MONONINE 1000

দেশ: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

COAGULATION FACTOR IX (HUMAN)

থেকে পাওয়া:

GENMEDIX , ISRAEL

এটিসি কোড:

B02BD04

ফার্মাসিউটিকাল ফর্ম:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

রচনা:

COAGULATION FACTOR IX (HUMAN) 1000 IU/VIAL

প্রশাসন রুট:

I.V

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

CSL BEHRING GmbH, GERMANY

থেরাপিউটিক গ্রুপ:

COAGULATION FACTOR IX

থেরাপিউটিক এলাকা:

COAGULATION FACTOR IX

থেরাপিউটিক ইঙ্গিত:

For the prevention and control of bleeding in Factor IX deficiency, also known as Haemophilia B or Christmas disease.

অনুমোদন তারিখ:

2013-08-31

তথ্য লিফলেট

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( הרמחה עדימ עדימ עדימ
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ל ןולעב )תוחיטב
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ךיראת :
513..30.51
םושירה רפסמו תילגנאב רישכת םש :
)
139 54 31723 00
MONONINE 1000 (
םושירה לעב םש
GENMEDIX
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.2 POSOLOGY
AND
METHOD
OF
ADMINISTRATION
[..]
_ _
_Previously untreated patients _
The safety and efficacy of Mononine in previously untreated patients
have
not yet been established.
_Paediatric population _
Dosing in children is based on body weight and is therefore generally
based
on the same
guidelines as for adults. The frequency of administration should
always be
oriented to the
clinical effectiveness in the individual case.
[..]
4.4 SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR USE
[..]
Cardiovascular events
In patients with existing cardiovascular risk factors, substitution
therapy with FIX may increase the cardiovascular risk.
Catheter-related complications
If a central venous access device (CVAD) is required, risk of CVAD-
related complications including local infections, bacteraemia and
catheter site thrombosis should be considered.
[..]
Paediatric population
The listed warnings and precautions apply both to adults and
children.
There is no safety and efficacy data for continuous infusion
application in children, particularly the potential for development of
inhibitors is unknown (see section 4.2).
4.8
UNDESIRABLE
EFFECTS
The following adverse reactions are based on post-marketing
experience as well as scientific literature. The following
standard categories of frequency are used:
Very common: _>_1/10
Common:_>_1/100 and <1/10
Uncommon:_>_1/1,000 and <1/100
Rare:_>_1/10,000 and <1/1,000
Very rare:<1/10,000 (including reported s

পণ্য বৈশিষ্ট্য

1
1.
NAME OF THE MEDICINAL PRODUCT
MONONINE
1000
, 1000 IU,
powder and solvent for solution for injection /infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains nominally:
1000 IU human coagulation factor IX (FIX).
Mononine contains approximately 100 IU/ml factor IX after
reconstitution with 10 ml of
water for injections.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test.
The mean specific activity of Mononine is not less than 190 IU/mg
protein.
Produced from the plasma of human donors.
Excipient with a known effect:
Sodium approximately 66 mmol/l (1.5 mg /ml).
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection /infusion.
White powder and clear, colourless solvent for solution for
injection/infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention and control of bleeding in Factor IX deficiency,
also known as
Hemophilia B or christmas disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
_POSOLOGY _
The dosage and duration of the substitution therapy depend on the
severity of the factor IX
deficiency, on the location and extent of the bleeding and on the
patient’s clinical condition.
The number of units of factor IX administered is expressed in
International Units (IU),
which are related to the current WHO standard for factor IX products.
Factor IX activity in
2
plasma is expressed either as a percentage (relative to normal human
plasma) or in
International Units (relative to an International Standard for factor
IX in plasma).
One International Unit (IU) of factor IX activity is equivalent to
that quantity of factor IX in
one ml of normal human plasma.
_On demand treatment _
The calculation of the required dose of factor IX is based on the
empirical finding that 1 IU
factor IX per kg body weight raises the plasma factor IX activity by
1.0 % of normal
activity. The