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Pedea (ibuprofen) – Package leaflet - C01EB16

Updated on site: 09-Oct-2017

Medication namePedea
ATC CodeC01EB16
Substanceibuprofen
ManufacturerOrphan Europe S.A.R.L.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pedea 5mg/ml solution for injection

Ibuprofen

Read all of this leaflet carefully before this medicine is administered to your baby.

-Keep this leaflet. You may need to read it again.

-If you have further questions, please ask your doctor or your pharmacist.

-This medicine has been prescribed for your baby. Do not pass it on to others. It may harm them, even if their symptoms are the same as your baby’s.

-If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

1.What Pedea is and what it is used for

2.Before Pedea is administered to your baby

3.How Pedea is used

4.Possible side effects

5.How to store Pedea

6.Further information

1.WHAT PEDEA IS AND WHAT IT IS USED FOR

While a baby is inside its mother’s womb it does not need to use its lungs. An unborn baby has 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 starts using its lungs theductus arteriosus normally closes. However, in some cases this does not happen. The medical term for this condition is ‘patentductus arteriosus’, i.e. an open ductus arteriosus. This can cause heart problems in your baby. This condition is much more frequent in premature newborn than in full-term newborn infants.

Pedea, when given to your baby, can help to close the ductus arteriosus.

The active substance in P edea production of prostaglandin, a arteriosus open.

i s i buprofen.Pedea closes theductus arteriosus by i nhibiting t he na turally oc curring c hemical i n t he body wkeepshich t he ductus

2.BEFORE PEDEA IS ADMINISTERED TO YOUR BABY

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professionals.

Do not use Pedea

-if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea;

-if your baby has a life-threatening infection which has not been treated;

-if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines;

-if your baby hasa decrease of blood cells called platelets (thrombocytopenia) or otherproblems with their blood clotting;

-if your baby has kidney problems;

-if your baby has other problems with their heart which require theductus arteriosus to remain open so that adequate circulation of the blood is maintained;

-if your baby has or is suspected to havecertain problems with their intestines (a condition called necrotising enterocolitis);

Take special care with Pedea

-Before treatment with Pedea, your baby’s heart will be examined to confirm that the ductus arteriosus is open.

-Pedea should not be given in the first 6 hours of life.

-If your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes.

-If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby’s condition.

-Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.

-Ibuprofen may reduce the ability of your baby’s blood to clot. Your baby should therefore be watched for signs of prolonged bleeding.

-Your baby may develop some bleeding from the intestines and the kidneys. To detect this, your baby’s stools and urine may be tested to determine if there is any blood present in them.

-Pedea may reduce the amount of urine your baby passes. If this is significant, your baby’s treatment may be stopped until the volume of urine returns to normal.

-Pedea may be less effective in very premature babies less than 27 weeks of gestational age.

Using other medicines

Please tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Certain medicines, if given together with Pedea, may cause side effects. These are detailed below:

-your baby may have problems passing urine and may have been prescribed diuretics. Ibuprofen may reduce the effect of these medicines.

-your baby may be given anticoagulants (medicine preventing blood clotting). Ibuprofen may increase the anti-clotting effect of this product.

-your baby may be given nitric oxide to improve blood oxygenation. Ibuprofen may increase the risk of bleeding.

-your baby may be given corticosteroids to prevent inflammation. Ibuprofen may increase the risk of bleeding in the stomach and intestines.

-your baby may be given aminosides (one family of antibiotics) to treat infection. Ibuprofen may increase blood concentrations and thus increase the risk of toxicity on kidney and ear

Important information about some of the ingredients of Pedea

This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodium- free’.

3.HOW PEDEA IS USED

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.

A course of therapy is defined as three intravenous injections of Pedea given at 24hour intervals. The dose to be administered will be calculated from the weight of your baby. It is 10mg/kg for the first administration and 5 mg/kg for the second and the third administrations.

This calculated amount will be given by infusion in a vein over a period of 15 minutes.

If af ter this f irst c ourse o f t reatment, theductus arteriosus is no t c losed o r r-opens, y our ba by’s doctor may decide to give a second course of treatment.

If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.

4.POSSIBLE SIDE EFFECTS

Like all medicines, Pedea can cause side effects, although not everybody gets them. However, it is difficult t o di stinguish them f rom f requent c omplications oc curring i n p remature babies and complications due to the disease.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data)

Very common:

-Decrease in the number of platelets in the blood (thrombocytopenia),

-Decrease in white blood cells called neutrophils (neutropenia),

-Increase in creatinine level in the blood,

-Decrease in sodium level in the blood,

-Breathing problems (bronchopulmonary dysplasia),

Common:

-Bleeding i nside t he s kull ( intraventricular ha emorrhage) a nd b rain i njury ( periventricular leukomalacia),

-Bleeding in the lung,

-Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis),

-Reduced volume of urine passed, blood in the urine, fluid retention

Uncommon:

-Acute failure of the kidney’s functions

-Bleeding in the intestine

-Below normal oxygen content in the arterial blood (hypoxemia)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby’s doctor or your pharmacist.

5.HOW TO STORE PEDEA

Keep out of reach and sight of children.

Do not use Pedea after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After opening, Pedea should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Pedea contains

-The a ctive substance is ibuprofen. E ach m l co ntainsmg5 i buprofen. E ach 2 m l a mpoule contains 10 mg ibuprofen.

-The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.

What Pedea looks like and contents of the pack

Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution. Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.

