OCTANORM 165 mg /Ml Injectable Solution

Зміст інструкції

1. What is Octanorm and what is it used for
2. What you need to know before using Octanorm
3. How to use Octanorm
4. POSSIBLE UNDESIRABLE EFFECTS
5. How to store Octanorm
6. Contents of the pack and other information

Octanorm, 165 mg/ml, injectable solution
Normal human immunoglobulin

Read this leaflet carefully before you use this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if
their symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. See section 4.

Contents of this leaflet:

• 1. What Octanorm is and what it is used for
• 2. What you need to know before you use Octanorm
• 3. How to use Octanorm
• 4. Possible side effects
• 5. How to store Octanorm
• 6. Contents of the pack and other information

1. What is Octanorm and what is it used for

Octanorm is an immunoglobulin solution and contains antibodies against bacteria and viruses. The
antibodies protect the body and increase its resistance to infections. The purpose of this
treatment is to achieve normal antibody levels.
Octanorm is used as replacement therapy in adults, children and adolescents (0-18
years) in

• patients born with reduced ability or inability to produce immunoglobulins (primary immunodeficiencies)
• patients with chronic lymphocytic leukemia, some types of blood cancers that determine an antibody deficiency and recurrent infections when antibiotics have proven ineffective or cannot be administered
• patients with multiple myeloma, another type of blood cancer that determines an antibody deficiency and recurrent infections
• patients with antibody deficiency before and after hematopoietic stem cell transplantation

2. What you need to know before using Octanorm

Do not use Octanorm:

• if you are allergic to normal human immunoglobulin or to any of the other ingredients of this medicine (listed in section 6).
• intravenously (Octanorm must not be administered into a blood vessel).
• intramuscularly (do not administer Octanorm into a muscle) in case of bleeding disorders. Intramuscular injection must be performed by a doctor or nurse.

Warnings and precautions
Talk to your doctor or pharmacist before using Octanorm:

• if you suffer from any other illness.
• if you have diabetes and if you have ever had vascular disease or the development of a blood clot.
• if you have an increased risk of developing blood clots.
• if you are confined to bed for a long time. When a blood sample is taken from you, inform the doctor that you are taking immunoglobulin, as this treatment may affect the results.

If Octanorm is accidentally administered into a blood vessel, you may experience
shock. For instructions on how to avoid injecting Octanorm into a blood vessel, see
section “3. How to use Octanorm”, sub-section “Operating instructions” (below).
Some undesirable effects may occur more frequently in people who
receive Octanorm for the first time or, in rare cases, when the
medicine based on normal human immunoglobulin is replaced or when a
longer period has elapsed since the previous treatment.
Viral safety
When medicines are prepared from human blood or plasma, certain measures are taken to prevent the risk of transmitting infections to patients. These
measures include

• careful selection of blood and plasma donors to ensure the exclusion of subjects at risk of transmitting infectious diseases
• examination of each donation and plasma pools to check for signs of viruses/infections.
• inclusion in the processing of blood or plasma of measures capable of inactivating or removing viruses. Despite these measures, when administering medicines prepared from human blood or plasma, it is not possible to completely exclude the possibility of transmitting infectious diseases. This also applies to viruses of unknown or emerging nature or other types of infections. The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may have limited value against non-enveloped viruses, such as the hepatitis A virus and parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, probably because the antibodies against these infections contained in the medicinal product are protective. With each administration of Octanorm, it is strongly recommended to record the patient's name and the batch number of the product, in order to keep a record of the batches used.

Children and adolescents
The warnings and precautions listed apply to both adults and children.

Other medicines and Octanorm

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines, or if you have been vaccinated in the last three months.
• Octanorm may weaken the effect of vaccines such as measles, rubella, mumps and varicella. Three months must elapse after treatment with Octanorm before undergoing any of the aforementioned vaccines. To undergo the measles vaccine, you must wait one year after treatment with Octanorm. It is therefore important to inform the doctor performing the vaccination if you have had or are currently undergoing treatment with Octanorm.

