Instructions for use of Rigvir

Before taking the drug, please read carefully the entire insert as it contains important information for you:

  • Keep this insert! You may need to reread it later.
  • If you have any questions, please ask your doctor or pharmacist.
  • This drug has been prescribed for you only. Do not give it to others. It may harm them, even if they have similar signs of disease.
  • If you experience any side effects, talk to your doctor or pharmacist. It also refers to any possible side effects not listed in this insert. See item 4.

This insert contains the following information:

  1. What Rigvir is and what it is used for
  2. What you need to know prior to taking Rigvir
  3. How to take Rigvir
  4. Possible side effects
  5. How to store Rigvir
  6. The content of the package and other information

1. What Rigvir is and what it is used for:

Rigvir belongs to the groups of drugs called immunomodulators.

Rigvir is a viral immunomodulator with antitumoral effect. Rigvir is taken:

  • for melanoma treatment, topical treatment of cutaneous and subcutaneous metastases of melanoma, prevention of relapses and metastases after radical surgery.

2. What you need to know prior to taking Rigvir

Do not take Rigvir in the following cases:

  • during radiation therapy and chemotherapy.
  • in case of an acute infection.

The long-term physical load should be restricted after Rigvir injection in order to avoid inhibition of body reaction to Rigvir immune stimulating effect.

Other drugs and Rigvir

Tell your doctor about all the drugs you are taking or have recently taken, including drugs bought over the counter.

Rigvir is not recommended for use along with other drugs in order to avoid inhibition of body reaction to Rigvir immune stimulating effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, if you think you may be pregnant or planning to become pregnant, please consult your doctor before taking this drug.

There are no data about Rigvir use during pregnancy, therefore Rigvir should not be taken during pregnancy unless your doctor thinks it is absolutely necessary.

It is unknown whether Rigvir is excreted in human milk. Breastfeeding is forbidden during Rigvir therapy.

Rigvir administration and food

There are no restrictions on food and beverage use during Rigvir therapy if your doctor has not prescribed you a special diet. During Rigvir therapy you should avoid alcohol because Rigvir therapy is inefficient when combined with alcohol.

Driving and using machines

Rigvir does not affect the ability to drive and use machines.

Sodium content in Rigvir

This drug contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially sodium-free.

3. How to take Rigvir

Always use Rigvir exactly as prescribed by your doctor. In case of doubt please ask your doctor.

Each vial contains one dose.

The drug should be administered by intramuscular (i.m.) injection.

Regular blood count and immunological indicator follow-up are required during its use; immunologist’s consultation is recommended.

Use in children and adolescents

Clinical trials in children have not been performed. Children under 18 years should not take Rigvir.

Elderly patients and patients with renal and hepatic impairments

There is no need to adapt the doses for elderly patients and patients with renal and/or hepatic impairments.

If you forgot to take Rigvir

If you forgot to take Rigvir, please contact your attending physician to find out how to continue taking Rigvir.

If you have any questions about the use of this drug, please ask your doctor.

4. Possible side effects

Like any drug, Rigvir may cause side effects, although they do not manifest in all patients.

The following classification of frequency is used for side effect assessment:

4. Possible side effects

After Rigvir administration the patient may experience short-term (1-3 days) increase in body temperature (37.0 ‑37.5 °C). Drowsiness, fatigue, dyspepsia (diarrhoea) and pain in the area of the tumour is experienced very rarely during the treatment. Side effects are temporary and do not require special treatment.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. It also refers to any possible side effects not listed in this insert. You can also report side effect directly to the State Agency of Medicines of the Republic of Latvia at Jersikas iela 15, Riga, LV-1003. Phone: +371 67078400; Fax: +371 67078428. Web site: www.zva.gov.lv .

By reporting the side effect, you can help provide more information about the drug safety.

5. How to store Rigvir

Store in a freezer (-20 ± 2 °C).

To be transported frozen.

Keep out of reach and sight of children.

Do not use this drug after the expiry date stated on the label and the package: Expiry date

The expiry date refers to the last date of the indicated month.

Do not dispose of drug into sewer lines or household waste. Ask your pharmacist how to dispose of the drug you no longer use.

6. Content of the package and other information

What Rigvir contains:
Active substance is Rigvir ECHO-7 virus strain.
One vial contains 2 ml Rigvir with titre ≥106 TCID50/ml.
Excipients: sodium chloride, water for injections, MEM medium traces: minerals, amino acids, vitamins.

Rigvir appearance and packaging:

6 ml vial with 2 ml frozen solution.

After thawing at room temperature (the vial may be heated in hands), the solution is clear, colourless or slightly pink.

Marketing Authorisation Holder: SIA Latima, Teātra iela 9-9, Rīga, LV-1050, Latvia, Phone: +371-29839806, e-mail: rigvir@rigvir.lv

Manufacturer for SIA Latima: AS Kevelt, Teaduspargi 3/1, Tallinn, EE‑12618, Estonia.

The date of the last revision of this package insert: 5 Jan. 2017