165 mg/ml, solution for injection,
Human normal immunoglobulin
1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR
Gammanorm is immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infection. The treatment aims to achieve normal antibody levels.
Gammanorm is used as replacement treatment for adults, children, and adolescents (aged 0 to 18 years) in:
- patients born with or without the ability to produce immunoglobulins (primary immunodeficiency)
- patients with chronic lymphocytic leukemia , a certain type of blood cancer leading to a lack of antibodies and recurrent infections , when antibiotic treatment has failed or may not be given
- patients with multiple myeloma , another type of blood cancer which leads to lack of antibody Ar and recurrent infection s
- Patients with a lack of antibodies and with recurrent infection before and after a hematopoietic stem cell transplant .
2. What you need to know before using Gammanorm
Do not use Gammanorm
- if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
- intravascular (Gammanorm must not be given in a blood vessel).
- intramuscularly (do not give Gammanorm in a muscle) if there is any bleeding disorder. An intramuscular injection must be given by a doctor or nurse.
Warnings and cautions
Talk to your doctor before using Gammanorm:
– if you have any other diseases.
– if you have diabetes and if you have ever had vascular disease or blood clot.
– if you have an increased risk of blood clots
– if you have been in bed for a long time.
Tell your doctor that you are being treated with immunoglobulin when you provide blood tests, as the treatment may affect the results.
If Gammanorm is accidentally given into a blood vessel, the patient may develop shock. For instructions on how to avoid injecting Gammanorm into a blood vessel, see section 3, How to use Gammanorm in the Handling Instructions.
Some side effects may occur more often in people receiving Gammanorm for the first time or, in rare cases, when changing human normal immunoglobulin preparations or when it has been a long time since the previous treatment.
Virus security
When medicines are made from human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes:
- careful selection of blood and plasma donors to ensure that people at risk of becoming carriers are excluded
- testing of all individual donations and plasma pools for signs of virus / infection
- measures to process blood and plasma that can inactivate or remove viruses .
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infections.
The measures taken are considered effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C viruses.
The measures may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with infections of hepatitis A or parvovirus B19, probably because the antibody is present in the product has a protective effect.
When using Gammanorm, it is recommended that product names and batch numbers be registered to enable tracking of used products.
Children and young people
The warnings and precautions given apply to both adults and children.
Other medicines and Gammanorm
- Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or if you have been vaccinated in the last three months.
- Gamma norm can reduce the effect of vaccine against e.g. measles, rubella, mumps and chickenpox. After treatment with Gammanorm, it should take three months before you are vaccinated with any of these vaccines. In the case of measles vaccine, you may have to wait up to a year after treatment with Gammanorm. It is therefore important that the doctor performing the vaccination knows that you are receiving, or have received, treatment with Gammanorm.
Gamma norm with food and drink and alcohol
No effects were observed.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. There is limited experience with the use of Gammanorm during pregnancy and lactation.
Immunoglobulin is excreted in milk and may contribute to the transmission of protective antibodies to the newborn.
Driving and using machines
The ability to drive and use machines may be affected by certain side effects associated with Gammanorm. If you get any side effects during treatment, wait until they have disappeared before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Gamma norm contains sodium
For 6 ml vials:
This medicine contains less than 1 mmol (23 mg) sodium (the main ingredient in common salt/table salt) per vial, ie is essentially ‘sodium-free.
For 10 ml, 12 ml, 20 ml, 24 ml, and 48 ml vials:
This medicine contains
25 mg sodium (the main ingredient in table salt/table salt) per 10 ml vial
30 mg sodium per 12 ml vial
50 mg sodium per 20 ml vial
60 mg sodium per 24 ml vial
120 mg sodium per 48 ml vial .
This corresponds to 1.25%, 1.5, 2.5, 3.0%, and 6.0% respectively of the highest recommended daily intake of sodium for adults.
