Rotarix vaccine 1 ml. GLAXOSMITHKLINE

Rotarix vaccine 1 ml.   GLAXOSMITHKLINE
€ 139.00
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Rotarix is a viral vaccine containing live, attenuated (weakened) human rotavirus. It helps protect your child from the age of 6 weeks of age against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection.
Rotavirus infection is the most common cause of severe diarrhea in infants and young children.

Rotarix vaccine 1 ml. - GLAXOSMITHKLINE
 

ROTARIX WHAT IS AND WHAT IT IS USED

Rotarix is a viral vaccine containing live, attenuated (weakened) human rotavirus. It helps protect your child from the age of 6 weeks of age against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection.
Rotavirus infection is the most common cause of severe diarrhea in infants and young children.
Rotavirus is easily spread from hand-to-mouth contact with the feces of an infected person. Most children with rotavirus diarrhea by itself. However, some children severe disease occurs with severe vomiting, diarrhea and life-threatening loss of fluids that requires hospitalization.
 
When the vaccine person's immune system (the body's natural defenses) will make antibodies against the most commonly occurring types of rotavirus. These antibodies protect against disease caused by these types of rotavirus.
As with all vaccines, Rotarix may not fully protect all vaccinated for rotavirus infections against which it was intended.
 

 BEFORE YOUR CHILD RECEIVES ROTARIX

 
Rotarix should be applied:
  if your child has had an allergic reaction to rotavirus vaccines or any component of Rotarix. Active substances and other ingredients in Rotarix are listed at the end of this leaflet. Symptoms of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
  If your child was born with a malformation of the intestines, which can lead to intussusception.
  if your child has a rare inherited disease that affects the immune system, called severe combined immunodeficiency (SCID).
 
 if your child has a severe infection with high fever. In such cases it may be necessary to delay vaksinatsiyata recovery. A minor infection such as a cold should not be a problem, but your doctor first.
  If your child has diarrhea or is vomiting. In such cases it may be necessary to delay vaksinatsiyata recovery.
 
Take special care with Rotarix
 
Before your child receives Rotarix your doctor / health care professional if he / she:
  been in close contact with a family member who has a weakened immune system, for example, a person with cancer or taking medicines that can weaken the immune system.
  there is damage to the gastrointestinal system.
  Do not gaining weight and growing as expected.
  has any illness or taking any medication that reduces his / her resistance to infection.
 
Once your child has received Rotarix, tell your doctor / health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stool, swollen abdomen and / or fever.
As always, wash your hands thoroughly after changing soiled nappies.
 
Using other vaccines
 
Tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Rotarix can be given to your child at the same time as other routinely recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, poliomyelitis (oral or inactivated vaccine) Hepatitis B vaccines pneumococcal and meningococcal serogroup C conjugate vaccines.
 
Using Rotarix with food and drink
 
There are no restrictions on the intake of food and fluids your child, both before and after vaccination.
 
Breastfeeding
 
Based on data obtained in clinical trials found that breastfeeding reduces the protection afforded by Rotarix against rotavirus gastroenteritis. Therefore, breastfeeding can continue during the administration of the vaccine.
 
Important information about some of the ingredients in Rotarix
 
Please consult your doctor before using this vaccine if you have been told, that the child to be vaccinated has an intolerance to some sugars.
 

 HOW TO TAKE ROTARIX

 
The doctor or nurse will administer the recommended dose of Rotarix to your child. Vaccine (1,5 ml liquid) will be given orally. Under no circumstance should this vaccine should not be administered by injection.
 
Your child will receive two doses of vaccine. For each dose will require a separate visit, between the two doses should be an interval of at least 4 weeks. The first dose may be given after the age of 6 weeks old. Two doses of vaccine should be administered until the age of 24 weeks, preferably have been given to be completed by the age of 16 weeks.
 
Rotarix can be given to premature babies by the same vaccination course, provided that the pregnancy had lasted at least 27 weeks.
 
In case your child spits out or regurgitates most of the vaccine during the same visit to the doctor can give a single replacement dose of Rotarix.
If Rotarix is given to your child for the first dose, it is recommended to receive Rotarix (and not another rotavirus vaccine) for the second dose.
It is important to follow your doctor or nurse on your next visit. Ask your doctor if you forget to go at the scheduled time.
 

 POSSIBLE SIDE EFFECTS

 
Like all medicines, Rotarix can cause side effects, although not everybody gets them.
 
Adverse reactions observed in clinical trials with Rotarix, were as follows:
  Common (may affect up to 1 in 10 doses of vaccine): 
 diarrhea
 irritability
  Uncommon (may affect up to 1 in 100 doses of vaccine):
 abdominal pain, accumulation of gas in the stomach and intestines
 inflammation of the skin
 
Adverse events reported during the use of Rotarix after his appearance on the market include:
  intussusception (part of the intestine is blocked or twisted). Symptoms may include abdominal pain, persistent vomiting, blood in the stools, bloating and / or high temperature.
 blood in the stool
 in babies born prematurely (at or before the 28th gestational week) for 2-3 days after vaccination may be higher than normal between breaths.
 Children with a rare inherited disorder called severe combined immunodeficiency (SCID), may have inflammation of the stomach and intestines (gastroenteritis) and to give the vaccine virus in their stool. Symptoms of gastroenteritis may include nausea, vomiting, stomach cramps or diarrhea. 
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
 

 HOW TO STORE ROTARIX

 
Keep out of reach of children.
Do not use Rotarix after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
 
Do not freeze.
 
Store in the original package to protect from light.
The vaccine should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
 

 ADDITIONAL INFORMATION

 
What Rotarix
The active ingredient is: 
Human rotavirus strain RIX4414
(Live, attenuated) * not less than 106,0 CCID50
 Propagated in Vero cells 
The other ingredients in Rotarix are:
Sucrose, disodium adipate, Dulbecco's Modified Eagle Dyulbeko (DMEM), sterile water 
Rotarix looks like and contents of pack
Oral suspension in pre-filled oral applicator.
Rotarix is supplied as a clear and colorless liquid in single dose pre-filled oral applicator (1,5 ml).
Rotarix is available in packs of 1, 5, 10 or 25.
Not all pack sizes may be marketed.
 
The following information is intended for healthcare professionals only:
  The vaccine is a clear colorless liquid, free from visible particles, for oral administration.
  The vaccine is ready for use (no reconstitution or dilution is required).
  The vaccine should be administered orally without mixing with any other vaccines or solutions.
  The vaccine should be inspected visually for particulate matter and / or abnormal physical appearance prior to administration. In the event of either being observed, the vaccine should be discarded.
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
 
Instructions for administration of the vaccine:
 
Discard the empty oral applicator and tip cap in biological waste containers approved in accordance with the local requirements.
 
 Remove the protective tip cap from the oral applicator.
 This vaccine is for oral administration. The child should be seated in a reclining. Administer orally (ie into the child's mouth on the inside of the cheek).
 Do not inject.
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