Octanorm with food, drinks and alcohol
No effects have been observed.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor for advice before taking this medicine.
Experience with the use of Octanorm during pregnancy and breastfeeding is limited.
Immunoglobulins are excreted in breast milk and may contribute to the transmission of
protective antibodies to the newborn.

Driving and operating machinery
Some adverse reactions associated with Octanorm may impair your ability to drive
vehicles and operate machinery. If you experience adverse reactions during treatment, you
should wait until they have resolved before driving or using machinery.

Octanorm contains sodium
For the 6 ml vial:
This medicine contains less than 23 mg of sodium (the main component of table
salt) per vial, i.e. essentially ‘sodium-free’.
For the 10 ml, 12 ml, 20 ml, 24 ml and 48 ml vials:
This medicine contains
25 mg of sodium (the main component of table salt) per 10 ml vial,
30 mg of sodium per 12 ml vial,
50 mg of sodium per 20 ml vial,
60 mg of sodium per 24 ml vial,
120 mg of sodium per 48 ml vial.
This corresponds to 1.25%, 1.5%, 2.5%, 3.0% and 6.0% of the maximum
recommended daily intake with the diet of an adult, respectively.

3. How to use Octanorm

Use this medicine following the doctor's instructions exactly. If you have any doubts,
consult your doctor. Treatment will be initiated by a doctor experienced in providing
assistance for home treatment with subcutaneous immunoglobulin. The doctor
will ensure to train and provide clear information on the administration of Octanorm (e.g. on
the use of the infusion pump and/or syringe and on the infusion technique), on
keeping a treatment diary and on the actions to be taken in case of serious adverse
effects. As soon as the patient is able to perform the treatment independently and
if no adverse effects have occurred, the doctor will allow the continuation of
treatment at home.

Dosage
The individual dose and the infusion rate will be determined by the doctor, who will adjust the
dose to the patient's specific needs. Always follow the doctor's instructions.

Method and route of administration
This product must be administered subcutaneously (under the skin). In special
cases where it is not possible to administer Octanorm subcutaneously, intramuscular
administration (into the muscle) is possible.
Intramuscular injection must be performed by a doctor or nurse.

Instructions:
Use this medicine following the doctor's instructions exactly. If you have any doubts
consult your doctor.
The product must be brought to room or body temperature before use.
The solution must be clear or slightly opalescent and colorless or pale yellow or light
brown. Do not use solutions that are cloudy, containing particles or with deposits.
Operating instructions:

• Remove the protective cap from the vial and clean the rubber stopper with alcohol.
• For drawing Octanorm, use a sterile needle syringe or a transfer device (e.g. Minispike or Medimop vial adapter).
• Inject into the vial an amount of air equal to the amount of Octanorm to be drawn. Then draw Octanorm from the vial. If more vials are needed to obtain the desired amount of Octanorm, repeat this operation.
• If using a pump: follow the manufacturer's instructions for pump preparation. To ensure there is no air in the tube, fill the tube/needle with Octanorm.
• Clean the injection site (e.g. lower abdomen, thigh) with an antiseptic solution.
• Hold the skin between two fingers and insert the needle into the subcutaneous tissue as indicated by the doctor.
• Octanormmust not be injected into a blood vessel.Check that the needle has not accidentally penetrated a blood vessel by gently pulling back on the syringe plunger and check that there is no blood in the tube. If there is blood, remove and dispose of the needle and tube. Repeat the preparation and injection operations using new needle and tube, as well as a new injection site.
• Secure the needle in place by applying sterile gauze or a transparent bandage.
• Infusion of Octanorm using a pumpor Follow the manufacturer's instructions for the pump. o In neonates and children, the injection site should be changed after 5-15 ml.

o In adults, the injection site can be changed according to your own
preferences. The maximum volume to be infused per site should not exceed 25 ml
during the first 10 infusions. Afterwards, the volume per site can be
gradually increased to 35 ml, if tolerated.
o Multiple injection sites can be used simultaneously. Injection sites
must be at least 5 cm apart.

