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אקט-היב ACT-HIB (HAEMOPHILUS B)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תת-עורי, תוך-שרירי : S.C, I.M

צורת מינון:

אבקה מיובשת בהקפאה להזרקה : LYOPHILIZED POWDER FOR INJECTION

Posology : מינונים

2 DOSAGE AND ADMINISTRATION
For intramuscular or deep subcutaneous route use only
The recommended injection sites are the antero-lateral aspect of the thigh (middle third) for infants and toddlers and the deltoid region for older children.
Do not inject by the intravascular route

2.1 Immunization Series
•   Before 6 months of age, 3 successive doses of 0.5 ml administered one or two months apart, followed by a booster injection (fourth dose) one year after the third injection.
•   Between 6 and 12 months of age, 2 doses of 0.5 ml administered one month apart, followed by a booster injection (0.5 ml) at 18 months of age.
•   From 1 to 5 years of age, a single dose of 0.5 ml.
For contact cases: in the event of contact with a case of invasive Haemophilus influenzae type b disease (family or childcare), vaccination should be implemented according to the schedule for the contact case’s age.
The index case should also be vaccinated

2.2 Reconstitution
ActHIB vaccine is a solution for injection supplied as single-dose vials of lyophilized vaccine to be reconstituted only with the accompanying saline diluent (0.4% Sodium Chloride). To reconstitute ActHIB vaccine, withdraw 0.6 mL of saline diluent and inject into the vial of lyophilized ActHIB vaccine. Agitate the vial to ensure complete reconstitution. The reconstituted ActHIB vaccine will appear clear and colorless. Withdraw a 0.5-mL dose of the reconstituted vaccine and inject intramuscularly or deep subcutaneously. After reconstitution, if ActHIB vaccine is not administered promptly store at 2° to 8°C and administer within 24 hours. Stored vaccine should be re-agitated prior to injection.
Refer to Figures 1, 2, 3, and 4
Instructions for Reconstitution of ActHIB Vaccine with Saline Diluent (0.4% Sodium Chloride)



Figure 1.                Figure 2.
Figure 3               Figure 4.
Disinfect the            Cleanse the ActHIB
Agitate vial           After reconstitution,
diluent vial stopper,    vaccine stopper,
thoroughly             withdraw 0.5 mL of inject the needle        insert reconstituted vaccine and withdraw 0.6         the syringe needle and administer mL of 0.4%               into the vial, and intramuscularly
Sodium Chloride          inject the or deep diluent as               total volume of subcutaneously indicated.               diluent.

2.3 Administration
Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.
The recommended injection sites are the antero-lateral aspect of the thigh (middle third) for infants and toddlers and the deltoid region for older children
Do not administer this product intravenously or intradermally..
ActHIB vaccine should not be mixed in the same syringe with other parenteral products.

שימוש לפי פנקס קופ''ח כללית 1994 Immunization of children 2 months to 5 years of age against invasive disease caused by Haemophilus influenzae type b
תאריך הכללה מקורי בסל 01/01/1995
הגבלות תרופה שאושרה לשימוש כללי בקופ'ח

בעל רישום

MEDICI MEDICAL LTD, ISRAEL

רישום

111 40 27558 00

מחיר

0 ₪

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28.10.10 - עלון לרופא 10.01.21 - עלון לרופא

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