Ropivacaine bioq

Package leaflet: Information for the patient

Ropivacaine BioQ, 2 mg/ml, infusion solution in a delivery system
ropivacaini hydrochloridum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet

1. What Ropivacaine BioQ is and what it is used for
2. Important information before using Ropivacaine BioQ
3. How to use Ropivacaine BioQ
4. Possible side effects
5. How to store Ropivacaine BioQ
6. Contents of the pack and other information

1. What Ropivacaine BioQ is and what it is used for

The name of the medicine is Ropivacaine BioQ, 2 mg/ml, infusion solution in a delivery system. It contains
the active substance called ropivacaine hydrochloride, which belongs to a group of medicines known as
local anaesthetics.
Ropivacaine BioQ is used in adults for the treatment of acute pain. It causes anaesthesia of
various parts of the body, for example after a surgical procedure.

2. Important information before using Ropivacaine BioQ

When not to use Ropivacaine BioQ

• if the patient is allergic to ropivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to any other local anaesthetic medicines from the same group (e.g. lidocaine or bupivacaine);
• if administered into a blood vessel, spinal canal, joint, or cervix for regional anaesthesia or for pain relief during labour.

If the patient is unsure whether the above warnings apply, they should consult their doctor before using Ropivacaine BioQ.

Warnings and precautions

Before starting treatment with Ropivacaine BioQ, discuss this with a doctor or nurse, especially if:

• the patient has heart, liver, or kidney disease;
• the patient or a family member suffers from porphyria, a rare blood pigment disorder; inform the doctor, as another medicine may need to be used;
• the patient suffers from other diseases or medical conditions.

Ropivacaine BioQ and other medicines

Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. Ropivacaine BioQ may affect the action of certain other medicines, and some medicines may in turn affect the action of Ropivacaine BioQ.

In particular, inform the doctor if the patient is taking the following medicines:

• other local anaesthetics;
• strong painkillers such as morphine or codeine;
• medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine or mexiletine.

The doctor must be aware of these medicines in order to assess whether Ropivacaine BioQ can be administered to the patient.

Also inform the doctor if the patient is taking any of the following medicines:

• medicines used to treat depression (e.g. fluvoxamine);
• antibiotics used to treat bacterial infections (e.g. enoxacin).

This is because elimination of Ropivacaine BioQ from the body may be prolonged when these medicines are taken.

If the patient is taking any of these medicines, prolonged use of Ropivacaine BioQ should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

It is not known whether ropivacaine hydrochloride passes into human milk.

As a precautionary measure, it is recommended to avoid using Ropivacaine BioQ during pregnancy.

During treatment with Ropivacaine BioQ, breastfeeding should be temporarily discontinued. During this time, breast milk should be expressed and discarded.

Driving and operating machinery

Ropivacaine BioQ may cause drowsiness and slowed reactions. After receiving Ropivacaine BioQ, the patient should not drive or operate machinery until the following day.

Ropivacaine BioQ contains sodium

This medicine contains 3.4 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the adult diet.

3. How to use Ropivacaine BioQ

Ropivacaine BioQ will be administered to the patient by a doctor.
Ropivacaine BioQ will be given as an intravenous infusion for postoperative pain relief. It will be administered as a nerve block (perineural) or into the surgical wound (wound infiltration). For wound infiltration analgesia, the doctor will place a catheter into the wound during the surgical procedure, which can be connected to the Ropivacaine ReadyfusOR infusion pump (also referred to as the “infusion device”).

The infusion pump is a delivery device containing the infusion solution and equipped with a permanently attached tubing with a connector that can be attached to the catheter placed in the wound or to a port near the nerve.

The doctor or nurse will activate the infusion device and connect it to the catheter/port. The patient does not need to do anything with the infusion device.

Once activated, the infusion device will continuously deliver a fixed dose of the active substance sufficient to relieve pain.

Warnings

• Avoid bending the tubing, as this may result in incorrect infusion rate.
• The tubing should not be tightly wrapped.
• The infusion device must not be used if any part is damaged or cracked, or if the connector on the tubing appears broken, cracked, or otherwise damaged.
• The flow restrictor (transparent rectangle) must remain adhered to the patient's skin. Removing the tape or loss of contact between the flow restrictor and the patient's skin may result in incorrect infusion rate.
• Do not apply warm or cold compresses to the flow restrictor, as this may affect the infusion rate.
• If the infusion device accidentally disconnects from the catheter/port during administration, do not reconnect it, as this may cause infection. Contact the doctor or nurse and inform them that the infusion device has become disconnected.
• The patient should not bathe or take a shower with the infusion device in place or while the catheter/port is still in position, as this may lead to infection.
• The patient should not disturb the wound dressing or the catheter/port, as this may lead to infection.

Overdose of Ropivacaine BioQ
Because the infusion device continuously delivers a fixed dose of the active substance, serious adverse effects due to overdose of Ropivacaine BioQ are very unlikely.
If the dose is too high, the patient will require special treatment—the attending physician is trained to manage such situations. The first signs of overdose with Ropivacaine BioQ are usually:

• dizziness or a feeling of emptiness in the head;
• numbness of the lips and area around the mouth;
• tongue numbness;
• hearing disturbances;
• visual disturbances.

