Ibuprofen Gen.Orph 5 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofeno Gen.Orph 5 mg/ml solution for injection

Ibuprofen

Read the entire leaflet carefully before you start taking this medicine, because 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.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Ibuprofeno Gen.Orph is and what it is used for
2. What you need to know before using Ibuprofeno Gen.Orph
3. How to use Ibuprofeno Gen.Orph
4. Possible adverse effects
5. How to store Ibuprofeno Gen.Orph
6. Contents of the pack and other information

1. What Ibuprofeno Gen.Orph is and what it is used for

While the baby is inside the mother's womb, the lungs are not needed. Fetuses have a blood vessel called the ductus arteriosus near the heart, which allows the baby's blood to bypass the lungs and circulate to the rest of the body.

When the baby is born and begins to use the lungs, the ductus arteriosus normally closes. However, in some cases, this does not happen. The medical term for this condition is "patent ductus arteriosus," meaning an open ductus arteriosus. This can cause heart problems in your baby. This condition is much more common in premature newborns than in those born at term.

Ibuprofeno Gen.Orph, when administered to the baby, can help close the ductus arteriosus.

The active substance in Ibuprofeno Gen.Orph is ibuprofen. Ibuprofeno Gen.Orph closes the ductus arteriosus by inhibiting the production of prostaglandin, a chemical substance naturally produced in the body that keeps the ductus arteriosus open.

2. What you need to know before starting Ibuprofeno Gen.Orph

Ibuprofeno Gen.Orph will only be administered to your baby in a neonatal intensive care unit by qualified healthcare professionals.

Do not use Ibuprofeno Gen.Orph

• if your baby is allergic (hypersensitive) to ibuprofen or to any of the other components of Ibuprofeno Gen.Orph;
• if your baby has a life-threatening infection that has not been treated;
• if your baby has bleeding, especially if the bleeding is inside the skull or in the intestines;
• if your baby has a decrease in blood cells called platelets (thrombocytopenia) or other blood clotting disorders;
• if your baby has kidney problems;
• if your baby has other heart problems that require the ductus arteriosus to remain open to maintain adequate blood circulation;
• if your baby has or is suspected of having certain intestinal problems (a condition called necrotizing enterocolitis).

Warnings and precautions

• Before starting treatment with Ibuprofeno Gen.Orph, a heart examination will be performed on your baby to confirm that the ductus arteriosus is open.
• Ibuprofeno Gen.Orph must not be administered within the first 6 hours of life.
• If liver disease is suspected in your baby, signs and symptoms of which include yellowing of the skin and eyes.
• If your baby already has an infection being treated, the doctor will only treat your baby with Ibuprofeno Gen.Orph after carefully evaluating your baby's condition.
• Healthcare staff must administer Ibuprofeno Gen.Orph to your baby with caution to avoid damage to the skin and surrounding tissues.
• Ibuprofen may reduce your baby's blood clotting ability. Therefore, your baby should be monitored for signs of prolonged bleeding.
• Your baby may develop some bleeding in the intestines and kidneys. To detect this, your baby's stools and urine may be tested to check for the presence of blood.
• Ibuprofeno Gen.Orph may reduce the amount of urine produced by your baby. If this reduction is significant, treatment may be interrupted until urine output returns to normal levels.
• Ibuprofeno Gen.Orph may be less effective in very premature babies under 27 weeks of gestational age.
• Serious skin reactions have been reported with treatment using Ibuprofeno Gen.Orph.
• Stop using Ibuprofeno Gen.Orph and contact a doctor immediately if any skin rash, lesions on mucous membranes, blisters, or other signs of allergy occur, as these may be early signs of a severe skin reaction. See section 4.

Use of Ibuprofeno Gen.Orph with other medicines

Inform your doctor or pharmacist if your baby is taking, has recently taken, or might need to take any other medicines.

Certain medicines, if administered together with Ibuprofeno Gen.Orph, may cause adverse reactions. These are listed below:

• your baby may have difficulty passing urine and may have been prescribed diuretics.
• Ibuprofen could reduce the effect of these medicines.
• your baby may be receiving anticoagulants (medicines that prevent blood from clotting). Ibuprofen may enhance the anticoagulant effect of these products.
• your baby may be receiving nitric oxide to improve blood oxygenation. Ibuprofen could increase the risk of bleeding.
• your baby may be receiving corticosteroids to prevent inflammation. Ibuprofen could increase the risk of gastrointestinal and intestinal bleeding.
• your baby may be receiving other NSAIDs: concomitant use of more than one NSAID should be avoided due to increased risk of adverse reactions.
• to treat an infection, your baby may be given aminoglycosides (a class of antibiotics). Ibuprofen may increase blood levels of these drugs, thereby increasing the risk of kidney and ear toxicity.

Ibuprofeno Gen.Orph contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 2 ml, i.e., essentially "sodium-free".

3. How to take Ibuprofen Gen.Orph

Your baby will only be administered Ibuprofen Gen.Orph by a qualified healthcare professional in a specialized neonatal intensive care unit.

