Hyalgan 20 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Hyalgan 20 mg injectable solution in pre-filled syringe
Sodium hyaluronate
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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Hyalgan is and what it is used for
- What you need to know before using Hyalgan
- How to use Hyalgan
- Possible side effects
- How to store Hyalgan
- Contents of the pack and other information
1. What Hyalgan is and what it is used for
Hyalgan belongs to a group of medicines called other medicines for musculoskeletal system disorders.
This medicine is used for the symptomatic treatment of knee osteoarthritis.
2. What you need to know before using Hyalgan
Do not use Hyalgan
- If you are allergic to hyaluronic acid or to any of the other ingredients of this medicine listed in section 6.
- If you are allergic (hypersensitive) to proteins derived from birds, feathers, or egg products.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Hyalgan.
- If joint effusion (knee swelling) is observed, your doctor should drain it before injecting this medicine.
- If possible signs of acute inflammation are detected.
- In patients with infection or skin disorders at or near the injection site.
- The use of this medicine with disinfectants containing quaternary ammonium salts is not recommended.
- Avoid overloading the treated joint immediately after treatment.
- The injection technique must be performed under aseptic conditions to prevent possible infections at the administration site.
Children
Use in children is not recommended due to lack of data on safety and efficacy.
Use of Hyalgan with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not use together with quaternary ammonium salts, as they may cause precipitation of hyaluronic acid.
Mixing or simultaneous administration with other intra-articular drugs is not recommended.
Use with local anesthetics such as lidocaine or bupivacaine may result in prolonged anesthetic effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are insufficient data on its use in pregnant or breast-feeding women.
It should not be used during pregnancy or breast-feeding unless strictly necessary.
Driving and use of machines
No effects on the ability to drive or operate machinery have been reported.
Hyalgan contains sodium; this medicine contains less than 1 mmol of sodium (23 mg) per 2 ml pre-filled syringe; therefore, it is essentially “sodium-free”.
3. How to use Hyalgan
This medicine will only be administered by experienced medical personnel at your clinic.
This medicine is administered by intra-articular route.
Your doctor will determine the duration of your treatment, although the usual recommended dose is one intra-articular injection once a week for five consecutive weeks, following the injection technique described below.
Dose adjustment is not necessary in elderly patients.
The injection site must be carefully cleaned with an antiseptic to ensure sterility. Remove any air bubbles from the syringe before administering Hyalgan.
The injection must be performed exactly into the intra-articular space of the affected knee. Administration will be performed at the most accessible injection site. A lateral site is generally chosen, but in some cases an anterior site may be preferable.
If synovial fluid accumulation is observed prior to injecting the medicine, it should be drained by arthrocentesis (removal of synovial fluid) using a 20G needle until no more synovial fluid can be withdrawn, without compromising the accuracy of the subsequent intra-articular injection of the medicine. The fluid withdrawn should be examined and bacterial infection ruled out before injection.
The medicine may be injected through the same needle used for arthrocentesis, by removing the aspiration syringe and attaching the syringe containing the hyaluronic acid solution.
To confirm correct needle placement, a small amount of synovial fluid should be aspirated before slowly injecting the medicine. If the patient experiences pain during injection, the doctor will stop the procedure and assess whether to continue treatment.
After administration, passive flexion-extension movements are recommended to ensure better intra-articular distribution of the medicine.
Keep the treated knee at rest for the first 48 hours following treatment, avoiding any strenuous or prolonged activity. In the following days, you may gradually return to normal activity.
If you receive more Hyalgan than you should
Since this medicine is administered only by experienced medical personnel at your clinic, it is unlikely that you will receive more than the intended dose.
Nevertheless, if you think you have been given more medicine than you should have, inform your doctor immediately.
If you missed a dose of Hyalgan
Since this medicine is administered only by experienced medical personnel at your clinic, it is unlikely that you will miss a scheduled dose. However, if you believe a dose was missed, inform your doctor immediately.
If you stop treatment with Hyalgan
Symptoms may return, and you may not achieve the desired effects.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Local reactions such as pain, swelling, warmth or redness at the injection site have been reported; these are generally short-lived and resolve spontaneously within a few days by keeping the joint at rest and applying ice to the area. Occasionally, these reactions have been more intense and longer-lasting.
There have also been some reported cases of fever, sometimes associated with the local reactions mentioned above.
In the presence of clear signs of inflammation, intra-articular administration of hyaluronic acid may rarely worsen these symptoms.
Very rare cases of intra-articular infection have been reported (see "How to use Hyalgan").
Rarely, systemic allergic reactions (skin rash, hives, and itching) have been reported.
The adverse effects listed below have been observed in patients receiving this medicine, both in clinical trials and during routine use.
Rare adverse effects (occur in up to 1 in 1,000 patients):
Reactions at the injection site such as: pain, swelling, leakage, irritation, impaired movement of the affected joint, inflammation, redness, rash, discomfort, warmth, itching, hypersensitivity, hives.
Very rare adverse effects (occur in up to 1 in 10,000 patients):
Other reactions at the injection site such as:
Nodules;
Bleeding;
Numbness, tingling;
Blisters;
Sensation of warmth;
Fever;
Synovitis (inflammation of the membrane lining the joints);
Joint stiffness;
Joint inflammation due to infection (septic arthritis or reactive arthritis);
Hypersensitivity;
Urticaria (hives);
Allergic reactions, which in some cases may be severe;
Serum sickness-like illness, similar to an allergic reaction caused by protein-containing medicines.
Other signs and symptoms of allergic reactions such as:
Angioedema (swelling beneath the skin), facial swelling, epiglottis swelling, laryngeal swelling, lip swelling, eyelid swelling;
Generalized rash;
Generalized itching;
Eczema;
Generalized skin redness;
Dermatitis
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Hyalgan
Keep the product in its original packaging, protected from light, and below 25°C. Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the solution is not clear, has changed colour, or contains particles in suspension.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Hyalgan
- The active substance is sodium hyaluronate. Each pre-filled syringe contains 20 mg of sodium hyaluronate.
- The other components are sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Nature and contents of the container
This medicine is presented in pre-filled syringes, packed in cardboard boxes containing 1 or 5 pre-filled syringes with a sterile, pyrogen-free, viscous, transparent solution free from visible particles.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Avda. de Europa 24 - Edificio Torona.
Parque Empresarial "La Moraleja" Edificio A - Oficina 1ºB, 28108
Alcobendas (Madrid)
Spain
Manufacturer:
Fidia Farmaceutici S.p.A.
Vía Ponte della Fabbrica 3/A
35031 Abano Terme (Italy)
Date of the most recent revision of this leaflet: October 2018.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/