To minimize the risk of serious adverse effects, the doctor will immediately stop administration of Ropivacaine BioQ if any of these symptoms occur. This means that if any of these symptoms appear in the patient, or if the patient suspects having received more than the recommended dose of Ropivacaine BioQ, the patient should immediately inform the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Important adverse reactions to be aware of
Sudden, life-threatening allergic reactions (such as anaphylaxis) are rare and occur in 1 to
10 patients per 10,000. Possible symptoms include: sudden onset of rash, itching, or raised,
itchy rash (urticaria); swelling of the face, lips, tongue, or other body parts; and shortness of breath,
wheezing, or difficulty breathing. If the patient notices that Ropivacaine BioQ is causing an
allergic reaction, they should inform their doctor immediately.
Other possible adverse reactions
Very common (may affect more than 1 in 10 patients)

• Low blood pressure (hypotension) which may cause dizziness or a feeling of emptiness in the head.
• Nausea.

Common (may affect up to 1 in 10 patients)

• Tingling.
• Dizziness.
• Headache.
• Slow or fast heartbeat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• Nausea (vomiting).
• Difficulty passing urine.
• High temperature (fever) and shivering (chills).
• Back pain.

Uncommon (may affect up to 1 in 100 patients)

• Anxiety.
• Loss of skin sensation or sensitivity.
• Fainting.
• Breathing difficulties.
• Decreased body temperature (hypothermia).
• Some symptoms may occur if the patient receives a higher than recommended dose of Ropivacaine BioQ (see also “Use of a higher than recommended dose of Ropivacaine BioQ” above). These include: seizures, dizziness or a feeling of emptiness in the head, numbness of the lips and area around the mouth, numbness of the tongue, hearing problems, vision problems, speech difficulties, muscle stiffness, and tremor.

Rare (may affect up to 1 in 1,000 patients)

• Heart attack (cardiac arrest).
• Irregular heartbeat (arrhythmias).

Unknown (frequency cannot be estimated from the available data)

• Involuntary muscle movements (dyskinesia).

Possible adverse reactions observed with other local anaesthetics, which may also be caused by
Ropivacaine BioQ
Rare (may affect up to 1 in 1,000 patients)

• Nerve damage which may lead to permanent problems.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl . Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ropivacaine BioQ

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: “Expiry”. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Ropivacaine BioQ is usually stored by a doctor or hospital, and they are responsible for the product's quality. The solution should be inspected visually before use. It should only be used if it is clear and practically free from particles, and if the container is undamaged.
The doctor or hospital is also responsible for the proper disposal of any unused Ropivacaine BioQ.

6. Contents of the package and other information

What Ropivacaine BioQ contains

• The active substance is ropivacaine hydrochloride (Ropivacaini hydrochloridum). One ml contains 2 mg of ropivacaine hydrochloride.
• The other components are: sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), and water for injections.

What Ropivacaine BioQ looks like and contents of the pack
Ropivacaine BioQ is a clear, colourless solution for infusion.
The Ropivacaine ReadyfusOR infusion pump is an orange cylinder with black caps on both ends. It is designed to hold a transparent, collapsible polyethylene container made of high-density polyethylene (HDPE), containing 250 ml of ropivacaine hydrochloride solution for infusion. A non-latex administration tube with connector (Luer Lock type) is permanently attached.
Each pack contains one Ropivacaine ReadyfusOR infusion pump and a carrying case. Also available are kits which additionally include a sterile, non-latex fenestrated wound catheter (6.5 or 15 cm in length) for placement in the wound.

Marketing Authorisation Holder and Manufacturer
BioQ Pharma B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands

Manufacturer
BioQ Pharma B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands
Geryon Pharma Ltd
18 Owen Drive
Liverpool L24 1YL
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Ropivacain ReadyfusOR 2 mg/ml Infusionslösung im Applikationssystem
Belgium Ropivacaine Readyfusor 2 mg/ml solution pour perfusion en système d’administration
Croatia Ropivakain BioQ Pharma 2 mg/ml otopina za infuziju u sustavu za primjenu
Czech Republic Ropivacaine BioQ 2 mg/ml infuzní roztok v aplikačním systému
Denmark Ropivacaine BioQ 2 mg/ml infusionsvæske, opløsning i administrationssystem
Finland Ropivacaine BioQ 2 mg/ml infuusioneste, liuos, antovälineistö
France Ropivacaine Readyfusor 2 mg/ml solution pour perfusion en système d’administration
Greece Ropivacaine/ReadyfusOR 2 mg/ml διάλυμα για έγχυση σε σύστημα χορήγησης
Spain Ropivacaína Readyfusor 2 mg/ml solución para perfusión en sistema de administración
Luxembourg Ropivacaine ReadyfusOR 2 mg/ml solution pour perfusion en système d'administration
Norway Ropivacaine BioQ 2 mg/ml infusjonsvæske, oppløsning i administreringssystem
Poland Ropivacaine BioQ, 2 mg/ml, roztwór do infuzji w zestawie do podawania
Portugal Ropivacaína BioQ 2 mg/ml solução para perfusão em sistema de administração
Slovakia Ropivacaine Readyfusor 2 mg/ml infúzny roztok v aplikačnom systéme
Sweden Ropivacaine BioQ 2 mg/ml infusionsvätska, lösning i administreringssats
United Kingdom Ropivacaine 2 mg/ml solution for infusion in administration system (Northern Ireland)
Italy Ropivacaina BioQ ReadyfusOR 2 mg/ml soluzione per infusione in sistema di somministrazione

