Powder and solvent for solution for injection in pre-filled syringe
Rabies virus (inactivated, Flury LEP strain)<\/p>\n\n\n\n
What Rabipur is<\/strong><\/p>\n\n\n\n Rabipur is a vaccine that contains inactivated rabies virus. After vaccination, the immune system (the body’s natural defense system) produces antibodies against the rabies virus. These antibodies protect against infections or diseases caused by the virus that causes rabies. None of the vaccine’s components can cause rabies.<\/p>\n\n\n\n What Rabipur is used for<\/strong><\/p>\n\n\n\n Rabipur can be used for people of all ages.<\/p>\n\n\n\n Rabipur can be used to prevent rabies:<\/p>\n\n\n\n Rabies is an\u00a0infection\u00a0that can be transmitted if you are bitten, torn, or even licked by an infected animal, especially if the skin is already damaged.\u00a0Contact with animal traps that infected animals have licked or bitten can also cause\u00a0infection\u00a0in humans.<\/p>\n\n\n\n You \/ your child must not be vaccinated with Rabipur before any risk of exposure to rabies virus if you \/ your child:<\/strong><\/p>\n\n\n\n After suspected or proven exposure to rabies virus, you \/ your child may receive Rabipur<\/strong><\/p>\n\n\n\n Because rabies is a very serious disease, Rabipur can be given to anyone who has been exposed to rabies, including pregnant women.<\/p>\n\n\n\n Severe allergic reactions (hypersensitivity)<\/strong><\/p>\n\n\n\n If it is known that you \/ your child is at risk of a serious\u00a0allergic reaction\u00a0to the vaccine or any of the ingredients, you \/ your child may receive another rabies vaccine that does not contain these substances.\u00a0If there is no alternative vaccine, your doctor or nurse will discuss the risks of vaccination and rabies infection with you before you or your child are vaccinated.<\/p>\n\n\n\n In acute illness that requires treatment, the vaccination is generally postponed for at least 2 weeks after recovery. A minor infection usually does not require a delay in vaccination, but talk to a doctor or nurse first.<\/p>\n\n\n\n Talk to a doctor or nurse before you or your child are vaccinated with Rabipur after rabies exposure if you \/ your child:<\/p>\n\n\n\n Fainting can occur after or even before a needle injection.\u00a0Therefore, tell your doctor or nurse if you have fainted from any previous\u00a0injection.<\/p>\n\n\n\n Cases of very rare but serious conditions affecting the nervous system have been reported following vaccination with Rabipur. See section 4<\/strong> . Anti-inflammatory drugs ( steroids such as cortisone preparations) that are often used to treat such conditions may impair the effectiveness of the vaccine (see below, Other drugs and Rabipur<\/strong> ). Your doctor or nurse will decide how to proceed in such circumstances.<\/p>\n\n\n\n As with all vaccines, Rabipur may not provide adequate protection for everyone who has been vaccinated.<\/p>\n\n\n\n The vaccine should not be given in the buttocks, under the skin, or in a blood vessel.<\/p>\n\n\n\n Tell your doctor or nurse if you \/ your child are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.\u00a0Unless your doctor tells you otherwise, you \/ your child should continue to take all prescribed medicines as usual.<\/p>\n\n\n\n If you or your child already have a weakened immune system or are already taking medicines that reduce the body’s resistance to\u00a0infection, Rabipur can still be given, but you \/ your child may not have as good protection as others.\u00a0In this case, the doctor may decide to take blood samples after the vaccine has been given to check if the body has produced enough\u00a0antibodies\u00a0against the\u00a0virus.\u00a0If necessary, you \/ your child will receive an extra\u00a0dose\u00a0of the vaccine (see\u00a0section 3<\/strong>\u00a0of this leaflet).<\/p>\n\n\n\n Rabipur can be given at the same time as other inactivated vaccines. A separate injection site should be used for each type of vaccine.<\/p>\n\n\n\n You \/ your child may also need to receive an\u00a0injection\u00a0of <\/strong>antibodies\u00a0against rabies\u00a0(so-called\u00a0rabies immunoglobulin\u00a0) if you or your child have not been completely vaccinated against rabies and if it is very likely that you \/ your child has already been infected with the\u00a0virus.