Octanorm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Octanorm, 165 mg/ml, injection solution

Normal human immunoglobulin
Please read all of this leaflet carefully before using 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 give it to other people, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this
leaflet, contact 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 using 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 Octanorm is and what it is used for

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

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

2. What you should 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).
• by intravascular route (Octanorm must not be administered into a blood vessel).
• by intramuscular route (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 disease.
• if you have diabetes or have ever had a vascular disease or developed a blood clot.
• if you are at increased risk of developing blood clots.
• if you have been confined to bed for a long time. When a blood sample is taken, inform the doctor that you are receiving immunoglobulin, as this treatment may affect test 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”, subsection “Operational instructions” (below).
Some adverse effects may occur more frequently in individuals receiving Octanorm for the first time, or, rarely, when switching from another normal human immunoglobulin medicine, or after a longer interval 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 exclusion of individuals at risk of transmitting infectious diseases,
• testing of each donation and plasma pools for signs of viruses/infections,
• inclusion in the manufacturing process of steps capable of inactivating or removing viruses.

Despite these measures, it is not possible to completely exclude the risk of transmitting infectious diseases when administering medicines prepared from human blood or plasma. This also applies to viruses of hitherto unknown nature or emerging viruses, or other types of infections. The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. The measures may have limited effectiveness against non-enveloped viruses such as 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. For each administration of Octanorm, it is strongly recommended to record the patient's name and the product batch number, in order to maintain a record of the batches used.

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

Other medicines and Octanorm

• Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or if you have received a vaccination within the last three months.
• Octanorm may weaken the effect of vaccines such as measles, rubella, mumps, and varicella. After treatment with Octanorm, a period of three months should elapse before receiving any of these vaccines. For the measles vaccine, a waiting period of one year after Octanorm treatment is required. It is therefore important to inform the doctor administering the vaccination about current or past treatment with Octanorm.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor 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 using machines
Some adverse reactions associated with Octanorm may impair your ability to drive vehicles or operate machinery. If you experience adverse reactions during treatment, you should wait until they have resolved before driving or operating 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 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 dietary intake of sodium for an adult, respectively.

3. How to use Octanorm

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Treatment will be initiated by a doctor experienced in managing home-based therapy with subcutaneous immunoglobulin. The doctor will ensure that you are properly trained and provided with clear instructions on the administration of Octanorm (e.g. on the use of an infusion pump and/or syringe and infusion technique), on maintaining a treatment diary, and on actions to take in case of serious adverse reactions. Once you are able to perform the treatment independently and no adverse reactions have occurred, your doctor will allow you to continue treatment at home.

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

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

Instructions:
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The product should be brought to room or body temperature before use.
The solution should be clear or slightly opalescent, colourless or pale yellow or light brown. Do not use solutions that are cloudy, contain particles, or have deposits.

Instructions for use:

• Remove the protective cap from the vial and clean the rubber stopper with alcohol.

• To withdraw Octanorm, use a syringe with a sterile needle or a transfer device (e.g. Minispike or Medimop vial adapter).

• Inject into the vial an amount of air equal to the volume of Octanorm to be withdrawn. Then withdraw the required amount of Octanorm from the vial. If more than one vial is needed to obtain the desired amount of Octanorm, repeat this procedure.

• If using a pump: follow the manufacturer's instructions for pump preparation. To ensure there is no air in the tubing, prime the tubing/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 directed by your doctor.

• Octanorm must not be injected into a blood vessel. To confirm the needle has not accidentally entered a blood vessel, gently pull back on the syringe plunger to check for blood in the tubing. If blood appears, remove and dispose of the needle and tubing. Repeat the preparation and injection procedure using a new needle and tubing, and a new injection site.

• Secure the needle in place using sterile gauze or a transparent dressing.

• Infusion of Octanorm using a pump

  • Follow the manufacturer's instructions for the pump.
  • In neonates and children, the injection site should be changed after 5–15 ml.
  • In adults, the injection site may be changed according to personal preference.
  • The maximum volume to be infused per site must not exceed 25 ml during the first 10 infusions. Thereafter, the volume per site may be gradually increased up to 35 ml, if tolerated.
  • Multiple injection sites may be used simultaneously. Injection sites must be at least 5 cm apart.

• Infusion of Octanorm using a syringe

  • A "butterfly" type catheter may be used, which allows for faster administration. Depending on the application system used, the procedure may differ slightly in minor details.
  • Only one injection site may be used at a time. The daily dose may need to be administered across multiple injection sites.
  • Begin pushing the plunger: subcutaneous immunoglobulin is viscous and will offer resistance when the plunger is pushed.
  • Choose a comfortable injection speed. The recommended maximum infusion rate is approximately 1–2 ml/min. Take all the time you need: the injection should not be painful. Some injection sites may tolerate larger volumes than others. If necessary, use a new injection site.
  • In neonates and children, the maximum volume to be infused per injection site must not exceed 5–15 ml.
  • In adults, the maximum volume to be infused per injection site must not exceed 25 ml.
  • The dosage is determined by the doctor and tailored 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 the Poison Information Centre if you have used 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 SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In rare cases, Octanorm may cause a sudden drop in blood pressure and a severe hypersensitivity reaction (anaphylactic reaction), even in individuals who previously tolerated treatments with normal human immunoglobulin.
If you suspect an allergy or experience a severe allergic reaction (anaphylactic reaction), you must immediately inform your doctor. Symptoms may include, for example, dizziness, irregular heartbeat, drop in blood pressure, difficulty breathing or swallowing, tightness in the chest, itching, generalized 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 blood clot, such as shortness of breath, pain or swelling in an arm or leg, changes in vision or chest pain, seek immediate medical attention. The occurrence of this side effect is very rare.
If you experience a severe headache accompanied by symptoms such as neck stiffness, insomnia, fever, sensitivity to light, nausea or vomiting, seek immediate medical attention. These symptoms may be signs of meningitis. The frequency of these side effects is unknown.
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, sensation of warmth, itching, bruising or skin 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, sensation of warmth, sensation 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, skin rash, itching, influenza-like symptoms, facial swelling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on 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 the box 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 shelf-life period, the medicine may be stored at a temperature below 25 °C for up to 1 month, without returning it to the refrigerator during this period, and must be discarded if not used within this time.
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 via 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. Package contents and other information

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

Description of the appearance of Octanorm and package contents
Octanorm is an injectable solution available in the following pack sizes:
6 ml, 10 ml, 12 ml, 20 ml, 24 ml or 48 ml of solution in 20 ml vials (Type I glass)

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

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

Manufacturer
Octapharma AB
SE-112 75 Stockholm
Sweden

This medicinal product is authorized in the European Economic Area Member States under the following names: