Intraline For Men is transparent, injectable implants in the form of a viscous, sterile, non-pyrogenic gel.
Intraline For Men is composed of cross-linked sodium hyaluronate of non-animal origin.
Intraline For Men is supplied in a graded, disposable, 1.0ml glass syringe.
The product is for single use only.
Two disposable sterile needles are provided with each syringe.
Information about the needle size and sterilization method can be found on the outer package of the needle.
The volume in each syringe is stated on the outer package.
Two patient record labels will be included in each package to ensure product traceability.
Indications Intraline For Men is intended for treatment of deep wrinkles and folds, and facial tissue augmentation.
The product should be injected intradermally through a needle into the deep layer of the dermis and/or the surface layer of the subcutis.
Warnings and Precautions - Always observe the general precautions applicable to intradermal injections.
- Intraline For Men contain traces of BDDE (1,4-butanediol diglycidyl ether, less than 0.0001%) used as cross-linking agent, which in rare cases can cause irritation to the dermis.
- Intraline For Men may only be used as an intradermal implant by properly trained, qualified physicians or the authorized staff members in accordance with national legislation.
- The customary intradermal injection technique must be used.
- Ensure that the integrity of the syringe and needle has not been compromised and check the expiry date prior to use.
- Do not mix Intraline For Men with other products or inject the products into the blood stream.
- Do not inject Intraline For Men directly adjacent to a permanent implant or in connection with other on-going or planned skin treatments, e.g.
laser treatment, in the same area.
- Do not use Intraline For Men on patients with infections or inflammations in the intended injection area.
- Please notice that injections of Intraline For Men can reactivate a latent herpes simplex virus or cause angioedematype swelling.
- If using substances that may have an effect on the platelet function, such as anti-inflammatory drugs or aspirin, the patient may to a larger extent experience bruising or bleeding at injection sites.
- Intraline For Men has not been tested on pregnant or breast-feeding women or on children Contraindications - Intraline For Men must not be administered to patients with any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
- Intraline For Men must not be administered to patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.
Patient Information - After treatment with Intraline For Men, undesirable short-term reactions may occur at the injection site, such as pain, tenderness, redness or swelling.
The reactions normally appear shortly after treatment and may last up to 7 days for injections into the skin and up to 14 for injection into the lips.
If the patient should experience the discomfort as severe or if the site gives rise to other conditions, such as oedema or prolonged swelling, contact the physician who administered the treatment.
- Intraline For Men breaks down naturally over time and are reabsorbed by the surrounding tissue. Durability varies with the patient and the site of the implant.
- The patient must not expose the treated area to extreme temperatures (e.g.cold, heat, sun bathing, solarium etc.) during the first week after treatment or until any undesirable reactions have fully healed.
Strenuous exercise should be avoided within the first day or two following application.
- The patient should be informed not to apply make-up prior to, and up to at least 12 hours after, treatment.
Directions For Use N.B.
DO NOT USE THE PRODUCT IF THE PACKAGE HAS BEEN OPENED OR DAMAGED! General Directions: - Strict aseptic technique must be performed at all times.
- The products are to be injected intrad
|Country Origin||This product is of European origin|