\u00a0In this case,\u00a0injection\u00a0of one of the rabies immunoglobulins (given\u00a0only once\u00a0and usually at the same time as the first dose of vaccine) and the vaccine will be given\u00a0in different parts of the body.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should still get the rabies vaccine if you have or have probably been in contact with the\u00a0virus.<\/p>\n\n\n\n You can also be vaccinated with Rabipur during pregnancy or lactation and before exposure to the\u00a0virus\u00a0if the risk of contact with the\u00a0virus\u00a0is considered significant.\u00a0Then the doctor will discuss the risks of vaccination and rabies infection with you and advise on the best time for a vaccination with Rabipur.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Less than 23 mg\u00a0sodium\u00a0per\u00a0dose, and is therefore largely “sodium-free”.<\/p>\n\n\n\n You \/ your child will be vaccinated with Rabipur by a doctor or nurse trained in vaccination. Treatment that may be required to deal with the very severe types of allergic reactions that may occur after injection of the vaccine should be available (see section 4<\/strong> of this leaflet). The vaccine should be given at a clinic or doctor’s office that has the equipment required to treat such reactions.<\/p>\n\n\n\n Instructions for doctors and medical staff on the preparation of the vaccine can be found at the end of this leaflet.<\/p>\n\n\n\n The recommended\u00a0dose\u00a0for adults and children of all ages is one milliliter (1.0 ml) per\u00a0injection.<\/p>\n\n\n\n The doctor will decide how many\u00a0doses\u00a0you \/ your child should receive, and this depends on whether you \/ your child receive Rabipur before or after any contact with the\u00a0virus.<\/p>\n\n\n\n The vaccine is given as an injection into a muscle (usually in the upper arm, or on small children in the thigh muscle).<\/p>\n\n\n\n BEFORE ANY CONTACT WITH VIRUS ET<\/strong><\/p>\n\n\n\n If you \/ your child have never<\/strong> received a rabies vaccine before:<\/p>\n\n\n\n If you \/ your child misses an appointment for an\u00a0injection, be sure to get the vaccine as soon as possible after the missed time.<\/p>\n\n\n\n The need for repeated doses for continued effect (booster doses) depends on the risk of contact with the rabies virus. Your doctor will find out the official recommendations for rabies vaccination and will tell you when a booster dose is needed.<\/p>\n\n\n\n If you are constantly at high risk<\/strong> of infection, your doctor may also ask you to provide regular blood tests to measure the level of antibodies to rabies in your blood so that booster doses can be given as soon as needed. Experience shows that booster doses are generally required every two to five years.<\/p>\n\n\n\n AFTER SUSPICIOUS OR PROVEN CONTACT WITH VIRUS ET<\/strong><\/p>\n\n\n\n Vaccinated people<\/em><\/strong><\/p>\n\n\n\n If you \/ your child have already been vaccinated against rabies and\/or followed up with booster doses, and have been in contact with a rabies-infected or suspected rabies-infected animal, you \/ your child usually need 2 additional doses of the vaccine (1.0 ml per\u00a0dose\u00a0).\u00a0The first\u00a0dose\u00a0is given as soon as possible after contact and the second 3 days later.<\/p>\n\n\n\n Non-vaccinated persons<\/em><\/strong><\/p>\n\n\n\n If you \/ your child have not been vaccinated before or have received insufficient basic immunization, either 4 or 5 doses (1.0 ml per dose ) will be given according to one of the following schedules:<\/p>\n\n\n\n After possible contact<\/strong> with the rabies virus, the doctor assesses the risk of infection based on the type of contact you \/ your child has had. For example, if you have been bitten or torn by an animal that may have been infected with the virus or have been in contact with bats, you are at a much greater risk of infection with rabies than a person who has been licked without a hole in the skin.