1000 mg powder and solvent for solution for infusion alpha
1 -proteinase inhibitor, human
What Prolastina is and what it is used for
Prolastina belongs to a class of drugs called proteinase inhibitors.
Alpha 1 -proteinase inhibitor is a substance that is formed in the body to inhibit the effect of substances called elastases and which damage the lungs. In the case of hereditary deficiency of alpha 1 -proteinase inhibitors, there is an imbalance between alpha 1 -proteinase inhibitors and elastase. This can lead to gradual degradation of lung tissue and the development of pulmonary emphysema. Pulmonary emphysema is an abnormal enlargement of the lungs, with degradation of the lung tissue. Prolactin is used to restore the balance between alpha 1 -proteinase inhibitors and elastase in the lungs, which prevents further deterioration of the pulmonary emphysema.
Prolactin is used for the long-term treatment of patients with certain forms of alpha 1 -proteinase inhibitor deficiency, as determined by your doctor.
What you need to know before using Prolastina
Do not use Prolastina
- if you are allergic (hypersensitive) to the active substance alpha 1 -proteinase inhibitor or any of the other ingredients of Prolastina (listed in section 6).
- if you have a known deficiency of certain immunoglobulins ( IgA ) because severe allergic reactions and even anaphylactic shock then may occur.
Warnings and cautions
- Talk to your doctor, pharmacist, or nurse before using Prolastina.
- Talk to your doctor if you have a very weak heart ( heart failure ). Particular care should be taken as Prolastina may lead to a temporary increase in blood volume.
Allergic reactions ( hypersensitivity reactions)
In rare cases, your hypersensitivity reaction to Prolastina may occur even if you have tolerated alpha 1 proteinase inhibitors well with prior administration.
Your doctor will inform you about the signs of allergic reactions and what to do if they occur (see also section 4).
Tell your doctor or nurse immediately if you experience an allergic reaction during the infusion of this medicine.
Safety information regarding the risk of infections
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 individual donations and plasma pools for signs of virus/infection,
- the inclusion of steps in the processing of blood and plasma that can inactivate and secrete 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 infection.
The measures taken are considered to be effective against enveloped viruses such as HIV, hepatitis B, and hepatitis C virus. They may be of limited value against non-enveloped viruses such as hepatitis A and parvovirus B19. Parvovirus B19 infection can be serious in pregnant women (fetal infection ) and immunocompromised individuals or patients with certain types of anemia (eg hemolytic anemia ).
Your doctor may suggest hepatitis A and B vaccination if you are regularly / repeatedly treated with plasma-derived human proteinase inhibitors.
the product name and batch number must be registered each time you are given Prolastina, to maintain a register of the batch numbers of Prolastina you have received.
Smoking
As the effect of Prolastina is negatively affected by tobacco smoke in the lungs, smoking cessation is recommended.
Children and young people
There is no experience in the use of Prolastina in children and adolescents up to 18 years of age.
Other medicines and Prolastina
There are no known interactions between Prolastina and other medicines.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
There is no experience with the use of Prolastina during pregnancy. Tell your doctor if you are pregnant or planning to become pregnant.
It is not known if Prolastina passes into breast milk. Ask your doctor if you are breastfeeding.
Driving and using machines
There is no evidence that Prolastina affects your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Prolastina contains sodium
Prolastina contains approximately 110.4 mg sodium (the main ingredient in table salt/table salt) per vial. If the patient weighs 75 kg, this corresponds to 24.84% of the highest recommended daily intake of sodium for adults. Talk to your doctor or pharmacist if you have been prescribed a low-salt diet.
How to use Prolastina
After reconstitution with the supplied bottle of solvent, Prolastina is given as an infusion into a vein. A physician experienced in the treatment of patients with chronic obstructive pulmonary disease will monitor the first infusions. with Prolastina.
Treatment at home
After the first infusions, other healthcare professionals can also give Prolastina, but only after receiving adequate training. Your treating physician will determine if you are suitable for treatment at home and will ensure that your healthcare professional receives instructions on:
- how to prepare and give the finished infusion solution (see the illustrated instructions at the end of this leaflet).
- how to keep the medicine sterile (aseptic infusion techniques).
- how to keep a treatment diary.
