Vaccination with coronavirus vaccines by Johnson & Johnson in Lithuania: what is written on your insert?

This will be the fourth vaccine against COVID-19 infection to be administered to the Lithuanian population.

The vaccine will be distinguished from the others by the fact that only one dose of the vaccine will be sufficient to produce immunity. This medicine, like AstraZeneca, is based on an adenovirus. Its effects, developed immunity and possible side effects should also be the same as those of the AstraZeneca vaccines.

IWT chief Gytis Andrulionis told reporters that

Lithuania has decided to acquire 700 thousand. vaccine doses from this manufacturer. The vaccine package insert has already been posted on the IWT website.

We suggest that you familiarize yourself with what is written on it.

Package leaflet: information for the user

COVID-19 Vaccine Janssen suspension for injection

Vaccina COVID-19 (Ad26.COV2-S [rekombinantinė])

Additional monitoring of this drug is underway. This will help you quickly identify new security information. You can help us by reporting any side effects you experience. For information on reporting side effects, see At the end of Chapter 4.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Do not throw away this leaflet, as you may have to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

• If any of the side effects get serious or if you notice any side effect not mentioned in this leaflet, tell your doctor, pharmacist or nurse. See Chapter 4.

What’s in the leaflet?

1. What is the COVID-19 Janssen vaccine and what is it used for?

2. What you need to know before using the COVID-19 Janssen vaccine

3. How to use the COVID-19 Janssen vaccine

4. Possible side effects

5. How to store the COVID-19 Janssen vaccine

6. Container contents and other information

1. What is the COVID-19 Janssen vaccine and what is it used for?

COVID-19 Vaccine Janssen is a vaccine to prevent COVID-19 disease caused by the SARS-CoV-2 virus.

COVID-19 Vaccine Janssen, allowed for adults 18 years and older.

The vaccine stimulates the immune system (the body’s natural defenses) to produce antibodies and special white blood cells that act against the virus, creating protection against COVID-19. None of the components of the vaccine can cause COVID-19 disease.

2. What you need to know before using the COVID-19 Janssen vaccine

This vaccine should not be used:

• if you are allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving the COVID-19 Janssen vaccine if:

• You have ever had a severe allergic reaction after any other vaccination.
• have ever passed out after a needle injection
• You have a severe infection and a high fever (over 38 ° C). However, you can get vaccinated if you have a mild fever or an upper respiratory infection, such as a cold.
• You have problems with bleeding or bruising (bruising) quickly, or you are taking medicines to thin your blood (to prevent blood clots from forming).
• Your immune system is not working properly (reduced immunity) or you are taking medicines that weaken your immune system (such as high doses of corticosteroids, medicines that suppress the immune system, or medicines used to treat cancer).

As with any vaccine, the COVID-19 Vaccine Janssen vaccine may not fully protect people vaccinated with this vaccine. It is not known how long the vaccine will protect you.

For children and teenagers

The use of the COVID-19 Janssen vaccine is not recommended in children under 18 years of age. There is insufficient information on the use of the COVID-19 Janssen vaccine in children and adolescents under 18 years of age.

Other medicines and COVID-19 vaccine Janssen

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, ask your doctor, pharmacist or nurse whether you can receive the vaccine.

Driving and using machines

Some of the side effects listed in Section 4 (Possible Side Effects) of the Janssen COVID-19 vaccine may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before driving or operating machinery.

COVID-9 Janssen Vaccine Contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, ie essentially ‘sodium-free’.

COVID-19 Janssen Vaccine Contains Ethanol

Each 0.5 ml dose of this medicine contains 2 mg of alcohol (ethanol). This amount of ethanol in the medicine corresponds to less than 1 ml of beer or wine. The low alcohol content of this medicine does not produce noticeable effects.

3. How to use the COVID-19 Janssen vaccine

Your doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in the upper arm.

How much vaccine will you get?

A single dose (0.5 ml) of COVID-19 Vaccine Janssen is administered.

Your doctor, pharmacist, or nurse will monitor you for signs of an allergic reaction for about 15 minutes after the vaccine has been given.

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

4. Possible side effects

COVID-19 Vaccine Janssen, like all vaccines, can cause side effects, although not everyone gets them. Most side effects occur within 1 to 2 days after vaccination.