<\/p>\n\n\n\n People with the weakened immune system (poor immunity to\u00a0infection\u00a0)<\/em><\/strong><\/p>\n\n\n\n If you \/ your child is at increased risk<\/strong> of rabies infection due to the immune system not working properly, you \/ your child will need five or six doses (1.0 ml each) of the rabies vaccine after contact with a rabies-infected or suspected rabies-infected animal. The vaccination is given in combination with local treatment of the wound and rabies immunoglobulin.<\/p>\n\n\n\n If 6\u00a0doses\u00a0are used, the first 2 are given as soon as possible after contact, and then a\u00a0dose\u00a0is given on days 3, 7, 14, and 28 after the first\u00a0dose.<\/p>\n\n\n\n If 5\u00a0doses\u00a0are used, the first\u00a0dose\u00a0is given as soon as possible after contact, and then the remaining days 3, 7, 14, and 28 after the first\u00a0dose\u00a0are given.<\/p>\n\n\n\n You \/ your child may also need to submit blood samples to measure the number of\u00a0antibodies\u00a0against the rabies virus in the blood so that extra vaccine doses can be given if needed.\u00a0The doctor explains what needs to be done and when you should come for extra tests or\u00a0doses.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Severe allergic reactions affecting the whole body, sometimes associated with shock (dangerously low blood pressure ) * may occur after vaccination with Rabipur. Appropriate medical treatment and monitoring should always be readily available in the event of a rare severe allergic reaction to the vaccine. Talk to a doctor immediately if this happens. <\/p>\n\n\n\n The most common\u00a0side effects\u00a0reported after using Rabipur are injection site pain, mainly pain due to\u00a0injection\u00a0one, or hardening of the skin at the injection site.\u00a0These reactions are very common (affect more than 1 in 10 people).\u00a0Most injection site reactions were not severe and resolved within 24 to 48 hours after\u00a0injection.<\/p>\n\n\n\n Other side effects include:<\/p>\n\n\n\n Very common (may affect more than 1 in 10 people):<\/strong><\/p>\n\n\n\n headache<\/p>\n\n\n\n dizziness<\/p>\n\n\n\n rash<\/p>\n\n\n\n general malaise<\/p>\n\n\n\n fatigue<\/p>\n\n\n\n weakness<\/p>\n\n\n\n fever.<\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n swollen glands<\/p>\n\n\n\n decreased appetite<\/p>\n\n\n\n nausea<\/p>\n\n\n\n vomiting<\/p>\n\n\n\n diarrhea<\/p>\n\n\n\n abdominal pain\/discomfort<\/p>\n\n\n\n hives<\/p>\n\n\n\n muscle pain<\/p>\n\n\n\n joint pain.<\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people):<\/strong><\/p>\n\n\n\n allergic reactions<\/p>\n\n\n\n tingling or a tingling sensation<\/p>\n\n\n\n sweating<\/p>\n\n\n\n overindulge.<\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people):<\/strong><\/p>\n\n\n\n encephalitis, nerve disorders that can cause weakness, inability to move, or loss of sensation in certain parts of the body *<\/p>\n\n\n\n fainting, instability with dizziness *<\/p>\n\n\n\n the severe\u00a0allergic reaction\u00a0that causes swelling of the face or neck *.<\/p>\n\n\n\n * Description of side effects from spontaneous reporting<\/p>\n\n\n\n Additional side effects are in children<\/strong><\/p>\n\n\n\n The frequency, type, and severity of\u00a0adverse reactions\u00a0in children are expected to be the same as in adults.<\/p>\n\n\n\n Keep this vaccine out of the reach and sight of children.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C to 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Keep the vial and syringe in the outer carton. Sensitive to light.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton (after EXP). The expiration date is the last day of the specified month. Vaccines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\nWhat you need to know before you \/ your child is vaccinated with RABIPUR<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Rabipur<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Rabipur contains:<\/h2>\n\n\n\n
How to use Rabipur<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Rabipur<\/h2>\n\n\n\n
Contents of the package and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n