ALVEOFACT® 54mg 45mg/ml Injection

Country: United Arab Emirates

Language: English

Source: MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

Active ingredient:

phospholipids

Available from:

Gulf Drug LLC Dubai-Street No 10

INN (International Name):

phospholipids

Dosage:

45mg/ml

Pharmaceutical form:

Injection

Units in package:

1 Kit ( Powder Vial + Pre-filled Syringe with 1.2ml solvent + 1 canulla + 1 vial-adapter)

Class:

Conventional Medicines

Prescription type:

Prescription Only Medicine (POM)

Manufactured by:

LYOMARK PHARMA GmbH, Germany, Oberhaching

Therapeutic area:

RESPIRATORY SYSTEM-RESPIRATORY STIMULANTS , SURFACTANTS

Product summary:

Price: 1653 AED; Country of origin: Germany

Authorization status:

Registered

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
ALVEOFACT
®
45 mg/ml
LYOMARK PHARMA
10140026e
1
1. NAME OF THE MEDICINAL PRODUCT
Alveofact
® 45 mg/ml
54 mg, powder and solvent for
preparation of a suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Phospholipid fraction
from bovine lung (surfactant)
1 vial with 54 mg contains 50.76 to 60.00
mg of a phospholipid fraction (powder)
from cattle lung, equivalent to a content
of 66 µmol or 54 mg total phospholipids
as freeze-dried powder.
1 vial with 108 mg contains 101.52 to
120.00
mg
of
a
phospholipid
fraction
(powder) from cattle lung, equivalent to a
content of 132
µmol
or
108 mg
total
phospholipids as freeze-dried powder.
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Powder and solvent for preparation of a
suspension
White poweder and a clear, colourless
solvent (pH 7.3 8.3).
The pH of the reconstituted suspension
is 6.0 – 7.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alveofact is used in neonates.
Preventive use in premature neonates
with a high risk of respiratory distress
syndrome (RDS). 4.2. POSOLOGY AND METHOD OF
ADMINISTRATION
A single dose of 1.2 ml Alveofact per kg
body weight (equivalent to 54 mg total
phospholipids per kg body weight) and
application _within the first hour after birth_
is recommended_._
Depending on the need for ventilation
the following dosing scheme should be
applied:
-
Starting
dose
54
mg:
up
to
three
subsequent applications of 54 mg
-
Starting
dose
108
mg:
up
to
one
subsequent application of 108, or up
to two subsequent applications with
54 mg,
The total dose should not exceed 216
mg
total
phospholipids
per
kg
body
weight within the first 5 days of life.
_ _
Treatment with Alveofact powder is given
_only by endotracheopulmonary _
_instillation_.
_ _
_INSTRUCTION _
_FOR _
_THE _
_RECONSTITUTION _
_OF _
_THE POWDER_:
There are two options:
Option 1 – with vial adapter
Option 2 – with cannula
OPTION 1 – WITH VIAL ADAPTER
Caution: The syringe and vial adapter
remain connected to the v