- how to identify side effects, including signs of allergic reactions, and measures to be taken if such side effects occur (see also section 4)
Dosage
The amount of Prolastina you receive is based on your body weight. A weekly dose of 60 mg of active substance per kg body weight (equivalent to, if the patient weighs 75 kg, 180 ml of reconstituted solution for infusion containing 25 mg/ml human alpha 1 proteinase inhibitor) is usually sufficient to maintain protective levels of human serum alpha 1 proteinase inhibitor, which prevents further worsening of pulmonary emphysema.
The doctor responsible for treatment determines the length of the treatment period. Today, there are no signs that the length of treatment needs to be limited.
If you have the impression that the effect of Prolastina is too strong or too weak, talk to your doctor or pharmacist.
If you use more Prolastina than you should
To date, there are no known consequences of overdose.
- Talk to your doctor or healthcare professional if you think you have been given more Prolastina than you should. He or she will take appropriate action.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If you forget to use Prolastina
- Talk to your doctor, who will decide if you should be given the missed dose.
- Do not take a double dose to make up for a forgotten infusion.
If you stop using Prolastina
If treatment with Prolastina is stopped, your condition may worsen. Talk to the doctor in charge of your treatment if you want treatment with Prolastina to be stopped prematurely.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, Prolastina can cause side effects, although not everybody gets them.
If side effects occur during infusion with Prolastina, the infusion should be stopped temporarily or stopped completely depending on the type of side effect and its severity.
Any serious side effects ar
In rare cases (may affect up to 1 in 1,000 people) hypersensitivity reactions may occur, in some very rare cases (may affect up to 1 in 10,000 users) these reactions may occur as allergic reactions of some kind, although You have not experienced any signs of allergy with previous infusions.
If you notice any of the following signs, tell your doctor or nurse immediately :
- rash, hives, itching,
- difficulty swallowing,
- swelling of the face or mouth,
- redness,
- difficulty breathing ( dyspnoea ),
- drop in blood pressure,
- change in heart rate,
- overindulge.
Your doctor or healthcare professional may decide to slow down or discontinue the infusion completely and initiate appropriate necessary treatment.
During treatment at home, the infusion should be stopped immediately and a doctor or healthcare professional should be contacted.
The following side effects have been observed with Prolastina.
Uncommon (may affect 1 in 100 people):
chills, fever, flu-like symptoms, chest pain
– hives ( urticaria )
– dizziness, fainting, headache
– difficulty breathing ( dyspnoea )
rash
– nausea
– joint pain (arthralgia)
Rare (may affect up to 1 in 1,000 people):
– hypersensitivity reaction er
– fast pulse ( tachycardia )
– low blood pressure ( hypotension )
– high blood pressure ( hypertension )
– back pain
Very rare (may affect up to 1 in 10,000 people):
– allergic shock
How to store Prolastina
Do not store above 25 ° C. Do not freeze.
The reconstituted solution should not be stored in the refrigerator and should always be used within three hours after reconstitution. Any unused product should be discarded. The medicine 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.
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 bottle label and carton. The expiration date is the last day of the specified month.
Do not use Prolastina if you notice that the reconstituted solution is not ready.
Package contents and other information other information
Content declaration
- The active substance is alpha 1 -proteinase inhibitor, human (extracted from human blood or plasma ).
- The other ingredients are sodium chloride, sodium dihydrogen phosphate, and water for injections (solvent).
What the medicine looks like and the contents of the pack
Alpha 1 proteinase inhibitor is a white to beige powder.
The finished solution is ready.
1 ml of reconstituted solution contains 25 mg alpha 1 proteinase inhibitors.
The 1000mg prolactin carton contains:
- 1 vial of powder containing 1000 mg alpha 1 – proteinase inhibitor, human.
- 1 vial with 40 ml liquid (water for injections).
- 1 Mix2Vial transfer cartridge for reconstitution.
Prolastina multi-pack contains:
- 4 simple Prolastina cartons with 1000 mg
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Grifols Deutschland GmbH
Colmar Straße 22
60528 Frankfurt
Germany
Tel. +49/69/660 593 100
Manufacturer
Instituto Grifols, SA
Can Guasc, 2 – Parets del Vallès
08150 Barcelona
Spain