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Bitalshin 100 mg/mL Injection

NAFDAC Reg. No. A4-101140 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Bitalshin 100 mg/mL Injection
NAFDAC number
A4-101140
Active ingredient
Phenobarbital
Strength
100 mg/mL
Form
Solution for injection
Pack size
1 mL x 100's (in amber glass ampoules)
Manufacturer
Not listed
Applicant (holder)
Shinfield Pharmaceuticals Limited
Approved
18 Dec 2024
Status
Active View on NAFDAC ↗
Registration valid to
17 Dec 2029
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Bitalshin 100 mg/mL Injection is on the NAFDAC register with an active registration (A4-101140). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Bitalshin 100 mg/mL Injection is used for

From the official U.S. FDA label for phenobarbital, the active ingredient registered with NAFDAC.

What it is used for

Sedative Anticonvulsant- For the treatment of generalized and partial seizures.

Possible side effects

The following adverse reactions have been reported: CNS Depression- Residual sedation or "hangover," drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children. Like other nonanalgesic hypnotic drugs, barbiturates such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. …

Do not use if

Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.

Warnings

1. Habit-Forming Phenobarbital may be habit-forming. Tolerance and psychological and physical dependence may occur with continued use ( see Drug Abuse and Dependence and Pharmacokinetics under Clinical Pharmacology ). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. …

Pregnancy & breastfeeding

3. Usage in Pregnancy Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver and brain. …

Storage

STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68° -77°F). [See USP]

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Bitalshin 100 mg/mL Injection

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Bitalshin 100 mg/mL Injection

What is in Bitalshin 100 mg/mL Injection?

Bitalshin 100 mg/mL Injection contains Phenobarbital (100 mg/mL), as solution for injection, according to its NAFDAC registration record.

Is Bitalshin 100 mg/mL Injection registered with NAFDAC?

Yes. Bitalshin 100 mg/mL Injection is listed on the NAFDAC register under registration number A4-101140, and its registration is active as of 5 November 2026.

Has Bitalshin 100 mg/mL Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Bitalshin 100 mg/mL Injection in our automatically synced alert list.

How can I check that my pack of Bitalshin 100 mg/mL Injection is genuine?

Run a free authenticity scan with the NAFDAC number A4-101140, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Bitalshin 100 mg/mL Injection used for?

Sedative Anticonvulsant- For the treatment of generalized and partial seizures. (Summarised from the official U.S. FDA label for phenobarbital. Always follow your doctor or pharmacist.)

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