A treatment cycle is defined as three intravenous injections of Ibuprofen Gen.Orph given at 24-hour intervals. The dose to be administered will be calculated based on your baby's weight: 10 mg/kg for the first dose and 5 mg/kg for the second and third doses.

The calculated amount will be given by infusion into a vein over a period of 15 minutes.

If, after this first treatment cycle, the ductus arteriosus remains open or reopens, your baby's doctor may decide to administer a second treatment cycle.

If the ductus arteriosus remains open after the second treatment cycle, surgery may then be considered.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

However, it is difficult to distinguish them from common complications occurring in premature babies and complications due to the underlying disease.

The possible adverse effects are listed below.

Very common (may affect more than 1 in 10 people)

• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells called neutrophils (neutropenia)
• Increased blood creatinine levels
• Decreased blood sodium levels
• Breathing problems (bronchopulmonary dysplasia)

Common (may affect up to 1 in 10 people)

• Bleeding inside the skull (intraventricular hemorrhage) and brain injury (periventricular leukomalacia)
• Pulmonary hemorrhage
• Intestinal perforation and intestinal tissue damage (necrotizing enterocolitis)
• Reduced urine volume, blood in the urine, fluid retention

Uncommon (may affect up to 1 in 100 people)

• Acute kidney failure
• Intestinal bleeding
• Arterial blood oxygen levels below normal (hypoxemia)

Frequency not known (cannot be estimated from available data)

• Stomach perforation
• Widespread scaly red rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Ibuprofeno Gen.Orph if you experience these symptoms and seek immediate medical attention. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno Gen.Orph

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Once opened, Ibuprofeno Gen.Orph should be administered immediately.

Do not use this medicine if you notice any visible signs of deterioration in the solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofeno Gen.Orph contains

• The active substance is ibuprofen. Each ml contains 5 mg of ibuprofen. Each 2 ml ampoule contains 10 mg of ibuprofen.
• The other components are trometamol, sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH) and water for injections. See section 2. Ibuprofeno Gen.Orph contains sodium.

What Ibuprofeno Gen.Orph looks like and contents of the pack

Ibuprofeno Gen.Orph 5 mg/ml injectable solution is a clear, colourless to pale yellow solution.

Ibuprofeno Gen.Orph 5 mg/ml injectable solution is available in packs of four 2 ml ampoules.

Marketing Authorization Holder

Gen.Orph

185 Bureaux de la Colline

92213 Saint Cloud Cedex

France

Manufacturer

Haupt Pharma

1 rue Comte de Sinard

26250 Livron-sur-Drôme

France

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Like all parenteral products, vials of Ibuprofeno Gen.Orph should be inspected visually for particulate matter and container integrity prior to use. The vials are intended for single use; any unused portion should be discarded.

Dosage and method of administration (see also section 3)

For intravenous use only. Treatment with Ibuprofeno Gen.Orph must only be performed in a neonatal intensive care unit under the supervision of an experienced neonatologist.

A treatment cycle is defined as three intravenous doses of Ibuprofeno Gen.Orph administered at 24-hour intervals.

The ibuprofen dose is adjusted according to body weight as follows:

• 1st injection: 10 mg/kg,
• 2nd and 3rd injection: 5 mg/kg.

If the ductus arteriosus has not closed within 48 hours after the last injection or if it reopens, a second cycle of three doses may be administered as described above.

If the condition persists after a second treatment cycle, surgical intervention for persistent patent ductus arteriosus may be required.

If manifest anuria or oliguria occurs after the first or second dose, the next dose should be postponed until urine output returns to normal levels.

Method of administration:

Ibuprofeno Gen.Orph should be administered as a short infusion over 15 minutes, preferably undiluted. To facilitate administration, an infusion pump may be used.

If necessary, the injection volume may be adjusted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection in a non-PVC bag. Any unused portion of the solution should be discarded.

The total volume of infused solution in premature newborns should take into account the total daily fluid intake. Typically, a maximum volume of 80 ml/kg/day should be respected during the first day of life; this volume may be gradually increased over the following 1–2 weeks (approximately 20 ml/kg of birth weight/day) up to a maximum of 180 ml/kg of birth weight/day.

Incompatibilities

Chlorhexidine must not be used to disinfect the vial neck, as it is incompatible with the Ibuprofeno Gen.Orph solution. Therefore, to perform aseptic preparation of the vial before use, 60% ethanol or 70% isopropyl alcohol is recommended.

To avoid any interaction with the Ibuprofeno Gen.Orph solution during disinfection of the vial neck with an antiseptic, the vial must be completely dry before opening.

This medicinal product must not be mixed with other medicinal products except with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection in a non-PVC bag.

To avoid any significant change in pH due to the presence of acidic drugs that may remain in the infusion line, the line should be flushed before and after administration of Ibuprofeno Gen.Orph with 1.5 to 2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection in a non-PVC bag.