Label: Information for the User

Ketorolaco Kabi 30 mg/ml Injectable Solution EFG

ketorolaco trometamol

Ketorolaco Kabi contains a medicine called ketorolaco trometamol. This is a "non-steroidal anti-inflammatory drug" (NSAID).

Ketorolaco is used in the hospital to relieve pain after operations in patients 16 years of age or older. Ketorolaco may reduce pain, swelling, redness, and heat (inflammation).

Do not receive ketorolaco if you are allergic (hypersensitive) to:

Do not give ketorolaco if:

Do not receive ketorolaco if you are in any of the situations mentioned above. If you are unsure, inform your doctor or nurse before ketorolaco is administered to you.

Ketorolaco contains alcohol and is therefore not suitable for epidural or intrathecal use (injection into the spinal column).

Warnings and precautions

Severe skin reactions have been reported with the use of NSAIDs, which manifest as red patches, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The highest risk of severe skin reactions is in the first weeks of treatment, but they may start to develop several months after administration of the medication (see section 4). If you have developed any severe skin reaction after using Ketorolaco Kabi, do not restart treatment at any time. If you develop a skin rash or these symptoms, discontinue treatment with Ketorolaco Kabi and contact your doctor or seek medical attention immediately.

Speak with your doctor or nurse before receiving ketorolaco. If you have heart problems, a previous stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss your treatment with your doctor or nurse.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using Ketorolaco Kabi, as Ketorolaco Kabi may sometimes worsen the healing of intestinal wounds after surgery.

Consult with your doctor or nurse before receiving ketorolaco if:

If you have any of the above conditions, or if you are unsure, speak with your doctor or nurse before receiving ketorolaco.

Use in children and adolescents

Ketorolaco is not recommended for use in children under 16 years of age.

Use of other medications with ketorolaco

Inform your doctor, nurse, or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription.

Particularly, inform your doctor or nurse if you are taking any of the following medications before receiving ketorolaco:

If you are taking any of the medications mentioned above,do not receive ketorolaco.

Inform your doctor or nurse if you are taking:

If you are in any of the situations mentioned above, or if you are unsure, speak with your doctor or nurse before receiving ketorolaco.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

Do not take ketorolaco if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take ketorolaco during the first 6 months of pregnancy unless it is strictly necessary and your doctor tells you to. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, ketorolaco may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for a period of more than a few days, your doctor may recommend additional checks.

Ketorolaco may make it more difficult to become pregnant. Inform your doctor if you plan to become pregnant or have difficulty becoming pregnant.

Do not receive ketorolaco if you are pregnant, in labor, or breastfeeding.

Driving and operating machinery

Ketorolaco may cause drowsiness, dizziness, blurred vision, balance problems, or difficulty sleeping. Speak with your doctor if you experience any of these and do not drive or operate tools or machinery.

Ketorolaco Kabi contains sodium and alcohol

This medication contains less than 23 mg of sodium (1mmol) per 1 ml ampoule, which is essentially "sodium-free".

This medication contains 100 mg of alcohol (ethanol) per vial, which is equivalent to 100 mg/ml (9.9% v/v). The amount contained in 1 ml of this medication is equivalent to less than 2.5 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medication will not have noticeable effects.

Ketorolaco will be administered by a doctor or nurse. It will be given by injection into a muscle (such as in your arm) or into a vein.

Medicines like ketorolaco may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with higher doses and prolonged treatment (over a longer period).

The maximum duration of treatment should be two days.

Use in children and adolescents

Ketorolaco is not recommended for use in children under 16 years.

Use in adults

Use in patients over 65 years, or with kidney problems or weighing less than 50 kg

If you have more questions about the use of this medicine, consult your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Medicines like ketorolaco may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke.

Severe side effects

Inform your doctor or nurse IMMEDIATELY if any of the following occur. You may need urgent medical treatment:

Severe stomach or intestinal problems, the signs include:

• Bleeding from the stomach, such as vomiting blood, or fragments that look like coffee grounds.
• Rectal bleeding (anus), such as black and sticky stools (diarrhea) or diarrhea with blood.
• Ulcers or holes that form in the stomach or intestine. This may be seen as stomach discomfort with stomach pain, fever, feeling or being sick.
• Problems with your pancreas, such as severe stomach pain that extends to your back.
• Worsening of ulcerative colitis or Crohn's disease, such as pain, diarrhea, vomiting, and weight loss.

Allergic reactions, the signs include:

• Sudden swelling of your throat, face, hands, or feet.
• Difficulty breathing, chest tightness.
• Rashes on your skin, blisters, or itching.

Severe skin eruptions, the signs include:

• A severe rash that develops rapidly, with blisters or skin peeling and possibly blisters in your mouth, throat, or eyes. You may have fever, headache, cough, and body aches at the same time.

Heart attack, the signs include:

• Chest pain that may extend to your neck and shoulders and down your left arm.

Stroke, the signs include:

• Muscle weakness and numbness. This may occur on one side of your body.
• A sudden change in your sense of smell, taste, hearing, or vision, confusion.

Meningitis, the signs include:

• Fever, feeling or being sick, neck stiffness, headache, sensitivity to bright light, and confusion (more likely in people with autoimmune diseases such as systemic lupus erythematosus).