• Infusion of Octanorm using a syringeo A “butterfly” type catheter can be used, which allows for faster administration. Depending on the application system used, the procedure may differ in some minor details. o Only one injection site can be used at a time. It may be necessary to administer the daily dose at multiple injection sites. o Start pushing the plunger: subcutaneous immunoglobulin is viscous and offers resistance when pushing the plunger. o Choose the most comfortable injection speed. The recommended maximum infusion rate is approximately 1-2 ml/minute. Take your time: the injection should not be painful. Some injection sites will tolerate larger volumes than others. If necessary, use a new injection site. o In neonates and children, the maximum volume to be infused per injection site should not exceed 5-15 ml o In adults, the maximum volume to be infused per injection site should not exceed 25 ml o The dosage is determined by the doctor and adjusted to individual needs. It is essential to always adhere to this dosage.
• Remove the detachable label from the Octanorm vial and use it to complete the patient record.

If you use more Octanorm than you should
The risks of overdose with Octanorm are unknown. Contact your doctor or poison information center if you have taken more Octanorm than prescribed.

If you forget to use Octanorm
Do not take a double dose to make up for a missed dose.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, this medicine can cause undesirable effects, although not everyone will experience them.
In rare cases, Octanorm may cause a sudden decrease in blood pressure and
a serious hypersensitivity reaction (anaphylactic reaction), even in people who previously
tolerated treatments with normal human immunoglobulin.
If you suspect an allergy or a serious allergic reaction (anaphylactic reaction), you must
inform your doctor immediately. Symptoms include, for example, dizziness,
irregular heartbeat, low blood pressure, difficulty breathing and swallowing,
a feeling of tightness in the chest, itching, widespread hives, swelling of the face, tongue
or throat, collapse or skin rash. Any of these conditions requires
immediate emergency treatment.
If you experience symptoms related to the presence of a thrombus such as shortness of breath, pain or
swelling of an arm or leg, changes in vision or chest pain, seek
immediate medical attention. The occurrence of this undesirable effect is very rare.
If you experience a severe headache associated with symptoms such as stiff neck, insomnia, fever,
sensitivity to light, nausea, vomiting, seek immediate medical attention. These symptoms
may be signs of meningitis. The frequency of these undesirable effects is unknown.
Other undesirable effects are listed below.

Very common: may affect more than 1 in 10 people
Local reactions at the injection site such as swelling, sensitivity, pain, redness, hardening,
feeling of warmth, itching, bruising or rash.

Common: may affect up to 1 in 10 people
Headache, dizziness, nausea, vomiting, muscle pain, fatigue.

Uncommon: may affect up to 1 in 100 people
Tremor, feeling of warmth, feeling of cold, malaise, weakness, pallor, abdominal 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.

Frequency not known
Cough, back pain, flushing, rash, itching, flu-like symptoms, facial swelling
Reporting of undesirable effects
If you experience any undesirable effects, including those not listed in this leaflet,
consult your doctor or pharmacist.
You can also report undesirable effects directly through the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting undesirable effects, you can contribute to providing more information about
the safety of this medicine.

5. How to store Octanorm

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 on the
pack after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8  C). Do not freeze. Keep the vial in the outer packaging
to protect the medicine from light.
Within the period of validity, the medicine may be stored at a temperature below
25 °C for 1 month, without returning it to the refrigerator during this time, and must be
discarded if not used after this period.
After first opening, use the product immediately.
Do not use Octanorm if the solution is cloudy or contains particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Do not dispose of used syringes with ordinary household waste.

6. Contents of the pack and other information

What Octanorm contains
The active substance is normal human immunoglobulin 165 mg/ml (at least 95% is immunoglobulin G).
The other ingredients are glycine, sodium chloride, sodium acetate, polysorbate 80 and
water for injections.

Description of the appearance of Octanorm and contents of the pack
Octanorm is an injectable solution and is available in the following formats:
6 ml, 10 ml, 12 ml, 20 ml, 24 ml or 48 ml of solution in a 20 ml vial (type I glass)

• pack sizes of 1, 10 or 20. Not all pack sizes may be marketed.

Marketing Authorisation Holder
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56100 Pisa
Italy

Manufacturer
Octapharma AB
SE-112 75 Stockholm
Sweden

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations: