10 mg / ml injection solution
of sodium hyaluronate
1. What Hyalgan is and what it is used for
Hyalgan contains sodium hyaluronate, which is a body-specific substance that is found in the body’s joints, among other things. In the case of joint wear and tear ( osteoarthritis ), the levels of sodium hyaluronate in the synovial fluid fall. By injecting the substance directly into the joint, the body is stimulated to produce more sodium hyaluronate.
Hyalgan is used to treat mild to moderate osteoarthritis of the knee joint. The drug reduces pain and improves joint function. The effect lasts for a few months.
2. What you need to know before using Hyalgan
Do not use Hyalgan
- if you are allergic to sodium hyaluronate or any of the other ingredients of this medicine (listed in section 6).
- if the bone to be injected has a reduced outflow of blood or lymph .
- if you are allergic to chicken protein.
Warnings and cautions
- If your skin in the injection site is infected or affected by another disease.
- If your knee joint is severely inflamed.
- Hypersensitivity reactions may occur, but as the product is highly purified, it is very uncommon.
- Injection must be given in a careful and hygienic manner to minimize the risk of infection .
- Before treatment with Hyalgan, any excess synovial fluid should be removed.
- Hyalga must not be injected into blood vessels.
- Experience of treating children is lacking.
- One should avoid strenuous physical activity and carrying heavy hours after injection one.
- Hyalgan should also not be used at the same time as disinfectants that contain so-called quaternary ammonium salts, as these can destroy the active substance.
Talk to your doctor, pharmacist, or nurse before using Hyalgan.
Other medicines and Hyalgan
Hyalgan should not be injected into the knee joint at the same time as any other drug is injected into the same joint, as there is no experience of this.
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.
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.
Pregnancy: Experience with Hyalgan during pregnancy is limited.
Breast-feeding: Sodium hyaluronate passes into breast milk but is unlikely to affect the baby.
Driving and using machines
Hyalgae can in rare cases cause pain and swelling in the knee. This can affect safety when driving a vehicle.
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.
Hyalgan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.
3. How to use Hyalgan
Hyalgae will be given to you by healthcare professionals, as an injection into the knee joint. Ask your doctor or pharmacist if you are unsure.
If you use more Hyalgan than you should
If you have received too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (affects less than 1 user in 1,000):
Local reactions: pain, vomiting, swelling, irritation, inflammation , redness , reduced joint mobility, discomfort, feeling hot, hypersensitivity, itching , rash.
Very rare (affects less than 1 user in 10,000):
Local reactions: bleeding, lump, lump, numbness, blistering, inflammation of the joint capsule or joint, joint stiffness, infection in the joint, (severe) hypersensitivity reactions , various types of skin rashes and redness, eczema , itching , hives . General fever, fever, serum sickness ( delayed hypersensitivity reaction such as itching , rash, fever, joint pain and fatigue), various types of swelling such as swelling of the oral and throat mucosa and face.
Stop taking Hyalgan and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hyalgan
Do not store above 25 ° C. Store in the original package. Sensitive to light.
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 carton after EXP. dat. The expiration date is the last day of the specified month.
Medicines 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.
6. Contents of the packaging and other information
- The active substance is sodium hyaluronate 10 mg / ml.
- The other ingredients are sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
What the medicine looks like and contents of the pack
Hyalgan injection is a clear and viscous solution.
Vial glass with rubber stopper and aluminum seal: 1×2 ml (unit dose), 5×2 ml (single dose).
Pre-filled syringe in glass with plastic flask and rubber seal: 1×2 ml (single dose), 5×2 ml (single dose).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Takeda Pharma AB
Vasagatan 7, 6 tr
111 20 Stockholm
Tel. 08-731 28 00