Immediately Seek medical attention if you experience symptoms of a severe allergic reaction. Such reactions can occur in any combination of the following symptoms:

• feeling weak or dizzy;
• changes in heart rate;
• difficulty breathing;
• wheezing
• swelling of the lips, face, or throat (throat);
• hives or rash;
• nausea or vomiting;
• stomach ache.

The following side effects can occur after the vaccine is given.

Very common (may affect more than 1 in 10 people):

• headache;
• nausea;
• Muscle pain;
• pain at the injection site;
• feeling very tired

Common (may affect less than 1 in 10 people):

• redness at the injection site;
• swelling at the injection site;
• shaking chills;
• joint pain;
• cough;
• fever.

Uncommon (may affect less than 1 in 100 people):

• rash;
• muscular weakness;
• pain in the hands or feet;
• feeling weak;
• poor general well-being;
• sneezing
• Throat pain;
• Back pain;
• shaking;
• heavy sweating

Rare (may affect less than 1 in 1,000 people):

• allergic reaction;
• urticaria.

Not known (cannot be estimated from the available data):

• severe allergic reaction.

Tell your doctor, pharmacist or nurse if you experience any side effect that bothers you or does not go away.

Notification of side effects

If any of the side effects get serious or if you notice any side effect not mentioned in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Appendix V and include the serial number, if available. By reporting side effects, you can help us learn more about the safety of this drug.

5. How to store the COVID-19 Janssen vaccine

Keep this vaccine out of the sight and reach of children.

Keep the vial in the outer carton in order to protect from light.

Your doctor, pharmacist or nurse are responsible for the storage conditions of this vaccine and the proper handling of any unused product.

Store and transport frozen at -25 ° C to -15 ° C. The expiration date when stored at -25 ° C to -15 ° C is printed on the vial and outer carton after EXP.

The vaccine is supplied ready for use after thawing. The vaccine can be supplied frozen between -25 ° C and -15 ° C or thawed between 2 ° C and 8 ° C.

The vaccine, when frozen between -25 ° C and 15 ° C, can be thawed between 2 ° C and 8 ° C or at room temperature:

• 2 ° C – 8 ° C: it will take approximately 12 hours for a box of 10 vials to warm up and approximately 2 hours for a vial to warm;
• at room temperature (maximum 25 ° C): the box containing 10 vials will take about 2 hours to warm up and approximately one hour for one vial to warm up.

Thawed vaccine must not be refrozen.

The vaccine can also be stored in a refrigerator at 2 ° C to 8 ° C for up to 3 months, until the expiration date printed by the manufacturer (EXP). After transfer at 2 ° C – 8 ° C storage temperature, the expiration date should be written on the outer carton and the vaccine should be used before the expiration date or discarded. The initial expiration date must be made illegible. The vaccine can also be transported at 2 ° C – 8 ° C provided the proper storage conditions (temperature, time) are met.

6. Container contents and other information

Composition of the COVID-19 Janssen vaccine

• The active substance is adenovirus type 26, which encodes the peak glycoprotein * of SARS-CoV-2 (Ad26.COV2-S), which contains at least 8.92 log10 infectious units (Inf.V.) per dose of 0, 5 ml.

* Produced using PER.C6 TetR cell line using recombinant DNA technology.

This medicine contains genetically modified organisms (GMOs).

• The other ingredients are 2-hydroxypropyl-β-cyclodextrin (HBCD), citric acid monohydrate, ethanol, hydrochloric acid, polysorbate 80, sodium chloride, sodium hydroxide, trisodium citrate dihydrate, water for injections (see section 2 “COVID vaccine -19 J sodium and COVID-19 Vaccine Janssen contains ethanol).

What the COVID-19 Janssen vaccine looks like and contents of the pack

Injectable suspension (injectable). The suspension is colorless to yellowish, transparent to very opalescent (pH 6-6.4).

2.5 ml of suspension is contained in a type I multidose glass vial with a rubber stopper, an aluminum cap and a blue plastic cap. Each vial contains 5 doses of 0.5 ml.

The COVID-19 Janssen vaccine is supplied in packs of 10 multidose vials.

Registrant

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Maker

Janssen Biologics BV

Einsteinweg 101

2333 CB Leiden

The Netherlands

Janssen Pharmaceutica NV

Turnhoutseweg 30

2340 Beerse

Belgium

To find out the manufacturer of the vaccine you have received, find the lot serial number on the box or vial and contact your local registrant.

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Lithuania

UAB “JOHNSON & JOHNSON”

Tel: +37052142002/0080056540088