1250 anti-Xa IU / ml solution for injection
danaparoid sodium
What Orgaran is and what it is used for
Orgaran contains danaparoid sodium and belongs to a group of medicines called antithrombotic drugs. The organ is used to prevent blood clots from forming in the blood vessels and is used in patients undergoing surgery or patients who have had a stroke caused by a blood clot.
Orgaran is also used to treat blood clots in patients who cannot be given heparin, including patients with a condition called heparin-induced thrombocytopenia (a sharp decrease in the number of platelets caused by hypersensitivity to heparin ).
Danaparoid sodium contained in Orgaran may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Orgaran
Do not take Orgaran:
- if you are allergic (hypersensitive) to danaparoid sodium or any of the other ingredients of this medicine (listed in section 6)
- if you have had a stroke caused by a ruptured blood vessel
- if you have a bleeding that can not be stopped
- if you have very high blood pressure
- if you have damage to the retina of the eye caused by diabetes
- if you have an infection in the inner surface layer or valves of the heart ( acute bacterial endocarditis )
- if you are receiving heparin (a common anticoagulant) for the treatment of blood clots, you should not be given spinal or epidural anesthesia before surgery.
Warnings and cautions
Talk to your doctor before taking Orgaran if:
- you are or have been hypersensitive to sulphite, as it may cause severe allergic reactions in asthma patients
- The organ has been or will be used during bypass surgery on the heart
- you are undergoing or are about to undergo medical examinations or surgery where spinal / epidural injection is necessary.
Extra monitoring may be necessary in case of a tendency to bleed profusely, for example, haemophilia, or increased risk of bleeding in connection with:
- ulcers in the stomach or small intestine
- kidney or liver disease.
Children
There is limited experience of Orgaran in children.
Other medicines and Orgaran
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Orgaran may affect other medicines or be affected by other medicines.
Medicines that may increase the risk of bleeding while taking Orgaran at the same time:
- oral anticoagulants (medicines used to prevent the formation of blood clots)
- thrombolytics (medicines used to dissolve blood clots)
- acetylsalicylic acid and other anti-inflammatory drugs (such as NSAIDs ), for example for the treatment of rheumatism
- drugs that can cause stomach ulcers (such as corticosteroids ).
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The organ can be used during breastfeeding if alternative treatments are inappropriate for medical reasons.
Fertility
There is no information available regarding the effect of Orgaran on fertility.
Driving and using machines
The organ has no known effect on the ability to drive and use machines.
The organ contains excipients
Orgaran contains sodium sulfite
Due to its sulfite content, the organ can in rare cases cause severe hypersensitivity reactions and difficulty breathing ( bronchospasm ).
Orgaran contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 0.6 ml, ie essentially ‘sodium-free’. it is in practice “sodium-free”.
See Section 6 for a complete list of ingredients.
How to take Orgaran
The organ is given as an injection by a doctor or nurse.
Dosage
Prevention of blood clots
Prevention of blood clots in situations where heparin can not be used.
One dose for the prevention of blood clots is 1 ampoule (750 units) twice daily for 7-10 days. In some cases, you can get Orgaran for a longer period.
Patients with an acute sharp decrease in platelet count during heparin treatment ( thrombocytopenia, see section 1) usually need a higher dose.
Treatment of blood clots in patients with heparin-induced thrombocytopenia
For the treatment of blood clots, a starting dose of 3 ampoules (2,250 units) is usually given as an injection (more or less can be given depending on your weight and at the doctor’s discretion), after which the dose is gradually reduced.
Your doctor will calculate the dose of Orgaran you need based on:
- the underlying disease that you are suffering from
- the risk of blood clots
- the risk of bleeding
- your state of health and your physical characteristics (eg weight)
- if you are hypersensitive to heparin or not.
How Orgaran is given
You will be given Orgaran by a doctor or nurse. Orgaran is given either as an injection under the skin or as an injection into a vein.
Use for children and adolescents
The organ can be given to children. Your doctor will take into account age and weight to determine dose one.
If you use more Orgaran than you should
As your doctor or nurse will monitor your condition closely, it is unlikely that you will receive too much Orgaran and they will adjust dose one if necessary.
If you get an overdose, you may notice abnormal bleeding. It can be shown by:
- nosebleeds, bleeding gums
- black stools (may indicate blood loss from the stomach or intestines)
- blood in the urine
- unusually heavy menstruation.
Talk to your doctor or nurse if you notice any of these or any other symptoms of unusual blood loss.
If you forget to use Orgaran
Because your doctor and nurse are closely monitoring your medical condition, it is unlikely that you will receive a too low dose of Orgaran. They will adjust dose one if necessary.
If you stop using Orgaran
Your doctor will decide when to stop taking Orgaran.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Heparin (an anticoagulant) should not be used at the same time as an injection with spinal or epidural anesthesia before surgery, as it may cause blood clots in the spine.
This occurs in very rare cases and not necessarily with Orgaran (see section 2) but if you notice any of the following symptoms:
- back pain
- tingling, numbness or weakness in the legs
- problems with bowel or bladder
you should inform your doctor or nurse immediately, as you may need treatment.
The organ can increase the risk of bleeding. Bleeding after surgery and bleeding or leakage near the surgical site may occur.
Usual
(may affect up to 1 in 10 users)
- a sharp decrease in the number of cells that coagulate the blood ( thrombocytopenia ) in patients with hypersensitivity to heparin
- increased bleeding after surgery
- rash.
Less common
(may affect up to 1 in 100 users)
- bruising, pain or bleeding around the injection site
- allergic (hypersensitivity) reactions
- itching .
Rare
(may affect up to 1 in 1,000 users)
- increased bleeding or swelling that contains blood at the surgical site (hematoma)
- a decrease in the number of platelets caused by an autoimmune disease ( autoimmune thrombocytopenia ).
If you get any side effects, or if you get any side effects, talk to your doctor.
This also applies to any side effects not mentioned in this information.
How to store the Organ
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
At the hospital, Orgaran is stored following established storage instructions.
Contents of the pack and other information
Content declaration
- The active substance is danaparoid sodium (750 anti-factor Xa units in 0.6 ml solution or 1,250 anti-factor Xa units / ml).
- The other ingredients are sodium sulphite, sodium chloride, water for injections and hydrochloric acid (for pH adjustment ).
What the medicine looks like and contents of the pack
Orgaran is a clear, colorless to light yellow solution for injection.
It is delivered in glass ampoules (10 per carton). Each ampoule contains 0.6 ml solution of 750 anti-factor Xa units of danaparoid sodium.
Marketing Authorization Holder and Manufacturer
Manufacturer
FAMAR Health Care Services Madrid, SAU
Avda. Leganés, 62
Alcorcón 28923
Madrid
Spain
Aspen Bad Oldesloe GmbH
Industiestraβe 32-36
23843 Bad Oldesloe
Germany