Document: Gammanorm solution for injection ENG PL change

• Gammanorm solution for injection PL
• Gammanorm solution for injection ENG PL

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Package leaflet: Information for the user

Gammanorm, 165 mg/ml, solution for injection

Human normal immunoglobulin

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

• Keep this leaflet. You may need to read it again.

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

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infections. The purpose of this treatment is to attain normal antibody levels.

Gammanorm is used to treat antibody deficiency in adults and children (0-18 years).

• Patients with inborn deficiency of antibodies (primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies)

• Patients with diseases of the blood that lead to a lack of antibodies and to recurrent infections (Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections)

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).

• intravenously (Gammanorm must not be administered into a vein).

• intramuscularly (do not administer Gammanorm into a muscle) if there are any bleeding disorders. Intramuscular injection must be given by a physician or nurse.

Warnings and precautions:

Talk to your doctor or pharmacist before using Gammanorm:

• If you have any other illness.

• If you have diabetes and if you have ever had a vascular disease or a blood clot.

• If you have an increased risk of blood clots.

• If you are bedridden for a long time.

If Gammanorm is accidentally administered into a blood vessel patient could develop shock.

Certain side effects may occur more often in people who are receiving Gammanorm for the first time or, in rare cases, when changing human normal immunoglobulin products, or when treatment is suspended for more than eight weeks.

Virus safety

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of the blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove the viruses. Despite these measures, when medicines prepared from human blood or plasma are administrated, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.

The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

It is strongly recommended that every time you receive a dose of Gammanorm the name and batch number of the product are recorded in order to maintain a record of the batch used.

Other medicines and Gammanorm:

• Inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even over-the-counter ones, or if you have received a vaccination in the last three months.

• Gammanorm may weaken the effect of vaccines such as measles, rubella, mumps, and chicken pox. Following treatment with Gammanorm, three months should have elapsed before you are vaccinated with any of these vaccines. Where measles vaccine is concerned, you may need to wait up to a year following treatment with Gammanorm. It is therefore important that the doctor carrying out the vaccination is aware that you are having, or have had treatment with Gammanorm.

• Inform your doctor that you are taking immunoglobulin when you give a blood sample, as this treatment may affect the results.

Pregnancy and breastfeeding:

There is limited experience of usage of Gammanorm during pregnancy and breastfeeding. You should therefore consult your doctor before use of Gammanorm when you are pregnant or breastfeeding.

Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the newborn.

Driving and using machines:

No effect has been observed upon the ability to drive or operate machinery.

Gammanorm contains Sodium

This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose (40 ml). To be taken into consideration by patients on a controlled sodium diet.

The treatment will be started off by your doctor who should be experienced in the guidance for home treatment with subcutaneous immunoglobulin. He will ensure that you receive training and precise information on using the infusion pump, infusion technique, keeping a treatment diary, and what action to take in the event of serious side effects. As soon as you are able to treat yourself, and if no side effects have arisen during treatment, your doctor may allow you to continue treatment at home.

Your individual dosage and infusion speed will be determined by your doctor, who will adapt the dose especially for you. Always follow your doctor’s instructions.

This product should be administered subcutaneously (under the skin). In special cases where Gammanorm cannot be given subcutaneously, it may be administered intramuscularly (into muscle).

An intramuscular injection must be given by a doctor or nurse.

Instructions:

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The product should be at room or body temperature prior to use.

The solution should be clear or slightly opalescent and colourless or pale yellow or light brown.

Do not use solution that is cloudy, contains particles, or has deposits.

Handling instructions:

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

• For withdrawing Gammanorm, use a sterile syringe and a needle or a transfer device (e.g. Minispike^® or Medimop^® vial adapter).

• Inject air into the vial that is equivalent to the amount of Gammanorm to be withdrawn. Then withdraw Gammanorm from the vial. If multiple vials are required to achieve the desired amount of Gammanorm, repeat this step.

• Priming: Follow the manufacturer’s instructions for preparing the pump. In order to ensure that no air is left in the tubing fill the tubing/needle with Gammanorm.

• Clean the injection site(s) (e.g. lower abdomen, thigh) with antiseptic solution.