Marketing Authorisation Holder

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F- 92800 Puteaux

France

Manufacturer

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

France

or

Orphan Europe SARL Eco River Parc

30, rue des Peupliers F-92000 Nanterre France

For an y i nformation ab out t his m edicine, p lease c ontact t he l ocal r epresentative o f t he M arketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

Orphan Europe Benelux

Orphan Europe AB

Koning Albert I laan 48 bus 3

Isafjordsgatan 30C, plan 3

BE-1780 Wemmel (Brussels)

S-164 40 Kista

Tél/Tel: +32 2 46101 36

Švedija

 

Tel: + 46 8 545 80 230

България

Luxembourg/Luxemburg

Orphan Europe (Germany) GmbH

Orphan Europe Benelux

Eberhard-Finckh-Straße 55

Koning Albert I laan 48 bus 3

D-89075 Ulm

BE-1780 Wemmel(Brussels)

Германия

Belgique/Belgien

Tel: +49 731 140 554 0

Tél/Tel: +32 2 46101 36

Česká republika

Orphan Europe (Germany) GmbH Eberhard-Finckh-Straße 55

D-89075 Ulm Německo

Tel: +49 731 140 554 0

Danmark

Orphan Europe AB

Isafjordsgatan 30C, plan 3

S-164 40 Kista

Sverige

Tlf : +46 8 545 80 230

Deutschland

Orphan Europe (Germany) GmbH

Eberhard-Finckh-Straße 55

D-89075 Ulm

Tel: +49 731 140 554 0

Eesti

Orphan Europe AB

Isafjordsgatan 30C, plan 3

S-164 40 Kista

Rootsi

Tel: + 46 8 545 80 230

Ελλάδα

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

Γαλλία

Τηλ: +33 1 47 73 64 58

España

Orphan Europe, S.L.

C/ Isla de la Palma, 37, 2a planta

E-28700 San Sebastián de los Reyes, Madrid Tel: + 34 91 659 28 90

France

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

Tél: +33 (0)1 47 73 64 58

Magyarország

Orphan Europe (Germany) GmbH

Eberhard-Finckh-Straße 55

D-89075 Ulm

Németország

Tel: +49 731 140 554 0

Malta

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

Franza

Tel: +33 1 47 73 64 58

Nederland

Orphan Europe Benelux

Koning Albert I Iaan 48 bus 3

BE-1780 Wemmel (Brussels)

België

Tel: +32 2 46101 36

Norge

Orphan Europe AB

Isafjordsgatan 30C, plan 3

S-164 40 Kista

Sverige

Tlf : +46 8 545 80 230

Österreich

Orphan Europe (Germany) GmbH Eberhard-Finckh-Straße 55 D-89075 Ulm

Deutschland

Tel: +49 731 140 554 0

Polska

Orphan Europe (Germany) GmbH

Eberhard-Finckh-Straße 55

D-89075 Ulm

Niemcy

Tel: +49 731 140 554 0

Portugal

Orphan Europe, S.L.

C/ Isla de la Palma, 37, 2a planta

E-28700 San Sebastián de los Reyes, Madrid Espanha

Tel: +34 91 659 28 90

Hrvatska

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

Francuska

Tél: +33 (0)1 47 73 64 58

Ireland

Orphan Europe (UK) Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT – UK United Kingdom

Tel: +44 1491 414333

Ísland

Orphan Europe AB Isafjordsgatan 30C, plan 3 S-164 40 Kista

Svíþjóð

Simi:+46 8 545 80 230

Italia

Orphan Europe (Italy) Srl

Via Marostica, 1

I-20146 Milano

Tel: +39 02 487 87 173

Κύπρος

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F – 92800 Puteaux

Γαλλία Τηλ : +33 1 47 73 64 58

România

Orphan Europe (Germany) GmbH

Eberhard-Finckh-Straße 55

D-89075 Ulm

Germania

Tel: +49 731 140 554 0

Slovenija

Orphan Europe (Germany) GmbH

Eberhard-Finckh-Straße 55

D-89075 Ulm

Nemčija

Tel: +49 731 140 554 0

Slovenská republika

Orphan Europe (Germany) GmbH Eberhard-Finckh-Straße 55

D-89075 Ulm Nemecko

Tel: +49 731 140 554 0

Suomi/Finland

Orphan Europe AB Isafjordsgatan 30C, plan 3 S-164 40 Kista

Sverige

Puh/Tel : +46 8 545 80 230

Sverige

Orphan Europe AB Isafjordsgatan 30C, plan 3 S-164 40 Kista

Tel : +46 8 545 80 230

Latvija

Orphan Europe AB Isafjordsgatan 30C, plan 3 S-164 40 Kista

Zviedrija

Tel: + 46 8 545 80 230

This leaflet was last approved in

United Kingdom

Orphan Europe (UK) Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT - UK Tel: +44 (0)1491 414333

Detailed information o n this m edicine i s av ailable o n t he E uropean m edicines A gency w ebsite: http://emea.europa.eu

The following information is intended for medical or healthcare professionals only:

As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.

Posology and method of administration (see also section 3)

For intravenous use only. Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.

A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals. The ibuprofen dose is adjusted to the body weight as follows:

-1st injection: 10 mg/kg,

-2nd and 3rd injections: 5 mg/kg.

If the ductus arteriosus does not close 48 hours after the last injection or if it re -opens, a second course of 3 doses, as above, may be given.

If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.

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

Method of administration:

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

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

The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered. A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day.

Incompatibilities

Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution. Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.

When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.

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

In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.

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