PREVENAR 13 antipneumococcal vaccine

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PREVENAR 13 antipneumococcal vaccine
€ 109.00
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The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases. 

PREVENAR 13 antipneumococcal vaccine

 
 
What Prevenar 13 and what it is used
Prevenar 13 is a pneumococcal vaccine, which is administered at :
children from 6 weeks to 17 years to help to protect against diseases such as meningitis (inflammation around the brain ) , sepsis or bacteraemia (bacteria in the blood) , pneumonia ( lung infection ) and ear infections ;
adults aged 18 and over 18 years helping to prevent diseases such as pneumonia with bacteremia ( infection of the lungs by bacteria in the blood) , bacteremia (bacteria in the blood) and meningitis (inflammation around the brain ) caused by 13 types of the bacteria Streptococcus pneumoniae.
The vaccine works by helping the body to make its own antibodies , which protect you or your child against these diseases.

2 . What you should know before you or your child receive Prevenar 13
Prevenar 13 should be applied :
if you or your child are allergic (hypersensitive ) to the active substances, to any of the ingredients or any other vaccine that contains diphtheria toxoid . Active substance and other ingredients are listed in the " What's in Prevenar 13" in section 6 ;
if you or your child have a severe infection with a high temperature (over 38 ° C). If this applies to you or your child , then the vaccination will be postponed until you or your child feel better. A minor infection such as a cold should not be a problem. However, talk to your doctor, pharmacist or nurse.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before the vaccination :
if you or your child have or have had health problems after a dose of Prevenar or Prevenar 13 as an allergic reaction or breathing problems ;
if you or your child have any problems with bleeding or easy bruising ;
if you or your child have a weakened immune system (such as in HIV infection) , you / he / she may not get the full benefit of Prevenar 13.
As with any vaccine, Prevenar 13 will not protect 100 % of people who receive the vaccine.
Prevenar 13 provides protection only against ear infections in children , caused by the type of Streptococcus pneumoniae, which is designed for the vaccine. It will not protect against other infectious agents that can cause ear infections .

Other medicines / vaccines and Prevenar 13:
Your doctor may ask you to give your child paracetamol or other drugs that bring down the temperature before being administered Prevenar 13. This will help to reduce some side effects of Prevenar 13.
Tell your doctor, pharmacist or nurse if you or your child is taking, have recently taken or to take other medicines or have recently / received any other vaccine .

Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.

Prevenar 13 contains the sodium
This medicinal product contains sodium less than 1 mmol ( 23 mg) per dose, ie essentially sodium .

3 . How to use Prevenar 13
The doctor or nurse will inject the recommended dose (0,5 ml) of the vaccine into the muscle of your arm or into the muscle of the arm or leg of your child.

Infants aged 6 weeks to 6 months
Usually, your child should receive an initial course of three injections of the vaccine followed by a booster dose.
The first injection can be given from six weeks of age ;
Each injection will be administered with an interval of at least 1 month between injections ;
Fourth injection ( booster ) will apply between the ages of 11 and 15 months;
You will be told when your child should be brought to the next injection.
According to official recommendations in your party can use an alternative scheme by your healthcare professional . Please talk to your doctor, pharmacist or nurse for more information.

Unvaccinated infants , children and adolescents aged 7 months
Infants aged 7 to 11 months should receive two injections. Each injection will be administered with an interval of at least 1 month between injections . Third injection will be applied in the second year of life.
Children aged 12 to 23 months should receive two injections. Each injection will be administered with an interval of at least 2 months between injections .
Children aged 2 to 17 years should receive a single injection.

Infants, children and adolescents who have previously been vaccinated with Prevenar
Infants and children who previously received Prevenar, Prevenar can get 13 to complete the course injections.
For children 1 to 5 years previously vaccinated with Prevenar, your doctor or nurse will recommend how Prevenar 13 injections are needed .
Children and adolescents aged 6 to 17 years should receive a single injection.
It is important to follow the instructions of your doctor / pharmacist or nurse so that your child completes the course injections.
If you forget to go back in due time, ask your doctor , pharmacist or nurse what to do.

adults
Adults should receive a single injection.
Tell your doctor, pharmacist or nurse if you applied before pneumococcal vaccine.

If you have any further questions on the use of Prevenar 13 , ask your doctor , pharmacist or nurse.

4 . Possible side effects
Like all vaccines , Prevenar 13 can cause side effects, although not everybody gets them .

