| ANTI-CHF
VACCINE |
| |
| CRIMEAN
HAEMORRHAGIC FEVER VACCINE, INACTIVATED |
| |
| COMPOSITION |
One dose of the vaccine ( 1 ml ) consist of: |
| Active
substance: |
| Inactived
antigen (CHF virus strain V 42/81) with titer in RBC |
not
less than 1:300 |
| Àuxilary
substances: |
| Aluminium
hydroxide |
aluminum 0.8 mg/ml |
| Thiomersal |
0.2
mg/ml |
| Sodium
hydrogen carbonate |
0.38
mg/ml |
| Sodium
chloride |
8.5
mg/ ml |
| Phenol
red as indicator |
0.2
mg/ml |
| Tobramycin |
traces |
| Water
for injection |
q.
s. 1 ml |
DOSSAGE AND PACKAGE
|
The
vaccine is an injection suspension (for subcutaneous injection)
of 1 ml - 1 dose.
In one secondary package there are 50 ampoules. |
PHARMACO-THERAPEUTIC GROUP OR EFFECT
|
The
vaccine builds specific active protective immunity against
the CHF virus - 14 days after the first injection. The appearance
of complement-binding antibodies is established.
|
THERAPEUTIC INDICATIONS |
The
vaccine is designed for the protection against infection with
the CHF Virus for persons over 16 years of age (boarder army
units, medical workers, agricultural workers and other persons,
living in CHF endemic regions).
|
CONTRAINDICATIONS |
- acute
infectious diseases, including during the period of convalescence,
30 days after the clinical symptoms
- febrile
conditions
- active
form of tuberculosis
- decompensated
hearth disease
- diabetes,
thyrotoxicosis and adrenal insufficiency in decompensation
phase
- acute
phlogistic diseases of the central nervous system - meningitis,
encephalitis, meningo-encephalitis
Recovered
patients of CHF need no immunization
- Chronic
or active hepatitis and liver cirrhosis
After
entering clinic and biochemical remission, immunization
is allowed after consultation with a specialist
- Acute
glomerulonephritis
The immunizations are to be deferred until the 6th
month after recovery
- Neurotic
syndrome
The immunizations are to be deferred until the corticosteroid
treatment is brought to an end
- Allergy
-children with direct hereditary allergies (parents, other
children in the family) are to be immunized under the protection
of anti-allergic means;
- contra-indications of immunization are anamnestic data
of shock, edema of Quince and other severe allergic reactions
to allergens, contained in the vaccines.
- Autoimmune
diseases
|
SPECIAL PRECAUTIONS FOR USE
|
The
immunization is to begin after an examination by a physician.
The vaccine is to be used only before its "expiry"
term has expired and if the intactness of the ampoule is preserved
and the vaccine looks normal. The vaccine looks normal if
it is with yellow to orange over-suspension liquid and whitish
suspension, which when shaken homogenizes - to opalescence
without aggregated particles.
When the ampoule is opened and the injection is made with
all the necessary requirements for antiseptics.
If persons with hypersensitivity are immunized, antihistamine
preparations must be prescribed together with the immunization,
at the discretion of the physician.
|
The
vaccine must NOT be made intravenously |
MEDICAL
INTERACTIONS AND OTHER FORMS OF INTERACTIONS |
After
the application of gamma-globulin specific for CHF, if immunization
with CHF vaccine is necessary, 30 days should pass. In case
of corticosteroid preparations use or immunosuppressive treatment,
when according to vital indications, it is possible that the
vaccination may turn out unsuccessful. This necessitates establishing
the protective status (availability of complement-binding
antibodies) with the view of a possible continuation of the
immunization with CHF vaccine.
No interactions with alcohol, tobacco and foods are described.
|
SPECIAL
PRECAUTIONS CONCERNING USE BY SPECIFIC GROUPS OF PATIENTS (CHILDREN,
PREGNANT AND BREAST-FEEDING WOMEN, ELDERY PATIENTS, PERSONS
IN SPECIFIC PATHOLOGICAL CONDITIONS). |
No
tests have been carried out for possible terratogen action
of the medicinal product during pregnancy, thus the vaccine
is not recommended in such cases. For breast-feeding - no
side interactions of the medicinal product have been described
in the practice.
|
INFLUENCE ON THE ABILITY TO DRIVE AND OPERATE MACHINES
|
There
are no data for influence on the ability to drive and operate
machines. |
DATA FOR AUXILIARY SUBSTANCES THAT ARE TO BE KNOWN REGARDING
THE PRODUCT SAFETY |
| Thiomersal
- may cause allergic reaction. |
INFORMATION
ON THE CORRECT USE:
DOSAGE AND MODE OF APPLICATION:
|
| 1
ampoule = 1ml = 1 dose |
| Before
use shake energetically the ampouled vaccine until it turns
into homogeneous suspension. The vaccine from an open ampoule
is to be applied immediately deep subcutaneously in the area
of the shoulder blade under its lower edge. |
PRIMARY
IMMUNIZATION |
| Two
injections of 1 ml (one dose) with an interval of 30 - 45 days.
|
REIMMUNIZATION
|
| The
first reimmunization is to be done with one injection of 1 ml
(one dose) 1 year after the first application and then every
5 years. |
It
is advisable that the immunization starts in the pre-epidemic
period (March-April). |
DURATION
OF THE TREATMENT WHEN IT HAS TO BE RESTRICTED |
| See Reimmunization |
WHAT
TO DO IN CASE OF OVER-DOSE (SYMPTOMS, EMERGENCY MEASURES) |
| No
over-dosing is allowed. |
WHAT
TO DO IN CASE OF MISSED DOSES |
| The
course shall be started anew - with the primary immunization.
|
INSTRUCTIONS
IN CASE OF NECESSITY, WHEN DISCONTINUING THE PRODUCT USE IS
CONNECTED WITH RISKS |
| In
case of tick bite and temperature over 37.5°C, immediately apply
specific CHF-bulin. |
UNDESIRED
SIDE REACTINS: |
| The
application of CHF vaccine may be accompanied with local and
general reactions of the organism. The local reactions manifest
themselves in slight reddening of the place of injected. The
general reaction may manifest itself in an increase of the body
temperature up to 37.5°C. |
STORAGE |
ANTI-CHF VACCINE should be stored and transported between
+2°C and +8°C
IT MUST NOT BE FROZEN.
Keep away from children. |
SHELF
LIFE |
The
vaccine has an expiry term of 24 months as of the date of
production, printed on the package. Never use a vaccine with
an expired term. |
NAME AND ADDRESS OF MANUFACTURER
|
BB
- NCIPD Ltd. BULGARIA
1504 Sofia, 26 Yanko Sakazov Blvd.
Tel.:**359 2 944 61 91
Fax: **359 2 943 30 75
E-mail: bulbio@bulbio.com |
Last
Revision: May 2007 |