3. HOW TO USE GAMMANORM
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. The treatment will be started by your doctor who should have experience in giving advice and tips when treating with subcutaneous immunoglobulin at home. Your doctor will make sure that you receive training and clear information on how to administer Gammanorm (eg on how to use the infusion pump and syringe and on the infusion technique), how to keep a treatment diary, and what steps to take. serious side effects would occur. As soon as you can treat yourself, and if no side effects have occurred during treatment, your doctor may allow you to continue treatment at home.
Dosage
Your dosage and infusion rate are determined by your doctor, who will adjust the dose specifically for you. Always follow your doctor’s prescription.
Method of administration and route of administration
This medicine should be given subcutaneously (under the skin). In special cases, when Gammanorm cannot be given subcutaneously, it can be administered intramuscularly (in a muscle).
An intramuscular injection must be given by a doctor or nurse.
Instructions:
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The medicine should be at room or body temperature before use.
The solution should be clear or slightly opalescent and colorless or pale yellow or light brown. Do not use a solution that is cloudy, contains particles, or precipitate.
Handling instructions:
- Remove the protective cap from the bottle and wipe the rubber stopper with alcohol.
- Use a sterile syringe and needle or a transfer aid (eg Minispike ® or Medimop ® vial adapter) to pull up Gammanorm.
- Inject as much air into the bottle as corresponds to the amount of Gammanorm to be drawn up. Then pull up Gammanorm from the bottle. If several bottles must be used to obtain the desired amount of Gammanorm, this step should be repeated.
- If an infusion pump is used: Follow the manufacturer’s instructions for preparing the infusion pump. To ensure that there is no air left in the hoses, the hoses / needle must be filled with Gammanorm.
- Wash the infusion site (s) (eg stomach or thigh) with antiseptic solution.
- Grasp the skin between two fingers and insert the butterfly needle into the subcutaneous tissue one as instructed by your doctor.
- Gamma norms must not be injected into a blood vessel . Test that any blood vessel has not been accidentally hit by gently pulling back the plunger of the syringe and checking for blood in the tubing. If this happens, the needle and tubing should be removed and destroyed. Repeat the preparation of the pump and injection one with a new needle, new tubing and a new injection site.
- Fix the butterfly needle using a sterile compress or medical tape.
Infusion of Gammanorm with infusion pump :
- Follow the manufacturer’s instructions for the pump.
- In infants and children, the injection site can be changed after 5–15 ml.
- In adults, the injection site can be changed at will. The maximum volume per infusion site should not exceed 25 ml during the first 10 infusions . Thereafter, the volume per site can be gradually increased to 35 ml if tolerated.
- Multiple infusion sites can be used simultaneously. There must be at least 5 cm distance between the infusion sites.
Infusion of Gammanorm with a syringe:
- You can use a butterfly needle, which allows faster administration . The procedure may differ in small respects depending on the delivery system you use.
- You may only use one injection site at a time. It may be necessary to administer the daily dose at more than one injection site.
- Start pushing in the piston. Subcutaneous immunoglobulin is viscous and will resist when pressed.
- You should choose an injection rate that you feel comfortable with. The recommended maximum infusion rate is approximately 1‑2 ml / minute. Take the time you need, injection one should not hurt. Some injection sites may take larger volumes than others. If necessary, change to a new injection site.
- In infants and children, the maximum volume per injection site should not exceed 5‑15 ml.
- In adults, the maximum volume per injection site should not exceed 25 ml.
- The doctor determines the dose and dose range, specially adapted to your specific needs. It is important that you always follow the prescribed dosage one.
Remove the removable label from the Gammanorm bottle and paste it into the patient diary.
If you use too much Gammanorm
There are no known risks of overdosing on Gammanorm. Contact your doctor or the Poison Information Center if you have used more Gammanorm than prescribed.
If you forget to use Gammanorm
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gammanorm can cause side effects, although not everybody gets them.
In rare cases, Gammanorm may cause a drop in blood pressure and a severe hypersensitivity reaction ( anaphylactic reaction ), even in patients who have previously tolerated treatment with human normal immunoglobulin .
If you suspect an allergy or severe allergic reaction ( anaphylactic reaction ), talk to your doctor immediately. Symptoms include dizziness, abnormal heartbeat, drop in blood pressure, difficulty breathing and swallowing, pressure over the chest, itching , hives all over the body, swelling of the face, tongue or throat, fatigue or rash. All of these conditions require immediate emergency care.