• Grasp the skin between two fingers and insert the needle into the subcutaneous tissue as trained by your doctor.

• Gammanorm must not be injected into a blood vessel. Test that no blood vessel has been accidentally hit by gently pulling back on the syringe plunger, and look to see if any blood is flowing back into the tubing. If you see any blood, remove and discard the needle and tubing. Repeat priming and needle injection steps using a new needle, tubing and a new injection site.

• Secure the needle in place by applying sterile gauze or transparent dressing.

• Infuse Gammanorm following the manufacturer’s instructions for the pump.

• The injection site should be changed after 5 – 15 ml.

• Multiple injection sites can be used simultaneously. Injection sites should be at least
  5 cm apart.

• Remove the peel-off label from the Gammanorm vial and use this to complete the patient diary.

If you use more Gammanorm than you should

The risks of overdosing with Gammanormare not known. Contact your doctor or Poison Information Centre if you have taken more Gammanorm than prescribed.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In rare cases, Gammanorm may cause a fall in blood pressure and a severe hypersensitivity reaction (anaphylactic reaction), even in people who previously tolerated treatment with human normal immunoglobulin.

In case of a suspected allergy or a serious allergic reaction (anaphylactic reaction), you should inform your doctor immediately. The symptoms are, for example, dizziness, heart beat abnormalities, drop in blood pressure, difficulty in breathing and swallowing, tightness of the chest, itching, generalised hives, swelling of the face, tongue or throat, collapse or rash. Any of these conditions requires immediate emergency treatment.

If you get symptoms of a blood clot such as shortness of breath, pain or swelling of an arm or a leg, changes of vision or chest pain, contact your doctor immediately. The occurrence of this side effect is very rare.

Other side effects are listed below.

Common side effects (frequency: affects 1 to 10 users in 100):

local reactions at the injection site such as swelling, tenderness, pain, redness, hardening, a sensation of heat, itching, bruising, or rashes.

Rare side effects (frequency: affects 1 to 10 users in 10,000):

low blood pressure.

Very rare side effects (frequency: affects less than 1 user in 10,000):

headache, dizziness, nausea, vomiting, pain in the lower back, joint pains, fever, shivering, tiredness, anaphylactic shock (severe hypersensitivity reaction).

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. 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.

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 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 carton.

Within its 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 if not used after this.

After first opening, the product should be used immediately.

Do not use Gammanorm if the solution is cloudy or contains particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Never discard used syringes with ordinary household waste.

What Gammanorm contains

• The active substance is human normal 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.

What Gammanorm looks like and contents of the pack

Gammanorm is a solution for injection and is available as:

6 ml, 10 ml, 12 ml, 20 ml, 24 ml or 48 ml of solution in a vial (Type I glass) - pack size of 1, 10 or 20.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

Octapharma AB

SE-112 75 Stockholm

Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Gammanorm 165 mg/ml
Belgium	Gammanorm 165 mg/ml solution injectable
Bulgaria	Гаманорм 165 mg/ml инжекционен разтвор
Croatia	Gammanorm 165 mg/ml otopina za injekciju
Czech Republic	Gammanorm 165 mg/ml
Denmark	Gammanorm
Estonia	Gammanorm süstelahus 165 mg/ml
Finland	Gammanorm 165 mg/ml injektioneste, liuos
France	Gammanorm, 165 mg/ml, solution injectable
Germany	Gammanorm
Hungary	Gammanorm 165 mg/ml oldatos injekció
Ireland	Gammanorm, 165 mg/ml, solution for injection
Iceland	Gammanorm
Italia	OCTANORM, 165 mg/ml, soluzione per iniezione
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, oplossing voor injectie
Norway	Gammanorm 165 mg/ml injeksjonsvæske, oppløsning
Poland	Gammanorm
Portugal	GAMMANORM, 165 mg/ml solução injectável
Romania	GAMMANORM 165 mg/ml solutie injectabilă
Slovak Republic	Gammanorm sol inj
Slovenia	GAMMANORM 165 mg/ml raztopina injiciranje
Sweden	Gammanorm165 mg/ml injektionsvätska, lösning
United Kingdom	GAMMANORM

This leaflet was last approved 2015-03-04