IBUPROFENE 5 mg /Ml Инъекционный Раствор

Содержание инструкции

1. Ibuprofene Gen.Orph 5 mg/mL injectable solution
   1. What is Ibuprofene Gen.Orph and what is it used for
   2. What you need to know before giving Ibuprofene Gen.Orph
   3. How to take Ibuprofene Gen.Orph
   4. Possible side effects
   5. How to store Ibuprofene Gen.Orph
   6. Package Contents and Other Information

Ibuprofene Gen.Orph 5 mg/mL injectable solution

ibuprofene

Read this leaflet carefully before taking 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.
• 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 is Ibuprofene Gen.Orph and what it is used for
• 2. What you need to know before you take Ibuprofene Gen.Orph
• 3. How to take Ibuprofene Gen.Orph
• 4. Possible side effects
• 5. How to store Ibuprofene Gen.Orph
• 6. Contents of the pack and other information

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

When in the womb, the fetus does not need to use its lungs. The fetus has a blood vessel near the heart called the ductus arteriosus, which allows blood to bypass pulmonary circulation and circulate to the rest of the body.
At birth, the newborn begins to use its lungs and, as a rule, the ductus arteriosus closes. In some cases, however, this does not happen. The medical term for this condition is “patent ductus arteriosus”, that is, an open ductus arteriosus. This condition, which can cause heart problems in the baby, is much more common in premature babies than in full-term babies.
Ibuprofene Gen.Orph, administered to your baby, can help close the ductus arteriosus.
The active ingredient contained in Ibuprofene Gen.Orph is ibuprofen. Ibuprofene Gen.Orph closes the ductus arteriosus by inhibiting the production of prostaglandin, a chemical substance naturally produced by the body that keeps the ductus arteriosus open.

2. What you need to know before giving Ibuprofene Gen.Orph

Ibuprofene Gen.Orph will be administered to your baby exclusively by a qualified healthcare professional in a specialized neonatal intensive care unit.

Do not use Ibuprofene Gen.Orph.

• if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuprofene Gen.Orph;
• if your baby has an infection, life-threatening, that has not been treated;
• if your baby has ongoing bleeding, particularly intracranial (inside the skull) and intestinal bleeding;
• if your baby has a reduced number of blood cells called platelets (thrombocytopenia) or other blood coagulation problems;
• if your baby has kidney problems;
• if your baby has other heart problems where the ductus arteriosus needs to remain open to maintain adequate blood circulation;
• if your baby has or is suspected to have certain intestinal problems (a disease called necrotizing enterocolitis).

Warnings and precautions

• Before treatment with Ibuprofene Gen.Orph, your baby will undergo a heart examination to ensure that the ductus arteriosus is open.
• Ibuprofene Gen.Orph should not be administered within the first 6 hours of life.
• If you suspect that your baby has a liver disease, whose signs and symptoms include yellowish discoloration of the skin and eyes.
• If your baby has an infection for which they are being treated, the doctor will administer Ibuprofene Gen.Orph only after carefully assessing the baby's condition.
• Ibuprofene Gen.Orph must be administered with caution by the healthcare professional to avoid damage to the skin and surrounding tissues.
• Since ibuprofen can reduce the ability of blood to clot, the baby should be monitored for any signs of prolonged bleeding.
• Intestinal and kidney bleeding may occur in the baby; for this reason, tests on stool and urine may be performed to determine the presence of blood.
• Ibuprofene Gen.Orph may reduce the amount of urine eliminated by the baby. If this occurs to a significant extent, the baby's treatment may be interrupted until the urine volume returns to normal.
• The effectiveness of Ibuprofene Gen.Orph may be lower in very premature newborns with a gestational age of less than 27 weeks.
• Serious skin reactions have been reported in association with treatment with Ibuprofene Gen.Orph. Stop treatment with Ibuprofene Gen.Orph and consult your doctor immediately if rash, mucous membrane lesions, blisters or other signs of allergy occur, as they may be the first signs of a very serious skin reaction. See section 4.

