural block: Pediatric patients from 0 to 12 years inclusive:
Conc. Volume Dose
mg/ml ml/kg mg/kg
ACUTE PAIN TREATMENT
(peri- and post-operative)
Continuous epidural infusion
In children with body weight up to 25 kg
From 0 to 6 months
Infusion up to 72 hours 2.0 0.1 ml/kg/h 0.2 mg/kg/h
From 6 to 12 months
Infusion up to 72 hours 2.0 0.2 ml/kg/h 0.4 mg/kg/h
From 1 to 12 years
Infusion up to 72 hours 2.0 0.2 ml/kg/h 0.4 mg/kg/h
The doses listed in the table should be considered as a guideline for pediatric use. Individual adjustments may be necessary. In pediatric patients with high body weight, a gradual dose reduction is often required, based on ideal body weight. The volume for a single caudal epidural block and for epidural bolus doses must not exceed 25 ml for any patient. Reference textbooks should be consulted regarding factors affecting specific block techniques and individual patient requirements.
Peripheral nerve blocks: Infants and children from 1 to 12 years inclusive:

Doses for peripheral block in infants and children provide guidance for use in children without serious diseases. More conservative doses and careful monitoring are recommended for children with serious diseases.
The use of ropivacaine in premature infants has not been documented.

Method of administration
For perineural and epidural use.
To avoid intravascular administration, careful aspiration is recommended before and during injection. The patient's vital parameters must be closely monitored during injection. If signs of toxicity occur, administration must be immediately discontinued.

In most patients, a single caudal epidural injection of 2 mg/ml ropivacaine below the T12 level provides adequate postoperative analgesia when a dose of 2 mg/kg in a volume of 1 ml/kg is used. The volume of caudal epidural injection can be adjusted to achieve a different sensory block distribution, as indicated in reference texts. In children above 4 years of age, doses up to 3 mg/kg have been evaluated using a ropivacaine concentration of 3 mg/ml. However, at this concentration, a higher incidence of motor block is observed.

Gradual administration of the calculated dose of local anesthetic is recommended, regardless of the route of administration.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Precipitation may occur in alkaline solutions, as ropivacaine has poor solubility at pH > 6.0.

Remove the overwrap immediately before administration.
Ropivacaine hydrochloride Altan Pharma is preservative-free and for single use only. Any residual solution must be discarded.
Before administration, the solution should be inspected visually: do not use unless the solution is clear, colourless, and the container is undamaged.
The intact primary container must not be resterilized.

Ropivacaine hydrochloride Altan Pharma infusion solution in infusion bags is chemically and physically compatible with the following medicinal products:

Concentration of ROPIVACAINE: 1–2 mg/ml
Additive Concentration*
Fentanyl citrate 1–10 micrograms/ml
Sufentanil citrate 0.4–4 micrograms/ml
Morphine sulfate 20–100 micrograms/ml
Clonidine hydrochloride 5–50 micrograms/ml
* The concentration ranges indicated in the table are broader than those used in clinical practice. Epidural infusions of Ropivacaine hydrochloride Altan Pharma/sufentanil citrate, Ropivacaine hydrochloride Altan Pharma/morphine sulfate, and Ropivacaine hydrochloride Altan Pharma/clonidine hydrochloride have not been evaluated in clinical studies.

The mixtures are chemically and physically stable for 30 days at a temperature between 20 and 30°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C.

Other pack sizes:
Ropivacaine hydrochloride Altan 2 mg/ml injectable solution: 10 ml vials
Ropivacaine hydrochloride Altan 7.5 mg/ml injectable solution: 10 ml vials
Ropivacaine hydrochloride Altan 10 mg/ml injectable solution: 10 ml vials