The following adverse reactions reported include Prevenar 13 for infants and children (ages 6 weeks to 5 years) :
The most common side effects (likely to affect more than 1 in 10 doses of the vaccine ) are:
Decreased appetite ;
Fever ; irritability ; pain, soreness, redness , swelling or induration at the vaccination site ; dizziness ; restless sleep .
Common side effects (likely to occur in up to 1 in 10 doses of the vaccine) are:
High temperature above 39 ° C; soreness at the vaccination site , hindering the movement , redness, induration, swelling at the vaccination of 2,5 - 7,0 cm.
Uncommon side effects (likely to occur in up to 1 in 100 doses of the vaccine) are:
vomiting ; diarrhea ;
Redness, swelling or induration at the site of vaccination of more than 7 cm; crying.
Rare side effects (likely to occur in up to 1 in 1000 doses of the vaccine ) are:
Seizures (or fits) , including those caused by high temperatures ;
Episode of hypotonia - attenuated response ( collapse or shock-like state ) ;
Allergic reaction ( hypersensitivity) reaction , including swelling of the face and / or lips , difficulty breathing ;
rash ; urticaria or urticaria-like rash (hives) ;
Redness.
Prevenar 13 protects against 13 types of Streptococcus pneumoniae bacteria and replaces Prevenar, which provide protection against 7 types .

The following adverse reactions include reported for Prevenar 13 in children and adolescents (aged 6 to 17 years):
The most common side effects (likely to affect more than 1 in 10 doses of the vaccine ) are:
Decreased appetite ;
irritability ; redness on any place of administration; Solidification / swelling or pain / tenderness ; somnolence ; poor quality of sleep ; tenderness at the site of vaccination (including movement disorder ) .
Common side effects (likely to occur in up to 1 in 10 doses of the vaccine) are:
headaches ;
vomiting ; diarrhea ;
rash ; urticaria or urticaria-like rash ;
Fever .
The following additional adverse reactions have been observed in Prevenar 13 through post in infants and children up to 5 years of age:
Anaphylactic / anaphylactoid reactions including shock ( cardiovascular collapse ) ; angioedema ( swelling of the lips , face and throat) ;
Urticaria (hives) , dermatitis ( redness and inflammation) and pruritus ( itching) at the vaccination site ; redness ;
Enlarged lymph nodes or glands ( lymphadenopathy ) near the site of vaccination , such as the armpit or groin ;
Erythema multiforme (rash causing itchy red spots ) .
In babies born very prematurely prematurely ( and before 28 weeks of gestation ) may appear in long pauses between normal breaths for 2-3 days after vaccination.

The following adverse reactions include reported for Prevenar 13:
The most common side effects (likely to affect more than 1 in 10 doses of the vaccine ) are:
Decreased appetite ; headache ; diarrhea ; vomiting ( 18 - to 49 -year-olds ) ;
chills ; tiredness ; a rash , pain, redness, swelling or tenderness hardened at the vaccination site , preventing the movement of the hand ( severe pain or tenderness at the site of vaccination for 18 - to 39 -year-olds and severe restriction of movement of the hand for 18 - to 39 -year-olds ) ;
Worsening or new pain in your joints , worsening or new pain in your muscles ;
High temperature ( 18 - to 29 -year-olds ) .
Common side effects (likely to occur in up to 1 in 10 doses of the vaccine) are:
Vomiting (for 50 - and 50 - year-olds) ; high temperature.
Uncommon side effects (likely to occur in up to 1 in 100 doses of the vaccine) are:
nausea ;
Allergic reaction ( hypersensitivity) reaction , including swelling of the face and / or lips , difficulty breathing ;
Enlarged lymph nodes or glands ( lymphadenopathy ) in the vicinity of the vaccine , such as in the armpit .
Adverse event reporting
If you or your child get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet . You can also report side effects directly through the national system of notification referred to in Annex V. As reported side effects , you can do your bit to get more information on the safety of this medicine.

5 . How to store Prevenar 13
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and label after " EXP" . The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C- 8 ° C).
Do not freeze .
Prevenar 13 was stable at temperatures up to 25 ° C for four days. At the end of this period Prevenar 13 should be used or discarded. These data are intended to guide health care professionals in the event of temporary deviations in storage temperature .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Contents of the pack and other information
What does Prevenar 13
The active substances are :
2,2 ?g polysaccharide of serotypes 1 , 3, 4, 5 , 6A, 7F, 9V, 14 , 18C, 19A, 19F and 23F;
4,4 ?g of polysaccharide for serotype 6B.
Conjugated to CRM197 carrier protein and adsorbed onto aluminum phosphate (0,125 mg aluminum).
The other ingredients are sodium chloride , succinic acid , polysorbate 80 and water for injections.

Prevenar 13 looks like and contents of the pack
The vaccine is a white suspension for injection offered in single-dose vial (0,5 ml).
Pack of 1, 5 , 10, 25 and 50 vials .
 
 
€ 109.00
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