Intraline One

Indications Used to Treat:

Medium Wrinkles
Marionette Lines
Nasolabial Folds
Cupid's Bow
Oral Commissures
Lip Enhancement

Total HA Concentration 20 MG/ML 
Average Sphere Size M
Cross Linking BDDE (<1 UG/ML)
Level of Injection Mid-Dermis
Packaging 1 X 1.0ML Glass Syringe with 2 X Disposable Sterile Needles
Volume 1.0ML
Needle Brand Terumo
Needle Size 27G
Duration Up to 12 Months*

Intraline Two

Indications used to Treat:

Deep-set Wrinkles 
Facial Contouring 
Lip Enhancement 
Marionette Lines 
Nasolabial Folds 
Chin & Jaw Line 
Oral Commissures

 

Total HA Concentration 20 MG/ML 
Average Sphere Size L
Cross Linking BDDE (<1 UG/ML)
Level of Injection Mid-Dermis
Packaging 1 X 1.0ML Glass Syringe with 2 X Disposable Sterile Needles
Volume 1.0ML
Needle Brand Terumo
Needle Size 27G
Duration Up to 12 Months*

For digital version of Intralines Instructions For Use for Intraline One and Intraline Two please click here.

The digital version is translated into 11 languages (English, Swedish, German, French, Italian, Spanish, Portuguese, Polish, Russian, Arabic, and Thai) or please see below for the English version.

Instructions For Use
Intraline One / Intraline Two

Preparation Intraline One Intraline Two
Contents:
Sodium Hyaluronate, Cross-Linked 20 mg/ml 20 mg/ml
Sodium Chloride Solution q.s. q.s.
Physiological Buffer q.s. q.s.

Description

Intraline One and Intraline Two are transparent, injectable implants in the form of a viscous, sterile, non-pyrogenic gel. Intraline One and Intraline Two are composed of cross-linked sodium hyaluronate of non-animal origin.

Intraline One and Intraline Two are 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 One is intended for treatment of moderate wrinkles and lip enhancement. The product should be injected intradermally through a needle into mid dermis.

Intraline Two 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 One and Intraline Two 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 One and Intraline Two 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 One and Intraline Two with other products or inject the products into the blood stream.

- Do not inject Intraline One and Intraline Two 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 One or Intraline Two on patients with infections or inflammations in the intended injection area.

- Please notice that injections of Intraline One or Intraline Two 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 One and Intraline Two have not been tested on pregnant or breast-feeding women or on children

Contraindications

- Intraline One and Intraline Two 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 One and Intraline Two must not be administered to patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.

Patient Information

- After treatment with Intraline One and/or Intraline Two, 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 One and Intraline Two break 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 intradermally into the dermis under the wrinkle or fold, increasing volume and adding lift and shape. When correcting wrinkles and folds, although they will be smoothed out, the line will always remain.

- The result of the treatment is based on using a correct injection technique. Intraline One and Intraline Two must therefore only be administered by authorized personnel in accordance with local legislation.

- The expected results of treatment must be assessed for each patient individually. Patients with unrealizable expectations should not be subject to treatment.

- The patient’s medical background should always be checked before treatment in order to ensure that there are no contraindications. The patient should be informed about the indications, contraindications as well as warnings and precautions.

- The need for any pain relief should be determined.

- In order to achieve and sustain the maximum desired result, the patient should be informed of the need for additional treatment(s).

Directions before and during treatment:

- For information on how to assemble the needle and syringe, please see below.

- To avoid the risk of infection during implant, ensure that the skin has been completely disinfected with alcohol, or other antiseptic solution. Standard practice to prevent infections is always to be exercised.

- Do not inject the products too deep as this will shorten the effect of the application.

- Do not inject the products too superficially as this may result in visible lumps and/or discoloration of the skin.

- Inject slowly into the dermis while pulling the needle backwards.

- Complete the injection a couple of millimetres before the entry point in the skin to prevent material from leaking out of the injection site.

- Correction should only be made to 100% of the desired volume effect. Do not over-correct.

- It is recommended to change needle/cannula for each new treatment site.

- For each treatment site a maximum dosage of 2 ml per treatment session is recommended.

- Following an injection of Intraline One or Intraline Two, the skin may be lightly massaged to encourage the product to follow the contours of the surrounding tissue.

- If stored below room temperature, allow product to equilibrate to room temperature for at least 20 minutes prior to use.

Disposal and single use:

- The syringe, needle and any unused material must be discarded immediately after the treatment.

- No material remaining after treatment may be used for more than one patient, be saved or be re-sterilized.

- Disposal should be in accordance with accepted medical practice and applicable national or local laws and guidelines.

N.B. ANY ADVERSE EVENTS MUST BE REPORTED TO THE LOCAL DISTRIBUTOR OR DIRECTLY TO THE MANUFACTURER.

Assembly of Needle and Syringe
To avoid separation of the needle and syringe during implant, please notice the following instructions:

- Remove the tip cap as displayed (pictures 1 and 2).

- Mount the needle by using the thumb and forefinger (3) to hold firmly around both the glass syringe barrel and the luer-lock adapter, grasp the needle, (still inside the needle protector) with the other hand (3).

- To facilitate proper assembly, both push and rotate firmly (4).

- Remove the needle protector in a straight, forward motion (5). Strict aseptic technique must be performed at all times.

Storage and Shelf Life

- Store the products at a temperature of 2-25 °C (36-77 °F).

- The products must not freeze.

- Keep out of direct sunlight.

- The expiry date of the product is indicated on the package.

Manufactured By
Bohus BioTech AB, Trädgårdsgatan 4, SE-452 31 Strömstad, Sweden
Website: www.bohusbiotech.com
E-mail: info(at)bohusbiotech.com

DISTRIBUTED BY INTRALINE® Pte Ltd.
Tele: 1.855.381.3286
Website: www.intraline.com
E-mail: info(at)intraline.com