Bronchodilators / Respiratory System

Kurosurf, 80 mg/ml, sterile endotracheal suspension for newborns, 1.5 ml, 1 pc.

Brands: Chiesi Pharmaceutici S.p.A. (Italy)

$972.00

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Kurosurf, 80 mg/ml, sterile endotracheal suspension for newborns, 1.5 ml, 1 pc. quantity

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Sku:

a9b137932dd0

Brands:: Chiesi Pharmaceutici S.p.A. (Italy)

Description

The instruction for medical use

of KUROSURF® medicine

the Trade name
of Kurosurf®

the International unlicensed name
Is not present

the Dosage form
Suspension for endotracheal introduction of 80 mg/ml

Structure
of 1 ml of suspension contains
active agent – a poraktant an alpha of 80 mg,
excipients: sodium chloride, water for injections.

The description
White or cream-white suspension

Pharmacotherapeutic group
Other drugs for treatment of diseases of respiratory organs. Pulmonary surfactants. Natural phospholipids.
The code of automatic telephone exchange R07AA02

the Pharmacological

Pharmacokinetics of Kurosurf® properties after intratracheal introduction generally is late in lungs with the period of semi-life of 14C-marked dipalmitoil-phosphatidylsincaline of 67 hours at newborn rabbits. Only traces of lipids of surfactant can be found in serum and other bodies in 48 hours after introduction.

The pharmacodynamics
the Drug Kurosurf® (the grouping name – a poraktant the Alpha), is natural surfactant, containing almost exclusively polar lipids, first of all phosphatidylsincaline (about 70% of the general content of phospholipids) and about 1% of specific hydrophobic low-molecular proteins of SP-B and SP-C.
Куросурф® compensates for the deficiency of endogenous pulmonary surfactant. Covers the internal surface of alveoluses, reduces surface intention in lungs, stabilizes alveoluses, preventing their adhesion at the end of an expiratory phase, promotes the adequate gas exchange supported during all respiratory cycle. It is evenly distributed in lungs and extends to the surfaces of alveoluses. At premature newborn children restores oxygenation level that demands decrease in concentration of the inhaled oxygen in gas mix.

Indications
– prevention of development respiratory a distress syndrome at the children born in time from 24 weeks to 31 weeks of a gestation
– a respiratory distress syndrome at newborn children with body weight not less than 700 g

the Route of administration and doses
the Recommended technology of introduction Kurosurfa® is fast bolyusny instillation in a trachea: through a dvukhprosvetny tube or via the side adapter of an endotracheal tube.
For the purpose of prevention the drug is administered in a single dose 100 mg/kg (1.25 ml/kg) within the first minutes after the child’s birth. The second dose of drug of 100 mg/kg is entered in 6-12 hours.
Treatment begin at the first signs of development respiratory a distress syndrome. An initial single dose – 200 mg/kg (2.5 ml/kg), if necessary apply one or two additional half doses – 100 mg/kg with an interval of 12 hours. After each introduction of the poraktant manual ventilation within 1-2 minutes with the concentration of the inhaled oxygen equal to an initial indicator on the device. The maximum general dose – 300-400 mg/kg.
Before the use the bottle is heated to 37 °C, carefully overturn top a bottom, avoiding stirring. Suspension is gathered from a bottle with use of sterile needles and syringes and entered into a lower part of a trachea. The child has to be turned sideways for the best distribution of surfactant in the corresponding lung.

Side effects
– pulmonary bleeding
– allergic reactions

of the Contraindication
– hypersensitivity to drug components

Medicinal interactions
are not established

Special instructions
After introduction perhaps fast increase in pulmonary elasticity and extensibility (vital lung volume) demanding immediate change-over of indicators AVL (artificial ventilation of the lungs). Restoration of gas exchange in alveoluses can lead to fast increase in oxygen concentration in the arterial course therefore it is recommended to carry out long monitoring of gas composition of arterial blood, the fabric content of oxygen.
Drug has to be used only in the conditions of a hospital by the doctors having experience of treatment and resuscitation of premature children. Before an initiation of treatment it is necessary to carry out correction of acidosis, hypotension, anemia, a hypoglycemia and hypothermia.
Surfactant use considerably reduces weight of a course respiratory a distress syndrome. After performing therapy the decrease in electric activity of a brain is noted temporary (2-10 min.).
The bottles which are warmed up before the use should not be placed back in the fridge.
The drug which remained in a bottle is not subject to reuse.

Overdose
So far the overdose phenomena as a result of use of Kurosurfa® were not noted. Nevertheless, in case of overdose and only in the presence of accurate clinical manifestations (from breath, ventilation or oxygenation) the greatest possible aspiration of the weighed contents from lungs and the therapy directed to support of water and electrolytic balance has to be carried out.
A form of release and packing
On 1.5 ml of drug in the bottle from colourless glass closed by a stopper from chlorbutyl, which is pressed out by an aluminum cap and closed by a plastic cover. One bottle in a case from polyfoam placed in a plastic container together with the instruction for medical use is placed in a cardboard box.

To Store storage conditions in the dark place at a temperature from +2 to + 8 °C.
To store out of children’s reach!

Not to use a period of storage of 18 months after expiry date.

Prescription status
According to the prescription

the Producer Nikomed Austria GmbH, Austria. Producer of Kyezi Pharmatseutitsi S. of the item. And., Italy

Representation in
RK Nikomed Ostevropa Marketing Service GmbH, Begalina 136 and, ph. 2444004, fax 2444005

Additional information