If you get symptoms of a blood clot, e.g. shortness of breath, pain or swelling in an arm or leg, vision changes or chest pain, you should contact your doctor immediately. This side effect is very rare.
Contact a doctor immediately if you get a severe headache in combination with any of the following symptoms such as. stiff neck, drowsiness, fever, photosensitivity, nausea, vomiting. These symptoms may be signs of meningitis. This side effect occurs in an unknown number of people.
Other side effects are listed below.
Very common : (may affect more than 1 in 10 people ) :
Local reactions at the injection site, such as swelling, tenderness, pain, redness , hardening, feeling hot, itching , bruising or rash.
Common: (may affect up to 1 in 10 people):
Headache, dizziness, nausea, vomiting, muscle aches, fatigue.
Uncommon: (may affect up to 1 in 100 people ) :
Trembling, feeling hot, cold, feeling sick, weakness, paleness, stomach pain, diarrhea, shortness of breath, difficulty breathing or wheezing, hypersensitivity.
Rare: (may affect up to 1 in 1,000 people ) :
Low blood pressure .
Very rare : (may affect up to 1 in 10,000 people ) :
Chills, fever, joint pain. Has been reported: occurs in an unknown number of people
Cough, back pain, hot flashes, skin rash, hives , itching , flu-like symptoms , swelling of the face.
Reporting of side effects ar
If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
5. HOW TO STORE GAMMANORM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Keep the vial in the outer carton.
During the shelf life, the product may be stored below 25 ° C for up to 1 month without being refrigerated again during this period, and must be discarded thereafter.
The product should be used immediately after first opening.
Do not use Gammanorm if the solution is cloudy or contains particles.
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.
Never throw used syringes in the normal household waste.
6. Contents of the packaging and other information
Content declaration
- The active substance is human normal immunoglobulin 165 mg / ml (at least 95% is immunoglobulin G).
- The other ingredients are glycine , sodium chloride and sodium acetate, polysorbate 80 and water for injections.
What the medicine looks like and contents of the pack
Gammanorm is a solution for injection and is supplied as:
6 ml, 10 ml, 12 ml, 20 ml, 24 ml or 48 ml solution in vial (type I glass) – pack size of 1, 10 or 20.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Octapharma AB
112 75 Stockholm
Tel: 08–566 430 00
Customer contact: 020-31 10 20.
This medicinal product is authorized under the European Economic Area under the names:
Austria: Gammanorm 165 mg / ml
Belgium: Gammanorm 165 mg / ml solution injectable
Bulgaria: Gamanorm 165 mg/ml Injection Injection
Croatia: Gammanorm 165 mg / ml utopian for injection
Czech Republic: Gammanorm 165 mg / ml
Denmark: Gammanorm
Estonia: Gammanorm süstelahus 165 mg / ml
Finland: Gammanorm 165 mg / ml injection test, liuos
France: Gammanorm, 165 mg/ml, injectable solution
Germany: Gammanorm
Hungary: Gammanorm 165 mg/ml oldatos injection
Ireland: Gammanorm, 165 mg / ml, solution for injection
Iceland: Gammanorm
Italy: OCTANORM, 165 mg / ml, initiation solution
Latvia: GAMMANORM 165 mg / ml solution for injection
Lithuania: gammanorm 165 mg/ml injekcinis tirpalas
Luxembourg: Gammanorm
Malta: GAMMANORM 165 mg / ml solution for injection
Netherlands: Gammanorm 165 mg/ml, solution for injection
Norway: Gammanorm 165 mg/ml solution for injection
Poland: Gammanorm
Portugal: GAMMANORM, 165 mg/ml injectable solution
Romania: GAMMANORM 165 mg / ml injectable solution
Slovakia: Gammanorm sol in
Slovenia: GAMMANORM 165 mg/ml raztopina injection
Sweden: Gammanorm 165 mg / ml injection solution
United Kingdom: GAMMANORM