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אדסל ADACEL (DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ (FHA), FIMBRAE TUPES 2 + 3 (FIM), PERTACTIN (PRN), PERTUSSIS TOXOID VACCINE, TETANUS TOXOID)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שרירי : I.M

צורת מינון:

תרחיף להזרקה : SUSPENSION FOR INJECTION

Posology : מינונים

4.2. Posology and method of administration

Posology
Recommended Dose
The immunization schedule with ADACEL should follow local recommendations. ADACEL (0.5mL) should be administered as a booster dose by the intramuscular route.
Re-dosing with ADACEL can be used to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 year intervals.
The preferred site is into the deltoid muscle.
Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined.
The use of ADACEL in management of tetanus-prone wounds should follow local recommendations.
Canada's National Advisory Committee on Immunization ( NACI ) and US Advisory Committee on Immunization Practices ( ACIP ) have issued guidelines for tetanus prophylaxis in routine wound management as shown in the Table below
NACI Recommended Use of Immunizing Agents in Wound Management

Clean, Minor Wounds                      All Other Wounds
History of                                                 TIG †                              TIG † Tetanus                        Td *                        (Human) Td *                       (Human) Immunization

Uncertain or <3 doses of an                    Yes                         No           Yes                   Yes immunization series
‡
≥ 3 doses received in an                          No §                        No           No **                 No †† immunization series ‡

* Adult-type tetanus and diphtheria toxoid.
† Tetanus immune globulin, given at a separate site from the Td.
‡ Primary immunization is at least 3 doses at age appropriate intervals.
§ Yes, if >10 years since last booster.
** Yes, if >5 years since last booster.
†† Yes, if persons are known to have a significant humoral immune deficiency state (e.g., hiv, agammaglobulinemia) since immune response to tetanus toxoid may be suboptimal.

A thorough attempt must be made to determine whether a patient has completed primary immunization.
Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus-prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years.


Method of administration

Inspect for extraneous particulate matter and/or discolouration before use. If these conditions exist, the product should not be administered.

Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal seal holding it in place. Aseptic technique must be used. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual recipient, to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
Administer the total volume of 0.5 mL intramuscularly (IM). The preferred site of injection is the deltoid muscle.

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בעל רישום

SANOFI ISRAEL LTD

רישום

142 16 32020 00

מחיר

0 ₪

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15.09.20 - עלון לרופא 08.05.23 - עלון לרופא 28.05.24 - עלון לרופא

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15.09.20 - החמרה לעלון 08.05.23 - החמרה לעלון

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