Other medicines and Ibuprofene Gen.Orph
Tell your doctor or pharmacist if your baby is taking, has recently taken or might
take any other medicine.
Some medicines, when given together with Ibuprofene Gen.Orph, may cause adverse
effects. These are described below:

• the baby may have problems with urination, for which diuretics have been prescribed. Ibuprofen may reduce the effect of these medicines;
• the baby may be given anticoagulants (medicines that prevent blood clotting). Ibuprofen may increase the anticoagulant effect of these products;
• the baby may be given nitric oxide to improve blood oxygenation. Ibuprofen may increase the risk of bleeding;
• the baby may be given corticosteroids to prevent inflammation. Ibuprofen may increase the risk of blood loss in the stomach and intestines.
• the baby may be given other NSAIDs: the concomitant use of more than one NSAID should be avoided due to the increased risk of adverse reactions;
• the baby may be given aminoglycosides (a family of antibiotics) for the treatment of infections. Ibuprofen may increase their concentration in the blood and thus increase the risk of toxicity to the kidneys and ear.

Ibuprofene Gen.Orph contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 2 mL, i.e. essentially ‘sodium-free’.

3. How to take Ibuprofene Gen.Orph

Ibuprofene Gen.Orph must be administered to newborns exclusively by a qualified healthcare professional
in a specialized neonatal intensive care unit.
A therapeutic cycle is defined as three intravenous doses of Ibuprofene Gen.Orph administered at
intervals of 24 hours. The dose to be administered will be calculated based on the newborn's weight. It is 10 mg/kg
for the first administration and 5 mg/kg for the second and third.
This calculated amount will be administered by infusion into a vein over 15 minutes.
If, after this first cycle of treatment, the ductus arteriosus does not close or reopens, the doctor may
decide to administer a second cycle of treatment to the newborn.
If after the second cycle of treatment the ductus arteriosus is still not closed, surgery may be proposed.
If you have any doubts about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
However, it is difficult to distinguish them from the frequent complications that occur in premature infants
and from the complications induced by the disease.
Possible side effects are listed below.

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

• Reduction in the number of platelets in the blood (thrombocytopenia)
• Reduction in white blood cells called neutrophils (neutropenia)
• Increase in creatinine levels in the blood
• Reduction in sodium levels in the blood
• Breathing problems (bronchopulmonary dysplasia).

Common (may affect up to 1 in 10 people)

• Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia)
• Lung bleeding
• Bowel perforation and damage to intestinal tissue (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
• Oxygen content in arterial blood below normal (hypoxemia).

Not known (frequency cannot be estimated from available data)

• Stomach perforation.
• A widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Ibuprofene Gen.Orph if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
described in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Ibuprofene Gen.Orph

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After opening, Ibuprofene Gen.Orph must be administered immediately.
Do not use this medicine if you notice visible signs of deterioration of the solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ibuprofene Gen.Orph Contains

• The active ingredient is ibuprofen. Each mL contains 5 mg of ibuprofen. Each vial of 2 mL contains 10 mg of ibuprofen.
• The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), 25% hydrochloric acid (for pH adjustment), water for injections. See section 2. Ibuprofene Gen.Orph contains sodium.

Description of the Appearance of Ibuprofene Gen.Orph and Package Contents
Ibuprofene Gen.Orph 5 mg/mL injectable solution is a clear solution, from colorless to
slightly yellow.
Ibuprofene Gen.Orph 5 mg/mL injectable solution is supplied in boxes containing four 2 mL vials.

Marketing Authorisation 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Gen.Orph
Tél/Tel: +32 (0)496 85 87 49
e-mail: [email protected]

Lietuva
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

България
Диакомерс ЕООД
Тел.: +359 2 807 50 00
Е-mail: [email protected]

Luxembourg/Luxemburg
Gen.Orph
Tél/Tel.: +33 (0)1 47 71 04 50
email: [email protected]

Česká republika
Gen. Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Magyarország
Gen.Orph
Tel.: +33 (0)1 47 71 04 50
e-mail: [email protected]

Danmark
Gen.Orph
Tlf: +46 (0)8 21 54 45
e-mail:
[email protected]

Malta
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Deutschland
Gen.Orph
Tel: +49 30 8560687897
email:
[email protected]

