Patient leaflet - Celvapan
What Celvapan is and what it is used for
Celvapan is a vaccine to
When a person is given the vaccine, the immune system (the body’s natural defense system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
You should not receive Celvapan:
2. What you need to know bef
ceive Celvapan
- if you previously had 1 sudden life-threatening allergic reaction to any ingredient of Celvapan
or to any of the substances that may be present in trace amounts as follows: formaldehyde,
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
If
not sure, talk to your doctor or nurse before having this vaccine.
Take special care with Celvapan:
Check with your doctor or nurse before you are given Celvapan if
you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose. (see section 6. Further information).
you have a severe infection with a high temperature (over 38 °C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be problem, but your doctor or nurse should advise whether you could still be vaccinated with Celvapan.
you have problems with your immune system, since your response to the vaccine may then be poor.
you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Celvapan the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given Celvapan.
you have a bleeding condition or a bleeding problem or you bruise easily.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Celvapan. This is because the vaccination may not be recommended, or may need to be delayed.
Other medicines and Celvapan
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, inc medicines obtained without a prescription or have recently been given any other vaccine.
There is no information on administration of the vaccine Celvapan with other vaccines. H this cannot be avoided, the vaccines should be injected into separate limbs. In such cases be aware that the side effects may be more intense.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will discuss with you whether you should be given Celvapan.
The vaccine may be used during breast-feeding.
Driving and using machines
Some effects mentioned under section 4. “Possible side effects” may affect your ability to drive or use machines.
3. How Celvapan is given
Your doctor or nurse will administer t The vaccine will be injected int given into a vein.
Adults and older peop^
in accordance with official recommendations.
ly in the upper arm). The vaccine should never be
A dose (0.5 ml) of the vaccine will be given.
A second dose of the vaccine should be given after an interval of at least three weeks.
Children an d adolescents aged 6 months to 17 years of age:
A dose (0.5 ml) of the vaccine will be given.
A second dose of the vaccine should be given after an interval of at least three weeks.
Children aged less than 6 months:
accination is not currently recommended in this age group.
When Celvapan is given for the first dose, it is recommended that Celvapan (and not another vaccine against (H1N1)v) be given for the complete vaccination course.
4. Possible side effects
Like all medicines, Celvapan can cause side effects, although not everybody gets them.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Side effects from clinical studies in adults and older people
The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people. In the clinical studies, most side effects were mild in nature and short term.
Very common:
- Headache
- Feeling tired
Runny nose and sore throat
Insomnia (difficulty sleeping)
Dizziness
Eye irritation
Stomach pain
Increased sweating
Rash, hives
Joint and muscle pain
Fever, shivering, generally feeling unwell
Pain, redness, swelling or a hard lump where the inj arm injected
was given, reduced movement in the
Side effects from clinical studies in children
Children and adolescents 6 months to 17
f age
In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan. However, some differences in frequency and type of side effects were observed. Specifically, headache, vertigo (spinning feeling), cough, feeling sick, vomiting, diarrhoea, pain in the arms or legs and tiredness were observed commonly in children and adolescents.
Additionally, in the case of the 9 to 17 year olds pain at the injection site was very common.
In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, restlessness, irritability, crying and drowsiness were common.
Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v
Adults aged 18 years and older:
Res ults from a clinical study done on marketed vaccine confirmed the safety profile as observed in the clinical studies. The following adverse reactions were reported at a higher frequency category than in the other clinical studies:
Very common: Pain and redness where the injection was given, aching muscles Uncommon: Influenza like illness
Children and adolescents aged 5to17 years:
Very common: Feeling tired, headache
Uncommon: Cough
Children aged 6 months to 5 years:
Very common: Redness where the injection was given, drowsiness, irritability, loss of appetite, crying
- Clinical trials with a similar vaccine
♦ J
In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy adults and older people, subjects with a weakened immune system and patients with long-term conditions, the safety profile was similar to that in healthy adults.
- Side effects observed during post-marketing surveillance
The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the pandemic flu vaccination program.
-
– Allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock. Your doctors know that this might happen and will have emergency treatment ready to use.
-
– Fits due to fever
-
– Reduced skin sensitivity
-
– Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
-
– Flu-like illness
-
– Swelling of tissue just below the skin.
- Side effects observed with flu vaccines given routinely every year
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Celvapan.
Uncommon:
- generalized skin reactions including urticaria (hives)
Rare:
- severe stabbing or throbbing pain along one or more nerves
- low blood platelet count which can result in bleeding or bruising
Very rare:
- vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems)
- neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barre Syndrome
If any of these side effects occur, please tell your doctor or nurse immediately.
Reporting of side effects
If you get any of the side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Celvapan
Keep this medicine out of the sight and reach of children.
Do not use Celvapan after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Store in the original package in order to protect from light.
Do not freeze.
After first opening the vial is to be used within a maximum of 3 hours.
at to do
Do not throw away any medicines via wastewater or household waste. Ask your p with medicines you no longer use. These measures will help to protect the environ
6. Contents of the pack and other information
What Celvapan contains
Active substance:
Whole virion influenza vaccine,
A/California/07/2009 (H1N1)v per 0.5 ml dose
f strain*:
7.5 micrograms**
-
* propagated in Vero cells (continuous cell line of mammalian origin)
-
* * haemagglutinin
What Celvapan looks li
Celvapan is a cl One pack of Cel
Other ingredients:
The other ingredients are: tr
, sodium chloride, water for injections, polysorbate 80.
and contents of the pack
Marketi
escent, translucent liquid.
contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
orization Holder:
Na
8
eutics Bohumil, s.r.o. 8
Jevany ech Republic anufacturer:
Baxter AG
Uferstrasse 15
A-2304 Orth/Donau
Austria
This leaflet was last revised in {month/YYYY}
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:.
The following information is intended for medical or health care professionals only:
Prior to administration, the vaccine should be allowed to reach room temperature and the vial sho be shaken well.
After first opening, the vial is to be used within a maximum of 3 hours.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
The vaccine should not be administered intravascularly.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
30
Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, cyanosis, pyrexia, flushing, angioedema, and urticaria
Musculoskeletal and connective tissue disorders:
Pain in extremity (in the majority of cases reported as pain in the injection site arm)
General disorders and administration site conditions:
Influenza-like illness