INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MUTAGRIP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MUTAGRIP
Suspension for Injection, 2005 strains

DESCRIPTIVE NAME OF MEDICINE:
Influenza Vaccine (SPLIT VIRION)

COMPOSITION:
Composition per 0.5 mL dose
The active substance is influenza virus*, split, inactivated, containing antigens equivalent to:

·	A/New Caledonia/20/99(H1N1)-like strain (A/New Caledonia/20/99 (IVR-116)) 15 micrograms**
·	A/Wellington/1/2004(H3N2)-like strain (A/Wellington/1/2004 (IVR-139)) 15 micrograms**
·	B/Shanghai/361/2002-like strain (B/Jiangsu/10/2003) 15 micrograms**

*Propagated in eggs
**Haemagglutinin

The vaccine complies with the WHO Southern Hemisphere recommendations 2005. These strains may change for subsequent years.
This vaccine is propagated on eggs. It is then split, purified and inactivated.
The other components include the following: buffer solution containing sodium chloride, disodium phosphate dihydrate, monopotassium phosphate, potassium chloride and water for injection.

PHARMACOLOGICAL CLASSIFICATION:
A 30.1 Antigens

PHARMACOLOGICAL ACTION:
Purified polyvalent vaccine for active immunisation against influenza. The vaccine is an inactivated split virus mixture of different group A and B viral strains.

INDICATIONS:

1.	Persons who are at high risk for influenza and its complications because of underlying medical conditions and who are receiving regular medical care for conditions such as pulmonary and cardiac diseases, chronic renal diseases, diabetes mellitus and similar metabolic disorders and individuals who are immunosuppressed (including HIV infected persons with CD4 counts above 200/mL)
2.	Residents of old-age homes and chronic care rehabilitation institutions.
3.	Children on long term aspirin therapy.
4.	Medical and nursing staff responsible for the care of high-risk cases.
5.	Adults and children who are family contacts of high-risk cases.
6.	All persons over the age of 65.
7.	Any persons wishing to protect themselves from the risk of contracting influenza, especially in industrial settings, where large-scale absenteeism could cause significant economic loss.

CONTRA-INDICATIONS:

1.	Persons with an allergy to the active substances, any excipients, egg or chicken protein, Neomycin, formaldehyde and octoxynol-9
2.	Persons with acute febrile illness or an acute infection should preferably be immunised after the symptoms have disappeared.

WARNINGS
This vaccine must never be administered by intravenous injection.
Do not administer to children below 6 months of age.

PREGNANCY AND LACTATION
Limited data from vaccinations of pregnant women do not indicate that adverse fœtal and maternal outcomes were attributable to the vaccine. The use this vaccine may be considered from the second trimester of prenancy. For Pregnant women with medical conditions that increase the risk of complications from influenza, administration of the vaccine is recommended, irrespective of the stage of pregnancy.
MUTAGRIP may be used during lactation.

DOSAGE AND DIRECTIONS FOR USE:
Shake well before use
Vaccination is by intramuscular or deep subcutaneous injection.
The vaccine must be placed at room temperature before use
Adults and children from 36 months: one 0,5 mL dose.
Children from 6 to 35 months: one 0,25 mL dose.
Children under 8 years old who have not been previously vaccinated, should receive a second dose after an interval of at least 4 weeks.
NOTE: When the 0.5 mL prefilled syringe (adult dose) is used for the immunization of a child under 3 years of age requiring half a dose, push the plunger exactly to the edge of the mark on the syringe so that half of the volume is expelled. The remaining volume (0,25 mL) should be injected.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects
The safety of MUTAGRIP trivalent inactivated influenza vaccine is assessed in open label, uncontrolled clinical trials performed as an annual update requirement, including at least 50 adults aged 18 –60 years of age and at least 50 elderly adults aged 60 years or older. Safety evaluation is performed during the first 3 days following vaccination.
Undesirable effects reported are listed according to the following frequency.
Adverse events from clinical trials:
Common (>1/100, <1/10):
Local reactions: redness, swelling, pain, ecchymosis, induration.
Systemic reactions: fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia.
These reactions usually disappear within 1-2 days without treatment.
From post-marketing surveillance additionally, the following adverse events have been reported:
Uncommon (>1/1,000, <1/100):
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Rare (>1/10,000, <1/1,000):
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Allergic reactions, in rare cases leading to shock, have been reported.
Very rare (<1/10,000)
Vasculitis with transient renal involvement.
Neurological disorders such as encephalomyelitis, neuritis and Guillain-Barré syndrome.
Special Precautions
Care should be exercised when administering VAXIGRIP to persons:

-	with Immunosuppression
-	who have shown an allergic or another abnormal reaction to a previous vaccination.

Adrenaline 1:1000 injection and a means for its administration should be available in case of anaphylactic reactions.
A febrile reaction could precipitate an attack in patients with drepanocytemia (sickle cell disease).
Interactions
When concomitant administration with other vaccines is considered necessary, the vaccines must be given with different syringes at different injection sites.
The immunological response may be diminished in patients undergoing immunosuppressant treatment.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Cases of overdosage are not known with this product.

IDENTIFICATION:
A clear to whitish, slightly opalescent solution, free from visible foreign matter.

PRESENTATION:
One single-dose prefilled syringe 0,5 mL.

STORAGE DIRECTIONS:
The product should be stored in a refrigerator (2°C - 8°C) and protected from light
Do not freeze.
This vaccine must not be used in the event of colouring or presence of foreign particles.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use after the expiry date indicated on the label or the package.

REGISTRATION NUMBER:
320216

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:
AVENTIS PHARMA (PTY) LTD
2 Bond Street
Grand Central Ext. 1
MIDRAND
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 2005

New addition to this site: February 2005
Source: Pharmaceutical Industry
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