Patient leaflet - EXEMBOL 1 MG / ML SOLUTION FOR INFUSION
Exembol*
Exembol 1 mg/ml solution for infusion argatroban monohydrate
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.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Exembol is and what it is used for
-
2. What you need to know before you use Exembol
-
3. How to use Exembol
-
4. Possible side effects
-
5. How to store Exembol
-
6. Contents of the pack and other information
1. what exembol is and what it is used for
Exembol is an anticoagulant (a drug that helps to prevent blood clots from forming in your blood circulation). It works by blocking the action of thrombin, a substance in your blood that is important in blood clotting.
Exembol is used if you are suffering from a disorder known as heparin-induced thrombocytopenia type II (HIT type II). If you have HIT type II, you are at risk of developing blood clots in your blood circulation that can cause heart attacks, stroke, breathing problems and problems with the blood supply to your limbs. Exembol can prevent these problems or prevent them from becoming worse.
2. what you need to know before you use exembol
Do not use Exembol
Exembol will not be given to you:
- If you have uncontrolled bleeding
- If you are allergic (hypersensitive) to argatroban or to any of the other ingredients of Exembol
- If you have severely impaired liver function
Warnings and precautions
Exembol will be given to you with special care:
- If there is an increased risk of bleeding
- If you have recently had injections or infusions of other anticoagulants such as heparin
- If you have liver disease
Children and Adolescents
It is not advised to give this medicine to children or adolescents as the safe or effective dose of Exembol has not been clearly established.
Other medicines and Exembol
Please tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without prescription.
Combined use with other blood thinning or blood clot dissolving medicines can increase the risk of bleeding. Because Exembol contains ethanol, this can influence the effect of other medicines containing metronidazole (for infections) or disulfiram (for alcoholism).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before Exembol is given to you.
As a precautionary measure, it is preferable to avoid the use of Exembol during pregnancy.
Avoid breast-feeding while you are being given Exembol (see also “Exembol contains alcohol").
Driving and using machines
Since Exembol contains alcohol you should not drive a car or use machines in connection with the treatment (see also “Exembol contains alcohol").
Exembol contains alcohol
This product contains 4 mg/ml or 0.5% by volume of alcohol (ethanol). The daily dose may therefore contain up to 5 ml (4 g) of alcohol, corresponding to 100 ml beer or 40 ml wine. This may be harmful for persons suffering from liver disease, alcoholism or epilepsy as well as for pregnant and nursing women and their children. This may also influence the effect of other medicines.
Exembol contains sorbitol
If you are intolerant to certain sugars, you must tell your doctor.
Exembol contains sodium
This medicinal product contains 3.6 mg sodium per ml, to be taken into consideration by patients on a controlled sodium diet.
3. how to use exembol
Exembol will always be given to you by medical personnel. Exembol will be given to you intravenously (into a vein) by continuous infusion. The doctor will decide the dose and how long you will be treated.
4. possible side effects
Like all medicines, Exembol can cause side effects, although not everybody gets them.
The most common side-effects are bleeding. Major bleeding can occur in about 5% of patients and minor bleeding in about 39% of patients. You must tell your doctor immediately if you experience any of the following symptoms:
- bleeding or bruising,
- blood in urine or stools
- vomiting or coughing up blood
- black stools
- difficulty in breathing
- cold sweaty skin
- dry mouth
- dilated pupils and/or weak rapid pulse.
These symptoms could indicate that you are experiencing bleeding problems.
Common side effects (may affect up to 1 in 10 people):
- anaemia
- blood clotting
- bleeding, including numerous small bleedings in skin and mucus membranes (purpura)
- nausea
Uncommon side effects (may affect up to 1 in 100 people):
- infections such as urinary tract infection
- changes in blood values
- blood clotting
- lack of appetite
- low blood sugar levels
- low sodium levels in the blood
- confusion
- dizziness
- fainting
- headache
- stroke
- muscle disorders
- speech disorder
- vision problems
- deafness
- heart attack
- fluid in the heart sac
- abnormal heart rhythm
- fast heartbeat
- low blood pressure
- high blood pressure
- inflammation of veins
- shock
- reduced oxygen supply to the tissues
- breathing difficulties
- fluid around the lungs
- hiccup
- blood in cough, vomit or stools
- constipation
- diarrhoea
- stomach inflammation
- difficulty in swallowing
- tongue disorder
- abnormal liver function
- jaundice (yellowing of the skin and eyes)
- changes in blood tests for liver function
- rash including including nettle rash
- itching
- increased sweating
- hair loss
- muscle weakness
- muscle pain
- kidney failure
- fever
- pain
- tiredness
- injection site reactions
- swelling of the legs
- increased wound drainage
- abnormal laboratory results.
5. how to store exembol
Keep this medicine out of the sight and reach of children. Keep vial in the outer carton in order to protect from light.
Do not refrigerate or freeze.
The solution should be used immediately after opening.
In-use the solution should not be exposed to direct sunlight.
Solutions should not be used if they are cloudy or contain any particles.
Do not use Exembol after the expiry date which is stated on the carton/vial after “EXP". The expiry date refers to the last day of that month.
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 protect the environment.
6. contents of the pack and other information
What Exembol contains
The active substance is argatroban monohydrate 1 mg/ml.
1 ml solution for infusion contains 1 mg argatroban monohydrate.
1 vial with 50 ml solution for infusion contains 50 mg argatroban monohydrate.
The other ingredients are anhydrous ethanol, sorbitol, sodium chloride and water for injections.
This medicinal product must not be mixed with other medicinal products.
What Exembol looks like and contents of the pack
This medicinal product is a clear colourless to pale yellow solution for infusion. Each vial contains 50 ml of solution and the vials are packed in cardboard boxes of 4 or 12 vials.Not all pack sizes may be marketed.
Marketing authorisation holder
Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom.
Manufacturer
Tjoapack Netherlands B.V., Nieuwe Donk 9, Etten-Leur, 4879AC, Netherlands.
This medicinal product is authorised in the Member States of the eEa under the following names:
Austria Argatra
Germany Argatra
France Arganova
Sweden Novastan
United Kingdom Exembol
This leaflet was last revised in: April 2019
The following information is intended for healthcare professionals only.
Instructions for use, handling and disposal
Exembol 1 mg/ml Solution for Infusion is ready to use and requires no dilution before administration. It is recommended for use with a syringe driver to control the rate of administration.
The drug product is unpreserved and intended for single use only. The solution should be used immediately after opening. Any unused solution should be discarded.
If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded.
Light resistant measures such as foil protection for intravenous lines are not necessary. No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing.
Any unused product or waste material should be disposed of in accordance with local requirements.
| ARTWORK DETAILS | |
| Customer | Mitsubishi Tanabe Pharma Europe Ltd |
| Product Name | Exembol PIL – RTU |
| Market | United Kingdom – (UK) |
| Language/s | English |
| QRD Doc Ref. | rtu-pil-UK-tracked.doc |
| Client Job No.: | N/A |
| Item Code | PXXXX |
| Manufacturer Code | |
| PD Ref. | PD-UK-RTU-PIL-v09 – (** to follow final proof ) |
| Issue | 09 |
| Date | 08 May 2019 |
| SPECIFICATION DETAILS | |
| Origination | 10 November 2014 — (as Issue 01) |
| Dimensions | 200 × 300 mm |
| Border | 5 mm |
| Pharmacode No. | N/A |
| Font details | Main title: (custom EPS graphic) Sub-titles: Frutiger LT Std – 75 Black — 11 pt Body copy: Frutiger LT Std – 55 Roman — 9 pt |
| Colours | Black – K |