Nederland
Gen.Orph
Tel: +32 (0)496 85 87 49
e-mail: [email protected]

Eesti
Gen.Orph
Tel: +33 (0)1 47 71 04 50
email: [email protected]

Norge
Gen.Orph
Tlf: +46 (0)8 21 54 45
e-mail: [email protected]

Ελλάδα
Gen.Orph
Τηλ: +33 (0)1 47 71 04 50
email: [email protected]

Österreich
Gen.Orph
Tel : +33 (0)1 47 71 04 50
e-mail: [email protected]

España
Pharma International S.A.
Tel: +34 915 635 856
e-mail: [email protected]

Polska
Gen.Orph
Tel.: +33 (0)1 47 71 04 50
e-mail: [email protected]

Francia
Gen.Orph
Tél.: +33 (0)1 47 71 04 50
e-mail: [email protected]

Portugal
Biojam, S.A.
Tel: +351 212 697 912
e-mail: [email protected]

Hrvatska
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

România
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Ireland
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Slovenija
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Ísland
Gen.Orph
Simi: +33 (0)1 47 71 04 50
e-mail: [email protected]

Slovenská republika
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]
Italia
Gen.Orph

Suomi/Finland
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]
Puh/Tel : +46 (0)8 21 54 45
e-mail: [email protected]

Κύπρος
Gen.Orph
Tel: +33 (0)1 47 71 04 50
e-mail: [email protected]

Sverige
Gen.Orph
Tel: +46 (0)8 21 54 45
e-mail :
[email protected]
Latvija
Gen.Orph
Tel: +33 (0)1 47 71 04 50
email:[email protected]
United Kingdom
Gen.Orph
Tel: +33 (0)1 47 71 04 50
email:[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu ..
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The following information is intended for healthcare professionals:
As with all products for parenteral use, visually inspect the vials of Ibuprofene Gen.Orph
before use, to exclude the presence of particulate matter and to verify the integrity of the container. The
vials are for single use only; dispose of any unused residual solution.

Dosage and Administration (see also section 3)
For intravenous use only. Treatment with Ibuprofene Gen.Orph can only be carried out
in a neonatal intensive care unit, under the supervision of an experienced neonatologist.
A therapeutic cycle is defined as three doses of Ibuprofene Gen.Orph to be administered intravenously at
intervals of 24 hours.
Determine the dose of ibuprofen according to body weight as indicated below:

• 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 can be administered, as illustrated above.
If no changes are observed even after the second cycle of therapy, surgical closure of the patent ductus
arteriosus may be necessary.
In case of manifest anuria or oliguria after the first or second dose, the next dose should not be
administered until urine output has returned to normal.
Method of administration
Ibuprofene Gen.Orph must be administered by a short infusion lasting 15 minutes, preferably undiluted. An
infusion pump can be used to facilitate administration.
If necessary, adjust the injection volume with sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%)
solution in a PVC-free bag. Dispose of any unused residual solution.
In preterm neonates, the total volume of solution injected must take into account the total daily volume of
fluids administered. A maximum volume of 80 mL/kg/day should generally be administered on the first day
of life; this volume should then be gradually increased in the following 1-2 weeks (approximately 20 mL/kg
of birth weight/day) up to a maximum volume of 180 mL/kg of birth weight/day.

Incompatibilities
Chlorhexidine is incompatible with Ibuprofene Gen.Orph solution and therefore should not be
used to disinfect the vial. A 60% ethanol or 70% isopropyl alcohol solution is recommended for the
asepsis of the vial before use.
When disinfecting the vial with an antiseptic, the vial must be completely dry before being opened to avoid
any contact with the Ibuprofene Gen.Orph solution.
This medicinal product must not be mixed with other medicinal products except for sodium chloride 9 mg/mL
(0.9%) or glucose 50 mg/mL (5%) solution in a PVC-free bag.
To avoid significant changes in pH due to the presence of acidic medicinal products that may remain
in the infusion line, flush the line before and after the administration of Ibuprofene Gen.Orph with 1.5 - 2 mL
of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution in a PVC-free bag.