Information intended exclusively for medical professionals:

The medicinal product Ropivacaine BioQ does not contain preservatives and is intended for single use only.
The solution should be inspected visually before use. Only use if it is clear, free from particles, and the container is undamaged.

Infusion pump Ropivacaine ReadyfusOR
The infusion pump Ropivacaine ReadyfusOR (hereinafter also referred to as "the dispenser") is a non-electric drug delivery device designed for wound-site administration.
The dispenser contains an accordion bottle holding 250 ml of ropivacaine hydrochloride monohydrate infusion solution. A permanently attached tubing with a connector (Luer Lock type) is fixed to it.
The tubing, connector, and sterile fenestrated catheter (if included in the set, see section 6) are latex-free.

For wound infiltration anesthesia, the fenestrated catheter should be placed within the wound during surgery, according to clinical guidelines specific to the surgical site. The catheter (if included in the set) ensures even distribution of the medicinal product Ropivacaine BioQ along the wound length with 360° coverage.

The fluid volume indicator consists of green arrows indicating the amount of remaining fluid to be administered.

Instructions for use

1. Check the dispenser, flow restrictor, and tubing for damage or tampering.

□ Check whether the orange seal on the activation cap has been broken.

□ Check whether the orange seal on the tubing cap has been broken.
If any damage is detected or if either seal has been removed or broken, do not use this dispenser.

2. Start fluid administration by turning the activation cap clockwise until the arrow on the orange seal aligns approximately with the arrow on the label. Considerable force is required. This is normal and prevents accidental activation. Internal components of the dispenser will move during activation.
   Activation of the dispenser is indicated by the appearance of green arrows in the viewing window, indicating the amount of remaining fluid. Fluid flow will be visible above the filter within a few seconds, but flow will remain paused until the vented cap is removed.

Unscrew the tubing cap to break the seal.
Ensure the clamp is not closed, and confirm that fluid administration has started by observing fluid flow through the tubing and flow restrictor. After 1–2 minutes, fluid will begin to drip very slowly from the end of the tubing.

4. Connect the dispenser tubing to the patient's port/catheter. Do not connect to intravenous lines.

5. Secure the flow restrictor (transparent rectangle) to the patient's skin with tape. Apply the tape directly over the flow restrictor as shown in the illustration, away from the wound, avoiding traction on the tubing and displacement of the catheter/port. Finally, secure the tubing and connectors with tape.

Warning: The flow restrictor must remain taped and in contact with the patient's skin. Loss of contact may result in incorrect fluid administration rate.

6. Place the dispenser into the provided

carrying case. The case can be worn by the patient over the shoulder or around the waist like a belt.
To prevent dislodgement of the catheter/port, it is recommended that the case with the dispenser remains attached to the patient's body at all times.

7. Fluid administration can be monitored through the dispenser window. The dispenser delivers approximately 5 ml of fluid per hour.

The green arrows in the window indicate the amount of fluid remaining in the dispenser (in ml).
The position of the fluid volume indicator arrows should be monitored periodically for signs of excessive flow rate. For information on symptoms of overdose, see "Administration of a higher than recommended dose of Ropivacaine BioQ" (section 3).

8. Administration is complete when the unit dose container is empty, indicated by the green arrows showing zero in the viewing window.
9. After completion of administration, remove the dispenser from the patient.
10. After use, dispose of the empty dispenser, including any unused solution residue, according to local regulatory requirements.

Warnings

• The dispenser is intended for single use only. Do not reuse or reconnect the dispenser.

• The dispenser must not be autoclaved. The fluid pathway within the delivery system has been sterilized.

• Do not connect the dispenser to intravenous lines.

• Avoid bending the tubing, as this may result in incorrect fluid administration rate.

• Do not tightly wrap the tubing.

• Do not use the dispenser if any part is damaged or cracked, or if the connector on the tubing appears broken, cracked, or otherwise damaged.

• The flow restrictor (transparent rectangle) must remain taped to the patient's skin. Removing the tape or loss of contact between the flow restrictor and the patient's skin may result in incorrect fluid administration rate.

• Do not apply warm or cold compresses to the flow restrictor, as this may affect the fluid administration rate.

• If the dispenser is accidentally disconnected from the catheter/port during drug administration, do not reconnect it, as this may cause infection.

• The patient should not bathe or shower with the dispenser in place or while the catheter/port remains in situ, as this may lead to infection.

• The patient should not disturb wound dressings or the catheter/port, as this may lead to infection.