Liver problems, the signs include:

• Yellowing of your skin or the white of your eyes (jaundice).
• Feeling tired, loss of appetite, feeling or being sick, pale stools (hepatitis), and problems (including hepatitis) that show up in blood tests.

Urinary problems, the signs include:

• A feeling of fullness and the need to urinate, but with difficulty emptying your bladder.

If you notice any of the severe side effects mentioned above, inform your doctor or nurse immediately.

Other side effects

Inform your doctor or nurse if you have any of the following symptoms:

Stomach and intestines

• Heartburn, indigestion, stomach pain, feeling or being sick, constipation, diarrhea, gas.
• Belching or feeling full.

Blood

• Bleeding from a wound after surgery or nasal bleeding.
• A swollen, blood-filled area.
• Problems with your blood, such as too much potassium or too little sodium.
• Problems with your blood, such as anemia, platelet deficiency, or changes in the number of white blood cells.

Mental health

• Difficulty sleeping or changes in your sleep patterns.
• Depression.
• Feeling anxious or nervous or extremely happy (euphoria).
• Seeing and possibly hearing things that don't really exist (hallucinations).
• Mental problems that may make you feel confused, restless, and agitated and lose contact with reality.

Nervous system

• Headache.
• Seizures or convulsions, feeling dizzy or lightheaded, or drowsiness.
• Feeling pins and needles or numbness in your hands and feet.
• Difficulty with memory or concentration.

Eyes and ears

• Changes in your vision, eye pain.
• Changes in your hearing, including ringing in your ears (tinnitus) and hearing loss.
• Dizziness that causes problems with your balance.

Heart and circulation

• Swelling of your hands, feet, or legs (edema). This may lead to chest pain, fatigue, shortness of breath (heart failure).
• A feeling of fluttering in your heart (palpitations), slow heartbeats, or high blood pressure.
• Problems with how your heart pumps blood around your body. The signs may include fatigue, shortness of breath, feeling faint.

Chest

• Difficulty breathing, including shortness of breath, wheezing, or coughing.
• Swelling of your lungs.

Skin and hair

• Sensitivity to light, rashes on your skin that include redness, hives, acne, and blisters on your body and face.
• Itching or sweating, pale skin, or redness of your face and neck (erythema).

Urinary system

• Blood in your urine or kidney problems.
• Urinating more frequently or less frequently.
• Pain in your side.

Other

• Pain at the injection site.
• Thirst, dry mouth, changes in taste, fever, weight gain or loss.
• General feeling of discomfort or feeling tired.
• Mouth pain.
• Muscle spasms, pain, or weakness.
• In women, problems getting pregnant.

If any of the side effects worsen, or if you notice any side effect not mentioned in this leaflet, inform your doctor or nurse.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's about possible side effects that don't appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or on the ampoule label after CAD. The expiration date is the last day of the month indicated.

Store the ampoules in the outer packaging to protect them from light.

Short-term storage at low temperatures (up to 3 weeks) is permitted down to -20°C.

Before administration, the product must be visually inspected. Do not use this medication if you observe particles.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE ?? of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Ketorolaco Kabi Composition:

• The active ingredient is ketorolac trometamol. Each 1 ml of liquid medication contains 30 mg (milligrams) of ketorolac trometamol.
• The other components are: ethanol (96 percent), sodium chloride, disodium edetate, sodium hydroxide or hydrochloric acid (1M solutions for pH adjustment), water for injectable preparations.

Product Appearance and Packaging Contents:

Ketorolaco Kabi is a transparent, slightly yellowish injectable solution. This injectable solution can be further diluted to attenuate it before administration.

Ketorolaco Kabi is supplied in glass ampoules containing 1 ml of solution, in packs of 5, 6, or 10.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

Marina 16-18

08005 Barcelona

Spain

Responsible for Manufacturing:

S.C. Rompharm Company S.R.L.

Str. Eroilor, no. 1A

075100, Otopeni, Ilfov County,

Romania

Last Review Date of this Leaflet: January 2024

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es“

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The following information is intended only for healthcare professionals:

Dosage and Administration.

Ketorolac is administered by intravenous or intramuscular injection.

Adults

The recommended initial dose of ketorolac is 10 mg, followed by a dose of 10 to 30 mg every 4 to 6 hours as needed. The total daily dose should not exceed 90 mg. The maximum duration of treatment should not exceed two days.

Elderly

The elderly have a higher risk of suffering from severe adverse reactions. The total daily dose should not exceed 60 mg (see section 4.4).

Pediatric population

Ketorolac is not recommended for use in children under 16 years.

Renal impairment

Ketorolac is contraindicated in moderate to severe renal impairment; and a reduced dose should be administered in patients with lesser degrees of renal impairment (not exceeding an IV or IM dose of 60 mg/day).

Incompatibilities

Ketorolac should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, pethidine hydrochloride, promethazine hydrochloride, or hydroxyzine hydrochloride, as precipitation of ketorolac may occur.

Ketorolac is compatible with sodium chloride 0.9%, glucose 5%, Ringer 5%, and Ringer lactate solutions. The compatibility of ketorolac with other medications is unknown.

Special Precautions for Storage

Keep the ampoules in the outer packaging to protect them from light.

Short-term storage at low temperatures (up to 3 weeks) is permitted down to -20°C.

Special Precautions for Disposal

No special instructions are available.

Any unused medication or waste should be disposed of in accordance with local requirements.